[Title 29 CFR ]
[Code of Federal Regulations (annual edition) - July 1, 2023 Edition]
[From the U.S. Government Publishing Office]



[[Page i]]

          
          
          Title 29

Labor


________________________

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

                         Revised as of July 1, 2021

          Containing a codification of documents of general 
          applicability and future effect

          As of July 1, 2021
                    Published by the Office of the Federal Register 
                    National Archives and Records Administration as a 
                    Special Edition of the Federal Register

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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........................     689
      Alphabetical List of Agencies Appearing in the CFR......     709
      Table of OMB Control Numbers............................     719
      List of CFR Sections Affected...........................     721

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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.

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

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                               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 
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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 
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LEGAL STATUS

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[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
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[[Page vii]]

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    Oliver A. Potts,
    Director,
    Office of the Federal Register
    July 1, 2021







[[Page ix]]



                               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, 2021.

    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.

    For this volume, Cheryl E. Sirofchuck was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of John 
Hyrum Martinez, assisted by Stephen J. Frattini.

[[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

[[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.
1910.1024 Beryllium.
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.
1910.1053 Respirable crystalline silica.
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.
1910.1451-1910.1499 [Reserved]



                Subpart Z_Toxic and Hazardous Substances

    Authority: 29 U.S.C. 653, 655, 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), or 5-2007 (72 FR 31159), 
4-2010 (75 FR 55355) or 1-2012 (77 FR 3912), as applicable; and 29 CFR 
part 1911.
    All of subpart Z issued under 29 U.S.C. 655(b), except those 
substances that have exposure limits listed in Tables Z-1, Z-2, and Z-3 
of Sec.  1910.1000. The latter were issued under 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, 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 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 Public Law 106-430, 114 Stat. 
1901.
    Section 1910.1201 also issued under 49 U.S.C. 1801-1819 and 5 U.S.C. 
553.

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

    Editorial Note: Nomenclature changes to part 1910 appear at 84 FR 
21597, May 14, 2019.



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

(2 x 150 + 2 x 75 + 4 x 50) / 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  ............  ...........
 see 1926.1124 \8\.
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

[[Page 10]]

 
Butadiene (1,3-Butadiene); See 29 CFR             106-99-0  1 ppm/5 ppm
 1910.1051; 29 CFR 1910.19(l).                                  STEL
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

[[Page 11]]

 
Chrysene; see Coal tar pitch volatiles.
Clopidol..................................       2971-90-6
    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........

[[Page 12]]

 
Dimethylaniline (N,N-Dimethylaniline).....        121-69-7         5           25      X
Dimethylbenzene; see Xylene.
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.

[[Page 13]]

 
Graphite, natural, respirable dust........       7782-42-5  ............    (\3\)
Graphite, synthetic.......................
    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

[[Page 14]]

 
Methyl acetylene (Propyne)................         74-99-7      1000         1650
Methyl acetylene-propadiene mixture (MAPP)  ..............      1000         1800
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

[[Page 15]]

 
Ozone.....................................      10028-15-6         0.1          0.2
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

[[Page 16]]

 
Selenium hexafluoride (as Se).............       7783-79-1         0.05         0.4
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, respirable dust
    Cristobalite; see 1910.1053 \7\.......      14464-46-1
    Quartz; see 1910.1053 \7\.............      14808-60-7
    Tripoli (as quartz); see 1910.1053 \7\       1317-95-9
    Tridymite; see 1910.1053 \7\..........      15468-32-3
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

[[Page 17]]

 
Thiram....................................        137-26-8  ............        5
Tin, inorganic compounds (except oxides)         7440-31-5  ............        2
 (as Sn).
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]]

 
\7\ See Table Z-3 for the exposure limit for any operations or sectors where the exposure limit in Sec.
  1910.1053 is stayed or is otherwise not in effect.
\8\ See Table Z-2 for the exposure limits for any operations or sectors where the exposure limits in Sec.
  1910.1024 are stayed or otherwise not in effect.


                                                    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) \d\.
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.
\d\ This standard applies to any operations or sectors for which the exposure limits in the beryllium standard,
  Sec.   1910.1024, are stayed or is otherwise not in effect.


                        Table Z-3--Mineral Dusts
------------------------------------------------------------------------
                   Substance                     mppcf \a\     mg/m\3\
------------------------------------------------------------------------
Silica:
  Crystalline
    Quartz (Respirable) \f\...................     250\b\     10 mg/m\3\
                                                                 \e\
                                               -------------------------
                                                 % SiO2 + 5   % SiO2 + 2
  Cristobalite: Use \1/2\ the value calculated
   from the count or mass formulae for quartz
   \f\........................................
  Tridymite: Use \1/2\ the value calculated
   from the formulae for quartz \f\...........
 
Amorphous, including natural diatomaceous                20   80 mg/m\3\
 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
 

[[Page 19]]

 
Coal Dust:
 
  Respirable fraction less than 5% SiO2.......  ...........    2.4 mg/m
                                                               \3\ \e\
 
                                                ...........  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\.
\f\ This standard applies to any operations or sectors for which the
  respirable crystalline silica standard, 1910.1053, is stayed or is
  otherwise not in effect.


[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; 81 FR 16861, Mar. 25, 2016; 81 FR 31167, May 18, 
2016; 81 FR 60272, Sept. 1, 2016; 82 FR 2735, Jan. 9, 2017]



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.

[[Page 20]]

    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 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

[[Page 21]]

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, 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.

[[Page 22]]

    (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 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.

[[Page 23]]

    (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 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

[[Page 24]]

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.
    (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) The employer shall ensure that 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, bear 
labels in accordance with paragraph (j) 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) The employer shall ensure that contaminated clothing is 
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

[[Page 25]]

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 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) Hazard communication--general. (i) Chemical manufacturers, 
importers, distributors and employers shall comply with all requirements 
of the Hazard Communication Standard (HCS) (Sec.  1910.1200) for 
asbestos.
    (ii) In classifying the hazards of asbestos at least the following 
hazards are to be addressed: Cancer and lung effects.
    (iii) Employers shall include asbestos in the hazard communication 
program established to comply with the HCS (Sec.  1910.1200). Employers 
shall ensure that each employee has access to labels on containers of 
asbestos and to safety data sheets, and is trained in accordance with 
the requirements of HCS and paragraph (j)(7) of this section.
    (2) 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

[[Page 26]]

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.
    (3) 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 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.
    (4) 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)(4)(i) of this 
section shall bear the following legend:

DANGER
ASBESTOS
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
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:

WEAR RESPIRATORY PROTECTION AND PROTECTIVE CLOTHING IN THIS AREA

    (C) Prior to June 1, 2016, employers may use the following legend in 
lieu of that specified in paragraph (j)(4)(ii)(A) of this section:

DANGER
ASBESTOS
CANCER AND LUNG DISEASE
HAZARD
AUTHORIZED PERSONNEL ONLY

    (D) Prior to June 1, 2016, employers may use the following legend in 
lieu of that specified in paragraph (j)(4)(ii)(B) of this section:

RESPIRATORS AND PROTECTIVE CLOTHING ARE REQUIRED IN THIS AREA

    (iii) The employer shall ensure that employees working in and 
contiguous to regulated areas comprehend the warning signs required to 
be posted by paragraph (j)(4)(i) of this section. Means to ensure 
employee comprehension may include the use of foreign languages, 
pictographs and graphics.
    (iv) 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.
    (5) Warning labels--(i) Labeling. 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

[[Page 27]]

who are likely to be exposed, such as at the entrance to mechanical 
room/areas. Signs required by paragraph (j) of this section may be 
posted in lieu of labels so long as they contain the information 
required for labeling.
    (ii) Label specifications. In addition to the requirements of 
paragraph (j)(1), the employer shall ensure that labels of bags or 
containers of protective clothing and equipment, scrap, waste, and 
debris containing asbestos fibers include the following information:

DANGER
CONTAINS ASBESTOS FIBERS
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
DO NOT BREATHE DUST
AVOID CREATING DUST

    (iii) Prior to June 1, 2015, employers may include the following 
information on raw materials, mixtures or labels of bags or containers 
of protective clothing and equipment, scrap, waste, and debris 
containing asbestos fibers in lieu of the labeling requirements in 
paragraphs (j)(1)(i) and (j)(5)(ii) of this section:

DANGER
CONTAINS ASBESTOS FIBERS
AVOID CREATING DUST
CANCER AND LUNG DISEASE HAZARD

    (6) The provisions for labels and for safety data sheets required by 
paragraph (j) 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 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

[[Page 28]]

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
    (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.

[[Page 29]]

    (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 14- by 17-inch or 
other reasonably-sized standard film or digital posterior-anterior chest 
X-ray; pulmonary function tests to include forced vital capacity (FVC) 
and forced expiratory volume at 1 second (FEV1); and any 
additional tests deemed appropriate by the examining physician. 
Classification of all chest X-rays 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 X-rays shall be conducted in 
accordance with Table 1 to this section, and the abbreviated 
standardized questionnaire contained in part 2 of appendix D to this 
section shall be administered to the employee.

                              Table 1 to Sec.   1910.1001--Frequency of Chest X-ray
----------------------------------------------------------------------------------------------------------------
                                                                 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

[[Page 30]]

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 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 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.

[[Page 31]]

    (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 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 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. The employer shall comply with the 
requirements concerning transfer of records set forth in 29 CFR 
1910.1020(h).
    (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.

[[Page 32]]

    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 10x eyepiece and a 40 to 45x objective for a 
total magnification of approximately 400x 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.
    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

[[Page 33]]

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

    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,

[[Page 34]]

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 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

[[Page 35]]

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 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:

[[Page 36]]



------------------------------------------------------------------------
                 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 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.

[[Page 37]]

                        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 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.

[[Page 38]]

    (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 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

[[Page 39]]

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 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

[[Page 40]]

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:

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.
------------------------------------------------------------------------


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                Appendix C to Sec.  1910.1001 [Reserved]

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

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Appendix E to Sec.  1910.1001--Classification of Chest X-Rays--Mandatory

    (a) Chest X-rays shall be classified in accordance with the 
Guidelines for the use of the ILO International Classification of 
Radiographs of Pneumoconioses (revised edition 2011) (incorporated by 
reference, see Sec.  1910.6), and recorded on a classification 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 through 4) shall be 
included. This form is not to be submitted to NIOSH.
    (b) All X-rays shall be classified only by a B-Reader, a board 
eligible/certified radiologist, or an experienced physician with known 
expertise in pneumoconioses.
    (c) Whenever classifying chest X-ray film, the physician shall have 
immediately available for reference a complete set of the ILO standard 
format radiographs provided for use with the Guidelines for the use of 
the ILO International Classification of Radiographs of Pneumoconioses 
(revised edition 2011).

[[Page 59]]

    (d) Whenever classifying digitally-acquired chest X-rays, the 
physician shall have immediately available for reference a complete set 
of ILO standard digital chest radiographic images provided for use with 
the Guidelines for the Use of the ILO International Classification of 
Radiographs of Pneumoconioses (revised edition 2011). Classification of 
digitally-acquired chest X-rays shall be based on the viewing of images 
displayed as electronic copies and shall not be based on the viewing of 
hard copy printed transparencies of images.

 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 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)(5) 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

[[Page 60]]

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 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.

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    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 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, and may also show asbestosis 
(i.e., small irregular parenchymal opacities). Symptoms characteristic 
of mesothelioma include shortness of breath, pain in the chest or 
abdominal pain. Mesothelioma has a much longer average 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 a fatal 
disease.
    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 most commonly based on a history of exposure to asbestos, 
the presence of characteristic radiologic abnormalities, end-inspiratory 
crackles (rales), and other clinical features of fibrosing lung disease. 
Pleural plaques and thickening may be observed on chest X-rays. 
Asbestosis is often a progressive disease even in the absence of 
continued exposure, although this

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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 in section III of this appendix, 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 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 of this section.
    (iii) A physical examination including a chest X-ray 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 the standard in this section (including all 
appendices to this section); a description of the employee'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.

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    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 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                   (Mg,Fe)7 Si8 O22(OH)2
 (Amosite)..............................
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.

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    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 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

[[Page 65]]

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 
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

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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.

                   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.

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                         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.

                               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 Safety data sheet (SDS).

                             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 1 x 3 inches 1mm 
thick, precleaned.
    (k) Cover Slips 22 x 22 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

[[Page 68]]

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.

    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

[[Page 69]]

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.
    (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 70]]

[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 71]]

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 40 x 
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 400 x . 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 72]]

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 160 x 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 2.99 x 10\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 73]]

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 74]]

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 75]]

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 76]]

    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]

    Editorial Note: For Federal Register citations affecting Sec.  
1910.1001, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



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 
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

[[Page 77]]

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-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.

[[Page 78]]

    (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) Employers must provide each employee engaged in handling 
operations involving the carcinogens 
4-Nitrobiphenyl, alpha-Naphthylamine, 3,3'-Dichlorobenzidine (and its 
salts), beta-Naphthylamine, Benzidine, 
4-Aminodiphenyl, 
2-Acetylaminofluorene, -Dimethylaminoazo-benzene, and 
N-Nitrosodimethylamine, addressed by this section, with, and ensure that 
each of these employees wears and uses, a NIOSH-certified air-purifying, 
half-mask respirator with particulate filters. Employers also must 
provide each employee engaged in handling operations involving the 
carcinogens methyl chloromethyl ether, bis-Chloromethyl ether, 
Ethyleneimine, and beta-Propiolactone, addressed by this section, with, 
and ensure that each of these employees wears and uses any self-
contained breathing apparatus that has a full facepiece and is operated 
in a pressure-demand or other positive-pressure mode, or any supplied-
air respirator that has a full facepiece and is operated in a pressure-
demand or other positive-pressure mode in combination with an auxiliary 
self-contained positive-pressure breathing apparatus. Employers may 
substitute a respirator affording employees higher levels of protection 
than these respirators.
    (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 paragraph (e) 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.

[[Page 79]]

    (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 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.
    (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) 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 
5N-Nitrosodimethylamine.
    (e) Communication of hazards--(1) Hazard communication. (i) Chemical 
manufacturers, importers, distributors and employers shall comply with 
all requirements of the Hazard Communication Standard (HCS) (Sec.  
1910.1200) for each carcinogen listed in paragraph (e)(1)(iv) of this 
section.
    (ii) In classifying the hazards of carcinogens listed in paragraph 
(e)(1)(iv) of this section, at least the hazards listed in paragraph 
(e)(1)(iv) are to be addressed.
    (iii) Employers shall include the carcinogens listed in paragraph 
(e)(1)(iv) of this section in the hazard communication program 
established to comply with the HCS (Sec.  1910.1200). Employers shall 
ensure that each employee has access to labels on containers of the 
carcinogens listed in paragraph (e)(1)(iv) and to safety data sheets, 
and

[[Page 80]]

is trained in accordance with the requirements of HCS and paragraph 
(e)(4) of this section.
    (iv) List of Carcinogens:
    (A) 4-Nitrobiphenyl: Cancer.
    (B) alpha-Naphthylamine: Cancer; skin irritation; and acute toxicity 
effects.
    (C) Methyl chloromethyl ether: Cancer; skin, eye and respiratory 
effects; acute toxicity effects; and flammability.
    (D) 3,3'-Dichlorobenzidine (and its salts): Cancer and skin 
sensitization.
    (E) bis-Chloromethyl ether: Cancer; skin, eye, and respiratory tract 
effects; acute toxicity effects; and flammability.
    (F) beta-Naphthylamine: Cancer and acute toxicity effects.
    (G) Benzidine: Cancer and acute toxicity effects.
    (H) 4-Aminodiphenyl: Cancer.
    (I) Ethyleneimine: Cancer; mutagenicity; skin and eye effects; liver 
effects; kidney effects; acute toxicity effects; and flammability.
    (J) beta-Propiolactone: Cancer; skin irritation; eye effects; and 
acute toxicity effects.
    (K) 2-Acetylaminofluorene: Cancer.
    (L) 4-Dimethylaminoazo-benzene: Cancer; skin effects; and 
respiratory tract irritation.
    (M) N-Nitrosodimethylamine: Cancer; liver effects; and acute 
toxicity effects.
    (2) Signs. (i) The employer shall post entrances to regulated areas 
with signs bearing the legend:

DANGER
(CHEMICAL IDENTIFICATION)
MAY CAUSE CANCER
AUTHORIZED PERSONNEL ONLY

    (ii) The employer shall post signs at entrances to regulated areas 
containing operations covered in paragraph (c)(5) of this section. The 
signs shall bear the legend:

DANGER
(CHEMICAL IDENTIFICATION)
MAY CAUSE CANCER
WEAR AIR-SUPPLIED HOODS, IMPERVIOUS SUITS, AND PROTECTIVE EQUIPMENT IN 
THIS AREA
AUTHORIZED PERSONNEL ONLY

    (iii) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (e)(2)(i) of this section:

CANCER-SUSPECT AGENT
AUTHORIZED PERSONNEL ONLY

    (iv) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (e)(2)(ii) of this section:

CANCER-SUSPECT AGENT EXPOSED IN THIS AREA
IMPERVIOUS SUIT INCLUDING GLOVES, BOOTS, AND AIR-SUPPLIED HOOD REQUIRED 
AT ALL TIMES
AUTHORIZED PERSONNEL ONLY

    (v) 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.
    (3) 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.
    (4) 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;

[[Page 81]]

    (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.
    (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.
    (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; 76 FR 33608, June 8, 2011; 76 FR 80740, 
Dec. 27, 2011; 77 FR 17779, Mar. 26, 2012]



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]

[[Page 82]]



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.
    (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:

[[Page 83]]

    (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.
    (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

[[Page 84]]

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 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).

[[Page 85]]

    (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.
    (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) Communication of hazards--(1) Hazard communication--general. (i) 
Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for vinyl chloride and polyvinyl chloride.
    (ii) In classifying the hazards of vinyl chloride at least the 
following hazards are to be addressed: Cancer; central nervous system 
effects; liver effects; blood effects; and flammability.
    (iii) Employers shall include vinyl chloride in the hazard 
communication program established to comply with the HCS (Sec.  
1910.1200). Employers shall ensure that each employee has access to 
labels on containers of vinyl chloride and to safety data sheets, and is 
trained in accordance with the requirements of HCS and paragraph (j) of 
this section.
    (2) Signs. (i) The employer shall post entrances to regulated areas 
with legible signs bearing the legend:

DANGER
VINYL CHLORIDE
MAY CAUSE CANCER
AUTHORIZED PERSONNEL ONLY

    (ii) The employer shall post signs at areas containing hazardous 
operations or where emergencies currently exist. The signs shall be 
legible and bear the legend:

DANGER
VINYL CHLORIDE
MAY CAUSE CANCER
WEAR RESPIRATORY PROTECTION AND PROTECTIVE CLOTHING IN THIS AREA
AUTHORIZED PERSONNEL ONLY

    (iii) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (l)(2)(i) of this section:

CANCER-SUSPECT AGENT AREA
AUTHORIZED PERSONNEL ONLY

    (iv) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (l)(2)(ii) of this section:

CANCER-SUSPECT AGENT IN THIS AREA
PROTECTIVE EQUIPMENT REQUIRED
AUTHORIZED PERSONNEL ONLY


[[Page 86]]


    (3) Labels. (i) In addition to the other requirements in this 
paragraph (l), the employer shall ensure that labels for containers of 
polyvinyl chloride resin waste from reactors or other waste contaminated 
with vinyl chloride are legible and include the following information:

CONTAMINATED WITH VINYL CHLORIDE
MAY CAUSE CANCER

    (ii) Prior to June 1, 2015, employers may include the following 
information on labels of containers of polyvinyl chloride resin waste 
from reactors or other waste contaminated with vinyl chloride in lieu of 
the labeling requirements in paragraphs (l)(3)(i) of this section:

CONTAMINATED WITH VINYL CHLORIDE
CANCER-SUSPECT AGENT

    (4) Prior to June 1, 2015, employers may include the following 
information for containers of polyvinyl chloride in lieu of the labeling 
requirements in paragraphs (l)(1)(i) of this section:

POLYVINYL CHLORIDE (OR TRADE NAME)
Contains
VINYL CHLORIDE
VINYL CHLORIDE IS A CANCER-SUSPECT AGENT

    (5)(i) Prior to June 1, 2015, employers may include either the 
following information in either paragraph (l)(5)(i) or (l)(5)(ii) of 
this section on containers of vinyl chloride in lieu of the labeling 
requirements in paragraph (l)(1)(i) of this section:

VINYL CHLORIDE
EXTREMELY FLAMMABLE GAS UNDER PRESSURE
CANCER-SUSPECT AGENT

    (ii) In accordance with 49 CFR Parts 170-189, with the additional 
legend applied near the label or placard:

CANCER-SUSPECT AGENT

    (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 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.
    (n) 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 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).

[[Page 87]]

    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. Redesignated at 40 FR 23072, May 28, 1975]

    Editorial Note: For Federal Register citations affecting Sec.  
1910.1017, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



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.
    (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

[[Page 88]]

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.
    (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

[[Page 89]]

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 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

[[Page 90]]

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) Labels on contaminated protective clothing and equipment.
    (A) The employer shall ensure that the containers of contaminated 
protective clothing and equipment in the workplace or which are to be 
removed from the workplace are labeled and that the labels include the 
following information:

DANGER: CONTAMINATED WITH INORGANIC ARSENIC. MAY CAUSE CANCER. DO NOT 
REMOVE DUST BY BLOWING OR SHAKING. DISPOSE OF INORGANIC ARSENIC 
CONTAMINATED WASH WATER IN ACCORDANCE WITH APPLICABLE LOCAL, STATE OR 
FEDERAL REGULATIONS.

    (B) Prior to June 1, 2015, employers may include the following 
information on containers of protective clothing and equipment in lieu 
of the labeling requirements in paragraphs (j)(2)(vii) of this section:


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 maintain the effectiveness of the system and a notation 
kept of the last check of effectiveness and cleaning or maintenance.
    (l) [Reserved]

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    (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 film or digital 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 arsenic or because of 
required respirator use.
    (3) Periodic examinations. (i) Examinations must be provided in 
accordance with paragraphs (n)(2)(i) and

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(n)(2)(ii)(B) and (C) of this section at least annually.
    (ii) Whenever a covered employee has not taken the examinations 
specified in paragraphs (n)(2)(i) and (n)(2)(ii)(B) and (C) 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 93]]

    (p) Communication of hazards--(1) Hazard communication--General. (i) 
Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for inorganic arsenic.
    (ii) In classifying the hazards of inorganic arsenic at least the 
following hazards are to be addressed: Cancer; liver effects; skin 
effects; respiratory irritation; nervous system effects; and acute 
toxicity effects.
    (iii) Employers shall include inorganic arsenic in the hazard 
communication program established to comply with the HCS (Sec.  
1910.1200). Employers shall ensure that each employee has access to 
labels on containers of inorganic arsenic and to safety data sheets, and 
is trained in accordance with the requirements of HCS and paragraph (o) 
of this section.
    (iv) The employer shall ensure that no statement appears on or near 
any sign or label required by this paragraph (p) 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
MAY CAUSE CANCER
DO NOT EAT, DRINK OR SMOKE
WEAR RESPIRATORY PROTECTION IN THIS AREA
AUTHORIZED PERSONNEL ONLY

    (ii) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (p)(2)(i) of this section:

DANGER
INORGANIC ARSENIC
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY
NO SMOKING OR EATING
RESPIRATOR REQUIRED

    (iii) The employer shall ensure that signs required by this 
paragraph (p) are illuminated and cleaned as necessary so that the 
legend is readily visible.
    (3)(i) Prior to June 1, 2015, in lieu of the labeling requirements 
in paragraphs (p)(1)(i) of this section, employers may apply 
precautionary labels to all shipping and storage containers of inorganic 
arsenic, and to all products containing inorganic arsenic, bearing the 
following legend:

DANGER
CONTAINS INORGANIC ARSENIC
CANCER HAZARD
HARMFUL IF INHALED OR SWALLOWED
USE ONLY WITH ADEQUATE VENTILATION OR RESPIRATORY PROTECTION

    (ii) Labels are not required 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.)
    (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 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 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

[[Page 94]]

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 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) 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.

[[Page 95]]

                 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 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 [micro]g/
m3)--(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 (during 
initial examination only); skin examination and a nasal examination. The 
examining physician will provide a written opinion to your employer 
containing the results of the 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.

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    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.

    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/m3) 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/m3 (after 
August 1, 1978) 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[sec] by 17[sec] or other reasonably-sized standard film or 
digital 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 in the first paragraph of this section. 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 or chest X-ray 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 the chest X-ray, and 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

[[Page 97]]

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 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.

[[Page 98]]

    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; 76 FR 33608, June 8, 2011; 77 
FR 17780, Mar. 26, 2012; 84 FR 21470, May 14, 2019]



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, 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:

[[Page 99]]

    (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.
    (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:

[[Page 100]]

    (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.
    (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

[[Page 101]]

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 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

[[Page 102]]

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 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

[[Page 103]]

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 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;

[[Page 104]]

    (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:
    (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

[[Page 105]]

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:
    (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.
    (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

[[Page 106]]

 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 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

[[Page 107]]

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 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; 76 FR 33608, June 8, 2011]



Sec.  1910.1024  Beryllium.

    (a) Scope and application. (1) This standard applies to occupational 
exposure to beryllium in all forms, compounds, and mixtures in general 
industry, except those articles and materials exempted by paragraphs 
(a)(2) and (a)(3) of this standard.
    (2) This standard does not apply to articles, as defined in the 
Hazard Communication standard (HCS) (Sec.  1910.1200(c)), that contain 
beryllium and that the employer does not process.
    (3) This standard does not apply to materials containing less than 
0.1% beryllium by weight where the employer has objective data 
demonstrating that employee exposure to beryllium will remain below the 
action level as an 8-hour TWA under any foreseeable conditions.
    (b) Definitions. As used in this standard:
    Action level means a concentration of airborne beryllium of 0.1 
micrograms per cubic meter of air ([micro]g/m\3\) calculated as an 8-
hour time-weighted average (TWA).
    Airborne exposure and airborne exposure to beryllium mean the 
exposure to airborne beryllium that would occur if the employee were not 
using a respirator.
    Assistant Secretary means the Assistant Secretary of Labor for 
Occupational Safety and Health, United States Department of Labor, or 
designee.
    Beryllium lymphocyte proliferation test (BeLPT) means the 
measurement of blood lymphocyte proliferation in a laboratory test when 
lymphocytes are challenged with a soluble beryllium salt.
    Beryllium sensitization means a response in the immune system of a 
specific individual who has been exposed to beryllium. There are no 
associated physical or clinical symptoms and no illness or disability 
with beryllium sensitization alone, but the response that occurs through 
beryllium sensitization can enable the immune system to recognize and 
react to beryllium. While not every beryllium-sensitized person will 
develop chronic beryllium disease (CBD), beryllium sensitization is 
essential for development of CBD.
    Beryllium work area means any work area where materials that contain 
at least 0.1 percent beryllium by weight are processed either:
    (1) During any of the operations listed in Appendix A of this 
standard; or
    (2) Where employees are, or can reasonably be expected to be, 
exposed to airborne beryllium at or above the action level.
    CBD diagnostic center means a medical diagnostic center that has a 
pulmonologist or pulmonary specialist on staff and on-site facilities to 
perform a clinical evaluation for the presence of chronic beryllium 
disease (CBD). The CBD diagnostic center must have the capacity to 
perform pulmonary function testing (as outlined by the American Thoracic 
Society criteria), bronchoalveolar lavage (BAL), and transbronchial 
biopsy. The CBD diagnostic center must also have the capacity to 
transfer BAL samples to a laboratory for appropriate diagnostic testing 
within 24 hours. The pulmonologist or pulmonary specialist must be able 
to interpret the biopsy pathology and the BAL diagnostic test results.
    Chronic beryllium disease (CBD) means a chronic granulomatous lung 
disease caused by inhalation of airborne beryllium by an individual who 
is beryllium sensitized.
    Confirmed positive means the person tested has had two abnormal 
BeLPT test results, an abnormal and a borderline test result, or three 
borderline test results, obtained from tests conducted within a three-
year period. It also means the result of a more reliable and accurate 
test indicating a person has been identified as having beryllium 
sensitization.

[[Page 108]]

    Contaminated with beryllium and beryllium-contaminated mean 
contaminated with dust, fumes, mists, or solutions containing beryllium 
in concentrations greater than or equal to 0.1 percent by weight.
    Dermal contact with beryllium means skin exposure to:
    (1) Soluble beryllium compounds containing beryllium in 
concentrations greater than or equal to 0.1 percent by weight;
    (2) Solutions containing beryllium in concentrations greater than or 
equal to 0.1 percent by weight; or
    (3) Visible dust, fumes, or mists containing beryllium in 
concentrations greater than or equal to 0.1 percent by weight. The 
handling of beryllium materials in non-particulate solid form that are 
free from visible dust containing beryllium in concentrations greater 
than or equal to 0.1 percent by weight is not considered dermal contact 
under the standard.
    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 such as, but not limited to, 
equipment failure, rupture of containers, or failure of control 
equipment, which may or does result in an uncontrolled and unintended 
release of airborne beryllium that presents a significant hazard.
    High-efficiency particulate air (HEPA) filter means a filter that is 
at least 99.97 percent efficient in removing particles 0.3 micrometers 
in diameter.
    Objective data means information, such as air monitoring data from 
industry-wide surveys or calculations based on the composition of a 
substance, demonstrating airborne exposure to beryllium associated with 
a particular product or material or a specific process, task, or 
activity. The data must reflect workplace conditions closely resembling 
or with a higher airborne exposure potential than 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) means 
an individual whose legally permitted scope of practice (i.e., license, 
registration, or certification) allows the individual to independently 
provide or be delegated the responsibility to provide some or all of the 
health care services required by paragraph (k) of this standard.
    Regulated area means an area, including temporary work areas where 
maintenance or non-routine tasks are performed, where an employee's 
airborne exposure exceeds, or can reasonably be expected to exceed, 
either the time-weighted average (TWA) permissible exposure limit (PEL) 
or short term exposure limit (STEL).
    This standard means this beryllium standard, 29 CFR 1910.1024.
    (c) Permissible Exposure Limits (PELs)--(1) Time-weighted average 
(TWA) PEL. The employer must ensure that no employee is exposed to an 
airborne concentration of beryllium in excess of 0.2 [micro]g/m\3\ 
calculated as an 8-hour TWA.
    (2) Short-term exposure limit (STEL). The employer must ensure that 
no employee is exposed to an airborne concentration of beryllium in 
excess of 2.0 [micro]g/m\3\ as determined over a sampling period of 15 
minutes.
    (d) Exposure assessment--(1) General. The employer must assess the 
airborne exposure of each employee who is or may reasonably be expected 
to be exposed to airborne beryllium in accordance with either the 
performance option in paragraph (d)(2) or the scheduled monitoring 
option in paragraph (d)(3) of this standard.
    (2) Performance option. The employer must assess the 8-hour TWA 
exposure and the 15-minute short-term exposure for each employee on the 
basis of any combination of air monitoring data and objective data 
sufficient to accurately characterize airborne exposure to beryllium.
    (3) Scheduled monitoring option. (i) The employer must perform 
initial monitoring to assess the 8-hour TWA exposure for each employee 
on the basis of one or more personal breathing zone air samples that 
reflect the airborne exposure of employees on each shift, for each job 
classification, and in each work area.
    (ii) The employer must perform initial monitoring to assess the 
short-term exposure from 15-minute personal

[[Page 109]]

breathing zone air samples measured in operations that are likely to 
produce airborne exposure above the STEL for each work shift, for each 
job classification, and in each work area.
    (iii) Where several employees perform the same tasks on the same 
shift and in the same work area, the employer may sample a 
representative fraction of these employees in order to meet the 
requirements of this paragraph (d)(3). In representative sampling, the 
employer must sample the employee(s) expected to have the highest 
airborne exposure to beryllium.
    (iv) If initial monitoring indicates that airborne exposure is below 
the action level and at or below the STEL, the employer may discontinue 
monitoring for those employees whose airborne exposure is represented by 
such monitoring.
    (v) Where the most recent exposure monitoring indicates that 
airborne exposure is at or above the action level but at or below the 
TWA PEL, the employer must repeat such monitoring within six months of 
the most recent monitoring.
    (vi) Where the most recent exposure monitoring indicates that 
airborne exposure is above the TWA PEL, the employer must repeat such 
monitoring within three months of the most recent 8-hour TWA exposure 
monitoring.
    (vii) Where the most recent (non-initial) exposure monitoring 
indicates that airborne exposure is below the action level, the employer 
must repeat such monitoring within six months of the most recent 
monitoring until two consecutive measurements, taken 7 or more days 
apart, are below the action level, at which time the employer may 
discontinue 8-hour TWA exposure monitoring for those employees whose 
exposure is represented by such monitoring, except as otherwise provided 
in paragraph (d)(4) of this standard.
    (viii) Where the most recent exposure monitoring indicates that 
airborne exposure is above the STEL, the employer must repeat such 
monitoring within three months of the most recent short-term exposure 
monitoring until two consecutive measurements, taken 7 or more days 
apart, are below the STEL, at which time the employer may discontinue 
short-term exposure monitoring for those employees whose exposure is 
represented by such monitoring, except as otherwise provided in 
paragraph (d)(4) of this standard.
    (4) Reassessment of exposure. The employer must reassess airborne 
exposure whenever a change in the production, process, control 
equipment, personnel, or work practices may reasonably be expected to 
result in new or additional airborne exposure at or above the action 
level or STEL, or when the employer has any reason to believe that new 
or additional airborne exposure at or above the action level or STEL has 
occurred.
    (5) Methods of sample analysis. The employer must ensure that all 
air monitoring samples used to satisfy the monitoring requirements of 
paragraph (d) of this standard are evaluated by a laboratory that can 
measure beryllium to an accuracy of plus or minus 25 percent within a 
statistical confidence level of 95 percent for airborne concentrations 
at or above the action level.
    (6) Employee notification of assessment results. (i) Within 15 
working days after completing an exposure assessment in accordance with 
paragraph (d) of this standard, the employer must notify each employee 
whose airborne exposure is represented by the assessment of the results 
of that assessment individually in writing or post the results in an 
appropriate location that is accessible to each of these employees.
    (ii) Whenever an exposure assessment indicates that airborne 
exposure is above the TWA PEL or STEL, the employer must describe in the 
written notification the corrective action being taken to reduce 
airborne exposure to or below the exposure limit(s) exceeded where 
feasible corrective action exists but had not been implemented when the 
monitoring was conducted.
    (7) Observation of monitoring. (i) The employer must provide an 
opportunity to observe any exposure monitoring required by this standard 
to each employee whose airborne exposure is measured or represented by 
the monitoring and each employee's representative(s).
    (ii) When observation of monitoring requires entry into an area 
where the use of personal protective clothing or

[[Page 110]]

equipment (which may include respirators) is required, the employer must 
provide each observer with appropriate personal protective clothing and 
equipment at no cost to the observer and must ensure that each observer 
uses such clothing and equipment.
    (iii) The employer must ensure that each observer follows all other 
applicable safety and health procedures.
    (e) Beryllium work areas and regulated areas--(1) Establishment. (i) 
The employer must establish and maintain a beryllium work area wherever 
the criteria for a ``beryllium work area'' set forth in paragraph (b) of 
this standard are met.
    (ii) The employer must establish and maintain a regulated area 
wherever employees are, or can reasonably be expected to be, exposed to 
airborne beryllium at levels above the TWA PEL or STEL.
    (2) Demarcation. (i) The employer must identify each beryllium work 
area through signs or any other methods that adequately establish and 
inform each employee of the boundaries of each beryllium work area.
    (ii) The employer must identify each regulated area in accordance 
with paragraph (m)(2) of this standard.
    (3) Access. The employer must limit access to regulated areas to:
    (i) Persons the employer authorizes or requires to be in a regulated 
area to perform work duties;
    (ii) Persons entering a regulated area as designated representatives 
of employees for the purpose of exercising the right to observe exposure 
monitoring procedures under paragraph (d)(7) of this standard; and
    (iii) Persons authorized by law to be in a regulated area.
    (4) Provision of personal protective clothing and equipment, 
including respirators. The employer must provide and ensure that each 
employee entering a regulated area uses:
    (i) Respiratory protection in accordance with paragraph (g) of this 
standard; and
    (ii) Personal protective clothing and equipment in accordance with 
paragraph (h) of this standard.
    (f) Methods of compliance--(1) Written exposure control plan. (i) 
The employer must establish, implement, and maintain a written exposure 
control plan, which must contain:
    (A) A list of operations and job titles reasonably expected to 
involve airborne exposure to or dermal contact with beryllium;
    (B) A list of operations and job titles reasonably expected to 
involve airborne exposure at or above the action level;
    (C) A list of operations and job titles reasonably expected to 
involve airborne exposure above the TWA PEL or STEL;
    (D) Procedures for minimizing cross-contamination, including the 
transfer of beryllium between surfaces, equipment, clothing, materials, 
and articles within beryllium work areas;
    (E) Procedures for keeping surfaces as free as practicable of 
beryllium;
    (F) Procedures for minimizing the migration of beryllium from 
beryllium work areas to other locations within or outside the workplace;
    (G) A list of engineering controls, work practices, and respiratory 
protection required by paragraph (f)(2) of this standard;
    (H) A list of personal protective clothing and equipment required by 
paragraph (h) of this standard; and
    (I) Procedures for removing, laundering, storing, cleaning, 
repairing, and disposing of beryllium-contaminated personal protective 
clothing and equipment, including respirators.
    (ii) The employer must review and evaluate the effectiveness of each 
written exposure control plan at least annually and update it, as 
necessary, when:
    (A) Any change in production processes, materials, equipment, 
personnel, work practices, or control methods results, or can reasonably 
be expected to result, in new or additional airborne exposure to 
beryllium;
    (B) The employer is notified that an employee is eligible for 
medical removal in accordance with paragraph (l)(1) of this standard, 
referred for evaluation at a CBD diagnostic center, or shows signs or 
symptoms associated with exposure to beryllium; or
    (C) The employer has any reason to believe that new or additional 
airborne exposure is occurring or will occur.

[[Page 111]]

    (iii) The employer must make a copy of the written exposure control 
plan accessible to each employee who is, or can reasonably be expected 
to be, exposed to airborne beryllium in accordance with OSHA's Access to 
Employee Exposure and Medical Records (Records Access) standard (Sec.  
1910.1020(e)).
    (2) Engineering and work practice controls. (i) The employer must 
use engineering and work practice controls to reduce and maintain 
employee airborne exposure to beryllium to or below the PEL and STEL, 
unless the employer can demonstrate that such controls are not feasible. 
Wherever the employer demonstrates that it is not feasible to reduce 
airborne exposure to or below the PELs with engineering and work 
practice controls, the employer must implement and maintain engineering 
and work practice controls to reduce airborne exposure to the lowest 
levels feasible and supplement these controls using respiratory 
protection in accordance with paragraph (g) of this standard.
    (ii) For each operation in a beryllium work area that releases 
airborne beryllium, the employer must ensure that at least one of the 
following is in place to reduce airborne exposure:
    (A) Material and/or process substitution;
    (B) Isolation, such as ventilated partial or full enclosures;
    (C) Local exhaust ventilation, such as at the points of operation, 
material handling, and transfer; or
    (D) Process control, such as wet methods and automation.
    (iii) An employer is exempt from using the controls listed in 
paragraph (f)(2)(ii) of this standard to the extent that:
    (A) The employer can establish that such controls are not feasible; 
or
    (B) The employer can demonstrate that airborne exposure is below the 
action level, using no fewer than two representative personal breathing 
zone samples taken at least 7 days apart, for each affected operation.
    (3) Prohibition of rotation. The employer must not rotate employees 
to different jobs to achieve compliance with the PELs.
    (g) Respiratory protection--(1) General. The employer must provide 
respiratory protection at no cost to the employee and ensure that each 
employee uses respiratory protection:
    (i) During periods necessary to install or implement feasible 
engineering and work practice controls where airborne exposure exceeds, 
or can reasonably be expected to exceed, the TWA PEL or STEL;
    (ii) During operations, including maintenance and repair activities 
and non-routine tasks, when engineering and work practice controls are 
not feasible and airborne exposure exceeds, or can reasonably be 
expected to exceed, the TWA PEL or STEL;
    (iii) During operations for which an employer has implemented all 
feasible engineering and work practice controls when such controls are 
not sufficient to reduce airborne exposure to or below the TWA PEL or 
STEL;
    (iv) During emergencies; and
    (v) When an employee who is eligible for medical removal under 
paragraph (l)(1) chooses to remain in a job with airborne exposure at or 
above the action level, as permitted by paragraph (l)(2)(ii) of this 
standard.
    (2) Respiratory protection program. Where this standard requires an 
employer to provide respiratory protection, the selection and use of 
such respiratory protection must be in accordance with the Respiratory 
Protection standard (Sec.  1910.134).
    (3) The employer must provide at no cost to the employee a powered 
air-purifying respirator (PAPR) instead of a negative pressure 
respirator when:
    (i) Respiratory protection is required by this standard;
    (ii) An employee entitled to such respiratory protection requests a 
PAPR; and
    (iii) The PAPR provides adequate protection to the employee in 
accordance with paragraph (g)(2) of this standard.
    (h) Personal protective clothing and equipment--(1) Provision and 
use. The employer must provide at no cost, and ensure that each employee 
uses, appropriate personal protective clothing and equipment in 
accordance with the written exposure control plan required under 
paragraph (f)(1) of this standard and OSHA's Personal Protective 
Equipment standards (subpart I of this part):

[[Page 112]]

    (i) Where airborne exposure exceeds, or can reasonably be expected 
to exceed, the TWA PEL or STEL; or
    (ii) Where there is a reasonable expectation of dermal contact with 
beryllium.
    (2) Removal and storage. (i) The employer must ensure that each 
employee removes all beryllium-contaminated personal protective clothing 
and equipment at the end of the work shift, at the completion of all 
tasks involving beryllium, or when personal protective clothing or 
equipment becomes visibly contaminated with beryllium, whichever comes 
first.
    (ii) The employer must ensure that each employee removes beryllium-
contaminated personal protective clothing and equipment as specified in 
the written exposure control plan required by paragraph (f)(1) of this 
standard.
    (iii) The employer must ensure that each employee stores and keeps 
beryllium-contaminated personal protective clothing and equipment 
separate from street clothing and that storage facilities prevent cross-
contamination as specified in the written exposure control plan required 
by paragraph (f)(1) of this standard.
    (iv) The employer must ensure that no employee removes beryllium-
contaminated personal protective clothing or equipment from the 
workplace, except for employees authorized to do so for the purposes of 
laundering, cleaning, maintaining or disposing of beryllium-contaminated 
personal protective clothing and equipment at an appropriate location or 
facility away from the workplace.
    (v) When personal protective clothing or equipment required by this 
standard is removed from the workplace for laundering, cleaning, 
maintenance or disposal, the employer must ensure that personal 
protective clothing and equipment are stored and transported in sealed 
bags or other closed containers that are impermeable and are labeled in 
accordance with paragraph (m)(3) of this standard and the HCS (Sec.  
1910.1200).
    (3) Cleaning and replacement. (i) The employer must ensure that all 
reusable personal protective clothing and equipment required by this 
standard is cleaned, laundered, repaired, and replaced as needed to 
maintain its effectiveness.
    (ii) The employer must ensure that beryllium is not removed from 
beryllium-contaminated personal protective clothing and equipment by 
blowing, shaking, or any other means that disperses beryllium into the 
air.
    (iii) The employer must inform in writing the persons or the 
business entities who launder, clean, or repair the personal protective 
clothing or equipment required by this standard of the potentially 
harmful effects of exposure to beryllium and that the personal 
protective clothing and equipment must be handled in accordance with 
this standard.
    (i) Hygiene areas and practices--(1) General. For each employee 
working in a beryllium work area or who can reasonably be expected to 
have dermal contact with beryllium, the employer must:
    (i) Provide readily accessible washing facilities in accordance with 
this standard and the Sanitation standard (Sec.  1910.141) to remove 
beryllium from the hands, face, and neck; and
    (ii) Ensure that employees who have dermal contact with beryllium 
wash any exposed skin at the end of the activity, process, or work shift 
and prior to eating, drinking, smoking, chewing tobacco or gum, applying 
cosmetics, or using the toilet.
    (2) Change rooms. In addition to the requirements of paragraph 
(i)(1)(i) of this standard, the employer must provide employees who are 
required to use personal protective clothing or equipment under 
paragraph (h)(1)(ii) of this standard with a designated change room in 
accordance with this standard and the Sanitation standard (Sec.  
1910.141) where employees are required to remove their personal 
clothing.
    (3) Showers. (i) The employer must provide showers in accordance 
with the Sanitation standard (Sec.  1910.141) where:
    (A) Airborne exposure exceeds, or can reasonably be expected to 
exceed, the TWA PEL or STEL; and
    (B) Employee's hair or body parts other than hands, face, and neck 
can reasonably be expected to become contaminated with beryllium.
    (ii) Employers required to provide showers under paragraph (i)(3)(i) 
of this

[[Page 113]]

standard must ensure that each employee showers at the end of the work 
shift or work activity if:
    (A) The employee reasonably could have had airborne exposure above 
the TWA PEL or STEL; and
    (B) The employee's hair or body parts other than hands, face, and 
neck could reasonably have become contaminated with beryllium.
    (4) Eating and drinking areas. Wherever the employer allows 
employees to consume food or beverages at a worksite where beryllium is 
present, the employer must ensure that:
    (i) Beryllium-contaminated surfaces in eating and drinking areas are 
as free as practicable of beryllium;
    (ii) No employees enter any eating or drinking area with beryllium-
contaminated personal protective clothing or equipment unless, prior to 
entry, it is cleaned, as necessary, to be as free as practicable of 
beryllium by methods that do not disperse beryllium into the air or onto 
an employee's body; and
    (iii) Eating and drinking facilities provided by the employer are in 
accordance with the Sanitation standard (Sec.  1910.141).
    (5) Prohibited activities. The employer must ensure that no 
employees eat, drink, smoke, chew tobacco or gum, or apply cosmetics in 
regulated areas.
    (j) Housekeeping--(1) General. (i) The employer must maintain all 
surfaces in beryllium work areas and regulated areas as free as 
practicable of beryllium and in accordance with the written exposure 
control plan required under paragraph (f)(1) and the cleaning methods 
required under paragraph (j)(2) of this standard; and
    (ii) The employer must ensure that all spills and emergency releases 
of beryllium are cleaned up promptly and in accordance with the written 
exposure control plan required under paragraph (f)(1) and the cleaning 
methods required under paragraph (j)(2) of this standard.
    (2) Cleaning methods.
    (i) The employer must ensure that surfaces in beryllium work areas 
and regulated areas are cleaned by HEPA-filtered vacuuming or other 
methods that minimize the likelihood and level of airborne exposure.
    (ii) The employer must not allow dry sweeping or brushing for 
cleaning surfaces in beryllium work areas or regulated areas unless 
HEPA-filtered vacuuming or other methods that minimize the likelihood 
and level of airborne exposure are not safe or effective.
    (iii) The employer must not allow the use of compressed air for 
cleaning beryllium-contaminated surfaces unless the compressed air is 
used in conjunction with a ventilation system designed to capture the 
particulates made airborne by the use of compressed air.
    (iv) Where employees use dry sweeping, brushing, or compressed air 
to clean beryllium-contaminated surfaces, the employer must provide, and 
ensure that each employee uses, respiratory protection and personal 
protective clothing and equipment in accordance with paragraphs (g) and 
(h) of this standard.
    (v) The employer must ensure that cleaning equipment is handled and 
maintained in a manner that minimizes the likelihood and level of 
airborne exposure and the re-entrainment of airborne beryllium in the 
workplace.
    (3) Disposal, recycling, and reuse. (i) Except for intra-plant 
transfers, when the employer transfers materials that contain at least 
0.1 percent beryllium by weight or are contaminated with beryllium for 
disposal, recycling, or reuse, the employer must label the materials in 
accordance with paragraph (m)(3) of this standard;
    (ii) Except for intra-plant transfers, materials designated for 
disposal that contain at least 0.1 percent beryllium by weight or are 
contaminated with beryllium must be cleaned to be as free as practicable 
of beryllium or placed in enclosures that prevent the release of 
beryllium-containing particulate or solutions under normal conditions of 
use, storage, or transport, such as bags or containers; and
    (iii) Except for intra-plant transfers, materials designated for 
recycling or reuse that contain at least 0.1 percent beryllium by weight 
or are contaminated with beryllium must be cleaned

[[Page 114]]

to be as free as practicable of beryllium or placed in enclosures that 
prevent the release of beryllium-containing particulate or solutions 
under normal conditions of use, storage, or transport, such as bags or 
containers.
    (k) Medical surveillance--(1) General. (i) The employer must make 
medical surveillance required by this paragraph available at no cost to 
the employee, and at a reasonable time and place, to each employee:
    (A) Who is or is reasonably expected to be exposed at or above the 
action level for more than 30 days per year;
    (B) Who shows signs or symptoms of CBD or other beryllium-related 
health effects;
    (C) Who is exposed to beryllium during an emergency; or
    (D) Whose most recent written medical opinion required by paragraph 
(k)(6) or (k)(7) of this standard recommends periodic medical 
surveillance.
    (ii) The employer must ensure that all medical examinations and 
procedures required by this standard are performed by, or under the 
direction of, a licensed physician.
    (2) Frequency. The employer must provide a medical examination:
    (i) Within 30 days after determining that:
    (A) An employee meets the criteria of paragraph (k)(1)(i)(A), unless 
the employee has received a medical examination, provided in accordance 
with this standard, within the last two years; or
    (B) An employee meets the criteria of paragraph (k)(1)(i)(B) of this 
standard.
    (ii) At least every two years thereafter for each employee who 
continues to meet the criteria of paragraph (k)(1)(i)(A), (B), or (D) of 
this standard.
    (iii) At the termination of employment for each employee who meets 
any of the criteria of paragraph (k)(1)(i) of this standard at the time 
the employee's employment terminates, unless an examination has been 
provided in accordance with this standard during the six months prior to 
the date of termination. Each employee who meets the criteria of 
paragraph (k)(1)(i)(C) of this standard and who has not received an 
examination since exposure to beryllium during the emergency must be 
provided an examination at the time the employee's employment 
terminates.
    (iv) For an employee who meets the criteria of paragraph 
(k)(1)(i)(C) of this standard:
    (A) If that employee has not received a medical examination within 
the previous two years pursuant to paragraph (k)(1)(i) of this standard, 
then within 30 days after the employee meets the criteria of paragraph 
(k)(1)(i)(C) of this standard; or
    (B) If that employee has received a medical examination within the 
previous two years pursuant to paragraph (k)(1)(i) of this standard, 
then at least one year but no more than two years after the employee 
meets the criteria of paragraph (k)(1)(i)(C) of this standard.
    (3) Contents of examination. (i) The employer must ensure that the 
PLHCP conducting the examination advises the employee of the risks and 
benefits of participating in the medical surveillance program and the 
employee's right to opt out of any or all parts of the medical 
examination.
    (ii) The employer must ensure that the employee is offered a medical 
examination that includes:
    (A) A medical and work history, with emphasis on past and present 
airborne exposure to or dermal contact with beryllium, smoking history, 
and any history of respiratory system dysfunction;
    (B) A physical examination with emphasis on the respiratory system;
    (C) A physical examination for skin rashes;
    (D) Pulmonary function tests, performed in accordance with the 
guidelines established by the American Thoracic Society including forced 
vital capacity (FVC) and forced expiratory volume in one second 
(FEV1);
    (E) A standardized BeLPT or equivalent test, upon the first 
examination and at least every two years thereafter, unless the employee 
is confirmed positive. If the results of the BeLPT are other than 
normal, a follow-up BeLPT must be offered within 30 days, unless the 
employee has been confirmed positive. Samples must be analyzed in a 
laboratory certified under the College of American Pathologists/Clinical 
Laboratory Improvement Amendments

[[Page 115]]

(CLIA) guidelines to perform the BeLPT.
    (F) A low dose computed tomography (LDCT) scan, when recommended by 
the PLHCP after considering the employee's history of exposure to 
beryllium along with other risk factors, such as smoking history, family 
medical history, sex, age, and presence of existing lung disease; and
    (G) Any other test deemed appropriate by the PLHCP.
    (4) Information provided to the PLHCP. The employer must ensure that 
the examining PLHCP (and the agreed-upon CBD diagnostic center, if an 
evaluation is required under paragraph (k)(7) of this standard) has a 
copy of this standard and must provide the following information, if 
known:
    (i) A description of the employee's former and current duties that 
relate to the employee's airborne exposure to and dermal contact with 
beryllium;
    (ii) The employee's former and current levels of airborne exposure;
    (iii) A description of any personal protective clothing and 
equipment, including respirators, used by the employee, including when 
and for how long the employee has used that personal protective clothing 
and equipment; and
    (iv) Information from records of employment-related medical 
examinations previously provided to the employee, currently within the 
control of the employer, after obtaining written consent from the 
employee.
    (5) Licensed physician's written medical report for the employee. 
The employer must ensure that the employee receives a written medical 
report from the licensed physician within 45 days of the examination 
(including any follow-up BeLPT required under paragraph (k)(3)(ii)(E) of 
this standard) and that the PLHCP explains the results of the 
examination to the employee. The written medical report must contain:
    (i) A statement indicating the results of the medical examination, 
including the licensed physician's opinion as to whether the employee 
has:
    (A) Any detected medical condition, such as CBD or beryllium 
sensitization (i.e., the employee is confirmed positive, as defined in 
paragraph (b) of this standard), that may place the employee at 
increased risk from further airborne exposure, and
    (B) Any medical conditions related to airborne exposure that require 
further evaluation or treatment.
    (ii) Any recommendations on:
    (A) The employee's use of respirators, protective clothing, or 
equipment; or
    (B) Limitations on the employee's airborne exposure to beryllium.
    (iii) If the employee is confirmed positive or diagnosed with CBD or 
if the licensed physician otherwise deems it appropriate, the written 
report must also contain a referral for an evaluation at a CBD 
diagnostic center.
    (iv) If the employee is confirmed positive or diagnosed with CBD the 
written report must also contain a recommendation for continued periodic 
medical surveillance.
    (v) If the employee is confirmed positive or diagnosed with CBD the 
written report must also contain a recommendation for medical removal 
from airborne exposure to beryllium, as described in paragraph (l) of 
this standard.
    (6) Licensed physician's written medical opinion for the employer. 
(i) The employer must obtain a written medical opinion from the licensed 
physician within 45 days of the medical examination (including any 
follow-up BeLPT required under paragraph (k)(3)(ii)(E) of this 
standard). The written medical opinion must contain only the following:
    (A) The date of the examination;
    (B) A statement that the examination has met the requirements of 
this standard;
    (C) Any recommended limitations on the employee's use of 
respirators, protective clothing, or equipment; and
    (D) A statement that the PLHCP has explained the results of the 
medical examination to the employee, including any tests conducted, any 
medical conditions related to airborne exposure that require further 
evaluation or treatment, and any special provisions for use of personal 
protective clothing or equipment;
    (ii) If the employee provides written authorization, the written 
opinion must also contain any recommended limitations on the employee's 
airborne exposure to beryllium.

[[Page 116]]

    (iii) If the employee is confirmed positive or diagnosed with CBD or 
if the licensed physician otherwise deems it appropriate, and the 
employee provides written authorization, the written opinion must also 
contain a referral for an evaluation at a CBD diagnostic center.
    (iv) If the employee is confirmed positive or diagnosed with CBD and 
the employee provides written authorization, the written opinion must 
also contain a recommendation for continued periodic medical 
surveillance.
    (v) If the employee is confirmed positive or diagnosed with CBD and 
the employee provides written authorization, the written opinion must 
also contain a recommendation for medical removal from airborne exposure 
to beryllium, as described in paragraph (l) of this standard.
    (vi) The employer must ensure that each employee receives a copy of 
the written medical opinion described in paragraph (k)(6) of this 
standard within 45 days of any medical examination (including any 
follow-up BeLPT required under paragraph (k)(3)(ii)(E) of this standard) 
performed for that employee.
    (7) CBD diagnostic center. (i) The employer must provide an 
evaluation at no cost to the employee at a CBD diagnostic center that is 
mutually agreed upon by the employer and the employee. The evaluation at 
the CBD diagnostic center must be scheduled within 30 days, and must 
occur within a reasonable time, of:
    (A) The employer's receipt of a physician's written medical opinion 
to the employer that recommends referral to a CBD diagnostic center; or
    (B) The employee presenting to the employer a physician's written 
medical report indicating that the employee has been confirmed positive 
or diagnosed with CBD, or recommending referral to a CBD diagnostic 
center.
    (ii) The employer must ensure that, as part of the evaluation, the 
employee is offered any tests deemed appropriate by the examining 
physician at the CBD diagnostic center, such as pulmonary function 
testing (as outlined by the American Thoracic Society criteria), 
bronchoalveolar lavage (BAL), and transbronchial biopsy. If any of the 
tests deemed appropriate by the examining physician are not available at 
the CBD diagnostic center, they may be performed at another location 
that is mutually agreed upon by the employer and the employee.
    (iii) The employer must ensure that the employee receives a written 
medical report from the CBD diagnostic center that contains all the 
information required in paragraph (k)(5)(i), (ii), (iv), and (v) of this 
standard and that the PLHCP explains the results of the examination to 
the employee within 30 days of the examination.
    (iv) The employer must obtain a written medical opinion from the CBD 
diagnostic center within 30 days of the medical examination. The written 
medical opinion must contain only the information in paragraph 
(k)(6)(i), as applicable, unless the employee provides written 
authorization to release additional information. If the employee 
provides written authorization, the written opinion must also contain 
the information from paragraphs (k)(6)(ii), (iv), and (v), if 
applicable.
    (v) The employer must ensure that each employee receives a copy of 
the written medical opinion from the CBD diagnostic center described in 
paragraph (k)(7) of this standard within 30 days of any medical 
examination performed for that employee.
    (vi) After an employee has received the initial clinical evaluation 
at a CBD diagnostic center described in paragraphs (k)(7)(i) and (ii) of 
this standard, the employee may choose to have any subsequent medical 
examinations for which the employee is eligible under paragraph (k) of 
this standard performed at a CBD diagnostic center mutually agreed upon 
by the employer and the employee, and the employer must provide such 
examinations at no cost to the employee.
    (l) Medical removal. (1) An employee is eligible for medical 
removal, if the employee works in a job with airborne exposure at or 
above the action level and either:
    (i) The employee provides the employer with:
    (A) A written medical report indicating a confirmed positive finding 
or CBD diagnosis; or

[[Page 117]]

    (B) A written medical report recommending removal from airborne 
exposure to beryllium in accordance with paragraph (k)(5)(v) or 
(k)(7)(iii) of this standard; or
    (ii) The employer receives a written medical opinion recommending 
removal from airborne exposure to beryllium in accordance with paragraph 
(k)(6)(v) or (k)(7)(iv) of this standard.
    (2) If an employee is eligible for medical removal, the employer 
must provide the employee with the employee's choice of:
    (i) Removal as described in paragraph (l)(3) of this standard; or
    (ii) Remaining in a job with airborne exposure at or above the 
action level, provided that the employer provides, and ensures that the 
employee uses, respiratory protection that complies with paragraph (g) 
of this standard whenever airborne exposures are at or above the action 
level.
    (3) If the employee chooses removal:
    (i) If a comparable job is available where airborne exposures to 
beryllium are below the action level, and the employee is qualified for 
that job or can be trained within one month, the employer must remove 
the employee to that job. The employer must maintain for six months from 
the time of removal the employee's base earnings, seniority, and other 
rights and benefits that existed at the time of removal.
    (ii) If comparable work is not available, the employer must maintain 
the employee's base earnings, seniority, and other rights and benefits 
that existed at the time of removal for six months or until such time 
that comparable work described in paragraph (l)(3)(i) becomes available, 
whichever comes first.
    (4) 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 from a publicly or employer-funded compensation program, or 
receives income from another employer made possible by virtue of the 
employee's removal.
    (m) Communication of hazards--(1) General. (i) Chemical 
manufacturers, importers, distributors, and employers must comply with 
all requirements of the HCS (Sec.  1910.1200) for beryllium.
    (ii) In classifying the hazards of beryllium, at least the following 
hazards must be addressed: Cancer; lung effects (CBD and acute beryllium 
disease); beryllium sensitization; skin sensitization; and skin, eye, 
and respiratory tract irritation.
    (iii) Employers must include beryllium in the hazard communication 
program established to comply with the HCS. Employers must ensure that 
each employee has access to labels on containers of beryllium and to 
safety data sheets, and is trained in accordance with the requirements 
of the HCS (Sec.  1910.1200) and paragraph (m)(4) of this standard.
    (2) Warning signs. (i) Posting. The employer must provide and 
display warning signs at each approach to a regulated area so that each 
employee is able to read and understand the signs and take necessary 
protective steps before entering the area.
    (ii) Sign specification. (A) The employer must ensure that the 
warning signs required by paragraph (m)(2)(i) of this standard are 
legible and readily visible.
    (B) The employer must ensure each warning sign required by paragraph 
(m)(2)(i) of this standard bears the following legend:

DANGER
REGULATED AREA
BERYLLIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
AUTHORIZED PERSONNEL ONLY
WEAR RESPIRATORY PROTECTION AND PERSONAL PROTECTIVE CLOTHING AND 
EQUIPMENT IN THIS AREA

    (3) Warning labels. Consistent with the HCS (Sec.  1910.1200), the 
employer must label each immediate container of clothing, equipment, and 
materials contaminated with beryllium, and must, at a minimum, include 
the following on the label:

DANGER
CONTAINS BERYLLIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
AVOID CREATING DUST
DO NOT GET ON SKIN

    (4) Employee information and training. (i) For each employee who 
has, or can

[[Page 118]]

reasonably be expected to have, airborne exposure to or dermal contact 
with beryllium:
    (A) The employer must provide information and training in accordance 
with the HCS (Sec.  1910.1200(h));
    (B) The employer must provide initial training to each employee by 
the time of initial assignment; and
    (C) The employer must repeat the training required under this 
standard annually for each employee.
    (ii) The employer must ensure that each employee who is, or can 
reasonably be expected to be, exposed to airborne beryllium can 
demonstrate knowledge and understanding of the following:
    (A) The health hazards associated with airborne exposure to and 
dermal contact with beryllium, including the signs and symptoms of CBD;
    (B) The written exposure control plan, with emphasis on the 
location(s) of beryllium work areas, including any regulated areas, and 
the specific nature of operations that could result in airborne 
exposure, especially airborne exposure above the TWA PEL or STEL;
    (C) The purpose, proper selection, fitting, proper use, and 
limitations of personal protective clothing and equipment, including 
respirators;
    (D) Applicable emergency procedures;
    (E) Measures employees can take to protect themselves from airborne 
exposure to and dermal contact with beryllium, including personal 
hygiene practices;
    (F) The purpose and a description of the medical surveillance 
program required by paragraph (k) of this standard including risks and 
benefits of each test to be offered;
    (G) The purpose and a description of the medical removal protection 
provided under paragraph (l) of this standard;
    (H) The contents of the standard; and
    (I) The employee's right of access to records under the Records 
Access standard (Sec.  1910.1020).
    (iii) When a workplace change (such as modification of equipment, 
tasks, or procedures) results in new or increased airborne exposure that 
exceeds, or can reasonably be expected to exceed, either the TWA PEL or 
the STEL, the employer must provide additional training to those 
employees affected by the change in airborne exposure.
    (iv) Employee information. The employer must make a copy of this 
standard and its appendices readily available at no cost to each 
employee and designated employee representative(s).
    (n) Recordkeeping--(1) Air monitoring data. (i) The employer must 
make and maintain a record of all exposure measurements taken to assess 
airborne exposure as prescribed in paragraph (d) of this standard.
    (ii) This record must include at least the following information:
    (A) The date of measurement for each sample taken;
    (B) The task that is being monitored;
    (C) The sampling and analytical methods used and evidence of their 
accuracy;
    (D) The number, duration, and results of samples taken;
    (E) The type of personal protective clothing and equipment, 
including respirators, worn by monitored employees at the time of 
monitoring; and
    (F) The name and job classification of each employee represented by 
the monitoring, indicating which employees were actually monitored.
    (iii) The employer must ensure that exposure records are maintained 
and made available in accordance with the Records Access standard (Sec.  
1910.1020).
    (2) Objective data. (i) Where an employer uses objective data to 
satisfy the exposure assessment requirements under paragraph (d)(2) of 
this standard, the employer must make and maintain a record of the 
objective data relied upon.
    (ii) This record must include at least the following information:
    (A) The data relied upon;
    (B) The beryllium-containing material in question;
    (C) The source of the objective data;
    (D) A description of the process, task, or activity on which the 
objective data were based; and
    (E) Other data relevant to the process, task, activity, material, or 
airborne exposure on which the objective data were based.
    (iii) The employer must ensure that objective data are maintained 
and made available in accordance with the Records Access standard (Sec.  
1910.1020).

[[Page 119]]

    (3) Medical surveillance. (i) The employer must make and maintain a 
record for each employee covered by medical surveillance under paragraph 
(k) of this standard.
    (ii) The record must include the following information about each 
employee:
    (A) Name and job classification;
    (B) A copy of all licensed physicians' written medical opinions for 
each employee; and
    (C) A copy of the information provided to the PLHCP as required by 
paragraph (k)(4) of this standard.
    (iii) The employer must ensure that medical records are maintained 
and made available in accordance with the Records Access standard (Sec.  
1910.1020).
    (4) Training. (i) At the completion of any training required by this 
standard, the employer must prepare a record that indicates the name and 
job classification of each employee trained, the date the training was 
completed, and the topic of the training.
    (ii) This record must be maintained for three years after the 
completion of training.
    (5) Access to records. Upon request, the employer must make all 
records maintained as a requirement of this standard available for 
examination and copying to the Assistant Secretary, the Director, each 
employee, and each employee's designated representative(s) in accordance 
the Records Access standard (Sec.  1910.1020).
    (6) Transfer of records. The employer must comply with the 
requirements involving transfer of records set forth in the Records 
Access standard (Sec.  1910.1020).
    (o) Dates--(1) Effective date. This standard shall become effective 
March 10, 2017.
    (2) Compliance dates. (i) Obligations contained in paragraphs (c), 
(d), (g), (k), and (l) of this standard: March 12, 2018;
    (ii) Change rooms and showers required by paragraph (i) of this 
standard: March 11, 2019;
    (iii) Engineering controls required by paragraph (f) of this 
standard: March 10, 2020; and
    (iv) All other obligations of this standard: December 12, 2018.
    (p) Appendix. Table A.1 in this appendix sets forth the operations 
that, where performed under the circumstances described in the column 
heading above the particular operations, trigger the requirement for a 
beryllium work area.



    Sec. Appendix A to Sec.  1910.1024--Operations for Establishing 
                          Beryllium Work Areas

    Paragraph (b) of this standard defines a beryllium work area as any 
work area where materials that contain at least 0.1 percent beryllium by 
weight are processed (1) during any of the operations listed in Appendix 
A of this standard, or (2) where employees are, or can reasonably be 
expected to be, exposed to airborne beryllium at or above the action 
level. Table A.1 in this appendix sets forth the operations that, where 
performed under the circumstances described in the column heading above 
the particular operations, trigger the requirement for a beryllium work 
area.

    Table A.1--Operations for Establishing Beryllium Work Areas Where
Processing Materials Containing at Least 0.1 Percent Beryllium by Weight
------------------------------------------------------------------------
                          Beryllium composite
 Beryllium metal alloy  operations  (generally
operations  (generally      10%           Beryllium oxide
   <10% beryllium by     beryllium by weight)          operations
        weight)           and beryllium metal
                              operations
------------------------------------------------------------------------
Abrasive Blasting.      Abrasive Blasting.      Abrasive Blasting.
Abrasive Processing.    Abrasive Processing.    Abrasive Processing.
Abrasive Sawing.        Abrasive Sawing.        Abrasive Sawing.
Annealing.              Annealing.              Boring.
Bright Cleaning.        Atomizing.              Brazing (1,100 [deg]C).
Brushing.               Attritioning.           Broaching with green
                                                 ceramic.
Buffing.                Blanking.               Brushing.
Burnishing.             Bonding.                Buffing.
Casting.                Boring.                 Centerless grinding.
Centerless Grinding.    Breaking.               Chemical Cleaning.
Chemical Cleaning.      Bright Cleaning.        Chemical Etching.
Chemical Etching.       Broaching.              CNC Machining.
Chemical Milling.       Brushing.               Cold Isostatic Pressing
                                                 (CIP).
Dross Handling.         Buffing.                Crushing.
Deburring (grinding).   Burnishing.             Cutting.

[[Page 120]]

 
Electrical Chemical     Casting.                Deburring (grinding).
 Machining (ECM).
Electrical Discharge    Centerless Grinding.    Deburring (non-
 Machining (EDM).                                grinding).
Extrusion.              Chemical Cleaning.      Destructive Testing.
Forging.                Chemical Etching        Dicing.
Grinding.               Chemical Milling.       Drilling.
Heat Treating (in       CNC Machining           Dry/wet Tumbling.
 air).
High Speed Machining    Cold Isostatic          Extrusion.
 (10,000      Pressing.
 rpm).
Hot Rolling.            Cold Pilger.            Filing by Hand.
Lapping.                Crushing.               Firing of Green Ceramic.
Laser Cutting.          Cutting.                Firing of Refractory
                                                 Metallization (1,100 [deg]C).
Laser Machining.        Deburring.              Grinding.
Laser Scribing.         Dicing.                 Honing.
Laser Marking.          Drawing.                Hot Isostatic Pressing
                                                 (HIP).
Melting.                Drilling.               Lapping.
Photo-Etching.          Dross Handling.         Laser Cutting.
Pickling.               Electrical Chemical     Laser Machining.
                         Machining (ECM).
Point and Chamfer.      Electrical Discharge    Laser Scribing.
                         Machining (EDM).
Polishing.              Extrusion.              Laser Marking.
Torch Cutting (i.e.,    Filing by Hand.         Machining.
 oxy-acetylene).
Tumbling.               Forging.                Milling.
Water-jet Cutting.      Grinding.               Piercing.
Welding.                Heading.                Mixing.
Sanding.                Heat Treating.          Plasma Spray.
Slab Milling.           Honing.                 Polishing.
                        Hot Isostatic Pressing  Powder Handling.
                         (HIP).
                        Lapping.                Powder Pressing.
                        Laser Cutting.          Reaming.
                        Laser Machining.        Sanding.
                        Laser Scribing.         Sectioning.
                        Laser Marking.          Shearing.
                        Machining.              Sintering of Green
                                                 Ceramic.
                        Melting.                Sintering of Refractory
                                                 Metallization (1,100 [deg]C).
                        Milling.                Snapping.
                        Mixing.                 Spray Drying.
                        Photo-Etching.          Tape Casting.
                        Pickling.               Turning.
                        Piercing.               Water Jet Cutting.
                        Pilger.
                        Plasma Spray.
                        Point and Chamfer.
                        Polishing.
                        Powder Handling.
                        Powder Pressing.
                        Pressing.
                        Reaming.
                        Roll Bonding.
                        Rolling.
                        Sanding.
                        Sawing (tooth blade).
                        Shearing.
                        Sizing.
                        Skiving.
                        Slitting.
                        Snapping.
                        Sputtering.
                        Stamping.
                        Spray Drying.
                        Tapping.
                        Tensile Testing.
                        Torch Cutting (i.e.,
                         oxy acetylene).
                        Trepanning.
                        Tumbling
                        Turning.
                        Vapor Deposition.
                        Water-Jet Cutting.
                        Welding.
------------------------------------------------------------------------


[[Page 121]]


[82 FR 2736, Jan. 9, 2017, as amended at 83 FR 19948, May 7, 2018; 83 FR 
39360, Aug. 9, 2018; 85 FR 42625, July 14, 2020]



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.
    (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

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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 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 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

[[Page 123]]

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)(5) 
of this section, 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 
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

[[Page 124]]

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.
    (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

[[Page 125]]

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) Labeling of contaminated protective clothing and equipment.
    (A) The employer shall ensure that labels of bags or containers of 
contaminated protective clothing and equipment include the following 
information:

DANGER: CLOTHING AND EQUIPMENT CONTAMINATED WITH LEAD. MAY DAMAGE 
FERTILITY OR THE UNBORN CHILD. CAUSES DAMAGE TO THE CENTRAL NERVOUS 
SYSTEM. DO NOT EAT, DRINK OR SMOKE WHEN HANDLING. DO NOT REMOVE DUST BY 
BLOWING OR SHAKING. DISPOSE OF LEAD CONTAMINATED WASH WATER IN 
ACCORDANCE WITH APPLICABLE LOCAL, STATE, OR FEDERAL REGULATIONS.

    (B) Prior to June 1, 2015, employers may include the following 
information on bags or containers of contaminated protective clothing 
and equipment in lieu of the labeling requirements in paragraphs 
(g)(2)(vii)(A) of this section:

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

[[Page 126]]

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.
    (j) Medical surveillance--(1) General. (i) The employer shall 
institute a medical surveillance program for all employees who are or 
may be exposed at or 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 is at or 
above 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 is at or above 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 
is at or above 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

[[Page 127]]

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:
    (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.

[[Page 128]]

    (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);
    (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

[[Page 129]]

sampling test indicates a blood lead level 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.
    (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 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

[[Page 130]]

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 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

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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 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) Communication of hazards--(1) Hazard communication--general. (i) 
Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for lead.
    (ii) In classifying the hazards of lead at least the following 
hazards are to be addressed: Reproductive/developmental toxicity; 
central nervous system effects; kidney effects; blood effects; and acute 
toxicity effects.
    (iii) Employers shall include lead in the hazard communication 
program established to comply with the HCS (Sec.  1910.1200). Employers 
shall ensure that each employee has access to labels on containers of 
lead and to safety data sheets, and is trained in accordance with the 
requirements of HCS and paragraph (l) of this section.
    (2) Signs. (i) The employer shall post the following warning signs 
in each work area where the PEL is exceeded:

DANGER
LEAD
MAY DAMAGE FERTILITY OR THE UNBORN CHILD
CAUSES DAMAGE TO THE CENTRAL NERVOUS SYSTEM
DO NOT EAT, DRINK OR SMOKE IN THIS AREA

    (ii) The employer shall ensure that no statement appears on or near 
any sign required by this paragraph (m)(2) which contradicts or detracts 
from the meaning of the required sign.
    (iii) The employer shall ensure that signs required by this 
paragraph (m)(2) are illuminated and cleaned as necessary so that the 
legend is readily visible.

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    (iv) The employer may use signs required by other statutes, 
regulations, or ordinances in addition to, or in combination with, signs 
required by this paragraph (m)(2).
    (v) Prior to June 1, 2016, employers may use the following legend in 
lieu of that specified in paragraph (m)(2)(ii) of this section:

WARNING
LEAD WORK AREA
POISON
NO SMOKING OR EATING
    (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 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 and description of the duties of the employee;
    (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 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

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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) 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;
    (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.

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    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, 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

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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 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

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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 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

[[Page 137]]

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 
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

[[Page 138]]

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 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

[[Page 139]]

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 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:

[[Page 140]]



----------------------------------------------------------------------------------------------------------------
                                          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 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).

[[Page 141]]

    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 
the work areas when the exposure to lead exceeds the PEL:

DANGER
LEAD
MAY DAMAGE FERTILITY OR THE UNBORN CHILD
CAUSES DAMAGE TO THE CENTRAL NERVOUS SYSTEM
DO NOT EAT, DRINK OR SMOKE IN THIS AREA

    However, prior to June 1, 2016, employers may use the following 
legend in lieu of that specified above:

WARNING
LEAD WORK AREA
POISON
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, the date of your removal and return, how the removal 
was or is being accomplished, and whether or not the 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

[[Page 142]]

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.
    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.


[[Page 143]]

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.
    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.

[[Page 144]]

 
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 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

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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 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

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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 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

[[Page 147]]

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.
    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-

[[Page 148]]

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, 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.

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    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 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

[[Page 150]]

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 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

[[Page 151]]

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.
    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 at www.govinfo.gov.



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.

[[Page 152]]

    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, 
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,

[[Page 153]]

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) Within 15 
work days after making an exposure determination in accordance with 
paragraph (d)(2) or paragraph (d)(3) of this section, the employer shall 
individually notify each affected employee in writing of the results of 
that determination or post the results in an appropriate location 
accessible to all affected employees.
    (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 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.

[[Page 154]]

    (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 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) The employer shall ensure that bags or containers of 
contaminated protective clothing or equipment that are removed from 
change rooms for laundering, cleaning, maintenance, or disposal are 
labeled in accordance with the requirements of the Hazard Communication 
Standard, Sec.  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

[[Page 155]]

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:
    (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

[[Page 156]]

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);
    (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) Hazard 
communication--general--(i) Chemical manufacturers, importers, 
distributors and employers shall comply with all requirements of the 
Hazard Communication Standard (HCS) (Sec.  1910.1200) for chromium (VI).

[[Page 157]]

    (ii) In classifying the hazards of chromium (VI) at least the 
following hazards are to be addressed: Cancer, eye irritation, and skin 
sensitization.
    (iii) Employers shall include chromium (VI) in the hazard 
communication program established to comply with the HCS (Sec.  
1910.1200). Employers shall ensure that each employee has access to 
labels on containers of chromium (VI) and to safety data sheets, and is 
trained in accordance with the requirements of HCS and paragraph (l)(2) 
of this section.
    (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 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 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

[[Page 158]]

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;
    (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 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

[[Page 159]]

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.
    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

[[Page 160]]

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.
    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.

         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

[[Page 161]]

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 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

[[Page 162]]

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; 75 FR 12686, Mar. 17, 2010; 77 FR 17781, 
Mar. 26, 2012]



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 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

[[Page 163]]

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 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

[[Page 164]]

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 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.;

[[Page 165]]

    (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.
    (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.

[[Page 166]]

    (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.
    (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

[[Page 167]]

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, 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) 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.

[[Page 168]]

    (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.
    (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:

[[Page 169]]

    (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 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

[[Page 170]]

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-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 other reasonably-sized standard film or 
digital 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

[[Page 171]]

    (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 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,

[[Page 172]]

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 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;

[[Page 173]]

    (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 
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

[[Page 174]]

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.
    (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

[[Page 175]]

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.
    (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) Hazard 
communication.--general. (i) Chemical manufacturers, importers, 
distributors and employers shall comply with all requirements of the 
Hazard Communication Standard (HCS) (Sec.  1910.1200) for cadmium.
    (ii) In classifying the hazards of cadmium at least the following 
hazards are to be addressed: Cancer; lung effects; kidney effects; and 
acute toxicity effects.
    (iii) Employers shall include cadmium in the hazard communication 
program established to comply with the HCS (Sec.  1910.1200). Employers 
shall ensure that each employee has access to labels on containers of 
cadmium and to safety data sheets, and is trained in accordance with the 
requirements of HCS and paragraph (m)(4) of this section.
    (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

[[Page 176]]

protective steps before entering the area.
    (ii) Warning signs required by paragraph (m)(2)(i) of this section 
shall bear the following legend:

DANGER
CADMIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS AND KIDNEYS
WEAR RESPIRATORY PROTECTION IN THIS AREA
AUTHORIZED PERSONNEL ONLY

    (iii) The employer shall ensure that signs required by this 
paragraph (m)(2) are illuminated, cleaned, and maintained as necessary 
so that the legend is readily visible.
    (iv) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (m)(2)(ii) of this section:

DANGER
CADMIUM
CANCER HAZARD
CAN CAUSE LUNG AND KIDNEY DISEASE
AUTHORIZED PERSONNEL ONLY
RESPIRATORS REQUIRED IN THIS AREA

    (3) Warning labels. (i) Shipping and storage containers containing 
cadmium or cadmium compounds shall bear appropriate warning labels, as 
specified in paragraph (m)(1) of this section.
    (ii) The warning labels for containers of contaminated protective 
clothing, equipment, waste, scrap, or debris shall include at least the 
following information:

DANGER
CONTAINS CADMIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS AND KIDNEYS
AVOID CREATING DUST

    (iii) Prior to June 1, 2015, employers may include the following 
information on shipping and storage containers containing cadmium, 
cadmium compounds, or cadmium contaminated clothing, equipment, waste, 
scrap, or debris in lieu of the labeling requirements specified in 
paragraphs (m)(1)(i) and (m)(3)(ii) of this section:

DANGER
CONTAINS CADMIUM
CANCER HAZARD
AVOID CREATING DUST
CAN CAUSE LUNG AND KIDNEY DISEASE

    (iv) 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
    (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.

[[Page 177]]

    (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 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 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) Availability. (i) Except as otherwise provided for in this 
section, access to all records required to be maintained by paragraphs 
(n)(1) through (3) of this section shall be in accordance with the 
provisions of 29 CFR 1910.1020.
    (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.
    (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.

[[Page 178]]

    (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.
    (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

[[Page 179]]

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 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

[[Page 180]]

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 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.,

[[Page 181]]

(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 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

[[Page 182]]

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 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.

[[Page 183]]

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.)
    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)

[[Page 184]]

 
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

                                          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.


[[Page 185]]


                                      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, 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,

[[Page 186]]

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.

   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.

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    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.
    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.

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    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 trifluoride 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

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     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 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

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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 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

[[Page 203]]

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.
    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

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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.
    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

[[Page 205]]

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 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.

[[Page 206]]

    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 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

[[Page 207]]

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 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

[[Page 208]]

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.)

 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

[[Page 209]]

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 
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

[[Page 210]]

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.
    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.

[[Page 211]]

    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.
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.

[[Page 212]]

 
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             0.5 x                          1.0 x                          2.0 x
---------------------------------------  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                     0.1 x
--------------------------------------------------------   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
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                0.5 x                       1.0 x                       2.0 x
----------------------------------------------  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

[[Page 213]]

 
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  ..........
----------------------------------------------------------------------------------------------------------------

  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.

[[Page 214]]

    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 
commercial 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 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.

[[Page 215]]

    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.
    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

[[Page 216]]

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 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;

[[Page 217]]

    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 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

[[Page 218]]

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;
    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

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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.

             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.

[[Page 220]]

    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 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.)

[[Page 221]]

                         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.

   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.
------------------------------------------------------------------------


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    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.
    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;

[[Page 223]]

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 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.

[[Page 224]]

                 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 
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

[[Page 225]]

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 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

[[Page 226]]

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 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.

[[Page 227]]

    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 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.

[[Page 228]]

    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 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

[[Page 229]]



 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 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

[[Page 230]]

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 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

[[Page 231]]

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/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%.

[[Page 232]]

    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 (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 233]]



                                                                   Table 4--Blood Cadmium Concentrations of U.S. Population Not Occupationally Exposed to Cadmium \a\
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                   No. in                                                               Arithmetic mean (S.D.)    Absolute range or    minusGSD)      percentile of       percentile of         Reference
                                    (n)                                                                           \c\               (95% CI) \d\               \e\             distribution \f\    distribution \f\
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1...............................       80  M.................  4 to 69...........  NS,S..............  1.13....................  0.35-3.3..........  0.981.71.                                                         (1979).
                                       88  F.................  4 to 69...........  NS,S..............  1.03....................  0.21-3.3..........  0.911.63.
                                      115  M/F...............  4 to 69...........  NS................  0.95....................  0.21-3.3..........  0.851.59.
                                       31  M/F...............  4 to 69...........  S.................  1.54....................  0.4-3.3...........  1.371.65.
2...............................       10  M.................  Adults............  (?)...............  2.02.1.                                                                                                        (1983).
3...............................       24  M.................  Adults............  NS................  ........................  ..................  0.61/87.                                                         Vahter (1983).
                                       20  M.................  Adults............  S.................  ........................  ..................  1.22.13.
                                       64  F.................  Adults............  NS................  ........................  ..................  0.51.85.
                                       39  F.................  Adults............  S.................  ........................  ..................  0.82.22.
4...............................       32  M.................  Adults............  S,NS..............  ........................  ..................  1.22.0.                                                          (1989).
5...............................       35  M.................  Adults............  (?)...............  2.12.1.                                                                                                        (1989).
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\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.

    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.

[[Page 234]]

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.

                                                                                  Table 5--Blood Cadmium in Workers Exposed to Cadmium in the Workplace
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                          Concentrations of Cadmium in blood \a\
                                  Work environment                                           Mean concentration ------------------------------------------------------------------------------------------------------------------------
          Study number           (worker population    Number in study      Employment in     of cadmium in air   Arithmetic mean (S.D.)   Absolute range or    Geometric mean     percentile of      percentile of        Reference
                                                                                                                            \b\              (95% C.I.) \c\       (GSD) \d\      range \e\ ( ) \f\  range \e\ ( ) \f\
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1..............................  Ni-Cd battery       ..................  3-40..............  <=90..............  ........................  .................  .................  .................  .................  Lauwerys et al.
                                  plant and Cd                                                                                                                                                                          1976.
                                  production plant:
                                  (Workers without   96................  ..................  ..................  21.41.9.
                                  (Workers with      25................  ..................  ..................  38.83.8.
2..............................  Ni-Cd battery       ..................  ..................  ..................  ........................  .................  .................  .................  .................  Adamsson et al.
                                  plant:                                                                                                                                                                                (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       ..................  ..................  ..................  ........................  .................  .................  .................  .................  Sukuri et al.
                                  plant:                                                                                                                                                                                1982.
                                  (High exposure     7.................  (10.6)............  [1,000-5 yrs;.....  20.87.1.
                                  (Low exposure      9.................  (7.3).............  40-5 yrs].........  7.11.1.
4..............................  Retrospective       19................  15-41.............  ..................  ........................  .................  .................  .................  .................  Roels et al.
                                  study of workers                                                                                                                                                                      1982.
                                  with renal
                                  problems:
                                  (Before removal).  ..................  (27.2)............  ..................  39.93.7.
                                  (After removal)..  ..................  \g\(4.2)..........  ..................  14.15.6.
5..............................  Cadmium production  ..................  ..................  ..................  ........................  .................  .................  .................  .................  Ellis et al.
                                  plant:                                                                                                                                                                                1983.
                                  (Workers without   33................  1-34..............  ..................  155.7.
                                  dysfunction).
                                  (Workers with      18................  10-34.............  ..................  248.5.
                                  dysfunction).
6..............................  Cd-Cu alloy plant.  75................  Up to 39..........  ..................  ........................  .................  8.81.1.                                              1988.
7..............................  Cadmium recovery    45................  (19.0)............  ..................  ........................  .................  7.92.0.
                                  t (19) and former
                                  (26) workers.
8..............................  Cadmium recovery    40................  ..................  ..................  10.25.3.                                                                                               1989.
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\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 235]]

    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 236]]

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.
    Techniques for deriving cadmium as a ratio of CRTU, and the 
confidence limits for

[[Page 237]]

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 238]]

                    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 239]]



 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 240]]



                                                                          Table 8--Urine Cadmium Concentrations in Workers Exposed to Cadmium in the Workplace
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                          Concentration of cadmium in Urine \a\
                                  Work environment                                           Mean Concentration ------------------------------------------------------------------------------------------------------------------------
          Study number           (worker population    Number in Study      Employment in     of cadmium in air   Arithmetic mean (S.D.)   Absolute range or    Geometric mean     percentile of      percentile of        Reference
                                                                                                                            \b\              (95% C.I.) \c\       (GSD) \d\      range \e\ ( ) \f\  range \e\ ( ) \f\
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1..............................  Ni-Cd battery       ..................  3-40..............  <=90..............  ........................  .................  .................  .................  .................  Lauwerys et al.
                                  plant and Cd                                                                                                                                                                          1976.
                                  production plant.
                                  (Workers without   96................  ..................  ..................  16.316.7.
                                  (Workers with      25................  ..................  ..................  48.242.6.
2..............................  Ni-Cd battery       ..................  ..................  ..................  ........................  .................  .................  .................  .................  Adamsson et al.
                                  plant.                                                                                                                                                                                (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       148...............  (15.4)............  ..................  15.8....................  2-150............  .................  .................  .................  Butchet et al.
                                  production                                                                                                                                                                            1980.
                                  facility.
4..............................  Retrospective       19................  15-41.............  ..................  ........................  .................  .................  .................  .................  Roels et al.
                                  study of workers                                                                                                                                                                      1982.
                                  with renal
                                  problems.
                                  (Before removal).  ..................  (27.2)............  ..................  39.428.1.
                                  (After removal)..  ..................  (4.2) \g\.........  ..................  16.49.0.
5..............................  Cadmium production  ..................  ..................  ..................  ........................  .................  .................  .................  .................  Ellis et al.
                                  plant.                                                                                                                                                                                1983.
                                  (Workers without   33................  1-34..............  ..................  9.46.9.
                                  dysfunction).
                                  (Workers with      18................  10-34.............  ..................  22.812.7.
                                  dysfunction).
6..............................  Cd-Cu alloy plant.  75................  Up to 39..........  Note h............  6.99.4.                                                                                               1988.
7..............................  Cadmium recovery    45................  (19)..............  87................  9.36.9.
8..............................  Pigment             29................  (12.8)............  0.18-3.0..........  ........................  0.2-9.5..........  1.1..............  .................  .................  Mueller et al.
                                  manufacturing                                                                                                                                                                         1989.
                                  plant.
9..............................  Pigment             26................  (12.1)............  <=3.0.............  ........................  .................  1.25                                         1990.
                                  plant.                                                                                                                       2.45.
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Concentrations reported in [micro]g/g Cr.
\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.
\h\ Equivalent to 50 for 20-22 yrs


[[Page 241]]

    Data in Table 8 from Lauwerys et al. (1976) and Ellis et al. (1983) 
indicate that CDU concentrations are higher among those exhibiting 
kidney lesions or dysfunction than among those lacking these symptoms. 
Data from the study by Roels et al. (1982) indicate that CDU levels 
decrease among workers removed from occupational exposure to cadmium in 
comparison to workers experiencing ongoing exposure. In both cases, 
however, the distinction between the 2 groups is not as clear as with 
CDB; there is more overlap in CDU levels observed among each of the 
paired populations than is true for corresponding CDB levels. As with 
CDB levels, the data in Table 8 suggest increased CDU concentrations 
among workers who experienced increased overall exposure.
    Although a few occupationally-exposed workers in the studies 
presented in Table 8 exhibit CDU levels below 3 [micro]g/g CRTU, most of 
those workers exposed to cadmium levels in excess of the PEL defined in 
the final cadmium rule exhibit CDU levels above 3 [micro]g/g CRTU; this 
level represents the upper 95th percentile of the CDU distribution 
observed among those who are not occupationally exposed to cadmium 
(Table 7).
    The mean CDU levels reported in Table 8 among occupationally-exposed 
groups studied (except 2) exceed 3 [micro]g/g CRTU. Correspondingly, the 
level of exposure reported in these studies (with 1 exception) are 
significantly higher than what workers will experience under the final 
cadmium rule. The 2 exceptions are from the studies by Mueller et al. 
(1989) and Kawada et al. (1990); these studies indicate that workers 
exposed to cadmium during pigment manufacture do not exhibit CDU levels 
as high as those levels observed among workers exposed to cadmium in 
other occupations. Exposure levels, however, were lower in the pigment 
manufacturing plants studied. Significantly, workers removed from 
occupational cadmium exposure for an average of 4 years still exhibited 
CDU levels in excess of 3 [micro]g/g CRTU (Roels et al. 1982). In the 
single-exception study with a reported level of cadmium exposure lower 
than levels proposed in the final rule (i.e., the study of a pigment 
manufacturing plant by Kawada et al. 1990), most of the workers 
exhibited CDU levels less than 3 [micro]g/g CRTU (i.e., the mean value 
was only 1.3 [micro]g/g CRTU). CDU levels among workers with such 
limited cadmium exposure are expected to be significantly lower than 
levels of other studies reported in Table 8.
    Based on the above data, a CDU level of 3 [micro]g/g CRTU appear to 
represent a threshold above which significant work place exposure to 
cadmium occurs over the work span of those being monitored. Note that 
this threshold is not as distinct as the corresponding threshold 
described for CDB. In general, the variability associated with CDU 
measurements among exposed workers appears to be higher than the 
variability associated with CDB measurements among similar workers.

              5.2.8 Conclusions and Recommendations for CDU

    The above evaluation supports the following recommendations for a 
CDU proficiency program. These recommendations address only sampling and 
analysis procedures for CDU determinations specifically, which are to be 
reported as an unadjusted [micro]g Cd/l urine. Normalizing this result 
to creatinine requires a second analysis for CRTU so that the ratio of 
the 2 measurements can be obtained. Creatinine analysis is addressed in 
Section 5.4. Formal procedures for combining the 2 measurements to 
derive a value and a confidence limit for CDU in [micro]g/g CRTU are 
provided in Section 3.3.3.

                       5.2.8.1 Recommended method

    The method of Pruszkowska et al. (1983) should be adopted for CDU 
analysis. This method is recommended because it is simple, 
straightforward and reliable (i.e., small variations in experimental 
conditions do not affect the analytical results).
    A synopsis of the methods used by laboratories to determine CDU 
under the interlaboratory program administered by the CTQ (1991) 
indicates that more than 78% (24 of 31) of the participating 
laboratories use a dilution method to prepare urine samples for CDU 
analysis. Laboratories may adopt alternate methods, but it is the 
responsibility of the laboratory to demonstrate that the alternate 
methods provide results of comparable quality to the Pruszkowska method.

                     5.2.8.2 Data quality objectives

    The following data quality objectives should facilitate 
interpretation of analytical results, and are achievable based on the 
above evaluation.
    Limit of Detection. A level of 0.5 [micro]g/l (i.e., corresponding 
to a detection limit of 0.5 [micro]g/g CRTU, assuming 1 g CRT/l urine) 
should be achievable. Pruszkowska et al. (1983) achieved a limit of 
detection of 0.04 [micro]g/l for CDU based on the slope of the curve for 
their working standards (0.35 pg Cd/0.0044, A signal = 1% absorbance 
using GF-AAS).
    The CDC reports a minimum detection limit for CDU of 0.07 [micro]g/l 
using a modified Pruszkowska method. This limit of detection was defined 
as 3 times the standard deviation calculated from 10 repeated 
measurements of a ``low level'' CDU test sample (Attachment 8 of exhibit 
106 of OSHA docket H057A).
    Stoeppler and Brandt (1980) report a limit of detection for CDU of 
0.2 [micro]g/l using an aqueous dilution (1:2) of the urine samples.
    Accuracy. A recent report from the CTQ (Weber, private 
communication) indicates that 36% of the laboratories in the program

[[Page 242]]

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 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 243]]

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 244]]

                  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 245]]

 
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 246]]

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 247]]

(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 248]]

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.

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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 253]]

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 254]]

    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 [supreg] 
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 [supreg] showed a good correlation. (See 
Specific Performance Characteristics).
    *Note: Numbered subscripts refer to the bibliography and lettered 
subscripts refer to footnotes.
    Autoanalyzer [supreg], 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 255]]

    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 [supreg] 
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 \7 8   Drug concentration
                                                                              9\           ---------------------
                            Antibiotic                             ------------------------
                                                                       mg/dL     [mmol/L]     mg/dL     [mmol/L]
----------------------------------------------------------------------------------------------------------------
Cephaloridine.....................................................    1.4         0.3              25        6.0
Cephalexin........................................................  0.6-2.0     0.2-0.6            25        7.2
Cephamandole......................................................  1.3-2.5     0.3-0.5            25        4.9
Cephapirin........................................................    2.0        D0.4              25        5.6
Cephradine........................................................  1.5-2.0     0.4-0.6            25        7.1
Cefazolin.........................................................  2.5-5.0     0.55-1.1           50       11.0
----------------------------------------------------------------------------------------------------------------

     The following cephalosporin antibiotics have been 
shown to affect CREA results when present at the indicated 
concentrations. System inaccuracies (bias) due to these substances are 
greater that 0.1 mg/dL [8.84 [micro]mol/L] at CREA concentrations of:

----------------------------------------------------------------------------------------------------------------
                                                           Peak serum level \8          Drug concentration
                                                                   10\          --------------------------------
                       Antibiotic                       ------------------------
                                                            mg/dL     [mmol/L]     mg/dL     [mmol/L]    Effect
----------------------------------------------------------------------------------------------------------------
Cephalothin............................................    1-6       0.2-1.5           100       25.2  [darr]20-
                                                                                                             25%
Cephoxitin.............................................    2.0         0.5             5.0        1.2  [uarr]35-
                                                                                                             40%
----------------------------------------------------------------------------------------------------------------


[[Page 256]]

     The single wavelength measurement used in this 
method eliminates interference from chromophores whose 510 nm absorbance 
is constant throughout the measurement period.
     Each laboratory should determine the 
acceptability of its own blood collection tubes and serum separation 
products. Variations in these products may exist between manufacturers 
and, at times, from lot to lot.

    d. Systeme International d'unites (S.I. Units) are in brackets.

    Procedure:

                                                 Test Materials
----------------------------------------------------------------------------------------------------------------
                                                                    II, III Du    IV, SX Du Pont  V Du Pont Cat.
                              Item                                 Pont Cat. No.     Cat. No.           No.
----------------------------------------------------------------------------------------------------------------
ACA [supreg] CREA Analytical Test Pack..........................       701976901       701976901       701976901
Sample System Kit or............................................       710642901       710642901       713697901
Micro Sample System Kit and.....................................       702694901       710356901              NA
Micro Sample System Holders.....................................       702785000              NA              NA
DYLUX [supreg] Photosensitive...................................
Printer Paper...................................................       700036000              NA              NA
Thermal Printer Paper...........................................              NA       710639901       713645901
Du Pont Purified Water..........................................       704209901       710615901       710815901
Cell Wash Solution..............................................       701864901       710664901       710864901
----------------------------------------------------------------------------------------------------------------

    Test Steps: The operator need only load the sample kit and 
appropriate test pack(s) into a properly prepared ACA [supreg] discrete 
clinical analyzer. It automatically advances the pack(s) through the 
test steps and prints a result(s). See the Instrument Manual of the ACA 
[supreg] analyzer for details of mechanical travel of the test pack(s).

                Preset Creatinine (CREA)--Test Conditions

 Sample Volume: 200 [micro]L
 Diluent: Purified Water
 Temperature: 37.0 0.1 [deg]C
 Reaction Period: 29 seconds
 Type of Measurement: Rate
 Measurement Period: 17.07 seconds
 Wavelength: 510 nm
 Units: mg/dL [[micro]mol/L]

    CALIBRATION: The general calibration procedure is described in the 
Calibration/Verification chapter of the Manuals.
    The following information should be considered when calibrating the 
CREA method.

 Assay Range: 0-20 mg/mL [0-1768 [micro]mol/L] \e\.
 Reference Material: Protein containing primary 
standards \f\ or secondary calibrators such as Du Pont Elevated 
Chemistry Control (Cat. 790035903) and Normal Chemistry Control 
(Cat.790035905) \g\.
 Suggested Calibration Levels: 1,5,20, mg/mL [88, 442, 
1768 [micro]mol/L].
 Calibration Scheme: 3 levels, 3 packs per level.
 Frequency: Each new pack lot. Every 3 months for any 
one pack lot.

    e. For the results in S.I. units [[micro]mol/L] the conversion 
factory is 88.4.
    f. Refer to the Creatinine Standard Preparation and Calibration 
Procedure available on request from a Du Pont Representative.
    g. If the Du Pont Chemistry Controls are being used, prepare them 
according to the instructions on the product insert sheets.

                Preset Creatinine (CREA) Test Conditions
------------------------------------------------------------------------
                                    ACA [supreg] II    ACA [supreg] III,
              Item                     analyzer       IV, SX, V analyzer
------------------------------------------------------------------------
Count by........................  One (1)...........  NA
                                  [Five (5)]........
Decimal Point...................  0.0 mg/dL.........  000.0 mg/dL
Location........................  [000.0 [micro]mol/  [000 [micro]mol/L]
                                   L].
Assigned Starting...............  999.8.............  -1.000 E1
Point or Offset Co..............  [9823.]...........  [-8.840 E2]
Scale Factor or Assigned........  0.2000............  2.004 E-1 \h\
                                  mg/dL/count \h\...
Linear Term C1 h................  [0.3536 [micro]mol/ [1.772E1]
                                   L/count].
------------------------------------------------------------------------

    h. The preset scale factor (linear term) was derived from the molar 
absorptivity of the indicator and is based on an absorbance to activity 
relationship (sensitivity) of 0.596 (mA/min)/(U/L). Due to small 
differences in filters and electronic components between instruments, 
the actual scale factor (linear

[[Page 257]]

term) may differ slightly from that given above.
    Quality Control: Two types of quality control procedures are 
recommended:
     General Instrument Check. Refer to the Filter 
Balance Procedure and the Absorbance Test Method described in the ACA 
Analyzer Instrument Manual. Refer also to the ABS Test Methodology 
literature.
     Creatinine Method Check. At least once daily run 
a CREA test on a solution of known creatinine activity such as an 
assayed control or calibration standard other than that used to 
calibrate the CREA method. For further details review the Quality 
Assurance Section of the Chemistry Manual. The result obtained should 
fall within acceptable limits defined by the day-to-day variability of 
the system as measured in the user's laboratory. (See SPECIFIC 
PERFORMANCE CHARACTERISTICS for guidance.) If the result falls outside 
the laboratory's acceptable limits, follow the procedure outlined in the 
Chemistry Troubleshooting Section of the Chemistry Manual.
    A possible system malfunction is indicated when analysis of a sample 
with five consecutive test packs gives the following results:

------------------------------------------------------------------------
                  Level                                  SD
------------------------------------------------------------------------
1 mg/dL..................................  0.15 mg/dL
[88 [micro]mol/L]........................  [13 [micro]mol/L]
20 mg/dL.................................  0.68 mg/dL
[1768 [micro]mol/L]......................  [60 [micro]mol/L]
------------------------------------------------------------------------

    Refer to the procedure outlined in the Trouble Shooting Section of 
the Manual.
    Results: The ACA [supreg] analyzer automatically calculates and 
prints the CREA result in mg/dL [[micro]mol/L].

 Limitation of Procedure: Results 20 mg/dL [1768 [micro]mol/
                                   L]:

     Dilute with suitable protein base diluent. 
Reassay. Correct for diluting before reporting.
    The reporting system contains error messages to warn the operator of 
specific malfunctions. Any report slip containing a letter code or word 
immediately following the numerical value should not be reported. Refer 
to the Manual for the definition of error codes.

                           Reference Interval

Serum: \11 i\
  Males                              0.8-1.3 md/dL
                                     [71-115 [micro]mol/L]
  Females                            0.6-1.0 md/dL
                                     [53-88 [micro]mol/L]
Urine: \12\
  Males                              0.6-2.5 g/24 hr
                                     [53-221 mmol/24 hr]
  Females                            0.6-1.5 g/24 hr
                                     [53-133 mmol/24 hr]
 

    i. Reference interval data obtained from 200 apparently healthy 
individuals (71 males, 129 females) between the ages of 19 and 72.

    Each laboratory should establish its own reference intervals for 
CREA as performed on the analyzer.

                Specific Performance Characteristics \j\

                                               Reproducibility \k\
----------------------------------------------------------------------------------------------------------------
                                                                            Standard deviation (% CV)
               Material                          Mean          -------------------------------------------------
                                                                       Within-run              Between-day
----------------------------------------------------------------------------------------------------------------
Lyophilized..........................  1.3....................  0.05 (3.7).............  0.05 (3.7)
Control..............................  [115]..................  [4.4]..................  [4.4]
Lyophilized..........................  20.6...................  0.12 (0.6).............  0.37 (1.8)
Control..............................  [1821].................  [10.6].................  [32.7]
----------------------------------------------------------------------------------------------------------------


                                     Correlation--Regression Statistics \l\
----------------------------------------------------------------------------------------------------------------
                                                                                             Correlation
                        Comparative method                            Slope      Intercept   coefficient     n
----------------------------------------------------------------------------------------------------------------
Autoanalyzer [supreg]............................................         1.03    0.03[2.7]        0.997     260
----------------------------------------------------------------------------------------------------------------

    j. All specific performance characteristics tests were run after 
normal recommended equipment quality control checks were performed (see 
Instrument Manual).
    k. Specimens at each level were analyzed in duplicate for twenty 
days. The within-run and between-day standard deviations were calculated 
by the analysis of variance method.
    l. Model equation for regression statistics is:

[[Page 258]]

[GRAPHIC] [TIFF OMITTED] TC15NO91.189

                             Assay Range \m\

0.0-20.0 mg/dl
[0-1768 [micro]mol]

    m. See REPRODUCIBILITY for method performance within the assay 
range.

                         Analytical Specificity

    See KNOWN INTERFERING SUBSTANCES section for details.

                              Bibliography

    \1\ Larsen, K, Clin Chem Acta 41, 209 (1972).
    \2\ Tietz, NW, Fundamentals of Clinical Chemistry, W. B. Saunders 
Co., Philadelphia, PA, 1976, pp 47-52, 1211.
    \3\ Supplementary information pertaining to the effects of various 
drugs and patient conditions on in vivo or in vitro diagnostic levels 
can be found in ``Drug Interferences with Clinical Laboratory Tests,'' 
Clin. Chem 21 (5) (1975), and ``Effects of Disease on Clinical 
Laboratory Tests,'' Clin Chem, 26 (4) 1D-476D (1980).
    \4\ Watkins, R. Fieldkamp, SC, Thibert, RJ, and Zak, B, Clin Chem, 
21, 1002 (1975).
    \5\ Kawas, EE, Richards, AH, and Bigger, R, An Evaluation of a 
Kinetic Creatinine Test for the Du Pont ACA, Du Pont Company, 
Wilmington, DE (February 1973). (Reprints available from DuPont Company, 
Diagnostic Systems)
    \6\ Westgard, JO, Effects of Hemolysis and Lipemia on ACA Creatinine 
Method, 0.200 [micro]L, Sample Size, Du Pont Company, Wilmington, DE 
(October 1972).
    \7\ Physicians' Desk Reference, Medical Economics Company, 33 
Edition, 1979.
    \8\ Henry, JB, Clinical Diagnosis and Management by Laboratory 
Methods, W.B. Saunders Co., Philadelphia, PA 1979, Vol. III.
    \9\ Krupp, MA, Tierney, LM Jr., Jawetz, E, Roe, RI, Camargo, CA, 
Physicians Handbook, Lange Medical Publications, Los Altos, CA, 1982 pp 
635-636.
    \10\ Sarah, AJ, Koch, TR, Drusano, GL, Celoxitin Falsely Elevates 
Creatinine Levels, JAMA 247, 205-206 (1982).
    \11\ Gadsden, RH, and Phelps, CA, A Normal Range Study of Amylase in 
Urine and Serum on the Du Pont ACA, Du Pont Company, Wilmington, DE 
(March 1978). (Reprints available from DuPont Company, Diagnostic 
Systems)
    \12\ Dicht, JJ, Reference Intervals for Serum Amylase and Urinary 
Creatinine on the Du Pont ACA [supreg] Discrete Clinical Analyzer, Du 
Pont Company, Wilmington, DE (November 1984).

 Attachment 3--Analysis of Creatinine for the Normalization of Cadmium 
   and Beta-2-Microglobulin Concentrations in Urine (OSLTC Procedure).

    Matrix: Urine.
    Target concentration: 1.1 g/L (this amount is representative of 
creatinine concentrations found in urine).
    Procedure: A 1.0 mL aliquot of urine is passed through a C18 SEP-PAK 
[supreg] (Waters Associates). Approximately 30 mL of HPLC (high 
performance liquid chromatography) grade water is then run through the 
SEP-PAK. The resulting solution is diluted to volume in a 100-mL 
volumetric flask and analyzed by HPLC using an ultraviolet (UV) 
detector.
    Special requirements: After collection, samples should be 
appropriately stabilized for cadmium (Cd) analysis by using 10% high 
purity (with low Cd background levels) nitric acid (exactly 1.0 mL of 
10% nitric acid per 10 mL of urine) or stabilized for Beta-2-
Microglobulin (B2M) by taking to pH 7 with dilute NaOH (exactly 1.0 mL 
of 0.11 N NaOH per 10 mL of urine). If not immediately analyzed, the 
samples should be frozen and shipped by overnight mail in an insulated 
container.

    Dated: January 1992.

David B. Armitage,

Duane Lee,

    Chemists.

Organic Service Branch II, OSHA Technical Center, Salt Lake City, Utah

                          1. General Discussion

1.1 Background
    1.1.1. History of procedure
    Creatinine has been analyzed by several methods in the past. The 
earliest methods were of the wet chemical type. As an example, 
creatinine reacts with sodium picrate in basic solution to form a red 
complex, which is then analyzed colorimetrically (Refs. 5.1. and 5.2.).
    Since industrial hygiene laboratories will be analyzing for Cd and 
B2M in urine, they will be normalizing those concentrations to the 
concentration of creatinine in urine. A literature search revealed 
several HPLC methods (Refs. 5.3., 5.4., 5.5. and 5.6.) for creatinine in 
urine and because many industrial hygiene laboratories have HPLC 
equipment, it was desirable to develop an industrial hygiene HPLC method 
for creatinine in urine. The method of Hausen, Fuchs, and Wachter was 
chosen as the starting point for method development. SEP-PAKs were used 
for sample clarification and cleanup

[[Page 259]]

in this method to protect the analytical column. The urine aliquot which 
has been passed through the SEP-PAK is then analyzed by reverse-phase 
HPLC using ion-pair techniques.
    This method is very similar to that of Ogata and Taguchi (Ref. 
5.6.), except they used centrifugation for sample clean-up. It is also 
of note that they did a comparison of their HPLC results to those of the 
Jaffe method (a picric acid method commonly used in the health care 
industry) and found a linear relationship of close to 1:1. This 
indicates that either HPLC or colorimetric methods may be used to 
measure creatinine concentrations in urine.
    1.1.2. Physical properties (Ref. 5.7.)
Molecular weight: 113.12
Molecular formula: C4-H7-N3-0
Chemical name: 2-amino-1,5-dihydro-1-methyl-4H-imidazol-4-one
CAS No.: 60-27-5
Melting point: 300 [deg]C (decomposes)
Appearance: white powder
Solubility: soluble in water; slightly soluble in alcohol; practically 
insoluble in acetone, ether, and chloroform
Synonyms: 1-methylglycocyamidine, 1-methylhydantoin-2-imide
Structure: see Figure 1
[GRAPHIC] [TIFF OMITTED] TC28OC91.015

1.2. Advantages
    1.2.1. This method offers a simple, straightforward, and specific 
alternative method to the Jaffe method.
    1.2.2. HPLC instrumentation is commonly found in many industrial 
hygiene laboratories.

                    2. Sample stabilization procedure

2.1. Apparatus
    Metal-free plastic container for urine sample.
2.2. Reagents
    2.2.1. Stabilizing Solution--
    (1) Nitric acid (10%, high purity with low Cd background levels) for 
stabilizing urine for Cd analysis or
    (2) NaOH, 0.11 N, for stabilizing urine for B2M analysis.
    2.2.2. HPLC grade water
2.3. Technique
    2.3.1. Stabilizing solution is added to the urine sample (see 
section 2.2.1.). The stabilizing solution should be such that for each 
10 mL of urine, add exactly 1.0 mL of stabilizer solution. (Never add 
water or urine to acid or base. Always add acid or base to water or 
urine.) Exactly 1.0 mL of 0.11 N NaOH added to 10 mL of urine should 
result in a pH of 7. Or add 1.0 mL of 10% nitric acid to 10 mL of urine.
    2.3.2. After sample collection seal the plastic bottle securely and 
wrap it with an appropriate seal. Urine samples should be frozen and 
then shipped by overnight mail (if shipping is necessary) in an 
insulated container. (Do not fill plastic bottle too full. This will 
allow for expansion of contents during the freezing process.)
2.4. The Effect of Preparation and Stabilization Techniques on 
          Creatinine Concentrations
    Three urine samples were prepared by making one sample acidic, not 
treating a second sample, and adjusting a third sample to pH 7. The 
samples were analyzed in duplicate by two different procedures. For the 
first procedure a 1.0 mL aliquot of urine was put in a 100-mL volumetric 
flask, diluted to volume with HPLC grade water, and then analyzed 
directly on an HPLC. The other procedure used SEP-PAKs. The SEP-PAK was 
rinsed with approximately 5 mL of methanol followed by approximately 10 
mL of HPLC grade water and both rinses were discarded. Then, 1.0 mL of 
the urine sample was put through the SEP-PAK, followed by 30 mL of HPLC 
grade water. The urine and water were transferred to a 100-mL volumetric 
flask, diluted to volume with HPLC grade water, and analyzed by HPLC. 
These three urine samples were analyzed on the day they were obtained 
and then frozen. The results show that whether the urine is acidic, 
untreated or adjusted to pH 7, the resulting answer for creatinine is 
essentially unchanged. The purpose of stabilizing the urine by making it 
acidic or neutral is for the analysis of Cd or B2M respectively.

[[Page 260]]



          Comparison of Preparation & Stabilization Techniques
------------------------------------------------------------------------
                                                   w/o SEP-    with SEP-
                     Sample                         PAK g/L     PAK g/L
                                                  creatinine  creatinine
------------------------------------------------------------------------
Acid............................................        1.10        1.10
Acid............................................        1.11        1.10
Untreated.......................................        1.12        1.11
Untreated.......................................        1.11        1.12
pH 7............................................        1.08        1.02
pH 7............................................        1.11        1.08
------------------------------------------------------------------------

2.5. Storage
    After 4 days and 54 days of storage in a freezer, the samples were 
thawed, brought to room temperature and analyzed using the same 
procedures as in section 2.4. The results of several days of storage 
show that the resulting answer of creatinine is essentially unchanged.

                                                  Storage Data
----------------------------------------------------------------------------------------------------------------
                                                                       4 days                    54 days
                                                             ---------------------------------------------------
                           Sample                             w/o SEP-PAK   with SEP-   w/o SEP-PAK   with SEP-
                                                                  g/L        PAK g/L        g/L        PAK g/L
                                                               creatinine   creatinine   creatinine   creatinine
----------------------------------------------------------------------------------------------------------------
Acid........................................................         1.09         1.09         1.08         1.09
Acid........................................................         1.10         1.10         1.09         1.10
Acid........................................................  ...........  ...........         1.09         1.09
Untreated...................................................         1.13         1.14         1.09         1.11
Untreated...................................................         1.15         1.14         1.10         1.10
Untreated...................................................  ...........  ...........         1.09         1.10
pH 7........................................................         1.14         1.13         1.12         1.12
pH 7........................................................         1.14         1.13         1.12         1.12
pH 7........................................................  ...........  ...........         1.12         1.12
----------------------------------------------------------------------------------------------------------------

2.6. Interferences
    None.
2.7. Safety precautions
    2.7.1. Make sure samples are properly sealed and frozen before 
shipment to avoid leakage.
    2.7.2. Follow the appropriate shipping procedures.
    The following modified special safety precautions are based on those 
recommended by the Centers for Disease Control (CDC) (Ref. 5.8.). and 
OSHA's Bloodborne Pathogens standard (29 CFR 1910.1039).
    2.7.3. Wear gloves, lab coat, and safety glasses while handling all 
human urine products. Disposable plastic, glass, and paper (pipet tips, 
gloves, etc.) that contact urine should be placed in a biohazard 
autoclave bag. These bags should be kept in appropriate containers until 
sealed and autoclaved. Wipe down all work surfaces with 10% sodium 
hypochlorite solution when work is finished.
    2.7.4. Dispose of all biological samples and diluted specimens in a 
biohazard autoclave bag at the end of the analytical run.
    2.7.5. Special care should be taken when handling and dispensing 
nitric acid. Always remember to add acid to water (or urine). Nitric 
acid is a corrosive chemical capable of severe eye and skin damage. Wear 
metal-free gloves, a lab coat, and safety glasses. If the nitric acid 
comes in contact with any part of the body, quickly wash with copious 
quantities of water for at least 15 minutes.
    2.7.6. Special care should be taken when handling and dispensing 
NaOH. Always remember to add base to water (or urine). NaOH can cause 
severe eye and skin damage. Always wear the appropriate gloves, a lab 
coat, and safety glasses. If the NaOH comes in contact with any part of 
the body, quickly wash with copious quantities of water for at least 15 
minutes.

                         3. Analytical procedure

3.1. Apparatus
    3.1.1. A high performance liquid chromatograph equipped with pump, 
sample injector and UV detector.
    3.1.2. A C18 HPLC column; 25 cm x 4.6 mm I.D.
    3.1.3. An electronic integrator, or some other suitable means of 
determining analyte response.
    3.1.4. Stripchart recorder.
    3.1.5. C18 SEP-PAKs (Waters Associates) or equivalent.
    3.1.6. Luer-lock syringe for sample preparation (5 mL or 10 mL).
    3.1.7. Volumetric pipettes and flasks for standard and sample 
preparation.

[[Page 261]]

    3.1.8. Vacuum system to aid sample preparation (optional).
3.2. Reagents
    3.2.1. Water, HPLC grade.
    3.2.2. Methanol, HPLC grade.
    3.2.3. PIC B-7 [supreg] (Waters Associates) in small vials.
    3.2.4. Creatinine, anhydrous, Sigma hemical Corp., purity not 
listed.
    3.2.5. 1-Heptanesulfonic acid, sodium salt monohydrate.
    3.2.6. Phosphoric acid.
    3.2.7. Mobile phase. It can be prepared by mixing one vial of PIC B-
7 into a 1 L solution of 50% methanol and 50% water. The mobile phase 
can also be made by preparing a solution that is 50% methanol and 50% 
water with 0.005M heptanesulfonic acid and adjusting the pH of the 
solution to 3.5 with phosphoric acid.
3.3. Standard preparation
    3.3.1. Stock standards are prepared by weighing 10 to 15 mg of 
creatinine. This is transferred to a 25-mL volumetric flask and diluted 
to volume with HPLC grade water.
    3.3.2. Dilutions to a working range of 3 to 35 [micro]g/mL are made 
in either HPLC grade water or HPLC mobile phase (standards give the same 
detector response in either solution).
3.4. Sample preparation
    3.4.1. The C18 SEP-PAK is connected to a Luer-lock syringe. It is 
rinsed with 5 mL HPLC grade methanol and then 10 mL of HPLC grade water. 
These rinses are discarded.
    3.4.2. Exactly 1.0 mL of urine is pipetted into the syringe. The 
urine is put through the SEP-PAK into a suitable container using a 
vacuum system.
    3.4.3. The walls of the syringe are rinsed in several stages with a 
total of approximately 30 mL of HPLC grade water. These rinses are put 
through the SEP-PAK into the same container. The resulting solution is 
transferred to a 100-mL volumetric flask and then brought to volume with 
HPLC grade water.
3.5. Analysis (conditions and hardware are those used in this 
          evaluation.)
    3.5.1. Instrument conditions

    Column: Zorbax [supreg] ODS, 5-6 [micro]m particle size; 25 cm x 4.6 
mm I.D.
    Mobile phase: See Section 3.2.7.
    Detector: Dual wavelength UV; 229 nm (primary) 254 nm (secondary)
    Flow rate: 0.7 mL/ minute
    Retention time: 7.2 minutes
    Sensitivity: 0.05 AUFS
    Injection volume: 20[micro]l

    3.5.2. Chromatogram (see Figure 2)

[[Page 262]]

[GRAPHIC] [TIFF OMITTED] TC28OC91.016

3.6. Interferences
    3.6.1. Any compound that has the same retention time as creatinine 
and absorbs at 229 nm is an interference.
    3.6.2. HPLC conditions may be varied to circumvent interferences. In 
addition, analysis at another UV wavelength (i.e., 254 nm) would allow a 
comparison of the ratio of response of a standard to that of a sample. 
Any deviations would indicate an interference.
3.7. Calculations

[[Page 263]]

    3.7.1. A calibration curve is constructed by plotting detector 
response versus standard concentration (See Figure 3).
    3.7.2. The concentration of creatinine in a sample is determined by 
finding the concentration corresponding to its detector response. (See 
Figure 3).
[GRAPHIC] [TIFF OMITTED] TC28OC91.017


[[Page 264]]


    3.7.3. The [micro]g/mL creatinine from section 3.7.2. is then 
multiplied by 100 (the dilution factor). This value is equivalent to the 
micrograms of creatinine in the 1.0 mL stabilized urine aliquot or the 
milligrams of creatinine per liter of urine. The desired units, g/L, is 
determined by the following relationship:
[GRAPHIC] [TIFF OMITTED] TC15NO91.190

    3.7.4. The resulting value for creatinine is used to normalize the 
urinary concentration of the desired analyte (A) (Cd or B2M) by using 
the following formula.
[GRAPHIC] [TIFF OMITTED] TC15NO91.191

Where A is the desired analyte. The protocol of reporting such 
          normalized results is [micro]g A/g creatinine.

                3.8. Safety precautions See section 2.7.

                             4. Conclusions

    The determination of creatinine in urine by HPLC is a good 
alternative to the Jaffe method for industrial hygiene laboratories. 
Sample clarification with SEP-PAKs did not change the amount of 
creatinine found in urine samples. However, it does protect the 
analytical column. The results of this creatinine in urine procedure are 
unaffected by the pH of the urine sample under the conditions tested by 
this procedure. Therefore, no special measures are required for 
creatinine analysis whether the urine sample has been stabilized with 
10% nitric acid for the Cd analysis or brought to a pH of 7 with 0.11 N 
NaOH for the B2M analysis.

                              5. References

5.1. Clark, L.C.; Thompson, H.L.; Anal. Chem. 1949, 21, 1218.
5.2. Peters, J.H.; J. Biol. Chem. 1942, 146, 176.
5.3. Hausen, V.A.; Fuchs, D.; Wachter, H.; J. Clin. Chem. Clin. Biochem. 
          1981, 19, 373-378.
5.4. Clark, P.M.S.; Kricka L.J.; Patel, A.; J. Liq. Chrom. 1980, 3(7), 
          1031-1046.
5.5. Ballerini, R.; Chinol, M.; Cambi, A.; J. Chrom. 1979, 179, 365-369.
5.6. Ogata, M.; Taguchi, T.; Industrial Health 1987, 25, 225-228.
5.7. ``Merck Index'', 11th ed.; Windholz, Martha Ed.; Merck: Rahway, 
          N.J., 1989; p 403.
5.8. Kimberly, M.; ``Determination of Cadmium in Urine by Graphite 
          Furnace Atomic Absorption Spectrometry with Zeeman Background 
          Correction.'', Centers for Disease Control, Atlanta, Georgia, 
          unpublished, update 1990.

[57 FR 42389, Sept. 14, 1992, as amended at 57 FR 49272, Oct. 30, 1992; 
58 FR 21781, Apr. 23, 1993; 61 FR 5508, Feb. 13, 1996; 63 FR 1288, Jan. 
8, 1998; 70 FR 1142, Jan. 5, 2005; 71 FR 16672, 16673, Apr. 3, 2006; 71 
FR 50189, Aug. 24, 2006; 73 FR 75585, Dec. 12, 2008; 76 FR 33608, June 
8, 2011; 77 FR 17781, Mar. 26, 2012; 84 FR 21477, May 14, 2019; 85 FR 
8732, Feb. 18, 2020]



Sec.  1910.1028  Benzene.

    (a) Scope and application. (1) This section applies to all 
occupational exposures to benzene. Chemical Abstracts Service Registry 
No. 71-43-2, except as provided in paragraphs (a)(2) and (a)(3) of this 
section.
    (2) This section does not apply to:
    (i) The storage, transportation, distribution, dispensing, sale or 
use of gasoline, motor fuels, or other fuels containing benzene 
subsequent to its final discharge from bulk wholesale storage 
facilities, except that operations where gasoline or motor fuels are 
dispensed for more than 4 hours per day in an indoor location are 
covered by this section.
    (ii) Loading and unloading operations at bulk wholesale storage 
facilities which use vapor control systems for all loading and unloading 
operations, except for the provisions of 29 CFR 1910.1200 as 
incorporated into this section and the emergency provisions of 
paragraphs (g) and (i)(4) of this section.
    (iii) The storage, transportation, distribution or sale of benzene 
or liquid mixtures containing more than 0.1 percent benzene in intact 
containers or in transportation pipelines while sealed in such a manner 
as to contain benzene

[[Page 265]]

vapors or liquid, except for the provisions of 29 CFR 1910.1200 as 
incorporated into this section and the emergency provisions of 
paragraphs (g) and (i)(4) of this section.
    (iv) Containers and pipelines carrying mixtures with less than 0.1 
percent benzene and natural gas processing plants processing gas with 
less than 0.1 percent benzene.
    (v) Work operations where the only exposure to benzene is from 
liquid mixtures containing 0.5 percent or less of benzene by volume, or 
the vapors released from such liquids until September 12, 1988; work 
operations where the only exposure to benzene is from liquid mixtures 
containing 0.3 percent or less of benzene by volume or the vapors 
released from such liquids from September 12, 1988, to September 12, 
1989; and work operations where the only exposure to benzene is from 
liquid mixtures containing 0.1 percent or less of benzene by volume or 
the vapors released from such liquids after September 12, 1989; except 
that tire building machine operators using solvents with more than 0.1 
percent benzene are covered by paragraph (i) of this section.
    (vi) Oil and gas drilling, production and servicing operations.
    (vii) Coke oven batteries.
    (3) The cleaning and repair of barges and tankers which have 
contained benzene are excluded from paragraph (f) methods of compliance, 
paragraph (e)(1) exposure monitoring-general, and paragraph (e)(6) 
accuracy of monitoring. Engineering and work practice controls shall be 
used to keep exposures below 10 ppm unless it is proven to be not 
feasible.
    (b) Definitions. Action level means an airborne concentration of 
benzene of 0.5 ppm calculated as an 8-hour time-weighted average.
    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 (l) of this section, or any 
other person authorized by the Act or regulations issued under the Act.
    Benzene (C6 H6) (CAS Registry No. 71-43-2) 
means liquefied or gaseous benzene. It includes benzene contained in 
liquid mixtures and the benzene vapors released by these liquids. It 
does not include trace amounts of unreacted benzene contained in solid 
materials.
    Bulk wholesale storage facility means a bulk terminal or bulk plant 
where fuel is stored prior to its delivery to wholesale customers.
    Container means any barrel, bottle, can, cylinder, drum, reaction 
vessel, storage tank, or the like, but does not include piping systems.
    Day means any part of a calendar day.
    Director means the Director of the National Institute for 
Occupational Safety and Health, U.S. Department of Health and Human 
Services, or designee.
    Emergency means any occurrence such as, but not limited to, 
equipment failure, rupture of containers, or failure of control 
equipment which may or does result in an unexpected significant release 
of benzene.
    Employee exposure means exposure to airborne benzene which would 
occur if the employee were not using respiratory protective equipment.
    Regulated area means any area where airborne concentrations of 
benzene exceed or can reasonably be expected to exceed, the permissible 
exposure limits, either the 8-hour time weighted average exposure of 1 
ppm or the short-term exposure limit of 5 ppm for 15 minutes.
    Vapor control system means any equipment used for containing the 
total vapors displaced during the loading of gasoline, motor fuel or 
other fuel tank trucks and the displacing of these vapors through a 
vapor processing system or balancing the vapor with the storage tank. 
This equipment also includes systems containing the vapors displaced 
from the storage tank during the unloading of the tank truck which 
balance the vapors back to the tank truck.

[[Page 266]]

    (c) Permissible exposure limits (PELs)--(1) Time-weighted average 
limit (TWA). The employer shall assure that no employee is exposed to an 
airborne concentration of benzene in excess of one part of benzene per 
million parts of air (1 ppm) as an 8-hour time-weighted average.
    (2) Short-term exposure limit (STEL). The employer shall assure that 
no employee is exposed to an airborne concentration of benzene in excess 
of five (5) ppm as averaged over any 15 minute period.
    (d) Regulated areas. (1) The employer shall establish a regulated 
area wherever the airborne concentration of benzene exceeds or can 
reasonably be expected to exceed the permissible exposure limits, either 
the 8-hour time weighted average exposure of 1 ppm or the short-term 
exposure limit of 5 ppm for 15 minutes.
    (2) Access to regulated areas shall be limited to authorized 
persons.
    (3) Regulated areas shall be determined from the rest of the 
workplace in any manner that minimizes the number of employees exposed 
to benzene within the regulated area.
    (e) Exposure monitoring--(1) General. (i) Determinations of employee 
exposure shall be made from breathing zone air samples that are 
representative of each employee's average exposure to airborne benzene.
    (ii) Representative 8-hour TWA employee exposures shall be 
determined on the basis of one sample or samples representing the full 
shift exposure for each job classification in each work area.
    (iii) Determinations of compliance with the STEL shall be made from 
15 minute employee breathing zone samples measured at operations where 
there is reason to believe exposures are high, such as where tanks are 
opened, filled, unloaded or gauged; where containers or process 
equipment are opened and where benzene is used for cleaning or as a 
solvent in an uncontrolled situation. The employer may use objective 
data, such as measurements from brief period measuring devices, to 
determine where STEL monitoring is needed.
    (iv) Except for initial monitoring as required under paragraph 
(e)(2) of this section, where the employer can document that one shift 
will consistently have higher employee exposures for an operation, the 
employer shall only be required to determine representative employee 
exposure for that operation during the shift on which the highest 
exposure is expected.
    (2) Initial monitoring. (i) Each employer who has a place of 
employment covered under paragraph (a)(1) of this section shall monitor 
each of these workplaces and work operations to determine accurately the 
airborne concentrations of benzene to which employees may be exposed.
    (ii) The initial monitoring required under paragraph (e)(2)(i) of 
this section shall be completed by 60 days after the effective date of 
this standard or within 30 days of the introduction of benzene into the 
workplace. Where the employer has monitored within one year prior to the 
effective date of this standard 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 (e)(2)(i) of 
this section.
    (3) Periodic monitoring and monitoring frequency. (i) If the 
monitoring required by paragraph (e)(2)(i) of this section reveals 
employee exposure at or above the action level but at or below the TWA, 
the employer shall repeat such monitoring for each such employee at 
least every year.
    (ii) If the monitoring required by paragraph (e)(2)(i) of this 
section reveals employee exposure above the TWA, the employer shall 
repeat such monitoring for each such employee at least every six (6) 
months.
    (iii) The employer may alter the monitoring schedule from every six 
months to annually for any employee for whom two consecutive 
measurements taken at least 7 days apart indicate that the employee 
exposure has decreased to the TWA or below, but is at or above the 
action level.
    (iv) Monitoring for the STEL shall be repeated as necessary to 
evaluate exposures of employees subject to short term exposures.
    (4) Termination of monitoring. (i) If the initial monitoring 
required by paragraph (e)(2)(i) of this section reveals

[[Page 267]]

employee exposure to be below the action level the employer may 
discontinue the monitoring for that employee, except as otherwise 
required by paragraph (e)(5) of this section.
    (ii) If the periodic monitoring required by paragraph (e)(3) of this 
section reveals that employee exposures, as indicated by at least two 
consecutive measurements taken at least 7 days apart, are below the 
action level the employer may discontinue the monitoring for that 
employee, except as otherwise required by paragraph (e)(5).
    (5) Additional monitoring. (i) The employer shall institute the 
exposure monitoring required under paragraphs (e)(2) and (e)(3) of this 
section when there has been a change in the production, process, control 
equipment, personnel or work practices which may result in new or 
additional exposures to benzene, or when the employer has any reason to 
suspect a change which may result in new or additional exposures.
    (ii) Whenever spills, leaks, ruptures or other breakdowns occur that 
may lead to employee exposure, the employer shall monitor (using area or 
personal sampling) after the cleanup of the spill or repair of the leak, 
rupture or other breakdown to ensure that exposures have returned to the 
level that existed prior to the incident.
    (6) Accuracy of monitoring. Monitoring shall be accurate, to a 
confidence level of 95 percent, to within plus or minus 25 percent for 
airborne concentrations of benzene.
    (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 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) Whenever the PELs are exceeded, the written notification 
required by paragraph (e)(7)(i) of this section shall contain the 
corrective action being taken by the employer to reduce the employee 
exposure to or below the PEL, or shall refer to a document available to 
the employee which states the corrective actions to be taken.
    (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 benzene at or 
below the permissible exposure limits, except to the extent that the 
employer can establish that these controls are not feasible or where the 
provisions of paragraph (f)(1)(iii) or (g)(1) of this section apply.
    (ii) Wherever the feasible engineering controls and work practices 
which can be instituted are not sufficient to reduce employee exposure 
to or below the PELs, 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 which complies with 
the requirements of paragraph (g) of this section.
    (iii) Where the employer can document that benzene is used in a 
workplace less than a total of 30 days per year, the employer shall use 
engineering controls, work practice controls or respiratory protection 
or any combination of these controls to reduce employee exposure to 
benzene to or below the PELs, except that employers shall use 
engineering and work practice controls, if feasible, to reduce exposure 
to or below 10 ppm as an 8-hour TWA.
    (2) Compliance program. (i) When any exposures are over the PEL, the 
employer shall establish and implement a written program to reduce 
employee exposure to or below the PEL primarily by means of engineering 
and work practice controls, as required by paragraph (f)(1) of this 
section.
    (ii) The written program shall include a schedule for development 
and implementation of the engineering and work practice controls. These 
plans shall be reviewed and revised as appropriate based on the most 
recent exposure monitoring data, to reflect the current status of the 
program.
    (iii) Written compliance programs shall be furnished upon request 
for examination and copying to the Assistant Secretary, the Director, 
affected employees and designated employee representatives.
    (g) Respiratory protection--(1) General. For employees who use 
respirators required by this section, the employer

[[Page 268]]

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 for which the employer establishes that 
compliance with either the TWA or STEL through the use of engineering 
and work-practice controls is not feasible; for example, some 
maintenance and repair activities, vessel cleaning, or other operations 
for which engineering and work-practice controls are infeasible because 
exposures are intermittent and limited in duration.
    (iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient, or are not required under 
paragraph (f)(1)(iii) of this section, to reduce employee exposure to or 
below the PELs.
    (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), (d)(3)(iii)(b)(1) and (2)), and (f) 
through (m), which covers each employee required by this section to use 
a respirator.
    (ii) For air-purifying respirators, the employer must replace the 
air-purifying element at the expiration of its service life or at the 
beginning of each shift in which such elements are used, whichever comes 
first.
    (iii) If NIOSH approves an air-purifying element with an end-of-
service-life indicator for benzene, such an element may be used until 
the indicator shows no further useful life.
    (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 any organic vapor gas mask or any self-
contained breathing apparatus with a full facepiece to use for escape.
    (C) Use an organic vapor cartridge or canister with powered and non-
powered air-purifying respirators, and a chin-style canister with full 
facepiece gas masks.
    (D) Ensure that canisters used with non-powered air-purifying 
respirators have a minimum service life of four hours when tested at 150 
ppm benzene at a flow rate of 64 liters per minute (LPM), a temperature 
of 25 [deg]C, and a relative humidity of 85%; for canisters used with 
tight-fitting or loose-fitting powered air-purifying respirators, the 
flow rates for testing must be 115 LPM and 170 LPM, respectively.
    (ii) Any employee who cannot use a negative-pressure respirator must 
be allowed to use a respirator with less breathing resistance, such as a 
powered air-purifying respirator or supplied-air respirator.
    (h) Protective clothing and equipment. Personal protective clothing 
and equipment shall be worn where appropriate to prevent eye contact and 
limit dermal exposure to liquid benzene. Protective clothing and 
equipment shall be provided by the employer at no cost to the employee 
and the employer shall assure its use where appropriate. Eye and face 
protection shall meet the requirements of 29 CFR 1910.133.
    (i) Medical surveillance--(1) General. (i) The employer shall make 
available a medical surveillance program for employees who are or may be 
exposed to benzene at or above the action level 30 or more days per 
year; for employees who are or may be exposed to benzene at or above the 
PELs 10 or more days per year; for employees who have been exposed to 
more than 10 ppm of benzene for 30 or more days in a year prior to the 
effective date of the standard when employed by their current employer; 
and for employees involved in the tire building operations called tire 
building machine operators, who use solvents containing greater than 0.1 
percent benzene.
    (ii) The employer shall assure that all medical examinations and 
procedures are performed by or under the supervision of a licensed 
physician and that all laboratory tests are conducted by an accredited 
laboratory.
    (iii) The employer shall assure that persons other than licensed 
physicians who administer the pulmonary function testing required by 
this section shall complete a training course in

[[Page 269]]

spirometry sponsored by an appropriate governmental, academic or 
professional institution.
    (iv) The employer shall assure that all examinations and procedures 
are provided without cost to the employee and at a reasonable time and 
place.
    (2) Initial examination. (i) Within 60 days of the effective date of 
this standard, or before the time of initial assignment, the employer 
shall provide each employee covered by paragraph (i)(1)(i) of this 
section with a medical examination including the following elements:
    (A) A detailed occupational history which includes:
    (1) Past work exposure to benzene or any other hematological toxins,
    (2) A family history of blood dyscrasias including hematological 
neoplasms;
    (3) A history of blood dyscrasias including genetic hemoglobin 
abnormalities, bleeding abnormalities, abnormal function of formed blood 
elements;
    (4) A history of renal or liver dysfunction;
    (5) A history of medicinal drugs routinely taken;
    (6) A history of previous exposure to ionizing radiation and
    (7) Exposure to marrow toxins outside of the current work situation.
    (B) A complete physical examination.
    (C) Laboratory tests. A complete blood count including a leukocyte 
count with differential, a quantitative thrombocyte count, hematocrit, 
hemoglobin, erythrocyte count and erythrocyte indices (MCV, MCH, MCHC). 
The results of these tests shall be reviewed by the examining physician.
    (D) Additional tests as necessary in the opinion of the examining 
physician, based on alterations to the components of the blood or other 
signs which may be related to benzene exposure; and
    (E) For all workers required to wear respirators for at least 30 
days a year, the physical examination shall pay special attention to the 
cardiopulmonary system and shall include a pulmonary function test.
    (ii) No initial medical examination is required to satisfy the 
requirements of paragraph (i)(2)(i) of this section if adequate records 
show that the employee has been examined in accordance with the 
procedures of paragraph (i)(2)(i) of this section within the twelve 
months prior to the effective date of this standard.
    (3) Periodic examinations. (i) The employer shall provide each 
employee covered under paragraph (i)(1)(i) of this section with a 
medical examination annually following the previous examination. These 
periodic examinations shall incude at least the following elements:
    (A) A brief history regarding any new exposure to potential marrow 
toxins, changes in medicinal drug use, and the appearance of physical 
signs relating to blood disorders:
    (B) A complete blood count including a leukocyte count with 
differential, quantitative thrombocyte count, hemoglobin, hematocrit, 
erythrocyte count and erythrocyte indices (MCV, MCH, MCHC); and
    (C) Appropriate additional tests as necessary, in the opinion of the 
examining physician, in consequence of alterations in the components of 
the blood or other signs which may be related to benzene exposure.
    (ii) Where the employee develops signs and symptoms commonly 
associated with toxic exposure to benzene, the employer shall provide 
the employee with an additional medical examination which shall include 
those elements considered appropriate by the examining physician.
    (iii) For persons required to use respirators for at least 30 days a 
year, a pulmonary function test shall be performed every three (3) 
years. A specific evaluation of the cardiopulmonary system shall be made 
at the time of the pulmonary function test.
    (4) Emergency examinations. (i) In addition to the surveillance 
required by (i)(1)(i), if an employee is exposed to benzene in an 
emergency situation, the employer shall have the employee provide a 
urine sample at the end of the employee's shift and have a urinary 
phenol test performed on the sample within 72 hours. The urine specific 
gravity shall be corrected to 1.024.
    (ii) If the result of the urinary phenol test is below 75 mg phenol/
L of urine, no further testing is required.
    (iii) If the result of the urinary phenol test is equal to or 
greater than 75 mg phenol/L of urine, the employer

[[Page 270]]

shall provide the employee with a complete blood count including an 
erythrocyte count, leukocyte count with differential and thrombocyte 
count at monthly intervals for a duration of three (3) months following 
the emergency exposure.
    (iv) If any of the conditions specified in paragraph (i)(5)(i) of 
this section exists, then the further requirements of paragraph (i)(5) 
of this section shall be met and the employer shall, in addition, 
provide the employees with periodic examinations if directed by the 
physician.
    (5) Additional examinations and referrals. (i) Where the results of 
the complete blood count required for the initial and periodic 
examinations indicate any of the following abnormal conditions exist, 
then the blood count shall be repeated within 2 weeks.
    (A) The hemoglobin level or the hematocrit falls below the normal 
limit [outside the 95% confidence interval (C.I.)] as determined by the 
laboratory for the particular geographic area and/or these indices show 
a persistent downward trend from the individual's pre-exposure norms; 
provided these findings cannot be explained by other medical reasons.
    (B) The thrombocyte (platelet) count varies more than 20 percent 
below the employee's most recent values or falls outside the normal 
limit (95% C.I.) as determined by the laboratory.
    (C) The leukocyte count is below 4,000 per mm\3\ or there is an 
abnormal differential count.
    (ii) If the abnormality persists, the examining physician shall 
refer the employee to a hematologist or an internist for further 
evaluation unless the physician has good reason to believe such referral 
is unnecessary. (See appendix C for examples of conditions where a 
referral may be unnecessary.)
    (iii) The employer shall provide the hematologist or internist with 
the information required to be provided to the physician under paragraph 
(i)(6) of this section and the medical record required to be maintained 
by paragraph (k)(2)(ii) of this section.
    (iv) The hematologist's or internist's evaluation shall include a 
determination as to the need for additional tests, and the employer 
shall assure that these tests are provided.
    (6) Information provided to the physician. The employer shall 
provide the following information to the examining physician:
    (i) A copy of this regulation and its appendices;
    (ii) A description of the affected employee's duties as they relate 
to the employee's exposure;
    (iii) The employee's actual or representative exposure level:
    (iv) A description of any personal protective equipment used or to 
be used; and
    (v) Information from previous employment-related medical 
examinations of the affected employee which is not otherwise available 
to the examining physician.
    (7) Physician's written opinions. (i) For each examination under 
this section, the employer shall obtain and provide the employee with a 
copy of the examining physician's written opinion within 15 days of the 
examination. The written opinion shall be limited to the following 
information:
    (A) The occupationally pertinent results of the medical examination 
and tests;
    (B) The physician's opinion concerning whether the employee has any 
detected medical conditions which would place the employee's health at 
greater than normal risk of material impairment from exposure to 
benzene;
    (C) The physician's recommended limitations upon the employee's 
exposure to benzene or upon the employee's use of protective clothing or 
equipment and respirators.
    (D) A statement that the employee has been informed by the physician 
of the results of the medical examination and any medical conditions 
resulting from benzene exposure which require further explanation or 
treatment.
    (ii) The written opinion obtained by the employer shall not reveal 
specific records, findings and diagnoses that have no bearing on the 
employee's ability to work in a benzene-exposed workplace.
    (8) Medical removal plan. (i) When a physician makes a referral to a 
hematologist/internist as required under paragraph (i)(5)(ii) of this 
section, the

[[Page 271]]

employee shall be removed from areas where exposures may exceed the 
action level until such time as the physician makes a determination 
under paragraph (i)(8)(ii) of this section.
    (ii) Following the examination and evaluation by the hematologist/
internist, a decision to remove an employee from areas where benzene 
exposure is above the action level or to allow the employee to return to 
areas where benzene exposure is above the action level shall be made by 
the physician in consultation with the hematologist/internist. This 
decision shall be communicated in writing to the employer and employee. 
In the case of removal, the physician shall state the required probable 
duration of removal from occupational exposure to benzene above the 
action level and the requirements for future medical examinations to 
review the decision.
    (iii) For any employee who is removed pursuant to paragraph 
(i)(8)(ii) of this section, the employer shall provide a follow-up 
examination. The physician, in consultation with the hematologist/
internist, shall make a decision within 6 months of the date the 
employee was removed as to whether the employee shall be returned to the 
usual job or whether the employee should be removed permanently.
    (iv) Whenever an employee is temporarily removed from benzene 
exposure pursuant to paragraph (i)(8)(i) or (i)(8)(ii) of this section, 
the employer shall transfer the employee to a comparable job for which 
the employee is qualified (or can be trained for in a short period) and 
where benzene exposures are as low as possible, but in no event higher 
than the action level. The employer shall maintain the employee's 
current wage rate, seniority and other benefits. If there is no such job 
available, the employer shall provide medical removal protection 
benefits until such a job becomes available or for 6 months, whichever 
comes first.
    (v) Whenever an employee is removed permanently from benzene 
exposure based on a physician's recommendation pursuant to paragraph 
(i)(8)(iii) of this section, the employee shall be given the opportunity 
to transfer to another position which is available or later becomes 
available for which the employee is qualified (or can be trained for in 
a short period) and where benzene exposures are as low as possible but 
in no event higher than the action level. The employer shall assure that 
such employee suffers no reduction in current wage rate, seniority or 
other benefits as a result of the transfer.
    (9) Medical removal protection benefits. (i) The employer shall 
provide to an employee 6 months of medical removal protection benefits 
immediately following each occasion an employee is removed from exposure 
to benzene because of hematological findings pursuant to paragraphs 
(i)(8) (i) and (ii) of this section, unless the employee has been 
transferred to a comparable job where benzene exposures are below the 
action level.
    (ii) For the purposes of this section, the requirement that an 
employer provide medical removal protection benefits means that the 
employer shall maintain the current wage rate, seniority and other 
benefits of an employee as though the employee had not been removed.
    (iii) 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 from employment with another employer made possible by 
virtue of the employee's removal.
    (j) Communication of hazards--(1) Hazard communication--general. 
Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for benzene.
    (ii) In classifying the hazards of benzene at least the following 
hazards are to be addressed: Cancer; central nervous system effects; 
blood effects; aspiration; skin, eye, and respiratory tract irritation; 
and flammability.
    (iii) Employers shall include benzene in the hazard communication 
program established to comply with the HCS (Sec.  1910.1200). Employers 
shall ensure that each employee has access to labels on containers of 
benzene and to safety

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data sheets, and is trained in accordance with the requirements of HCS 
and paragraph (j)(3) of this section.
    (2) Warning signs and labels. (i)The employer shall post signs at 
entrances to regulated areas. The signs shall bear the following legend:

DANGER
BENZENE
MAY CAUSE CANCER
HIGHLY FLAMMABLE LIQUID AND VAPOR
DO NOT SMOKE
WEAR RESPIRATORY PROTECTION IN THIS AREA
AUTHORIZED PERSONNEL ONLY

    (ii) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (j)(2)(i) of this section:

DANGER
BENZENE
CANCER HAZARD
FLAMMABLE--NO SMOKING
AUTHORIZED PERSONNEL ONLY
RESPIRATOR REQUIRED

    (iii) The employer shall ensure that labels or other appropriate 
forms of warning are provided for containers of benzene within the 
workplace. There is no requirement to label pipes. The labels shall 
comply with the requirements of paragraph (j)(1) of this section and 
Sec.  1910.1200(f).
    (iv) Prior to June 1, 2015, employers shall include the following 
legend or similar language on the labels or other appropriate forms of 
warning:

DANGER
CONTAINS BENZENE
CANCER HAZARD

    (3) Information and training. (i) The employer shall provide 
employees with information and training at the time of their initial 
assignment to a work area where benzene is present. If exposures are 
above the action level, employees shall be provided with information and 
training at least annually thereafter.
    (ii) The training program shall be in accordance with the 
requirements of 29 CFR 1910.1200(h) (1) and (2), and shall include 
specific information on benzene for each category of information 
included in that section.
    (iii) In addition to the information required under 29 CFR 
1910.1200, the employer shall:
    (A) Provide employees with an explanation of the contents of this 
section, including Appendices A and B, and indicate to them where the 
standard is available; and
    (B) Describe the medical surveillance program required under 
paragraph (i) of this section, and explain the information contained in 
appendix C.
    (k) Recordkeeping--(1) Exposure measurements. (i) The employer shall 
establish and maintain an accurate record of all measurements required 
by paragraph (e) of this section, in accordance with 29 CFR 1910.20.
    (ii) This record shall include:
    (A) The dates, number, duration, and results of each of the samples 
taken, including a description of the procedure used to determine 
representative employee exposures;
    (B) A description of the sampling and analytical methods used;
    (C) A description of the type of respiratory protective devices 
worn, if any; and
    (D) The name, job classification and exposure levels of the employee 
monitored and all other employees whose exposure the measurement is 
intended to represent.
    (iii) The employer shall maintain this record for at least 30 years, 
in accordance with 29 CFR 1910.20.
    (2) Medical surveillance. (i) The employer shall establish and 
maintain an accurate record for each employee subject to medical 
surveillance required by paragraph (i) of this section, in accordance 
with 29 CFR 1910.20.
    (ii) This record shall include:
    (A) The name of the employee;
    (B) The employer's copy of the physician's written opinion on the 
initial, periodic and special examinations, including results of medical 
examinations and all tests, opinions and recommendations;
    (C) Any employee medical complaints related to exposure to benzene;
    (D) A copy of the information provided to the physician as required 
by paragraphs (i)(6) (ii) through (v) of this section; and
    (E) A copy of the employee's medical and work history related to 
exposure to benzene or any other hematologic toxins.

[[Page 273]]

    (iii) The employer shall maintain this record for at least the 
duration of employment plus 30 years, in accordance with 29 CFR 1910.20.
    (3) Availability. (i) The employer shall assure that all records 
required to be maintained by this section shall be made available upon 
request to the Assistant Secretary and the Director for examination and 
copying.
    (ii) Employee exposure monitoring records required by this paragraph 
shall be provided upon request for examination and copying to employees, 
employee representatives, and the Assistant Secretary in accordance with 
29 CFR 1910.20 (a) through (e) and (g) through (i).
    (iii) Employee medical records required by this paragraph shall be 
provided upon request for examination and copying, to the subject 
employee, to anyone having the specific written consent of the subject 
employee, and to the Assistant Secretary in accordance with 29 CFR 
1910.20.
    (4) Transfer of records. The employer shall comply with the 
requirements involving transfer of records as set forth in 29 CFR 
1910.1020(h).
    (l) Observation of monitoring--(1) Employee observation. The 
employer shall provide affected employees, or their designated 
representatives, an opportunity to observe the measuring or monitoring 
of employee exposure to benzene conducted pursuant to paragraph (e) of 
this section.
    (2) Observation procedures. When observation of the measuring or 
monitoring of employee exposure to benzene requires entry into areas 
where the use of protective clothing and equipment or respirators is 
required, the employer shall provide the observer with personal 
protective clothing and equipment or respirators required to be worn by 
employees working in the area, assure the use of such clothing and 
equipment or respirators, and require the observer to comply with all 
other applicable safety and health procedures.
    (m) [Reserved]
    (n) Appendices. The information contained in Appendices A, B, C, and 
D is not intended, by itself, to create any additional obligations not 
otherwise imposed or to detract from any existing obligations.

   Appendix A to Sec.  1910.1028--Substance Safety Data Sheet, Benzene

                       I. Substance Identification

    A. Substance: Benzene.
    B. Permissible Exposure: Except as to the use of gasoline, motor 
fuels and other fuels subsequent to discharge from bulk terminals and 
other exemptions specified in Sec.  1910.1028(a)(2):
    1. Airborne: The maximum time-weighted average (TWA) exposure limit 
is 1 part of benzene vapor per million parts of air (1 ppm) for an 8-
hour workday and the maximum short-term exposure limit (STEL) is 5 ppm 
for any 15-minute period.
    2. Dermal: Eye contact shall be prevented and skin contact with 
liquid benzene shall be limited.
    C. Appearance and odor: Benzene is a clear, colorless liquid with a 
pleasant, sweet odor. The odor of benzene does not provide adequate 
warning of its hazard.

                         II. Health Hazard Data

    A. Ways in which benzene affects your health. Benzene can affect 
your health if you inhale it, or if it comes in contact with your skin 
or eyes. Benzene is also harmful if you happen to swallow it.
    B. Effects of overexposure. 1. Short-term (acute) overexposure: If 
you are overexposed to high concentrations of benzene, well above the 
levels where its odor is first recognizable, you may feel breathless, 
irritable, euphoric, or giddy; you may experience irritation in eyes, 
nose, and respiratory tract. You may develop a headache, feel dizzy, 
nauseated, or intoxicated. Severe exposures may lead to convulsions and 
loss of consciousness.
    2. Long-term (chronic) exposure. Repeated or prolonged exposure to 
benzene, even at relatively low concentrations, may result in various 
blood disorders, ranging from anemia to leukemia, an irreversible, fatal 
disease. Many blood disorders associated with benzene exposure may occur 
without symptoms.

                 III. Protective Clothing and Equipment

    A. Respirators. Respirators are required for those operations in 
which engineering controls or work practice controls are not feasible to 
reduce exposure to the permissible level. However, where employers can 
document that benzene is present in the workplace less than 30 days a 
year, respirators may be used in lieu of engineering controls. If 
respirators are worn, they must have joint Mine Safety and Health 
Administration and the National Institute for Occupational Safety and 
Health (NIOSH) seal of approval, and cartridge or canisters must be 
replaced before the end of their service life, or the end of the shift, 
whichever occurs first. If you experience difficulty breathing while 
wearing a

[[Page 274]]

respirator, you may request a positive pressure respirator from your 
employer. You must be thoroughly trained to use the assigned respirator, 
and the training will be provided by your employer.
    B. Protective Clothing. You must wear appropriate protective 
clothing (such as boots, gloves, sleeves, aprons, etc.) over any parts 
of your body that could be exposed to liquid benzene.
    C. Eye and Face Protection. You must wear splash-proof safety 
goggles if it is possible that benzene may get into your eyes. In 
addition, you must wear a face shield if your face could be splashed 
with benzene liquid.

                 IV. Emergency and First Aid Procedures

    A. Eye and face exposure. If benzene is splashed in your eyes, wash 
it out immediately with large amounts of water. If irritation persists 
or vision appears to be affected see a doctor as soon as possible.
    B. Skin exposure. If benzene is spilled on your clothing or skin, 
remove the contaminated clothing and wash the exposed skin with large 
amounts of water and soap immediately. Wash contaminated clothing before 
you wear it again.
    C. Breathing. If you or any other person breathes in large amounts 
of benzene, get the exposed person to fresh air at once. Apply 
artificial respiration if breathing has stopped. Call for medical 
assistance or a doctor as soon as possible. Never enter any vessel or 
confined space where the benzene concentration might be high without 
proper safety equipment and at least one other person present who will 
stay outside. A life line should be used.
    D. Swallowing. If benzene has been swallowed and the patient is 
conscious, do not induce vomiting. Call for medical assistance or a 
doctor immediately.

                         V. Medical Requirements

    If you are exposed to benzene at a concentration at or above 0.5 ppm 
as an 8-hour time-weighted average, or have been exposed at or above 10 
ppm in the past while employed by your current employer, your employer 
is required to provide a medical examination and history and laboratory 
tests within 60 days of the effective date of this standard and annually 
thereafter. These tests shall be provided without cost to you. In 
addition, if you are accidentally exposed to benzene (either by 
ingestion, inhalation, or skin/eye contact) under emergency conditions 
known or suspected to constitute toxic exposure to benzene, your 
employer is required to make special laboratory tests available to you.

                      VI. Observation of Monitoring

    Your employer is required to perform measurements that are 
representative of your exposure to benzene 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.

                         VII. Access to Records

    You or your representative are entitled to see the records of 
measurements of your exposure to benzene upon written request to your 
employer. Your medical examination records can be furnished to yourself, 
your physician or designated representative upon request by you to your 
employer.

          VIII. Precautions for Safe Use, Handling and Storage

    Benzene liquid is highly flammable. It should be stored in tightly 
closed containers in a cool, well ventilated area. Benzene vapor may 
form explosive mixtures in air. All sources of ignition must be 
controlled. Use nonsparking tools when opening or closing benzene 
containers. Fire extinguishers, where provided, must be readily 
available. Know where they are located and how to operate them. Smoking 
is prohibited in areas where benzene is used or stored. Ask your 
supervisor where benzene is used in your area and for additional plant 
safety rules.

 Appendix B to Sec.  1910.1028--Substance Technical Guidelines, Benzene

                      I. Physical and Chemical Data

    A. Substance identification.
    1. Synonyms: Benzol, benzole, coal naphtha, cyclohexatriene, phene, 
phenyl hydride, pyrobenzol. (Benzin, petroleum benzin and Benzine do not 
contain benzene).
    2. Formula: C6 H6 (CAS Registry Number: 71-43-
2)
    B. Physical data.
    1. Boiling Point (760 mm Hg); 80.1 [deg]C (176 [deg]F)
    2. Specific Gravity (water = 1): 0.879
    3. Vapor Density (air = 1): 2.7
    4. Melting Point: 5.5 [deg]C (42 [deg]F)
    5. Vapor Pressure at 20 [deg]C (68 [deg]F): 75 mm Hg
    6. Solubility in Water: .06%
    7. Evaporation Rate (ether = 1): 2.8
    8. Appearance and Odor: Clear, colorless liquid with a distinctive 
sweet odor.

             II. Fire, Explosion, and Reactivity Hazard Data

    A. Fire.
    1. Flash Point (closed cup): -11 [deg]C (12 [deg]F)

[[Page 275]]

    2. Autoignition Temperature: 580 [deg]C (1076 [deg]F)
    3. Flammable limits in Air. % by Volume: Lower: 1.3%, Upper: 7.5%
    4. Extinguishing Media: Carbon dioxide, dry chemical, or foam.
    5. Special Fire-Fighting procedures: Do not use solid stream of 
water, since stream will scatter and spread fire. Fine water spray can 
be used to keep fire-exposed containers cool.
    6. Unusual fire and explosion hazards: Benzene is a flammable 
liquid. Its vapors can form explosive mixtures. All ignition sources 
must be controlled when benzene is used, handled, or stored. Where 
liquid or vapor may be released, such areas shall be considered as 
hazardous locations. Benzene vapors are heavier than air; thus the 
vapors may travel along the ground and be ignited by open flames or 
sparks at locations remote from the site at which benzene is handled.
    7. Benzene is classified as a 1 B flammable liquid for the purpose 
of conforming to the requirements of 29 CFR 1910.106. A concentration 
exceeding 3,250 ppm is considered a potential fire explosion hazard. 
Locations where benzene may be present in quantities sufficient to 
produce explosive or ignitable mixtures are considered Class I Group D 
for the purposes of conforming to the requirements of 29 CFR 1910.309.
    B. Reactivity.
    1. Conditions contributing to instability: Heat.
    2. Incompatibility: Heat and oxidizing materials.
    3. Hazardous decomposition products: Toxic gases and vapors (such as 
carbon monoxide).

                     III. Spill and Leak Procedures

    A. Steps to be taken if the material is released or spilled. As much 
benzene as possible should be absorbed with suitable materials, such as 
dry sand or earth. That remaining must be flushed with large amounts of 
water. Do not flush benzene into a confined space, such as a sewer, 
because of explosion danger. Remove all ignition sources. Ventilate 
enclosed places.
    B. Waste disposal method. Disposal methods must conform to other 
jurisdictional regulations. If allowed, benzene may be disposed of: (a) 
By absorbing it in dry sand or earth and disposing in a sanitary 
landfill; (b) if small quantities, by removing it to a safe location 
from buildings or other combustible sources, pouring it in dry sand or 
earth and cautiously igniting it; and (c) if large quantities, by 
atomizing it in a suitable combustion chamber.

                      IV. Miscellaneous Precautions

    A. High exposure to benzene can occur when transferring the liquid 
from one container to another. Such operations should be well ventilated 
and good work practices must be established to avoid spills.
    B. Use non-sparking tools to open benzene containers which are 
effectively grounded and bonded prior to opening and pouring.
    C. Employers must advise employees of all plant areas and operations 
where exposure to benzene could occur. Common operations in which high 
exposures to benzene may be encountered are: the primary production and 
utilization of benzene, and transfer of benzene.

   Appendix C to Sec.  1910.1028--Medical Surveillance Guidelines for 
                                 Benzene

                            I. Route of Entry

    Inhalation; skin absorption.

                             II. Toxicology

    Benzene is primarily an inhalation hazard. Systemic absorption may 
cause depression of the hematopoietic system, pancytopenia, aplastic 
anemia, and leukemia. Inhalation of high concentrations can affect 
central nervous system function. Aspiration of small amounts of liquid 
benzene immediately causes pulmonary edema and hemorrhage of pulmonary 
tissue. There is some absorption through the skin. Absorption may be 
more rapid in the case of abraded skin, and benzene may be more readily 
absorbed if it is present in a mixture or as a contaminant in solvents 
which are readily absorbed. The defatting action of benzene may produce 
primary irritation due to repeated or prolonged contact with the skin. 
High concentration are irritating to the eyes and the mucuous membranes 
of the nose, and respiratory tract.

                         III. Signs and Symptoms

    Direct skin contact with benzene may cause erythema. Repeated or 
prolonged contact may result in drying, scaling dermatitis, or 
development of secondary skin infections. In addition, there is benzene 
absorption through the skin. Local effects of benzene vapor or liquid on 
the eye are slight. Only at very high concentrations is there any 
smarting sensation in the eye. Inhalation of high concentrations of 
benzene may have an initial stimulatory effect on the central nervous 
system characterized by exhilaration, nervous excitation, and/or 
giddiness, followed by a period of depression, drowsiness, or fatigue. A 
sensation of tightness in the chest accompanied by breathlessness may 
occur and ultimately the victim may lose consciousness. Tremors, 
convulsions and death may follow from respiratory paralysis or 
circulatory collapse in a few minutes to several hours following severe 
exposures.
    The detrimental effect on the blood-forming system of prolonged 
exposure to small

[[Page 276]]

quantities of benzene vapor is of extreme importance. The hematopoietic 
system is the chief target for benzene's toxic effects which are 
manifested by alterations in the levels of formed elements in the 
peripheral blood. These effects have occurred at concentrations of 
benzene which may not cause irritation of mucous membranes, or any 
unpleasant sensory effects. Early signs and symptoms of benzene 
morbidity are varied, often not readily noticed and non-specific. 
Subjective complaints of headache, dizziness, and loss of appetite may 
precede or follow clinical signs. Rapid pulse and low blood pressure, in 
addition to a physical appearance of anemia, may accompany a subjective 
complaint of shortness of breath and excessive tiredness. Bleeding from 
the nose, gums, or mucous membranes, and the development of purpuric 
spots (small bruises) may occur as the condition progresses. Clinical 
evidence of leukopenia, anemia, and thrombocytopenia, singly or in 
combination, has been frequently reported among the first signs.
    Bone marrow may appear normal, aplastic, or hyperplastic, and may 
not, in all situations, correlate with peripheral blood forming tissues. 
Because of variations in the susceptibility to benzene morbidity, there 
is no ``typical'' blood picture. The onset of effects of prolonged 
benzene exposure may be delayed for many months or years after the 
actual exposure has ceased and identification or correlation with 
benzene exposure must be sought out in the occupational history.

                  IV. Treatment of Acute Toxic Effects

    Remove from exposure immediately. Make sure you are adequately 
protected and do not risk being overcome by fumes. Give oxygen or 
artificial resuscitation if indicated. Flush eyes, wash skin if 
contaminated and remove all contaminated clothing. Symptoms of 
intoxication may persist following severe exposures. Recovery from mild 
exposures is usually rapid and complete.

              V. Surveillance and Preventive Considerations

                               A. General

    The principal effects of benzene exposure which form the basis for 
this regulation are pathological changes in the hematopoietic system, 
reflected by changes in the peripheral blood and manifesting clinically 
as pancytopenia, aplastic anemia, and leukemia. Consequently, the 
medical surveillance program is designed to observe, on a regular basis, 
blood indices for early signs of these effects, and although early signs 
of leukemia are not usually available, emerging diagnostic technology 
and innovative regimes make consistent surveillance for leukemia, as 
well as other hematopoietic effects, essential.
    Initial examinations are to be provided within 60 days of the 
effective date of this standard, or at the time of initial assignment, 
and periodic examinations annually thereafter. There are special 
provisions for medical tests in the event of hematologic abnormalities 
or for emergency situations.
    The blood values which require referral to a hematologist or 
internist are noted in the standard in paragraph (i)(5). The standard 
specifies that blood abnormalities that persist must be referred 
``unless the physician has good reason to believe such referral is 
unnecessary'' (paragraph (i)(5)). Examples of conditions that could make 
a referral unnecessary despite abnormal blood limits are iron or folate 
deficiency, menorrhagia, or blood loss due to some unrelated medical 
abnormality.
    Symptoms and signs of benzene toxicity can be non-specific. Only a 
detailed history and appropriate investigative procedures will enable a 
physician to rule out or confirm conditions that place the employee at 
increased risk. To assist the examining physician with regard to which 
laboratory tests are necessary and when to refer an employee to the 
specialist, OSHA has established the following guidelines.

                        B. Hematology Guidelines

    A minimum battery of tests is to be performed by strictly 
standardized methods.
    1. Red cell, white cell, platelet counts, white blood cell 
differential, hematacrit and red cell indices must be performed by an 
accredited laboratory. The normal ranges for the red cell and white cell 
counts are influenced by altitude, race, and sex, and therefore should 
be determined by the accredited laboratory in the specific area where 
the tests are performed.
    Either a decline from an absolute normal or an individual's base 
line to a subnormal value or a rise to a supra-normal value, are 
indicative of potential toxicity, particularly if all blood parameters 
decline. The normal total white blood count is approximately 7,200/mm\3\ 
plus or minus 3,000. For cigarette smokers the white count may be higher 
and the upper range may be 2,000 cells higher than normal for the 
laboratory. In addition, infection, allergies and some drugs may raise 
the white cell count. The normal platelet count is approximately 250,000 
with a range of 140,000 to 400,000. Counts outside this range should be 
regarded as possible evidence of benzene toxicity.
    Certain abnormalities found through routine screening are of greater 
significance in the benzene-exposed worker and require prompt 
consultation with a specialist, namely:
    a. Thrombocytopenia.
    b. A trend of decreasing white cell, red cell, or platelet indices 
in an individual over time

[[Page 277]]

is more worrisome than an isolated abnormal finding at one test time. 
The importance of trend highlights the need to compare an individual's 
test results to baseline and/or previous periodic tests.
    c. A constellation or pattern of abnormalities in the different 
blood indices is of more significance than a single abnormality. A low 
white count not associated with any abnormalities in other cell indices 
may be a normal statistical variation, whereas if the low white count is 
accompanied by decreases in the platelet and/or red cell indices, such a 
pattern is more likely to be associated with benzene toxicity and merits 
thorough investigation.
    Anemia, leukopenia, macrocytosis or an abnormal differential white 
blood cell count should alert the physician to further investigate and/
or refer the patient if repeat tests confirm the abnormalities. If 
routine screening detects an abnormality, follow-up tests which may be 
helpful in establishing the etiology of the abnormality are the 
peripheral blood smear and the reticulocyte count.
    The extreme range of normal for reticulocytes is 0.4 to 2.5 percent 
of the red cells, the usual range being 0.5 to 1.2 percent of the red 
cells, but the typical value is in the range of 0.8 to 1.0 percent. A 
decline in reticulocytes to levels of less than 0.4 percent is to be 
regarded as possible evidence (unless another specific cause is found) 
of benzene toxicity requiring accelerated surveillance. An increase in 
reticulocyte levels to about 2.5 percent may also be consistent with 
(but is not as characteristic of) benzene toxicity.
    2. An important diagnostic test is a careful examination of the 
peripheral blood smear. As with reticulocyte count the smear should be 
with fresh uncoagulated blood obtained from a needle tip following 
venipuncture or from a drop of earlobe blood (capillary blood). If 
necessary, the smear may, under certain limited conditions, be made from 
a blood sample anticoagulated with EDTA (but never with oxalate or 
heparin). When the smear is to be prepared from a specimen of venous 
blood which has been collected by a commercial Vacutainer [supreg] type 
tube containing neutral EDTA, the smear should be made as soon as 
possible after the venesection. A delay of up to 12 hours is permissible 
between the drawing of the blood specimen into EDTA and the preparation 
of the smear if the blood is stored at refrigerator (not freezing) 
temperature.
    3. The minimum mandatory observations to be made from the smear are:
    a. The differential white blood cell count.
    b. Description of abnormalities in the appearance of red cells.
    c. Description of any abnormalities in the platelets.
    d. A careful search must be made throughout of every blood smear for 
immature white cells such as band forms (in more than normal proportion, 
i.e., over 10 percent of the total differential count), any number of 
metamyelocytes, myelocytes or myeloblasts. Any nucleate or 
multinucleated red blood cells should be reported. Large ``giant'' 
platelets or fragments of megakaryocytes must be recognized.
    An increase in the proportion of band forms among the neutrophilic 
granulocytes is an abnormality deserving special mention, for it may 
represent a change which should be considered as an early warning of 
benzene toxicity in the absence of other causative factors (most 
commonly infection). Likewise, the appearance of metamyelocytes, in the 
absence of another probable cause, is to be considered a possible 
indication of benzene-induced toxicity.
    An upward trend in the number of basophils, which normally do not 
exceed about 2.0 percent of the total white cells, is to be regarded as 
possible evidence of benzene toxicity. A rise in the eosinophil count is 
less specific but also may be suspicious of toxicity if the rises above 
6.0 percent of the total white count.
    The normal range of monocytes is from 2.0 to 8.0 percent of the 
total white count with an average of about 5.0 percent. About 20 percent 
of individuals reported to have mild but persisting abnormalities caused 
by exposure to benzene show a persistent monocytosis. The findings of a 
monocyte count which persists at more than 10 to 12 percent of the 
normal white cell count (when the total count is normal) or persistence 
of an absolute monocyte count in excess of 800/mm\3\ should be regarded 
as a possible sign of benzene-induced toxicity.
    A less frequent but more serious indication of benzene toxicity is 
the finding in the peripheral blood of the so-called ``pseudo'' (or 
acquired) Pelger-Huet anomaly. In this anomaly many, or sometimes the 
majority, of the neutrophilic granulocytes possess two round nuclear 
segements--less often one or three round segments--rather than three 
normally elongated segments. When this anomaly is not hereditary, it is 
often but not invariably predictive of subsequent leukemia. However, 
only about two percent of patients who ultimately develop acute 
myelogenous leukemia show the acquired Pelger-Huet anomaly. Other tests 
that can be administered to investigate blood abnormalities are 
discussed below; however, such procedures should be undertaken by the 
hematologist.
    An uncommon sign, which cannot be detected from the smear, but can 
be elicited by a ``sucrose water test'' of peripheral blood, is 
transient paroxysmal nocturnal hemoglobinuria (PNH), which may first 
occur insidiously during a period of established aplastic anemia, and 
may be followed within

[[Page 278]]

one to a few years by the appearance of rapidly fatal acute myelogenous 
leukemia. Clinical detection of PNH, which occurs in only one or two 
percent of those destined to have acute myelogenous leukemia, may be 
difficult; if the ``sucrose water test'' is positive, the somewhat more 
definitive Ham test, also known as the acid-serum hemolysis test, may 
provide confirmation.
    e. Individuals documented to have developed acute myelogenous 
leukemia years after initial exposure to benzene may have progressed 
through a preliminary phase of hematologic abnormality. In some 
instances pancytopenia (i.e., a lowering in the counts of all 
circulating blood cells of bone marrow origin, but not to the extent 
implied by the term ``aplastic anemia'') preceded leukemia for many 
years. Depression of a single blood cell type or platelets may represent 
a harbinger of aplasia or leukemia. The finding of two or more 
cytopenias, or pancytopenia in a benzene-exposed individual, must be 
regarded as highly suspicious of more advanced although still 
reversible, toxicity. ``Pancytopenia'' coupled with the appearance of 
immature cells (myelocytes, myeloblasts, erythroblasts, etc.), with 
abnormal cells (pseudo Pelger-Huet anomaly, atypical nuclear 
heterochromatin, etc.), or unexplained elevations of white blood cells 
must be regarded as evidence of benzene overexposure unless proved 
otherwise. Many severely aplastic patients manifested the ominous 
finding of 5-10 percent myeloblasts in the marrow, occasional 
myeloblasts and myelocytes in the blood and 20-30% monocytes. It is 
evident that isolated cytopenias, pancytopenias, and even aplastic 
anemias induced by benzene may be reversible and complete recovery has 
been reported on cessation of exposure. However, since any of these 
abnormalities is serious, the employee must immediately be removed from 
any possible exposure to benzene vapor. Certain tests may substantiate 
the employee's prospects for progression or regression. One such test 
would be an examination of the bone marrow, but the decision to perform 
a bone marrow aspiration or needle biopsy is made by the hematologist.
    The findings of basophilic stippling in circulating red blood cells 
(usually found in 1 to 5% of red cells following marrow injury), and 
detection in the bone marrow of what are termed ``ringed sideroblasts'' 
must be taken seriously, as they have been noted in recent years to be 
premonitory signs of subsequent leukemia.
    Recently peroxidase-staining of circulating or marrow neutrophil 
granulocytes, employing benzidine dihydrochloride, have revealed the 
disappearance of, or diminution in, peroxidase in a sizable proportion 
of the granulocytes, and this has been reported as an early sign of 
leukemia. However, relatively few patients have been studied to date. 
Granulocyte granules are normally strongly peroxidase positive. A steady 
decline in leukocyte alkaline phosphatase has also been reported as 
suggestive of early acute leukemia. Exposure to benzene may cause an 
early rise in serum iron, often but not always associated with a fall in 
the reticulocyte count. Thus, serial measurements of serum iron levels 
may provide a means of determining whether or not there is a trend 
representing sustained suppression of erythropoiesis.
    Measurement of serum iron, determination of peroxidase and of 
alkaline phosphatase activity in peripheral granulocytes can be 
performed in most pathology laboratories. Peroxidase and alkaline 
phosphatase staining are usually undertaken when the index of suspecion 
for leukemia is high.

   Appendix D to Sec.  1910.1028--Sampling and Analytical Methods for 
              Benzene Monitoring and Measurement Procedures

    Measurements taken for the purpose of determining employee exposure 
to benzene are best taken so that the representative average 8-hour 
exposure may be determined from a single 8-hour sample or two (2) 4-hour 
samples. Short-time interval samples (or grab samples) may also be used 
to determine average exposure level if a minimum of five measurements 
are taken in a random manner over the 8-hour work shift. Random sampling 
means that any portion of the work shift has the same change of being 
sampled as any other. The arithmetic average of all such random samples 
taken on one work shift is an estimate of an employee's average level of 
exposure for that work shift. Air samples should be taken in the 
employee's breathing zone (air that would most nearly represent that 
inhaled by the employee). Sampling and analysis must be performed with 
procedures meeting the requirements of the standard.
    There are a number of methods available for monitoring employee 
exposures to benzene. The sampling and analysis may be performed by 
collection of the benzene vaptor or charcoal absorption tubes, with 
subsequent chemical analysis by gas chromatography. Sampling and 
analysis may also be performed by portable direct reading instruments, 
real-time continuous monitoring systems, passive dosimeters or other 
suitable methods. The employer has the obligation of selecting a 
monitoring method which meets the accuracy and precision requirements of 
the standard under his unique field conditions. The standard requires 
that the method of monitoring must have an accuracy, to a 95 percent 
confidence level, of not less than plus or minus 25 percent for 
concentrations of benzene greater than or equal to 0.5 ppm.
    The OSHA Laboratory modified NIOSH Method S311 and evaluated it at a 
benzene air concentration of 1 ppm. A procedure for

[[Page 279]]

determining the benzene concentration in bulk material samples was also 
evalauted. This work, reported in OSHA Laboratory Method No. 12, 
includes the following two analytical procedures:

                    I. OSHA Method 12 for Air Samples

Analyte: Benzene
Matrix: Air
Procedure: Adsorption on charcoal, desorption with carbon disulfide, 
analysis by GC.
Detection limit: 0.04 ppm
Recommended air volume and sampling rate: 10L to 0.2 L/min.
    1. Principle of the Method.
    1.1 A known volume of air is drawn through a charcoal tube to trap 
the organic vapors present.
    1.2. The charcoal in the tube is transferred to a small, stoppered 
vial, and the anlyte is desorbed with carbon disulfide.
    1.3. An aliquot of the desorbed sample is injected into a gas 
chromatograph.
    1.4 The area of the resulting peak is determined and compared with 
areas obtained from standards.
    2. Advantages and disadvantages of the method.
    2.1 The sampling device is small, portable, and involved no liquids. 
Interferences are minimal, and most of those which do occur can be 
eliminated by altering chromatographic conditions. The samples are 
analyzed by means of a quick, instrumental method.
    2.2 The amount of sample which can be taken is limited by the number 
of milligrams that the tube will hold before overloading. When the 
sample value obtained for the backup section of the charcoal tube 
exceeds 25 percent of that found on the front section, the possibility 
of sample loss exists.
    3. Apparatus.
    3.1 A calibrated personal sampling pump whose flow can be determined 
within 5 percent at the recommended flow rate.
    3.2. Charcoal tubes: Glass with both ends flame sealed, 7 cm long 
with a 6-mm O.D. and a 4-mm I.D., containing 2 sections of 20/40 mesh 
activated charcoal separated by a 2-mm portion of urethane foam. The 
activated charcoal is prepared from coconut shells and is fired at 600 
[deg]C prior to packing. The adsorbing section contains 100 mg of 
charcoal, the back-up section 50 mg. A 3-mm portion of urethane foam is 
placed between the outlet end of the tube and the back-up section. A 
plug of silanized glass wool is placed in front of the adsorbing 
section. The pressure drop across the tube must be less than one inch of 
mercury at a flow rate of 1 liter per minute.
    3.3. Gas chromatograph equipped with a flame ionization detector.
    3.4. Column (10-ft x \1/8\-in stainless steel) packed with 80/100 
Supelcoport coated with 20 percent SP 2100, 0.1 percent CW 1500.
    3.5. An electronic integrator or some other suitable method for 
measuring peak area.
    3.6. Two-milliliter sample vials with Teflon-lined caps.
    3.7. Microliter syringes: 10-microliter (10-[micro]L syringe, and 
other convenient sizes for making standards, 1-[micro]L syringe for 
sample injections.
    3.8. Pipets: 1.0 mL delivery pipets
    3.9. Volumetric flasks: convenient sizes for making standard 
solutions.
    4. Reagents.
    4.1. Chromatographic quality carbon disulfide (CS2). Most 
commercially available carbon disulfide contains a trace of benzene 
which must be removed. It can be removed with the following procedure:
    Heat under reflux for 2 to 3 hours, 500 mL of carbon disulfide, 10 
mL concentrated sulfuric acid, and 5 drops of concentrated nitric acid. 
The benzene is converted to nitrobenzene. The carbon disulfide layer is 
removed, dried with anhydrous sodium sulfate, and distilled. The 
recovered carbon disulfide should be benzene free. (It has recently been 
determined that benzene can also be removed by passing the carbon 
disulfide through 13x molecular sieve).
    4.2. Benzene, reagent grade.
    4.3. p-Cymene, reagent grade, (internal standard).
    4.4. Desorbing reagent. The desorbing reagent is prepared by adding 
0.05 mL of p-cymene per milliliter of carbon disulfide. (The internal 
standard offers a convenient means correcting analytical response for 
slight inconsistencies in the size of sample injections. If the external 
standard technique is preferred, the internal standard can be 
eliminated).
    4.5. Purified GC grade helium, hydrogen and air.
    5. Procedure.
    5.1. Cleaning of equipment. All glassware used for the laboratory 
analysis should be properly cleaned and free of organics which could 
interfere in the analysis.
    5.2. Calibration of personal pumps. Each pump must be calibrated 
with a representative charcoal tube in the line.
    5.3. Collection and shipping of samples.
    5.3.1. Immediately before sampling, break the ends of the tube to 
provide an opening at least one-half the internal diameter of the tube 
(2 mm).
    5.3.2. The smaller section of the charcoal is used as the backup and 
should be placed nearest the sampling pump.
    5.3.3. The charcoal tube should be placed in a vertical position 
during sampling to minimize channeling through the charcoal.
    5.3.4 Air being sampled should not be passed through any hose or 
tubing before entering the charcoal tube.
    5.3.5. A sample size of 10 liters is recommended. Sample at a flow 
rate of approximately 0.2 liters per minute. The flow rate

[[Page 280]]

should be known with an accuracy of at least 5 
percent.
    5.3.6. The charcoal tubes should be capped with the supplied plastic 
caps immediately after sampling.
    5.3.7. Submit at least one blank tube (a charcoal tube subjected to 
the same handling procedures, without having any air drawn through it) 
with each set of samples.
    5.3.8. Take necessary shipping and packing precautions to minimize 
breakage of samples.
    5.4. Analysis of samples.
    5.4.1. Preparation of samples. In preparation for analysis, each 
charcoal tube is scored with a file in front of the first section of 
charcoal and broken open. The glass wool is removed and discarded. The 
charcoal in the first (larger) section is transferred to a 2-ml vial. 
The separating section of foam is removed and discarded; the second 
section is transferred to another capped vial. These two sections are 
analyzed separately.
    5.4.2. Desorption of samples. Prior to analysis, 1.0 mL of desorbing 
solution is pipetted into each sample container. The desorbing solution 
consists of 0.05 [micro]L internal standard per mL of carbon disulfide. 
The sample vials are capped as soon as the solvent is added. Desorption 
should be done for 30 minutes with occasional shaking.
    5.4.3. GC conditions. Typical operating conditions for the gas 
chromatograph are:
    1.30 mL/min (60 psig) helium carrier gas flow.
    2.30 mL/min (40 psig) hydrogen gas flow to detector.
    3.240 mL/min (40 psig) air flow to detector.
    4.150 [deg]C injector temperature.
    5.250 [deg]C detector temperature.
    6.100 [deg]C column temperature.
    5.4.4. Injection size. 1 [micro]L.
    5.4.5. Measurement of area. The peak areas are measured by an 
electronic integrator or some other suitable form of area measurement.
    5.4.6. An internal standard procedure is used. The integrator is 
calibrated to report results in ppm for a 10 liter air sample after 
correction for desorption efficiency.
    5.5. Determination of desorption efficiency.
    5.5.1. Importance of determination. The desorption efficiency of a 
particular compound can vary from one laboratory to another and from one 
lot of chemical to another. Thus, it is necessary to determine, at least 
once, the percentage of the specific compound that is removed in the 
desorption process, provided the same batch of charcoal is used.
    5.5.2. Procedure for determining desorption efficiency. The 
reference portion of the charcoal tube is removed. To the remaining 
portion, amounts representing 0.5X, 1X, and 2X and (X represents target 
concentration) based on a 10 L air sample are injected into several 
tubes at each level. Dilutions of benzene with carbon disulfide are made 
to allow injection of measurable quantities. These tubes are then 
allowed to equilibrate at least overnight. Following equilibration they 
are analyzed following the same procedure as the samples. Desorption 
efficiency is determined by dividing the amount of benzene found by 
amount spiked on the tube.
    6. Calibration and standards. A series of standards varying in 
concentration over the range of interest is prepared and analyzed under 
the same GC conditions that will be used on the samples. A calibration 
curve is prepared by plotting concentration ([micro]g/mL) versus peak 
area.
    7. Calculations. Benzene air concentration can be calculated from 
the following equation:

mg/m\3\ = (A)(B)/(C)(D)

Where:

A = [micro]g/mL benzene, obtained from the calibration curve
B = desorption volume (1 mL)
C = Liters of air sampled
D = desorption efficiency

    The concentration in mg/m\3\ can be converted to ppm (at 25[deg] and 
760 mm) with following equation:

ppm = (mg/m\3\)(24.46)/(78.11)

Where:

24.46 = molar volume of an ideal gas
25 [deg]C and 760 mm
78.11 = molecular weight of benzene

    8. Backup Data.
    8.1 Detection limit--Air Samples.
    The detection limit for the analytical procedure is 1.28 ng with a 
coefficient of variation of 0.023 at this level. This would be 
equivalent to an air concentration of 0.04 ppm for a 10 L air sample. 
This amount provided a chromatographic peak that could be identifiable 
in the presence of possible interferences. The detection limit data were 
obtained by making 1 [micro]L injections of a 1.283 [micro]g/mL 
standard.

------------------------------------------------------------------------
                                            Area
                Injection                  Count
------------------------------------------------------------------------
1.......................................    655.4
2.......................................    617.5
3.......................................    662.0  X = 640.2
4.......................................    641.1  SD = 14.9
5.......................................    636.4  CV = 0.023
6.......................................    629.2  .....................
------------------------------------------------------------------------

    8.2. Pooled coefficient of variation--Air Samples. The pooled 
coefficient of variation for the analytical procedure was determined by 
1 [micro]L replicate injections of analytical standards. The standards 
were 16.04, 32.08, and 64.16 [micro]g/mL, which are equivalent to 0.5, 
1.0, and 2.0 ppm for a 10 L air sample respectively.

[[Page 281]]



------------------------------------------------------------------------
                                                 Area Counts
             Injection              ------------------------------------
                                       0.5 ppm     1.0 ppm     2.0 ppm
------------------------------------------------------------------------
1..................................   3996.5      8130.2      16481
2..................................   4059.4      8235.6      16493
3..................................   4052.0      8307.9      16535
4..................................   4027.2      8263.2      16609
5..................................   4046.8      8291.1      16552
6..................................   4137.9      8288.8      16618
X=                                    4053.3      8254.0      16548.3
SD=                                     47.2        62.5         57.1
CV =                                     0.0116      0.0076       0.0034
CV = 0.008.........................  ..........  ..........  ...........
------------------------------------------------------------------------

    8.3. Storage data--Air Samples
    Samples were generated at 1.03 ppm benzene at 80% relative humidity, 
22 [deg]C, and 643 mm. All samples were taken for 50 minutes at 0.2 L/
min. Six samples were analyzed immediately and the rest of the samples 
were divided into two groups by fifteen samples each. One group was 
stored at refrigerated temperature of -25 [deg]C, and the other group 
was stored at ambient temperature (approximately 23 [deg]C). These 
samples were analyzed over a period of fifteen days. The results are 
tabulated below.

                            Percent Recovery
------------------------------------------------------------------------
          Day analyzed               Refrigerated           Ambient
------------------------------------------------------------------------
0...............................      97.4 98.7 98.9      97.4 98.7 98.9
0...............................    97.1 100.6 100.9    97.1 100.6 100.9
2...............................      95.8 96.4 95.4      95.4 96.6 96.9
5...............................      93.9 93.7 92.4      92.4 94.3 94.1
9...............................      93.6 95.5 94.6      95.2 95.6 96.6
13..............................      94.3 95.3 93.7      91.0 95.0 94.6
15..............................      96.8 95.8 94.2      92.9 96.3 95.9
------------------------------------------------------------------------

    8.4. Desorption data.
    Samples were prepared by injecting liquid benzene onto the A section 
of charcoal tubes. Samples were prepared that would be equivalent to 
0.5, 1.0, and 2.0 ppm for a 10 L air sample.

                            Percent Recovery
------------------------------------------------------------------------
                   Sample                    0.5 ppm  1.0 ppm   2.0 ppm
------------------------------------------------------------------------
1..........................................  99.4     98.8       99.5
2..........................................  99.5     98.7       99.7
3..........................................  99.2     98.6       99.8
4..........................................  99.4     99.1      100.0
5..........................................  99.2     99.0       99.7
6..........................................  99.8     99.1       99.9
X=.........................................  99.4     98.9       99.8
SD=........................................   0.22     0.21       0.18
CV =.......................................   0.0022   0.0021     0.0018
X = 99.4
------------------------------------------------------------------------

    8.5. Carbon disulfide.
    Carbon disulfide from a number of sources was analyzed for benzene 
contamination. The results are given in the following table. The benzene 
contamiant can be removed with the procedures given in section 4.1.

------------------------------------------------------------------------
                                                                  ppm
                                                    [micro]g  equivalent
                      Sample                        Benzene/   (for 10 L
                                                       mL         air
                                                                sample)
------------------------------------------------------------------------
Aldrich Lot 83017.................................      4.20       0.13
Baker Lot 720364..................................      1.01       0.03
Baker Lot 822351..................................      1.01       0.03
Malinkrodt Lot WEMP...............................      1.74       0.05
Malinkrodt Lot WDSJ...............................      5.65       0.18
Malinkrodt Lot WHGA...............................      2.90       0.09
Treated CS2.......................................  ........  ..........
------------------------------------------------------------------------

           II. OSHA Laboratory Method No. 12 for Bulk Samples

    Analyte: Benzene.
    Matrix: Bulk Samples.
    Procedure: Bulk Samples are analyzed directly by high performance 
liquid chromatography (HPLC).
    Detection limits: 0.01% by volume.
    1. Principle of the method.
    1.1. An aliquot of the bulk sample to be analyzed is injected into a 
liquid chromatograph.
    1.2. The peak area for benzene is determined and compared to areas 
obtained from standards.
    2. Advantages and disadvantages of the method.
    2.1. The analytical procedure is quick, sensitive, and reproducible.
    2.2. Reanalysis of samples is possible.
    2.3. Interferences can be circumvented by proper selection of HPLC 
parameters.
    2.4. Samples must be free of any particulates that may clog the 
capillary tubing in the liquid chromatograph. This may require 
distilling the sample or clarifying with a clarification kit.
    3. Apparatus.
    3.1. Liquid chromatograph equipped with a UV detector.
    3.2. HPLC Column that will separate benzene from other components in 
the bulk sample being analyzed. The column used for validation studies 
was a Waters uBondapack C18, 30 cm x 3.9 mm.
    3.3. A clarification kit to remove any particulates in the bulk if 
necessary.
    3.4. A micro-distillation apparatus to distill any samples if 
necessary.
    3.5. An electronic integrator or some other suitable method of 
measuring peak areas.
    3.6. Microliter syringes--10 [micro]L syringe and other convenient 
sizes for making standards. 10 [micro]L syringe for sample injections.
    3.7. Volumetric flasks, 5 mL and other convenient sizes for 
preparing standards and making dilutions.
    4. Reagents.
    4.1. Benzene, reagent grade.
    4.2. HPLC grade water, methyl alcohol, and isopropyl alcohol.
    5. Collection and shipment of samples.
    5.1. Samples should be transported in glass containers with Teflon-
lined caps.

[[Page 282]]

    5.2. Samples should not be put in the same container used for air 
samples.
    6. Analysis of samples.
    6.1. Sample preparation.
    If necessary, the samples are distilled or clarified. Samples are 
analyzed undiluted. If the benzene concentration is out of the working 
range, suitable dilutions are made with isopropyl alcohol.
    6.2. HPLC conditions.
    The typical operating conditions for the high performance liquid 
chromatograph are:
    1. Mobile phase--Methyl alcohol/water, 50/50
    1. Analytical wavelength--254 nm
    3. Injection size--10 [micro]L
    6.3. Measurement of peak area and calibration.
    Peak areas are measured by an integrator or other suitable means. 
The integrator is calibrated to report results % in benzene by volume.
    7. Calculations.
    Since the integrator is programmed to report results in % benzene by 
volume in an undiluted sample, the following equation is used:

% Benzene by Volume = A x B

Where:

A = % by volume on report
B = Dilution Factor
(B = 1 for undiluted sample)

    8. Backup Data.
    8.1. Detection limit--Bulk Samples.
    The detection limit for the analytical procedure for bulk samples is 
0.88 [micro]g, with a coefficient of variation of 0.019 at this level. 
This amount provided a chromatographic peak that could be identifiable 
in the presence of possible interferences. The detection limit date were 
obtained by making 10 [micro]L injections of a 0.10% by volume standard.

------------------------------------------------------------------------
              Injection                 Area Count
------------------------------------------------------------------------
1....................................        45386
2....................................        44214
3....................................        43822  X = 44040.1
4....................................        44062  SD = 852.5
6....................................        42724  CV = 0.019
------------------------------------------------------------------------

    8.2. Pooled coefficient of variation--Bulk Samples.
    The pooled coefficient of variation for analytical procedure was 
determined by 50 [micro]L replicate injections of analytical standards. 
The standards were 0.01, 0.02, 0.04, 0.10, 1.0, and 2.0% benzene by 
volume.

                                              Area count (Percent)
----------------------------------------------------------------------------------------------------------------
                    Injection No.                       0.01      0.02      0.04      0.10       1.0       2.0
----------------------------------------------------------------------------------------------------------------
1...................................................     45386     84737    166097    448497   4395380   9339150
2...................................................     44241     84300    170832    441299   4590800   9484900
3...................................................     43822     83835    164160    443719   4593200   9557580
4...................................................     44062     84381    164445    444842   4642350   9677060
5...................................................     44006     83012    168398    442564   4646430   9766240
6...................................................     42724     81957    173002    443975   4646260
X =                                                    44040.1   83703.6    167872    444149   4585767   9564986
SD =                                                     852.5    1042.2    3589.8    2459.1   96839.3    166233
CV =                                                    0.0194    0.0125    0.0213    0.0055    0.0211    0.0174
CV =                                                     0.017
----------------------------------------------------------------------------------------------------------------


[52 FR 34562, Sept. 11, 1987, as amended at 54 FR 24334, June 7, 1989; 
61 FR 5508, Feb. 13, 1996; 63 FR 1289, Jan. 8, 1998; 63 FR 20099, Apr. 
23, 1998; 70 FR 1142, Jan. 5, 2005; 71 FR 16673, Apr. 3, 2006; 71 FR 
50189, Aug. 24, 2006; 73 FR 75585, Dec. 12, 2008; 76 FR 33608, June 8, 
2011; 77 FR 17781, Mar. 26, 2012]



Sec.  1910.1029  Coke oven emissions.

    (a) Scope and application. This section applies to the control of 
employee exposure to coke oven emissions, except that this section shall 
not apply to working conditions with regard to which other Federal 
agencies exercise statutory authority to prescribe or enforce standards 
affecting occupational safety and health.
    (b) Definitions. For the purpose of this section:
    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 opportunity to observe 
monitoring and measuring procedures under paragraph (n) of this section.
    Beehive oven means a coke oven in which the products of 
carbonization other than coke are not recovered, but are released into 
the ambient air.
    Coke oven means a retort in which coke is produced by the 
destructive distillation or carbonization of coal.

[[Page 283]]

    Coke oven battery means a structure containing a number of slot-type 
coke ovens.
    Coke oven emissions means the benzene-soluble fraction of total 
particulate matter present during the destructive distillation or 
carbonization of coal for the production of coke.
    Director means the Director, National Institute for Occupational 
Safety and Health, U.S. Department of Health, Education, and Welfare, or 
his or her designee.
    Emergency means any occurance such as, but not limited to, equipment 
failure which is likely to, or does, result in any massive release of 
coke oven emissions.
    Existing coke oven battery means a battery in operation or under 
construction on January 20, 1977, and which is not a rehabilitated coke 
oven battery.
    Rehabilitated coke oven battery means a battery which is rebuilt, 
overhauled, renovated, or restored such as from the pad up, after 
January 20, 1977.
    Secretary means the Secretary of Labor, U.S. Department of Labor, or 
his or her designee.
    Stage charging means a procedure by which a predetermined volume of 
coal in each larry car hopper is introduced into an oven such that no 
more than two hoppers are discharging simultaneously.
    Sequential charging means a procedure, usually automatically timed, 
by which a predetermined volume of coal in each larry car hopper is 
introduced into an oven such that no more than two hoppers commence or 
finish discharging simultaneously although, at some point, all hoppers 
are discharging simultaneously.
    Pipeline charging means any apparatus used to introduce coal into an 
oven which uses a pipe or duct permanently mounted onto an oven and 
through which coal is charged.
    Green plush means coke which when removed from the oven results in 
emissions due to the presence of unvolatilized coal.
    (c) Permissible exposure limit. The employer shall assure that no 
employee in the regulated area is exposed to coke oven emissions at 
concentrations greater than 150 micrograms per cubic meter of air (150 
[micro]g/m\3\), averaged over any 8-hour period.
    (d) Regulated areas. (1) The employer shall establish regulated 
areas and shall limit access to them to authorized persons.
    (2) The employer shall establish the following as regulated areas:
    (i) The coke oven battery including topside and its machinery, 
pushside and its machinery, coke side and its machinery, and the battery 
ends; the wharf; and the screening station;
    (ii) The beehive oven and its machinery.
    (e) Exposure monitoring and measurement--(1) Monitoring program. (i) 
Each employer who has a place of employment where coke oven emissions 
are present shall monitor employees employed in the regulated area to 
measure their exposure to coke oven emissions.
    (ii) The employer shall obtain measurements which are representative 
of each employee's exposure to coke oven emissions over an eight-hour 
period. All measurements shall determine exposure without regard to the 
use of respiratory protection.
    (iii) The employer shall collect fullshift (for at least seven 
continuous hours) personal samples, including at least one sample during 
each shift for each battery and each job classification within the 
regulated areas including at least the following job classifications:
    (a) Lidman;
    (b) Tar chaser;
    (c) Larry car operator;
    (d) Luterman;
    (e) Machine operator, coke side;
    (f) Benchman, coke side;
    (g) Benchman, pusher side;
    (h) Heater;
    (i) Quenching car operator;
    (j) Pusher machine operator;
    (k) Screening station operator;
    (l) Wharfman;
    (m) Oven patcher;
    (n) Oven repairman;
    (o) Spellman; and
    (p) Maintenance personnel.
    (iv) The employer shall repeat the monitoring and measurements 
required by this paragraph (e)(1) at least every three months.

[[Page 284]]

    (2) Redetermination. Whenever there has been a production, process, 
or control change which may result in new or additional exposure to coke 
oven emissions, or whenever the employer has any other reason to suspect 
an increase in employee exposure, the employer shall repeat the 
monitoring and measurements required by paragraph (e)(1) of this section 
for those employees affected by such change or increase.
    (3) 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 employees.
    (ii) Whenever such results indicate that the representative employee 
exposure exceeds the permissible exposure limit, the employer shall, in 
such notification, inform each employee of that fact and of the 
corrective action being taken to reduce exposure to or below the 
permissible exposure limit.
    (4) Accuracy of measurement. The employer shall use a method of 
monitoring and measurement which has an accuracy (with a confidence 
level of 95%) of not less than plus or minus 35% for concentrations of 
coke oven emissions greater than or equal to 150 [micro]g/m\3\.
    (f) Methods of compliance. The employer shall control employee 
exposure to coke oven emissions by the use of engineering controls, work 
practices and respiratory protection as follows:
    (1) Priority of compliance methods--(i) Existing coke oven 
batteries. (a) The employer shall institute the engineering and work 
practice controls listed in paragraphs (f)(2), (f)(3) and (f)(4) of this 
section in existing coke oven batteries at the earliest possible time, 
but not later than January 20, 1980, except to the extent that the 
employer can establish that such controls are not feasible. In 
determining the earliest possible time for institution of engineering 
and work practice controls, the requirement, effective August 27, 1971, 
to implement feasible administrative or engineering controls to reduce 
exposures to coal tar pitch volatiles, shall be considered. Wherever the 
engineering and work practice controls which can be instituted are not 
sufficient to reduce employee exposures to or below the permissible 
exposure limit, the employer shall nonetheless use them to reduce 
exposures to the lowest level achievable by these controls and shall 
supplement them by the use of respiratory protection which complies with 
the requirements of paragraph (g) of this section.
    (b) The engineering and work practice controls required under 
paragraphs (f)(2), (f)(3) and (f)(4) of this section are minimum 
requirements generally applicable to all existing coke oven batteries. 
If, after implementing all controls required by paragraphs (f)(2), 
(f)(3) and (f)(4) of this section, or after January 20, 1980, whichever 
is sooner, employee exposures still exceed the permissible exposure 
limit, employers shall implement any other engineering and work practice 
controls necessary to reduce exposure to or below the permissible 
exposure limit except to the extent that the employer can establish that 
such controls are not feasible. Whenever the engineering and work 
practice controls which can be instituted are not sufficient to reduce 
employee exposures to or below the permissible exposure limit, the 
employer shall nonetheless use them to reduce exposures to the lowest 
level achievable by these controls and shall supplement them by the use 
of respiratory protection which complies with the requirements of 
paragraph (g) of this section.
    (ii) New or rehabilitated coke oven batteries. (a) The employer 
shall institute the best available engineering and work practice 
controls on all new or rehabilitated coke oven batteries to reduce and 
maintain employee exposures at or below the permissible exposure limit, 
except to the extent that the employer can establish that such controls 
are not feasible. Wherever the engineering and work practice controls 
which can be instituted are not sufficient to reduce employee exposures 
to or below the permissible exposure limit, the employer shall 
nonetheless use them to reduce exposures to the lowest level achievable 
by these controls and shall supplement them by the use of respiratory 
protection which

[[Page 285]]

complies with the requirements of paragraph (g) of this section.
    (b) If, after implementing all the engineering and work practice 
controls required by paragraph (f)(1)(ii)(a) of this section, employee 
exposures still exceed the permissible exposure limit, the employer 
shall implement any other engineering and work practice controls 
necessary to reduce exposure to or below the permissible exposure limit 
except to the extent that the employer can establish that such controls 
are not feasible. Wherever the engineering and work practice controls 
which can be instituted are not sufficient to reduce employee exposures 
to or below the permissible exposure limit, the employer shall 
nonetheless use them to reduce exposures to the lowest level achievable 
by these controls and shall supplement them by the use of respiratory 
protection which complies with the requirements of paragraph (g) of this 
section.
    (iii) Beehive ovens. (a) The employer shall institute engineering 
and work practice controls on all beehive ovens at the earliest possible 
time to reduce and maintain employee exposures at or below the 
permissible exposure limit, except to the extent that the employer can 
establish that such controls are not feasible. In determining the 
earliest possible time for institution of engineering and work practice 
controls, the requirement, effective August 27, 1971, to implement 
feasible administrative or engineering controls to reduce exposures to 
coal tar pitch volatiles, shall be considered. Wherever the engineering 
and work practice controls which can be instituted are not sufficient to 
reduce employee exposures to or below the permissible exposure limit, 
the employer shall nonetheless use them to reduce exposures to the 
lowest level achievable by these controls and shall supplement them by 
the use of respiratory protection which complies with the requirements 
of paragraph (g) of this section.
    (b) If, after implementing all engineering and work practice 
controls required by paragraph (f)(1)(iii)(a) of this section, employee 
exposures still exceed the permissible exposure limit, the employer 
shall implement any other engineering and work practice controls 
necessary 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. Whenever the engineering and work practice controls 
which can be instituted are not sufficient to reduce employee exposures 
to or below the permissible exposure limit, the employer shall 
nonetheless use them to reduce exposures to the lowest level achievable 
by these controls and shall supplement them by the use of respiratory 
protection which complies with the requirements of paragraph (g) of this 
section.
    (2) Engineering controls--(i) Charging. The employer shall equip and 
operate existing coke oven batteries with all of the following 
engineering controls to control coke oven emissions during charging 
operations:
    (a) One of the following methods of charging:
    (1) Stage charging as described in paragraph (f)(3)(i)(b) of this 
section; or
    (2) Sequential charging as described in paragraph (f)(3)(i)(b) of 
this section except that paragraph (f)(3)(i)(b)(3)(iv) of this section 
does not apply to sequential charging; or
    (3) Pipeline charging or other forms of enclosed charging in 
accordance with paragraph (f)(2)(i) of this section, except that 
paragraphs (f)(2)(i)(b), (d), (e), (f) and (h) of this section do not 
apply;
    (b) Drafting from two or more points in the oven being charged, 
through the use of double collector mains, or a fixed or moveable jumper 
pipe system to another oven, to effectively remove the gases from the 
oven to the collector mains;
    (c) Aspiration systems designed and operated to provide sufficient 
negative pressure and flow volume to effectively move the gases evolved 
during charging into the collector mains, including sufficient steam 
pressure, and steam jets of sufficient diameter;
    (d) Mechanical volumetric controls on each larry car hopper to 
provide the proper amount of coal to be charged through each charging 
hole so that the tunnel head will be sufficient to permit the gases to 
move from the oven into the collector mains;

[[Page 286]]

    (e) Devices to facilitate the rapid and continuous flow of coal into 
the oven being charged, such as stainless steel liners, coal vibrators 
or pneumatic shells;
    (f) Individually operated larry car drop sleeves and slide gates 
designed and maintained so that the gases are effectively removed from 
the oven into the collector mains;
    (g) Mechanized gooseneck and standpipe cleaners;
    (h) Air seals on the pusher machine leveler bars to control air 
infiltration during charging; and
    (i) Roof carbon cutters or a compressed air system or both on the 
pusher machine rams to remove roof carbon.
    (ii) Coking. The employer shall equip and operate existing coke oven 
batteries with all of the following engineering controls to control coke 
oven emissions during coking operations;
    (a) A pressure control system on each battery to obtain uniform 
collector main pressure;
    (b) Ready access to door repair facilities capable of prompt and 
efficient repair of doors, door sealing edges and all door parts;
    (c) An adequate number of spare doors available for replacement 
purposes;
    (d) Chuck door gaskets to control chuck door emissions until such 
door is repaired, or replaced; and
    (e) Heat shields on door machines.
    (3) Work practice controls--(i) Charging. The employer shall operate 
existing coke oven batteries with all of the following work practices to 
control coke oven emissions during the charging operation:
    (a) Establishment and implementation of a detailed, written 
inspection and cleaning procedure for each battery consisting of at 
least the following elements:
    (1) Prompt and effective repair or replacement of all engineering 
controls;
    (2) Inspection and cleaning of goosenecks and standpipes prior to 
each charge to a specified minimum diameter sufficient to effectively 
move the evolved gases from the oven to the collector mains;
    (3) Inspection for roof carbon build-up prior to each charge and 
removal of roof carbon as necessary to provide an adequate gas channel 
so that the gases are effectively moved from the oven into the collector 
mains;
    (4) Inspection of the steam aspiration system prior to each charge 
so that sufficient pressure and volume is maintained to effectively move 
the gases from the oven to the collector mains;
    (5) Inspection of steam nozzles and liquor sprays prior to each 
charge and cleaning as necessary so that the steam nozzles and liquor 
sprays are clean;
    (6) Inspection of standpipe caps prior to each charge and cleaning 
and luting or both as necessary so that the gases are effectively moved 
from the oven to the collector mains; and
    (7) Inspection of charging holes and lids for cracks, warpage and 
other defects prior to each charge and removal of carbon to prevent 
emissions, and application of luting material to standpipe and charging 
hole lids where necessary to obtain a proper seal.
    (b) Establishment and implementation of a detailed written charging 
procedure, designed and operated to eliminate emissions during charging 
for each battery, consisting of at least the following elements:
    (1) Larry car hoppers filled with coal to a predetermined level in 
accordance with the mechanical volumetric controls required under 
paragraph (f)(2)(i)(d) of this section so as to maintain a sufficient 
gas passage in the oven to be charged;
    (2) The larry car aligned over the oven to be charged, so that the 
drop sleeves fit tightly over the charging holes; and
    (3) The oven charged in accordance with the following sequence of 
requirements:
    (i) The aspiration system turned on;
    (ii) Coal charged through the outermost hoppers, either individually 
or together depending on the capacity of the aspiration system to 
collect the gases involved;
    (iii) The charging holes used under paragraph (f)(3)(i)(b)(3)(ii) of 
this section relidded or otherwise sealed off to prevent leakage of coke 
oven emissions;

[[Page 287]]

    (iv) If four hoppers are used, the third hopper discharged and 
relidded or otherwise sealed off to prevent leakage of coke oven 
emissions;
    (v) The final hopper discharged until the gas channel at the top of 
the oven is blocked and then the chuck door opened and the coal leveled;
    (vi) When the coal from the final hopper is discharged and the 
leveling operation complete, the charging hole relidded or otherwise 
sealed off to prevent leakage of coke oven emissions; and
    (vii) The aspiration system turned off only after the charging holes 
have been closed.
    (c) Establishment and implementation of a detailed written charging 
procedure, designed and operated to eliminate emissions during charging 
of each pipeline or enclosed charged battery.
    (ii) Coking. The employer shall operate existing coke oven batteries 
pursuant to a detailed written procedure established and implemented for 
the control of coke oven emissions during coking, consisting of at least 
the following elements:
    (a) Checking oven back pressure controls to maintain uniform 
pressure conditions in the collecting main;
    (b) Repair, replacement and adjustment of oven doors and chuck doors 
and replacement of door jambs so as to provide a continuous metal-to-
metal fit;
    (c) Cleaning of oven doors, chuck doors and door jambs each coking 
cycle so as to provide an effective seal;
    (d) An inspection system and corrective action program to control 
door emissions to the maximum extent possible; and
    (e) Luting of doors that are sealed by luting each coking cycle and 
reluting, replacing or adjusting as necessary to control leakage.
    (iii) Pushing. The employer shall operate existing coke oven 
batteries with the following work practices to control coke oven 
emissions during pushing operations:
    (a) Coke and coal spillage quenched as soon as practicable and not 
shoveled into a heated oven; and
    (b) A detailed written procedure for each battery established and 
implemented for the control of emissions during pushing consisting of 
the following elements:
    (1) Dampering off the ovens and removal of charging hole lids to 
effectively control coke oven emissions during the push;
    (2) Heating of the coal charge uniformly for a sufficient period so 
as to obtain proper coking including preventing green pushes;
    (3) Prevention of green pushes to the maximum extent possible;
    (4) Inspection, adjustment and correction of heating flue 
temperatures and defective flues at least weekly and after any green 
push, so as to prevent green pushes;
    (5) Cleaning of heating flues and related equipment to prevent green 
pushes, at least weekly and after any green push.
    (iv) Maintenance and repair. The employer shall operate existing 
coke oven batteries pursuant to a detailed written procedure of 
maintenance and repair established and implemented for the effective 
control of coke oven emissions consisting of the following elements:
    (a) Regular inspection of all controls, including goosenecks, 
standpipes, standpipe caps, charging hold lids and castings, jumper 
pipes and air seals for cracks, misalignment or other defects and prompt 
implementation of the necessary repairs as soon as possible;
    (b) Maintaining the regulated area in a neat, orderly condition free 
of coal and coke spillage and debris;
    (c) Regular inspection of the damper system, aspiration system and 
collector main for cracks or leakage, and prompt implementation of the 
necessary repairs;
    (d) Regular inspection of the heating system and prompt 
implementation of the necessary repairs;
    (e) Prevention of miscellaneous fugitive topside emissions;
    (f) Regular inspection and patching of oven brickwork;
    (g) Maintenance of battery equipment and controls in good working 
order;
    (h) Maintenance and repair of coke oven doors, chuck doors, door 
jambs and seals; and

[[Page 288]]

    (i) Repairs instituted and completed as soon as possible, including 
temporary repair measures instituted and completed where necessary, 
including but not limited to:
    (1) Prevention of miscellaneous fugitive topside emissions; and
    (2) Chuck door gaskets, which shall be installed prior to the start 
of the next coking cycle.
    (4) Filtered air. (i) The employer shall provided positive-pressure, 
temperature controlled filtered air for larry car, pusher machine, door 
machine, and quench car cabs.
    (ii) The employer shall provide standby pulpits on the battery 
topside, at the wharf, and at ther screening station, equipped with 
positive-pressure, temperature controlled filtered air.
    (5) Emergencies. Whenever an emergency occurs, the next coking cycle 
may not begin until the cause of the emergency is determined and 
corrected, unless the employer can establish that it is necessary to 
initiate the next coking cycle in order to determine the cause of the 
emergency.
    (6) Compliance program. (i) Each employer shall establish and 
implement a written program to reduce exposures solely by means of the 
engineering and work practice controls required in paragraph (f) of this 
section.
    (ii) The written program shall include at least the following:
    (a) A description of each coke oven operation by battery, including 
work force and operating crew, coking time, operating procedures and 
maintenance practices;
    (b) Engineering plans and other studies used to determine the 
controls for the coke battery;
    (c) A report of the technology considered in meeting the permissible 
exposure limit;
    (d) Monitoring data obtained in accordance with paragraph (e) of 
this section;
    (e) A detailed schedule for the implementation of the engineering 
and work practice controls required in paragraph (f) of this section; 
and
    (f) Other relevant information.
    (iii) If, after implementing all controls required by paragraph 
(f)(2)-(f)(4) of this section, or after January 20, 1980, whichever is 
sooner, or after completion of a new or rehabilitated battery the 
permissible exposure limit is still exceeded, the employer shall develop 
a detailed written program and schedule for the implementation of any 
additional engineering controls and work practices necessary to reduce 
exposure to or below the permissible exposure limit.
    (iv) Written plans for such programs shall be submitted, upon 
request, to the Secretary and the Director, and shall be available at 
the worksite for examination and copying by the Secretary, the Director, 
and the authorized employee representative. The plans required under 
paragraph (f)(6) of this section shall be revised and updated at least 
annually to reflect the current status of the program.
    (7) Training in compliance procedures. The employer shall 
incorporate all written procedures and schedules required under this 
paragraph (f) in the information and training program required under 
paragraph (k) of this section and, where appropriate, post in the 
regulated area.
    (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 activity, for 
which engineering and work-practice controls are technologically 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 permissible exposure limit.
    (iv) Emergencies.
    (2) Respirator program. 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.
    (3) Respirator selection. Employers must select, and provide to 
employees, the appropriate respirators specified in paragraph 
(d)(3)(i)(A) of 29 CFR

[[Page 289]]

1910.134; however, employers may use a filtering facepiece respirator 
only when it functions as a filter respirator for coke oven emissions 
particulates.
    (h) Protective clothing and equipment--(1) Provision and use. The 
employer shall provide and assure the use of appropriate protective 
clothing and equipment, such as but not limited to:
    (i) Flame resistant jacket and pants;
    (ii) Flame resistant gloves;
    (iii) Face shields or vented goggles which comply with Sec.  
1910.133(a)(2) of this part;
    (iv) Footwear providing insulation from hot surfaces for footwear;
    (v) Safety shoes which comply with Sec.  1910.136 of this part; and
    (vi) Protective helmets which comply with Sec.  1910.135 of this 
part.
    (2) Cleaning and replacement. (i) The employer shall provide the 
protective clothing required by paragraphs (h)(1) (i) and (ii) of this 
section in a clean and dry condition at least weekly.
    (ii) The employer shall clean, launder, or dispose of protective 
clothing required by paragraphs (h)(1) (i) and (ii) 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 (i)(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 
closable container in the change room.
    (vi) The employer shall inform any person who cleans or launders 
protective clothing required by this section, of the potentially harmful 
effects of exposure to coke oven emissions.
    (i) Hygiene facilities and practices--(1) Change rooms. The employer 
shall provide clean change rooms equipped with storage facilities for 
street clothes and separate storage facilities for protective clothing 
and equipment whenever employees are required to wear protective 
clothing and equipment in accordance with paragraph (h)(1) of this 
section.
    (2) Showers. (i) The employer shall assure that employees working in 
the regulated area 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.
    (3) Lunchrooms. The employer shall provide lunchroom facilities 
which have a temperature controlled, positive pressure, filtered air 
supply, and which are readily accessible to employees working in the 
regulated area.
    (4) Lavatories. (i) The employer shall assure that employees working 
in the regulated area wash their hands and face prior to eating.
    (ii) The employer shall provide lavatory facilities in accordance 
with Sec.  1910.141(d) (1) and (2) of this part.
    (5) Prohibition of activities in the regulated area. (i) The 
employer shall assure that in the regulated area, food or beverages are 
not present or consumed, smoking products are not present or used, and 
cosmetics are not applied, except that these activities may be conducted 
in the lunchrooms, change rooms and showers required under paragraphs 
(i)(1)-(i)(3) of this section.
    (ii) Drinking water may be consumed in the regulated area.
    (j) Medical surveillance--(1) General requirements. (i) Each 
employer shall institute a medical surveillance program for all 
employees who are employed in a regulated area at least 30 days per 
year.
    (ii) This program shall provide each employee covered under 
paragraph (j)(1)(i) of this section with an opportunity for medical 
examinations in accordance with this paragraph (j).
    (iii) The employer shall inform any employee who refuses any 
required medical examination of the possible health consequences of such 
refusal and shall obtain a signed statement from the employee indicating 
that the employee understands the risk involved in the refusal to be 
examined.
    (iv) The employer shall assure that all medical examinations and 
procedures are performed by or under the supervision of a licensed 
physician, and are provided without cost to the employee.
    (2) Initial examinations. At the time of initial assignment to a 
regulated area

[[Page 290]]

or upon the institution of the medical surveillance program, the 
employer shall provide a medical examination for employees covered under 
paragraph (j)(1)(i) of this section including at least the following 
elements:
    (i) A work history and medical history which shall include smoking 
history and the presence and degree of respiratory symptoms, such as 
breathlessness, cough, sputum production, and wheezing;
    (ii) A 14- by 17-inch or other reasonably-sized standard film or 
digital posterior-anterior chest X-ray;
    (iii) Pulmonary function tests including forced vital capacity (FVC) 
and forced expiratory volume at one second (FEV 1.0) with recording of 
type of equipment used;
    (iv) Weight;
    (v) A skin examination;
    (vi) Urinalysis for sugar, albumin, and hematuria; and
    (vii) A urinary cytology examination.
    (3) Periodic examinations. (i) The employer shall provide the 
examinations specified in paragraphs (j)(2)(i) and (iii) through (vi) of 
this section at least annually for employees covered under paragraph 
(j)(1)(i) of this section.
    (ii) The employer must provide the examinations specified in 
paragraphs (j)(2)(i) and (iii) through (vii) of this section at least 
annually for employees 45 years of age or older or with five (5) or more 
years employment in the regulated area.
    (iii) Whenever an employee who is 45 years of age or older or with 
five (5) or more years employment in a regulated area transfers or is 
transferred from employment in a regulated area, the employer must 
continue to provide the examinations specified in paragraphs (j)(2)(i) 
and (iii) through (vii) of this section at least annually as long as 
that employee is employed by the same employer or a successor employer.
    (4) Information provided to the physician. The employer shall 
provide the following information to the examining physician:
    (i) A copy of this regulation and its Appendixes;
    (ii) A description of the affected employee's duties as they relate 
to the employee's exposure;
    (iii) The employee's exposure level or estimated 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.
    (5) 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 examinations;
    (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 
coke oven emissions;
    (c) Any recommended limitations upon the employee's exposure to coke 
oven emissions 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.
    (k) Employee information and training--(1) Training program. (i) The 
employer shall train each employee who is employed in a regulated area 
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 as of January 27, 1977 
for employees who are employed in the regulated area at that time or at 
the time of initial assignment to a regulated area.
    (iii) The training program shall be provided at least annually for 
all employees who are employed in the regulated area, except that 
training regarding the occupational safety and health hazards associated 
with exposure to

[[Page 291]]

coke oven emissions and the purpose, proper use, and limitations of 
respiratory protective devices shall be provided at least quarterly 
until January 20, 1978.
    (iv) The training program shall include informing each employee of:
    (a) The information contained in the substance information sheet for 
coke oven emissions (Appendix A);
    (b) The purpose, proper use, and limitations of respiratory 
protective devices required in accordance with paragraph (g) of this 
section;
    (c) The purpose for and a description of the medical surveillance 
program required by paragraph (j) of this section including information 
on the occupational safety and health hazards associated with exposure 
to coke oven emissions;
    (d) A review of all written procedures and schedules required under 
paragraph (f) of this section; and
    (e) A review of this standard.
    (2) Access to training materials. (i) The employer shall make a copy 
of this standard and its appendixes readily available to all employees 
who are employed in the regulated area.
    (ii) The employer shall provide upon request all materials relating 
to the employee information and training program to the Secretary and 
the Director.
    (l) Communication of hazards--(1) Hazard communication--general. The 
employer shall include coke oven emissions in the program established to 
comply with the Hazard Communication Standard (HCS) (Sec.  1910.1200). 
The employer shall ensure that each employee has access to labels on 
containers of chemicals and substances associated with coke oven 
processes and to safety data sheets, and is trained in accordance with 
the provisions of HCS and paragraph (k) of this section. The employer 
shall ensure that at least the following hazard is addressed: Cancer.
    (2) Signs. (i) The employer shall post signs in the regulated area 
bearing the legend:

DANGER
COKE OVEN EMISSIONS
MAY CAUSE CANCER
DO NOT EAT, DRINK OR SMOKE
WEAR RESPIRATORY PROTECTION IN THIS AREA
AUTHORIZED PERSONNEL ONLY

    (ii) In addition, the employer shall post signs in the areas where 
the permissible exposure limit is exceeded bearing the legend:

WEAR RESPIRATORY PROTECTION IN THIS AREA

    (iii) The employer shall ensure that no statement appears on or near 
any sign required by this paragraph (l) which contradicts or detracts 
from the effects of the required sign.
    (iv) The employer shall ensure that signs required by this paragraph 
(l)(2) are illuminated and cleaned as necessary so that the legend is 
readily visible.
    (v) Prior to June 1, 2016, employers may use the following legend in 
lieu of that specified in paragraph (l)(2)(i) of this section:

DANGER
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY
NO SMOKING OR EATING

    (vi) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (l)(2)(ii) of this section:

DANGER
RESPIRATOR REQUIRED

    (3) Labels. (i) The employer shall ensure that labels of containers 
of contaminated protective clothing and equipment include the following 
information:

CONTAMINATED WITH COKE EMISSIONS
MAY CAUSE CANCER
DO NOT REMOVE DUST BY BLOWING OR SHAKING

    (ii) Prior to June 1, 2015, employers may include the following 
information on contaminated protective clothing and equipment in lieu of 
the labeling requirements in paragraph (l)(3)(i) of this section:

CAUTION
CLOTHING CONTAMINATED WITH COKE EMISSIONS
DO NOT REMOVE DUST BY BLOWING OR SHAKING

    (m) Recordkeeping--(1) Exposure measurements. The employer shall 
establish and maintain an accurate record of all measurements taken to 
monitor employee exposure to coke oven emissions

[[Page 292]]

required in paragraph (e) of this section.
    (i) This record shall include:
    (a) Name and job classification of the employees monitored;
    (b) The date(s), number, duration and results of each of the samples 
taken, including a description of the sampling procedure used to 
determine representative employee exposure where applicable;
    (c) The type of respiratory protective devices worn, if any;
    (d) A description of the sampling and analytical methods used and 
evidence of their accuracy; and
    (e) The environmental variables that could affect the measurement of 
employee exposure.
    (ii) The employer shall maintain this record for at lest 40 years or 
for the duration of employment plus 20 years, whichever is longer.
    (2) Medical surveillance. The employer shall establish and maintain 
an accurate record for each employee subject to medical surveillance as 
required by paragraph (j) of this section.
    (i) The record shall include:
    (a) The name and description of duties of the employee;
    (b) A copy of the physician's written opinion;
    (c) The signed statement of any refusal to take a medical 
examination under paragraph (j)(1)(ii) of this section; and
    (d) Any employee medical complaints related to exposure to coke oven 
emissions.
    (ii) 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)(2) of this section;
    (b) A description of the laboratory procedures used and a copy of 
any standards or guidelines used to interpret the test results;
    (c) The initial x-ray;
    (d) The x-rays for the most recent five (5) years;
    (e) Any x-ray with a demonstrated abnormality and all subsequent x-
rays;
    (f) The initial cytologic examination slide and written description;
    (g) The cytologic examination slide and written description for the 
most recent 10 years; and
    (h) Any cytologic examination slides with demonstrated atypia, if 
such atypia persists for 3 years, and all subsequent slides and written 
descriptions.
    (iii) The employer shall maintain medical records required under 
paragraph (m)(2) of this section 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 paragraph (m) of this section 
to the Secretary and the Director for examination and copying.
    (ii) Employee exposure measurement records and employee 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 (g)-(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 paragraph (m) of this section.
    (ii) The employer shall also comply with any additional requirements 
involving transfer of records set forth in 29 CFR 1910.1020(h).
    (n) Observation of monitoring--(1) Employee observation. The 
employer shall provide affected employees or their representatives an 
opportunity to observe any measuring or monitoring of employee exposure 
to coke oven emissions conducted pursuant to paragraph (e) of this 
section.
    (2) Observation procedures. (i) Whenever observation of the 
measuring or monitoring of employee exposure to coke oven emissions 
requires entry into an area where the ues of protective clothing or 
equipment is required, the employer shall provide the observer with and 
assure the use of such equipment and shall require the observer to 
comply with all other applicable safety and health procedures.
    (ii) Without interfering with the measurement, observers shall be 
entitled to:
    (a) An Explanation of the measurement procedures;

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    (b) Observe all steps related to the measurement of coke oven 
emissions performed at the place of exposure; and
    (c) Record the results obtained.
    (o) [Reserved]
    (p) Appendices. The information contained in the appendixes to this 
section is not intended, by itself, to create any additional obligations 
not otherwise imposed or to detract from any existing obligation.

Appendix A to Sec.  1910.1029--Coke Oven Emissions Substance Information 
                                  Sheet

                       i. Substance Identification

    A. Substance: Coke Oven Emissions
    B. Definition: The benzene-soluble fraction of total particulate 
matter present during the destructive distillation or carbonization of 
coal for the production of coke.
    C. Permissible Exposure Limit: 150 micrograms per cubic meter of air 
determined as an average over an 8-hour period.
    D. Regulated areas: Only employees authorized by your employer 
should enter a regulated area. The employer is required to designate the 
following areas as regulated areas: the coke oven battery, including 
topside and its machinery, pushside and its machinery, cokeside and its 
machinery, and the battery ends; the screening station; and the wharf; 
and the beehive ovens and their machinery.

                         ii. Health Hazard Data

    Exposure to coke oven emissions is a cause of lung cancer, and 
kidney cancer, in humans. Although there have not been an excess number 
of skin cancer cases in humans, repeated skin contact with coke oven 
emissions should be avoided.

                 iii. Protective Clothing and Equipment

    A. Respirators: Respirators will be provided by your employer 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 to reduce exposure to 
or below the PEL. You must wear respirators for non-routine activities 
or in emergency situations where you are likely to be exposed to levels 
of coke oven emissions in excess of the permissible exposure limit. 
Until January 20, 1978, the routine wearing of respirators is voluntary. 
Until that date, if you choose not to wear a respirator you do not have 
to do so. You must still have your respirator with you and you must 
still wear it if you are near visible emissions. 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 and rapid and will be explained to you 
during your training sessions.
    B. Protective clothing: Your employer is required to provide, and 
you must wear, appropriate, clean, protective clothing and equipment to 
protect your body from repeated skin contact with coke oven emissions 
and from the heat generated during the coking process. This clothing 
should include such items as jacket and pants and flame resistant 
gloves. Protective equipment should include face shield or vented 
goggles, protective helmets and safety shoes, insulated from hot 
surfaces where appropriate.

                  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. Your employer is required to provide lunchrooms and other 
areas for these purposes.
    Your employer is required to provide showers, washing facilities, 
and change rooms. If you work in a regulated area, you must wash your 
face, and hands before eating. You must shower at the end of the work 
shift. Do not take used protective clothing out of the 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. In regulated 
areas where coke oven emissions are above the permissible exposure 
limit, the signs should also warn that respirators must be worn.

                        vi. Medical Examinations

    If you work in a regulated area at least 30 days per year, your 
employer is required to provide you with a medical examination every 
year. The initial medical examination must include a medical history, a 
chest X-ray, pulmonary function test, weight comparison, skin 
examination, a urinalysis, and a urine cytology exam for early detection 
of urinary cancer. Periodic examinations shall include all tests 
required in the initial examination, except that (1) the x-ray is to be 
performed during initial examination only and (2) the urine cytologic 
test is to be performed only on those employees who are 45 years or 
older or who have worked for 5 or more years in the regulated area. The 
examining physician will provide a written opinion to your

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employer containing the results of the medical exams. You should also 
receive a copy of this opinion.

                     vii. Observation of Monitoring

    Your employer is required to monitor your exposure to coke oven 
emissions and you are entitled to observe the monitoring procedure. You 
are entitled to receive an explanation of the measurement procedure, 
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 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 coke oven emissions upon request to your employer. Your medical 
examination records can be furnished to your physician upon request to 
your employer.

                       ix. Training and Education

    Additional information on all of these items plus training as to 
hazards of coke oven emissions and the engineering and work practice 
controls associated with your job will also be provided by your 
employer.

     Appendix B to Sec.  1910.1029--Industrial Hygiene and Medical 
                         Surveillance Guidelines

                    i. industrial hygiene guidelines

    A. Sampling (Benzene-Soluble Fraction Total Particulate Matter).
    Samples collected should be full shift (at least 7-hour) samples. 
Sampling should be done using a personal sampling pump with pulsation 
damper at a flow rate of 2 liters per minute. Samples should be 
collected on 0.8 micrometer pore size silver membrane filters (37 mm 
diameter) preceded by Gelman glass fiber type A-E filters encased in 
three-piece plastic (polystyrene) field monitor cassettes. The cassette 
face cap should be on and the plug removed. The rotameter should be 
checked every hour to ensure that proper flow rates are maintained.
    A minimum of three full-shift samples should be collected for each 
job classification on each battery, at least one from each shift. If 
disparate results are obtained for particular job classification, 
sampling should be repeated. It is advisable to sample each shift on 
more than one day to account for environmental variables (wind, 
precipitation, etc.) which may affect sampling. Differences in exposures 
among different work shifts may indicate a need to improve work 
practices on a particular shift. Sampling results from different shifts 
for each job classification should not be averaged. Multiple samples 
from same shift on each battery may be used to calculate an average 
exposure for a particular job classification.
    B. Analysis.
    1. All extraction glassware is cleaned with dichromic acid cleaning 
solution, rinsed with tap water, then dionized water, acetone, and 
allowed to dry completely. The glassware is rinsed with nanograde 
benzene before use. The Teflon cups are cleaned with benzene then with 
acetone.
    2. Pre-weigh the 2 ml Teflon cups to one hundredth of a milligram 
(0.01 mg) on an autobalance AD 2 Tare weight of the cups is about 50 mg.
    3. Place the silver membrane filter and glass fiber filter into a 15 
ml test tube.
    4. Extract with 5 ml of benzene for five minutes in an ultrasonic 
cleaner.
    5. Filter the extract in 15 ml medium glass fritted funnels.
    6. Rinse test tube and filters with two 1.5 ml aliquots of benzene 
and filter through the fritted glass funnel.
    7. Collect the extract and two rinses in a 10 ml Kontes graduated 
evaporative concentrator.
    8. Evaporate down to 1 ml while rinsing the sides with benzene.
    9. Pipet 0.5 ml into the Teflon cup and evaporate to dryness in a 
vacuum oven at 40 [deg]C for 3 hours.
    10. Weigh the Teflon cup and the weight gain is due to the benzene 
soluble residue in half the Sample.

                   ii. medical surveillance guidelines

    A. General. The minimum requirements for the medical examination for 
coke oven workers are given in the standard in paragraph (j) of this 
section. The initial examination is to be provided to all coke oven 
workers who work at least 30 days in the regulated area. The examination 
includes a 14[sec] by 17[sec] or other reasonably-sized standard film or 
digital posterior-anterior chest X-ray reading, pulmonary function tests 
(FVC and FEV1), weight, urinalysis, skin examination, and a 
urinary cytologic examination. These tests are needed to serve as the 
baseline for comparing the employee's future test results. Periodic 
exams include all the elements of the initial exams, except that (1) the 
x-ray is to be performed during initial examination only and (2) the 
urine cytologic test is to be performed only on those employees who are 
45 years or older or who have worked for 5 or more years in the 
regulated area. The examination contents are minimum requirements; 
additional tests such as lateral and oblique X-rays or additional 
pulmonary function tests may be performed if deemed necessary.
    B. Pulmonary function tests.

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    Pulmonary function tests should be performed in a manner which 
minimizes subject and operator bias. There has been shown to be learning 
effects with regard to the results obtained from certain tests, such as 
FEV 1.0. Best results can be obtained by multiple trials for each 
subject. The best of three trials or the average of the last three of 
five trials may be used in obtaining reliable results. The type of 
equipment used (manufacturer, model, etc.) should be recorded with the 
results as reliability and accuracy varies and such information may be 
important in the evaluation of test results. Care should be exercised to 
obtain the best possible testing equipment.

[39 FR 23502, June 27, 1974, 41 FR 46784, Oct. 22, 1976, as amended at 
42 FR 3304, Jan. 18, 1977; 45 FR 35283, May 23, 1980; 50 FR 37353, 
37354, Sept. 13, 1985; 54 FR 24334, June 7, 1989; 61 FR 5508, Feb. 13, 
1996; 63 FR 1290, Jan. 8, 1998; 63 FR 33468, June 18, 1998; 70 FR 1142, 
Jan. 5, 2005; 71 FR 16672, 16673, Apr. 3, 2006; 71 FR 50189, Aug. 24, 
2006; 73 FR 75585, Dec. 12, 2008; 76 FR 33608, June 8, 2011; 77 FR 
17782, Mar. 26, 2012; 84 FR 21490, May 14, 2019]



Sec.  1910.1030  Bloodborne pathogens.

    (a) Scope and Application. This section applies to all occupational 
exposure to blood or other potentially infectious materials as defined 
by paragraph (b) of this section.
    (b) Definitions. For purposes of this section, the following shall 
apply:
    Assistant Secretary means the Assistant Secretary of Labor for 
Occupational Safety and Health, or designated representative.
    Blood means human blood, human blood components, and products made 
from human blood.
    Bloodborne Pathogens means pathogenic microorganisms that are 
present in human blood and can cause disease in humans. These pathogens 
include, but are not limited to, hepatitis B virus (HBV) and human 
immunodeficiency virus (HIV).
    Clinical Laboratory means a workplace where diagnostic or other 
screening procedures are performed on blood or other potentially 
infectious materials.
    Contaminated means the presence or the reasonably anticipated 
presence of blood or other potentially infectious materials on an item 
or surface.
    Contaminated Laundry means laundry which has been soiled with blood 
or other potentially infectious materials or may contain sharps.
    Contaminated Sharps means any contaminated object that can penetrate 
the skin including, but not limited to, needles, scalpels, broken glass, 
broken capillary tubes, and exposed ends of dental wires.
    Decontamination means the use of physical or chemical means to 
remove, inactivate, or destroy bloodborne pathogens on a surface or item 
to the point where they are no longer capable of transmitting infectious 
particles and the surface or item is rendered safe for handling, use, or 
disposal.
    Director means the Director of the National Institute for 
Occupational Safety and Health, U.S. Department of Health and Human 
Services, or designated representative.
    Engineering controls means controls (e.g., sharps disposal 
containers, self-sheathing needles, safer medical devices, such as 
sharps with engineered sharps injury protections and needleless systems) 
that isolate or remove the bloodborne pathogens hazard from the 
workplace.
    Exposure Incident means a specific eye, mouth, other mucous 
membrane, non-intact skin, or parenteral contact with blood or other 
potentially infectious materials that results from the performance of an 
employee's duties.
    Handwashing facilities means a facility providing an adequate supply 
of running potable water, soap, and single-use towels or air-drying 
machines.
    Licensed Healthcare Professional is a person whose legally permitted 
scope of practice allows him or her to independently perform the 
activities required by paragraph (f) Hepatitis B Vaccination and Post-
exposure Evaluation and Follow-up.
    HBV means hepatitis B virus.
    HIV means human immunodeficiency virus.
    Needleless systems means a device that does not use needles for:
    (1) The collection of bodily fluids or withdrawal of body fluids 
after initial venous or arterial access is established;
    (2) The administration of medication or fluids; or
    (3) Any other procedure involving the potential for occupational 
exposure to bloodborne pathogens due to percutaneous injuries from 
contaminated sharps.

[[Page 296]]

    Occupational Exposure means reasonably anticipated skin, eye, mucous 
membrane, or parenteral contact with blood or other potentially 
infectious materials that may result from the performance of an 
employee's duties.
    Other Potentially Infectious Materials means
    (1) The following human body fluids: semen, vaginal secretions, 
cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, 
peritoneal fluid, amniotic fluid, saliva in dental procedures, any body 
fluid that is visibly contaminated with blood, and all body fluids in 
situations where it is difficult or impossible to differentiate between 
body fluids;
    (2) Any unfixed tissue or organ (other than intact skin) from a 
human (living or dead); and
    (3) HIV-containing cell or tissue cultures, organ cultures, and HIV- 
or HBV-containing culture medium or other solutions; and blood, organs, 
or other tissues from experimental animals infected with HIV or HBV.
    Parenteral means piercing mucous membranes or the skin barrier 
through such events as needlesticks, human bites, cuts, and abrasions.
    Personal Protective Equipment is specialized clothing or equipment 
worn by an employee for protection against a hazard. General work 
clothes (e.g., uniforms, pants, shirts or blouses) not intended to 
function as protection against a hazard are not considered to be 
personal protective equipment.
    Production Facility means a facility engaged in industrial-scale, 
large-volume or high concentration production of HIV or HBV.
    Regulated Waste means liquid or semi-liquid blood or other 
potentially infectious materials; contaminated items that would release 
blood or other potentially infectious materials in a liquid or semi-
liquid state if compressed; items that are caked with dried blood or 
other potentially infectious materials and are capable of releasing 
these materials during handling; contaminated sharps; and pathological 
and microbiological wastes containing blood or other potentially 
infectious materials.
    Research Laboratory means a laboratory producing or using research-
laboratory-scale amounts of HIV or HBV. Research laboratories may 
produce high concentrations of HIV or HBV but not in the volume found in 
production facilities.
    Sharps with engineered sharps injury protections means a nonneedle 
sharp or a needle device used for withdrawing body fluids, accessing a 
vein or artery, or administering medications or other fluids, with a 
built-in safety feature or mechanism that effectively reduces the risk 
of an exposure incident.
    Source Individual means any individual, living or dead, whose blood 
or other potentially infectious materials may be a source of 
occupational exposure to the employee. Examples include, but are not 
limited to, hospital and clinic patients; clients in institutions for 
the developmentally disabled; trauma victims; clients of drug and 
alcohol treatment facilities; residents of hospices and nursing homes; 
human remains; and individuals who donate or sell blood or blood 
components.
    Sterilize means the use of a physical or chemical procedure to 
destroy all microbial life including highly resistant bacterial 
endospores.
    Universal Precautions is an approach to infection control. According 
to the concept of Universal Precautions, all human blood and certain 
human body fluids are treated as if known to be infectious for HIV, HBV, 
and other bloodborne pathogens.
    Work Practice Controls means controls that reduce the likelihood of 
exposure by altering the manner in which a task is performed (e.g., 
prohibiting recapping of needles by a two-handed technique).
    (c) Exposure control--(1) Exposure Control Plan. (i) Each employer 
having an employee(s) with occupational exposure as defined by paragraph 
(b) of this section shall establish a written Exposure Control Plan 
designed to eliminate or minimize employee exposure.
    (ii) The Exposure Control Plan shall contain at least the following 
elements:
    (A) The exposure determination required by paragraph (c)(2),
    (B) The schedule and method of implementation for paragraphs (d) 
Methods of Compliance, (e) HIV and HBV Research Laboratories and 
Production

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Facilities, (f) Hepatitis B Vaccination and Post-Exposure Evaluation and 
Follow-up, (g) Communication of Hazards to Employees, and (h) 
Recordkeeping, of this standard, and
    (C) The procedure for the evaluation of circumstances surrounding 
exposure incidents as required by paragraph (f)(3)(i) of this standard.
    (iii) Each employer shall ensure that a copy of the Exposure Control 
Plan is accessible to employees in accordance with 29 CFR 1910.20(e).
    (iv) The Exposure Control Plan shall be reviewed and updated at 
least annually and whenever necessary to reflect new or modified tasks 
and procedures which affect occupational exposure and to reflect new or 
revised employee positions with occupational exposure. The review and 
update of such plans shall also:
    (A) Reflect changes in technology that eliminate or reduce exposure 
to bloodborne pathogens; and
    (B) Document annually consideration and implementation of 
appropriate commercially available and effective safer medical devices 
designed to eliminate or minimize occupational exposure.
    (v) An employer, who is required to establish an Exposure Control 
Plan shall solicit input from non-managerial employees responsible for 
direct patient care who are potentially exposed to injuries from 
contaminated sharps in the identification, evaluation, and selection of 
effective engineering and work practice controls and shall document the 
solicitation in the Exposure Control Plan.
    (vi) The Exposure Control Plan shall be made available to the 
Assistant Secretary and the Director upon request for examination and 
copying.
    (2) Exposure determination. (i) Each employer who has an employee(s) 
with occupational exposure as defined by paragraph (b) of this section 
shall prepare an exposure determination. This exposure determination 
shall contain the following:
    (A) A list of all job classifications in which all employees in 
those job classifications have occupational exposure;
    (B) A list of job classifications in which some employees have 
occupational exposure, and
    (C) A list of all tasks and procedures or groups of closely related 
task and procedures in which occupational exposure occurs and that are 
performed by employees in job classifications listed in accordance with 
the provisions of paragraph (c)(2)(i)(B) of this standard.
    (ii) This exposure determination shall be made without regard to the 
use of personal protective equipment.
    (d) Methods of compliance--(1) General. Universal precautions shall 
be observed to prevent contact with blood or other potentially 
infectious materials. Under circumstances in which differentiation 
between body fluid types is difficult or impossible, all body fluids 
shall be considered potentially infectious materials.
    (2) Engineering and work practice controls. (i) Engineering and work 
practice controls shall be used to eliminate or minimize employee 
exposure. Where occupational exposure remains after institution of these 
controls, personal protective equipment shall also be used.
    (ii) Engineering controls shall be examined and maintained or 
replaced on a regular schedule to ensure their effectiveness.
    (iii) Employers shall provide handwashing facilities which are 
readily accessible to employees.
    (iv) When provision of handwashing facilities is not feasible, the 
employer shall provide either an appropriate antiseptic hand cleanser in 
conjunction with clean cloth/paper towels or antiseptic towelettes. When 
antiseptic hand cleansers or towelettes are used, hands shall be washed 
with soap and running water as soon as feasible.
    (v) Employers shall ensure that employees wash their hands 
immediately or as soon as feasible after removal of gloves or other 
personal protective equipment.
    (vi) Employers shall ensure that employees wash hands and any other 
skin with soap and water, or flush mucous membranes with water 
immediately or as soon as feasible following contact of such body areas 
with blood or other potentially infectious materials.
    (vii) Contaminated needles and other contaminated sharps shall not 
be bent, recapped, or removed except as noted in paragraphs 
(d)(2)(vii)(A) and

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(d)(2)(vii)(B) below. Shearing or breaking of contaminated needles is 
prohibited.
    (A) Contaminated needles and other contaminated sharps shall not be 
bent, recapped or removed unless the employer can demonstrate that no 
alternative is feasible or that such action is required by a specific 
medical or dental procedure.
    (B) Such bending, recapping or needle removal must be accomplished 
through the use of a mechanical device or a one-handed technique.
    (viii) Immediately or as soon as possible after use, contaminated 
reusable sharps shall be placed in appropriate containers until properly 
reprocessed. These containers shall be:
    (A) Puncture resistant;
    (B) Labeled or color-coded in accordance with this standard;
    (C) Leakproof on the sides and bottom; and
    (D) In accordance with the requirements set forth in paragraph 
(d)(4)(ii)(E) for reusable sharps.
    (ix) Eating, drinking, smoking, applying cosmetics or lip balm, and 
handling contact lenses are prohibited in work areas where there is a 
reasonable likelihood of occupational exposure.
    (x) Food and drink shall not be kept in refrigerators, freezers, 
shelves, cabinets or on countertops or benchtops where blood or other 
potentially infectious materials are present.
    (xi) All procedures involving blood or other potentially infectious 
materials shall be performed in such a manner as to minimize splashing, 
spraying, spattering, and generation of droplets of these substances.
    (xii) Mouth pipetting/suctioning of blood or other potentially 
infectious materials is prohibited.
    (xiii) Specimens of blood or other potentially infectious materials 
shall be placed in a container which prevents leakage during collection, 
handling, processing, storage, transport, or shipping.
    (A) The container for storage, transport, or shipping shall be 
labeled or color-coded according to paragraph (g)(1)(i) and closed prior 
to being stored, transported, or shipped. When a facility utilizes 
Universal Precautions in the handling of all specimens, the labeling/
color-coding of specimens is not necessary provided containers are 
recognizable as containing specimens. This exemption only applies while 
such specimens/containers remain within the facility. Labeling or color-
coding in accordance with paragraph (g)(1)(i) is required when such 
specimens/containers leave the facility.
    (B) If outside contamination of the primary container occurs, the 
primary container shall be placed within a second container which 
prevents leakage during handling, processing, storage, transport, or 
shipping and is labeled or color-coded according to the requirements of 
this standard.
    (C) If the specimen could puncture the primary container, the 
primary container shall be placed within a secondary container which is 
puncture-resistant in addition to the above characteristics.
    (xiv) Equipment which may become contaminated with blood or other 
potentially infectious materials shall be examined prior to servicing or 
shipping and shall be decontaminated as necessary, unless the employer 
can demonstrate that decontamination of such equipment or portions of 
such equipment is not feasible.
    (A) A readily observable label in accordance with paragraph 
(g)(1)(i)(H) shall be attached to the equipment stating which portions 
remain contaminated.
    (B) The employer shall ensure that this information is conveyed to 
all affected employees, the servicing representative, and/or the 
manufacturer, as appropriate, prior to handling, servicing, or shipping 
so that appropriate precautions will be taken.
    (3) Personal protective equipment--(i) Provision. When there is 
occupational exposure, the employer shall provide, at no cost to the 
employee, appropriate personal protective equipment such as, but not 
limited to, gloves, gowns, laboratory coats, face shields or masks and 
eye protection, and mouthpieces, resuscitation bags, pocket masks, or 
other ventilation devices. Personal protective equipment will be 
considered ``appropriate'' only if it does not permit blood or other 
potentially infectious materials to pass through to or reach the 
employee's work clothes,

[[Page 299]]

street clothes, undergarments, skin, eyes, mouth, or other mucous 
membranes under normal conditions of use and for the duration of time 
which the protective equipment will be used.
    (ii) Use. The employer shall ensure that the employee uses 
appropriate personal protective equipment unless the employer shows that 
the employee temporarily and briefly declined to use personal protective 
equipment when, under rare and extraordinary circumstances, it was the 
employee's professional judgment that in the specific instance its use 
would have prevented the delivery of health care or public safety 
services or would have posed an increased hazard to the safety of the 
worker or co-worker. When the employee makes this judgement, the 
circumstances shall be investigated and documented in order to determine 
whether changes can be instituted to prevent such occurances in the 
future.
    (iii) Accessibility. The employer shall ensure that appropriate 
personal protective equipment in the appropriate sizes is readily 
accessible at the worksite or is issued to employees. Hypoallergenic 
gloves, glove liners, powderless gloves, or other similar alternatives 
shall be readily accessible to those employees who are allergic to the 
gloves normally provided.
    (iv) Cleaning, Laundering, and Disposal. The employer shall clean, 
launder, and dispose of personal protective equipment required by 
paragraphs (d) and (e) of this standard, at no cost to the employee.
    (v) Repair and Replacement. The employer shall repair or replace 
personal protective equipment as needed to maintain its effectiveness, 
at no cost to the employee.
    (vi) If a garment(s) is penetrated by blood or other potentially 
infectious materials, the garment(s) shall be removed immediately or as 
soon as feasible.
    (vii) All personal protective equipment shall be removed prior to 
leaving the work area.
    (viii) When personal protective equipment is removed it shall be 
placed in an appropriately designated area or container for storage, 
washing, decontamination or disposal.
    (ix) Gloves. Gloves shall be worn when it can be reasonably 
anticipated that the employee may have hand contact with blood, other 
potentially infectious materials, mucous membranes, and non-intact skin; 
when performing vascular access procedures except as specified in 
paragraph (d)(3)(ix)(D); and when handling or touching contaminated 
items or surfaces.
    (A) Disposable (single use) gloves such as surgical or examination 
gloves, shall be replaced as soon as practical when contaminated or as 
soon as feasible if they are torn, punctured, or when their ability to 
function as a barrier is compromised.
    (B) Disposable (single use) gloves shall not be washed or 
decontaminated for re-use.
    (C) Utility gloves may be decontaminated for re-use if the integrity 
of the glove is not compromised. However, they must be discarded if they 
are cracked, peeling, torn, punctured, or exhibit other signs of 
deterioration or when their ability to function as a barrier is 
compromised.
    (D) If an employer in a volunteer blood donation center judges that 
routine gloving for all phlebotomies is not necessary then the employer 
shall:
    (1) Periodically reevaluate this policy;
    (2) Make gloves available to all employees who wish to use them for 
phlebotomy;
    (3) Not discourage the use of gloves for phlebotomy; and
    (4) Require that gloves be used for phlebotomy in the following 
circumstances:
    (i) When the employee has cuts, scratches, or other breaks in his or 
her skin;
    (ii) When the employee judges that hand contamination with blood may 
occur, for example, when performing phlebotomy on an uncooperative 
source individual; and
    (iii) When the employee is receiving training in phlebotomy.
    (x) Masks, Eye Protection, and Face Shields. Masks in combination 
with eye protection devices, such as goggles or glasses with solid side 
shields, or chin-

[[Page 300]]

length face shields, shall be worn whenever splashes, spray, spatter, or 
droplets of blood or other potentially infectious materials may be 
generated and eye, nose, or mouth contamination can be reasonably 
anticipated.
    (xi) Gowns, Aprons, and Other Protective Body Clothing. Appropriate 
protective clothing such as, but not limited to, gowns, aprons, lab 
coats, clinic jackets, or similar outer garments shall be worn in 
occupational exposure situations. The type and characteristics will 
depend upon the task and degree of exposure anticipated.
    (xii) Surgical caps or hoods and/or shoe covers or boots shall be 
worn in instances when gross contamination can reasonably be anticipated 
(e.g., autopsies, orthopaedic surgery).
    (4) Housekeeping--(i) General. Employers shall ensure that the 
worksite is maintained in a clean and sanitary condition. The employer 
shall determine and implement an appropriate written schedule for 
cleaning and method of decontamination based upon the location within 
the facility, type of surface to be cleaned, type of soil present, and 
tasks or procedures being performed in the area.
    (ii) All equipment and environmental and working surfaces shall be 
cleaned and decontaminated after contact with blood or other potentially 
infectious materials.
    (A) Contaminated work surfaces shall be decontaminated with an 
appropriate disinfectant after completion of procedures; immediately or 
as soon as feasible when surfaces are overtly contaminated or after any 
spill of blood or other potentially infectious materials; and at the end 
of the work shift if the surface may have become contaminated since the 
last cleaning.
    (B) Protective coverings, such as plastic wrap, aluminum foil, or 
imperviously-backed absorbent paper used to cover equipment and 
environmental surfaces, shall be removed and replaced as soon as 
feasible when they become overtly contaminated or at the end of the 
workshift if they may have become contaminated during the shift.
    (C) All bins, pails, cans, and similar receptacles intended for 
reuse which have a reasonable likelihood for becoming contaminated with 
blood or other potentially infectious materials shall be inspected and 
decontaminated on a regularly scheduled basis and cleaned and 
decontaminated immediately or as soon as feasible upon visible 
contamination.
    (D) Broken glassware which may be contaminated shall not be picked 
up directly with the hands. It shall be cleaned up using mechanical 
means, such as a brush and dust pan, tongs, or forceps.
    (E) Reusable sharps that are contaminated with blood or other 
potentially infectious materials shall not be stored or processed in a 
manner that requires employees to reach by hand into the containers 
where these sharps have been placed.
    (iii) Regulated Waste--(A) Contaminated Sharps Discarding and 
Containment. (1) Contaminated sharps shall be discarded immediately or 
as soon as feasible in containers that are:
    (i) Closable;
    (ii) Puncture resistant;
    (iii) Leakproof on sides and bottom; and
    (iv) Labeled or color-coded in accordance with paragraph (g)(1)(i) 
of this standard.
    (2) During use, containers for contaminated sharps shall be:
    (i) Easily accessible to personnel and located as close as is 
feasible to the immediate area where sharps are used or can be 
reasonably anticipated to be found (e.g., laundries);
    (ii) Maintained upright throughout use; and
    (iii) Replaced routinely and not be allowed to overfill.
    (3) When moving containers of contaminated sharps from the area of 
use, the containers shall be:
    (i) Closed immediately prior to removal or replacement to prevent 
spillage or protrusion of contents during handling, storage, transport, 
or shipping;
    (ii) Placed in a secondary container if leakage is possible. The 
second container shall be:
    (A) Closable;
    (B) Constructed to contain all contents and prevent leakage during 
handling, storage, transport, or shipping; and

[[Page 301]]

    (C) Labeled or color-coded according to paragraph (g)(1)(i) of this 
standard.
    (4) Reusable containers shall not be opened, emptied, or cleaned 
manually or in any other manner which would expose employees to the risk 
of percutaneous injury.
    (B) Other Regulated Waste Containment--(1) Regulated waste shall be 
placed in containers which are:
    (i) Closable;
    (ii) Constructed to contain all contents and prevent leakage of 
fluids during handling, storage, transport or shipping;
    (iii) Labeled or color-coded in accordance with paragraph (g)(1)(i) 
this standard; and
    (iv) Closed prior to removal to prevent spillage or protrusion of 
contents during handling, storage, transport, or shipping.
    (2) If outside contamination of the regulated waste container 
occurs, it shall be placed in a second container. The second container 
shall be:
    (i) Closable;
    (ii) Constructed to contain all contents and prevent leakage of 
fluids during handling, storage, transport or shipping;
    (iii) Labeled or color-coded in accordance with paragraph (g)(1)(i) 
of this standard; and
    (iv) Closed prior to removal to prevent spillage or protrusion of 
contents during handling, storage, transport, or shipping.
    (C) Disposal of all regulated waste shall be in accordance with 
applicable regulations of the United States, States and Territories, and 
political subdivisions of States and Territories.
    (iv) Laundry. (A) Contaminated laundry shall be handled as little as 
possible with a minimum of agitation. (1) Contaminated laundry shall be 
bagged or containerized at the location where it was used and shall not 
be sorted or rinsed in the location of use.
    (2) Contaminated laundry shall be placed and transported in bags or 
containers labeled or color-coded in accordance with paragraph (g)(1)(i) 
of this standard. When a facility utilizes Universal Precautions in the 
handling of all soiled laundry, alternative labeling or color-coding is 
sufficient if it permits all employees to recognize the containers as 
requiring compliance with Universal Precautions.
    (3) Whenever contaminated laundry is wet and presents a reasonable 
likelihood of soak-through of or leakage from the bag or container, the 
laundry shall be placed and transported in bags or containers which 
prevent soak-through and/or leakage of fluids to the exterior.
    (B) The employer shall ensure that employees who have contact with 
contaminated laundry wear protective gloves and other appropriate 
personal protective equipment.
    (C) When a facility ships contaminated laundry off-site to a second 
facility which does not utilize Universal Precautions in the handling of 
all laundry, the facility generating the contaminated laundry must place 
such laundry in bags or containers which are labeled or color-coded in 
accordance with paragraph (g)(1)(i).
    (e) HIV and HBV Research Laboratories and Production Facilities. (1) 
This paragraph applies to research laboratories and production 
facilities engaged in the culture, production, concentration, 
experimentation, and manipulation of HIV and HBV. It does not apply to 
clinical or diagnostic laboratories engaged solely in the analysis of 
blood, tissues, or organs. These requirements apply in addition to the 
other requirements of the standard.
    (2) Research laboratories and production facilities shall meet the 
following criteria:
    (i) Standard microbiological practices. All regulated waste shall 
either be incinerated or decontaminated by a method such as autoclaving 
known to effectively destroy bloodborne pathogens.
    (ii) Special practices. (A) Laboratory doors shall be kept closed 
when work involving HIV or HBV is in progress.
    (B) Contaminated materials that are to be decontaminated at a site 
away from the work area shall be placed in a durable, leakproof, labeled 
or color-coded container that is closed before being removed from the 
work area.
    (C) Access to the work area shall be limited to authorized persons. 
Written policies and procedures shall be established whereby only 
persons who have

[[Page 302]]

been advised of the potential biohazard, who meet any specific entry 
requirements, and who comply with all entry and exit procedures shall be 
allowed to enter the work areas and animal rooms.
    (D) When other potentially infectious materials or infected animals 
are present in the work area or containment module, a hazard warning 
sign incorporating the universal biohazard symbol shall be posted on all 
access doors. The hazard warning sign shall comply with paragraph 
(g)(1)(ii) of this standard.
    (E) All activities involving other potentially infectious materials 
shall be conducted in biological safety cabinets or other physical-
containment devices within the containment module. No work with these 
other potentially infectious materials shall be conducted on the open 
bench.
    (F) Laboratory coats, gowns, smocks, uniforms, or other appropriate 
protective clothing shall be used in the work area and animal rooms. 
Protective clothing shall not be worn outside of the work area and shall 
be decontaminated before being laundered.
    (G) Special care shall be taken to avoid skin contact with other 
potentially infectious materials. Gloves shall be worn when handling 
infected animals and when making hand contact with other potentially 
infectious materials is unavoidable.
    (H) Before disposal all waste from work areas and from animal rooms 
shall either be incinerated or decontaminated by a method such as 
autoclaving known to effectively destroy bloodborne pathogens.
    (I) Vacuum lines shall be protected with liquid disinfectant traps 
and high-efficiency particulate air (HEPA) filters or filters of 
equivalent or superior efficiency and which are checked routinely and 
maintained or replaced as necessary.
    (J) Hypodermic needles and syringes shall be used only for 
parenteral injection and aspiration of fluids from laboratory animals 
and diaphragm bottles. Only needle-locking syringes or disposable 
syringe-needle units (i.e., the needle is integral to the syringe) shall 
be used for the injection or aspiration of other potentially infectious 
materials. Extreme caution shall be used when handling needles and 
syringes. A needle shall not be bent, sheared, replaced in the sheath or 
guard, or removed from the syringe following use. The needle and syringe 
shall be promptly placed in a puncture-resistant container and 
autoclaved or decontaminated before reuse or disposal.
    (K) All spills shall be immediately contained and cleaned up by 
appropriate professional staff or others properly trained and equipped 
to work with potentially concentrated infectious materials.
    (L) A spill or accident that results in an exposure incident shall 
be immediately reported to the laboratory director or other responsible 
person.
    (M) A biosafety manual shall be prepared or adopted and periodically 
reviewed and updated at least annually or more often if necessary. 
Personnel shall be advised of potential hazards, shall be required to 
read instructions on practices and procedures, and shall be required to 
follow them.
    (iii) Containment equipment. (A) Certified biological safety 
cabinets (Class I, II, or III) or other appropriate combinations of 
personal protection or physical containment devices, such as special 
protective clothing, respirators, centrifuge safety cups, sealed 
centrifuge rotors, and containment caging for animals, shall be used for 
all activities with other potentially infectious materials that pose a 
threat of exposure to droplets, splashes, spills, or aerosols.
    (B) Biological safety cabinets shall be certified when installed, 
whenever they are moved and at least annually.
    (3) HIV and HBV research laboratories shall meet the following 
criteria:
    (i) Each laboratory shall contain a facility for hand washing and an 
eye wash facility which is readily available within the work area.
    (ii) An autoclave for decontamination of regulated waste shall be 
available.
    (4) HIV and HBV production facilities shall meet the following 
criteria:
    (i) The work areas shall be separated from areas that are open to 
unrestricted traffic flow within the building. Passage through two sets 
of doors

[[Page 303]]

shall be the basic requirement for entry into the work area from access 
corridors or other contiguous areas. Physical separation of the high-
containment work area from access corridors or other areas or activities 
may also be provided by a double-doored clothes-change room (showers may 
be included), airlock, or other access facility that requires passing 
through two sets of doors before entering the work area.
    (ii) The surfaces of doors, walls, floors and ceilings in the work 
area shall be water resistant so that they can be easily cleaned. 
Penetrations in these surfaces shall be sealed or capable of being 
sealed to facilitate decontamination.
    (iii) Each work area shall contain a sink for washing hands and a 
readily available eye wash facility. The sink shall be foot, elbow, or 
automatically operated and shall be located near the exit door of the 
work area.
    (iv) Access doors to the work area or containment module shall be 
self-closing.
    (v) An autoclave for decontamination of regulated waste shall be 
available within or as near as possible to the work area.
    (vi) A ducted exhaust-air ventilation system shall be provided. This 
system shall create directional airflow that draws air into the work 
area through the entry area. The exhaust air shall not be recirculated 
to any other area of the building, shall be discharged to the outside, 
and shall be dispersed away from occupied areas and air intakes. The 
proper direction of the airflow shall be verified (i.e., into the work 
area).
    (5) Training Requirements. Additional training requirements for 
employees in HIV and HBV research laboratories and HIV and HBV 
production facilities are specified in paragraph (g)(2)(ix).
    (f) Hepatitis B vaccination and post-exposure evaluation and follow-
up--(1) General. (i) The employer shall make available the hepatitis B 
vaccine and vaccination series to all employees who have occupational 
exposure, and post-exposure evaluation and follow-up to all employees 
who have had an exposure incident.
    (ii) The employer shall ensure that all medical evaluations and 
procedures including the hepatitis B vaccine and vaccination series and 
post-exposure evaluation and follow-up, including prophylaxis, are:
    (A) Made available at no cost to the employee;
    (B) Made available to the employee at a reasonable time and place;
    (C) Performed by or under the supervision of a licensed physician or 
by or under the supervision of another licensed healthcare professional; 
and
    (D) Provided according to recommendations of the U.S. Public Health 
Service current at the time these evaluations and procedures take place, 
except as specified by this paragraph (f).
    (iii) The employer shall ensure that all laboratory tests are 
conducted by an accredited laboratory at no cost to the employee.
    (2) Hepatitis B Vaccination. (i) Hepatitis B vaccination shall be 
made available after the employee has received the training required in 
paragraph (g)(2)(vii)(I) and within 10 working days of initial 
assignment to all employees who have occupational exposure unless the 
employee has previously received the complete hepatitis B vaccination 
series, antibody testing has revealed that the employee is immune, or 
the vaccine is contraindicated for medical reasons.
    (ii) The employer shall not make participation in a prescreening 
program a prerequisite for receiving hepatitis B vaccination.
    (iii) If the employee initially declines hepatitis B vaccination but 
at a later date while still covered under the standard decides to accept 
the vaccination, the employer shall make available hepatitis B 
vaccination at that time.
    (iv) The employer shall assure that employees who decline to accept 
hepatitis B vaccination offered by the employer sign the statement in 
appendix A.
    (v) If a routine booster dose(s) of hepatitis B vaccine is 
recommended by the U.S. Public Health Service at a future date, such 
booster dose(s) shall be made available in accordance with section 
(f)(1)(ii).

[[Page 304]]

    (3) Post-exposure Evaluation and Follow-up. Following a report of an 
exposure incident, the employer shall make immediately available to the 
exposed employee a confidential medical evaluation and follow-up, 
including at least the following elements:
    (i) Documentation of the route(s) of exposure, and the circumstances 
under which the exposure incident occurred;
    (ii) Identification and documentation of the source individual, 
unless the employer can establish that identification is infeasible or 
prohibited by state or local law;
    (A) The source individual's blood shall be tested as soon as 
feasible and after consent is obtained in order to determine HBV and HIV 
infectivity. If consent is not obtained, the employer shall establish 
that legally required consent cannot be obtained. When the source 
individual's consent is not required by law, the source individual's 
blood, if available, shall be tested and the results documented.
    (B) When the source individual is already known to be infected with 
HBV or HIV, testing for the source individual's known HBV or HIV status 
need not be repeated.
    (C) Results of the source individual's testing shall be made 
available to the exposed employee, and the employee shall be informed of 
applicable laws and regulations concerning disclosure of the identity 
and infectious status of the source individual.
    (iii) Collection and testing of blood for HBV and HIV serological 
status;
    (A) The exposed employee's blood shall be collected as soon as 
feasible and tested after consent is obtained.
    (B) If the employee consents to baseline blood collection, but does 
not give consent at that time for HIV serologic testing, the sample 
shall be preserved for at least 90 days. If, within 90 days of the 
exposure incident, the employee elects to have the baseline sample 
tested, such testing shall be done as soon as feasible.
    (iv) Post-exposure prophylaxis, when medically indicated, as 
recommended by the U.S. Public Health Service;
    (v) Counseling; and
    (vi) Evaluation of reported illnesses.
    (4) Information Provided to the Healthcare Professional. (i) The 
employer shall ensure that the healthcare professional responsible for 
the employee's Hepatitis B vaccination is provided a copy of this 
regulation.
    (ii) The employer shall ensure that the healthcare professional 
evaluating an employee after an exposure incident is provided the 
following information:
    (A) A copy of this regulation;
    (B) A description of the exposed employee's duties as they relate to 
the exposure incident;
    (C) Documentation of the route(s) of exposure and circumstances 
under which exposure occurred;
    (D) Results of the source individual's blood testing, if available; 
and
    (E) All medical records relevant to the appropriate treatment of the 
employee including vaccination status which are the employer's 
responsibility to maintain.
    (5) Healthcare Professional's Written Opinion. The employer shall 
obtain and provide the employee with a copy of the evaluating healthcare 
professional's written opinion within 15 days of the completion of the 
evaluation.
    (i) The healthcare professional's written opinion for Hepatitis B 
vaccination shall be limited to whether Hepatitis B vaccination is 
indicated for an employee, and if the employee has received such 
vaccination.
    (ii) The healthcare professional's written opinion for post-exposure 
evaluation and follow-up shall be limited to the following information:
    (A) That the employee has been informed of the results of the 
evaluation; and
    (B) That the employee has been told about any medical conditions 
resulting from exposure to blood or other potentially infectious 
materials which require further evaluation or treatment. (iii) All other 
findings or diagnoses shall remain confidential and shall not be 
included in the written report.
    (6) Medical recordkeeping. Medical records required by this standard 
shall be maintained in accordance with paragraph (h)(1) of this section.
    (g) Communication of hazards to employees--(1) Labels and signs--(i) 
Labels. (A) Warning labels shall be affixed to containers of regulated 
waste, refrigerators and freezers containing blood

[[Page 305]]

or other potentially infectious material; and other containers used to 
store, transport or ship blood or other potentially infectious 
materials, except as provided in paragraph (g)(1)(i)(E), (F) and (G).
    (B) Labels required by this section shall include the following 
legend:
[GRAPHIC] [TIFF OMITTED] TC28OC91.018

    (C) These labels shall be fluorescent orange or orange-red or 
predominantly so, with lettering and symbols in a contrasting color.
    (D) Labels shall be affixed as close as feasible to the container by 
string, wire, adhesive, or other method that prevents their loss or 
unintentional removal.
    (E) Red bags or red containers may be substituted for labels.
    (F) Containers of blood, blood components, or blood products that 
are labeled as to their contents and have been released for transfusion 
or other clinical use are exempted from the labeling requirements of 
paragraph (g).
    (G) Individual containers of blood or other potentially infectious 
materials that are placed in a labeled container during storage, 
transport, shipment or disposal are exempted from the labeling 
requirement.
    (H) Labels required for contaminated equipment shall be in 
accordance with this paragraph and shall also state which portions of 
the equipment remain contaminated.
    (I) Regulated waste that has been decontaminated need not be labeled 
or color-coded.
    (ii) Signs. (A) The employer shall post signs at the entrance to 
work areas specified in paragraph (e), HIV and HBV Research Laboratory 
and Production Facilities, which shall bear the following legend:
[GRAPHIC] [TIFF OMITTED] TC28OC91.019

(Name of the Infectious Agent)
(Special requirements for entering the area)
(Name, telephone number of the laboratory director or other responsible 
          person.)

    (B) These signs shall be fluorescent orange-red or predominantly so, 
with lettering and symbols in a contrasting color.
    (2) Information and Training. (i) The employer shall train each 
employee with occupational exposure in accordance with the requirements 
of this section. Such training must be provided at no cost to the 
employee and during working hours. The employer shall institute a 
training program and ensure employee participation in the program.
    (ii) Training shall be provided as follows:
    (A) At the time of initial assignment to tasks where occupational 
exposure may take place;
    (B) At least annually thereafter.
    (iii) [Reserved]
    (iv) Annual training for all employees shall be provided within one 
year of their previous training.
    (v) Employers shall provide additional training when changes such as 
modification of tasks or procedures or institution of new tasks or 
procedures affect the employee's occupational exposure. The additional 
training may be limited to addressing the new exposures created.
    (vi) Material appropriate in content and vocabulary to educational 
level, literacy, and language of employees shall be used.
    (vii) The training program shall contain at a minimum the following 
elements:
    (A) An accessible copy of the regulatory text of this standard and 
an explanation of its contents;

[[Page 306]]

    (B) A general explanation of the epidemiology and symptoms of 
bloodborne diseases;
    (C) An explanation of the modes of transmission of bloodborne 
pathogens;
    (D) An explanation of the employer's exposure control plan and the 
means by which the employee can obtain a copy of the written plan;
    (E) An explanation of the appropriate methods for recognizing tasks 
and other activities that may involve exposure to blood and other 
potentially infectious materials;
    (F) An explanation of the use and limitations of methods that will 
prevent or reduce exposure including appropriate engineering controls, 
work practices, and personal protective equipment;
    (G) Information on the types, proper use, location, removal, 
handling, decontamination and disposal of personal protective equipment;
    (H) An explanation of the basis for selection of personal protective 
equipment;
    (I) Information on the hepatitis B vaccine, including information on 
its efficacy, safety, method of administration, the benefits of being 
vaccinated, and that the vaccine and vaccination will be offered free of 
charge;
    (J) Information on the appropriate actions to take and persons to 
contact in an emergency involving blood or other potentially infectious 
materials;
    (K) An explanation of the procedure to follow if an exposure 
incident occurs, including the method of reporting the incident and the 
medical follow-up that will be made available;
    (L) Information on the post-exposure evaluation and follow-up that 
the employer is required to provide for the employee following an 
exposure incident;
    (M) An explanation of the signs and labels and/or color coding 
required by paragraph (g)(1); and
    (N) An opportunity for interactive questions and answers with the 
person conducting the training session.
    (viii) The person conducting the training shall be knowledgeable in 
the subject matter covered by the elements contained in the training 
program as it relates to the workplace that the training will address.
    (ix) Additional Initial Training for Employees in HIV and HBV 
Laboratories and Production Facilities. Employees in HIV or HBV research 
laboratories and HIV or HBV production facilities shall receive the 
following initial training in addition to the above training 
requirements.
    (A) The employer shall assure that employees demonstrate proficiency 
in standard microbiological practices and techniques and in the 
practices and operations specific to the facility before being allowed 
to work with HIV or HBV.
    (B) The employer shall assure that employees have prior experience 
in the handling of human pathogens or tissue cultures before working 
with HIV or HBV.
    (C) The employer shall provide a training program to employees who 
have no prior experience in handling human pathogens. Initial work 
activities shall not include the handling of infectious agents. A 
progression of work activities shall be assigned as techniques are 
learned and proficiency is developed. The employer shall assure that 
employees participate in work activities involving infectious agents 
only after proficiency has been demonstrated.
    (h) Recordkeeping--(1) Medical Records. (i) The employer shall 
establish and maintain an accurate record for each employee with 
occupational exposure, in accordance with 29 CFR 1910.1020.
    (ii) This record shall include:
    (A) The name of the employee;
    (B) A copy of the employee's hepatitis B vaccination status 
including the dates of all the hepatitis B vaccinations and any medical 
records relative to the employee's ability to receive vaccination as 
required by paragraph (f)(2);
    (C) A copy of all results of examinations, medical testing, and 
follow-up procedures as required by paragraph (f)(3);
    (D) The employer's copy of the healthcare professional's written 
opinion as required by paragraph (f)(5); and
    (E) A copy of the information provided to the healthcare 
professional as required by paragraphs (f)(4)(ii)(B)(C) and (D).

[[Page 307]]

    (iii) Confidentiality. The employer shall ensure that employee 
medical records required by paragraph (h)(1) are:
    (A) Kept confidential; and
    (B) Not disclosed or reported without the employee's express written 
consent to any person within or outside the workplace except as required 
by this section or as may be required by law.
    (iv) The employer shall maintain the records required by paragraph 
(h) for at least the duration of employment plus 30 years in accordance 
with 29 CFR 1910.1020.
    (2) Training Records. (i) Training records shall include the 
following information:
    (A) The dates of the training sessions;
    (B) The contents or a summary of the training sessions;
    (C) The names and qualifications of persons conducting the training; 
and
    (D) The names and job titles of all persons attending the training 
sessions.
    (ii) Training records shall be maintained for 3 years from the date 
on which the training occurred.
    (3) Availability. (i) The employer shall ensure that all records 
required to be maintained by this section shall be made available upon 
request to the Assistant Secretary and the Director for examination and 
copying.
    (ii) Employee training records required by this paragraph shall be 
provided upon request for examination and copying to employees, to 
employee representatives, to the Director, and to the Assistant 
Secretary.
    (iii) Employee medical records required by this paragraph shall be 
provided upon request for examination and copying to the subject 
employee, to anyone having written consent of the subject employee, to 
the Director, and to the Assistant Secretary in accordance with 29 CFR 
1910.1020.
    (4) Transfer of Records. The employer shall comply with the 
requirements involving transfer of records set forth in 29 CFR 
1910.1020(h).
    (5) Sharps injury log. (i) The employer shall establish and maintain 
a sharps injury log for the recording of percutaneous injuries from 
contaminated sharps. The information in the sharps injury log shall be 
recorded and maintained in such manner as to protect the confidentiality 
of the injured employee. The sharps injury log shall contain, at a 
minimum:
    (A) The type and brand of device involved in the incident,
    (B) The department or work area where the exposure incident 
occurred, and
    (C) An explanation of how the incident occurred.
    (ii) The requirement to establish and maintain a sharps injury log 
shall apply to any employer who is required to maintain a log of 
occupational injuries and illnesses under 29 CFR part 1904.
    (iii) The sharps injury log shall be maintained for the period 
required by 29 CFR 1904.33.
    (i) Dates--(1) Effective Date. The standard shall become effective 
on March 6, 1992.
    (2) The Exposure Control Plan required by paragraph (c) of this 
section shall be completed on or before May 5, 1992.
    (3) Paragraphs (g)(2) Information and Training and (h) Recordkeeping 
of this section shall take effect on or before June 4, 1992.
    (4) Paragraphs (d)(2) Engineering and Work Practice Controls, (d)(3) 
Personal Protective Equipment, (d)(4) Housekeeping, (e) HIV and HBV 
Research Laboratories and Production Facilities, (f) Hepatitis B 
Vaccination and Post-Exposure Evaluation and Follow-up, and (g)(1) 
Labels and Signs of this section, shall take effect July 6, 1992.

    Appendix A to Section 1910.1030--Hepatitis B Vaccine Declination 
                               (Mandatory)

    I understand that due to my occupational exposure to blood or other 
potentially infectious materials I may be at risk of acquiring hepatitis 
B virus (HBV) infection. I have been given the opportunity to be 
vaccinated with hepatitis B vaccine, at no charge to myself. However, I 
decline hepatitis B vaccination at this time. I understand that by 
declining this vaccine, I continue to be at risk of acquiring hepatitis 
B, a serious disease. If in the future I continue to have occupational 
exposure to blood or other potentially infectious materials and I want 
to be vaccinated

[[Page 308]]

with hepatitis B vaccine, I can receive the vaccination series at no 
charge to me.

[56 FR 64175, Dec. 6, 1991, as amended at 57 FR 12717, Apr. 13, 1992; 57 
FR 29206, July 1, 1992; 61 FR 5508, Feb. 13, 1996; 66 FR 5325, Jan. 18, 
2001; 71 FR 16672, 16673, Apr. 3, 2006; 73 FR 75586, Dec. 12, 2008; 76 
FR 33608, June 8, 2011; 76 FR 80740, Dec. 27, 2011; 77 FR 19934, Apr. 3, 
2012]



Sec.  1910.1043  Cotton dust.

    (a) Scope and application. (1) This section, in its entirety, 
applies to the control of employee exposure to cotton dust in all 
workplaces where employees engage in yarn manufacturing, engage in 
slashing and weaving operations, or work in waste houses for textile 
operations.
    (2) This section does not apply to the handling or processing of 
woven or knitted materials; to maritime operations covered by 29 CFR 
Parts 1915 and 1918; to harvesting or ginning of cotton; or to the 
construction industry.
    (3) Only paragraphs (h) Medical surveillance, (k)(2) through (4) 
Recordkeeping--Medical Records, and appendices B, C and D of this 
section apply in all work places where employees exposed to cotton dust 
engage in cottonseed processing or waste processing operations.
    (4) This section applies to yarn manufacturing and slashing and 
weaving operations exclusively using washed cotton (as defined by 
paragraph (n) of this section) only to the extent specified by paragraph 
(n) of this section.
    (5) This section, in its entirety, applies to the control of all 
employees exposure to the cotton dust generated in the preparation of 
washed cotton from opening until the cotton is thoroughly wetted.
    (6) This section does not apply to knitting, classing or warehousing 
operations except that employers with these operations, if requested by 
NIOSH, shall grant NIOSH access to their employees and workplaces for 
exposure monitoring and medical examinations for purposes of a health 
study to be performed by NIOSH on a sampling basis.
    (b) Definitions. For the purpose of this section:
    Assistant Secretary means the Assistant Secretary of Labor for 
Occupational Safety and Health, U.S. Department of Labor, or designee;
    Blow down means the general cleaning of a room or a part of a room 
by the use of compressed air.
    Blow off means the use of compressed air for cleaning of short 
duration and usually for a specific machine or any portion of a machine.
    Cotton dust means dust present in the air during the handling or 
processing of cotton, which may contain a mixture of many substances 
including ground up plant matter, fiber, bacteria, fungi, soil, 
pesticides, non-cotton plant matter and other contaminants which may 
have accumulated with the cotton during the growing, harvesting and 
subsequent processing or storage periods. Any dust present during the 
handling and processing of cotton through the weaving or knitting of 
fabrics, and dust present in other operations or manufacturing processes 
using raw or waste cotton fibers or cotton fiber byproducts from textile 
mills are considered cotton dust within this definition. Lubricating oil 
mist associated with weaving operations is not considered cotton dust.
    Director means the Director of the National Institute for 
Occupational Safety and Health (NIOSH), U.S. Department of Health and 
Human Services, or designee.
    Equivalent Instrument means a cotton dust sampling device that meets 
the vertical elutriator equivalency requirements as described in 
paragraph (d)(1)(iii) of this section.
    Lint-free respirable cotton dust means particles of cotton dust of 
approximately 15 micrometers or less aerodynamic equivalent diameter;
    Vertical elutriator cotton dust sampler or vertical elutriator means 
a dust sampler which has a particle size cut-off at approximately 15 
micrometers aerodynamic equivalent diameter when operating at the flow 
rate of 7.4 0.2 liters of air per minute;
    Waste processing means waste recycling (sorting, blending, cleaning 
and willowing) and garnetting.
    Yarn manufacturing means all textile mill operations from opening 
to, but not including, slashing and weaving.
    (c) Permissible exposure limits and action levels--(1) Permissible 
exposure limits

[[Page 309]]

(PEL). (i) The employer shall assure that no employee who is exposed to 
cotton dust in yarn manufacturing and cotton washing operations is 
exposed to airborne concentrations of lint-free respirable cotton dust 
greater than 200 [micro]g/m\3\ mean concentration, averaged over an 
eight-hour period, as measured be a vertical elutriator or an equivalent 
instrument.
    (ii) The employer shall assure that no employee who is exposed to 
cotton dust in textile mill waste house operations or is exposed in yarn 
manufacturing to dust from ``lower grade washed cotton'' as defined in 
paragraph (n)(5) of this section is exposed to airborne concentrations 
of lint-free respirable cotton dust greater than 500 [micro]g/m\3\ mean 
concentration, averaged over an eight-hour period, as measured by a 
vertical elutriator or an equivalent instrument.
    (iii) The employer shall assure that no employee who is exposed to 
cotton dust in the textile processes known as slashing and weaving is 
exposed to airborne concentrations of lint-free respirable cotton dust 
greater than 750 [micro]g/m\3\ mean concentration, averaged over an 
eight hour period, as measured by a vertical elutriator or an equivalent 
instrument.
    (2) Action levels. (i) The action level for yarn manufacturing and 
cotton washing operations is an airborne concentration of lint-free 
respirable cotton dust of 100 [micro]g/m\3\ mean concentration, averaged 
over an eight-hour period, as measured by a vertical elutriator or an 
equivalent instrument.
    (ii) The action level for waste houses for textile operations is an 
airborne concentration of lint-free respirable cotton dust of 250 
[micro]g/m\3\ mean concentration, averaged over an eight-hour period, as 
measured by a vertical elutriator or an equivalent instrument.
    (iii) The action level for the textile processes known as slashing 
and weaving is an airborne concentration of lint-free respirable cotton 
dust of 375 [micro]g/m\3\ mean concentration, averaged over an eight-
hour period, as measured by a vertical elutriator or an equivalent 
instrument.
    (d) Exposure monitoring and measurement--(1) General. (i) For the 
purposes of this section, employee exposure is that exposure which would 
occur if the employee were not using a respirator.
    (ii) The sampling device to be used shall be either the vertical 
elutriator cotton dust sampler or an equivalent instrument.
    (iii) If an alternative to the vertical elutriator cotton dust 
sampler is used, the employer shall establish equivalency by reference 
to an OSHA opinion or by documenting, based on data developed by the 
employer or supplied by the manufacturer, that the alternative sampling 
devices meets the following criteria:
    (A) It collects respirable particulates in the same range as the 
vertical elutriator (approximately 15 microns);
    (B) Replicate exposure data used to establish equivalency are 
collected in side-by-side field and laboratory comparisons; and
    (C) A minimum of 100 samples over the range of 0.5 to 2 times the 
permissible exposure limit are collected, and 90% of these samples have 
an accuracy range of plus or minus 25 per cent of the vertical 
elutriator reading with a 95% confidence level as demonstrated by a 
statistically valid protocol. (An acceptable protocol for demonstrating 
equivalency is described in appendix E of this section.)
    (iv) OSHA will issue a written opinion stating that an instrument is 
equivalent to a vertical elutriator cotton dust sampler if
    (A) A manufacturer or employer requests an opinion in writing and 
supplies the following information:
    (1) Sufficient test data to demonstrate that the instrument meets 
the requirements specified in this paragraph and the protocol specified 
in appendix E of this section;
    (2) Any other relevant information about the instrument and its 
testing requested by OSHA; and
    (3) A certification by the manufacturer or employer that the 
information supplied is accurate, and
    (B) if OSHA finds, based on information submitted about the 
instrument, that the instrument meets the requirements for equivalency 
specified by paragraph (d) of this section.
    (2) Initial monitoring. Each employer who has a place of employment 
within the scope of paragraph (a)(1), (a)(4), or

[[Page 310]]

(a)(5) of this section shall conduct monitoring by obtaining 
measurements which are representative of the exposure of all employees 
to airborne concentrations of lint-free respirable cotton dust over an 
eight-hour period. The sampling program shall include at least one 
determination during each shift for each work area.
    (3) Periodic monitoring. (i) If the initial monitoring required by 
paragraph (d)(2) of this section or any subsequent monitoring reveals 
employee exposure to be at or below the permissible exposure limit, the 
employer shall repeat the monitoring for those employees at least 
annually.
    (ii) If the initial monitoring required by paragraph (d)(2) of this 
section or any subsequent monitoring reveals employee exposure to be 
above the PEL, the employer shall repeat the monitoring for those 
employees at least every six months.
    (iii) Whenever there has been a production, process, or control 
change which may result in new or additional exposure to cotton dust, or 
whenever the employer has any other reason to suspect an increase in 
employee exposure, the employer shall repeat the monitoring and 
measurements for those employees affected by the change or increase.
    (4) 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 employees.
    (ii) Whenever the results indicate that the employee's exposure 
exceeds the applicable permissible exposure limit specified in paragraph 
(c) of this section, 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 below the 
permissible exposure limit.
    (e) Methods of compliance--(1) Engineering and work practice 
controls. The employer shall institute engineering and work practice 
controls to reduce and maintain employee exposure to cotton dust at or 
below the permissible exposure limit specified in paragraph (c) of this 
section, except to the extent that the employer can establish that such 
controls are not feasible.
    (2) Whenever feasible engineering and work practice controls are not 
sufficient to reduce employee exposure to or below the permissible 
exposure limit, the employer shall nonetheless institute these controls 
to reduce exposure to the lowest feasible level, and shall supplement 
these controls with the use of respirators which shall comply with the 
provisions of paragraph (f) of this section.
    (3) Compliance program. (i) Where the most recent exposure 
monitoring data indicates that any employee is exposed to cotton dust 
levels greater than the permissible exposure limit, the employer shall 
establish and implement a written program sufficient to reduce exposures 
to or below the permissible exposure limit solely by means of 
engineering controls and work practices as required by paragraph (e)(1) 
of this section.
    (ii) The written program shall include at least the following:
    (A) A description of each operation or process resulting in employee 
exposure to cotton dust at levels greater than the PEL;
    (B) Engineering plans and other studies used to determine the 
controls for each process;
    (C) A report of the technology considered in meeting the permissible 
exposure limit;
    (D) Monitoring data obtained in accordance with paragraph (d) of 
this section;
    (E) A detailed schedule for development and implementation of 
engineering and work practice controls, including exposure levels 
projected to be achieved by such controls;
    (F) Work practice program; and
    (G) Other relevant information.
    (iii) The employer's schedule as set forth in the compliance 
program, shall project completion of the implementation of the 
compliance program no later than March 27, 1984 or as soon as possible 
if monitoring after March 27, 1984 reveals exposures over the PEL, 
except as provided in paragraph (m)(2)(ii)(B) of this section.

[[Page 311]]

    (iv) The employer shall complete the steps set forth in his program 
by the dates in the schedule.
    (v) 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, the 
Director, and any affected employee or their designated representatives.
    (vi) The written program required under paragraph (e)(3) of this 
section shall be revised and updated when necessary to reflect the 
current status of the program and current exposure levels.
    (4) Mechanical ventilation. When mechanical ventilation is used to 
control exposure, measurements which demonstrate the effectiveness of 
the system to control exposure, such as capture velocity, duct velocity, 
or static pressure shall be made at reasonable intervals.
    (f) Respiratory protection--(1) General. For employees who are 
required to use respirators 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) 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 permissible exposure limits.
    (iv) Work operations specified under paragraph (g)(1) of this 
section.
    (v) Periods for which 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) Whenever a physician determines that an employee who works in 
an area in which the cotton-dust concentration exceeds the PEL is unable 
to use a respirator, including a powered air-purifying respirator, the 
employee must be given the opportunity to transfer to an available 
position, or to a position that becomes available later, that has a 
cotton-dust concentration at or below the PEL. The employer must ensure 
that such employees retain their current wage rate or other benefits as 
a result of the transfer.
    (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; however, 
employers must not select or use filtering facepieces for protection 
against cotton dust concentrations greater than five times (5 x ) the 
PEL.
    (B) Provide HEPA filters for powered and non-powered air-purifying 
respirators used at cotton dust concentrations greater than ten times 
(10 x ) the PEL.
    (ii) Employers must provide an employee with a powered air-purifying 
respirator (PAPR) instead of a non-powered air-purifying respirator 
selected according to paragraph (f)(3)(i) of this standard when the 
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) Work practices. Each employer shall, regardless of the level of 
employee exposure, immediately establish and implement a written program 
of work practices which shall minimize cotton dust exposure. The 
following shall be included were applicable:
    (1) Compressed air ``blow down'' cleaning shall be prohibited where 
alternative means are feasible. Where compressed air is used for 
cleaning, the employees performing the ``blow down'' or ``blow off'' 
shall wear suitable respirators. Employees whose presence is not 
required to perform ``blow down'' or ``blow of'' shall be required to 
leave the area affected by the ``blow down'' or ``blow off'' during this 
cleaning operation.
    (2) Cleaning of clothing or floors with compressed air shall be 
prohibited.
    (3) Floor sweeping shall be performed with a vacuum or with methods 
designed to minimize dispersal of dust.

[[Page 312]]

    (4) In areas where employees are exposed to concentrations of cotton 
dust greater than the permissible exposure limit, cotton and cotton 
waste shall be stacked, sorted, baled, dumped, removed or otherwise 
handled by mechanical means, except where the employer can show that it 
is infeasible to do so. Where infeasible, the method used for handling 
cotton and cotton waste shall be the method which reduces exposure to 
the lowest level feasible.
    (h) Medical surveillance--(1) General. (i) Each employer covered by 
the standard shall institute a program of medical surveillance for all 
employees exposed to cotton dust.
    (ii) The employer shall assure that all medical examinations and 
procedures are performed by or under the supervision of a licensed 
physician and are provided without cost to the employee.
    (iii) Persons other than licensed physicians, who administer the 
pulmonary function testing required by this section shall have completed 
a NIOSH-approved training course in spirometry.
    (2) Initial examinations. The employer shall provide medical 
surveillance to each employee who is or may be exposed to cotton dust. 
For new employees, this examination shall be provided prior to initial 
assignment. The medical surveillance shall include at least the 
following:
    (i) A medical history;
    (ii) The standardized questionnaire contained in appendix B; and
    (iii) A pulmonary function measurement, including forced vital 
capacity (FVC) and forced expiratory volume in one second 
(FEV1), and determination of the FEV1/FVC ratio 
shall be made. FVC, FEV1, and FEV1/FVC ratio 
values shall be compared to appropriate race/ethnicity-specific Lower 
Limit of Normal (LLN) values and predicted values published in 
Spirometric Reference Values from a Sample of the General U.S. 
Population, American Journal of Respiratory and Critical Care Medicine, 
159(1): 179-187, January 1999 (commonly known as the NHANES III 
reference data set) (incorporated by reference, see Sec.  1910.6). To 
obtain reference values for Asian-Americans, Spirometric Reference 
Values FEV1 and FVC predicted and LLN values for Caucasians 
shall be multiplied by 0.88 to adjust for ethnic differences. These 
determinations shall be made for each employee before the employee 
enters the workplace on the first day of the work week, preceded by at 
least 35 hours of no exposure to cotton dust. The tests shall be 
repeated during the shift, no less than 4 and no more than 10 hours 
after the beginning of the work shift; and, in any event, no more than 
one hour after cessation of exposure. Such exposure shall be typical of 
the employee's usual workplace exposure.
    (iv) Based upon the questionnaire results, each employee shall be 
graded according to Schilling's byssinosis classification system.
    (3) Periodic examinations. (i) The employer shall provide at least 
annual medical surveillance for all employees exposed to cotton dust 
above the action level in yarn manufacturing, slashing and weaving, 
cotton washing and waste house operations. The employer shall provide 
medical surveillance at least every two years for all employees exposed 
to cotton dust at or below the action level, for all employees exposed 
to cotton dust from washed cotton (except from washed cotton defined in 
paragraph (n)(3) of this section), and for all employees exposed to 
cotton dust in cottonseed processing and waste processing operations. 
Periodic medical surveillance shall include at least an update of the 
medical history, standardized questionnaire (App. B-111), Schilling 
byssinosis grade, and the pulmonary function measurements in paragraph 
(h)(2)(iii) of this section.
    (ii) Medical surveillance as required in paragraph (h)(3)(i) of this 
section shall be provided every six months for all employees in the 
following categories:
    (A) An FEV1 greater than the LLN, but with an 
FEV1 decrement of 5 percent or 200 ml. on a first working 
day;
    (B) An FEV1 of less than the LLN; or
    (C) Where, in the opinion of the physician, any significant change 
in questionnaire findings, pulmonary function results, or other 
diagnostic tests have occurred.
    (iii) An employee whose FEV1 is less than 60 percent of 
the predicted value

[[Page 313]]

shall be referred to a physician for a detailed pulmonary examination.
    (iv) A comparison shall be made between the current examination 
results and those of previous examinations and a determination made by 
the physician as to whether there has been a significant change.
    (4) Information provided to the physician. The employer shall 
provide the following information to the examination physician:
    (i) A copy of this regulation and its Appendices:
    (ii) A description of the affected employee's duties as they relate 
to the employee's exposure;
    (iii) The employee's 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.
    (5) Physician's written opinion. (i) The employer shall obtain and 
furnish the employee with a copy of a written opinion from the examining 
physician containing the following:
    (A) The results of the medical examination and tests including the 
FEV1, FVC, AND FEV1/FVC ratio;
    (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 
cotton dust;
    (C) The physician's recommended limitations upon the employee's 
exposure to cotton dust or upon the employee's use of respirators 
including a determination of whether an employee can wear a negative 
pressure respirator, and where the employee cannot, a determination of 
the employee's ability to wear a powered air purifying respirator; 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 examination or treatment.
    (ii) The written opinion obtained by the employer shall not reveal 
specific findings or diagnoses unrelated to occupational exposure.
    (i) Employee education and training--(1) Training program. (i) The 
employer shall train each employee exposed to cotton dust 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 prior to initial 
assignment and shall be repeated annually for each employee exposed to 
cotton dust, when job assignments or work processes change and when 
employee performance indicates a need for retraining.
    (2) Access to training materials. (i) Each employer shall post a 
copy of this section with its appendices in a public location at the 
workplace, and shall, upon request, make copies available to employees.
    (ii) The employer shall provide all materials relating to the 
employee training and information program to the Assistant Secretary and 
the Director upon request.
    (j) Signs. (1) The employer shall post the following warning sign in 
each work area where the permissible exposure limit for cotton dust is 
exceeded:

DANGER
COTTON DUST
CAUSES DAMAGE TO LUNGS
(BYSSINOSIS)
WEAR RESPIRATORY PROTECTION IN THIS AREA

    (2) Prior to June 1, 2016, employers may use the following legend in 
lieu of that specified in paragraph (j)(1) of this section:

WARNING
COTTON DUST WORK AREA
MAY CAUSE ACUTE OR DELAYED
LUNG INJURY
(BYSSINOSIS)
RESPIRATORS
REQUIRED IN THIS AREA
    (k) Recordkeeping--(1) Exposure measurements. (i) The employer shall 
establish and maintain an accurate record of all measurements required 
by paragraph (d) of this section.
    (ii) The record shall include:
    (A) A log containing the items listed in paragraph IV (a) of 
appendix A, and

[[Page 314]]

the dates, number, duration, and results of each of the samples taken, 
including a description of the procedure used to determine 
representative employee exposure;
    (B) The type of protective devices worn, if any, and length of time 
worn; and
    (C) The names, job classifications, and exposure levels of employees 
whose exposure the measurement is intended to represent.
    (iii) The employer shall maintain this record for at least 20 years.
    (2) Medical surveillance. (i) The employer shall establish and 
maintain an accurate medical record for each employee subject to medical 
surveillance required by paragraph (h) of this section.
    (ii) The record shall include:
    (A) The name and description of the duties of the employee;
    (B) A copy of the medical examination results including the medical 
history, questionnaire response, results of all tests, and the 
physician's recommendation;
    (C) A copy of the physician's written opinion;
    (D) Any employee medical complaints related to exposure to cotton 
dust;
    (E) A copy of this standard and its appendices, except that the 
employer may keep one copy of the standard and the appendices for all 
employees, provided that he references the standard and appendices in 
the medical surveillance record of each employee; and
    (F) A copy of the information provided to the physician as required 
by paragraph (h)(4) of this section.
    (iii) The employer shall maintain this record for at least 20 years.
    (3) Availability. (i) The employer shall make all records required 
to be maintained by paragraph (k) of this section available to the 
Assistant Secretary and the Director for examination and copying.
    (ii) Employee exposure measurement records and employee 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) 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 paragraph (k) of this section.
    (ii) The employer shall also comply with any additional requirements 
involving transfer of records set forth in 29 CFR 1910.1020(h).
    (l) Observation of monitoring. (1) The employer shall provide 
affected employees or their designated representatives an opportunity to 
observe any measuring or monitoring of employee exposure to cotton dust 
conducted pursuant to paragraph (d) of this section.
    (2) Whenever observation of the measuring or monitoring of employee 
exposure to cotton dust requires entry into an area where the use of 
personal protective equipment is required, the employer shall provide 
the observer with and assure the use of such equipment and shall require 
the observer to comply with all other applicable safety and health 
procedures.
    (3) Without interfering with the measurement, observers shall be 
entitled to:
    (i) An explanation of the measurement procedures:
    (ii) An opportunity to observe all steps related to the measurement 
of airborne concentrations of cotton dust performed at the place of 
exposure; and
    (iii) An opportunity to record the results obtained.
    (m) Washed Cotton--(1) Exemptions. Cotton, after it has been washed 
by the processes described in this paragraph, is exempt from all or 
parts of this section as specified if the requirements of this paragraph 
are met.
    (2) Initial requirements. (i) In order for an employer to qualify as 
exempt or partially exempt from this standard for operations using 
washed cotton, the employer must demonstrate that the cotton was washed 
in a facility which is open to inspection by the Assistant Secretary and 
the employer must provide sufficient accurate documentary evidence to 
demonstrate that the washing methods utilized meet the requirements of 
this paragraph.
    (ii) An employer who handles or processes cotton which has been 
washed in a facility not under the employer's control and claims an 
exemption or

[[Page 315]]

partial exemption under this paragraph, must obtain from the cotton 
washer and make available at the worksite, to the Assistant Secretary, 
to any affected employee, or to their designated representative the 
following:
    (A) A certification by the washer of the cotton of the grade of 
cotton, the type of washing process, and that the batch meets the 
requirements of this paragraph;
    (B) Sufficient accurate documentation by the washer of the cotton 
grades and washing process; and
    (C) An authorization by the washer that the Assistant Secretary or 
the Director may inspect the washer's washing facilities and 
documentation of the process.
    (3) Medical and dyed cotton. Medical grade (USP) cotton, cotton that 
has been scoured, bleached and dyed, and mercerized yarn shall be exempt 
from all provisions of this standard.
    (4) Higher grade washed cotton. The handling or processing of cotton 
classed as ``low middling light spotted or better'' (color grade 52 or 
better and leaf grade code 5 or better according to the 1993 USDA 
classification system) shall be exempt from all provisions of the 
standard except the requirements of paragraphs (h) medical surveillance, 
(k)(2) through (4) recordkeeping--medical records, and Appendices B, C, 
and D of this section, if they have been washed on one of the following 
systems:
    (i) On a continuous batt system or a rayon rinse system including 
the following conditions:
    (A) With water;
    (B) At a temperature of no less than 60 [deg]C;
    (C) With a water-to-fiber ratio of no less than 40:1; and
    (D) With the bacterial levels in the wash water controlled to limit 
bacterial contamination of the cotton.
    (ii) On a batch kier washing system including the following 
conditions:
    (A) With water;
    (B) With cotton fiber mechanically opened and thoroughly prewetted 
before forming the cake;
    (C) For low-temperature processing, at a temperature of no less than 
60 [deg]C with a water-to-fiber ratio of no less than 40:1; or, for 
high-temperature processing, at a temperature of no less than 93 [deg]C 
with a water-to-fiber ratio of no less than 15:1;
    (D) With a minimum of one wash cycle followed by two rinse cycles 
for each batch, using fresh water in each cycle, and
    (E) With bacterial levels in the wash water controlled to limit 
bacterial contamination of the cotton.
    (5) Lower grade washed cotton. The handling and processing of cotton 
of grades lower than ``low middling light spotted,'' that has been 
washed as specified in paragraph (n)(4) of this section and has also 
been bleached, shall be exempt from all provisions of the standard 
except the requirements of paragraphs (c)(1)(ii) Permissible Exposure 
Limit, (d) Exposure Monitoring, (h) Medical Surveillance, (k) 
Recordkeeping, and Appendices B, C and D of this section.
    (6) Mixed grades of washed cotton. If more than one grade of washed 
cotton is being handled or processed together, the requirements of the 
grade with the most stringent exposure limit, medical and monitoring 
requirements shall be followed.
    (n) Appendices. (1) Appendices B and D of this section are 
incorporated as part of this section and the contents of these 
appendices are mandatory.
    (2) Appendix A of this section contains information which is not 
intended to create any additional obligations not otherwise imposed or 
to detract from any existing obligations.
    (3) Appendix E of this section is a protocol which may be followed 
in the validation of alternative measuring devices as equivalent to the 
vertical elutriator cotton dust sampler. Other protocols may be used if 
it is demonstrated that they are statistically valid, meet the 
requirements in paragraph (d)(l)(iii) of this section, and are 
appropriate for demonstrating equivalency.

[[Page 316]]

 Appendix A to Sec.  1910.1043--Air Sampling and Analytical Procedures 
              for Determining Concentrations of Cotton Dust

                          i. sampling locations

    The sampling procedures must be designed so that samples of the 
actual dust concentrations are collected accurately and consistently and 
reflect the concentrations of dust at the place and time of sampling. 
Sufficient number of 6-hour area samples in each distinct work area of 
the plant should be collected at locations which provide representative 
samples of air to which the worker is exposed. In order to avoid filter 
overloading, sampling time may be shortened when sampling in dusty 
areas. Samples in each work area should be gathered simultaneously or 
sequentially during a normal operating period. The daily time-weighted 
average (TWA) exposure of each worker can then be determined by using 
the following formula:

Summation of hours spent in each location and the dust concentration in 
                             that location.

                           Total hours exposed

A time-weighted average concentration should be computed for each worker 
and properly logged and maintained on file for review.

                         ii. sampling equipment

    (a) Sampler. The instrument selected for monitoring is the Lumsden-
Lynch vertical elutriator. It should operate at a flow rate of 7.40.2 liters/minute.

The samplers should be cleaned prior to sampling. The pumps should be 
monitored during sampling.
    (b) Filter Holder. A three-piece cassette constructed of polystyrene 
designed to hold a 37-mm diameter filter should be used. Care must be 
exercised to insure that an adequate seal exists between elements of the 
cassette.
    (c) Filers and Support Pads. The membrane filters used should be 
polyvinyl chloride with a 5-um pore size and 37-mm diameter. A support 
pad, commonly called a backup pad, should be used under the filter 
membrane in the field monitor cassette.
    (d) Balance. A balance sensitive to 10 micrograms should be used.
    (e) Monitoring equipment for use in Class III hazardous locations 
must be approved for use in such locations, in accordance with the 
requirements of the OSHA electrical standards in subpart S of part 1910.

                  iii. instrument calibration procedure

    Samplers shall be calibrated when first received from the factory, 
after repair, and after receiving any abuse. The samplers should be 
calibrated in the laboratory both before they are used in the field and 
after they have been used to collect a large number of field samples. 
The primary standard, such as a spirometer or other standard calibrating 
instruments such as a wet test meter or a large bubble meter or dry gas 
meter, should be used. Instructions for calibration with the wet test 
meter follow. If another calibration device is selected, equivalent 
procedures should be used:
    (a) Level wet test meter. Check the water level which should just 
touch the calibration point at the left side of the meter. If water 
level is low, add water 1-2 [deg]F. warmer than room temperature of till 
point. Run the meter for 30 minutes before calibration;
    (b) Place the polyvinyl chloride membrane filter in the filter 
cassette;
    (c) Assemble the calibration sampling train;
    (d) Connect the wet test meter to the train.

The pointer on the meter should run clockwise and a pressure drop of not 
more than 1.0 inch of water indicated. If the pressure drop is greater 
than 1.0, disconnect and check the system;
    (e) Operate the system for ten minutes before starting the 
calibration;
    (f) Check the vacuum gauge on the pump to insure that the pressure 
drop across the orifice exceeds 17 inches of mercury;
    (g) Record the following on calibration data sheets:
    (1) Wet test meter reading, start and finish;
    (2) Elapsed time, start and finish (at least two minutes);
    (3) Pressure drop at manometer;
    (4) Air temperature;
    (5) Barometric pressure; and
    (6) Limiting orifice number;
    (h) Calculate the flow rate and compare against the flow of 
7.40.2 liters/minute. If flow is between these 
limits, perform calibration again, average results, and record orifice 
number and flow rate. If flow is not within these limits, discard or 
modify orifice and repeat procedure;
    (i) Record the name of the person performing the calibration, the 
date, serial number of the wet test meter, and the number of the 
critical orifices being calibrated.

                         iv. sampling procedure

    (a) Sampling data sheets should include a log of:
    (1) The date of the sample collection;
    (2) The time of sampling;
    (3) The location of the sampler;
    (4) The sampler serial number;
    (5) The cassette number;
    (6) The time of starting and stopping the sampling and the duration 
of sampling;
    (7) The weight of the filter before and after sampling;
    (8) The weight of dust collected (corrected for controls);

[[Page 317]]

    (9) The dust concentration measured;
    (10) Other pertinent information; and
    (11) Name of person taking sample
    (b) Assembly of filter cassette should be as follows:
    (1) Loosely assemble 3-piece cassette;
    (2) Number cassette;
    (3) Place absorbant pad in cassette;
    (4) Weigh filter to an accuracy of 10 [micro]g;
    (5) Place filter in cassette;
    (6) Record weight of filter in log, using cassette number for 
identification;
    (7) Fully assemble cassette, using pressure to force parts tightly 
together;
    (8) Install plugs top and bottom;
    (9) Put shrink band on cassette, covering joint between center and 
bottom parts of cassette; and
    (10) Set cassette aside until shrink band dries thoroughly.
    (c) Sampling collection should be performed as follows:
    (1) Clean lint out of the motor and elutriator;
    (2) Install vertical elutriator in sampling locations specified 
above with inlet 4\1/2\ to 5\1/2\ feet from floor (breathing zone 
height);
    (3) Remove top section of cassette;
    (4) Install cassette in ferrule of elutriator;
    (5) Tape cassette to ferrule with masking tape or similar material 
for air-tight seal;
    (6) Remove bottom plug of cassette and attach hose containing 
critical orifice;
    (7) Start elutriator pump and check to see if gauge reads above 17 
in. of Hg vacuum;
    (8) Record starting time, cassette number, and sampler number;
    (9) At end of sampling period stop pump and record time; and
    (10) Controls with each batch of samples collected, two additional 
filter cassettes should be subjected to exactly the same handling as the 
samples, except that they are not opened. These control filters should 
be weighed in the same manner as the sample filters.

Any difference in weight in the control filters would indicate that the 
procedure for handling sample filters may not be adequate and should be 
evaluated to ascertain the cause of the difference, whether and what 
necessary corrections must be made, and whether additional samples must 
be collected.
    (d) Shipping. The cassette with samples should be collected, along 
with the appropriate number of blanks, and shipped to the analytical 
laboratory in a suitable container to prevent damage in transit.
    (e) Weighing of the sample should be achieved as follows:
    (1) Remove shrink band;
    (2) Remove top and middle sections of cassette and botton plug;
    (3) Remove filter from cassette and weigh to an accuracy of 10 
[micro]g; and
    (4) Record weight in log against original weight
    (f) Calculation of volume of air sampled should be determined as 
follows:
    (1) From starting and stopping times of sampling period, determine 
length of time in minutes of sampling period; and
    (2) Multiply sampling time in minutes by flow rate of critical 
orifice in liters per minute and divide by 1000 to find air quantity in 
cubic meters.
    (g) Calculation of Dust Concentrations should be made as follows:
    (1) Substract weight of clean filter from dirty filter and apply 
control correction to find actual weight of sample. Record this weight 
(in [micro]g) in log; and
    (2) Divide mass of sample in [micro]g by air volume in cubic meters 
to find dust concentration in [micro]g/m. Record in log.

       Appendix B-I to Sec.  1910.1043--Respiratory Questionnaire

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  Appendix B-II to Sec.  1910.1043--Respiratory Questionnaire for Non-
                 Textile Workers for the Cotton Industry

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Appendix B-III to Sec.  1910.1043--Abbreviated Respiratory Questionnaire

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                Appendix C to Sec.  1910.1043--[Reserved]

 Appendix D to Sec.  1910.1043--Pulmonary Function Standards for Cotton 
                              Dust Standard

    The spirometric measurements of pulmonary function shall conform to 
the following minimum standards, and these standards are not intended to 
preclude additional testing or alternate methods which can be determined 
to be superior.

                              I. Apparatus

    a. The instrument shall be accurate to within 50 milliliters or within 3 percent 
of reading, whichever is greater.
    b. 1. Instruments purchased on or before May 14, 2020 should be 
capable of measuring vital capacity from 0 to 7 liters BTPS
    2. Instruments purchased after May 14, 2020 should be capable of 
measuring vital capacity from 0 to 8 liters BTPS.
    c. The instrument shall have a low inertia and offer low resistance 
to airflow such that the resistance to airflow at 12 liters per second 
must be less than 1.5 cm H2 O/(liter/sec).
    d. The zero time point for the purpose of timing the FEV1 
shall be determined by extrapolating the steepest portion of the volume 
time curve back to the maximal inspiration volume (1, 2, 3, 4) or by an 
equivalent method.
    e. 1. Instruments purchased on or before May 14, 2020 that 
incorporate measurements of airflow to determine volume shall conform to 
the same volume accuracy stated in paragraph (a) of this section I when 
presented with flow rates from at least 0 to 12 liters per second.
    2. Instruments purchased after May 14, 2020 that incorporate 
measurements of airflow to determine volume shall conform to the same 
volume accuracy stated in paragraph (a) of this section I when presented 
with flow rates from at least 0 to 14 liters per second.
    f. The instrument or user of the instrument must have a means of 
correcting volumes to body temperature saturated with water vapor (BTPS) 
under conditions of varying ambient spirometer temperatures and 
barometric pressures.
    g. 1. Instruments purchased on or before May 14, 2020 shall provide 
a tracing or display of either flow versus volume or volume versus time 
during the entire forced expiration. A tracing or display is necessary 
to determine whether the patient has performed the test properly. The 
tracing must be stored and available for recall and must be of 
sufficient size that hand measurements may be made within the volume 
accuracy requirements of paragraph (a) of this section I. If a paper 
record is made it must have a paper speed of at least 2 cm/sec and a 
volume sensitivity of at least 10.0 mm of chart per liter of volume.
    2. Instruments purchased after May 14, 2020 shall provide during 
testing a paper tracing or real-time display of flow versus volume and 
volume versus time for the entire forced expiration. Such a tracing or 
display is necessary to determine whether the worker has performed the 
test properly. Flow-volume and volume-time curves must be stored and 
available for recall. Real-time displays shall have a volume scale of at 
least 5 mm/L, a time scale of at least 10 mm/s, and a flow scale of at 
least 2.5 mm/L/s, when both flow-volume and volume-time displays are 
visible. If hand measurements will be made, paper tracings must be of 
sufficient size to allow those measurements to be made within the volume 
accuracy requirements of paragraph (a) of this section I. If a paper 
record is made it must have a paper speed of at least 2 cm/sec and a 
volume sensitivity of at least 10.0 mm of chart per liter of volume.

[[Page 344]]

    h. 1. Instruments purchased on or before May 14, 2020 shall be 
capable of accumulating volume for a minimum of 10 seconds and shall not 
stop accumulating volume before (i) the volume change for a 0.5-second 
interval is less than 25 milliliters, or (ii) the flow is less than 50 
milliliters per second for a 0.5 second interval.
    2. Instruments purchased after May 14, 2020 shall be capable of 
accumulating volume for a minimum of 15 seconds and shall not stop 
accumulating volume before the volume change for a 1-second interval is 
less than 25 milliliters.
    i. The forced vital capacity (FVC) and forced expiratory volume in 1 
second (FEV1) measurements shall comply with the accuracy 
requirements stated in paragraph (a) of this section. That is, they 
should be accurately measured to within 50 ml or 
within 3 percent of reading, whichever is greater.
    j. 1. Instruments purchased on or before May 14, 2020 must be 
capable of being calibrated in the field with respect to the 
FEV1 and FVC. This calibration of the FEV1 and FVC 
may be either directly or indirectly through volume and time base 
measurements. The volume calibration source should provide a volume 
displacement of at least 2 liters and should be accurate to within + or-
30 milliliters.
    2. Instruments purchased after May 14, 2020 must be capable of 
having its calibration checked in the field and be recalibrated, if 
necessary, if the spirometer requires the technician to do so. The 
volume-calibration syringe shall provide a volume displacement of at 
least 3 liters and shall be accurate to within  
0.5 percent of 3 liters (15 milliliters).

     II. Technique for Measurement of Forced Vital Capacity Maneuver

    a. Use of a nose clip is recommended but not required. The 
procedures shall be explained in simple terms to the worker who shall be 
instructed to loosen any tight clothing and stand in front of the 
apparatus. The worker may sit, but care should be taken on repeat 
testing that the same position be used and, if possible, the same 
spirometer. Particular attention shall be given to ensure that the chin 
is slightly elevated with the neck slightly extended. The worker shall 
be instructed to make a full inspiration from a normal breathing pattern 
and then blow into the apparatus, without interruption, as hard, fast, 
and completely as possible. At least three and no more than eight forced 
expirations shall be carried out. During the maneuvers, the worker shall 
be observed for compliance with instruction. The expirations shall be 
checked visually for technical acceptability and repeatability from 
flow-volume or volume-time tracings or displays. The following efforts 
shall be judged technically unacceptable when the worker:
    1. Has not reached full inspiration preceding the forced expiration,
    2. Has not used maximal effort during the entire forced expiration,
    3. Has not tried to exhale continuously for at least 6 seconds and 
the volume-time curve shows no change in volume (<0.025 L) for at least 
one second,
    4. Has coughed in the first second or closed the glottis,
    5. Has an obstructed mouthpiece or a leak around the mouthpiece 
(obstruction due to tongue being placed in front of mouthpiece, false 
teeth falling in front of mouthpiece, etc.),
    6. Has an unsatisfactory start of expiration, one characterized by 
excessive hesitation (or false starts), and, therefore, not allowing 
back extrapolation of time 0 (extrapolated volume on the volume-time 
tracing must be less than 150 milliliters or 5 percent of the FVC, 
whichever is greater.), and
    7. Has an excessive variability between the acceptable curves. The 
difference between the two largest FVCs from the satisfactory tracings 
shall not exceed 150 milliliters and the difference between the two 
largest FEV1s of the satisfactory tracings shall not exceed 
150 milliliters.
    b. Calibration checks of the volume accuracy of the instrument for 
recording FVC and FEV1 shall be performed daily or more 
frequently if specified by the spirometer manufacturer, using a 3-liter 
syringe. Calibration checks to ensure that the spirometer is recording 3 
liters of injected air to within 3.5 percent, or 
2.90 to 3.10 liters, shall be conducted. Calibration checks of flow-type 
spirometers shall include injection of 3 liters air over a range of 
speeds, with injection times of 0.5 second, 3 seconds, and 6 or more 
seconds. Checks of volume-type spirometers shall include a single 
calibration check and a check to verify that the spirometer is not 
leaking more than 30 milliliters/minute air.

                    III. Interpretation of Spirogram

    a. The first step in evaluating a spirogram should be to determine 
whether or not the worker has performed the test properly or as 
described in section II of this appendix. From the three satisfactory 
tracings, the forced vital capacity (FVC) and forced expiratory volume 
in 1 second (FEV1) shall be measured and recorded. The 
largest observed FVC and largest observed FEV1 shall be used 
in the analysis regardless of the curve(s) on which they occur.
    b. [Reserved]

         IV. Qualifications of Personnel Administering the Test

    Technicians who perform pulmonary function testing should have the 
basic knowledge required to produce meaningful results. Training 
consisting of approximately 16

[[Page 345]]

hours of formal instruction should cover the following areas.
    a. Basic physiology of the forced vital-capacity maneuver and the 
determinants of airflow limitation, with emphasis on the relation to 
repeatability of results.
    b. Instrumentation requirements, including calibration check 
procedures, sources of error, and their correction.
    c. Performance of the testing including worker coaching, recognition 
of improperly performed maneuvers and corrective actions.
    d. Data quality with emphasis on repeatability.
    e. Actual use of the equipment under supervised conditions.
    f. Measurement of tracings and calculations of results.

[43 FR 27394, June 23, 1978; 43 FR 35035, Aug. 8, 1978, as amended at 45 
FR 67340, Oct. 10, 1980; 50 FR 51173, Dec. 13, 1985; 51 FR 24325, July 
3, 1986; 54 FR 24334, June 7, 1989; 61 FR 5508, Feb. 13, 1996; 63 FR 
1290, Jan. 8, 1998; 65 FR 76567, Dec. 7, 2000; 70 FR 1142, Jan. 5, 2005; 
71 FR 16672, 16673, Apr. 3, 2006; 71 FR 50189, Aug. 24, 2006; 73 FR 
75586, Dec. 12, 2008; 76 FR 33609, June 8, 2011; 77 FR 17782, Mar. 26, 
2012; 84 FR 21490, May 14, 2019]



Sec.  1910.1044  1,2-dibromo-3-chloropropane.

    (a) Scope and application. (1) This section applies to occupational 
exposure to 1,2-dibromo-3-chloropropane (DBCP).
    (2) This section does not apply to:
    (i) Exposure to DBCP which results solely from the application and 
use of DBCP as a pesticide; or
    (ii) The storage, transportation, distribution or sale of DBCP in 
intact containers sealed in such a manner as to prevent exposure to DBCP 
vapors or liquid, except for the requirements of paragraphs (i), (n) and 
(o) of this section.
    (b) Definitions. Authorized person means any person required by his 
duties to be present in regulated areas and authorized to do so by his 
employer, by this section, or by the Act. Authorized person also 
includes any person entering such areas as a designated representative 
of employees exercising an opportunity to observe employee exposure 
monitoring.
    DBCP means 1,2-dibromo-3-chloropropane, Chemical Abstracts Service 
Registry Number 96-12-8, and includes all forms of DBCP.
    Director means the Director, National Institute for Occupational 
Safety and Health, U.S. Department of Health and Human Services, or 
designee.
    Emergency means any occurrence such as, but not limited to equipment 
failure, rupture of containers, or failure of control equipment which 
may, or does, result in an unexpected release of DBCP.
    OSHA Area Office means the Area Office of the Occupational Safety 
and Health Administration having jurisdiction over the geographic area 
where the affected workplace is located.
    Assistant Secretary means the Assistant Secretary of Labor for 
Occupational Safety and Health, U.S. Department of Labor, or designee.
    (c) Permissible exposure limit--(1) Inhalation. The employer shall 
assure that no employee is exposed to an airborne concentration of DBCP 
in excess of 1 part DBCP per billion parts of air (ppb) as an 8-hour 
time-weighted average.
    (2) Dermal and eye exposure. The employer shall assure that no 
employee is exposed to eye or skin contact with DBCP.
    (d) [Reserved]
    (e) Regulated areas. (1) The employer shall establish, within each 
place of employment, regulated areas wherever DBCP concentrations are in 
excess of the permissible exposure limit.
    (2) The employer shall limit access to regulated areas to authorized 
persons.
    (f) 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 DBCP over an 8-hour period.
    (ii) For the purposes of this paragraph, employee exposure is that 
exposure which would occur if the employee were not using a respirator.
    (2) Initial. Each employer who has a place of employment in which 
DBCP is present, shall monitor each workplace and work operation to 
accurately determine the airborne concentrations of DBCP to which 
employees may be exposed.
    (3) Frequency. (i) If the monitoring required by this section 
reveals employee exposures to be at or below the permissible exposure 
limit, the employer must repeat these measurements at least every 6 
months.

[[Page 346]]

    (ii) If the monitoring required by this section reveals employee 
exposures to be in excess of the permissible exposure limit, the 
employer must repeat these measurements for each such employee at least 
quarterly. The employer must continue quarterly monitoring until at 
least two consecutive measurements, taken at least seven (7) days apart, 
are at or below the permissible exposure limit. Thereafter the employer 
must monitor at least every 6 months.
    (4) Additional. Whenever there has been a production, process, 
control, or personnel change which may result in any new or additional 
exposure to DBCP, or whenever the employer has any reason to suspect new 
or additional exposures to DBCP, the employer shall monitor the 
employees potentially affected by such change for the purpose of 
redetermining their exposure.
    (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 employee of these results either individually 
in writing or by posting the results in an appropriate location that is 
accessible to employees.
    (ii) Whenever the results indicate that 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 being taken to 
reduce exposure to or below the permissible exposure limit.
    (6) Accuracy of measurement. The employer shall use a method of 
measurement which has an accuracy, to a confidence level of 95 percent, 
of not less than plus or minus 25 percent for concentrations of DBCP at 
or above the permissible exposure limit.
    (g) Methods of compliance--(1) Priority of compliance methods. The 
employer shall institute engineering and work practice controls to 
reduce and maintain employee exposures to DBCP at or below the 
permissible exposure limit, except to the extent that the employer 
establishes that such controls are not feasible. Where feasible 
engineering and work practice controls are not sufficient to reduce 
employee exposures to within the permissible exposure limit, the 
employer shall nonetheless use them to reduce exposures to the lowest 
level achievable by these controls, and shall supplement them by use of 
respiratory protection.
    (2) Compliance program. (i) The employer shall establish and 
implement a written program to reduce employee exposures to DBCP to or 
below the permissible exposure limit solely by means of engineering and 
work practice controls as required by paragraph (g)(1) of this section.
    (ii) The written program shall include a detailed schedule for 
development and implementation of the engineering and work practice 
controls. These plans must be revised at least annually to reflect the 
current status of the program.
    (iii) Written plans for these compliance 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, the Director, and any affected employee or designated 
representative of employees.
    (iv) The employer shall institute and maintain at least the controls 
described in his most recent written compliance program.
    (h) Respiratory protection--(1) General. For employees who are 
required to use respirators 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) 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 permissible exposure limit.
    (iv) Emergencies.
    (2) Respirator program. 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

[[Page 347]]

covers each employee required by this section to use a respirator.
    (3) Respirator selection. Employers must:
    (i) Select, and provide to employees, the appropriate atmosphere-
supplying respirator specified in paragraph (d)(3)(i)(A) of 29 CFR 
1910.134.
    (ii) Provide employees with one of the following respirator options 
to use for entry into, or escape from, unknown DBCP concentrations:
    (A) A combination respirator that includes a supplied-air respirator 
with a full facepiece operated in a pressure-demand or other positive-
pressure or continuous-flow mode, as well as an auxiliary self-contained 
breathing apparatus (SCBA) operated in a pressure-demand or positive-
pressure mode.
    (B) An SCBA with a full facepiece operated in a pressure-demand or 
other positive-pressure mode.
    (i) Emergency situations--(1) Written plans. (i) A written plan for 
emergency situations shall be developed for each workplace in which DBCP 
is present.
    (ii) Appropriate portions of the plan shall be implemented in the 
event of an emergency.
    (2) Employees engaged in correcting emergency conditions shall be 
equipped as required in paragraphs (h) and (j) of this section until the 
emergency is abated.
    (3) Evacuation. Employees not engaged in correcting the emergency 
shall be removed and restricted from the area and normal operations in 
the affected area shall not be resumed until the emergency is abated.
    (4) Alerting employees. Where there is a possibility of employee 
exposure to DBCP due to the occurrence of an emergency, a general alarm 
shall be installed and maintained to promptly alert employees of such 
occurrences.
    (5) Medical surveillance. For any employee exposed to DBCP in an 
emergency situation, the employer shall provide medical surveillance in 
accordance with paragraph (m)(6) of this section.
    (6) Exposure monitoring. (i) Following an emergency, the employer 
shall conduct monitoring which complies with paragraph (f) of this 
section.
    (ii) In workplaces not normally subject to periodic monitoring, the 
employer may terminate monitoring when two consecutive measurements 
indicate exposures below the permissible exposure limit.
    (j) Protective clothing and equipments--(1) Provision and use. Where 
there is any possibility of eye or dermal contact with liquid or solid 
DBCP, the employer shall provide, at no cost to the employee, and assure 
that the employee wears impermeable protective clothing and equipment to 
protect the area of the body which may come in contact with DBCP. Eye 
and face protection shall meet the requirements of Sec.  1910.133 of 
this part.
    (2) Removal and storage. (i) The employer shall assure that 
employees remove DBCP contaminated work clothing only in change rooms 
provided in accordance with paragraph (l) (1) of this section.
    (ii) The employer shall assure that employees promptly remove any 
protective clothing and equipment which becomes contaminated with DBCP-
containing liquids and solids. This clothing shall not be reworn until 
the DBCP has been removed from the clothing or equipment.
    (iii) The employer shall assure that no employee takes DBCP 
contaminated protective devices and work clothing out of the change 
room, except those employees authorized to do so for the purpose of 
laundering, maintenance, of disposal.
    (iv) DBCP-contaminated protective devices and work clothing shall be 
placed and stored in closed containers which prevent dispersion of the 
DBCP outside the container.
    (v) Containers of DBCP-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 with the following 
information: CONTAMINATED WITH 1,2-Dibromo-3-chloropropane (DBCP), MAY 
CAUSE CANCER.
    (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 daily to each affected 
employee.

[[Page 348]]

    (ii) The employer shall inform any person who launders or clean 
DBCP-contaminated protective clothing or equipment of the potentially 
harmful effects of exposure to DBCP.
    (iii) The employer shall prohibit the removal of DBCP from 
protective clothing and equipment by blowing or shaking.
    (k) Housekeeping--(1) Surfaces. (i) All workplace surfaces shall be 
maintained free of visible accumulations of DBCP.
    (ii) Dry sweeping and the use of compressed air for the cleaning of 
floors and other surfaces is prohibited where DBCP dusts or liquids are 
present.
    (iii) Where vacuuming methods are selected to clean floors and other 
surfaces, either portable units or a permanent system may be used.
    (a) If a portable unit is selected, the exhaust shall be attached to 
the general workplace exhaust ventilation system or collected within the 
vacuum unit, equipped with high efficiency filters or other appropriate 
means of contaminant removal, so that DBCP is not reintroduced into the 
workplace air; and
    (b) Portable vacuum units used to collect DBCP may not be used for 
other cleaning purposes and shall be labeled as prescribed by paragraph 
(j)(2)(v) of this section.
    (iv) Cleaning of floors and other surfaces contaminated with DBCP-
containing dusts shall not be performed by washing down with a hose, 
unless a fine spray has first been laid down.
    (2) Liquids. Where DBCP is present in a liquid form, or as a 
resultant vapor, all containers or vessels containing DBCP shall be 
enclosed to the maximum extent feasible and tightly covered when not in 
use.
    (3) Waste disposal. DBCP waste scrap, debris, containers or 
equipment, shall be disposed of in sealed bags or other closed 
containers which prevent dispersion of DBCP outside the container.
    (l) Hygiene facilities and practices--(1) Change rooms. The employer 
shall provide clean change rooms equipped with storage facilities for 
street clothes and separate storage facilities for protective clothing 
and equipment whenever employees are required to wear protective 
clothing and equipment in accordance with paragraphs (h) and (j) of this 
section.
    (2) Showers. (i) The employer shall assure that employees working in 
the regulated area shower at the end of the work shift.
    (ii) The employer shall assure that employees whose skin becomes 
contaminated with DBCP-containing liquids or solids immediately wash or 
shower to remove any DBCP from the skin.
    (iii) The employer shall provide shower facilities in accordance 
with 29 CFR 1910.141(d)(3).
    (3) Lunchrooms. The employer shall provide lunchroom facilities 
which have a temperature controlled, positive pressure, filtered air 
supply, and which are readily accessible to employees working in 
regulated areas.
    (4) Lavatories. (i) The employer shall assure that employees working 
in the regulated area remove protective clothing and wash their hands 
and face prior to eating.
    (ii) The employer shall provide a sufficient number of lavatory 
facilities which comply with 29 CFR 1910.141(d) (1) and (2).
    (5) Prohibition of activities in regulated areas. The employer shall 
assure that, in regulated areas, food or beverages are not present or 
consumed, smoking products and implements are not present or used, and 
cosmetics are not present or applied.
    (m) Medical surveillance--(1) General. (i) The employer shall make 
available a medical surveillance program for employees who work in 
regulated areas and employees who are subjected to DBCP exposures in an 
emergency situation.
    (ii) 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.
    (2) Frequency and content. At the time of initial assignment, and 
annually thereafter, the employer shall provide a medical examination 
for employees who work in regulated areas, which includes at least the 
following:
    (i) A medical and occupational history including reproductive 
history.
    (ii) A physical examination, including examination of the genito-
urinary

[[Page 349]]

tract, testicle size and body habitus, including a determination of 
sperm count.
    (iii) A serum specimen shall be obtained and the following 
determinations made by radioimmunoassay techniques utilizing National 
Institutes of Health (NIH) specific antigen or one of equivalent 
sensitivity:
    (a) Serum follicle stimulating hormone (FSH);
    (b) Serum luteinizing hormone (LH); and
    (c) Serum total estrogen (females).
    (iv) Any other tests deemed appropriate by the examining physician.
    (3) Additional examinations. If the employee for any reason develops 
signs or symptoms commonly associated with exposure to DBCP, the 
employer shall provide the employee with a medical examination which 
shall include those elements considered appropriate by the examining 
physician.
    (4) Information provided to the physician. The employer shall 
provide the following information to the examining physician:
    (i) A copy of this regulation and its appendices;
    (ii) A description of the affected employee's duties as they relate 
to the employee's exposure;
    (iii) The level of DBCP to which the employee is exposed; and
    (iv) A description of any personal protective equipment used or to 
be used.
    (5) Physician's written opinion. (i) For each examination under this 
section, the employer shall obtain and provide the employee with a 
written opinion from the examining physician which shall include:
    (a) The results of the medical tests performed;
    (b) The physician's opinion as to whether the employee has any 
detected medical condition which would place the employee at an 
increased risk of material impairment of health from exposure to DBCP; 
and
    (c) Any recommended limitations upon the employee's exposure to DBCP 
or upon the use of protective clothing and equipment such as 
respirators.
    (ii) The employer shall instruct the physician not to reveal in the 
written opinion specific findings or diagnoses unrelated to occupational 
exposure.
    (6) Emergency situations. If the employee is exposed to DBCP in an 
emergency situation, the employer shall provide the employee with a 
sperm count test as soon as practicable, or, if the employee has been 
vasectionized or is unable to produce a semen specimen, the hormone 
tests contained in paragraph (m)(2)(iii) of this section. The employer 
shall provide these same tests three months later.
    (n) Employee information and training--(1) Training program. (i) The 
employer shall train each employee who may be exposed to DBCP in 
accordance with the requirements of this section. The employer shall 
institute a training program and ensure employee participation in the 
program.
    (ii) 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, release or storage of 
DBCP and the specific nature of operations which could result in 
exposure to DBCP as well as any necessary protective steps;
    (c) The purpose, proper use, and limitations of respirators;
    (d) The purpose and description of the medical surveillance program 
required by paragraph (m) of this section; and
    (e) A review of this standard, including appendices.
    (2) Access to training materials. (i) The employer shall make a copy 
of this standard and its appendices readily available to all affected 
employees.
    (ii) The employer shall provide, upon request, all materials 
relating to the employee information and training program to the 
Assistant Secretary and the Director.
    (o) Communication of hazards--(1) Hazard communication--general. (i) 
Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for DBCP.
    (ii) In classifying the hazards of DBCP at least the following 
hazards

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are to be addressed: Cancer; reproductive effects; liver effects; kidney 
effects; central nervous system effects; skin, eye and respiratory tract 
irritation; and acute toxicity effects.
    (iii) Employers shall include DBCP in the hazard communication 
program established to comply with the HCS (Sec.  1910.1200). Employers 
shall ensure that each employee has access to labels on containers of 
DBCP and to safety data sheets, and is trained in accordance with the 
requirements of HCS and paragraph (n) of this section.
    (iv) The employer shall ensure that no statement appears on or near 
any sign or label required by this paragraph (o) which contradicts or 
detracts from the meaning of the required sign or label.
    (2) Signs. (i) The employer shall post signs to clearly indicate all 
regulated areas. These signs shall bear the legend:

DANGER
1,2-Dibromo-3-chloropropane
MAY CAUSE CANCER
WEAR RESPIRATORY PROTECTION IN THIS AREA
AUTHORIZED PERSONNEL ONLY

    (ii) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (o)(2) of this section:

DANGER
1,2-Dibromo-3-chloropropane
(Insert appropriate trade or common names)
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY
RESPIRATOR REQUIRED

    (3) Labels. (i) Where DBCP or products containing DBCP are sold, 
distributed or otherwise leave the employer's workplace bearing 
appropriate labels required by EPA under the regulations in 40 CFR Part 
162, the labels required by this paragraph (o)(3) need not be affixed.
    (ii) The employer shall ensure that the precautionary labels 
required by this paragraph (o)(3) are readily visible and legible.
    (iii) Prior to June 1, 2015, employers may include the following 
information on containers of DBCP or products containing DBCP, DBCP-
contaminated protective devices or work clothing or DBCP-contaminated 
portable vacuums in lieu of the labeling requirements in paragraphs 
(j)(2)(v), (k)(l)(iii)(b) and (o)(1)(i) of this section:

DANGER
1,2-Dibromo-3-chloropropane
CANCER HAZARD

    (p) Recordkeeping--(1) Exposure monitoring. (i) The employer shall 
establish and maintain an accurate record of all monitoring required by 
paragraph (f) of this section.
    (ii) This record shall include:
    (a) The dates, number, duration and results of each of the samples 
taken, including a description of the sampling procedure used to 
determine representative employee exposure;
    (b) A description of the sampling and analytical methods used;
    (c) Type of respiratory protective devices worn, if any; and
    (d) Name and job classification of the employee monitored and of all 
other employees whose exposure the measurement is intended to represent.
    (iii) The employer shall maintain this record for at least 40 years 
or 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 required by paragraph (m) of this section.
    (ii) This record shall include:
    (a) The name of the employee;
    (b) A copy of the physician's written opinion;
    (c) Any employee medical complaints related to exposure to DBCP;
    (d) A copy of the information provided the physician as required by 
paragraphs (m)(4)(ii) through (m)(4)(iv) of this section; and
    (e) A copy of the employee's medical and work history.
    (iii) The employer shall maintain this record for at least 40 years 
or the duration of employment plus 20 years, whichever is longer.
    (3) Availability. (i) The employer shall assure that all records 
required to be maintained by this section be made available upon request 
to the Assistant Secretary and the Director for examination and copying.
    (ii) Employee exposure monitoring records and employee medical 
records

[[Page 351]]

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) If the employer ceases to do business, 
the successor employer shall receive and retain all records required to 
be maintained by paragraph (p) of this section for the prescribed 
period.
    (ii) The employer shall also comply with any additional requirements 
involving transfer of records set forth in 29 CFR 1910.1020(h).
    (q) Observation of monitoring--(1) Employee observation. The 
employer shall provide affected employees, or their designated 
representatives, with an opportunity to observe any monitoring of 
employee exposure to DBCP required by this section.
    (2) Observation procedures. (i) Whenever observation of the 
measuring or monitoring of employee exposure to DBCP requires entry into 
an area where the use of protective clothing or equipment is required, 
the employer shall provide the observer with personal protective 
clothing or equipment required to be worn by employees working in the 
area, assure the use of such clothing and equipment, and require the 
observer to comply with all other applicable safety and health 
procedures.
    (ii) Without interfering with the monitoring or measurement, 
observers shall be entitled to:
    (a) Receive an explanation of the measurement procedures;
    (b) Observe all steps related to the measurement of airborne 
concentrations of DBCP performed at the place of exposure; and
    (c) Record the results obtained.
    (r) Appendices. The information contained in the appendices is not 
intended, by itself, to create any additional obligations not otherwise 
imposed or to detract from any existing obligation.

   Appendix A to Sec.  1910.1044--Substance Safety Data Sheet For DBCP

                       i. Substance Identification

    A. Synonyms and trades names: DBCP; Dibromochloropropane; Fumazone 
(Dow Chemical Company TM); Nemafume; Nemagon (Shell Chemical Co. TM); 
Nemaset; BBC 12; and OS 1879.
    B. Permissible exposure:
    1. Airborne. 1 part DBCP vapor per billion parts of air (1 ppb); 
time-weighted average (TWA) for an 8-hour workday.
    2. Dermal. Eye contact and skin contact with DBCP are prohibited.
    C. Appearance and odor: Technical grade DBCP is a dense yellow or 
amber liquid with a pungent odor. It may also appear in granular form, 
or blended in varying concentrations with other liquids.
    D. Uses: DBCP is used to control nematodes, very small worm-like 
plant parasites, on crops including cotton, soybeans, fruits, nuts, 
vegetables and ornamentals.

                         ii. Health Hazard Data

    A. Routes of entry: Employees may be exposed:
    1. Through inhalation (breathing);
    2. Through ingestion (swallowing);
    3. Skin contact; and
    4. Eye contact.
    B. Effects of exposure:
    1. Acute exposure. DBCP may cause drowsiness, irritation of the 
eyes, nose, throat and skin, nausea and vomiting. In addition, 
overexposure may cause damage to the lungs, liver or kidneys.
    2. Chronic exposure. Prolonged or repeated exposure to DBCP has been 
shown to cause sterility in humans. It also has been shown to produce 
cancer and sterility in laboratory animals and has been determined to 
constitute an increased risk of cancer in man.
    3. Reporting Signs and Symptoms. If you develop any of the above 
signs or symptoms that you think are caused by exposure to DBCP, you 
should inform your employer.

                   iii. Emergency First Aid Procedures

    A. Eye exposure. If DBCP liquid or dust containing DBCP gets into 
your eyes, wash your eyes immediately with large amounts of water, 
lifting the lower and upper lids occasionally. Get medical attention 
immediately. Contact lenses should not be worn when working with DBCP.
    B. Skin exposure. If DBCP liquids or dusts containing DBCP get on 
your skin, immediately wash using soap or mild detergent and water. If 
DBCP liquids or dusts containing DBCP penetrate through your clothing, 
remove the clothing immediately and wash. If irritation is present after 
washing get medical attention.
    C. Breathing. If you or any person breathe in large amounts of DBCP, 
move the exposed person to fresh air at once. If breathing has stopped, 
perform artificial respiration. Do not use mouth-to-mouth. Keep the 
affected person warm and at rest. Get medical attention as soon as 
possible.

[[Page 352]]

    D. Swallowing. When DBCP has been swallowed and the person is 
conscious, give the person large amounts of water immediately. After the 
water has been swallowed, try to get the person to vomit by having him 
touch the back of his throat with his finger. Do not make an unconscious 
person vomit. Get medical attention immediately.
    E. Rescue. Notify someone. Put into effect the established emergency 
rescue procedures. Know the locations of the emergency rescue equipment 
before the need arises.

                 iv. Respirators and Protective Clothing

    A. Respirators. You may be required to wear a respirator in 
emergencies and while your employer is in the process of reducing DBCP 
exposures through engineering controls. If respirators are worn, they 
must have a National Institute for Occupational Safety and Health 
(NIOSH) approval label (Older respirators may have a Bureau of Mines 
Approval label). For effective protection, a respirator must fit your 
face and head snugly. The respirator should not be loosened or removed 
in work situations where its use is required. DBCP does not have a 
detectable odor except at 1,000 times or more above the permissible 
exposure limit. If you can smell DBCP while wearing a respirator, the 
respirator is not working correctly; go immediately to fresh air. If you 
experience difficulty breathing while wearing a respirator, tell your 
employer.
    B. Protective clothing. When working with DBCP you must wear for 
your protection impermeable work clothing provided by your employer. 
(Standard rubber and neoprene protective clothing do not offer adequate 
protection).
    DBCP must never be allowed to remain on the skin. Clothing and shoes 
must not be allowed to become contaminated with DBCP, and if they do, 
they must be promptly removed and not worn again until completely free 
of DBCP. Turn in impermeable clothing that has developed leaks for 
repair or replacement.
    C. Eye protection. You must wear splash-proof safety goggles where 
there is any possibility of DBCP liquid or dust contacting your eyes.

           v. Precautions for Safe Use, Handling, and Storage

    A. DBCP must be stored in tightly closed containers in a cool, well-
ventilated area.
    B. If your work clothing may have become contaminated with DBCP, or 
liquids or dusts containing DBCP, you must change into uncontaminated 
clothing before leaving the work premises.
    C. You must promptly remove any protective clothing that becomes 
contaminated with DBCP. This clothing must not be reworn until the DBCP 
is removed from the clothing.
    D. If your skin becomes contaminated with DBCP, you must immediately 
and thoroughly wash or shower with soap or mild detergent and water to 
remove any DBCP from your skin.
    E. You must not keep food, beverages, cosmetics, or smoking 
materials, nor eat or smoke, in regulated areas.
    F. If you work in a regulated area, you must wash your hands 
thoroughly with soap or mild detergent and water, before eating, smoking 
or using toilet facilities.
    G. If you work in a regulated area, you must remove any protective 
equipment or clothing before leaving the regulated area.
    H. Ask your supervisor where DBCP is used in your work area and for 
any additional safety and health rules.

                        vi. Access to Information

    A. Each year, your employer is required to inform you of the 
information contained in this Substance Safety Data Sheet for DBCP. In 
addition, your employer must instruct you in the safe use of DBCP, 
emergency procedures, and the correct use of protective equipment.
    B. Your employer is required to determine whether you are being 
exposed to DBCP. You or your representative have the right to observe 
employee exposure measurements and to record the result obtained. Your 
employer is required to inform you of your exposure. If your employer 
determines that you are being overexposed, he is required to inform you 
of the actions which are being taken to reduce your exposure.
    C. Your employer is required to keep records of your exposure and 
medical examinations. Your employer is required to keep exposure and 
medical data for at least 40 years or the duration of your employment 
plus 20 years, whichever is longer.
    D. Your employer is required to release exposure and medical records 
to you, your physician, or other individual designated by you upon your 
written request.

 Appendix B to Sec.  1910.1044--Substance Technical Guidelines for DBCP

                      i. Physical and Chemical Data

    A. Substance Identification
    1. Synonyms: 1,2-dibromo-3-chloropropane; DBCP, Fumazone; Nemafume; 
Nemagon; Nemaset; BBC 12; OS 1879. DBCP is also included in agricultural 
pesticides and fumigants which include the phrase ``Nema--'' in their 
name.
    2. Formula: C3H5Br2 C1.
    3. Molecular Weight: 236.
    B. Physical Data:
    1. Boiling point (760 mm HG): 195C (383F)
    2. Specific gravity (water = 1): 2.093.

[[Page 353]]

    3. Vapor density (air = 1 at boiling point of DBCP): Data not 
available.
    4. Melting point: 6C (43F).
    5. Vapor pressure at 20C (68F): 0.8 mm Hg
    6. Solubility in water: 1000 ppm.
    7. Evaporation rate (Butyl Acetate = 1): very much less than 1.
    8. Appearance and odor: Dense yellow or amber liquid with a pungent 
odor at high concentrations. Any detectable odor of DBCP indicates 
overexposure.

              ii. Fire Explosion and Reactivity Hazard Data

    A. Fire
    1. Flash point: 170F (77C)
    2. Autoignition temperature: Data not available.
    3. Flammable limits in air, percent by volume: Data not available.
    4. Extinguishing media: Carbon dioxide, dry chemical.
    5. Special fire-fighting procedures: Do not use a solid stream of 
water since a stream will scatter and spread the fire. Use water spray 
to cool containers exposed to a fire.
    6. Unusual fire and explosion hazards: None known.
    7. For purposes of complying with the requirements of Sec.  
1910.106, liquid DBCP is classified as a Category 4 flammable liquid.
    8. For the purpose of complying with Sec.  1910.309, the 
classification of hazardous locations as described in article 500 of the 
National Electrical Code for DBCP shall be Class I, Group D.
    9. For the purpose of compliance with Sec.  1910.157, DBCP is 
classified as a Class B fire hazard.
    10. For the purpose of compliance with Sec.  1910.178, locations 
classified as hazardous locations due to the presence of DBCP shall be 
Class I, Group D.
    11. Sources of ignition are prohibited where DBCP presents a fire or 
explosion hazard.
    B. Reactivity
    1. Conditions contributing to instability: None known.
    2. Incompatibilities: Reacts with chemically active metals, such as 
aluminum, magnesium and tin alloys.
    3. Hazardous decomposition products: Toxic gases and vapors (such as 
HBr, HCl and carbon monoxide) may be released in a fire involving DBCP.
    4. Special precautions: DBCP will attack some rubber materials and 
coatings.

                iii. Spill, Leak and Disposal Procedures

    A. If DBCP is spilled or leaked, the following steps should be 
taken:
    1. The area should be evacuated at once and re-entered only after 
thorough ventilation.
    2. Ventilate area of spill or leak.
    3. If in liquid form, collect for reclamation or absorb in paper, 
vermiculite, dry sand, earth or similar material.
    4. If in solid form, collect spilled material in the most convenient 
and safe manner for reclamation or for disposal.
    B. Persons not wearing protective equipment must be restricted from 
areas of spills or leaks until cleanup has been completed.
    C. Waste Disposal Methods:
    1. For small quantities of liquid DBCP, absorb on paper towels, 
remove to a safe place (such as a fume hood) and burn the paper. Large 
quantities can be reclaimed or collected and atomized in a suitable 
combustion chamber equipped with an appropriate effluent gas cleaning 
device. If liquid DBCP is absorbed in vermiculite, dry sand, earth or 
similar material and placed in sealed containers it may be disposed of 
in a State-approved sanitary landfill.
    2. If in solid form, for small quantities, place on paper towels, 
remove to a safe place (such as a fume hood) and burn. Large quantities 
may be reclaimed. However, if this is not practical, dissolve in a 
flammable solvent (such as alcohol) and atomize in a suitable combustion 
chamber equipped with an appropriate effluent gas cleaning device. DBCP 
in solid form may also be disposed in a state-approved sanitary 
landfill.

                iv. Monitoring and Measurement Procedures

    A. Exposure above the permissible exposure limit.
    1. Eight Hour Exposure Evaluation: Measurements taken for the 
purpose of determining employee exposure under this section are best 
taken so that the average 8-hour exposure may be determined from a 
single 8-hour sample or two (2) 4-hour samples. Air samples should be 
taken in the employee's breathing zone (air that would most nearly 
represent that inhaled by the employee).
    2. Monitoring Techniques: The sampling and analysis under this 
section may be performed by collecting the DBCP vapor on petroleum based 
charcoal absorption tubes with subsequent chemical analyses. The method 
of measurement chosen should determine the concentration of airborne 
DBCP at the permissible exposure limit to an accuracy of plus or minus 
25 percent. If charcoal tubes are used, a total volume of 10 liters 
should be collected at a flow rate of 50 cc. per minute for each tube. 
Analyze the resultant samples as you would samples of halogenated 
solvent.
    B. Since many of the duties relating to employee protection are 
dependent on the results of monitoring and measuring procedures, 
employers should assure that the evaluation of employee exposures is 
performed by a competent industrial hygienist or other technically 
qualified person.

[[Page 354]]

                         v. Protective Clothing

    Employees should be required to wear appropriate protective clothing 
to prevent any possibility of skin contact with DBCP. Because DBCP is 
absorbed through the skin, it is important to prevent skin contact with 
both liquid and solid forms of DBCP. Protective clothing should include 
impermeable coveralls or similar fullbody work clothing, gloves, 
headcoverings, and workshoes or shoe coverings. Standard rubber and 
neoprene gloves do not offer adequate protection and should not be 
relied upon to keep DBCP off the skin. DBCP should never be allowed to 
remain on the skin. Clothing and shoes should not be allowed to become 
contaminated with the material, and if they do, they should be promptly 
removed and not worn again until completely free of the material. Any 
protective clothing which has developed leaks or is otherwise found to 
be defective should be repaired or replaced. Employees should also be 
required to wear splash-proof safety goggles where there is any 
possibility of DBCP contacting the eyes.

                 vi. Housekeeping and Hygiene Facilities

    1. The workplace must be kept clean, orderly and in a sanitary 
condition;
    2. Dry sweeping and the use of compressed air is unsafe for the 
cleaning of floors and other surfaces where DBCP dust or liquids are 
found. To minimize the contamination of air with dust, vacuuming with 
either portable or permanent systems must be used. If a portable unit is 
selected, the exhaust must be attached to the general workplace exhaust 
ventilation system, or collected within the vacuum unit equipped with 
high efficiency filters or other appropriate means of contamination 
removal and not used for other purposes. Units used to collect DBCP must 
be labeled.
    3. Adequate washing facilities with hot and cold water must be 
provided, and maintained in a sanitary condition. Suitable cleansing 
agents should also be provided to assure the effective removal of DBCP 
from the skin.
    4. Change or dressing rooms with individual clothes storage 
facilities must be provided to prevent the contamination of street 
clothes with DBCP. Because of the hazardous nature of DBCP, contaminated 
protective clothing must be stored in closed containers for cleaning or 
disposal.

                     vii. Miscellaneous Precautions

    A. Store DBCP in tightly closed containers in a cool, well 
ventilated area.
    B. Use of supplied-air suits or other impervious clothing (such as 
acid suits) may be necessary to prevent skin contact with DBCP. 
Supplied-air suits should be selected, used, and maintained under the 
supervision of persons knowlegeable in the limitations and potential 
life-endangering characteristics of supplied-air suits.
    C. The use of air-conditioned suits may be necessary in warmer 
climates.
    D. Advise employees of all areas and operations where exposure to 
DBCP could occur.

                         viii. Common Operations

    Common operations in which exposure to DBCP is likely to occur are: 
during its production; and during its formulation into pesticides and 
fumigants.

 Appendix C to Sec.  1910.1044--Medical Surveillance Guidelines For DBCP

                            i. Route of Entry

    Inhalation; skin absorption

                             ii. Toxicology

    Recent data collected on workers involved in the manufacture and 
formulation of DBCP has shown that DBCP can cause sterility at very low 
levels of exposure. This finding is supported by studies showing that 
DBCP causes sterility in animals. Chronic exposure to DBCP resulted in 
pronounced necrotic action on the parenchymatous organs (i.e., liver, 
kidney, spleen) and on the testicles of rats at concentrations as low as 
5 ppm. Rats that were chronically exposed to DBCP also showed changes in 
the composition of the blood, showing low RBC, hemoglobin, and WBC, and 
high reticulocyte levels as well as functional hepatic disturbance, 
manifesting itself in a long prothrombin time. Reznik et al. noted a 
single dose of 100 mg produced profound depression of the nervous system 
of rats. Their condition gradually improved. Acute exposure also 
resulted in the destruction of the sex gland activity of male rats as 
well as causing changes in the estrous cycle in female rats. Animal 
studies have also associated DBCP with an increased incidence of 
carcinoma. Olson, et al. orally administered DBCP to rats and mice 5 
times per week at experimentally predetermined maximally tolerated doses 
and at half those doses. As early as ten weeks after initiation of 
treatment, DBCP induced a high incidence of squamous cell carcinomas of 
the stomach with metastases in both species. DBCP also induced mammary 
adenocarcinomas in the female rats at both dose levels.

                         iii. Signs and Symptoms

    A. Inhalation: Nausea, eye irritation, conjunctivitis, respiratory 
irritation, pulmonary congestion or edema, CNS depression with apathy, 
sluggishness, and ataxia.
    B. Dermal: Erythema or inflammation and dermatitis on repeated 
exposure.

[[Page 355]]

                            iv. Special Tests

    A. Semen analysis: The following information excerpted from the 
document ``Evaluation of Testicular Function'', submitted by the 
Corporate Medical Department of the Shell Oil Company (exhibit 39-3), 
may be useful to physicians conducting the medical surveillance program;
    In performing semen analyses certain minimal but specific criteria 
should be met:
    1. It is recommended that a minimum of three valid semen analyses be 
obtained in order to make a determination of an individual's average 
sperm count.
    2. A period of sexual abstinence is necessary prior to the 
collection of each masturbatory sample. It is recommended that 
intercourse or masturbation be performed 48 hours before the actual 
specimen collection. A period of 48 hours of abstinence would follow; 
then the masturbatory sample would be collected.
    3. Each semen specimen should be collected in a clean, widemouthed, 
glass jar (not necessarily pre-sterilized) in a manner designated by the 
examining physician. Any part of the seminal fluid exam should be 
initialed only after liquifaction is complete, i.e., 30 to 45 minutes 
after collection.
    4. Semen volume should be measured to the nearest \1/10\ of a cubic 
centimeter.
    5. Sperm density should be determined using routine techniques 
involving the use of a white cell pipette and a hemocytometer chamber. 
The immobilizing fluid most effective and most easily obtained for this 
process is distilled water.
    6. Thin, dry smears of the semen should be made for a morphologic 
classification of the sperm forms and should be stained with either 
hematoxalin or the more difficult, yet more precise, Papanicolaou 
technique. Also of importance to record is obvious sperm agglutination, 
pyospermia, delayed liquifaction (greater than 30 minutes), and 
hyperviscosity. In addition, pH, using nitrazine paper, should be 
determined.
    7. A total morphology evaluation should include percentages of the 
following:
    a. Normal (oval) forms,
    b. Tapered forms,
    c. Amorphous forms (include large and small sperm shapes),
    d. Duplicated (either heads or tails) forms, and
    e. Immature forms.
    8. Each sample should be evaluated for sperm viability (percent 
viable sperm moving at the time of examination) as well as sperm 
motility (subjective characterization of ``purposeful forward sperm 
progression'' of the majority of those viable sperm analyzed) within two 
hours after collection, ideally by the same or equally qualified 
examiner.
    B. Serum determinations: The following serum determinations should 
be performed by radioimmuno-assay techniques using National Institutes 
of Health (NIH) specific antigen or antigen preparations of equivalent 
sensitivity:
    1. Serum follicle stimulating hormone (FSH);
    2. Serum luteinizing hormone (LH); and
    3. Serum total estrogen (females only).

                              v. Treatment

    Remove from exposure immediately, give oxygen or artificial 
resuscitation if indicated. Contaminated clothing and shoes should be 
removed immediately. Flush eyes and wash contaminated skin. If swallowed 
and the person is conscious, induce vomiting. Recovery from mild 
exposures is usually rapid and complete.

             vi. Surveillance and Preventive Considerations

    A. Other considerations. DBCP can cause both acute and chronic 
effects. It is important that the physician become familiar with the 
operating conditions in which exposure to DBCP occurs. Those with 
respiratory disorders may not tolerate the wearing of negative pressure 
respirators.
    B. Surveillance and screening. Medical histories and laboratory 
examinations are required for each employee subject to exposure to DBCP. 
The employer should screen employees for history of certain medical 
conditions (listed below) which might place the employee at increased 
risk from exposure.
    1. Liver disease. The primary site of biotransformation and 
detoxification of DBCP is the liver. Liver dysfunctions likely to 
inhibit the conjugation reactions will tend to promote the toxic actions 
of DBCP. These precautions should be considered before exposing persons 
with impaired liver function to DBCP.
    2. Renal disease. Because DBCP has been associated with injury to 
the kidney it is important that special consideration be given to those 
with possible impairment of renal function.
    3. Skin desease. DBCP can penetrate the skin and can cause erythema 
on prolonged exposure. Persons with pre-existing skin disorders may be 
more susceptible to the effects of DBCP.
    4. Blood dyscrasias. DBCP has been shown to decrease the content of 
erythrocytes, hemoglobin, and leukocytes in the blood, as well as 
increase the prothrombin time. Persons with existing blood disorders may 
be more susceptible to the effects of DBCP.
    5. Reproductive disorders. Animal studies have associated DBCP with 
various effects on the reproductive organs. Among these effects are 
atrophy of the testicles and changes in the estrous cycle. Persons with 
pre-existing reproductive disorders may be at increased risk to these 
effects of DBCP.

[[Page 356]]

                               References

    1. Reznik, Ya. B. and Sprinchan, G. K.: Experimental Data on the 
Gonadotoxic effect of Nemagon, Gig. Sanit., (6), 1975, pp. 101-102, 
(translated from Russian).
    2. Faydysh, E. V., Rakhmatullaev, N. N. and Varshavskii, V. A.: The 
Cytotoxic Action of Nemagon in a Subacute Experiment, Med. Zh. 
Uzbekistana, (No. 1), 1970, pp. 64-65, (translated from Russian).
    3. Rakhmatullaev, N. N.: Hygienic Characteristics of the Nematocide 
Nemagon in Relation to Water Pollution Control, Hyg. Sanit., 36(3), 
1971, pp. 344-348, (translated from Russian).
    4. Olson, W. A. et al.: Induction of Stomach Cancer in Rats and Mice 
by Halogenated Aliphatic Fumigants, Journal of the National Cancer 
Institute, (51), 1973, pp. 1993-1995.
    5. Torkelson, T. R. et al.: Toxicologic Investigations of 1,2-
Dibromo-3-chloropropane, Toxicology and Applied Pharmacology, 3, 1961 
pp. 545-559.

[43 FR 11527, Mar. 17, 1978, as amended at 45 FR 35283, May 23, 1980; 49 
FR 18295, Apr. 30, 1984; 54 FR 24334, June 7, 1989; 58 FR 35310, June 
30, 1993; 61 FR 5508, Feb. 13, 1996; 63 FR 1291, Jan. 8, 1998; 70 FR 
1142, Jan. 5, 2005; 71 FR 16772, Apr. 3, 2006; 71 FR 50189, Aug. 24, 
2006; 73 FR 75586, Dec. 12, 2008; 76 FR 33609, June 8, 2011; 77 FR 
17782, Mar. 26, 2012; 78 FR 9313, Feb. 8, 2013]



Sec.  1910.1045  Acrylonitrile.

    (a) Scope and application. (1) This section applies to all 
occupational exposures to acrylonitrile (AN), Chemical Abstracts Service 
Registry No. 000107131, except as provided in paragraphs (a)(2) and 
(a)(3) of this section.
    (2) This section does not apply to exposures which result solely 
from the processing, use, and handling of the following materials:
    (i) ABS resins, SAN resins, nitrile barrier resins, solid nitrile 
elastomers, and acrylic and modacrylic fibers, when these listed 
materials are in the form of finished polymers, and products fabricated 
from such finished polymers;
    (ii) Materials made from and/or containing AN for which objective 
data is reasonably relied upon to demonstrate that the material is not 
capable of releasing AN in airborne concentrations in excess of 1 ppm as 
an eight (8)-hour time-weighted average, under the expected conditions 
of processing, use, and handling which will cause the greatest possible 
release; and
    (iii) Solid materials made from and/or containing AN which will not 
be heated above 170 [deg]F during handling, use, or processing.
    (3) An employer relying upon exemption under paragraph (a)(2)(ii) 
shall maintain records of the objective data supporting that exemption, 
and of the basis of the employer's reliance on the data, as provided in 
paragraph (q) of this section.
    (b) Definitions. Acrylonitrile or AN means acrylonitrile monomer, 
chemical formula CH2 = CHCN.
    Action level means a concentration of AN of 1 ppm as an eight (8)-
hour time-weighted average.
    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 opportunity to observe 
monitoring procedures under paragraph (r) of this section.
    Decontamination means treatment of materials and surfaces by water 
washdown, ventilation, or other means, to assure that the materials will 
not expose employees to airborne concentrations of AN above 1 means the 
Director, National Institute for Occupational Safety and Health, U.S. 
Department of Health and Human Services, or designee.
    Emergency means any occurrence such as, but not limited to, 
equipment failure, rupture of containers, or failure of control 
equipment, which results in an unexpected massive release of AN.
    Liquid AN means AN monomer in liquid form, and liquid or semiliquid 
polymer intermediates, including slurries, suspensions, emulsions, and 
solutions, produced during the polymerization of AN.
    OSHA Area Office means the Area Office of the Occupational Safety 
and Health Administration having jurisdiction over the geographic area 
where the affected workplace is located.
    (c) Permissible exposure limits--(1) Inhalation. (i) Time weighted 
average limit

[[Page 357]]

(TWA). The employer shall assure that no employee is exposed to an 
airborne concentration of acrylonitrile in excess of two (2) parts 
acrylonitrile per million parts of air (2 ppm) as an eight (8)-hour 
time-weighted average.
    (ii) Ceiling limit. The employer shall assure that no employee is 
exposed to an airborne concentration of acrylonitrile in excess of ten 
(10) ppm as averaged over any fifteen (15)-minute period during the work 
day.
    (2) Dermal and eye exposure. The employer shall assure that no 
employee is exposed to skin contact or eye contact with liquid AN.
    (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 AN 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.
    (2) Initial monitoring. Each employer who has a place of employment 
in which AN is present shall monitor each such workplace and work 
operation to accurately determine the airborne concentrations of AN to 
which employees may be exposed.
    (3) Frequency. (i) If the monitoring required by this section 
reveals employee exposure to be below the action level, the employer may 
discontinue monitoring for that employee.
    (ii) If the monitoring required by this section reveals employee 
exposure to be at or above the action level but at or below the 
permissible exposure limits, the employer must repeat such monitoring 
for each such employee at least every 6 months. The employer must 
continue these measurements every 6 months until at least two 
consecutive measurements taken at least seven (7) days a part, are below 
the action level, and thereafter the employer may discontinue monitoring 
for that employee.
    (iii) If the monitoring required by this section reveals employee 
exposure to be in excess of the permissible exposure limits, the 
employer must repeat these determinations for each such employee at 
least quarterly. The employer must continue these quarterly measurements 
until at least two consecutive measurements, taken at least seven (7) 
days apart, are at or below the permissible exposure limits, and 
thereafter the employer must monitor at least every 6 months.
    (4) Additional monitoring. Whenever there has been a production, 
process, control, or personnel change which may result in new or 
additional exposures to AN, or whenever the employer has any other 
reason to suspect a change which may result in new or additional 
exposures to AN, additional monitoring which complies with this 
paragraph 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 employees.
    (ii) Whenever the results indicate that the representative employee 
exposure exceeds the permissible exposure limits, the employer shall 
include in the written notice a statement that the permissible exposure 
limits were exceeded and a description of the corrective action being 
taken to reduce exposure to or below the permissible exposure limits.
    (6) Accuracy of measurement. The method of measurement of employee 
exposures shall be accurate to a confidence level of 95 percent, to 
within plus or minus 35 percent for concentrations of AN at or above the 
permissible exposure limits, and plus or minus 50 percent for 
concentrations of AN below the permissible exposure limits.
    (f) Regulated areas. (1) The employer shall establish regulated 
areas where AN concentrations are in excess of the permissible exposure 
limits.
    (2) 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 AN.
    (3) Access to regulated areas shall be limited to authorized persons 
or to persons otherwise authorized by the act or regulations issued 
pursuant thereto.

[[Page 358]]

    (4) The employer shall assure that food or beverages are not present 
or consumed, tobacco products are not present or used, and cosmetics are 
not applied in the regulated area.
    (g) Methods of compliance--(1) Engineering and work practice 
controls. (i) By November 2, 1980, the employer shall institute 
engineering and work practice controls to reduce and maintain employee 
exposures to AN, to or below the permissible exposure limits, except to 
the extent that the employer establishes that such controls are not 
feasible.
    (ii) Wherever the engineering and work practice controls which can 
be instituted are not sufficient to reduce employee exposures to or 
below the permissible exposure limits, the employer shall nonetheless 
use them to reduce exposures to the lowest levels achievable by these 
controls, and shall supplement them by the use of respiratory protection 
which complies with the requirements of paragraph (h) of this section.
    (2) Compliance program. (i) The employer shall establish and 
implement a written program to reduce employee exposures to or below the 
permissible exposure limits solely by means of engineering and work 
practice controls, as required by paragraph (g)(1) of this section.
    (ii) Written plans for these compliance programs shall include at 
least the following:
    (A) A description of each operation or process resulting in employee 
exposure to AN above the permissible exposure limits;
    (B) An outline of the nature of the engineering controls and work 
practices to be applied to the operation or process in question;
    (C) A report of the technology considered in meeting the permissible 
exposure limits;
    (D) A schedule for implementation of engineering and work practice 
controls for the operation or process, which shall project completion no 
later than November 2, 1980; and
    (E) Other relevant information.
    (iii) The employer shall complete the steps set forth in the 
compliance program by the dates in the schedule.
    (iv) Written plans 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, the Director, or any 
affected employee or representative.
    (v) 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 
and work-practice controls.
    (ii) Work operations, such as maintenance and repair activities or 
reactor cleaning, for which the employer establishes that 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 permissible exposure limits.
    (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), (d)(3)(iii)(b)(1), and (2)), and (f) 
through (m), which covers each employee required by this section to use 
a respirator.
    (ii) If air-purifying respirators (chemical-cartridge or chemical-
canister types) are used:
    (A) The air-purifying canister or cartridge must be replaced prior 
to the expiration of its service life or at the completion of each 
shift, whichever occurs first.
    (B) A label must be attached to the cartridge or canister to 
indicate the date and time at which it is first installed on the 
respirator.
    (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.

[[Page 359]]

    (ii) For escape, provide employees with any organic vapor respirator 
or any self-contained breathing apparatus permitted for use under 
paragraph (h)(3)(i) of this standard.
    (i) Emergency situations--(1) Written plans. (i) A written plan for 
emergency situations shall be developed for each workplace where liquid 
AN is present. Appropriate portions of the plan shall be implemented in 
the event of an emergency.
    (ii) The plan shall specifically provide that employees engaged in 
correcting emergency conditions shall be equipped as required in 
paragraph (h) of this section until the emergency is abated.
    (iii) Employees not engaged in correcting the emergency shall be 
evacuated from the area and shall not be permitted to return until the 
emergency is abated.
    (2) Alerting employees. Where there is the possibility of employee 
exposure to AN in excess of the ceiling limit, a general alarm shall be 
installed and used to promptly alert employees of such occurrences.
    (j) Protective clothing and equipment--(1) Provision and use. Where 
eye or skin contact with liquid AN may occur, the employer shall provide 
at no cost to the employee, and assure that employees wear, impermeable 
protective clothing or other equipment to protect any area of the body 
which may come in contact with liquid AN. The provision of Sec. Sec.  
1910.132 and 1910.133 shall be complied with.
    (2) Cleaning and replacement. (i) The employer shall clean, launder, 
maintain, or replace protective clothing and equipment required by this 
section as needed to maintain their effectiveness.
    (ii) The employer shall assure that impermeable protective clothing 
which contacts or is likely to have contacted liquid AN shall be 
decontaminated before being removed by the employee.
    (iii) The employer shall assure that an employee whose 
nonimpermeable clothing becomes wetted with liquid AN shall immediately 
remove that clothing and proceed to shower. The clothing shall be 
decontaminated before it is removed from the regulated area.
    (iv) The employer shall assure that no employee removes protective 
clothing or equipment from the change room, except for those employees 
authorized to do so for the purpose of laundering, maintenance, or 
disposal.
    (v) The employer shall inform any person who launders or cleans 
protective clothing or equipment of the potentially harmful effects of 
exposure to AN.
    (k) Housekeeping. (1) All surfaces shall be maintained free of 
visible accumulations of liquid AN.
    (2) For operations involving liquid AN, the employer shall institute 
a program for detecting leaks and spills of liquid AN, including regular 
visual inspections.
    (3) Where spills of liquid AN are detected, the employer shall 
assure that surfaces contacted by the liquid AN are decontaminated. 
Employees not engaged in decontamination activities shall leave the area 
of the spill, and shall not be permitted in the area until 
decontamination is completed.
    (l) Waste disposal. AN waste, scrap, debris, bags, containers, or 
equipment shall be decontaminated before being incorporated in the 
general waste disposal system.
    (m) Hygiene facilities and practices. (1) Where employees are 
exposed to airborne concentrations of AN above the permissible exposure 
limits, or where employees are required to wear protective clothing or 
equipment pursuant to paragraph (j) of this section, the facilities 
required by 29 CFR 1910.141, including clean change rooms and shower 
facilities, shall be provided by the employer for the use of those 
employees, and the employer shall assure that the employees use the 
facilities provided.
    (2) The employer shall assure that employees wearing protective 
clothing or equipment for protection from skin contact with liquid AN 
shall shower at the end of the work shift.
    (3) The employer shall assure that, in the event of skin or eye 
exposure to liquid AN, the affected employee shall shower immediately to 
minimize the danger of skin absorption.
    (4) The employer shall assure that employees working in the 
regulated area wash their hands and faces prior to eating.

[[Page 360]]

    (n) Medical surveillance--(1) General. (i) The employer shall 
institute a program of medical surveillance for each employee who is or 
will be exposed to AN at or above the action level, without regard to 
the use of respirators. The employer shall provide each such employee 
with an opportunity for medical examinations and tests in accordance 
with this paragraph.
    (ii) The employer shall assure that all medical examinations and 
procedures are performed by or under the supervision of a licensed 
physician, and that they shall be provided without cost to the employee.
    (2) Initial examinations. At the time of initial assignment, or upon 
institution of the medical surveillance program, the employer shall 
provide each affected employee an opportunity for a medical examination, 
including at least the following elements:
    (i) A work history and medical history with special attention to 
skin, respiratory, and gastrointestinal systems, and those nonspecific 
symptoms, such as headache, nausea, vomiting, dizziness, weakness, or 
other central nervous system dysfunctions that may be associated with 
acute or with chronic exposure to AN;
    (ii) A complete physical examination giving particular attention to 
the peripheral and central nervous system, gastrointestinal system, 
respiratory system, skin, and thyroid;
    (iii) A 14- by 17-inch or other reasonably-sized standard film or 
digital posterior-anterior chest X-ray; and
    (iv) Further tests of the intestinal tract, including fecal occult 
blood screening, for all workers 40 years of age or older, and for any 
other affected employees for whom, in the opinion of the physician, such 
testing is appropriate.
    (3) Periodic examinations. (i) The employer shall provide the 
examinations specified in paragraphs (n)(2)(i), (ii), and (iv) of this 
section at least annually for all employees specified in paragraph 
(n)(1) of this section.
    (ii) If an employee has not had the examination specified in 
paragraphs (n)(2)(i), (ii), and (iv) of this section within 6 months 
preceding termination of employment, the employer shall make such 
examination available to the employee prior to such termination.
    (4) Additional examinations. If the employee for any reason develops 
signs or symptoms which may be associated with exposure to AN, 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 appendixes;
    (ii) A description of the affected employee's duties as they relate 
to the employee's exposure;
    (iii) The employee's representative exposure level;
    (iv) The employee's anticipated or estimated exposure level (for 
preplacement examinations or in cases of exposure due to an emergency);
    (v) A description of any personal protective equipment used or to be 
used; and
    (vi) Information from previous medical examinations of the affected 
employee, which is not otherwise 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 test performed;
    (B) The physician's opinion as to whether the employee has any 
detected medical condition(s) which would place the employee at an 
increased risk of material impairment of the employee's health from 
exposure to AN;
    (C) Any recommended limitations upon the employee's exposure to AN 
or upon the use of protective clothing and 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 examination or treatment.
    (ii) The employer shall instruct the physician not to reveal in the 
written opinion specific findings or diagnoses unrelated to occupational 
exposure to AN.

[[Page 361]]

    (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 exposed to AN above the action level, 
each employee whose exposures are maintained below the action level by 
engineering and work practice controls, and each employee subject to 
potential skin or eye contact with liquid AN 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 at the time of initial assignment, 
or upon institution of the training program, and at least annually 
thereafter, and the employer shall assure that each employee is informed 
of the following:
    (A) The information contained in appendixes A and B;
    (B) The quantity, location, manner of use, release, or storage of 
AN, and the specific nature of operations which could result in exposure 
to AN, as well as any necessary protective steps;
    (C) The purpose, proper use, and limitations of respirators and 
protective clothing;
    (D) The purpose and a description of the medical surveillance 
program required by paragraph (n) of this section;
    (E) The emergency procedures developed, as required by paragraph (i) 
of this section;
    (F) Engineering and work practice controls, their function, and the 
employee's relationship to these controls; and
    (G) A review of this standard.
    (2) Access to training materials. (i) The employer shall make a copy 
of this standard and its appendixes readily available to all affected 
employees.
    (ii) The employer shall provide, upon request, all materials 
relating to the employee information and training program to the 
Assistant Secretary and the Director.
    (p) Communication of hazards--(1) Hazard communication--general. (i) 
Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for AN and AN-based materials not exempted under 
paragraph (a)(2) of this section.
    (ii) In classifying the hazards of AN and AN-based materials at 
least the following hazards are to be addressed: Cancer; central nervous 
system effects; liver effects; skin sensitization; skin, respiratory, 
and eye irritation; acute toxicity effects; and flammability.
    (iii) Employers shall include AN and AN-based materials in the 
hazard communication program established to comply with the HCS (Sec.  
1910.1200). Employers shall ensure that each employee has access to 
labels on containers of AN and AN-based materials and to safety data 
sheets, and is trained in accordance with the requirements of HCS and 
paragraph (o) of this section.
    (iv) The employer shall ensure that no statement appears on or near 
any sign or label required by this paragraph (p) that contradicts or 
detracts from the required sign or label.
    (2) Signs. (i) The employer shall post signs to clearly indicate all 
workplaces where AN concentrations exceed the permissible exposure 
limits. The signs shall bear the following legend:

DANGER
ACRYLONITRILE (AN)
MAY CAUSE CANCER
RESPIRATORY PROTECTION MAY BE REQURED IN THIS AREA
AUTHORIZED PERSONNEL ONLY

    (ii) The employer shall ensure that signs required by this paragraph 
(p)(2) are illuminated and cleaned as necessary so that the legend is 
readily visible.
    (iii) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (p)(2)(i) of this section:

DANGER
ACRYLONITRILE (AN)
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY
RESPIRATORS MAY BE REQUIRED

    (3) Labels. (i) The employer shall ensure that precautionary labels 
are in compliance with paragraph (p)(1)(i) of this section and are 
affixed to all containers of liquid AN and AN-based materials not 
exempted under paragraph (a)(2) of this section. The employer

[[Page 362]]

shall ensure that the labels remain affixed when the materials are sold, 
distributed, or otherwise leave the employer's workplace.
    (ii) Prior to June 1, 2015, employers may include the following 
information on precautionary labels required by this paragraph (p)(3) in 
lieu of the labeling requirements in paragraph (p)(1) of this section:

DANGER
CONTAINS ACRYLONITRILE (AN)
CANCER HAZARD

    (iii) The employer shall ensure that the precautionary labels 
required by this paragraph (p)(3) are readily visible and legible.
    (q) Recordkeeping--(1) Objective data for exempted operations. (i) 
Where the processing, use, and handling of materials made from or 
containing AN are exempted pursuant to paragraph (a)(2)(ii) of this 
section, the employer shall establish and maintain an accurate record of 
objective data reasonably relied upon in support of the exemption.
    (ii) This record shall include at least the following information:
    (A) The material 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 AN;
    (D) A description of the operation exempted and how the data 
supports the exemption; and
    (E) Other data relevant to the operations, materials, and processing 
covered by the exemption.
    (iii) The employer shall maintain this record for the duration of 
the employer's reliance upon such objective data.
    (2) 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 dates, number, duration, and results of each of the samples 
taken, including a description of the sampling procedure used to 
determine representative employee exposure;
    (B) A description of the sampling and analytical methods used and 
the data relied upon to establish that the methods used meet the 
accuracy and precision requirements of paragraph (e)(6) of this section;
    (C) Type of respiratory protective devices worn, if any; and
    (D) Name and job classification of the employee monitored and of all 
other employees whose exposure the measurement is intended to represent.
    (iii) The employer shall maintain this record for at least forty 
(40) years, or for the duration of employment plus twenty (20) years, 
whichever is longer.
    (3) 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) A copy of the physician's written opinions;
    (B) Any employee medical complaints related to exposure to AN;
    (C) A copy of the information provided to the physician as required 
by paragraph (n)(5) of this section; and
    (D) A copy of the employee's medical and work history.
    (iii) The employer shall assure that this record be maintained for 
at least forty (40) years, or for the duration of employment plus twenty 
(20) years, whichever is longer.
    (4) Availability. (i) The employer shall make all records required 
to be maintained by this section available, upon request, to the 
Assistant Secretary and the Director for examination and copying.
    (ii) Records required by paragraphs (q)(1) through (q)(3) of this 
section shall be provided upon request to employees, designated 
representatives, and the Assistant Secretary in accordance with 29 CFR 
1910.1020 (a) through (e) and (q) through (i). Records required by 
paragraph (q)(1) shall be provided in the same manner as exposure 
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 this section for the prescribed period.
    (ii) The employer shall also comply with any additional requirements 
involving transfer of records set forth in 29 CFR 1910.1020(h).

[[Page 363]]

    (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 AN conducted pursuant to paragraph (e) of this section.
    (2) Observation procedures. (i) Whenever observation of the 
monitoring of employee exposure to AN requires entry into an area where 
the use of protective clothing or equipment is required, the employer 
shall provide the observer with personal protective clothing and 
equipment required to be worn by employees working in the area, assure 
the use of such clothing and equipment, and require the observer to 
comply with all other applicable safety and health procedures.
    (ii) Without interfering with the monitoring, observers shall be 
entitled:
    (A) To receive an explanation of the measurement procedures;
    (B) To observe all steps related to the measurement of airborne 
concentrations of AN performed at the place of exposure; and
    (C) To record the results obtained.
    (s) [Reserved]
    (t) Appendixes. The information contained in the appendixes is not 
intended, by itself, to create any additional obligation not otherwise 
imposed, or to detract from any obligation.

     Appendix A to Sec.  1910.1045--Substance Safety Data Sheet for 
                              Acrylonitrile

                       i. Substance Identification

    A. Substance: Acrylonitrile (CH2 CHCN).
    B. Synonyms: Propenenitrile; vinyl cyanide; cyanoethylene; AN; VCN; 
acylon; carbacryl; fumigrian; ventox.
    C. Acrylonitrile can be found as a liquid or vapor, and can also be 
found in polymer resins, rubbers, plastics, polyols, and other polymers 
having acrylonitrile as a raw or intermediate material.
    D. AN is used in the manufacture of acrylic and modiacrylic fibers, 
acrylic plastics and resins, speciality polymers, nitrile rubbers, and 
other organic chemicals. It has also been used as a fumigant.
    E. Appearance and odor: Colorless to pale yellow liquid with a 
pungent odor which can only be detected at concentrations above the 
permissible exposure level, in a range of 13-19 parts AN per million 
parts of air (13-19 ppm).
    F. Permissible exposure: Exposure may not exceed either:
    1. Two parts AN per million parts of air (2 ppm) averaged over the 
8-hour workday; or
    2. Ten parts AN per million parts of air (10 ppm) averaged over any 
15-minute period in the workday.
    3. In addition, skin and eye contact with liquid AN is prohibited.

                         ii. Health Hazard Data

    A. Acrylonitrile can affect your body if you inhale the vapor 
(breathing), if it comes in contact with your eyes or skin, or if you 
swallow it. It may enter your body through your skin.
    B. Effects of overexposure: 1. Short-term exposure: Acrylonitrile 
can cause eye irritation, nausea, vomiting, headache, sneezing, 
weakness, and light-headedness. At high concentrations, the effects of 
exposure may go on to loss of consciousness and death. When 
acrylonitrile is held in contact with the skin after being absorbed into 
shoe leather or clothing, it may produce blisters following several 
hours of no apparent effect. Unless the shoes or clothing are removed 
immediately and the area washed, blistering will occur. Usually there is 
no pain or inflammation associated with blister formation.
    2. Long-term exposure: Acrylonitrile has been shown to cause cancer 
in laboratory animals and has been associated with higher incidences of 
cancer in humans. Repeated or prolonged exposure of the skin to 
acrylonitrile may produce irritation and dermatitis.
    3. Reporting signs and symptoms: You should inform your employer if 
you develop any signs or symptoms and suspect they are caused by 
exposure to acrylonitrile.

                   iii. Emergency First Aid Procedures

    A. Eye exposure: If acrylonitrile gets into your eyes, wash your 
eyes immediately with large amounts of water, lifting the lower and 
upper lids occasionally. Get medical attention immediately. Contact 
lenses should not be worn when working with this chemical.
    B. Skin exposure: If acrylonitrile gets on your skin, immediately 
wash the contaminated skin with water. If acrylonitrile soaks through 
your clothing, especially your shoes, remove the clothing immediately 
and wash the skin with water. If symptoms occur after washing, get 
medical attention immediately. Thoroughly wash the clothing before 
reusing. Contaminated leather shoes or other leather articles should be 
discarded.
    C. Inhalation: If you or any other person breathes in large amounts 
of acrylonitrile, move the exposed person to fresh air at once. If 
breathing has stopped, perform artificial respiration. Keep the affected 
person warm and at rest. Get medical attention as soon as possible.

[[Page 364]]

    D. Swallowing: When acrylonitrile has been swallowed, give the 
person large quantities of water immediately. After the water has been 
swallowed, try to get the person to vomit by having him touch the back 
of his throat with his finger. Do not make an unconscious person vomit. 
Get medical attention immediately.
    E. Rescue: Move the affected person from the hazardous exposure. If 
the exposed person has been overcome, notify someone else and put into 
effect the established emergency procedures. Do not become a casualty 
yourself. Understand your emergency rescue procedures and know the 
location of the emergency equipment before the need arises.
    F. Special first aid procedures: First aid kits containing an 
adequate supply (at least two dozen) of amyl nitrite pearls, each 
containing 0.3 ml, should be maintained at each site where acrylonitrile 
is used. When a person is suspected of receiving an overexposure to 
acrylonitrile, immediately remove that person from the contaminated area 
using established rescue procedures. Contaminated clothing must be 
removed and the acrylonitrile washed from the skin immediately. 
Artificial respiration should be started at once if breathing has 
stopped. If the person is unconscious, amyl nitrite may be used as an 
antidote by a properly trained individual in accordance with established 
emergency procedures. Medical aid should be obtained immediately.

                 iv. Respirators and Protective Clothing

    A. Respirators. You may be required to wear a respirator for 
nonroutine activities, in emergencies, while your employer is in the 
process of reducing acrylonitrile exposures through engineering 
controls, and in areas where engineering controls are not feasible. If 
respirators are worn, they must have a label issued by the National 
Institute for Occupational Safety and Health under the provisions of 42 
CFR part 84 stating that the respirators have been approved for use with 
organic vapors. For effective protection, respirators must fit your face 
and head snugly. Respirators must not be loosened or removed in work 
situations where their use is required.
    Acrylonitrile does not have a detectable odor except at levels above 
the permissible exposure limits. Do not depend on odor to warn you when 
a respirator cartridge or canister is exhausted. Cartridges or canisters 
must be changed daily or before the end-of-service-life, whichever comes 
first. Reuse of these may allow acrylonitrille to gradually filter 
through the cartridge and cause exposures which you cannot detect by 
odor. If you can smell acrylonitrile while wearing a respirator, proceed 
immediately to fresh air. If you experience difficulty breathing while 
wearing a respirator, tell your employer.
    B. Supplied-air suits: In some work situations, the wearing of 
supplied-air suits may be necessary. Your employer must instruct you in 
their proper use and operation.
    C. Protective clothing: You must wear impervious clothing, gloves, 
face shield, or other appropriate protective clothing to prevent skin 
contact with liquid acrylonitrile. Where protective clothing is 
required, your employer is required to provide clean garments to you as 
necessary to assume that the clothing protects you adequately.
    Replace or repair impervious clothing that has developed leaks.
    Acrylonitrile should never be allowed to remain on the skin. 
Clothing and shoes which are not impervious to acrylonitrile should not 
be allowed to become contaminated with acrylonitrile, and if they do the 
clothing and shoes should be promptly removed and decontaminated. The 
clothing should be laundered or discarded after the AN is removed. Once 
acrylonitrile penetrates shoes or other leather articles, they should 
not be worn again.
    D. Eye protection: You must wear splashproof safety goggles in areas 
where liquid acrylonitrile may contact your eyes. In addition, contact 
lenses should not be worn in areas where eye contact with acrylonitrile 
can occur.

           v. Precautions for Safe Use, Handling, and Storage

    A. Acrylonitrile is a flammable liquid, and its vapors can easily 
form explosive mixtures in air.
    B. Acrylonitrile must be stored in tightly closed containers in a 
cool, well-ventilated area, away from heat, sparks, flames, strong 
oxidizers (especially bromine), strong bases, copper, copper alloys, 
ammonia, and amines.
    C. Sources of ignition such as smoking and open flames are 
prohibited wherever acrylonitrile is handled, used, or stored in a 
manner that could create a potential fire or explosion hazard.
    D. You should use non-sparking tools when opening or closing metal 
containers of acrylonitrile, and containers must be bonded and grounded 
when pouring or transferring liquid acrylonitrile.
    E. You must immediately remove any non-impervious clothing that 
becomes wetted with acrylonitrile, and this clothing must not be reworn 
until the acrylonitrile is removed from the clothing.
    F. Impervious clothing wet with liquid acrylonitrile can be easily 
ignited. This clothing must be washed down with water before you remove 
it.
    G. If your skin becomes wet with liquid acrylonitrile, you must 
promptly and thoroughly wash or shower with soap or mild detergent to 
remove any acrylonitrile from your skin.

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    H. You must not keep food, beverages, or smoking materials, nor are 
you permitted to eat or smoke in regulated areas where acrylonitrile 
concentrations are above the permissible exposure limits.
    I. If you contact liquid acrylonitrile, you must wash your hands 
thoroughly with soap or mild detergent and water before eating, smoking, 
or using toilet facilities.
    J. Fire extinguishers and quick drenching facilities must be readily 
available, and you should know where they are and how to operate them.
    K. Ask your supervisor where acrylonitrile is used in your work area 
and for any additional plant safety and health rules.

                        vi. Access to Information

    A. Each year, your employer is required to inform you of the 
information contained in this Substance Safety Data Sheet for 
acrylonitrile. In addition, you employer must instruct you in the proper 
work practices for using acrylonitrile, emergency procedures, and the 
correct use of protective equipment.
    B. Your employer is required to determine whether you are being 
exposed to acrylonitrile. You or your representative has the right to 
observe employee measurements and to record the results obtained. Your 
employer is required to inform you of your exposure. If your employer 
determines that you are being overexposed, he or she is required to 
inform you of the actions which are being taken to reduce your exposure 
to within permissible exposure limits.
    C. Your employer is required to keep records of your exposures and 
medical examinations. These records must be kept by the employer for at 
least forty (40) years or for the period of your employment plus twenty 
(20) years, whichever is longer.
    D. Your employer is required to release your exposure and medical 
records to you or your representative upon your request.

   Appendix B to Sec.  1910.1045--Substance Technical Guidelines for 
                              Acrylonitrile

                      i. Physical and Chemical Data

    A. Substance identification: 1. Synonyms: AN; VCN; vinyl cyanide; 
propenenitrile; cyanoethylene; Acrylon; Carbacryl; Fumigrain; Ventox.
    2. Formula: CH2 = CHCN.
    3. Molecular weight: 53.1.
    B. Physical data: 1. Boiling point (760 mm Hg): 77.3 [deg]C (171 
[deg]F);
    2. Specific gravity (water = 1): 0.81 (at 20 [deg]C or 68 [deg]F);
    3. Vapor density (air = 1 at boiling point of acrylonitrile): 1.83;
    4. Melting point: -83 [deg]C (-117 [deg]F);
    5. Vapor pressure (@20 [deg]F): 83 mm Hg;
    6. Solubility in water, percent by weight @20 [deg]C (68 [deg]F): 
7.35;
    7. Evaporation rate (Butyl Acetate = 1): 4.54; and
    8. Appearance and odor: Colorless to pale yellow liquid with a 
pungent odor at concentrations above the permissible exposure level. Any 
detectable odor of acrylonitrile may indicate overexposure.

             ii. Fire, Explosion, and Reactivity Hazard Data

    A. Fire: 1. Flash point: -1 [deg]C (30 [deg]F) (closed cup).
    2. Autoignition temperature: 481 [deg]C (898 [deg]F).
    3. Flammable limits air, percent by volume: Lower: 3, Upper: 17.
    4. Extinguishing media: Alcohol foam, carbon dioxide, and dry 
chemical.
    5. Special fire-fighting procedures: Do not use a solid stream of 
water, since the stream will scatter and spread the fire. Use water to 
cool containers exposed to a fire.
    6. Unusual fire and explosion hazards: Acrylonitrile is a flammable 
liquid. Its vapors can easily form explosive mixtures with air. All 
ignition sources must be controlled where acrylonitrile is handled, 
used, or stored in a manner that could create a potential fire or 
explosion hazard. Acrylonitrile vapors are heavier than air and may 
travel along the ground and be ignited by open flames or sparks at 
locations remote from the site at which acrylonitrile is being handled.
    7. For purposes of compliance with the requirements of 29 CFR 
1910.106, acrylonitrile is classified as a class IB flammable liquid. 
For example, 7,500 ppm, approximately one-fourth of the lower flammable 
limit, would be considered to pose a potential fire and explosion 
hazard.
    8. For purposes of compliance with 29 CFR 1910.157, acrylonitrile is 
classified as a Class B fire hazard.
    9. For purpose of compliance with 29 CFR 1919.309, locations 
classified as hazardous due to the presence of acrylonitrile shall be 
Class I, Group D.
    B. Reactivity:
    1. Conditions contributing to instability: Acrylonitrile will 
polymerize when hot, and the additional heat liberated by the 
polymerization may cause containers to explode. Pure AN may self-
polymerize, with a rapid build-up of pressure, resulting in an explosion 
hazard. Inhibitors are added to the commercial product to prevent self-
polymerization.
    2. Incompatibilities: Contact with strong oxidizers (especially 
bromine) and strong bases may cause fires and explosions. Contact with 
copper, copper alloys, ammonia, and amines may start serious 
decomposition.
    3. Hazardous decompostion products: Toxic gases and vapors (such as 
hydrogen cyanide, oxides of nitrogen, and carbon monoxide)

[[Page 366]]

may be released in a fire involving acrylonitrile and certain polymers 
made from acrylonitrile.
    4. Special precautions: Liquid acrylonitrile will attack some forms 
of plastics, rubbers, and coatings.

                iii. Spill, Leak, and Disposal Procedures

    A. If acrylonitrile is spilled or leaked, the following steps should 
be taken:
    1. Remove all ignition sources.
    2. The area should be evacuated at once and re-entered only after 
the area has been thoroughly ventilated and washed down with water.
    3. If liquid acrylonitrile or polymer intermediate, collect for 
reclamation or absorb in paper, vermiculite, dry sand, earth, or similar 
material, or wash down with water into process sewer system.
    B. Persons not wearing protective equipment should be restricted 
from areas of spills or leaks until clean-up has been completed.
    C. Waste disposal methods: Waste material shall be disposed of in a 
manner that is not hazardous to employees or to the general population. 
Spills of acrylonitrile and flushing of such spills shall be channeled 
for appropriate treatment or collection for disposal. They shall not be 
channeled directly into the sanitary sewer system. In selecting the 
method of waste disposal, applicable local, State, and Federal 
regulations should be consulted.

                iv. Monitoring and Measurement Procedures

    A. Exposure above the Permissible Exposure Limit:
    1. Eight-hour exposure evaluation: Measurements taken for the 
purpose of determining employee exposure under this section are best 
taken so that the average 8-hour exposure may be determined from a 
single 8-hour sample or two (2) 4-hour samples. Air samples should be 
taken in the employee's breathing zone (air that would most nearly 
represent that inhaled by the employee.)
    2. Ceiling evaluation: Measurements taken for the purpose of 
determining employee exposure under this section must be taken during 
periods of maximum expected airborne concentrations of acrylonitrile in 
the employee's breathing zone. A minimum of three (3) measurements 
should be taken on one work shift. The average of all measurements taken 
is an estimate of the employee's ceiling exposure.
    3. Monitoring techniques: The sampling and analysis under this 
section may be performed by collecting the acrylonitrile vapor on 
charcoal adsorption tubes or other composition adsorption tubes, with 
subsequent chemical analysis. Sampling and analysis may also be 
performed by instruments such as real-time continuous monitoring 
systems, portable direct-reading instruments, or passive dosimeters. 
Analysis of resultant samples should be by gas chromatograph.
    Appendix D lists methods of sampling and analysis which have been 
tested by NIOSH and OSHA for use with acrylonitrile. NIOSH and OSHA have 
validated modifications of NIOSH Method S-156 (See appendix D) under 
laboratory conditions for concentrations below 1 ppm. The employer has 
the obligation of selecting a monitoring method which meets the accuracy 
and precision requirements of the standard under his unique field 
conditions. The standard requires that methods of monitoring must be 
accurate, to a 95-percent confidence level, to 35-
percent for concentrations of AN at or above 2 ppm, and to 50-percent for concentrations below 2 ppm. In addition 
to the methods described in appendix D, there are numerous other methods 
available for monitoring for AN in the workplace. Details on these other 
methods have been submitted by various companies to the rulemaking 
record, and are available at the OSHA Docket Office.
    B. Since many of the duties relating to employee exposure are 
dependent on the results of monitoring and measuring procedures, 
employers shall assure that the evaluation of employee exposures is 
performed by a competent industrial hygienist or other technically 
qualified person.

                         v. Protective Clothing

    Employees shall be provided with and required to wear appropriate 
protective clothing to prevent any possibility of skin contact with 
liquid AN. Because acrylonitrile is absorbed through the skin, it is 
important to prevent skin contact with liquid AN. Protective clothing 
shall include impermeable coveralls or similar full-body work clothing, 
gloves, head-coverings, as appropriate to protect areas of the body 
which may come in contact with liquid AN.
    Employers should ascertain that the protective garmets are 
impermeable to acrylonitrile. Non-impermeable clothing and shoes should 
not be allowed to become contaminated with liquid AN. If permeable 
clothing does become contaminated, it should be promptly removed, placed 
in a regulated area for removal of the AN, and not worn again until the 
AN is removed. If leather footwear or other leather garments become wet 
from acrylonitrile, they should be replaced and not worn again, due to 
the ability of leather to absorb acrylonitrile and hold it against the 
skin. Since there is no pain associated with the blistering which may 
result from skin contact with liquid AN, it is essential that the 
employee be informed of this hazard so that he or she can be protected.

[[Page 367]]

    Any protective clothing which has developed leaks or is otherwise 
found to be defective shall be repaired or replaced. Clean protective 
clothing shall be provided to the employee as necessary to assure its 
protectiveness. Whenever impervious clothing becomes wet with liquid AN, 
it shall be washed down with water before being removed by the employee. 
Employees are also required to wear splash-proof safety goggles where 
there is any possibility of acrylonitrile contacting the eyes.

                 vi. Housekeeping and Hygiene Facilities

    For purposes of complying with 29 CFR 1910.141, the following items 
should be emphasized:
    A. The workplace should be kept clean, orderly, and in a sanitary 
condition. The employer is required to institute a leak and spill 
detection program for operations involving liquid AN in order to detect 
sources of fugitive AN emissions.
    B. Dry sweeping and the use of compressed air is unsafe for the 
cleaning of floors and other surfaces where liquid AN may be found.
    C. Adequate washing facilities with hot and cold water are to be 
provided, and maintained in a sanitary condition. Suitable cleansing 
agents are also to be provided to assure the effective removal of 
acrylonitrile from the skin.
    D. Change or dressing rooms with individual clothes storage 
facilities must be provided to prevent the contamination of street 
clothes with acrylonitrile. Because of the hazardous nature of 
acrylonitrile, contaminated protective clothing should be placed in a 
regulated area designated by the employer for removal of the AN before 
the clothing is laundered or disposed of.

                     vii. Miscellaneous Precautions

    A. Store acrylonitrile in tightly-closed containers in a cool, well-
ventilated area and take necessary precautions to avoid any explosion 
hazard.
    B. High exposures to acrylonitrile can occur when transferring the 
liquid from one container to another.
    C. Non-sparking tools must be used to open and close metal 
acrylonitrile containers. These containers must be effectively grounded 
and bonded prior to pouring.
    D. Never store uninhibited acrylonitrile.
    E. Acrylonitrile vapors are not inhibited. They may form polymers 
and clog vents of storage tanks.
    F. Use of supplied-air suits or other impervious coverings may be 
necessary to prevent skin contact with and provide respiratory 
protection from acrylonitrile where the concentration of acrylonitrile 
is unknown or is above the ceiling limit. Supplied-air suits should be 
selected, used, and maintained under the immediate supervision of 
persons knowledgeable in the limitations and potential life-endangering 
characteristics of supplied-air suits.
    G. Employers shall advise employees of all areas and operations 
where exposure to acrylonitrile could occur.

                         viii. Common Operations

    Common operations in which exposure to acrylonitrile is likely to 
occur include the following: Manufacture of the acrylonitrile monomer; 
synthesis of acrylic fibers, ABS, SAN, and nitrile barrier plastics and 
resins, nitrile rubber, surface coatings, specialty chemicals, use as a 
chemical intermediate, use as a fumigant and in the cyanoethylation of 
cotton.

   Appendix C to Sec.  1910.1045--Medical Surveillance Guidelines for 
                              Acrylonitrile

                            i. route of entry

    Inhalation; skin absorption; ingestion.

                             ii. toxicology

    Acrylonitrile vapor is an asphyxiant due to inhibitory action on 
metabolic enzyme systems. Animals exposed to 75 or 100 ppm for 7 hours 
have shown signs of anoxia; in some animals which died at the higher 
level, cyanomethemoglobin was found in the blood. Two human fatalities 
from accidental poisioning have been reported; one was caused by 
inhalation of an unknown concentration of the vapor, and the other was 
thought to be caused by skin absorption or inhalation. Most cases of 
intoxication from industrial exposure have been mild, with rapid onset 
of eye irritation, headache, sneezing, and nausea. Weakness, 
lightheadedness, and vomiting may also occur. Exposure to high 
concentrations may produce profound weakness, asphyxia, and death. The 
vapor is a severe eye irritant. Prolonged skin contract with the liquid 
may result in absorption with systemic effects, and in the formation of 
large blisters after a latent period of several hours. Although there is 
usually little or no pain or inflammation, the affected skin resembles a 
second-degree thermal burn. Solutions spilled on exposed skin, or on 
areas covered only by a light layer of clothing, evaporate rapidly, 
leaving no irritation, or, at the most, mild transient redness. Repeated 
spills on exposed skin may result in dermatitis due to solvent effects.
    Results after 1 year of a planned 2-year animal study on the effects 
of exposure to acrylonitrile have indicated that rats ingesting as 
little as 35 ppm in their drinking water develop tumors of the central 
nervous system. The interim results of this study have been supported by 
a similar study being conducted by the same laboratory, involving

[[Page 368]]

exposure of rats by inhalation of acrylonitrile vapor, which has shown 
similar types of tumors in animals exposed to 80 ppm.
    In addition, the preliminary results of an epidemiological study 
being performed by duPont on a cohort of workers in their Camden, S.C. 
acrylic fiber plant indicate a statistically significant increase in the 
incidence of colon and lung cancers among employees exposed to 
acrylonitrile.

              iii. signs and symptoms of acute overexposure

    Asphyxia and death can occur from exposure to high concentrations of 
acrylonitrile. Symptoms of overexposure include eye irritation, 
headache, sneezing, nausea and vomiting, weakness, and light-headedness. 
Prolonged skin contact can cause blisters on the skin with appearance of 
a second-degree burn, but with little or no pain. Repeated skin contact 
may produce scaling dermatits.

                   iv. treatment of acute overexposure

    Remove employee from exposure. Immediately flush eyes with water and 
wash skin with soap or mild detergent and water. If AN has been 
swallowed, and person is conscious, induce vomiting. Give artificial 
resuscitation if indicated. More severe cases, such as those associated 
with loss of consciousness, may be treated by the intravenous 
administration of sodium nitrite, followed by sodium thiosulfate, 
although this is not as effective for acrylonitrile poisoning as for 
inorganic cyanide poisoning.

              v. surveillance and preventive considerations

    A. As noted above, exposure to acrylonitrile has been linked to 
increased incidence of cancers of the colon and lung in employees of the 
duPont acrylic fiber plant in Camden, S.C. In addition, the animal 
testing of acrylonitrile has resulted in the development of cancers of 
the central nervous system in rats exposed by either inhalation or 
ingestion. The physician should be aware of the findings of these 
studies in evaluating the health of employees exposed to acrylonitrile.
    Most reported acute effects of occupational exposure to 
acrylonitrile are due to its ability to cause tissue anoxia and 
asphyxia. The effects are similar to those caused by hydrogen cyanide. 
Liquid acrylonitrile can be absorbed through the skin upon prolonged 
contact. The liquid readily penetrates leather, and will produce burns 
of the feet if footwear contaminated with acrylonitrile is not removed.
    It is important for the physician to become familiar with the 
operating conditions in which exposure to acrylonitrile may occur. Those 
employees with skin diseases may not tolerate the wearing of whatever 
protective clothing may be necessary to protect them from exposure. In 
addition, those with chronic respiratory disease may not tolerate the 
wearing of negative-pressure respirators.
    B. Surveillance and screening. Medical histories and laboratory 
examinations are required for each employee subject to exposure to 
acrylonitrile above the action level. The employer must screen employees 
for history of certain medical conditions which might place the employee 
at increased risk from exposure.
    1. Central nervous system dysfunction. Acute effects of exposure to 
acrylonitrile generally involve the central nervous system. Symptoms of 
acrylonitrile exposure include headache, nausea, dizziness, and general 
weakness. The animal studies cited above suggest possible carcinogenic 
effects of acrylonitrile on the central nervous system, since rats 
exposed by either inhalation or ingestion have developed similar CNS 
tumors.
    2. Respiratory disease. The du Pont data indicate an increased risk 
of lung cancer among employees exposed to acrylonitrile.
    3. Gastrointestinal disease. The du Pont data indicate an increased 
risk of cancer of the colon among employees exposed to acrylonitrile. In 
addition, the animal studies show possible tumor production in the 
stomachs of the rats in the ingestion study.
    4. Skin disease. Acrylonitrile can cause skin burns when prolonged 
skin contact with the liquid occurs. In addition, repeated skin contact 
with the liquid can cause dermatitis.
    5. General. The purpose of the medical procedures outlined in the 
standard is to establish a baseline for future health monitoring. 
Persons unusually susceptible to the effects of anoxia or those with 
anemia would be expected to be at increased risk. In addition to 
emphasis on the CNS, respiratory and gastro-intestinal systems, the 
cardiovascular system, liver, and kidney function should also be 
stressed.

   Appendix D to Sec.  1910.1045--Sampling and Analytical Methods for 
                              Acrylonitrile

    There are many methods available for monitoring employee exposures 
to acrylonitrile. Most of these involve the use of charcoal tubes and 
sampling pumps, with analysis by gas chromatograph. The essential 
differences between the charcoal tube methods include, among others, the 
use of different desorbing solvents, the use of different lots of 
charcoal, and the use of different equipment for analysis of the 
samples.
    Besides charcoal, considerable work has been performed on methods 
using porous polymer sampling tubes and passive dosimeters. In addition, 
there are several portable gas analyzers and monitoring units available 
on the open market.
    This appendix contains details for the methods which have been 
tested at OSHA Analytical Laboratory in Salt Lake City,

[[Page 369]]

and NIOSH in Cincinnati. Each is a variation on NIOSH Method S-156, 
which is also included for reference. This does not indicate that these 
methods are the only ones which will be satisfactory. There also may be 
workplace situations in which these methods are not adequate, due to 
such factors as high humidity. Copies of the other methods available to 
OSHA are available in the rulemaking record, and may be obtained from 
the OSHA Docket Office. These include, the Union Carbide, Monsanto, Dow 
Chemical and Dow Badische methods, as well as NISOH Method P & CAM 127.
    Employers who note problems with sample breakthrough should try 
larger charcoal tubes. Tubes of larger capacity are available, and are 
often used for sampling vinyl chloride. In addition, lower flow rates 
and shorter sampling times should be beneficial in minimizing 
breakthrough problems.
    Whatever method the employer chooses, he must assure himself of the 
method's accuracy and precision under the unique conditions present in 
his workplace.

                     NIOSH Method S-156 (Unmodified)

Analyte: Acrylonitrile.
Matrix: Air.
Procedure: Absorption on charcoal, desorption with methanol, GC.

    1. Principle of the method (Reference 11.1).
    1.1 A known volume of air is drawn through a charcoal tube to trap 
the organic vapors present.
    1.2 The charcoal in the tube is transferred to a small, stoppered 
sample container, and the analyte is desorbed with methanol.
    1.3 An aliquot of the desorbed sample is injected into a gas 
chromatograph.
    1.4 The area of the resulting peak is determined and compared with 
areas obtained for standards.
    2. Range and sensitivity.
    2.1 This method was validated over the range of 17.5-70.0 mg/cu m at 
an atmospheric temperature and pressure of 22 [deg]C and 760 MM Hg, 
using a 20-liter sample. Under the conditions of sample size (20-liters) 
the probable useful range of this method is 4.5-135 mg-cu m. The method 
is capable of measuring much smaller amounts if the desorption 
efficiency is adequate. Desorption efficiency must be determined over 
the range used.
    2.2 The upper limit of the range of the method is dependent on the 
adsorptive capacity of the charcoal tube. This capacity varies with the 
concentrations of acrylonitrile and other substances in the air. The 
first section of the charcoal tube was found to hold at least 3.97 mg of 
acrylonitrile when a test atmosphere containing 92.0 mg/cu m of 
acrylonitrile in air was sampled 0.18 liter per minute for 240 minutes; 
at that time the concentration of acrylonitrile in the effluent was less 
than 5 percent of that in the influent. (The charcoal tube consists of 
two sections of activated charcoal separated by a section of urethane 
foam. See section 6.2.) If a particular atmosphere is suspected of 
containing a large amount of contaminant, a smaller sampling volume 
should be taken.
    3. Interference.
    3.1 When the amount of water in the air is so great that 
condensation actually occurs in the tube, organic vapors will not be 
trapped efficiently. Preliminary experiments using toluene indicate that 
high humidity severely decreases the breakthrough volume.
    3.2 When interfering compounds are known or suspected to be present 
in the air, such information, including their suspected identities, 
should be transmitted with the sample.
    3.3 It must be emphasized that any compound which has the same 
retention time as the analyte at the operating conditions described in 
this method is an interference. Retention time data on a single column 
cannot be considered proof of chemical identity.
    3.4 If the possibility of interference exists, separation conditions 
(column packing, temperature, etc.) must be changed to circumvent the 
problem.
    4. Precision and accuracy.
    4.1 The Coefficient of Variation (CVT) for the total 
analytical and sampling method in the range of 17.5-70.0 mg/cu m was 
0.073. This value corresponds to a 3.3 mg/cu m standard deviation at the 
(previous) OSHA standard level (20 ppm). Statistical information and 
details of the validation and experimental test procedures can be found 
in Reference 11.2.
    4.2 On the average the concentrations obtained at the 20 ppm level 
using the overall sampling and analytical method were 6.0 percent lower 
than the ``true'' concentrations for a limited number of laboratory 
experiments. Any difference between the ``found'' and ``true'' 
concentrations may not represent a bias in the sampling and analytical 
method, but rather a random variation from the experimentally determined 
``true'' concentration. Therefore, no recovery correction should be 
applied to the final result in section 10.5.
    5. Advantages and disadvantages of the method.
    5.1 The sampling device is small, portable, and involves no liquids. 
Interferences are minimal, and most of those which do occur can be 
eliminated by altering chromatographic conditions. The tubes are 
analyzed by means of a quick, instrumental method.
    The method can also be used for the simultaneous analysis of two or 
more substances suspected to be present in the same sample by simply 
changing gas chromatographic conditions.

[[Page 370]]

    5.2 One disadvantage of the method is that the amount of sample 
which can be taken is limited by the number of milligrams that the tube 
will hold before overloading. When the sample value obtained for the 
backup section of the charcoal tube exceeds 25 percent of that found on 
the front section, the possibility of sample loss exists.
    5.3 Furthermore, the precision of the method is limited by the 
reproducibility of the pressure drop across the tubes. This drop will 
affect the flow rate and cause the volume to be imprecise, because the 
pump is usually calibrated for one tube only.
    6. Apparatus.
    6.1 A calibrated personal sampling pump whose flow can be determined 
within 5 percent at the recommended flow rate. 
(Reference 11.3).
    6.2 Charcoal tubes: Glass tubes with both ends flame sealed, 7 cm 
long with a 6-mm O.D. and a 4-mm I.D., containing 2 sections of 20/40 
mesh activated charcoal separated by a 2-mm portion of urethane foam. 
The activated charcoals prepared from coconut shells and is fired at 600 
[deg]C prior to packing. The adsorbing section contains 100 mg of 
charcoal, the backup section 50 mg. A 3-mm portion of urethane foam is 
placed between the outlet end of the tube and the backup section. A plug 
of silicated glass wool is placed in front of the adsorbing section. The 
pressure drop across the tube must be less than 1 inch of mercury at a 
flow rate of 1 liter per minute.
    6.3 Gas chromatograph equipped with a flame ionization detector.
    6.4 Column (4-ft x \1/4\-in stainless steel) packed with 50/80 mesh 
Poropak, type Q.
    6.5 An electronic integrator or some other suitable method for 
measuring peak areas.
    6.6 Two-milliliter sample containers with glass stoppers or Teflon-
lined caps. If an automatic sample injector is used, the associated 
vials may be used.
    6.7 Microliter syringes: 10-microliter and other convenient sizes 
for making standards.
    6.8 Pipets: 1.0-ml delivery pipets.
    6.9 Volumetric flask: 10-ml or convenient sizes for making standard 
solutions.
    7. Reagents.
    7.1 Chromatographic quality methanol.
    7.2 Acrylonitrile, reagent grade.
    7.3 Hexane, reagent grade.
    7.4 Purified nitrogen.
    7.5 Prepurified hydrogen.
    7.6 Filtered compressed air.
    8. Procedure.
    8.1 Cleaning of equipment. All glassware used for the laboratory 
analysis should be detergent washed and thoroughly rinsed with tap water 
and distilled water.
    8.2 Calibration of personal pumps. Each personal pump must be 
calibrated with a representative charcoal tube in the line. This will 
minimize errors associated with uncertainties in the sample volume 
collected.
    8.3 Collection and shipping of samples.
    8.3.1 Immediately before sampling, break the ends of the tube to 
provide an opening at least one-half the internal diameter of the tube 
(2 mm).
    8.3.2 The smaller section of charcoal is used as a backup and should 
be positioned nearest the sampling pump.
    8.3.3 The charcoal tube should be placed in a vertical direction 
during sampling to minimize channeling through the charcoal.
    8.3.4 Air being sampled should not be passed through any hose or 
tubing before entering the charcoal tube.
    8.3.5 A maximum sample size of 20 liters is recommended. Sample at a 
flow of 0.20 liter per minute or less. The flow rate should be known 
with an accuracy of at least 5 percent.
    8.3.6 The temperature and pressure of the atmosphere being sampled 
should be recorded. If pressure reading is not available, record the 
elevation.
    8.3.7 The charcoal tubes should be capped with the supplied plastic 
caps immediately after sampling. Under no circumstances should rubber 
caps be used.
    8.3.8 With each batch of 10 samples submit one tube from the same 
lot of tubes which was used for sample collection and which is subjected 
to exactly the same handling as the samples except that no air is drawn 
through it. Label this as a blank.
    8.3.9 Capped tubes should be packed tightly and padded before they 
are shipped to minimize tube breakage during shipping.
    8.3.10 A sample of the bulk material should be submitted to the 
laboratory in a glass container with a Teflon-lined cap. This sample 
should not be transported in the same container as the charcoal tubes.
    8.4 Analysis of samples.
    8.4.1 Preparation of samples. In preparation for analysis, each 
charcoal tube is scored with a file in front of the first section of 
charcoal and broken open. The glass wool is removed and discarded. The 
charcoal in the first (larger) section is transferred to a 2-ml 
stoppered sample container. The separating section of foam is removed 
and discarded; the second section is transferred to another stoppered 
container. These two sections are analyzed separately.
    8.4.2 Desorption of samples. Prior to analysis, 1.0 ml of methanol 
is pipetted into each sample container. Desorption should be done for 30 
minutes. Tests indicate that this is adequate if the sample is agitated 
occasionally during this period. If an automatic sample injector is 
used, the sample vials should be capped as soon as the solvent is added 
to minimize volatilization.
    8.4.3 GC conditions. The typical operating conditions for the gas 
chromatograph are:
    1. 50 ml/min (60 psig) nitrogen carrier gas flow.

[[Page 371]]

    2. 65 ml/min (24 psig) hydrogen gas flow to detector.
    3. 500 ml/min (50 psig) air flow to detector.
    4. 235 [deg]C injector temperature.
    5. 255 [deg]C manifold temperature (detector).
    6. 155 [deg]C column temperature.
    8.4.4 Injection. The first step in the analysis is the injection of 
the sample into the gas chromatograph. To eliminate difficulties arising 
from blowback or distillation within the syringe needle, one should 
employ the solvent flush injection technique. The 10-microliter syringe 
is first flushed with solvent several times to wet the barrel and 
plunger. Three microliters of solvent are drawn into the syringe to 
increase the accuracy and reproducibility of the injected sample volume. 
The needle is removed from the solvent, and the plunger is pulled back 
about 0.2 microliter to separate the solvent flush from the sample with 
a pocket of air to be used as a marker. The needle is then immersed in 
the sample, and a 5-microliter aliquot is withdrawn, taking into 
consideration the volume of the needle, since the sample in the needle 
will be completely injected. After the needle is removed from the sample 
and prior to injection, the plunger is pulled back 1.2 microliters to 
minimize evaporation of the sample from the tip of the needle. Observe 
that the sample occupies 4.9-5.0 microliters in the barrel of the 
syringe. Duplicate injections of each sample and standard should be 
made. No more than a 3 percent difference in area is to be expected. An 
automatic sample injector can be used if it is shown to give 
reproducibility at least as good as the solvent flush method.
    8.4.5 Measurement of area. The area of the sample peak is measured 
by an electronic integrator or some other suitable form of area 
measurement, and preliminary results are read from a standard curve 
prepared as discussed below.
    8.5 Determination of desorption efficiency.
    8.5.1 Importance of determination. The desorption efficiency of a 
particular compound can vary from one laboratory to another and also 
from one batch of charcoal to another. Thus, it is necessary to 
determine at least once the percentage of the specific compound that is 
removed in the desorption process, provided the same batch of charcoal 
is used.
    8.5.2 Procedure for determining desorption efficiency. Activated 
charcoal equivalent to the amount in the first section of the sampling 
tube (100 mg) is measured into a 2.5 in, 4-mm I.D. glass tube, flame 
sealed at one end. This charcoal must be from the same batch as that 
used in obtaining the samples and can be obtained from unused charcoal 
tubes. The open end is capped with Parafilm. A known amount of hexane 
solution of acrylonitrile containing 0.239 g/ml is injected directly 
into the activated charcoal with a microliter syringe, and tube is 
capped with more Parafilm. When using an automatic sample injector, the 
sample injector vials, capped with Teflon-faced septa, may be used in 
place of the glass tube.
    The amount injected is equivalent to that present in a 20-liter air 
sample at the selected level.
    Six tubes at each of three levels (0.5X, 1X, and 2X of the standard) 
are prepared in this manner and allowed to stand for at least overnight 
to assure complete adsorption of the analyte onto the charcoal. These 
tubes are referred to as the sample. A parallel blank tube should be 
treated in the same manner except that no sample is added to it. The 
sample and blank tubes are desorbed and analyzed in exactly the same 
manner as the sampling tube described in section 8.4.
    Two or three standards are prepared by injecting the same volume of 
compound into 1.0 ml of methanol with the same syringe used in the 
preparation of the samples. These are analyzed with the samples.
    The desorption efficiency (D.E.) equals the average weight in mg 
recovered from the tube divided by the weight in mg added to the tube, 
or
[GRAPHIC] [TIFF OMITTED] TC15NO91.035

    The desorption efficiency is dependent on the amount of analyte 
collected on the charcoal. Plot the desorption efficiency versus weight 
of analyte found. This curve is used in section 10.4 to correct for 
adsorption losses.
    9. Calibration and standards.
    It is convenient to express concentration of standards in terms of 
mg/1.0 ml methanol, because samples are desorbed in this amount of 
methanol. The density of the analyte is used to convert mg into 
microliters for easy measurement with a microliter syringe. A series of 
standards, varying in concentration over the range of interest, is 
prepared and analyzed under the same GC conditions and during the same 
time period as the unknown samples. Curves are established by plotting 
concentration in mg/1.0 ml versus peak area.

    Note: Since no internal standard is used in the method, standard 
solutions must be analyzed at the same time that the sample analysis is 
done. This will minimize the effect of known day-to-day variations and 
variations during the same day of the FID response.

    10. Calculations.
    10.1 Read the weight, in mg, corresponding to each peak area from 
the standard curve. No volume corrections are needed, because the 
standard curve is based on mg/1.0 ml methanol and the volume of sample 
injected is identical to the volume of the standards injected.
    10.2 Corrections for the bank must be made for each sample.


[[Page 372]]


mg = mg sample-mg blank

Where:

mg sample = mg found in front section of sample tube.
mg sample = mg found in front section of blank tube.
    A similar procedure is followed for the backup sections.
    10.3 Add the weights found in the front and backup sections to get 
the total weight in the sample.
    10.4 Read the desorption efficiency from the curve (see sec. 8.5.2) 
for the amount found in the front section. Divide the total weight by 
this desorption efficiency to obtain the corrected mg/sample.
[GRAPHIC] [TIFF OMITTED] TC15NO91.036

    10.5 The concentration of the analyte in the air sampled can be 
expressed in mg/cu m.
[GRAPHIC] [TIFF OMITTED] TC15NO91.037

    10.6 Another method of expressing concentration is ppm.

ppm = m mg/cu x 24.45/M.W. x 760/P x T. + 273/298

Where:

P = Pressure (mm Hg) of air sampled.
T = Temperature ([deg]C) of air sampled.
24.45 = Molar volume (liter/mole) at 25 [deg]C and 760 mm Hg.
M.W. = Molecular weight (g/mole) of analyte.
760 = Standard pressure (mm Hg).
298 = Standard temperature ([deg]K).

    11. References.
    11.1 White, L. D. et al., ``A Convenient Optimized Method for the 
Analysis of Selected Solvent Vapors in the Industrial Atmosphere,'' 
Amer. Ind. Hyg. Assoc. J., 31:225 (1970).
    11.2 Documentation of NIOSH Validation Tests, NIOSH Contract No. 
CDC-99-74-45.
    11.3 Final Report, NIOSH Contract HSM-99-71-31, ``Personal Sampler 
Pump for Charcoal Tubes,'' September 15, 1972.

                NIOSH Modification of NIOSH Method S-156

    The NIOSH recommended method for low levels for acrylonitrile is a 
modification of method S-156. It differs in the following respects:
    (1) Samples are desorbed using 1 ml of 1 percent acetone in 
CS2 rather than methanol.
    (2) The analytical column and conditions are:
    Column: 20 percent SP-1000 on 80/100 Supelcoport 10 feet x \1/8\ 
inch S.S.
Conditions:
Injector temperature: 200 [deg]C.
Detector temperature: 100 [deg]C.
Column temperature: 85 [deg]C.
Helium flow: 25 ml/min.
Air flow: 450 ml/min.
Hydrogen flow: 55 ml/min.

    (3) A 2 [micro]l injection of the desorbed analyte is used.
    (4) A sampling rate of 100 ml/min is recommended.

           OSHA Laboratory Modification of NIOSH Method S-156

Analyte: Acrylonitrile.
Matrix: Air.
Procedure: Adsorption on charcoal, desorption with methanol, GC.

    1. Principle of the Method (Reference 1).
    1.1 A known volume of air is drawn through a charcoal tube to trap 
the organic vapors present.
    1.2 The charcoal in the tube is transferred to a small, stoppered 
sample vial, and the analyte is desorbed with methanol.
    1.3 An aliquot of the desorbed sample is injected into a gas 
chromatograph.
    1.4 The area of the resulting peak is determined and compared with 
areas obtained for standards.
    2. Advantages and disadvantages of the method.
    2.1 The sampling device is small, portable, and involves no liquids. 
Interferences are minimal, and most of those which do occur can be 
eliminated by altering chromatographic conditions. The tubes are 
analyzed by means of a quick, instrumental method.
    2.2 This method may not be adequate for the simultaneous analysis of 
two or more substances.
    2.3 The amount of sample which can be taken is limited by the number 
of milligrams that the tube will hold before overloading. When the 
sample value obtained for the backup section of the charcoal tube 
exceeds 25 percent of that found on the front section, the possibility 
of sample loss exists.
    2.4 The precision of the method is limited by the reproducibility of 
the pressure drop across the tubes. This drop will affect the flow rate 
and cause the volume to be imprecise, because the pump is usually 
calibrated for one tube only.
    3. Apparatus.

[[Page 373]]

    3.1 A calibrated personal sampling pump whose flow can be determined 
within 5 percent at the recommended flow rate.
    3.2 Charcoal tubes: Glass tube with both ends flame sealed, 7 cm 
long with a 6-mm O.D. and a 4-mm I.D., containing 2 sections of 20/40 
mesh activated charcoal separated by a 2-mm portion of urethane foam. 
The activated charcoal is prepared from coconut shells and is fired at 
600 [deg]C prior to packing. The adsorbing section contains 100 mg of 
charcoal, the back-up section 50 mg. A 3-mm portion of urethane foam is 
placed between the outlet end of the tube and the back-up section. A 
plug of sililated glass wool is placed in front of the adsorbing 
section. The pressure drop across the tube must be less than one inch of 
mercury at a flow rate of 1 liter per minute.
    3.3 Gas chromatograph equipped with a nitrogen phosphorus detector.
    3.4 Column (10-ft x 1/8-in stainless steel) packed with 
100/120 Supelcoport coated with 10 percent SP 1000.
    3.5 An electronic integrator or some other suitable method for 
measuring peak area.
    3.6 Two-milliliter sample vials with Teflon-lined caps
    3.7 Microliter syringes: 10-microliter, and other convenient sizes 
for making standards.
    3.8 Pipets: 1.0-ml delivery pipets.
    3.9 Volumetric flasks: convenient sizes for making standard 
solutions.
    4. Reagents.
    4.1 Chromatographic quality methanol.
    4.2 Acrylonitrile, reagent grade.
    4.3 Filtered compressed air.
    4.4 Purified hydrogen.
    4.5 Purified helium.
    5. Procedure.
    5.1 Cleaning of equipment. All glassware used for the laboratory 
analysis should be properly cleaned and free of organics which could 
interfere in the analysis.
    5.2 Calibration of personal pumps. Each pump must be calibrated with 
a representative charcoal tube in the line.
    5.3 Collection and shipping of samples.
    5.3.1 Immediately before sampling, break the ends of the tube to 
provide an opening at least one-half the internal diameter of the tube 
(2 mm).
    5.3.2 The smaller section of the charcoal is used as the backup and 
should be placed nearest the sampling pump.
    5.3.3 The charcoal should be placed in a vertical position during 
sampling to minimize channeling through the charcoal.
    5.3.4 Air being sampled should not be passed through any hose or 
tubing before entering the charcoal tube.
    5.3.5 A sample size of 20 liters is recommended. Sample at a flow 
rate of approximately 0.2 liters per minute. The flow rate should be 
known with an accuracy of at least 5 percent.
    5.3.6 The temperature and pressure of the atmosphere being sampled 
should be recorded.
    5.3.7 The charcoal tubes should be capped with the supplied plastic 
caps immediately after sampling. Rubber caps should not be used.
    5.3.8 Submit at least one blank tube (a charcoal tube subjected to 
the same handling procedures, without having any air drawn through it) 
with each set of samples.
    5.3.9. Take necessary shipping and packing precautions to minimize 
breakage of samples.
    5.4 Analysis of samples.
    5.4.1 Preparation of samples. In preparation for analysis, each 
charcoal tube is scored with a file in front of the first section of 
charcoal and broken open. The glass wool is removed and discarded. The 
charcoal in the first (larger) section is transferred to a 2-ml vial. 
The separating section of foam is removed and discarded; the section is 
transferred to another capped vial. These two sections are analyzed 
separately.
    5.4.2 Desorption of samples. Prior to analysis, 1.0 ml of methanol 
is pipetted into each sample container. Desorption should be done for 30 
minutes in an ultrasonic bath. The sample vials are recapped as soon as 
the solvent is added.
    5.4.3 GC conditions. The typical operating conditions for the gas 
chromatograph are:
    1. 30 ml/min (60 psig) helium carrier gas flow.
    2. 3.0 ml/min (30 psig) hydrogen gas flow to detector.
    3. 50 ml/min (60 psig) air flow to detector.
    4. 200 [deg]C injector temperature.
    5. 200 [deg]C dejector temperature.
    6. 100 [deg]C column temperature.
    5.4.4 Injection. Solvent flush technique or equivalent.
    5.4.5 Measurement of area. The area of the sample peak is measured 
by an electronic integator or some other suitable form of area 
measurement, and preliminary results are read from a standard curve 
prepared as discussed below.
    5.5 Determination of desorption efficiency.
    5.5.1 Importance of determination. The desorption efficiency of a 
particular compound can vary from one laboratory to another and also 
from one batch of charcoal to another. Thus, it is necessary to 
determine, at least once, the percentage of the specific compound that 
is removed in the desorption process, provided the same batch of 
charcoal is used.
    5.5.2 Procedure for determining desorption efficiency. The reference 
portion of the charcoal tube is removed. To the remaining portion, 
amounts representing 0.5X, 1X, and 2X (X represents TLV) based on a 20 l 
air sample are injected onto several tubes at each level. Dilutions of 
acrylonitrile with methanol are

[[Page 374]]

made to allow injection of measurable quantities. These tubes are then 
allowed to equilibrate at least overnight. Following equilibration they 
are analyzed following the same procedure as the samples A curve of the 
desorption efficiency amt recovered/amt added is plotted versus amount 
of analyte found. This curve is used to correct for adsorption losses.
    6. Calibration and standards.
    A series of standards, varying in concentration over the range of 
interest, is prepared and analyzed under the same GC conditions and 
during the same time period as the unknown samples. Curves are prepared 
by plotting concentration versus peak area.

    Note: Since no internal standard is used in the method, standard 
solutions must be analyzed at the same time that the sample analysis is 
done. This will minimize the effect of known day-to-day variations and 
variations during the same day of the NPD response. Multiple injections 
are necessary.

    7. Calculations.
    Read the weight, corresponding to each peak area from the standard 
curve, correct for the blank, correct for the desorption efficiency, and 
make necessary air volume corrections.

    8. Reference. NIOSH Method S-156.

[43 FR 45809, Oct. 3, 1978, as amended at 45 FR 35283, May 23, 1980; 54 
FR 24334, June 7, 1989; 58 FR 35310, June 30, 1993; 61 FR 5508, Feb. 13, 
1996; 63 FR 1291, Jan. 8, 1998; 63 FR 20099, Apr. 23, 1998; 70 FR 1142, 
Jan. 5, 2005; 71 FR 16672, 16673, Apr. 3, 2006; 71 FR 50190, Aug. 24, 
2006; 73 FR 75586, Dec. 12, 2008; 76 FR 33609, June 8, 2011; 77 FR 
17783, Mar. 26, 2012; 84 FR 21518, May 14, 2019]



Sec.  1910.1047  Ethylene oxide.

    (a) Scope and application. (1) This section applies to all 
occupational exposures to ethylene oxide (EtO), Chemical Abstracts 
Service Registry No. 75-21-8, except as provided in paragraph (a)(2) of 
this section.
    (2) This section does not apply to the processing, use, or handling 
of products containing EtO where objective data are reasonably relied 
upon that demonstrate that the product is not capable of releasing EtO 
in airborne concentrations at or above the action level, and may not 
reasonably be foreseen to release EtO in excess of the excursion limit, 
under the expected conditions of processing, use, or handling that will 
cause the greatest possible release.
    (3) Where products containing EtO are exempted under paragraph 
(a)(2) of this section, the employer shall maintain records of the 
objective data supporting that exemption and the basis for the 
employer's reliance on the data, as provided in paragraph (k)(1) of this 
section.
    (b) Definitions: For the purpose of this section, the following 
definitions shall apply:
    Action level means a concentration of airborne EtO of 0.5 ppm 
calculated as an eight (8)-hour time-weighted average.
    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 (l) of this section, or any 
other person authorized by the Act or regulations issued under the Act.
    Director means the Director of the National Institute for 
Occupational Safety and Health, U.S. Department of Health and Human 
Services, or designee.
    Emergency means any occurrence such as, but not limited to, 
equipment failure, rupture of containers, or failure of control 
equipment that is likely to or does result in an unexpected significant 
release of EtO.
    Employee exposure means exposure to airborne EtO which would occur 
if the employee were not using respiratory protective equipment.
    Ethylene oxide or EtO means the three-membered ring organic compound 
with chemical formula C2 H4 O.
    (c) Permissible exposure limits--(1) 8-hour time weighted average 
(TWA). The employer shall ensure that no employee is exposed to an 
airborne concentration of EtO in excess of one (1) part EtO per million 
parts of air (1 ppm) as an 8-hour time-weighted average (8-hour TWA).
    (2) Excursion limit. The employer shall ensure that no employee is 
exposed to an airborne concentration of EtO in excess of 5 parts of EtO 
per million parts

[[Page 375]]

of air (5 ppm) as averaged over a sampling period of fifteen (15) 
minutes.
    (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 15-minute short-term exposures of 
each employee.
    (ii) Representative 8-hour TWA employee exposure shall be determined 
on the basis of one or more samples representing full-shift exposure for 
each shift for each job classification in each work area. Representative 
15-minute short-term employee exposures shall be determined on the basis 
of one or more samples representing 15-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.
    (iii) Where the employer can document that exposure levels are 
equivalent for similar operations in different work shifts, the employer 
need only determine representative employee exposure for that operation 
during one shift.
    (2) Initial monitoring. (i) Each employer who has a workplace or 
work operation covered by this standard, except as provided for in 
paragraph (a)(2) or (d)(2)(ii) of this section, shall perform initial 
monitoring to determine accurately the airborne concentrations of EtO to 
which employees may be exposed.
    (ii) Where the employer has monitored after June 15, 1983 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 previously monitored for the excursion 
limit and the monitoring satisfies all other requirements of this 
sections, the employer may rely on such earlier monitoring results to 
satisfy the requirements of paragraph (d)(2)(i) of this section.
    (3) Monitoring frequency (periodic monitoring). (i) If the 
monitoring required by paragraph (d)(2) of this section reveals employee 
exposure at or above the action level but at or below the 8-hour TWA, 
the employer shall repeat such monitoring for each such employee at 
least every 6 months.
    (ii) If the monitoring required by paragraph (d)(2)(i) of this 
section reveals employee exposure above the 8-hour TWA, the employer 
shall repeat such monitoring for each such employee at least every 3 
months.
    (iii) The employer may alter the monitoring schedule from quarterly 
to semiannually for any employee for whom two consecutive measurements 
taken at least 7 days apart indicate that the employee's exposure has 
decreased to or below the 8-hour TWA.
    (iv) If the monitoring required by paragraph (d)(2)(i) of this 
section reveals employee exposure above the 15 minute excursion limit, 
the employer shall repeat such monitoring for each such employee at 
least every 3 months, and more often as necessary to evaluate exposure 
the employee's short-term exposures.
    (4) Termination of monitoring. (i) If the initial monitoring 
required by paragraph (d)(2)(i) of this section reveals employee 
exposure to be below the action level, the employer may discontinue TWA 
monitoring for those employees whose exposures are represented by the 
initial monitoring.
    (ii) If the periodic monitoring required by paragraph (d)(3) of this 
section reveals that employee exposures, as indicated by at least two 
consecutive measurements taken at least 7 days apart, are below the 
action level, the employer may discontinue TWA monitoring for those 
employees whose exposures are represented by such monitoring.
    (iii) If the initial monitoring required by paragraph (d)(2)(1) of 
this section reveals employee exposure to be at or below the excursion 
limit, the employer may discontinue excursion limit monitoring for those 
employees whose exposures are represented by the initial monitoring.
    (iv) If the periodic monitoring required by paragraph (d)(3) of this 
section reveals that employee exposures, as indicated by at least two 
consecutive measurements taken at least 7 days apart, are at or below 
the excursion limit, the employer may discontinue excursion limit 
monitoring

[[Page 376]]

for those employees whose exposures are represented by such monitoring.
    (5) Additional monitoring. Notwithstanding the provisions of 
paragraph (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 to EtO or when the employer has any 
reason to suspect that a change may result in new or additional 
exposures.
    (6) Accuracy of monitoring. (i) Monitoring shall be accurate, to a 
confidence level of 95 percent, to within plus or minus 25 percent for 
airborne concentrations of EtO at the 1 ppm TWA and to within plus or 
minus 35 percent for airborne concentrations of EtO at the action level 
of 0.5 ppm.
    (ii) Monitoring shall be accurate, to a confidence level of 95 
percent, to within plus or minus 35 percent for airborne concentrations 
of EtO at the excursion limit.
    (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 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) 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 has been exceeded.
    (e) Regulated areas. (1) The employer shall establish a regulated 
area wherever occupational exposure to airborne concentrations of EtO 
may exceed the TWA or wherever the EtO concentration exceeds or can 
reasonably be expected to exceed the excursion limit.
    (2) Access to regulated areas shall be limited to authorized 
persons.
    (3) Regulated areas shall be demarcated in any manner that minimizes 
the number of employees within the regulated area.
    (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 to or below the excursion limit, 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 to or below the excursion limit, 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) Engineering controls are generally infeasible for the 
following operations: collection of quality assurance sampling from 
sterilized materials removal of biological indicators from sterilized 
materials: loading and unloading of tank cars; changing of ethylene 
oxide tanks on sterilizers; and vessel cleaning. For these operations, 
engineering controls are required only where the Assistant Secretary 
demonstrates that such controls are feasible.
    (2) Compliance program. (i) Where the TWA or excursion limit is 
exceeded, the employer shall establish and implement a written program 
to reduce 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 required or permitted under this section.
    (ii) The compliance program shall include a schedule for periodic 
leak detection surveys and a written plan for emergency situations, as 
specified in paragraph (h)(i) of this section.
    (iii) Written plans for a program required in paragraph (f)(2) shall 
be developed and furnished upon request for examination and copying to 
the Assistant Secretary, the Director, affected employees and designated 
employee representatives. Such plans shall be reviewed at least every 12 
months, and shall be updated as necessary to reflect

[[Page 377]]

significant changes in the status of the employer's compliance program.
    (iv) The employer shall not implement a schedule of employee 
rotation as a means of compliance with the TWA or excursion limit.
    (g) Respiratory protection and personal protective equipment--(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 and 
vessel cleaning, 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.
    (iv) Emergencies.
    (2) Respirator program. The employer must implement a respiratory 
protection program in accordance with Sec.  1910.134(b) through (d) 
(except (d)(i)(iii)), and (f) through (m), which covers each employee 
required by this section to use a respirator.
    (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 half masks of any type because EtO may 
cause eye irritation or injury.
    (ii) Equip each air-purifying, full facepiece respirator with a 
front-or back-mounted canister approved for protection against ethylene 
oxide.
    (iii) For escape, provide employees with any respirator permitted 
for use under paragraphs (g)(3)(i) and (ii) of this standard.
    (4) Protective clothing and equipment. When employees could have eye 
or skin contact with EtO or EtO solutions, the employer must select and 
provide, at no cost to the employee, appropriate protective clothing or 
other equipment in accordance with 29 CFR 1910.132 and 1910.133 to 
protect any area of the employee's body that may come in contact with 
the EtO or EtO solution, and must ensure that the employee wears the 
protective clothing and equipment provided.
    (h) Emergency situations--(1) Written plan. (i) A written plan for 
emergency situations shall be developed for each workplace where there 
is a possibility of an emergency. Appropriate portions of the plan shall 
be implemented in the event of an emergency.
    (ii) The plan shall specifically provide that employees engaged in 
correcting emergency conditions shall be equipped with respiratory 
protection as required by paragraph (g) of this section until the 
emergency is abated.
    (iii) The plan shall include the elements prescribed in 29 CFR 
1910.38 and 29 CFR 1910.39, ``Emergency action plans'' and ``Fire 
prevention plans,'' respectively.
    (2) Alerting employees. Where there is the possibility of employee 
exposure to EtO due to an emergency, means shall be developed to alert 
potentially affected employees of such occurrences promptly. Affected 
employees shall be immediately evacuated from the area in the event that 
an emergency occurs.
    (i) Medical Surveillance--(1) General--(i) Employees covered. (A) 
The employer shall institute a medical surveillance program for all 
employees who are or may be exposed to EtO at or above the action level, 
without regard to the use of respirators, for at least 30 days a year.
    (B) The employer shall make available medical examinations and 
consultations to all employees who have been exposed to EtO in an 
emergency situation.
    (ii) Examination by a physician. The employer shall ensure that all 
medical examinations and procedures are performed by or under the 
supervision of a licensed physician, and are provided without cost to 
the employee, without loss of pay, and at a reasonable time and place.
    (2) Medical examinations and consultations--(i) Frequency. The 
employer shall make available medical examinations and consultations to 
each employee covered under paragraph (i)(1)(i) of this section on the 
following schedules:

[[Page 378]]

    (A) Prior to assignment of the employee to an area where exposure 
may be at or above the action level for at least 30 days a year.
    (B) At least annually each employee exposed at or above the action 
level for at least 30 days in the past year.
    (C) At termination of employment or reassignment to an area where 
exposure to EtO is not at or above the action level for at least 30 days 
a year.
    (D) As medically appropriate for any employee exposed during an 
emergency.
    (E) As soon as possible, upon notification by an employee either (1) 
that the employee has developed signs or symptoms indicating possible 
overexposure to EtO, or (2) that the employee desires medical advice 
concerning the effects of current or past exposure to EtO on the 
employee's ability to produce a healthy child.
    (F) If the examining physician determines that any of the 
examinations should be provided more frequently than specified, the 
employer shall provide such examinations to affected employees at the 
frequencies recommended by the physician.
    (ii) Content. (A) Medical examinations made available pursuant to 
paragraphs (i)(2)(i)(A)-(D) of this section shall include:
    (1) A medical and work history with special emphasis directed to 
symptoms related to the pulmonary, hematologic, neurologic, and 
reproductive systems and to the eyes and skin.
    (2) A physical examination with particular emphasis given to the 
pulmonary, hematologic, neurologic, and reproductive systems and to the 
eyes and skin.
    (3) A complete blood count to include at least a white cell count 
(including differential cell count), red cell count, hematocrit, and 
hemoglobin.
    (4) Any laboratory or other test which the examining physician deems 
necessary by sound medical practice.
    (B) The content of medical examinations or consultation made 
available pursuant to paragraph (i)(2)(i)(E) of this section shall be 
determined by the examining physician, and shall include pregnancy 
testing or laboratory evaluation of fertility, if requested by the 
employee and deemed appropriate by the physician.
    (3) Information provided to the physician. The employer shall 
provide the following information to the examining physician:
    (i) A copy of this standard and Appendices A, B, and C.
    (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.
    (4) 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 EtO;
    (B) Any recommended limitations on the employee or upon the use of 
personal protective equipment such as clothing or respirators; and
    (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 EtO exposure that require further explanation or 
treatment.
    (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 EtO.
    (iii) The employer shall provide a copy of the physician's written 
opinion to the affected employee within 15 days from its receipt.
    (j) Communication of hazards--(1) Hazard communication--general. (i) 
Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for EtO.

[[Page 379]]

    (ii) In classifying the hazards of EtO at least the following 
hazards are to be addressed: Cancer; reproductive effects; mutagenicity; 
central nervous system; skin sensitization; skin, eye and respiratory 
tract irritation; acute toxicity effects; and flammability.
    (iii) Employers shall include EtO in the hazard communication 
program established to comply with the HCS (Sec.  1910.1200). Employers 
shall ensure that each employee has access to labels on containers of 
EtO and to safety data sheets, and is trained in accordance with the 
requirements of HCS and paragraph (j)(3) of this section.
    (2) Signs and labels--(i) Signs. (A) The employer shall post and 
maintain legible signs demarcating regulated areas and entrances or 
access ways to regulated areas that bear the following legend:

DANGER
ETHYLENE OXIDE
MAY CAUSE CANCER
MAY DAMAGE FERTILITY OR THE UNBORN CHILD
RESPIRATORY PROTECTION AND PROTECTIVE CLOTHING MAY BE REQUIRED IN THIS 
AREA
AUTHORIZED PERSONNEL ONLY

    (B) Prior to June 1, 2016, employers may use the following legend in 
lieu of that specified in paragraph (j)(2)(i)(A) of this section:

DANGER
ETHYLENE OXIDE
CANCER HAZARD AND REPRODUCTIVE HAZARD
AUTHORIZED PERSONNEL ONLY
RESPIRATORS AND PROTECTIVE CLOTHING MAY BE REQUIRED TO BE WORN IN THIS 
AREA

    (ii) Labels. (A) The employer shall ensure that labels are affixed 
to all containers of EtO whose contents are capable of causing employee 
exposure at or above the action level or whose contents may reasonably 
be foreseen to cause employee exposure above the excursion limit, and 
that the labels remain affixed when the containers of EtO leave the 
workplace. For the purposes of this paragraph (j)(2)(ii), reaction 
vessels, storage tanks, and pipes or piping systems are not considered 
to be containers.
    (B) Prior to June 1, 2015, employers may include the following 
information on containers of EtO in lieu of the labeling requirements in 
paragraph (j)(1)(i) of this section:

(1) DANGER
CONTAINS ETHYLENE OXIDE
CANCER HAZARD AND REPRODUCTIVE HAZARD;
(2) A warning statement against breathing airborne concentrations of 
EtO.

    (C) The labeling requirements under this section do not apply where 
EtO is used as a pesticide, as such term is defined in the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), when 
it is labeled pursuant to that Act and regulations issued under that Act 
by the Environmental Protection Agency.
    (3) Information and training. (i) The employer shall provide 
employees who are potentially exposed to EtO at or above the action 
level or above the excursion limit with information and training on EtO 
at the time of initial assignment and at least annually thereafter.
    (ii) Employees shall be informed of the following:
    (A) The requirements of this section with an explanation of its 
contents, including Appendices A and B;
    (B) Any operations in their work area where EtO is present;
    (C) The location and availability of the written EtO final rule; and
    (D) The medical surveillance program required by paragraph (i) of 
this section with an explanation of the information in appendix C.
    (iii) Employee training shall include at least:
    (A) Methods and observations that may be used to detect the presence 
or release of EtO in the work area (such as monitoring conducted by the 
employer, continuous monitoring devices, etc.);
    (B) The physical and health hazards of EtO;
    (C) The measures employees can take to protect themselves from 
hazards associated with EtO exposure, including specific procedures the 
employer has implemented to protect employees from exposure to EtO, such 
as work practices, emergency procedures, and personal protective 
equipment to be used; and

[[Page 380]]

    (D) The details of the hazard communication program developed by the 
employer, including an explanation of the labeling system and how 
employees can obtain and use the appropriate hazard information.
    (k) Recordkeeping--(1) Objective data for exempted operations. (i) 
Where the processing, use, or handling of products made from or 
containing EtO are exempted from other requirements of this section 
under paragraph (a)(2) of this section, or where objective data have 
been relied on in lieu of initial monitoring under paragraph (d)(2)(ii) 
of this section, the employer shall establish and maintain an accurate 
record of objective data reasonably relied upon in support of the 
exemption.
    (ii) This record shall include at least the following information:
    (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 EtO;
    (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.
    (2) Exposure measurements. (i) The employer shall keep an accurate 
record of all measurements taken to monitor employee exposure to EtO 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 EtO 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 protective devices worn, if any; and
    (F) Name and exposure of the employees whose exposures are 
represented.
    (iii) The employer shall maintain this record for at least thirty 
(30) years, in accordance with 29 CFR 1910.1020.
    (3) Medical surveillance. (i) The employer shall establish and 
maintain an accurate record for each employee subject to medical 
surveillance by paragraph (i)(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 of the employee;
    (B) Physicians' written opinions;
    (C) Any employee medical complaints related to exposure to EtO; and
    (D) A copy of the information provided to the physician as required 
by paragraph (i)(3) 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) 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 exemption and 
exposure records required by paragraphs (k) (1) and (2) 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 (k)(3) of this section available for 
examination and copying to the subject employee, anyone having the 
specific written consent of the subject employee, and the Assistant 
Secretary, in accordance with 29 CFR 1910.1020.
    (5) Transfer of records. The employer shall comply with the 
requirements concerning transfer of records set forth in 29 CFR 
1910.1020(h).
    (l) 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 EtO conducted in accordance with paragraph (d) of this 
section.

[[Page 381]]

    (2) Observation procedures. When observation of the monitoring of 
employee exposure to EtO 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.
    (m) [Reserved]
    (n) Appendices. The information contained in the appendices is not 
intended by itself to create any additional obligations not otherwise 
imposed or to detract from any existing obligation.

Appendix A to Sec.  1910.1047--Substance Safety Data Sheet for Ethylene 
                          Oxide (Non-Mandatory)

                       i. Substance Identification

    A. Substance: Ethylene oxide (C2 H4 O).
    B. Synonyms: dihydrooxirene, dimethylene oxide, EO, 1,2-epoxyethane, 
EtO, ETO, oxacyclopropane, oxane, oxidoethane, alpha/beta-oxidoethane, 
oxiran, oxirane.
    C. Ethylene oxide can be found as a liquid or vapor.
    D. EtO is used in the manufacture of ethylene glycol, surfactants, 
ethanolamines, glycol ethers, and other organic chemicals. EtO is also 
used as a sterilant and fumigant.
    E. Appearance and odor: Colorless liquid below 10.7 [deg]C (51.3 
[deg]F) or colorless gas with ether-like odor detected at approximately 
700 parts EtO per million parts of air (700 ppm).
    F. Permissible Exposure: Exposure may not exceed 1 part EtO per 
million parts of air averaged over the 8-hour workday.

                         ii. Health Hazard Data

    A. Ethylene oxide can cause bodily harm if you inhale the vapor, if 
it comes into contact with your eyes or skin, or if you swallow it.
    B. Effects of overexposure:
    1. Ethylene oxide in liquid form can cause eye irritation and injury 
to the cornea, frostbite, and severe irritation and blistering of the 
skin upon prolonged or confined contact. Ingestion of EtO can cause 
gastric irritation and liver injury. Acute effects from inhalation of 
EtO vapors include respiratory irritation and lung injury, headache, 
nausea, vomiting, diarrhea, shortness of breath, and cyaonosis (blue or 
purple coloring of skin). Exposure has also been associated with the 
occurrence of cancer, reproductive effects, mutagenic changes, 
neurotoxicity, and sensitization.
    1. EtO has been shown to cause cancer in laboratory animals and has 
been associated with higher incidences of cancer in humans. Adverse 
reproductive effects and chromosome damage may also occur from EtO 
exposure.
    a. Reporting signs and symptoms: You should inform your employer if 
you develop any signs or symptoms and suspect that they are caused by 
exposure to EtO.

                   iii. Emergency First Aid Procedures

    A. Eye exposure: If EtO gets into your eyes, wash your eyes 
immediately with large amounts of water, lifting the lower and upper 
eyelids. Get medical attention immediately. Contact lenses should not be 
worn when working with this chemical.
    B. Skin exposure: If EtO gets on your skin, immediately wash the 
contaminated skin with water. If EtO soaks through your clothing, 
especially your shoes, remove the clothing immediately and wash the skin 
with water using an emergency deluge shower. Get medical attention 
immediately. Thoroughly wash contaminated clothing before reusing. 
Contaminated leather shoes or other leather articles should not be 
reused and should be discarded.
    C. Inhalation: If large amounts of EtO are inhaled, the exposed 
person must be moved to fresh air at once. If breathing has stopped, 
perform cardiopulmonary resuscitation. Keep the affected person warm and 
at rest. Get medical attention immediately.
    D. Swallowing: When EtO has been swallowed, give the person large 
quantities of water immediately. After the water has been swallowed, try 
to get the person to vomit by having him or her touch the back of the 
throat with his or her finger. Do not make an unconscious person vomit. 
Get medical attention immediately.
    E. 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 a casualty 
yourself. Understand your emergency rescue procedures and know the 
location of the emergency equipment before the need arises.

                 iv. Respirators and Protective Clothing

    A. Respirators. You may be required to wear a respirator for 
nonroutine activities, in emergencies, while your employer is in the 
process of reducing EtO exposures through engineering controls, and in 
areas where engineering controls are not feasible. As of the effective 
date of this standard, only air-supplied, positive-pressure, full-
facepiece respirators are approved for protection against EtO. If air-
purifying respirators are worn in the future, they must have a label

[[Page 382]]

issued by the National Institute for Occupational Safety and Health 
under the provisions of 42 CFR part 84 stating that the respirators have 
been approved for use with ethylene oxide. For effective protection, 
respirators must fit your face and head snugly. Respirators must not be 
loosened or removed in work situations where their use is required.
    EtO does not have a detectable odor except at levels well above the 
permissible exposure limits. If you can smell EtO while wearing a 
respirator, proceed immediately to fresh air. If you experience 
difficulty breathing while wearing a respirator, tell your employer.
    B. Protective clothing: You may be required to wear impermeable 
clothing, gloves, a face shield, or other appropriate protective 
clothing to prevent skin contact with liquid EtO or EtO-containing 
solutions. Where protective clothing is required, your employer must 
provide clean garments to you as necessary to assure that the clothing 
protects you adequately.
    Replace or repair protective clothing that has become torn or 
otherwise damaged.
    EtO must never be allowed to remain on the skin. Clothing and shoes 
which are not impermeable to EtO should not be allowed to become 
contaminated with EtO, and if they do, the clothing should be promptly 
removed and decontaminated. Contaminated leather shoes should be 
discarded. Once EtO penetrates shoes or other leather articles, they 
should not be worn again.
    C. Eye protection: You must wear splashproof safety goggles in areas 
where liquid EtO or EtO-containing solutions may contact your eyes. In 
addition, contact lenses should not be worn in areas where eye contact 
with EtO can occur.

           v. Precautions for Safe Use, Handling, and Storage

    A. EtO is a flammable liquid, and its vapors can easily form 
explosive mixtures in air.
    B. EtO must be stored in tighly closed containers in a cool, well-
ventilated area, away from heat, sparks, flames, strong oxidizers, 
alkalines, and acids, strong bases, acetylide-forming metals such as 
cooper, silver, mercury and their alloys.
    C. Sources of ignition such as smoking material, open flames and 
some electrical devices are prohibited wherever EtO is handled, used, or 
stored in a manner that could create a potential fire or explosion 
hazard.
    D. You should use non-sparking tools when opening or closing metal 
containers of EtO, and containers must be bonded and grounded in the 
rare instances in which liquid EtO is poured or transferred.
    E. Impermeable clothing wet with liquid EtO or EtO-containing 
solutions may be easily ignited. If your are wearing impermeable 
clothing and are splashed with liquid EtO or EtO-containing solution, 
you should immediately remove the clothing while under an emergency 
deluge shower.
    F. If your skin comes into contact with liquid EtO or EtO-containing 
solutions, you should immediately remove the EtO using an emergency 
deluge shower.
    G. You should not keep food, beverages, or smoking materials in 
regulated areas where employee exposures are above the permissible 
exposure limits.
    H. Fire extinguishers and emergency deluge showers for quick 
drenching should be readily available, and you should know where they 
are and how to operate them.
    I. Ask your supervisor where EtO is used in your work area and for 
any additional plant safety and health rules.

                        vi. Access to Information

    A. Each year, your employer is required to inform you of the 
information contained in this standard and appendices for EtO. In 
addition, your employer must instruct you in the proper work practices 
for using EtO emergency procedures, and the correct use of protective 
equipment.
    B. Your employer is required to determine whether you are being 
exposed to EtO. You or your representative has the right to observe 
employee measurements and to record the results obtained. Your employer 
is required to inform you of your exposure. If your employer determine 
that you are being overexposed, he or she is required to inform you of 
the actions which are being taken to reduce your exposure to within 
permissible exposure limits.
    C. Your employer is required to keep records of your exposures and 
medical examinations. These exposure records must be kept by the 
employer 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.

    vii. Sterilant Use of Eto in Hospitals and Health Care Facilities

    This section of appendix A, for informational purposes, sets forth 
EPA's recommendations for modifications in workplace design and practice 
in hospitals and health care facilities for which the Environmental 
Protection Agency has registered EtO for uses as a sterilant or fumigant 
under the Federal Insecticide, Funigicide, and Rodenticide Act, 7 U.S.C. 
136 et seq. These new recommendations, published in the Federal Register 
by EPA at 49 FR 15268, as modified in today's Register, are intended to 
help reduce the exposure of hospital and health care workers to EtO to 1 
ppm. EPA's

[[Page 383]]

recommended workplace design and workplace practice are as follows:

                           1. Workplace Design

    a. Installation of gas line hand valves. Hand valves must be 
installed on the gas supply line at the connection to the supply 
cylinders to minimize leakage during cylinder change.
    b. Installation of capture boxes. Sterilizer operations result in a 
gas/water discharge at the completion of the process. This discharge is 
routinely piped to a floor drain which is generally located in an 
equipment or an adjacent room. When the floor drain is not in the same 
room as the sterilizer and workers are not normally present, all that is 
necessary is that the room be well ventilated.
    The installation of a ``capture box'' will be required for those 
work place layouts where the floor drain is located in the same room as 
the sterilizer or in a room where workers are normally present. A 
``capture box'' is a piece of equipment that totally encloses the floor 
drain where the discharge from the sterilizer is pumped. The ``capture 
box'' is to be vented directly to a non-recirculating or dedicated 
ventilation system. Sufficient air intake should be allowed at the 
bottom of the box to handle the volume of air that is ventilated from 
the top of the box. The ``capture box'' can be made of metal, plastic, 
wood or other equivalent material. The box is intended to reduce levels 
of EtO discharged into the work room atmosphere. The use of a ``capture 
box'' is not required if: (1) The vacuum pump discharge floor drain is 
located in a well ventilated equipment or other room where workers are 
not normally present or (2) the water sealed vacuum pump discharges 
directly to a closed sealed sewer line (check local plumbing codes).
    If it is impractical to install a vented ``capture box'' and a well 
ventilated equipment or other room is not feasible, a box that can be 
sealed over the floor drain may be used if: (1) The floor drain is 
located in a room where workers are not normally present and EtO cannot 
leak into an occupied area, and (2) the sterilizer in use is less than 
12 cubic feet in capacity (check local plumbing codes).
    c. Ventilation of aeration units i. Existing aeration units. 
Existing units must be vented to a non-recirculating or dedicated system 
or vented to an equipment or other room where workers are not normally 
present and which is well ventilated. Aerator units must be positioned 
as close as possible to the sterilizer to minimize the exposure from the 
off-gassing of sterilized items.
    ii. Installation of new aerator units (where none exist). New 
aerator units must be vented as described above for existing aerators. 
Aerators must be in place by July 1, 1986.
    d. Ventilation during cylinder change. Workers may be exposed to 
short but relatively high levels of EtO during the change of gas 
cylinders. To reduce exposure from this route, users must select one of 
three alternatives designed to draw off gas that may be released when 
the line from the sterilizer to the cylinder is disconnected:
    i. Location of cylinders in a well ventilated equipment room or 
other room where workers are not normally present.
    ii. Installation of a flexible hose (at least 4 in 
diameter) to a non-recirculating or dedicated ventilation system and 
located in the area of cylinder change in such a way that the hose can 
be positioned at the point where the sterilizer gas line is disconnected 
from the cylinder.
    iii. Installation of a hood that is part of a non-recirculating or 
dedicated system and positioned no more than one foot above the point 
where the change of cylinders takes place.
    e. Ventilation of sterilizer door area. One of the major sources of 
exposure to EtO occurs when the sterilizer door is opened following the 
completion of the sterilization process. In order to reduce this avenue 
of exposure, a hood or metal canopy closed on each end must be installed 
over the sterilizer door. The hood or metal canopy must be connected to 
a non-recirculating or dedicated ventilation system or one that exhausts 
gases to a well ventilated equipment or other room where workers are not 
normally present. A hood or canopy over the sterilizer door is required 
for use even with those sterilizers that have a purge cycle and must be 
in place by July 1, 1986.
    f. Ventilation of sterilizer relief valve. Sterilizers are typically 
equipped with a safety relief device to release gas in case of increased 
pressure in the sterilizer. Generally, such relief devices are used on 
pressure vessels. Although these pressure relief devices are rarely 
opened for hospital and health care sterilizers, it is suggested that 
they be designed to exhaust vapor from the sterilizer by one of the 
following methods:
    i. Through a pipe connected to the outlet of the relief valve 
ventilated directly outdoors at a point high enough to be away from 
passers by, and not near any windows that open, or near any air 
conditioning or ventilation air intakes.
    ii. Through a connection to an existing or new non-recirculating or 
dedicated ventilation system.
    iii. Through a connection to a well ventilated equipment or other 
room where workers are not normally present.
    g. Ventilation systems. Each hospital and health care facility 
affected by this notice that uses EtO for the sterilization of equipment 
and supplies must have a ventilation system which enables compliance 
with the requirements of section (b) through (f) in the

[[Page 384]]

manner described in these sections and within the timeframes allowed. 
Thus, each affected hospital and health care facility must have or 
install a non-recirculating or dedicated ventilation equipment or other 
room where workers are not normally present in which to vent EtO.
    h. Installation of alarm systems. An audible and visual indicator 
alarm system must be installed to alert personnel of ventilation system 
failures, i.e., when the ventilation fan motor is not working.

                         2. Workplace Practices

    All the workplace practices discussed in this unit must be 
permanently posted near the door of each sterilizer prior to use by any 
operator.
    a. Changing of supply line filters. Filters in the sterilizer liquid 
line must be changed when necessary, by the following procedure:
    i. Close the cylinder valve and the hose valve.
    ii. Disconnect the cylinder hose (piping) from the cylinder.
    iii. Open the hose valve and bleed slowly into a proper ventilating 
system at or near the in-use supply cylinders.
    iv. Vacate the area until the line is empty.
    v. Change the filter.
    vi. Reconnect the lines and reverse the value position.
    vii. Check hoses, filters, and valves for leaks with a fluorocarbon 
leak detector (for those sterilizers using the 88 percent 
chlorofluorocarbon, 12 percent ethylene oxide mixture (12/88)).
    b. Restricted access area. i. Areas involving use of EtO must be 
designated as restricted access areas. They must be identified with 
signs or floor marks near the sterilizer door, aerator, vacuum pump 
floor drain discharge, and in-use cylinder storage.
    ii. All personnel must be excluded from the restricted area when 
certain operations are in progress, such as discharging a vacuum pump, 
emptying a sterilizer liquid line, or venting a non-purge sterilizer 
with the door ajar or other operations where EtO might be released 
directly into the face of workers.
    c. Door opening procedures. i. Sterilizers with purge cycles. A load 
treated in a sterilizer equipped with a purge cycle should be removed 
immediately upon completion of the cycle (provided no time is lost 
opening the door after cycle is completed). If this is not done, the 
purge cycle should be repeated before opening door.
    ii. Sterilizers without purge cycles. For a load treated in a 
sterilizer not equipped with a purge cycle, the sterilizer door must be 
ajar 6 for 15 minutes, and then fully opened for at least 
another 15 minutes before removing the treated load. The length of time 
of the second period should be established by peak monitoring for one 
hour after the two 15-minute periods suggested. If the level is above 10 
ppm time-weighted average for 8 hours, more time should be added to the 
second waiting period (door wide open). However, in no case may the 
second period be shortened to less than 15 minutes.
    d. Chamber unloading procedures. i. Procedures for unloading the 
chamber must include the use of baskets or rolling carts, or baskets and 
rolling tables to transfer treated loads quickly, thus avoiding 
excessive contact with treated articles, and reducing the duration of 
exposures.
    ii. If rolling carts are used, they should be pulled not pushed by 
the sterilizer operators to avoid offgassing exposure.
    e. Maintenance. A written log should be instituted and maintained 
documenting the date of each leak detection and any maintenance 
procedures undertaken. This is a suggested use practice and is not 
required.
    i. Leak detection. Sterilizer door gaskets, cylinder and vacuum 
piping, hoses, filters, and valves must be checked for leaks under full 
pressure with a Fluorocarbon leak detector (for 12/88 systems only) 
every two weeks by maintenance personnel. Also, the cylinder piping 
connections must be checked after changing cylinders. Particular 
attention in leak detection should be given to the automatic solenoid 
valves that control the flow of EtO to the sterilizer. Specifically, a 
check should be made at the EtO gasline entrance port to the sterilizer, 
while the sterilizer door is open and the solenoid valves are in a 
closed position.
    ii. Maintenance procedures. Sterilizer/areator door gaskets, valves, 
and fittings must be replaced when necessary as determined by 
maintenance personnel in their bi-weekly checks; in addition, visual 
inspection of the door gaskets for cracks, debris, and other foreign 
substances should be conducted daily by the operator.

   Appendix B to Sec.  1910.1047--Substance Technical Guidelines for 
                     Ethylene Oxide (Non-Mandatory)

                      i. Physical and Chemical Data

    A. Substance identification:
    1. Synonyms: dihydrooxirene, dimethylene oxide, EO, 1,2-epoxyethane, 
EtO ETO oxacyclopropane, oxane, oxidoethane, alpha/beta-oxidoethane, 
oxiran, oxirane.
    2. Formula: (C2 H4 O).
    3. Molecular weight: 44.06
    B. Physical data:
    1. Boiling point (760 mm Hg): 10.70 [deg]C (51.3 [deg]F);
    2. Specific gravity (water = 1): 0.87 (at 20 [deg]C or 68 [deg]F)
    3. Vapor density (air = 1): 1.49;
    4. Vapor pressure (at 20 [deg]C); 1,095 mm Hg;
    5. Solubility in water: complete;
    6. Appearance and odor: colorless liquid; gas at temperature above 
10.7 [deg]F or 51.3 [deg]C with ether-like odor above 700 ppm.

[[Page 385]]

             ii. Fire, Explosion, and Reactivity Hazard Data

    A. Fire:
    1. Flash point: less than O [deg]F (open cup);
    2. Stability: decomposes violently at temperatures above 800 [deg]F;
    3. Flammable limits in air, percent by volume: Lower: 3, Upper: 100;
    4. Extinguishing media: Carbon dioxide for small fires, polymer or 
alcohol foams for large fires;
    5. Special fire fighting procedures: Dilution of ethylene oxide with 
23 volumes of water renders it non-flammable;
    6. Unusual fire and explosion hazards: Vapors of EtO will burn 
without the presence of air or other oxidizers. EtO vapors are heavier 
than air and may travel along the ground and be ignited by open flames 
or sparks at locations remote from the site at which EtO is being used.
    7. For purposes of compliance with the requirements of 29 CFR 
1910.106, EtO is classified as a flammable gas. For example, 7,500 ppm, 
approximately one-fourth of the lower flammable limit, would be 
considered to pose a potential fire and explosion hazard.
    8. For purposes of compliance with 29 CFR 1910.155, EtO is 
classified as a Class B fire hazard.
    9. For purpose of compliance with 29 CFR 1919.307, locations 
classified as hazardous due to the presence of EtO shall be Class I.
    B. Reactivity:
    1. Conditions contributing to instability: EtO will polymerize 
violently if contaminated with aqueous alkalies, amines, mineral acids, 
metal chlorides, or metal oxides. Violent decomposition will also occur 
at temperatures above 800 [deg]F;
    2. Incompatabilities: Alkalines and acids;
    3. Hazardous decomposition products: Carbon monoxide and carbon 
dioxide.

                iii. Spill, Leak, and Disposal Procedures

    A. If EtO is spilled or leaked, the following steps should be taken:
    1. Remove all ignition sources.
    2. The area should be evacuated at once and re-entered only after 
the area has been thoroughly ventilated and washed down with water.
    B. Persons not wearing appropriate protective equipment should be 
restricted from areas of spills or leaks until cleanup has been 
completed.
    C. Waste disposal methods: Waste material should be disposed of in a 
manner that is not hazardous to employees or to the general population. 
In selecting the method of waste disposal, applicable local, State, and 
Federal regulations should be consulted.

                iv. Monitoring and Measurement Procedures

    A. Exposure above the Permissible Exposure Limit:
    1. Eight-hour exposure evaluation: Measurements taken for the 
purpose of determining employee exposure under this section are best 
taken with consecutive samples covering the full shift. Air samples 
should be taken in the employee's breathing zone (air that would most 
nearly represent that inhaled by the employee.)
    2. Monitoring techniques: The sampling and analysis under this 
section may be performed by collection of the EtO vapor on charcoal 
adsorption tubes or other composition adsorption tubes, with subsequent 
chemical analysis. Sampling and analysis may also be performed by 
instruments such as real-time continuous monitoring systems, portable 
direct reading instruments, or passive dosimeters as long as 
measurements taken using these methods accurately evaluate the 
concentration of EtO in employees' breathing zones.
    Appendix D describes the validated method of sampling and analysis 
which has been tested by OSHA for use with EtO. Other available methods 
are also described in appendix D. The employer has the obligation of 
selecting a monitoring method which meets the accuracy and precision 
requirements of the standard under his unique field conditions. The 
standard requires that the method of monitoring should be accurate, to a 
95 percent confidence level, to plus or minus 25 percent for 
concentrations of EtO at 1 ppm, and to plus or minus 35 percent for 
concentrations at 0.5 ppm. In addition to the method described in 
appendix D, there are numerous other methods available for monitoring 
for EtO in the workplace. Details on these other methods have been 
submitted by various companies to the rulemaking record, and are 
available at the OSHA Docket Office.
    B. Since many of the duties relating to employee exposure are 
dependent on the results of measurement procedures, employers should 
assure that the evaluation of employee exposures is performed by a 
technically qualified person.

                  v. Protective Clothing and Equipment

    Employees should be provided with and be required to wear 
appropriate protective clothing wherever there is significant potential 
for skin contact with liquid EtO or EtO-containing solutions. Protective 
clothing shall include impermeable coveralls or similar full-body work 
clothing, gloves, and head coverings, as appropriate to protect areas of 
the body which may come in contact with liquid EtO or EtO-containing 
solutions.
    Employers should ascertain that the protective garments are 
impermeable to EtO. Permeable clothing, including items made of

[[Page 386]]

rubber, and leather shoes should not be allowed to become contaminated 
with liquid EtO. If permeable clothing does become contaminated, it 
should be immediately removed, while the employer is under an emergency 
deluge shower. If leather footwear or other leather garments become wet 
from EtO they should be discarded and not be worn again, because leather 
absorbs EtO and holds it against the skin.
    Any protective clothing that has been damaged or is otherwise found 
to be defective should be repaired or replaced. Clean protective 
clothing should be provided to the employee as necessary to assure 
employee protection. Whenever impermeable clothing becomes wet with 
liquid EtO, it should be washed down with water before being removed by 
the employee. Employees are also required to wear splash-proof safety 
goggles where there is any possibility of EtO contacting the eyes.

                      vi. Miscellaneous Precautions

    A. Store EtO in tightly closed containers in a cool, well-ventilated 
area and take all necessary precautions to avoid any explosion hazard.
    B. Non-sparking tools must be used to open and close metal 
containers. These containers must be effectively grounded and bonded.
    C. Do not incinerate EtO cartridges, tanks or other containers.
    D. Employers should advise employees of all areas and operations 
where exposure to EtO occur.

                         vii. Common Operations

    Common operations in which exposure to EtO is likely to occur 
include the following: Manufacture of EtO, surfactants, ethanolamines, 
glycol ethers, and specialty chemicals, and use as a sterilant in the 
hospital, health product and spice industries.

   Appendix C to Sec.  1910.1047--Medical Surveillance Guidelines for 
                     Ethylene Oxide (Non-Mandatory)

                            i. route of entry

    Inhalation.

                             ii. toxicology

    Clinical evidence of adverse effects associated with the exposure to 
EtO is present in the form of increased incidence of cancer in 
laboratory animals (leukemia, stomach, brain), mutation in offspring in 
animals, and resorptions and spontaneous abortions in animals and human 
populations respectively. Findings in humans and experimental animals 
exposed to airborne concentrations of EtO also indicate damage to the 
genetic material (DNA). These include hemoglobin alkylation, 
unsecheduled DNA synthesis, sister chromatid exchange chromosomal 
aberration, and functional sperm abnormalities.
    Ethylene oxide in liquid form can cause eye irritation and injury to 
the cornea, frostbite, severe irritation, and blistering of the skin 
upon prolonged or confined contact. Ingestion of EtO can cause gastric 
irritation and liver injury. Other effects from inhalation of EtO vapors 
include respiratory irritation and lung injury, headache, nausea, 
vomiting, diarrhea, dyspnea and cyanosis.

              iii. signs and symptoms of acute overexposure

    The early effects of acute overexposure to EtO are nausea and 
vomiting, headache, and irritation of the eyes and respiratory passages. 
The patient may notice a ``peculiar taste'' in the mouth. Delayed 
effects can include pulmonary edema, drowsiness, weakness, and 
incoordination. Studies suggest that blood cell changes, an increase in 
chromosomal aberrations, and spontaneous abortion may also be causally 
related to acute overexposure to EtO.
    Skin contact with liquid or gaseous EtO causes characteristic burns 
and possibly even an allergic-type sensitization. The edema and erythema 
occurring from skin contact with EtO progress to vesiculation with a 
tendency to coalesce into blebs with desquamation. Healing occurs within 
three weeks, but there may be a residual brown pigmentation. A 40-80% 
solution is extremely dangerous, causing extensive blistering after only 
brief contact. Pure liquid EtO causes frostbite because of rapid 
evaporation. In contrast, the eye is relatively insensitive to EtO, but 
there may be some irritation of the cornea.
    Most reported acute effects of occupational exposure to EtO are due 
to contact with EtO in liquid phase. The liquid readily penetrates 
rubber and leather, and will produce blistering if clothing or footwear 
contaminated with EtO are not removed.

             iv. surveillance and preventive considerations

    As noted above, exposure to EtO has been linked to an increased risk 
of cancer and reproductive effects including decreased male fertility, 
fetotoxicity, and spontaneous abortion. EtO workers are more likely to 
have chromosomal damage than similar groups not exposed to EtO. At the 
present, limited studies of chronic effects in humans resulting from 
exposure to EtO suggest a causal association with leukemia. Animal 
studies indicate leukemia and cancers at other sites (brain, stomach) as 
well. The physician should be aware of the findings of these studies in 
evaluating the health of employees exposed to EtO.
    Adequate screening tests to determine an employee's potential for 
developing serious

[[Page 387]]

chronic diseases, such as cancer, from exposure to EtO do not presently 
exist. Laboratory tests may, however, give evidence to suggest that an 
employee is potentially overexposed to EtO. It is important for the 
physician to become familiar with the operating conditions in which 
exposure to EtO is likely to occur. The physician also must become 
familiar with the signs and symptoms that indicate a worker is receiving 
otherwise unrecognized and unacceptable exposure to EtO. These elements 
are especially important in evaluating the medical and work histories 
and in conducting the physical exam. When an unacceptable exposure in an 
active employee is identified by the physician, measures taken by the 
employer to lower 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 EtO at or above the 
action level (0.5 ppm) for at least 30 days per year, without regard to 
respirator use. All examinations and procedures must be performed by or 
under the supervision of a licensed physician at a reasonable time and 
place for the employee and at no cost to the employee.
    Although broad latitude in prescribing specific tests to be included 
in the medical surveillance program is extended to the examining 
physician, OSHA requires inclusion of the following elements in the 
routine examination:
    (i) Medical and work histories with special emphasis directed to 
symptoms related to the pulmonary, hematologic, neurologic, and 
reproductive systems and to the eyes and skin.
    (ii) Physical examination with particular emphasis given to the 
pulmonary, hematologic, neurologic, and reproductive systems and to the 
eyes and skin.
    (iii) Complete blood count to include at least a white cell count 
(including differential cell count), red cell count, hematocrit, and 
hemoglobin.
    (iv) Any laboratory or other test which the examining physician 
deems necessary by sound medical practice.
    If requested by the employee, the medical examinations shall include 
pregnancy testing or laboratory evaluation of fertility as deemed 
appropriate by the physician.
    In certain cases, to provide sound medical advice to the employer 
and the employee, the physician must evaluate situations not directly 
related to EtO. For example, employees with skin diseases may be unable 
to tolerate wearing protective clothing. In addition those with chronic 
respiratory diseases may not tolerate the wearing of negative pressure 
(air purifying) respirators. Additional tests and procedures that will 
help the physician determine which employees are medically unable to 
wear such respirators should include: An evaluation of cardiovascular 
function, a baseline chest x-ray to be repeated at five year intervals, 
and a pulmonary function test to be repeated every three years. The 
pulmonary function test should include measurement of the employee's 
forced vital capacity (FVC), forced expiratory volume at one second 
(FEV1), as well as calculation of the ratios of FEV1 to FVC, and 
measured FVC and measured FEV1 to expected values corrected for 
variation due to age, sex, race, and height.
    The employer is required to make the prescribed tests available at 
least annually to employees who are or will be exposed at or above the 
action level, for 30 or more days per year; more often than specified if 
recommended by the examining physician; and upon the employee's 
termination of employment or reassignment to another work area. While 
little is known about the long term consequences of high short-term 
exposures, it appears prudent to monitor such affected employees closely 
in light of existing health data. The employer shall provide physician 
recommended examinations to any employee exposed to EtO in emergency 
conditions. Likewise, the employer shall make available medical 
consultations including physician recommended exams to employees who 
believe they are suffering signs or symptoms of exposure to EtO.
    The employer is required to provide the physician with the following 
informatin: a copy of this standard and its appendices; a description of 
the affected employee's duties as they relate to the employee exposure 
level; and information from the employee's previous medical examinations 
which is not readily available to the examining 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, when required.
    The employer is required to obtain a written opinion from the 
examining physician containing the results of the medical examinations; 
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 his or her health from exposure to EtO; any 
recommended restrictions upon the employee's exposure to EtO, or upon 
the use of protective clothing or equipment such as respirators; and a 
statement that the employee has been informed by the physician of the 
results of the medical examination and of any medical conditions which 
require further explanation or treatment. This written opinion must not 
reveal specific findings or diagnoses unrelated to occupational exposure 
to EtO, and a copy of the opinion must be provided to the affected 
employee.
    The purpose in requiring the examining physician to supply the 
employer with a

[[Page 388]]

written opinion is to provide the employer with a medical basis to aid 
in the determination of initial placement of employees and to assess the 
employee's ability to use protective clothing and equipment.

   Appendix D to Sec.  1910.1047--Sampling and Analytical Methods for 
                     Ethylene Oxide (Non-Mandatory)

    A number of methods are available for monitoring employee exposures 
to EtO. Most of these involve the use of charcoal tubes and sampling 
pumps, followed by analysis of the samples by gas chromatograph. The 
essential differences between the charcoal tube methods include, among 
others, the use of different desorbing solvents, the use of different 
lots of charcoal, and the use of different equipment for analysis of the 
samples.
    Besides charcoal, methods using passive dosimeters, gas sampling 
bags, impingers, and detector tubes have been utilized for determination 
of EtO exposure. In addition, there are several commercially available 
portable gas analyzers and monitoring units.
    This appendix contains details for the method which has been tested 
at the OSHA Analytical Laboratory in Salt Lake City. Inclusion of this 
method in the appendix does not mean that this method is the only one 
which will be satisfactory. Copies of descriptions of other methods 
available are available in the rulemaking record, and may be obtained 
from the OSHA Docket Office. These include the Union Carbide, Dow 
Chemical, 3M, and DuPont methods, as well as NIOSH Method S-286. These 
methods are briefly described at the end of this appendix.
    Employers who note problems with sample breakthrough using the OSHA 
or other charcoal methods should try larger charcoal tubes. Tubes of 
larger capacity are available. In addition, lower flow rates and shorter 
sampling times should be beneficial in minimizing breakthrough problems. 
Whatever method the employer chooses, he must assure himself of the 
method's accuracy and precision under the unique conditions present in 
his workplace.

                             Ethylene Oxide

    Method No.: 30.
    Matrix: Air.
    Target Concentration: 1.0 ppm (1.8 mg/m\3\).
    Procedure: Samples are collected on two charcoal tubes in series and 
desorbed with 1% CS2 in benzene. The samples are derivatized 
with HBr and treated with sodium carbonate. Analysis is done by gas 
chromatography with an electron capture detector.
    Recommended Air Volume and Sampling Rate: 1 liter and 0.05 Lpm.
    Detection Limit of the Overall Procedure: 13.3 ppb (0.024 mg/m\3\) 
(Based on 1.0 liter air sample).
    Reliable Quantitation Limit: 52.2 ppb (0.094 mg/m\3\) (Based on 1.0 
liter air sample).
    Standard Error of Estimate: 6.59% (See Backup Section 4.6).
    Special Requirements: Samples must be analyzed within 15 days of 
sampling date.
    Status of Method: The sampling and analytical method has been 
subjected to the established evaluation procedures of the Organic Method 
Evaluations Branch.

    Date: August 1981.
    Chemist: Wayne D. Potter.

  Organic Solvents Branch, OSHA Analytical Laboratory, Salt Lake City, 
                                  Utah

    1. General Discussion.
    1.1 Background.
    1.1.1 History of Procedure.
    Ethylene oxide samples analyzed at the OSHA Laboratory have normally 
been collected on activated charcoal and desorbed with carbon disulfide. 
The analysis is performed with a gas chromatograph equipped with a FID 
(Flame ionization detector) as described in NIOSH Method S286 (Ref. 
5.1). This method is based on a PEL of 50 ppm and has a detection limit 
of about 1 ppm.
    Recent studies have prompted the need for a method to analyze and 
detect ethylene oxide at very low concentrations.
    Several attempts were made to form an ultraviolet (UV) sensitive 
derivative with ethylene oxide for analysis with HPLC. Among those 
tested that gave no detectable product were: p-anisidine, 
methylimidazole, aniline, and 2,3,6-trichlorobenzoic acid. Each was 
tested with catalysts such as triethylamine, aluminum chloride, 
methylene chloride and sulfuric acid but no detectable derivative was 
produced.
    The next derivatization attempt was to react ethylene oxide with HBr 
to form 2-bromoethanol. This reaction was successful. An ECD (electron 
capture detector) gave a very good response for 2-bromoethanol due to 
the presence of bromine. The use of carbon disulfide as the desorbing 
solvent gave too large a response and masked the 2-bromoethanol. Several 
other solvents were tested for both their response on the ECD and their 
ability to desorb ethylene oxide from the charcoal. Among those tested 
were toluene, xylene, ethyl benzene, hexane, cyclohexane and benzene. 
Benzene was the only solvent tested that gave a suitable response on the 
ECD and a high desorption. It was found that the desorption efficiency 
was improved by using 1% CS2 with the benzene. The carbon 
disulfide did not significantly improve the recovery with the other 
solvents. SKC Lot 120 was used in all tests done with activated 
charcoal.
    1.1.2 Physical Properties (Ref. 5.2-5.4).
    Synonyms: Oxirane; dimethylene oxide, 1,2-epoxy-ethane; oxane; 
C2 H4 O; ETO;
    Molecular Weight: 44.06

[[Page 389]]

    Boiling Point: 10.7 [deg]C (51.3[deg])
    Melting Point: -111 [deg]C
    Description: Colorless, flammable gas
    Vapor Pressure: 1095 mm. at 20 [deg]C
    Odor: Ether-like odor
    Lower Explosive Limits: 3.0% (by volume)
    Flash Point (TOC): Below 0 [deg]F
    Molecular Structure: CH2--CH2

    1.2 Limit Defining Parameters.
    1.2.1 Detection Limit of the Analytical Procedure.
    The detection limit of the analytical procedure is 12.0 picograms of 
ethylene oxide per injection. This is the amount of analyte which will 
give a peak whose height is five times the height of the baseline noise. 
(See Backup Data Section 4.1).
    1.2.2 Detection Limit of the Overall Procedure.
    The detection limit of the overall procedure is 24.0 ng of ethylene 
oxide per sample.
    This is the amount of analyte spiked on the sampling device which 
allows recovery of an amount of analyte equivalent to the detection 
limit of the analytical procedure. (See Backup Data Section 4.2).
    1.2.3 Reliable Quantitation Limit.
    The reliable quantitation limit is 94.0 nanograms of ethylene oxide 
per sample. This is the smallest amount of analyte which can be 
quantitated within the requirements of 75% recovery and 95% confidence 
limits. (See Backup Data Section 4.2).
    It must be recognized that the reliable quantitation limit and 
detection limits reported in the method are based upon optimization of 
the instrument for the smallest possible amount of analyte. When the 
target concentration of an analyte is exceptionally higher than these 
limits, they may not be attainable at the routine operating parameters. 
In this case, the limits reported on analysis reports will be based on 
the operating parameters used during the analysis of the samples.
    1.2.4 Sensitivity.
    The sensitivity of the analytical procedure over a concentration 
range representing 0.5 to 2 times the target concentration based on the 
recommended air volume is 34105 area units per [micro]g/mL. The 
sensitivity is determined by the slope of the calibration curve (See 
Backup Data Section 4.3).
    The sensitivity will vary somewhat with the particular instrument 
used in the analysis.
    1.2.5 Recovery.
    The recovery of analyte from the collection medium must be 75% or 
greater. The average recovery from spiked samples over the range of 0.5 
to 2 times the target concentration is 88.0% (See Backup Section 4.4). 
At lower concentrations the recovery appears to be non-linear.
    1.2.6 Precision (Analytical Method Only).
    The pooled coefficient of variation obtained from replicate 
determination of analytical standards at 0.5X, 1X and 2X the target 
concentration is 0.036 (See Backup Data Section 4.5).
    1.2.7 Precision (Overall Procedure).
    The overall procedure must provide results at the target 
concentration that are 25% of better at the 95% confidence level. The 
precision at the 95% confidence level for the 15 day storage test is 
plus or minus 12.9% (See Backup Data Section 4.6).
    This includes an additional plus or minus 5% for sampling error.
    1.3 Advantages.
    1.3.1 The sampling procedure is convenient.
    1.3.2 The analytical procedure is very sensitive and reproducible.
    1.3.3 Reanalysis of samples is possible.
    1.3.4 Samples are stable for at least 15 days at room temperature.
    1.3.5 Interferences are reduced by the longer GC retention time of 
the new derivative.
    1.4 Disadvantages.
    1.4.1 Two tubes in series must be used because of possible 
breakthrough and migration.
    1.4.2 The precision of the sampling rate may be limited by the 
reproducibility of the pressure drop across the tubes. The pumps are 
usually calibrated for one tube only.
    1.4.3 The use of benzene as the desorption solvent increases the 
hazards of analysis because of the potential carcinogenic effects of 
benzene.
    1.4.4 After repeated injections there can be a buildup of residue 
formed on the electron capture detector which decreases sensitivity.
    1.4.5 Recovery from the charcoal tubes appears to be nonlinear at 
low concentrations.
    2. Sampling Procedure.
    2.1 Apparatus.
    2.1.1 A calibrated personal sampling pump whose flow can be 
determined within plus or minus 5% of the recommended flow.
    2.1.2 SKC Lot 120 Charcoal tubes: glass tube with both ends flame 
sealed, 7 cm long with a 6 mm O.D. and a 4-mm I.D., containing 2 
sections of coconut shell charcoal separated by a 2-mm portion of 
urethane foam. The adsorbing section contains 100 mg of charcoal, the 
backup section 50 mg. A 3-mm portion of urethane foam is placed between 
the outlet end of the tube and the backup section. A plug of silylated 
glass wool is placed in front of the adsorbing section.
    2.2 Reagents.
    2.2.1 None required.
    2.3 Sampling Technique.
    2.3.1 Immediately before sampling, break the ends of the charcoal 
tubes. All tubes must be from the same lot.
    2.3.2 Connect two tubes in series to the sampling pump with a short 
section of flexible tubing. A minimum amount of tubing is

[[Page 390]]

used to connect the two sampling tubes together. The tube closer to the 
pump is used as a backup. This tube should be identified as the backup 
tube.
    2.3.3 The tubes should be placed in a vertical position during 
sampling to minimize channeling.
    2.3.4 Air being sampled should not pass through any hose or tubing 
before entering the charcoal tubes.
    2.3.5 Seal the charcoal tubes with plastic caps immediately after 
sampling. Also, seal each sample with OSHA seals lengthwise.
    2.3.6 With each batch of samples, submit at least one blank tube 
from the same lot used for samples. This tube should be subjected to 
exactly the same handling as the samples (break, seal, transport) except 
that no air is drawn through it.
    2.3.7 Transport the samples (and corresponding paperwork) to the lab 
for analysis.
    2.3.8 If bulk samples are submitted for analysis, they shoud be 
transported in glass containers with Teflon-lined caps. These samples 
must be mailed separately from the container used for the charcoal 
tubes.
    2.4 Breakthrough.
    2.4.1 The breakthrough (5% breakthrough) volume for a 3.0 mg/m 
ethylene oxide sample stream at approximately 85% relative humidity, 22 
[deg]C and 633 mm is 2.6 liters sampled at 0.05 liters per minute. This 
is equivalent to 7.8 [micro]g of ethylene oxide. Upon saturation of the 
tube it appeared that the water may be displacing ethylene oxide during 
sampling.
    2.5 Desorption Efficiency.
    2.5.1 The desorption efficiency, from liquid injection onto charcoal 
tubes, averaged 88.0% from 0.5 to 2.0 x the target concentration for a 
1.0 liter air sample. At lower ranges it appears that the desorption 
efficiency is non-linear (See Backup Data Section 4.2).
    2.5.2 The desorption efficiency may vary from one laboratory to 
another and also from one lot of charcoal to another. Thus, it is 
necessary to determine the desorption efficiency for a particular lot of 
charcoal.
    2.6 Recommended Air Volume and Sampling Rate.
    2.6.1 The recommended air volume is 1.0 liter.
    2.6.2 The recommended maximum sampling rate is 0.05 Lpm.
    2.7 Interferences.
    2.7.1 Ethylene glycol and Freon 12 at target concentration levels 
did not interfere with the collection of ethylene oxide.
    2.7.2 Suspected interferences should be listed on the sample data 
sheets.
    2.7.3 The relative humidity may affect the sampling procedure.
    2.8 Safety Precautions.
    2.8.1 Attach the sampling equipment to the employee so that it does 
not interfere with work performance.
    2.8.2 Wear safety glasses when breaking the ends of the sampling 
tubes.
    2.8.3 If possible, place the sampling tubes in a holder so the sharp 
end is not exposed while sampling.
    3. Analytical Method.
    3.1 Apparatus.
    3.1.1 Gas chromatograph equipped with a linearized electron capture 
detector.
    3.1.2 GC column capable of separating the derivative of ethylene 
oxide (2-bromoethanol) from any interferences and the 1% CS2 
in benzene solvent. The column used for validation studies was: 10 ft x 
\1/8\ inch stainless steel 20% SP-2100, .1% Carbowax 1500 on 100/120 
Supelcoport.
    3.1.3 An electronic integrator or some other suitable method of 
measuring peak areas.
    3.1.4 Two milliliter vials with Teflon-lined caps.
    3.1.5 Gas tight syringe--500 [micro]L or other convenient sizes for 
preparing standards.
    3.1.6 Microliter syringes--10 [micro]L or other convenient sizes for 
diluting standards and 1 [micro]L for sample injections.
    3.1.7 Pipets for dispensing the 1% CS2 in benzene 
solvent. The Glenco 1 mL dispenser is adequate and convenient.
    3.1.8 Volumetric flasks--5 mL and other convenient sizes for 
preparing standards.
    3.1.9 Disposable Pasteur pipets.
    3.2 Reagents.
    3.2.1 Benzene, reagent grade.
    3.2.2 Carbon Disulfide, reagent grade.
    3.2.3 Ethylene oxide, 99.7% pure.
    3.2.4 Hydrobromic Acid, 48% reagent grade.
    3.2.5 Sodium Carbonate, anhydrous, reagent grade.
    3.2.6 Desorbing reagent, 99% Benzene/1% CS2.
    3.3 Sample Preparation.
    3.3.1 The front and back sections of each sample are transferred to 
separate 2-mL vials.
    3.3.2 Each sample is desorbed with 1.0 mL of desorbing reagent.
    3.3.3 The vials are sealed immediately and allowed to desorb for one 
hour with occasional shaking.
    3.3.4 Desorbing reagent is drawn off the charcoal with a disposable 
pipet and put into clean 2-mL vials.
    3.3.5 One drop of HBr is added to each vial. Vials are resealed and 
HBr is mixed well with the desorbing reagent.
    3.3.6 About 0.15 gram of sodium carbonate is carefully added to each 
vial. Vials are again resealed and mixed well.
    3.4 Standard Preparation.
    3.4.1 Standards are prepared by injecting the pure ethylene oxide 
gas into the desorbing reagent.

[[Page 391]]

    3.4.2 A range of standards are prepared to make a calibration curve. 
A concentration of 1.0 [micro]L of ethylene oxide gas per 1 mL desorbing 
reagent is equivalent to 1.0 ppm air concentration (all gas volumes at 
25 [deg]C and 760 mm) for the recommended 1 liter air sample. This 
amount is uncorrected for desorption efficiency (See Backup Data Section 
4.2. for desorption efficiency corrections).
    3.4.3 One drop of HBr per mL of standard is added and mixed well.
    3.4.4 About 0.15 grams of sodium carbonate is carefully added for 
each drop of HBr (A small reaction will occur).
    3.5 Analysis.
    3.5.1 GC Conditions.
Nitrogen flow rate--10mL/min.
Injector Temperature--250 [deg]C
Detector Temperature--300 [deg]C
Column Temperature--100 [deg]C
Injection size--0.8 [micro]L
Elution time--3.9 minutes
    3.5.2 Peak areas are measured by an integrator or other suitable 
means.
    3.5.3 The integrator results are in area units and a calibration 
curve is set up with concentration vs. area units.
    3.6 Interferences.
    3.6.1 Any compound having the same retention time of 2-bromoethanol 
is a potential interference. Possible interferences should be listed on 
the sample data sheets.
    3.6.2 GC parameters may be changed to circumvent interferences.
    3.6.3 There are usually trace contaminants in benzene. These 
contaminants, however, posed no problem of interference.
    3.6.4 Retention time data on a single column is not considered proof 
of chemical identity. Samples over the 1.0 ppm target level should be 
confirmed by GC/Mass Spec or other suitable means.
    3.7 Calculations
    3.7.1 The concentration in [micro]g/mL for a sample is determined by 
comparing the area of a particular sample to the calibration curve, 
which has been prepared from analytical standards.
    3.7.2 The amount of analyte in each sample is corrected for 
desorption efficiency by use of a desorption curve.
    3.7.3 Analytical results (A) from the two tubes that compose a 
particular air sample are added together.
    3.7.4 The concentration for a sample is calculated by the following 
equation:
[GRAPHIC] [TIFF OMITTED] TC15NO91.038

where:

A = [micro]g/mL
B = desorption volume in milliliters
C = air volume in liters.

    3.7.5 To convert mg/m\3\ to parts per million (ppm) the following 
relationship is used:
[GRAPHIC] [TIFF OMITTED] TC15NO91.039

where:

mg/m\3\ = results from 3.7.4
24.45 = molar volume at 25 [deg]C and 760mm Hg
44.05 = molecular weight of ETO.

    3.8 Safety Precautions
    3.8.1 Ethylene oxide and benzene are potential carcinogens and care 
must be exercised when working with these compounds.
    3.8.2 All work done with the solvents (preparation of standards, 
desorption of samples, etc.) should be done in a hood.
    3.8.3 Avoid any skin contact with all of the solvents.
    3.8.4 Wear safety glasses at all times.
    3.8.5 Avoid skin contact with HBr because it is highly toxic and a 
strong irritant to eyes and skin.
    4. Backup Data.
    4.1 Detection Limit Data.
    The detection limit was determined by injecting 0.8 [micro]L of a 
0.015 [micro]g/mL standard of ethylene oxide into 1% CS2 in 
benzene. The detection limit of the analytical procedure is taken to be 
1.20 x 10-5 [micro]g per injection. This is equivalent to 8.3 
ppb (0.015 mg/m\3\) for the recommended air volume.
    4.2 Desorption Efficiency.
    Ethylene oxide was spiked onto charcoal tubes and the following 
recovery data was obtained.

------------------------------------------------------------------------
     Amount spiked           Amount recovered
       ([micro]g)               ([micro]g)           Percent recovery
------------------------------------------------------------------------
            4.5                      4.32                      96.0
            3.0                      2.61                      87.0
            2.25                     2.025                     90.0
            1.5                      1.365                     91.0
            1.5                      1.38                      92.0
             .75                      .6525                    87.0
             .375                     .315                     84.0
             .375                     .312                     83.2
             .1875                    .151                     80.5
             .094                     .070                     74.5
------------------------------------------------------------------------

    At lower amounts the recovery appears to be non-linear.
    4.3 Sensitivity Data.
    The following data was used to determine the calibration curve.

----------------------------------------------------------------------------------------------------------------
                                                                     0.5 x .75        1 x 1.5         2 x 3.0
                            Injection                               [micro]g/mL     [micro]g/mL     [micro]g/mL
----------------------------------------------------------------------------------------------------------------
1...............................................................           30904           59567          111778
2...............................................................           30987           62914          106016
3...............................................................           32555           58578          106122
4...............................................................           32242           57173          109716
X...............................................................           31672           59558          108408
----------------------------------------------------------------------------------------------------------------
Slope = 34.105.

    4.4 Recovery.
    The recovery was determined by spiking ethylene oxide onto lot 120 
charcoal tubes

[[Page 392]]

and desorbing with 1% CS2 in Benzene. Recoveries were done at 
0.5, 1.0, and 2.0x the target concentration (1 ppm) for the recommended 
air volume.

                            Percent Recovery
------------------------------------------------------------------------
                 Sample                     0.5x       1.0x       2.0x
------------------------------------------------------------------------
1......................................       88.7       95.0       91.7
2......................................       83.8       95.0       87.3
3......................................       84.2       91.0       86.0
4......................................       88.0       91.0       83.0
5......................................       88.0       86.0       85.0
X......................................       86.5       90.5       87.0
------------------------------------------------------------------------
Weighted Average = 88.2.

    4.5 Precision of the Analytical Procedure.
    The following data was used to determine the precision of the 
analytical method:

------------------------------------------------------------------------
                                         0.5 x .75   1 x 1.5    2 x 3.0
             Concentration               [micro]g/  [micro]g/  [micro]g/
                                             mL         mL         mL
------------------------------------------------------------------------
Injection..............................     .7421     1.4899     3.1184
                                            .7441     1.5826     3.0447
                                            .7831     1.4628     2.9149
                                            .7753     1.4244     2.9185
Average................................     .7612     1.4899     2.9991
Standard Deviation.....................     .0211      .0674      .0998
CV.....................................     .0277      .0452      .0333
------------------------------------------------------------------------

                                                               [GRAPHIC] [TIFF OMITTED] TC15NO91.040
                                                               
CV + 0.036
    4.6 Storage Data.
    Samples were generated at 1.5 mg/m\3\ ethylene oxide at 85% relative 
humidity, 22 [deg]C and 633 mm. All samples were taken for 20 minutes at 
0.05 Lpm. Six samples were analyzed as soon as possible and fifteen 
samples were stored at refrigerated temperature (5 [deg]C) and fifteen 
samples were stored at ambient temperature (23 [deg]C). These stored 
samples were analyzed over a period of nineteen days.

                            Percent Recovery
------------------------------------------------------------------------
                  Day analyzed                   Refrigerated   Ambient
------------------------------------------------------------------------
1..............................................         87.0        87.0
1..............................................         93.0        93.0
1..............................................         94.0        94.0
1..............................................         92.0        92.0
4..............................................         92.0        91.0
4..............................................         93.0        88.0
4..............................................         91.0        89.0
6..............................................         92.0
6..............................................         92.0
8..............................................  ............       92.0
8..............................................  ............       86.0
10.............................................         91.7
10.............................................         95.5
10.............................................         95.7
11.............................................  ............       90.0
11.............................................  ............       82.0
13.............................................         78.0
13.............................................         81.4
13.............................................         82.4
14.............................................  ............       78.5
14.............................................  ............       72.1
18.............................................         66.0
18.............................................         68.0
19.............................................  ............       64.0
19.............................................  ............       77.0
------------------------------------------------------------------------

    4.7 Breakthrough Data.
    Breakthrough studies were done at 2 ppm (3.6 mg/m\3\) at 
approximately 85% relative humidity at 22 [deg]C (ambient temperature). 
Two charcoal tubes were used in series. The backup tube was changed 
every 10 minutes and analyzed for breakthrough. The flow rate was 0.050 
Lpm.

------------------------------------------------------------------------
                                                    Time       Percent
                    Tube No.                     (minutes)  breakthrough
------------------------------------------------------------------------
1..............................................         10     (\1\)
2..............................................         20     (\1\)
3..............................................         30     (\1\)
4..............................................         40         1.23
5..............................................         50         3.46
6..............................................         60        18.71
7..............................................         70        39.2
8..............................................         80        53.3
9..............................................         90        72.0
10.............................................        100        96.0
11.............................................        110       113.0
12.............................................        120       133.9
------------------------------------------------------------------------
\1\ None.

    The 5% breakthrough volume was reached when 2.6 liters of test 
atmosphere were drawn through the charcoal tubes.
    5. References.
    5.1 ``NIOSH Manual of Analytical Methods,'' 2nd ed. NIOSH: 
Cincinnati, 1977; Method S286.
    5.2 ``IARC Monographs on the Evaluation of Carcinogenic Risk of 
Chemicals to Man,'' International Agency for Research on Cancer: Lyon, 
1976; Vol. II, p. 157.
    5.3 Sax., N.I. ``Dangerous Properties of Industrial Materials,'' 4th 
ed.; Van Nostrand Reinhold Company. New York, 1975; p. 741.
    5.4 ``The Condensed Chemical Dictionary'', 9th ed.; Hawley, G.G., 
ed.; Van Nostrand Reinhold Company, New York, 1977; p. 361.

                  Summary of Other Sampling Procedures

    OSHA believes that served other types of monitoring equipment and 
techniques exist for monitoring time-weighted averages. Considerable 
research and method development is currently being performed, which will 
lead to improvements and a wider variety of monitoring techniques. A 
combination of monitoring procedures can be used. There probably is no 
one best method for monitoring personal exposure to ethylene oxide in 
all cases. There are advantages, disadvantages,

[[Page 393]]

and limitations to each method. The method of choice will depend on the 
need and requirements. Some commonly used methods include the use of 
charcoal tubes, passive dosimeters, Tedler gas sampling bags, detector 
tubes, photoionization detection units, infrared detection units and gas 
chromatographs. A number of these methods are described below.

                  A. Charcoal Tube Sampling Procedures

    Qazi-Ketcham method (Ex. 11-133)--This method consists of collecting 
EtO on Columbia JXC activated carbon, desorbing the EtO with carbon 
disulfide and analyzing by gas chromatography with flame ionization 
detection. Union Carbide has recently updated and revalidated this 
monitoring procedures. This method is capable of determining both eight-
hour time-weighted average exposures and short-term exposures. The 
method was validated to 0.5 ppm. Like other charcoal collecting 
procedures, the method requires considerable analytical expertise.
    ASTM-proposed method--The Ethylene Oxide Industry Council (EOIC) has 
contracted with Clayton Environmental Consultants, Inc. to conduct a 
collaborative study for the proposed method. The ASTM-Proposed method is 
similar to the method published by Qazi and Ketcham is the November 1977 
American Industrial Hygiene Association Journal, and to the method of 
Pilney and Coyne, presented at the 1979 American Industrial Hygiene 
Conference. After the air to be sampled is drawn through an activated 
charcoal tube, the ethylene oxide is desorbed from the tube using carbon 
disulfide and is quantitated by gas chromatography utilizing a flame 
ionization detector. The ASTM-proposed method specifies a large two-
section charcoal tube, shipment in dry ice, storage at less
than -5 [deg]C, and analysis within three weeks to prevent migration and 
sample loss. Two types of charcoal tubes are being tested--Pittsburgh 
Coconut-Based (PCB) and Columbia JXC charcoal. This collaborative study 
will give an indication of the inter- and intralaboratory precision and 
accuracy of the ASTM-proposed method. Several laboratories have 
considerable expertise using the Qazi-Ketcham and Dow methods.
    B. Passive Monitors--Ethylene oxide diffuses into the monitor and is 
collected in the sampling media. The DuPont Pro-Tek badge collects EtO 
in an absorbing solution, which is analyzed colorimetrically to 
determine the amount of EtO present. The 3M 350 badge collects the EtO 
on chemically treated charcoal. Other passive monitors are currently 
being developed and tested. Both 3M and DuPont have submitted data 
indicating their dosimeters meet the precision and accuracy requirements 
of the proposed ethylene oxide standard. Both presented laboratory 
validation data to 0.2 ppm (Exs. 11-65, 4-20, 108, 109, 130).
    C. Tedlar Gas Sampling Bags-Samples are collected by drawing a known 
volume of air into a Tedlar gas sampling bag. The ethylene oxide 
concentration is often determined on-site using a portable gas 
chromatograph or portable infrared spectometer.
    D. Detector tubes--A known volume of air is drawn through a detector 
tube using a small hand pump. The concentration of EtO is related to the 
length of stain developed in the tube. Detector tubes are economical, 
easy to use, and give an immediate readout. Unfortunately, partly 
because they are nonspecific, their accuracy is often questionable. 
Since the sample is taken over a short period of time, they may be 
useful for determining the source of leaks.
    E. Direct Reading Instruments--There are numerous types of direct 
reading instruments, each having its own strengths and weaknesses (Exs. 
135B, 135C, 107, 11-78, 11-153). Many are relatively new, offering 
greater sensitivity and specificity. Popular ethylene oxide direct 
reading instruments include infrared detection units, photoionization 
detection units, and gas chromatographs.
    Portable infrared analyzers provide an immediate, continuous 
indication of a concentration value; making them particularly useful for 
locating high concentration pockets, in leak detection and in ambient 
air monitoring. In infrared detection units, the amount of infrared 
light absorbed by the gas being analyzed at selected infrared 
wavelengths is related to the concentration of a particular component. 
Various models have either fixed or variable infrared filters, differing 
cell pathlengths, and microcomputer controls for greater sensitivity, 
automation, and interference elimination.
    A fairly recent detection system is photoionization detection. The 
molecules are ionized by high energy ultraviolet light. The resulting 
current is measured. Since different substances have different 
ionization potentials, other organic compounds may be ionized. The lower 
the lamp energy, the better the selectivity. As a continuous monitor, 
photoionization detection can be useful for locating high concentration 
pockets, in leak detection, and continuous ambient air monitoring. Both 
portable and stationary gas chromatographs are available with various 
types of detectors, including photoionization detectors. A gas 
chromatograph with a photoionization detector retains the photionization 
sensitivity, but minimizes or eliminates interferences. For several GC/
PID units, the sensitivity is in the 0.1-0.2 ppm EtO range. The GC/PID 
with microprocessors can sample up to 20 sample points sequentially, 
calculate and record data, and activate alarms or ventilation systems. 
Many are quite flexible and can be configured to

[[Page 394]]

meet the specific analysis needs for the workplace.
    DuPont presented their laboratory validation data of the accuracy of 
the Qazi-Ketcham charcoal tube, the PCB charcoal tube, Miran 103 IR 
analyzer, 3M 3550 monitor and the Du Pont C-70 badge. Quoting Elbert V. 
Kring:

    We also believe that OSHA's proposed accuracy in this standard is 
appropriate. At plus or minus 25 percent at one part per million, and 
plus or minus 35 percent below that. And, our data indicates there's 
only one monitoring method, right now, that we've tested thoroughly, 
that meets that accuracy requirements. That is the Du Pont Pro-Tek 
badge* * *. We also believe that this kind of data should be confirmed 
by another independent laboratory, using the same type dynamic chamber 
testing (Tr. 1470)

Additional data by an independent laboratory following their exact 
protocol was not submitted. However, information was submitted on 
comparisons and precision and accuracy of those monitoring procedures 
which indicate far better precision and accuracy of those monitoring 
procedures than that obtained by Du Pont (Ex. 4-20, 130, 11-68, 11-133, 
130, 135A).
    The accuracy of any method depends to a large degree upon the skills 
and experience of those who not only collect the samples but also those 
who analyze the samples. Even for methods that are collaboratively 
tested, some laboratories are closer to the true values than others. 
Some laboratories may meet the precision and accuracy requirements of 
the method; others may consistently far exceed them for the same method.

[49 FR 25796, June 22, 1984, as amended at 50 FR 9801, Mar. 12, 1985; 50 
FR 41494, Oct. 11, 1985; 51 FR 25053, July 10, 1986; 53 FR 11436, 11437, 
Apr. 6, 1988; 53 FR 27960, July 26, 1988; 54 FR 24334, June 7, 1989; 61 
FR 5508, Feb. 13, 1996; 63 FR 1292, Jan. 8, 1998; 67 FR 67965, Nov. 7, 
2002; 70 FR 1143, Jan. 5, 2005; 71 FR 16672, 16673, Apr. 3, 2006; 71 FR 
50190, Aug. 24, 2006; 73 FR 75586, Dec. 12, 2008; 76 FR 33609, June 8, 
2011; 77 FR 17783, Mar. 26, 2012; 84 FR 21490, May 14, 2019]



Sec.  1910.1048  Formaldehyde.

    (a) Scope and application. This standard applies to all occupational 
exposures to formaldehyde, i.e. from formaldehyde gas, its solutions, 
and materials that release formaldehyde.
    (b) Definitions. For purposes of this standard, the following 
definitions shall apply:
    Action level means a concentration of 0.5 part formaldehyde per 
million parts of air (0.5 ppm) calculated as an eight (8)-hour time-
weighted average (TWA) concentration.
    Assistant Secretary means the Assistant Secretary of Labor for the 
Occupational Safety and Health Administration, U.S. Department of Labor, 
or designee.
    Authorized person means any person required by work duties to be 
present in regulated areas, or authorized to do so by the employer, by 
this section, or by the OSH Act of 1970.
    Director means the Director of the National Institute for 
Occupational Safety and Health, U.S. Department of Health and Human 
Services, or designee.
    Emergency is any occurrence, such as but not limited to equipment 
failure, rupture of containers, or failure of control equipment that 
results in an uncontrolled release of a significant amount of 
formaldehyde.
    Employee exposure means the exposure to airborne formaldehyde which 
would occur without corrections for protection provided by any 
respirator that is in use.
    Formaldehyde means the chemical substance, HCHO, Chemical Abstracts 
Service Registry No. 50-00-0.
    (c) Permissible Exposure Limit (PEL)--(1) TWA: The employer shall 
assure that no employee is exposed to an airborne concentration of 
formaldehyde which exceeds 0.75 parts formaldehyde per million parts of 
air (0.75 ppm) as an 8-hour TWA.
    (2) Short Term Exposure Limit (STEL): The employer shall assure that 
no employee is exposed to an airborne concentration of formaldehyde 
which exceeds two parts formaldehyde per million parts of air (2 ppm) as 
a 15-minute STEL.
    (d) Exposure monitoring--(1) General. (i) Each employer who has a 
workplace covered by this standard shall monitor employees to determine 
their exposure to formaldehyde.
    (ii) Exception. Where the employer documents, using objective data, 
that the presence of formaldehyde or formaldehyde-releasing products in 
the workplace cannot result in airborne concentrations of formaldehyde 
that would cause any employee to be exposed at or above the action level 
or the STEL under foreseeable conditions

[[Page 395]]

of use, the employer will not be required to measure employee exposure 
to formaldehyde.
    (iii) When an employee's exposure is determined from representative 
sampling, the measurements used shall be representative of the 
employee's full shift or short-term exposure to formaldehyde, as 
appropriate.
    (iv) Representative samples for each job classification in each work 
area shall be taken for each shift unless the employer can document with 
objective data that exposure levels for a given job classification are 
equivalent for different work shifts.
    (2) Initial monitoring. The employer shall identify all employees 
who may be exposed at or above the action level or at or above the STEL 
and accurately determine the exposure of each employee so identified.
    (i) Unless the employer chooses to measure the exposure of each 
employee potentially exposed to formaldehyde, the employer shall develop 
a representative sampling strategy and measure sufficient exposures 
within each job classification for each workshift to correctly 
characterize and not underestimate the exposure of any employee within 
each exposure group.
    (ii) The initial monitoring process shall be repeated each time 
there is a change in production, equipment, process, personnel, or 
control measures which may result in new or additional exposure to 
formaldehyde.
    (iii) If the employer receives reports of signs or symptoms of 
respiratory or dermal conditions associated with formaldehyde exposure, 
the employer shall promptly monitor the affected employee's exposure.
    (3) Periodic monitoring. (i) The employer shall periodically measure 
and accurately determine exposure to formaldehyde for employees shown by 
the initial monitoring to be exposed at or above the action level or at 
or above the STEL.
    (ii) If the last monitoring results reveal employee exposure at or 
above the action level, the employer shall repeat monitoring of the 
employees at least every 6 months.
    (iii) If the last monitoring results reveal employee exposure at or 
above the STEL, the employer shall repeat monitoring of the employees at 
least once a year under worst conditions.
    (4) Termination of monitoring. The employer may discontinue periodic 
monitoring for employees if results from two consecutive sampling 
periods taken at least 7 days apart show that employee exposure is below 
the action level and the STEL. The results must be statistically 
representative and consistent with the employer's knowledge of the job 
and work operation.
    (5) Accuracy of monitoring. Monitoring shall be accurate, at the 95 
percent confidence level, to within plus or minus 25 percent for 
airborne concentrations of formaldehyde at the TWA and the STEL and to 
within plus or minus 35 percent for airborne concentrations of 
formaldehyde at the action level.
    (6) 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 either individually in writing or by posting the 
results in an appropriate location that is accessible to employees. If 
employee exposure is above the PEL, affected employees shall be provided 
with a description of the corrective actions being taken by the employer 
to decrease exposure.
    (7) Observation of monitoring. (i) The employer shall provide 
affected employees or their designated representatives an opportunity to 
observe any monitoring of employee exposure to formaldehyde required by 
this standard.
    (ii) When observation of the monitoring of employee exposure to 
formaldehyde requires entry into an area where the use of protective 
clothing or equipment is required, the employer shall provide the 
clothing and equipment to the observer, require the observer to use such 
clothing and equipment, and assure that the observer complies with all 
other applicable safety and health procedures.
    (e) Regulated areas--(1) Signs. (i) The employer shall establish 
regulated areas where the concentration of airborne formaldehyde exceeds 
either the

[[Page 396]]

TWA or the STEL and post all entrances and access ways with signs 
bearing the following legend:

DANGER
FORMALDEHYDE
MAY CAUSE CANCER
CAUSES SKIN, EYE, AND RESPIRATORY IRRITATION
AUTHORIZED PERSONNEL ONLY

    (ii) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (e)(1)(i) of this section:

DANGER
FORMALDEHYDE
IRRITANT AND POTENTIAL CANCER HAZARD
AUTHORIZED PERSONNEL ONLY

    (2) The employer shall limit access to regulated areas to authorized 
persons who have been trained to recognize the hazards of formaldehyde.
    (3) An employer at a multiemployer worksite who establishes a 
regulated area shall communicate the access restrictions and locations 
of these areas to other employers with work operations at that worksite.
    (f) Methods of compliance--(1) Engineering controls and work 
practices. The employer shall institute engineering and work practice 
controls to reduce and maintain employee exposures to formaldehyde at or 
below the TWA and the STEL.
    (2) Exception. Whenever the employer has established that feasible 
engineering and work practice controls cannot reduce employee exposure 
to or below either of the PELs, the employer shall apply these controls 
to reduce employee exposures to the extent feasible and shall supplement 
them with respirators which satisfy this standard.
    (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 or 
vessel cleaning, for which the employer establishes that 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 PELs.
    (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), (d)(3)(iii)(b)(1), and (2)), and (f) 
through (m), which covers each employee required by this section to use 
a respirator.
    (ii) When employees use air-purifying respirators with chemical 
cartridges or canisters that do not contain end-of-service-life 
indicators approved by the National Institute for Occupational Safety 
and Health, employers must replace these cartridges or canisters as 
specified by paragraphs (d)(3)(iii)(B)(1) and (B)(2) of 29 CFR 1910.134, 
or at the end of the workshift, whichever condition occurs first.
    (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) Equip each air-purifying, full facepiece respirator with a 
canister or cartridge approved for protection against formaldehyde.
    (C) For escape, provide employees with one of the following 
respirator options: A self-contained breathing apparatus operated in the 
demand or pressure-demand mode; or a full facepiece respirator having a 
chin-style, or a front-or back-mounted industrial-size, canister or 
cartridge approved for protection against formaldehyde.
    (ii) Employers may substitute an air-purifying, half mask respirator 
for an air-purifying, full facepiece respirator when they equip the half 
mask respirator with a cartridge approved for protection against 
formaldehyde and provide the affected employee with effective gas-proof 
goggles.
    (iii) Employers must provide employees who have difficulty using 
negative pressure respirators with powered air-purifying respirators 
permitted for use under paragraph (g)(3)(i)(A) of this

[[Page 397]]

standard and that affords adequate protection against formaldehyde 
exposures.
    (h) Protective equipment and clothing. Employers shall comply with 
the provisions of 29 CFR 1910.132 and 29 CFR 1910.133. When protective 
equipment or clothing is provided under these provisions, the employer 
shall provide these protective devices at no cost to the employee and 
assure that the employee wears them.
    (1) Selection. The employer shall select protective clothing and 
equipment based upon the form of formaldehyde to be encountered, the 
conditions of use, and the hazard to be prevented.
    (i) All contact of the eyes and skin with liquids containing 1 
percent or more formaldehyde shall be prevented by the use of chemical 
protective clothing made of material impervious to formaldehyde and the 
use of other personal protective equipment, such as goggles and face 
shields, as appropriate to the operation.
    (ii) Contact with irritating or sensitizing materials shall be 
prevented to the extent necessary to eliminate the hazard.
    (iii) Where a face shield is worn, chemical safety goggles are also 
required if there is a danger of formaldehyde reaching the area of the 
eye.
    (iv) Full body protection shall be worn for entry into areas where 
concentrations exceed 100 ppm and for emergency reentry into areas of 
unknown concentration.
    (2) Maintenance of protective equipment and clothing. (i) The 
employer shall assure that protective equipment and clothing that has 
become contaminated with formaldehyde is cleaned or laundered before its 
reuse.
    (ii) When formaldehyde-contaminated clothing and equipment is 
ventilated, the employer shall establish storage areas so that employee 
exposure is minimized.
    (A) Signs. Storage areas for contaminated clothing and equipment 
shall have signs bearing the following legend:

DANGER
FORMALDEHYDE-CONTAMINATED [CLOTHING] EQUIPMENT
MAY CAUSE CANCER
CAUSES SKIN, EYE AND RESPIRATORY IRRITATION
DO NOT BREATHE VAPOR
DO NOT GET ON SKIN

    (B) Labels. The employer shall ensure containers for contaminated 
clothing and equipment are labeled consistent with the Hazard 
Communication Standard, Sec.  1910.1200, and shall, as a minimum, 
include the following:

DANGER
FORMALDEHYDE-CONTAMINATED [CLOTHING] EQUIPMENT
MAY CAUSE CANCER
CAUSES SKIN, EYE, AND RESPIRATORY IRRITATION
DO NOT BREATHE VAPOR
DO NOT GET ON SKIN

    (C) Prior to June 1, 2016, employers may use the following legend in 
lieu of that specified in paragraph (h)(2)(ii)(A) of this section:

DANGER
FORMALDEHYDE-CONTAMINATED [CLOTHING] EQUIPMENT
AVOID INHALATION AND SKIN CONTACT

    (D) Prior to June 1, 2015, employers may include the following 
information on containers of protective clothing and equipment in lieu 
of the labeling requirements in paragraphs (h)(2)(ii)(B) of this 
section:

DANGER
FORMALDEHYDE-CONTAMINATED [CLOTHING] EQUIPMENT
AVOID INHALATION AND SKIN CONTACT

    (iii) The employer shall assure that only persons trained to 
recognize the hazards of formaldehyde remove the contaminated material 
from the storage area for purposes of cleaning, laundering, or disposal.
    (iv) The employer shall assure that no employee takes home equipment 
or clothing that is contaminated with formaldehyde.
    (v) The employer shall repair or replace all required protective 
clothing and equipment for each affected employee as necessary to assure 
its effectiveness.
    (vi) The employer shall inform any person who launders, cleans, or 
repairs such clothing or equipment of formaldehyde's potentially harmful 
effects and of procedures to safely handle the clothing and equipment.

[[Page 398]]

    (i) Hygiene protection. (1) The employer shall provide change rooms, 
as described in 29 CFR 1910.141 for employees who are required to change 
from work clothing into protective clothing to prevent skin contact with 
formaldehyde.
    (2) If employees' skin may become spashed with solutions containing 
1 percent or greater formaldehyde, for example, because of equipment 
failure or improper work practices, the employer shall provide 
conveniently located quick drench showers and assure that affected 
employees use these facilities immediately.
    (3) If there is any possibility that an employee's eyes may be 
splashed with solutions containing 0.1 percent or greater formaldehyde, 
the employer shall provide acceptable eyewash facilities within the 
immediate work area for emergency use.
    (j) Housekeeping. For operations involving formaldehyde liquids or 
gas, the employer shall conduct a program to detect leaks and spills, 
including regular visual inspections.
    (1) Preventative maintenance of equipment, including surveys for 
leaks, shall be undertaken at regular intervals.
    (2) In work areas where spillage may occur, the employer shall make 
provisions to contain the spill, to decontaminate the work area, and to 
dispose of the waste.
    (3) The employer shall assure that all leaks are repaired and spills 
are cleaned promptly by employees wearing suitable protective equipment 
and trained in proper methods for cleanup and decontamination.
    (4) Formaldehyde-contaminated waste and debris resulting from leaks 
or spills shall be placed for disposal in sealed containers bearing a 
label warning of formaldehyde's presence and of the hazards associated 
with formaldehyde. The employer shall ensure that the labels are in 
accordance with paragraph (m) of this section.
    (k) Emergencies. For each workplace where there is the possibility 
of an emergency involving formaldehyde, the employer shall assure 
appropriate procedures are adopted to minimize injury and loss of life. 
Appropriate procedures shall be implemented in the event of an 
emergency.
    (l) Medical surveillance--(1) Employees covered. (i) The employer 
shall institute medical surveillance programs for all employees exposed 
to formaldehyde at concentrations at or exceeding the action level or 
exceeding the STEL.
    (ii) The employer shall make medical surveillance available for 
employees who develop signs and symptoms of overexposure to formaldehyde 
and for all employees exposed to formaldehyde in emergencies. When 
determining whether an employee may be experiencing signs and symptoms 
of possible overexposure to formaldehyde, the employer may rely on the 
evidence that signs and symptoms associated with formaldehyde exposure 
will occur only in exceptional circumstances when airborne exposure is 
less than 0.1 ppm and when formaldehyde is present in material in 
concentrations less than 0.1 percent.
    (2) Examination by a physician. All medical procedures, including 
administration of medical disease questionnaires, shall be 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.
    (3) Medical disease questionnaire. The employer shall make the 
following medical surveillance available to employees prior to 
assignment to a job where formaldehyde exposure is at or above the 
action level or above the STEL and annually thereafter. The employer 
shall also make the following medical surveillance available promptly 
upon determining that an employee is experiencing signs and symptoms 
indicative of possible overexposure to formaldehyde.
    (i) Administration of a medical disease questionnaire, such as in 
appendix D, which is designed to elicit information on work history, 
smoking history, any evidence of eye, nose, or throat irritation; 
chronic airway problems or hyperreactive airway disease: allergic skin 
conditions or dermatitis; and upper or lower respiratory problems.
    (ii) A determination by the physician, based on evaluation of the 
medical disease questionnaire, of whether a medical examination is 
necessary for

[[Page 399]]

employees not required to wear respirators to reduce exposure to 
formaldehyde.
    (4) Medical examinations. Medical examinations shall be given to any 
employee who the physician feels, based on information in the medical 
disease questionnaire, may be at increased risk from exposure to 
formaldehyde and at the time of initial assignment and at least annually 
thereafter to all employees required to wear a respirator to reduce 
exposure to formaldehyde. The medical examination shall include:
    (i) A physical examination with emphasis on evidence of irritation 
or sensitization of the skin and respiratory system, shortness of 
breath, or irritation of the eyes.
    (ii) Laboratory examinations for respirator wearers consisting of 
baseline and annual pulmonary function tests. As a minimum, these tests 
shall consist of forced vital capacity (FVC), forced expiratory volume 
in one second (FEV1), and forced expiratory flow (FEF).
    (iii) Any other test which the examining physician deems necessary 
to complete the written opinion.
    (iv) Counseling of employees having medical conditions that would be 
directly or indirectly aggravated by exposure to formaldehyde on the 
increased risk of impairment of their health.
    (5) Examinations for employees exposed in an emergency. The employer 
shall make medical examinations available as soon as possible to all 
employees who have been exposed to formaldehyde in an emergency.
    (i) The examination shall include a medical and work history with 
emphasis on any evidence of upper or lower respiratory problems, 
allergic conditions, skin reaction or hypersensitivity, and any evidence 
of eye, nose, or throat irritation.
    (ii) Other examinations shall consist of those elements considered 
appropriate by the examining physician.
    (6) Information provided to the physician. The employer shall 
provide the following information to the examining physician:
    (i) A copy of this standard and appendix A, C, D, and E;
    (ii) A description of the affected employee's job duties as they 
relate to the employee's exposure to formaldehyde;
    (iii) The representative exposure level for the employee's job 
assignment;
    (iv) Information concerning any personal protective equipment and 
respiratory protection used or to be used by the employee; and
    (v) Information from previous medical examinations of the affected 
employee within the control of the employer.
    (vi) In the event of a nonroutine examination because of an 
emergency, the employer shall provide to the physician as soon as 
possible: A description of how the emergency occurred and the exposure 
the victim may have received.
    (7) Physician's written opinion. (i) For each examination required 
under this standard, the employer shall obtain a written opinion from 
the examining physician. This written opinion shall contain the results 
of the medical examination except that it shall not reveal specific 
findings or diagnoses unrelated to occupational exposure to 
formaldehyde. The written opinion shall include:
    (A) The physician's opinion as to whether the employee has any 
medical condition that would place the employee at an increased risk of 
material impairment of health from exposure to formaldehyde;
    (B) Any recommended limitations on the employee's exposure or 
changes in the use of personal protective equipment, including 
respirators;
    (C) A statement that the employee has been informed by the physician 
of any medical conditions which would be aggravated by exposure to 
formaldehyde, whether these conditions may have resulted from past 
formaldehyde exposure or from exposure in an emergency, and whether 
there is a need for further examination or treatment.
    (ii) The employer shall provide for retention of the results of the 
medical examination and tests conducted by the physician.
    (iii) The employer shall provide a copy of the physician's written 
opinion to the affected employee within 15 days of its receipt.

[[Page 400]]

    (8) Medical removal. (i) The provisions of paragraph (l)(8) apply 
when an employee reports significant irritation of the mucosa of the 
eyes or the upper airways, respiratory sensitization, dermal irritation, 
or dermal sensitization attributed to workplace formaldehyde exposure. 
Medical removal provisions do not apply in the case of dermal irritation 
or dermal sensitization when the product suspected of causing the dermal 
condition contains less than 0.05% formaldehyde.
    (ii) An employee's report of signs or symptoms of possible 
overexposure to formaldehyde shall be evaluated by a physician selected 
by the employer pursuant to paragraph (l)(3). If the physician 
determines that a medical examination is not necessary under paragraph 
(l)(3)(ii), there shall be a two-week evaluation and remediation period 
to permit the employer to ascertain whether the signs or symptoms 
subside untreated or with the use of creams, gloves, first aid treatment 
or personal protective equipment. Industrial hygiene measures that limit 
the employee's exposure to formaldehyde may also be implemented during 
this period. The employee shall be referred immediately to a physician 
prior to expiration of the two-week period if the signs or symptoms 
worsen. Earnings, seniority and benefits may not be altered during the 
two-week period by virtue of the report.
    (iii) If the signs or symptoms have not subsided or been remedied by 
the end of the two-week period, or earlier if signs or symptoms warrant, 
the employee shall be examined by a physician selected by the employer. 
The physician shall presume, absent contrary evidence, that observed 
dermal irritation or dermal sensitization are not attributable to 
formaldehyde when products to which the affected employee is exposed 
contain less than 0.1% formaldehyde.
    (iv) Medical examinations shall be conducted in compliance with the 
requirements of paragraph (l)(5) (i) and (ii). Additional guidelines for 
conducting medical exams are contained in appendix C.
    (v) If the physician finds that significant irritation of the mucosa 
of the eyes or of the upper airways, respiratory sensitization, dermal 
irritation, or dermal sensitization result from workplace formaldehyde 
exposure and recommends restrictions or removal, the employer shall 
promptly comply with the restrictions or recommendation of removal. In 
the event of a recommendation of removal, the employer shall remove the 
effected employee from the current formaldehyde exposure and if 
possible, transfer the employee to work having no or significantly less 
exposure to formaldehyde.
    (vi) When an employee is removed pursuant to paragraph (l)(8)(v), 
the employer shall transfer the employee to comparable work for which 
the employee is qualified or can be trained in a short period (up to 6 
months), where the formaldehyde exposures are as low as possible, but 
not higher than the action level. The employeer shall maintain the 
employee's current earnings, seniority, and other benefits. If there is 
no such work available, the employer shall maintain the employee's 
current earnings, seniority and other benefits until such work becomes 
available, until the employee is determined to be unable to return to 
workplace formaldehyde exposure, until the employee is determined to be 
able to return to the original job status, or for six months, whichever 
comes first.
    (vii) The employer shall arrange for a follow-up medical examination 
to take place within six months after the employee is removed pursuant 
to this paragraph. This examination shall determine if the employee can 
return to the original job status, or if the removal is to be permanent. 
The physician shall make a decision within six months of the date the 
employee was removed as to whether the employee can be returned to the 
original job status, or if the removal is to be permanent.
    (viii) An employer's obligation to provide earnings, seniority and 
other benefits to a removed employee may 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 from employment with another employer made possible by virtue 
of the employee's removal.

[[Page 401]]

    (ix) In making determinations of the formaldehyde content of 
materials under this paragraph the employer may rely on objective data.
    (9) Multiple physician review. (i) After the employer selects the 
initial physician who conducts any medical examination or consultation 
to determine whether medical removal or restriction is appropriate, the 
employee may designate a second physician to review any findings, 
determinations or recommendations of the initial physician and to 
conduct such examinations, consultations, and laboratory tests as the 
second physician deems necessary and appropriate to evaluate the effects 
of formaldehyde exposure and 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 conducts a medical examination or consultation for the purpose 
of medical removal or restriction.
    (iii) 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 notification of 
the right to seek a second medical opinion, or receipt of the initial 
physician's written opinion, whichever is later;
    (A) The employee informs the employer of the intention to seek a 
second medical opinion, and
    (B) The employee initiates steps to make an appointment with a 
second physician.
    (iv) 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 the disagreement. If the two physicians are unable 
to quickly resolve their disagreement, then the employer and the 
employee through their respective physicians shall designate a third 
physician who shall be a specialist in the field at issue:
    (A) To review the findings, determinations or recommendations of the 
prior physicians; and
    (B) 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.
    (v) In the alternative, the employer and the employee or authorized 
employee representative may jointly designate such third physician.
    (vi) 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.
    (m) Communication of hazards--(1) Hazard communication--General. (i) 
Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for formaldehyde.
    (ii) In classifying the hazards of formaldehyde at least the 
following hazards are to be addressed: Cancer; skin and respiratory 
sensitization; eye, skin and respiratory tract irritation; acute 
toxicity effects; and flammability.
    (iii) Employers shall include formaldehyde in the hazard 
communication program established to comply with the HCS (Sec.  
1910.1200). Employers shall ensure that each employee has access to 
labels on containers of formaldehyde and to safety data sheets, and is 
trained in accordance with the requirements of HCS and paragraph (n) of 
this section.
    (iv) Paragraphs (m)(1)(i), (m)(1)(ii), and (m)(1)(iii) of this 
section apply to chemicals associated with formaldehyde gas, all 
mixtures or solutions composed of greater than 0.1 percent formaldehyde, 
and materials capable of releasing formaldehyde into the air at 
concentrations reaching or exceeding 0.1 ppm.
    (v) In making the determinations of anticipated levels of 
formaldehyde release, the employer may rely on objective data indicating 
the extent of potential formaldehyde release under reasonably 
foreseeable conditions of use.
    (2)(i) In addition to the requirements in paragraphs (m)(1) through 
(m)(1)(iv) of this section, for materials listed in

[[Page 402]]

paragraph (m)(1)(iv) capable of releasing formaldehyde at levels above 
0.5 ppm, labels shall appropriately address all hazards as defined in 
paragraph (d) of Sec.  1910.1200 and Appendices A and B to Sec.  
1910.1200, including cancer and respiratory sensitization, and shall 
contain the hazard statement ``May Cause Cancer.''
    (ii) As a minimum, for all materials listed in paragraph (m)(1)(i) 
and (iv) of this section capable of releasing formaldehyde at levels of 
0.1 ppm to 0.5 ppm, labels shall identify that the product contains 
formaldehyde; list the name and address of the responsible party; and 
state that physical and health hazard information is readily available 
from the employer and from safety data sheets.
    (iii) Prior to June 1, 2015, employers may include the phrase 
``Potential Cancer Hazard'' in lieu of ``May Cause Cancer'' as specified 
in paragraph (m)(2)(i) of this section.
    (n) Employee information and training--(1) Participation. The 
employer shall assure that all employees who are assigned to workplaces 
where there is exposure to formaldehyde participate in a training 
program, except that where the employer can show, using objective data, 
that employees are not exposed to formaldehyde at or above 0.1 ppm, the 
employer is not required to provide training.
    (2) Frequency. Employers shall provide such information and training 
to employees at the time of initial assignment, and whenever a new 
exposure to formaldehyde is introduced into the work area. The training 
shall be repeated at least annually.
    (3) Training program. The training program shall be conducted in a 
manner which the employee is able to understand and shall include:
    (i) A discussion of the contents of this regulation and the contents 
of the Material Safety Data Sheet.
    (ii) The purpose for and a description of the medical surveillance 
program required by this standard, including:
    (A) A description of the potential health hazards associated with 
exposure to formaldehyde and a description of the signs and symptoms of 
exposure to formaldehyde.
    (B) Instructions to immediately report to the employer the 
development of any adverse signs or symptoms that the employee suspects 
is attributable to formaldehyde exposure.
    (iii) Description of operations in the work area where formaldehyde 
is present and an explanation of the safe work practices appropriate for 
limiting exposure to formaldehyde in each job;
    (iv) The purpose for, proper use of, and limitations of personal 
protective clothing and equipment;
    (v) Instructions for the handling of spills, emergencies, and clean-
up procedures;
    (vi) An explanation of the importance of engineering and work 
practice controls for employee protection and any necessary instruction 
in the use of these controls; and
    (vii) A review of emergency procedures including the specific duties 
or assignments of each employee in the event of an emergency.
    (4) Access to training materials. (i) The employer shall inform all 
affected employees of the location of written training materials and 
shall make these materials readily available, without cost, to the 
affected employees.
    (ii) The employer shall provide, upon request, all training 
materials relating to the employee training program to the Assistant 
Secretary and the Director.
    (o) Recordkeeping--(1) Exposure measurements. The employer shall 
establish and maintain an accurate record of all measurements taken to 
monitor employee exposure to formaldehyde. This record shall include:
    (i) The date of measurement;
    (ii) The operation being monitored;
    (iii) The methods of sampling and analysis and evidence of their 
accuracy and precision;
    (iv) The number, durations, time, and results of samples taken;
    (v) The types of protective devices worn; and
    (vi) The names, job classifications, and exposure estimates of the 
employees whose exposures are represented by the actual monitoring 
results.
    (2) Exposure determinations. Where the employer has determined that 
no monitoring is required under this standard, the employer shall 
maintain a record

[[Page 403]]

of the objective data relied upon to support the determination that no 
employee is exposed to formaldehyde at or above the action level.
    (3) Medical surveillance. The employer shall establish and maintain 
an accurate record for each employee subject to medical surveillance 
under this standard. This record shall include:
    (i) The name of the employee;
    (ii) The physician's written opinion;
    (iii) A list of any employee health complaints that may be related 
to exposure to formaldehyde; and
    (iv) A copy of the medical examination results, including medical 
disease questionnaires and results of any medical tests required by the 
standard or mandated by the examining physician.
    (4) Respirator fit testing. (i) The employer shall establish and 
maintain accurate records for employees subject to negative pressure 
respirator fit testing required by this standard.
    (ii) This record shall include:
    (A) A copy of the protocol selected for respirator fit testing.
    (B) A copy of the results of any fit testing performed.
    (C) The size and manufacturer of the types of respirators available 
for selection.
    (D) The date of the most recent fit testing, the name of each tested 
employee, and the respirator type and facepiece selected.
    (5) Record retention. The employer shall retain records required by 
this standard for at least the following periods:
    (i) Exposure records and determinations shall be kept for at least 
30 years.
    (ii) Medical records shall be kept for the duration of employment 
plus 30 years.
    (iii) Respirator fit testing records shall be kept until replaced by 
a more recent record.
    (6) Availability of records. (i) Upon request, the employer shall 
make all records maintained as a requirement of this standard available 
for examination and copying to the Assistant Secretary and the Director.
    (ii) The employer shall make employee exposure records, including 
estimates made from representative monitoring and available upon request 
for examination, and copying to the subject employee, or former 
employee, and employee representatives in accordance with 29 CFR 
1910.1020 (a)-(e) and (g)-(i).
    (iii) Employee medical records required by this standard shall be 
provided upon request for examination and coying, to the subject 
employee or former employee or to anyone having the specific written 
consent of the subject employee or former employee in accordance with 29 
CFR 1910.1020 (a)-(e) and (g)-(i).

   Appendix A to Sec.  1910.1048--Substance Technical Guidelines for 
                                Formalin

    The following Substance Technical Guideline for Formalin provides 
information on uninhibited formalin solution (37% formaldehyde, no 
methanol stabilizer). It is designed to inform employees at the 
production level of their rights and duties under the formaldehyde 
standard whether their job title defines them as workers or supervisors. 
Much of the information provided is general; however, some information 
is specific for formalin. When employee exposure to formaldehyde is from 
resins capable of releasing formaldehyde, the resin itself and other 
impurities or decomposition products may also be toxic, and employers 
should include this information as well when informing employees of the 
hazards associated with the materials they handle. The precise hazards 
associated with exposure to formaldehyde depend both on the form (solid, 
liquid, or gas) of the material and the concentration of formaldehyde 
present. For example, 37-50 percent solutions of formaldehyde present a 
much greater hazard to the skin and eyes from spills or splashes than 
solutions containing less than 1 percent formaldehyde. Individual 
Substance Technical Guidelines used by the employer for training 
employees should be modified to properly give information on the 
material actually being used.

                        Substance Identification

Chemical Name: Formaldehyde
Chemical Family: Aldehyde
Chemical Formula: HCHO
Molecular Weight: 30.03
Chemical Abstracts Service Number (CAS Number): 50-00-0

    Synonyms: Formalin; Formic Aldehyde; Paraform; Formol; Formalin 
(Methanol-free); Fyde; Formalith; Methanal; Methyl Aldehyde; Methylene 
Glycol; Methylene Oxide; Tetraoxymethalene; Oxomethane; Oxymethylene

                       Components and Contaminants

Percent: 37.0 Formaldehyde
Percent: 63.0 Water


[[Page 404]]


(Note--Inhibited solutions contain methanol.)

Other Contaminants: Formic acid (alcohol free)
Exposure Limits:

OSHA TWA--0.75 ppm
OSHA STEL--2 ppm

                              Physical Data

Description: Colorless liquid, pungent odor
Boiling point: 214 [deg]F (101 [deg]C)
Specific Gravity: 1.08 (H2 O = 1 @ 20 [deg]C)
pH: 2.8-4.0
Solubility in Water: Miscible
Solvent Solubility: Soluble in alcohol and acetone
Vapor Density: 1.04 (Air = 1 @ 20 [deg]C)
Odor Threshold: 0.8-1 ppm

                        Fire and Explosion Hazard

    Moderate fire and explosion hazard when exposed to heat or flame.
    The flash point of 37% formaldehyde solutions is above normal room 
temperature, but the explosion range is very wide, from 7 to 73% by 
volume in air.
    Reaction of formaldehyde with nitrogen dioxide, nitromethane, 
perchloric acid and aniline, or peroxyformic acid yields explosive 
compounds.

Flash Point: 185 [deg]F (85 [deg]C) closed cup
Lower Explosion Limit: 7%
Upper Explosion Limit: 73%
Autoignition Temperature: 806 [deg]F (430 [deg]C)
Flammability (OSHA): Category 4 flammable liquid

    Extinguishing Media: Use dry chemical, ``alcohol foam'', carbon 
dioxide, or water in flooding amounts as fog. Solid streams may not be 
effective. Cool fire-exposed containers with water from side until well 
after fire is out.
    Use of water spray to flush spills can also dilute the spill to 
produce nonflammable mixtures. Water runoff, however, should be 
contained for treatment.

     National Fire Protection Association Section 325M Designation:

    Health: 2--Materials hazardous to health, but areas may be entered 
with full-faced mask self-contained breathing apparatus which provides 
eye protection.
    Flammability: 2--Materials which must be moderately heated before 
ignition will occur. Water spray may be used to extinguish the fire 
because the material can be cooled below its flash point.
    Reactivity: D--Materials which (in themselves) are normally stable 
even under fire exposure conditions and which are not reactive with 
water. Normal fire fighting procedures may be used.

                               Reactivity

    Stability: Formaldehyde solutions may self-polymerize to form 
paraformaldehyde which precipitates.
    Incompatibility (Materials to Avoid): Strong oxidizing agents, 
caustics, strong alkalies, isocyanates, anhydrides, oxides, and 
inorganic acids. Formaldehyde reacts with hydrochloric acid to form the 
potent carcinogen, bis-chloromethyl ether. Formaldehyde reacts with 
nitrogen dioxide, nitromethane, perchloric acid and aniline, or 
peroxyformic acid to yield explosive compounds. A violent reaction 
occurs when formaldehyde is mixed with strong oxidizers.
    Hazardous Combustion or Decomposition Products: Oxygen from the air 
can oxidize formaldehyde to formic acid, especially when heated. Formic 
acid is corrosive.

                           Health Hazard Data

                        Acute Effects of Exposure

    Ingestion (Swallowing): Liquids containing 10 to 40% formaldehyde 
cause severe irritation and inflammation of the mouth, throat, and 
stomach. Severe stomach pains will follow ingestion with possible loss 
of consciousness and death. Ingestion of dilute formaldehyde solutions 
(0.03-0.04%) may cause discomfort in the stomach and pharynx.
    Inhalation (Breathing): Formaldehyde is highly irritating to the 
upper respiratory tract and eyes. Concentrations of 0.5 to 2.0 ppm may 
irritate the eyes, nose, and throat of some individuals. Concentrations 
of 3 to 5 ppm also cause tearing of the eyes and are intolerable to some 
persons. Concentrations of 10 to 20 ppm cause difficulty in breathing, 
burning of the nose and throat, cough, and heavy tearing of the eyes, 
and 25 to 30 ppm causes severe respiratory tract injury leading to 
pulmonary edema and pneumonitis. A concentration of 100 ppm is 
immediately dangerous to life and health. Deaths from accidental 
exposure to high concentrations of formaldehyde have been reported.
    Skin (Dermal): Formalin is a severe skin irritant and a sensitizer. 
Contact with formalin causes white discoloration, smarting, drying, 
cracking, and scaling. Prolonged and repeated contact can cause numbness 
and a hardening or tanning of the skin. Previously exposed persons may 
react to future exposure with an allergic eczematous dermatitis or 
hives.
    Eye Contact: Formaldehyde solutions splashed in the eye can cause 
injuries ranging from transient discomfort to severe, permanent corneal 
clouding and loss of vision. The severity of the effect depends on the 
concentration of formaldehyde in the solution and whether or not the 
eyes are flushed with water immediately after the accident.


[[Page 405]]


    Note. The perception of formaldehyde by odor and eye irritation 
becomes less sensitive with time as one adapts to formaldehyde. This can 
lead to overexposure if a worker is relying on formaldehyde's warning 
properties to alert him or her to the potential for exposure.

Acute Animal Toxicity:
Oral, rats: LD50 = 800 mg/kg
Oral, mouse: LD50 = 42 mg/kg
Inhalation, rats: LCLo = 250 mg/kg
Inhalation, mouse: LCLo = 900 mg/kg
Inhalation, rats: LC50 = 590 mg/kg

                       Chronic Effects of Exposure

    Carcinogenicity: Formaldehyde has the potential to cause cancer in 
humans. Repeated and prolonged exposure increases the risk. Various 
animal experiments have conclusively shown formaldehyde to be a 
carcinogen in rats. In humans, formaldehyde exposure has been associated 
with cancers of the lung, nasopharynx and oropharynx, and nasal 
passages.
    Mutagenicity: Formaldehyde is genotoxic in several in vitro test 
systems showing properties of both an initiator and a promoter.
    Toxicity: Prolonged or repeated exposure to formaldehyde may result 
in respiratory impairment. Rats exposed to formaldehyde at 2 ppm 
developed benign nasal tumors and changes of the cell structure in the 
nose as well as inflamed mucous membranes of the nose. Structural 
changes in the epithelial cells in the human nose have also been 
observed. Some persons have developed asthma or bronchitis following 
exposure to formaldehyde, most often as the result of an accidental 
spill involving a single exposure to a high concentration of 
formaldehyde.

                   Emergency and First Aid Procedures

    Ingestion (Swallowing): If the victim is conscious, dilute, 
inactivate, or absorb the ingested formaldehyde by giving milk, 
activated charcoal, or water. Any organic material will inactivate 
formaldehyde. Keep affected person warm and at rest. Get medical 
attention immediately. If vomiting occurs, keep head lower than hips.
    Inhalation (Breathing): Remove the victim from the exposure area to 
fresh air immediately. Where the formaldehyde concentration may be very 
high, each rescuer must put on a self-contained breathing apparatus 
before attempting to remove the victim, and medical personnel should be 
informed of the formaldehyde exposure immediately. If breathing has 
stopped, give artificial respiration. Keep the affected person warm and 
at rest. Qualified first-aid or medical personnel should administer 
oxygen, if available, and maintain the patient's airways and blood 
pressure until the victim can be transported to a medical facility. If 
exposure results in a highly irritated upper respiratory tract and 
coughing continues for more than 10 minutes, the worker should be 
hospitalized for observation and treatment.
    Skin Contact: Remove contaminated clothing (including shoes) 
immediately. Wash the affected area of your body with soap or mild 
detergent and large amounts of water until no evidence of the chemical 
remains (at least 15 to 20 minutes). If there are chemical burns, get 
first aid to cover the area with sterile, dry dressing, and bandages. 
Get medical attention if you experience appreciable eye or respiratory 
irritation.
    Eye Contact: Wash the eyes immediately with large amounts of water 
occasionally lifting lower and upper lids, until no evidence of chemical 
remains (at least 15 to 20 minutes). In case of burns, apply sterile 
bandages loosely without medication. Get medical attention immediately. 
If you have experienced appreciable eye irritation from a splash or 
excessive exposure, you should be referred promptly to an opthamologist 
for evaluation.

                          Emergency Procedures

    Emergencies: If you work in an area where a large amount of 
formaldehyde could be released in an accident or from equipment failure, 
your employer must develop procedures to be followed in event of an 
emergency. You should be trained in your specific duties in the event of 
an emergency, and it is important that you clearly understand these 
duties. Emergency equipment must be accessible and you should be trained 
to use any equipment that you might need. Formaldehyde contaminated 
equipment must be cleaned before reuse.
    If a spill of appreciable quantity occurs, leave the area quickly 
unless you have specific emergency duties. Do not touch spilled 
material. Designated persons may stop the leak and shut off ignition 
sources if these procedures can be done without risk. Designated persons 
should isolate the hazard area and deny entry except for necessary 
people protected by suitable protective clothing and respirators 
adequate for the exposure. Use water spray to reduce vapors. Do not 
smoke, and prohibit all flames or flares in the hazard area.
    Special Firefighting Procedures: Learn procedures and 
responsibilities in the event of a fire in your workplace. Become 
familiar with the appropriate equipment and supplies and their location. 
In firefighting, withdraw immediately in case of rising sound from 
venting safety device or any discoloration of storage tank due to fire.

[[Page 406]]

                  Spill, Leak, and Disposal Procedures

    Occupational Spill: For small containers, place the leaking 
container in a well ventilated area. Take up small spills with absorbent 
material and place the waste into properly labeled containers for later 
disposal. For larger spills, dike the spill to minimize contamination 
and facilitate salvage or disposal. You may be able to neutralize the 
spill with sodium hydroxide or sodium sulfite. Your employer must comply 
with EPA rules regarding the clean-up of toxic waste and notify state 
and local authorities, if required. If the spill is greater than 1,000 
lb/day, it is reportable under EPA's Superfund legislation.
    Waste Disposal: Your employer must dispose of waste containing 
formaldehyde in accordance with applicable local, state, and Federal law 
and in a manner that minimizes exposure of employees at the site and of 
the clean-up crew.

                  Monitoring and Measurement Procedures

    Monitoring Requirements: If your exposure to formaldehyde exceeds 
the 0.5 ppm action level or the 2 ppm STEL, your employer must monitor 
your exposure. Your employer need not measure every exposure if a ``high 
exposure'' employee can be identified. This person usually spends the 
greatest amount of time nearest the process equipment. If you are a 
``representative employee'', you will be asked to wear a sampling device 
to collect formaldehyde. This device may be a passive badge, a sorbent 
tube attached to a pump, or an impinger containing liquid. You should 
perform your work as usual, but inform the person who is conducting the 
monitoring of any difficulties you are having wearing the device.
    Evaluation of 8-hour Exposure: Measurements taken for the purpose of 
determining time-weighted average (TWA) exposures are best taken with 
samples covering the full shift. Samples collected must be taken from 
the employee's breathing zone air.
    Short-term Exposure Evaluation: If there are tasks that involve 
brief but intense exposure to formaldehyde, employee exposure must be 
measured to assure compliance with the STEL. Sample collections are for 
brief periods, only 15 minutes, but several samples may be needed to 
identify the peak exposure.
    Monitoring Techniques: OSHA's only requirement for selecting a 
method for sampling and analysis is that the methods used accurately 
evaluate the concentration of formaldehyde in employees' breathing 
zones. Sampling and analysis may be performed by collection of 
formaldehyde on liquid or solid sorbents with subsequent chemical 
analysis. Sampling and analysis may also be performed by passive 
diffusion monitors and short-term exposure may be measured by 
instruments such as real-time continuous monitoring systems and portable 
direct reading instruments.
    Notification of Results: Your employer must inform you of the 
results of exposure monitoring representative of your job. You may be 
informed in writing, but posting the results where you have ready access 
to them constitutes compliance with the standard.

                    Protective Equipment and Clothing

    [Material impervious to formaldehyde is needed if the employee 
handles formaldehyde solutions of 1% or more. Other employees may also 
require protective clothing or equipment to prevent dermatitis.]
    Respiratory Protection: Use NIOSH-approved full facepiece negative 
pressure respirators equipped with approved cartridges or canisters 
within the use limitations of these devices. (Present restrictions on 
cartridges and canisters do not permit them to be used for a full 
workshift.) In all other situations, use positive pressure respirators 
such as the positive-pressure air purifying respirator or the self-
contained breathing apparatus (SCBA). If you use a negative pressure 
respirator, your employer must provide you with fit testing of the 
respirator at least once a year.
    Protective Gloves: Wear protective (impervious) gloves provided by 
your employer, at no cost, to prevent contact with formalin. Your 
employer should select these gloves based on the results of permeation 
testing and in accordance with the ACGIH Guidelines for Selection of 
Chemical Protective Clothing.
    Eye Protection: If you might be splashed in the eyes with formalin, 
it is essential that you wear goggles or some other type of complete 
protection for the eye. You may also need a face shield if your face is 
likely to be splashed with formalin, but you must not substitute face 
shields for eye protection. (This section pertains to formaldehyde 
solutions of 1% or more.)
    Other Protective Equipment: You must wear protective (impervious) 
clothing and equipment provided by your employer at no cost to prevent 
repeated or prolonged contact with formaldehyde liquids. If you are 
required to change into whole-body chemical protective clothing, your 
employer must provide a change room for your privacy and for storage of 
your normal clothing.
    If you are splashed with formaldehyde, use the emergency showers and 
eyewash fountains provided by your employer immediately to prevent 
serious injury. Report the incident to your supervisor and obtain 
necessary medical support.

                      Entry Into an IDLH Atmosphere

    Enter areas where the formaldehyde concentration might be 100 ppm or 
more only with complete body protection including a

[[Page 407]]

self-contained breathing apparatus with a full facepiece operated in a 
positive pressure mode or a supplied air respirator with full facepiece 
and operated in a positive pressure mode. This equipment is essential to 
protect your life and health under such extreme conditions.

                          Engineering Controls

    Ventilation is the most widely applied engineering control method 
for reducing the concentration of airborne substances in the breathing 
zones of workers. There are two distinct types of ventilation.
    Local Exhaust: Local exhaust ventilation is designed to capture 
airborne contaminants as near to the point of generation as possible. To 
protect you, the direction of contaminant flow must always be toward the 
local exhaust system inlet and away from you.
    General (Mechanical): General dilution ventilation involves 
continuous introduction of fresh air into the workroom to mix with the 
contaminated air and lower your breathing zone concentration of 
formaldehyde. Effectiveness depends on the number of air changes per 
hour. Where devices emitting formaldehyde are spread out over a large 
area, general dilution ventilation may be the only practical method of 
control.
    Work Practices: Work practices and administrative procedures are an 
important part of a control system. If you are asked to perform a task 
in a certain manner to limit your exposure to formaldehyde, it is 
extremely important that you follow these procedures.

                          Medical Surveillance

    Medical surveillance helps to protect employees' health. You are 
encouraged strongly to participate in the medical surveillance program.
    Your employer must make a medical surveillance program available at 
no expense to you and at a reasonable time and place if you are exposed 
to formaldehyde at concentrations above 0.5 ppm as an 8-hour average or 
2 ppm over any 15-minute period. You will be offered medical 
surveillance at the time of your initial assignment and once a year 
afterward as long as your exposure is at least 0.5 ppm (TWA) or 2 ppm 
(STEL). Even if your exposure is below these levels, you should inform 
your employer if you have signs and symptoms that you suspect, through 
your training, are related to your formaldehyde exposure because you may 
need medical surveillance to determine if your health is being impaired 
by your exposure.
    The surveillance plan includes:
    (a) A medical disease questionnaire.
    (b) A physical examination if the physician determines this is 
necessary.
    If you are required to wear a respirator, your employer must offer 
you a physical examination and a pulmonary function test every year.
    The physician must collect all information needed to determine if 
you are at increased risk from your exposure to formaldehyde. At the 
physician's discretion, the medical examination may include other tests, 
such as a chest x-ray, to make this determination.
    After a medical examination the physician will provide your employer 
with a written opinion which includes any special protective measures 
recommended and any restrictions on your exposure. The physician must 
inform you of any medical conditions you have which would be aggravated 
by exposure to formaldehyde.
    All records from your medical examinations, including disease 
surveys, must be retained at your employer's expense.

                               Emergencies

    If you are exposed to formaldehyde in an emergency and develop signs 
or symptoms associated with acute toxicity from formaldehyde exposure, 
your employer must provide you with a medical examination as soon as 
possible. This medical examination will include all steps necessary to 
stabilize your health. You may be kept in the hospital for observation 
if your symptoms are severe to ensure that any delayed effects are 
recognized and treated.

Appendix B to Sec.  1910.1048--Sampling Strategy and Analytical Methods 
                            for Formaldehyde

    To protect the health of employees, exposure measurements must be 
unbiased and representative of employee exposure. The proper measurement 
of employee exposure requires more than a token commitment on the part 
of the employer. OSHA's mandatory requirements establish a baseline; 
under the best of circumstances all questions regarding employee 
exposure will be answered. Many employers, however, will wish to conduct 
more extensive monitoring before undertaking expensive commitments, such 
as engineering controls, to assure that the modifications are truly 
necessary. The following sampling strategy, which was developed at NIOSH 
by Nelson A. Leidel, Kenneth A. Busch, and Jeremiah R. Lynch and 
described in NIOSH publication No. 77-173 (Occupational Exposure 
Sampling Strategy Manual) will assist the employer in developing a 
strategy for determining the exposure of his or her employees.
    There is no one correct way to determine employee exposure. 
Obviously, measuring the exposure of every employee exposed to 
formaldehyde will provide the most information on any given day. Where 
few employees are exposed, this may be a practical solution.

[[Page 408]]

For most employers, however, use of the following strategy will give 
just as much information at less cost.
    Exposure data collected on a single day will not automatically 
guarantee the employer that his or her workplace is always in compliance 
with the formaldehyde standard. This does not imply, however, that it is 
impossible for an employer to be sure that his or her worksite is in 
compliance with the standard. Indeed, a properly designed sampling 
strategy showing that all employees are exposed below the PELs, at least 
with a 95 percent certainty, is compelling evidence that the exposure 
limits are being achieved provided that measurements are conducted using 
valid sampling strategy and approved analytical methods.
    There are two PELs, the TWA concentration and the STEL. Most 
employers will find that one of these two limits is more critical in the 
control of their operations, and OSHA expects that the employer will 
concentrate monitoring efforts on the critical component. If the more 
difficult exposure is controlled, this information, along with 
calculations to support the assumptions, should be adequate to show that 
the other exposure limit is also being achieved.

                            Sampling Strategy

           Determination of the Need for Exposure Measurements

    The employer must determine whether employees may be exposed to 
concentrations in excess of the action level. This determination becomes 
the first step in an employee exposure monitoring program that minimizes 
employer sampling burdens while providing adequate employee protection. 
If employees may be exposed above the action level, the employer must 
measure exposure. Otherwise, an objective determination that employee 
exposure is low provides adequate evidence that exposure potential has 
been examined.
    The employer should examine all available relevant information, eg. 
insurance company and trade association data and information from 
suppliers or exposure data collected from similar operations. The 
employer may also use previously-conducted sampling including area 
monitoring. The employer must make a determination relevant to each 
operation although this need not be on a separate piece of paper. If the 
employer can demonstrate conclusively that no employee is exposed above 
the action level or the STEL through the use of objective data, the 
employer need proceed no further on employee exposure monitoring until 
such time that conditions have changed and the determination is no 
longer valid.
    If the employer cannot determine that employee exposure is less than 
the action level and the STEL, employee exposure monitoring will have to 
be conducted.

                        Workplace Material Survey

    The primary purpose of a survey of raw material is to determine if 
formaldehyde is being used in the work environment and if so, the 
conditions under which formaldehyde is being used.
    The first step is to tabulate all situations where formaldehyde is 
used in a manner such that it may be released into the workplace 
atmosphere or contaminate the skin. This information should be available 
through analysis of company records and information on the MSDSs 
available through provisions of this standard and the Hazard 
Communication standard.
    If there is an indication from materials handling records and 
accompanying MSDSs that formaldehyde is being used in the following 
types of processes or work operations, there may be a potential for 
releasing formaldehyde into the workplace atmosphere:
    (1) Any operation that involves grinding, sanding, sawing, cutting, 
crushing, screening, sieving, or any other manipulation of material that 
generates formaldehyde-bearing dust
    (2) Any processes where there have been employee complaints or 
symptoms indicative of exposure to formaldehyde
    (3) Any liquid or spray process involving formaldehyde
    (4) Any process that uses formaldehyde in preserved tissue
    (5) Any process that involves the heating of a formaldehyde-bearing 
resin.

Processes and work operations that use formaldehyde in these manners 
will probably require further investigation at the worksite to determine 
the extent of employee monitoring that should be conducted.

                         Workplace Observations

    To this point, the only intention has been to provide an indication 
as to the existence of potentially exposed employees. With this 
information, a visit to the workplace is needed to observe work 
operations, to identify potential health hazards, and to determine 
whether any employees may be exposed to hazardous concentrations of 
formaldehyde.
    In many circumstances, sources of formaldehyde can be identified 
through the sense of smell. However, this method of detection should be 
used with caution because of olfactory fatigue.
    Employee location in relation to source of formaldehyde is important 
in determining if an employee may be significantly exposed to 
formaldehyde. In most instances, the closer a worker is to the source, 
the higher the probability that a significant exposure will occur.

[[Page 409]]

    Other characteristics should be considered. Certain high temperature 
operations give rise to higher evaporation rates. Locations of open 
doors and windows provide natural ventilation that tend to dilute 
formaldehyde emissions. General room ventilation also provides a measure 
of control.

            Calculation of Potential Exposure Concentrations

    By knowing the ventilation rate in a workplace and the quantity of 
formaldehyde generated, the employer may be able to determine by 
calculation if the PELs might be exceeded. To account for poor mixing of 
formaldehyde into the entire room, locations of fans and proximity of 
employees to the work operation, the employer must include a safety 
factor. If an employee is relatively close to a source, particularly if 
he or she is located downwind, a safety factor of 100 may be necessary. 
For other situations, a factor of 10 may be acceptable. If the employer 
can demonstrate through such calculations that employee exposure does 
not exceed the action level or the STEL, the employer may use this 
information as objective data to demonstrate compliance with the 
standard.

                            Sampling Strategy

    Once the employer determines that there is a possibility of 
substantial employee exposure to formaldehyde, the employer is obligated 
to measure employee exposure.
    The next step is selection of a maximum risk employee. When there 
are different processes where employees may be exposed to formaldehyde, 
a maximum risk employee should be selected for each work operation.
    Selection of the maximum risk employee requires professional 
judgment. The best procedure for selecting the maximum risk employee is 
to observe employees and select the person closest to the source of 
formaldehyde. Employee mobility may affect this selection; eg. if the 
closest employee is mobile in his tasks, he may not be the maximum risk 
employee. Air movement patterns and differences in work habits will also 
affect selection of the maximum risk employee.
    When many employees perform essentially the same task, a maximum 
risk employee cannot be selected. In this circumstance, it is necessary 
to resort to random sampling of the group of workers. The objective is 
to select a subgroup of adequate size so that there is a high 
probability that the random sample will contain at least one worker with 
high exposure if one exists. The number of persons in the group 
influences the number that need to be sampled to ensure that at least 
one individual from the highest 10 percent exposure group is contained 
in the sample. For example, to have 90 percent confidence in the 
results, if the group size is 10, nine should be sampled; for 50, only 
18 need to be sampled.
    If measurement shows exposure to formaldehyde at or above the action 
level or the STEL, the employer needs to identify all other employees 
who may be exposed at or above the action level or STEL and measure or 
otherwise accurately characterize the exposure of these employees.
    Whether representative monitoring or random sampling are conducted, 
the purpose remains the same--to determine if the exposure of any 
employee is above the action level. If the exposure of the most exposed 
employee is less than the action level and the STEL, regardless of how 
the employee is identified, then it is reasonable to assume that 
measurements of exposure of the other employees in that operation would 
be below the action level and the STEL.

                          Exposure Measurements

    There is no ``best'' measurement strategy for all situations. Some 
elements to consider in developing a strategy are:
    (1) Availability and cost of sampling equipment
    (2) Availability and cost of analytic facilities
    (3) Availability and cost of personnel to take samples
    (4) Location of employees and work operations
    (5) Intraday and interday variations in the process
    (6) Precision and accuracy of sampling and analytic methods, and
    (7) Number of samples needed.
    Samples taken for determining compliance with the STEL differ from 
those that measure the TWA concentration in important ways. STEL samples 
are best taken in a nonrandom fashion using all available knowledge 
relating to the area, the individual, and the process to obtain samples 
during periods of maximum expected concentrations. At least three 
measurements on a shift are generally needed to spot gross errors or 
mistakes; however, only the highest value represents the STEL.
    If an operation remains constant throughout the workshift, a much 
greater number of samples would need to be taken over the 32 discrete 
nonoverlapping periods in an 8-hour workshift to verify compliance with 
a STEL. If employee exposure is truly uniform throughout the workshift, 
however, an employer in compliance with the l ppm TWA would be in 
compliance with the 2 ppm STEL, and this determination can probably be 
made using objective data.

                 Need To Repeat the Monitoring Strategy

    Interday and intraday fluctuations in employee exposure are mostly 
influenced by the physical processes that generate formaldehyde and the 
work habits of the employee. Hence, in-plant process variations 
influence

[[Page 410]]

the employer's determination of whether or not additional controls need 
to be imposed. Measurements that employee exposure is low on a day that 
is not representative of worst conditions may not provide sufficient 
information to determine whether or not additional engineering controls 
should be installed to achieve the PELs.
    The person responsible for conducting sampling must be aware of 
systematic changes which will negate the validity of the sampling 
results. Systematic changes in formaldehyde exposure concentration for 
an employee can occur due to:
    (1) The employee changing patterns of movement in the workplace
    (2) Closing of plant doors and windows
    (3) Changes in ventilation from season to season
    (4) Decreases in ventilation efficiency or abrupt failure of 
engineering control equipment
    (5) Changes in the production process or work habits of the 
employee.

Any of these changes, if they may result in additional exposure that 
reaches the next level of action (i.e. 0.5 or 1.0 ppm as an 8-hr average 
or 2 ppm over 15 minutes) require the employer to perform additional 
monitoring to reassess employee exposure.
    A number of methods are suitable for measuring employee exposure to 
formaldehyde or for characterizing emissions within the worksite. The 
preamble to this standard describes some methods that have been widely 
used or subjected to validation testing. A detailed analytical procedure 
derived from the OSHA Method 52 for acrolein and formaldehyde is 
presented below for informational purposes.
    Inclusion of OSHA's method in this appendix in no way implies that 
it is the only acceptable way to measure employee exposure to 
formaldehyde. Other methods that are free from significant interferences 
and that can determine formaldehyde at the permissible exposure limits 
within 25 percent of the ``true'' value at the 95 
percent confidence level are also acceptable. Where applicable, the 
method shou1d a1so be capab1e of measuring formaldehyde at the action 
level to 35 percent of the ``true'' value with a 
95 percent confidence level. OSHA encourages emp1oyers to choose methods 
that will be best for their individual needs. The employer must exercise 
caution, however, in choosing an appropriate method since some 
techniques suffer from interferences that are likely to be present in 
workplaces of certain industry sectors where formaldehyde is used.

                   OSHA's Analytical Laboratory Method

Method No: 52
Matrix: Air
Target Concentration: 1 ppm (1.2 mg/m\3\)
Procedures: Air samples are collected by drawing known volumes of air 
through sampling tubes containing XAD-2 adsorbent which have been coated 
with 2-(hydroxymethyl) piperidine. The samples are desorbed with toluene 
and then analyzed by gas chromatography using a nitrogen selective 
detector.
Recommended Sampling Rate and Air Volumes: 0.1 L/min and 24 L
Reliable Quantitation Limit:16 ppb (20 [micro]g/m\3\)
Standard Error of Estimate at the Target Concentration: 7.3%
Status of the Method: A sampling and analytical method that has been 
subjected to the established evaluation procedures of the Organic 
Methods Evaluation Branch.
Date: March 1985

                          1. General Discussion

    1.1 Background: The current OSHA method for collecting acrolein 
vapor recommends the use of activated 13X molecular sieves. The samples 
must be stored in an ice bath during and after sampling and also they 
must be analyzed within 48 hours of collection. The current OSHA method 
for collecting formaldehyde vapor recommends the use of bubblers 
containing 10% methanol in water as the trapping solution.
    This work was undertaken to resolve the sample stability problems 
associated with acrolein and also to eliminate the need to use bubb1ers 
to sample formaldehyde. A goal of this work was to develop and/or to 
evaluate a common sampling and analytical procedure for acrolein and 
formaldehyde.
    NIOSH has developed independent methodologies for acrolein and 
formaldehyde which recommend the use of reagent-coated adsorbent tubes 
to collect the aldehydes as stable derivatives. The formaldehyde 
sampling tubes contain Chromosorb 102 adsorbent coated with N-
benzylethanolamine (BEA) which reacts with formaldehyde vapor to form a 
stable oxazolidine compound. The acrolein sampling tubes contain XAD-2 
adsorbent coated with 2-(hydroxymethyl)piperidine (2-HMP) which reacts 
with acrolein vapor to form a different, stable oxazolidine derivative. 
Acrolein does not appear to react with BEA to give a suitable reaction 
product. Therefore, the formaldehyde procedure cannot provide a common 
method for both aldehydes. However, formaldehyde does react with 2-HMP 
to form a very suitable reaction product. It is the quantitative 
reaction of acrolein and formaldehyde with 2-HMP that provides the basis 
for this evaluation.
    This sampling and analytical procedure is very similar to the method 
recommended by NIOSH for acrolein. Some changes in the NIOSH methodology 
were necessary to permit the simultaneous determination of both 
aldehydes and also to accommodate OSHA

[[Page 411]]

laboratory equipment and analytical techniques.
    1.2 Limit-defining parameters: The analyte air concentrations 
reported in this method are based on the recommended air volume for each 
analyte collected separately and a desorption volume of 1 mL. The 
amounts are presented as acrolein and/or formaldehyde, even though the 
derivatives are the actual species analyzed.
    1.2.1 Detection limits of the analytical procedure: The detection 
limit of the analytical procedure was 386 pg per injection for 
formaldehyde. This was the amount of analyte which gave a peak whose 
height was about five times the height of the peak given by the residual 
formaldehyde derivative in a typical blank front section of the 
recommended sampling tube.
    1.2.2 Detection limits of the overall procedure: The detection 
limits of the overall procedure were 482 ng per sample (16 ppb or 20 
[micro]g/m\3\ for formaldehyde). This was the amount of analyte spiked 
on the sampling device which allowed recoveries approximately equal to 
the detection limit of the analytical procedure.
    1.2.3 Reliable quantitation limits: The reliable quantitation limit 
was 482 ng per sample (16 ppb or 20 [micro]g/m\3\) for formaldehyde. 
These were the smallest amounts of analyte which could be quantitated 
within the limits of a recovery of at least 75% and a precision (1.96 SD) of 25% or better.
________________________________________________________________________
    The reliable quantitation limit and detection limits reported in the 
method are based upon optimization of the instrument for the smallest 
possible amount of analyte. When the target concentration of an analyte 
is exceptionally higher than these limits, they may not be attainable at 
the routine operating parameters.

________________________________________________________________________
    1.2.4 Sensitivity: The sensitivity of the analytical procedure over 
concentration ranges representing 0.4 to 2 times the target 
concentration, based on the recommended air volumes, was 7,589 area 
units per [micro]g/mL for formaldehyde. This value was determined from 
the slope of the calibration curve. The sensitivity may vary with the 
particular instrument used in the analysis.
    1.2.5 Recovery: The recovery of formaldehyde from samples used in an 
18-day storage test remained above 92% when the samples were stored at 
ambient temperature. These values were determined from regression lines 
which were calculated from the storage data. The recovery of the analyte 
from the collection device must be at least 75% following storage.
    1.2.6 Precision (analytical method only): The pooled coefficient of 
variation obtained from replicate determinations of analytical standards 
over the range of 0.4 to 2 times the target concentration was 0.0052 for 
formaldehyde (Section 4.3).
    1.2.7 Precision (overall procedure): The precision at the 95% 
confidence level for the ambient temperature storage tests was 14.3% for formaldehyde. These values each include an 
additional 5% for sampling error. The overall 
procedure must provide results at the target concentrations that are 
25% at the 95% confidence level.
    1.2.8 Reproducibility: Samples collected from controlled test 
atmospheres and a draft copy of this procedure were given to a chemist 
unassociated with this evaluation. The formaldehyde samples were 
analyzed following 15 days storage. The average recovery was 96.3% and 
the standard deviation was 1.7%.
    1.3 Advantages:
    1.3.1 The sampling and analytical procedures permit the simultaneous 
determination of acrolein and formaldehyde.
    1.3.2 Samples are stable following storage at ambient temperature 
for at least 18 days.
    1.4 Disadvantages: None.

                          2. Sampling Procedure

    2.1 Apparatus:
    2.1.1 Samples are collected by use of a personal sampling pump that 
can be calibrated to within 5% of the recommended 
0.1 L/min sampling rate with the sampling tube in line.
    2.1.2 Samples are collected with laboratory prepared sampling tubes. 
The sampling tube is constructed of silane treated glass and is about 8-
cm long. The ID is 4 mm and the OD is 6 mm. One end of the tube is 
tapered so that a glass wool end plug will hold the contents of the tube 
in place during sampling. The other end of the sampling tube is open to 
its full 4-mm ID to facilitate packing of the tube. Both ends of the 
tube are fire-polished for safety. The tube is packed with a 75-mg 
backup section, located nearest the tapered end and a 150-mg sampling 
section of pretreated XAD-2 adsorbent which has been coated with 2-HMP. 
The two sections of coated adsorbent are separated and retained with 
small plugs of silanized glass wool. Following packing, the sampling 
tubes are sealed with two \7/32\ inch OD plastic end caps. Instructions 
for the pretreatment and the coating of XAD-2 adsorbent are presented in 
Section 4 of this method.
    2.1.3 Sampling tubes, similar to those recommended in this method, 
are marketed by Supelco, Inc. These tubes were not available when this 
work was initiated; therefore, they were not evaluated.
    2.2 Reagents: None required.
    2.3 Technique:
    2.3.1 Properly label the sampling tube before sampling and then 
remove the plastic end caps.

[[Page 412]]

    2.3.2 Attach the sampling tube to the pump using a section of 
flexible plastic tubing such that the large, front section of the 
sampling tube is exposed directly to the atmosphere. Do not place any 
tubing ahead of the sampling tube. The sampling tube should be attached 
in the worker's breathing zone in a vertical manner such that it does 
not impede work performance.
    2.3.3 After sampling for the appropriate time, remove the sampling 
tube from the pump and then seal the tube with plastic end caps.
    2.3.4 Include at least one blank for each sampling set. The blank 
should be handled in the same manner as the samples with the exception 
that air is not drawn through it.
    2.3.5 List any potential interferences on the sample data sheet.
    2.4 Breakthrough:
    2.4.1 Breakthrough was defined as the relative amount of analyte 
found on a backup sample in relation to the total amount of analyte 
collected on the sampling train.
    2.4.2 For formaldehyde collected from test atmospheres containing 6 
times the PEL, the average 5% breakthrough air volume was 41 L. The 
sampling rate was 0.1 L/min and the average mass of formaldehyde 
collected was 250 [micro]g.
    2.5 Desorption Efficiency: No desorption efficiency corrections are 
necessary to compute air sample results because analytical standards are 
prepared using coated adsorbent. Desorption efficiencies were 
determined, however, to investigate the recoveries of the analytes from 
the sampling device. The average recovery over the range of 0.4 to 2 
times the target concentration, based on the recommended air volumes, 
was 96.2% for formaldehyde. Desorption efficiencies were essentially 
constant over the ranges studied.
    2.6 Recommended Air Volume and Sampling Rate:
    2.6.1 The recommended air volume for formaldehyde is 24 L.
    2.6.2 The recommended sampling rate is 0.1 L/min.
    2.7 Interferences:
    2.7.1 Any collected substance that is capable of reacting 2-HMP and 
thereby depleting the derivatizing agent is a potential interference. 
Chemicals which contain a carbonyl group, such as acetone, may be 
capable or reacting with 2-HMP.
    2.7.2 There are no other known interferences to the sampling method.
    2.8 Safety Precautions:
    2.8.1 Attach the sampling equipment to the worker in such a manner 
that it well not interfere with work performance or safety.
    2.8.2 Follow all safety practices that apply to the work area being 
sampled.

                         3. Analytical Procedure

    3.1 Apparatus:
    3.1.1 A gas chromatograph (GC), equipped with a nitrogen selective 
detector. A Hewlett-Packard Model 5840A GC fitted with a nitrogen-
phosphorus flame ionization detector (NPD) was used for this evaluation. 
Injections were performed using a Hewlett-Packard Model 7671A automatic 
sampler.
    3.1.2 A GC column capable of resolving the analytes from any 
interference. A 6 ft x \1/4\ in OD (2mm ID) glass GC column containing 
10% UCON 50-HB-5100 + 2% KOH on 80/100 mesh Chromosorb W-AW was used for 
the evaluation. Injections were performed on-column.
    3.1.3 Vials, glass 2-mL with Teflon-lined caps.
    3.1.4 Volumetric flasks, pipets, and syringes for preparing 
standards, making dilutions, and performing injections.
    3.2 Reagents:
    3.2.1 Toluene and dimethylformamide. Burdick and Jackson solvents 
were used in this evaluation.
    3.2.2 Helium, hydrogen, and air, GC grade.
    3.2.3 Formaldehyde, 37%, by weight, in water. Aldrich Chemical, ACS 
Reagent Grade formaldehyde was used in this evaluation.
    3.2.4 Amberlite XAD-2 adsorbent coated with 2-(hydroxymethyl--
piperidine (2-HMP), 10% by weight (Section 4).
    3.2.5 Desorbing solution with internal standard. This solution was 
prepared by adding 20 [micro]L of dimethylformamide to 100 mL of 
toluene.
    3.3 Standard preparation:
    3.3.1 Formaldehyde: Prepare stock standards by diluting known 
volumes of 37% formaldehyde solution with methanol. A procedure to 
determine the formaldehyde content of these standards is presented in 
Section 4. A standard containing 7.7 mg/mL formaldehyde was prepared by 
diluting 1 mL of the 37% reagent to 50 mL with methanol.
    3.3.2 It is recommended that analytical standards be prepared about 
16 hours before the air samples are to be analyzed in order to ensure 
the complete reaction of the analytes with 2-HMP. However, rate studies 
have shown the reaction to be greater than 95% complete after 4 hours. 
Therefore, one or two standards can be analyzed after this reduced time 
if sample results are outside the concentration range of the prepared 
standards.
    3.3.3 Place 150-mg portions of coated XAD-2 adsorbent, from the same 
lot number as used to collect the air samples, into each of several 
glass 2-mL vials. Seal each vial with a Teflon-lined cap.
    3.3.4 Prepare fresh analytical standards each day by injecting 
appropriate amounts of the diluted analyte directly onto 150-mg portions 
of coated adsorbent. It is permissible to inject both acrolein and 
formaldehyde on the same adsorbent portion. Allow the standards to stand 
at room temperature. A standard, approximately the target levels,

[[Page 413]]

was prepared by injecting 11 [micro]L of the acrolein and 12 [micro]L of 
the formaldehyde stock standards onto a single coated XAD-2 adsorbent 
portion.
    3.3.5 Prepare a sufficient number of standards to generate the 
calibration curves. Analytical standard concentrations should bracket 
sample concentrations. Thus, if samples are not in the concentration 
range of the prepared standards, additional standards must be prepared 
to determine detector response.
    3.3.7 Desorb the standards in the same manner as the samples 
following the 16-hour reaction time.
    3.4 Sample preparation:
    3.4.1 Transfer the 150-mg section of the sampling tube to a 2-mL 
vial. Place the 75-mg section in a separate vial. If the glass wool 
plugs contain a significant number of adsorbent beads, place them with 
the appropriate sampling tube section. Discard the glass wool plugs if 
they do not contain a significant number of adsorbent beads.
    3.4.2 Add 1 mL of desorbing solution to each vial.
    3.4.3 Seal the vials with Teflon-lined caps and then allow them to 
desorb for one hour. Shake the vials by hand with vigorous force several 
times during the desorption time.
    3.4.4 Save the used sampling tubes to be cleaned and recycled.
    3.5 Analysis:
    3.5.1 GC Conditions

Column Temperature:
Bi-level temperature program--First level: 100 to 140 [deg]C at 4 
[deg]C/min following completion of the first level.
Second level: 140 to 180 [deg]C at 20 [deg]C/min following completion of 
the first level.
Isothermal period: Hold column at 180 [deg]C until the recorder pen 
returns to baseline (usually about 25 min after injection).

Injector temperature: 180 [deg]C
Helium flow rate: 30 mL/min (detector response will be reduced if 
nitrogen is substituted for helium carrier gas).
Injection volume: 0.8 [micro]L
GC column: Six-ft x \1/4\-in OD (2 mm ID) glass GC column containing 10% 
UCON 50-HB-5100 + 2% KOH on 80/100 Chromosorb W-AW.
    NPD conditions:
    Hydrogen flow rate: 3 mL/min
    Air flow rate: 50 mL/min
    Detector temperature: 275 [deg]C
    3.5.2 Chromatogram: For an example of a typical chromatogram, see 
Figure 4.11 in OSHA Method 52.
    3.5.3 Use a suitable method, such as electronic integration, to 
measure detector response.
    3.5.4 Use an internal standard method to prepare the calibration 
curve with several standard solutions of different concentrations. 
Prepare the calibration curve daily. Program the integrator to report 
results in [micro]g/mL.
    3.5.5 Bracket sample concentrations with standards.
    3.6 Interferences (Analytical)
    3.6.1 Any compound with the same general retention time as the 
analytes and which also gives a detector response is a potential 
interference. Possible interferences should be reported to the 
laboratory with submitted samples by the industrial hygienist.
    3.6.2 GC parameters (temperature, column, etc.) may be changed to 
circumvent interferences.
    3.6.3 A useful means of structure designation is GC/MS. It is 
recommended this procedure be used to confirm samples whenever possible.
    3.6.4 The coated adsorbent usually contains a very small amount of 
residual formaldehyde derivative (Section 4.8).
    3.7 Calculations:
    3.7.1 Results are obtained by use of calibration curves. Calibration 
curves are prepared by plotting detector response against concentration 
for each standard. The best line through the data points is determined 
by curve fitting.
    3.7.2 The concentration, in [micro]g/mL, for a particular sample is 
determined by comparing its detector response to the calibration curve. 
If either of the analytes is found on the backup section, it is added to 
the amount found on the front section. Blank corrections should be 
performed before adding the results together.
    3.7.3 The acrolein and/or formaldehyde air concentration can be 
expressed using the following equation:

mg/m\3\ = (A)(B)/C

where A = [micro]g/mL from 3.7.2, B = desorption volume, and C = L of 
          air sampled.

    No desorption efficiency corrections are required.
    3.7.4 The following equation can be used to convert results in mg/
m\3\ to ppm.

ppm = (mg/m\3\)(24.45)/MW

where mg/m\3\ = result from 3.7.3, 24.45 = molar volume of an ideal gas 
          at 760 mm Hg and 25 [deg]C, MW = molecular weight (30.0).

                             4. Backup Data

    4.1 Backup data on detection limits, reliable quantitation limits, 
sensitivity and precision of the analytical method, breakthrough, 
desorption efficiency, storage, reproducibility, and generation of test 
atmospheres are available in OSHA Method 52, developed by the Organics 
Methods Evaluation Branch, OSHA Analytical Laboratory, Salt Lake City, 
Utah.
    4.2 Procedure to Coat XAD-2 Adsorbent with 2-HMP:
    4.2.1 Apparatus: Soxhlet extraction apparatus, rotary evaporation 
apparatus, vacuum

[[Page 414]]

dessicator, 1-L vacuum flask, 1-L round-bottomed evaporative flask, 1-L 
Erlenmeyer flask, 250-mL Buchner funnel with a coarse fritted disc, etc.
    4.2.2 Reagents:
    4.2.2.1 Methanol, isooctane, and toluene.
    4.2.2.2 2-(Hydroxymethyl)piperidine.
    4.2.2.3 Amberlite XAD-2 non-ionic polymeric adsorbent, 20 to 60 
mesh, Aldrich Chemical XAD-2 was used in this evaluation.
    4.2.3 Procedure: Weigh 125 g of crude XAD-2 adsorbent into a 1-L 
Erlenmeyer flask. Add about 200 mL of water to the flask and then swirl 
the mixture to wash the adsorbent. Discard any adsorbent that floats to 
the top of the water and then filter the mixture using a fritted Buchner 
funnel. Air dry the adsorbent for 2 minutes. Transfer the adsorbent back 
to the Erlenmeyer flask and then add about 200 mL of methanol to the 
flask. Swirl and then filter the mixture as before. Transfer the washed 
adsorbent back to the Erlenmeyer flask and then add about 200 mL of 
methanol to the flask. Swirl and then filter the mixture as before. 
Transfer the washed adsorbent to a 1-L round-bottomed evaporative flask, 
add 13 g of 2-HMP and then 200 mL of methanol, swirl the mixture and 
then allow it to stand for one hour. Remove the methanol at about 40 
[deg]C and reduced pressure using a rotary evaporation apparatus. 
Transfer the coated adsorbent to a suitable container and store it in a 
vacuum desiccator at room temperature overnight. Transfer the coated 
adsorbent to a Soxhlet extractor and then extract the material with 
toluene for about 24 hours. Discard the contaminated toluene, add 
methanol in its place and then continue the Soxhlet extraction for an 
additional 4 hours. Transfer the adsorbent to a weighted 1-L round-
bottom evaporative flask and remove the methanol using the rotary 
evaporation apparatus. Determine the weight of the adsorbent and then 
add an amount of 2-HMP, which is 10% by weight of the adsorbent. Add 200 
mL of methanol and then swirl the mixture. Allow the mixture to stand 
for one hour. Remove the methanol by rotary evaporation. Transfer the 
coated adsorbent to a suitable container and store it in a vacuum 
desiccator until all traces of solvents are gone. Typically, this will 
take 2-3 days. The coated adsorbent should be protected from 
contamination. XAD-2 adsorbent treated in this manner will probably not 
contain residual acrolein derivative. However, this adsorbent will often 
contain residual formaldehyde derivative levels of about 0.1 [micro]g 
per 150 mg of adsorbent. If the blank values for a batch of coated 
adsorbent are too high, then the batch should be returned to the Soxhlet 
extractor, extracted with toluene again and then recoated. This process 
can be repeated until the desired blank levels are attained.
    The coated adsorbent is now ready to be packed into sampling tubes. 
The sampling tubes should be stored in a sealed container to prevent 
contamination. Sampling tubes should be stored in the dark at room 
temperature. The sampling tubes should be segregated by coated adsorbent 
lot number. A sufficient amount of each lot number of coated adsorbent 
should be retained to prepare analytical standards for use with air 
samples from that lot number.
    4.3 A Procedure to Determine Formaldehyde by Acid Titration: 
Standardize the 0.1 N HCl solution using sodium carbonate and methyl 
orange indicator.
    Place 50 mL of 0.1 M sodium sulfite and three drops of 
thymophthalein indicator into a 250-mL Erlenmeyer flask. Titrate the 
contents of the flask to a colorless endpoint with 0.1 N HCl (usually 
one or two drops is sufficient). Transfer 10 mL of the formaldehyde/
methanol solution (prepared in 3.3.1) into the same flask and titrate 
the mixture with 0.1 N HCl, again, to a colorless endpoint. The 
formaldehyde concentration of the standard may be calculated by the 
following equation:
[GRAPHIC] [TIFF OMITTED] TC15NO91.041

    This method is based on the quantitative liberation of sodium 
hydroxide when formaldehyde reacts with sodium sulfite to form the 
formaldehyde-bisulfite addition product. The volume of sample may be 
varied depending on the formaldehyde content but the solution to be 
titrated must contain excess sodium sulfite. Formaldehyde solutions 
containing substantial amounts of acid or base must be neutralized 
before analysis.

    Appendix C to Sec.  1910.1048--Medical Surveillance--Formaldehyde

                            I. Health Hazards

    The occupational health hazards of formaldehyde are primarily due to 
its toxic effects after inhalation, after direct contact with the skin 
or eyes by formaldehyde in liquid or vapor form, and after ingestion.

[[Page 415]]

                             II. Toxicology

                      A. Acute Effects of Exposure

    1. Inhalation (breathing): Formaldehyde is highly irritating to the 
upper airways. The concentration of formaldehyde that is immediately 
dangerous to life and health is 100 ppm. Concentrations above 50 ppm can 
cause severe pulmonary reactions within minutes. These include pulmonary 
edema, pneumonia, and bronchial irritation which can result in death. 
Concentrations above 5 ppm readily cause lower airway irritation 
characterized by cough, chest tightness and wheezing. There is some 
controversy regarding whether formaldehyde gas is a pulmonary sensitizer 
which can cause occupational asthma in a previously normal individual. 
Formaldehyde can produce symptoms of bronchial asthma in humans. The 
mechanism may be either sensitization of the individual by exposure to 
formaldehyde or direct irritation by formaldehyde in persons with pre-
existing asthma. Upper airway irritation is the most common respiratory 
effect reported by workers and can occur over a wide range of 
concentrations, most frequently above 1 ppm. However, airway irritation 
has occurred in some workers with exposures to formaldehyde as low as 
0.1 ppm. Symptoms of upper airway irritation include dry or sore throat, 
itching and burning sensations of the nose, and nasal congestion. 
Tolerance to this level of exposure may develop within 1-2 hours. This 
tolerance can permit workers remaining in an environment of gradually 
increasing formaldehyde concentrations to be unaware of their 
increasingly hazardous exposure.
    2. Eye contact: Concentrations of formaldehyde between 0.05 ppm and 
0.5 ppm produce a sensation of irritation in the eyes with burning, 
itching, redness, and tearing. Increased rate of blinking and eye 
closure generally protects the eye from damage at these low levels, but 
these protective mechanisms may interfere with some workers' work 
abilities. Tolerance can occur in workers continuously exposed to 
concentrations of formaldehyde in this range. Accidental splash injuries 
of human eyes to aqueous solutions of formaldehyde (formalin) have 
resulted in a wide range of ocular injuries including corneal opacities 
and blindness. The severity of the reactions have been directly 
dependent on the concentration of formaldehyde in solution and the 
amount of time lapsed before emergency and medical intervention.
    3. Skin contact: Exposure to formaldehyde solutions can cause 
irritation of the skin and allergic contact dermatitis. These skin 
diseases and disorders can occur at levels well below those encountered 
by many formaldehyde workers. Symptoms include erythema, edema, and 
vesiculation or hives. Exposure to liquid formalin or formaldehyde vapor 
can provoke skin reactions in sensitized individuals even when airborne 
concentrations of formaldehyde are well below 1 ppm.
    4. Ingestion: Ingestion of as little as 30 ml of a 37 percent 
solution of formaldehyde (formalin) can result in death. 
Gastrointestinal toxicity after ingestion is most severe in the stomach 
and results in symptoms which can include nausea, vomiting, and servere 
abdominal pain. Diverse damage to other organ systems including the 
liver, kidney, spleen, pancreas, brain, and central nervous systems can 
occur from the acute response to ingestion of formaldehyde.

                     B. Chronic Effects of Exposure

    Long term exposure to formaldehyde has been shown to be associated 
with an increased risk of cancer of the nose and accessory sinuses, 
nasopharyngeal and oropharyngeal cancer, and lung cancer in humans. 
Animal experiments provide conclusive evidence of a causal relationship 
between nasal cancer in rats and formaldehyde exposure. Concordant 
evidence of carcinogenicity includes DNA binding, genotoxicity in short-
term tests, and cytotoxic changes in the cells of the target organ 
suggesting both preneoplastic changes and a dose-rate effect. 
Formaldehyde is a complete carcinogen and appears to exert an effect on 
at least two stages of the carcinogenic process.

                    III. Surveillance considerations

                               A. History

    1. Medical and occupational history: Along with its acute irritative 
effects, formaldehyde can cause allergic sensitization and cancer. One 
of the goals of the work history should be to elicit information on any 
prior or additional exposure to formaldehyde in either the occupational 
or the non-occupational setting.
    2. Respiratory history: As noted above, formaldehyde has recognized 
properties as an airway irritant and has been reported by some authors 
as a cause of occupational asthma. In addition, formaldehyde has been 
associated with cancer of the entire respiratory system of humans. For 
these reasons, it is appropriate to include a comprehensive review of 
the respiratory system in the medical history. Components of this 
history might include questions regarding dyspnea on exertion, shortness 
of breath, chronic airway complaints, hyperreactive airway disease, 
rhinitis, bronchitis, bronchiolitis, asthma, emphysema, respiratory 
allergic reaction, or other preexisting pulmonary disease.
    In addition, generalized airway hypersensitivity can result from 
exposures to a single sensitizing agent. The examiner should, therefore, 
elicit any prior history of exposure to pulmonary irritants, and any 
short- or long-term effects of that exposure.

[[Page 416]]

    Smoking is known to decrease mucociliary clearance of materials 
deposited during respiration in the nose and upper airways. This may 
increase a worker's exposure to inhaled materials such as formaldehyde 
vapor. In addition, smoking is a potential confounding factor in the 
investigation of any chronic respiratory disease, including cancer. For 
these reasons, a complete smoking history should be obtained.
    3. Skin Disorders: Because of the dermal irritant and sensitizing 
effects of formaldehyde, a history of skin disorders should be obtained. 
Such a history might include the existence of skin irritation, 
previously documented skin sensitivity, and other dermatologic 
disorders. Previous exposure to formaldehyde and other dermal 
sensitizers should be recorded.
    4. History of atopic or allergic diseases: Since formaldehyde can 
cause allergic sensitization of the skin and airways, it might be useful 
to identify individuals with prior allergen sensitization. A history of 
atopic disease and allergies to formaldehyde or any other substances 
should also be obtained. It is not definitely known at this time whether 
atopic diseases and allergies to formaldehyde or any other substances 
should also be obtained. Also it is not definitely known at this time 
whether atopic individuals have a greater propensity to develop 
formaldehyde sensitivity than the general population, but identification 
of these individuals may be useful for ongoing surveillance.
    5. Use of disease questionnaires: Comparison of the results from 
previous years with present results provides the best method for 
detecting a general deterioration in health when toxic signs and 
symptoms are measured subjectively. In this way recall bias does not 
affect the results of the analysis. Consequently, OSHA has determined 
that the findings of the medical and work histories should be kept in a 
standardized form for comparison of the year-to-year results.

                         B. Physical Examination

    1. Mucosa of eyes and airways: Because of the irritant effects of 
formaldehyde, the examining physician should be alert to evidence of 
this irritation. A speculum examination of the nasal mucosa may be 
helpful in assessing possible irritation and cytotoxic changes, as may 
be indirect inspection of the posterior pharynx by mirror.
    2. Pulmonary system: A conventional respiratory examination, 
including inspection of the thorax and auscultation and percussion of 
the lung fields should be performed as part of the periodic medical 
examination. Although routine pulmonary function testing is only 
required by the standard once every year for persons who are exposed 
over the TWA concentration limit, these tests have an obvious value in 
investigating possible respiratory dysfunction and should be used 
wherever deemed appropriate by the physician. In cases of alleged 
formaldehyde-induced airway disease, other possible causes of pulmonary 
disfunction (including exposures to other substances) should be ruled 
out. A chest radiograph may be useful in these circumstances. In cases 
of suspected airway hypersensitivity or allergy, it may be appropriate 
to use bronchial challenge testing with formaldehyde or methacholine to 
determine the nature of the disorder. Such testing should be performed 
by or under the supervision of a physician experienced in the procedures 
involved.
    3. Skin: The physician should be alert to evidence of dermal 
irritation of sensitization, including reddening and inflammation, 
urticaria, blistering, scaling, formation of skin fissures, or other 
symptoms. Since the integrity of the skin barrier is compromised by 
other dermal diseases, the presence of such disease should be noted. 
Skin sensitivity testing carries with it some risk of inducing 
sensitivity, and therefore, skin testing for formaldehyde sensitivity 
should not be used as a routine screening test. Sensitivity testing may 
be indicated in the investigation of a suspected existing sensitivity. 
Guidelines for such testing have been prepared by the North American 
Contact Dermatitis Group.

                   C. Additional Examinations or Tests

    The physician may deem it necessary to perform other medical 
examinations or tests as indicated. The standard provides a mechanism 
whereby these additional investigations are covered under the standard 
for occupational exposure to formaldehyde.

                             D. Emergencies

    The examination of workers exposed in an emergency should be 
directed at the organ systems most likely to be affected. Much of the 
content of the examination will be similar to the periodic examination 
unless the patient has received a severe acute exposure requiring 
immediate attention to prevent serious consequences. If a severe 
overexposure requiring medical intervention or hospitalization has 
occurred, the physician must be alert to the possibility of delayed 
symptoms. Followup nonroutine examinations may be necessary to assure 
the patient's well-being.

                         E. Employer Obligations

    The employer is required to provide the physician with the following 
information: A copy of this standard and appendices A, C, D, and E; a 
description of the affected employee's duties as they relate to his or 
her exposure concentration; an estimate of the employee's exposure 
including duration (e.g., 15

[[Page 417]]

hr/wk, three 8-hour shifts, full-time); a description of any personal 
protective equipment, including respirators, used by the employee; and 
the results of any previous medical determinations for the affected 
employee related to formaldehyde exposure to the extent that this 
information is within the employer's control.

                       F. Physician's Obligations

    The standard requires the employer to obtain a written statement 
from the physician. This statement must contain the physician's opinion 
as to whether the employee has any medical condition which would place 
him or her at increased risk of impaired health from exposure to 
formaldehyde or use of respirators, as appropriate. The physician must 
also state his opinion regarding any restrictions that should be placed 
on the employee's exposure to formaldehyde or upon the use of protective 
clothing or equipment such as respirators. If the employee wears a 
respirator as a result of his or her exposure to formaldehyde, the 
physician's opinion must also contain a statement regarding the 
suitability of the employee to wear the type of respirator assigned. 
Finally, the physician must inform the employer that the employee has 
been told the results of the medical examination and of any medical 
conditions which require further explanation or treatment. This written 
opinion is not to contain any information on specific findings or 
diagnoses unrelated to occupational exposure to formaldehyde.
    The purpose in requiring the examining physician to supply the 
employer with a written opinion is to provide the employer with a 
medical basis to assist the employer in placing employees initially, in 
assuring that their health is not being inpaired by formaldehyde, and to 
assess the employee's ability to use any required protective equipment.

      Appendix D to Sec.  1910.1048--Nonmandatory Medical Disease 
                              Questionnaire

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[57 FR 22310, May 27, 1992; 57 FR 27161, June 18, 1992; 61 FR 5508, Feb. 
13, 1996; 63 FR 1292, Jan. 8, 1998; 63 FR 20099, Apr. 23, 1998; 70 FR 
1143, Jan. 5, 2005; 71 FR 16672, 16673, Apr. 3, 2006; 71 FR 50190, Aug. 
24, 2006; 73 FR 75586, Dec. 12, 2008; 77 FR 17784, Mar. 26, 2012; 84 FR 
21518, May 14, 2019]



Sec.  1910.1050  Methylenedianiline.

    (a) Scope and application. (1) This section applies to all 
occupational exposures to MDA, Chemical Abstracts Service Registry No. 
101-77-9, except as provided in paragraphs (a)(2) through (a)(7) of this 
section.
    (2) Except as provided in paragraphs (a)(8) and (e)(5) of this 
section, this section does not apply to the processing, use, and 
handling of products containing MDA where initial monitoring indicates 
that the product is not capable of releasing MDA in excess of the action 
level under the expected conditions of processing, use, and handling 
which will cause the greatest possible release; and where no ``dermal 
exposure to MDA'' can occur.
    (3) Except as provided in paragraph (a)(8) of this section, this 
section does not apply to the processing, use, and handling of products 
containing MDA where objective data are reasonably relied upon which 
demonstrate the product is not capable of releasing MDA under the 
expected conditions of processing, use, and handling which will cause 
the greatest possible release; and where no ``dermal exposure to MDA'' 
can occur.
    (4) This section does not apply to the storage, transportation, 
distribution or sale of MDA in intact containers sealed in such a manner 
as to contain the

[[Page 427]]

MDA dusts, vapors, or liquids, except for the provisions of 29 CFR 
1910.1200 and paragraph (d) of this section.
    (5) This section does not apply to the construction industry as 
defined in 29 CFR 1910.12(b). (Exposure to MDA in the construction 
industry is covered by 29 CFR 1926.60).
    (6) Except as provided in paragraph (a)(8) of this secton, this 
section does not apply to materials in any form which contain less than 
0.1% MDA by weight or volume.
    (7) Except as provided in paragraph (a)(8) of this section, this 
section does not apply to ``finished articles containing MDA.''
    (8) Where products containing MDA are exempted under paragraphs 
(a)(2) through (a)(7) of this section, the employer shall maintain 
records of the initial monitoring results or objective data supporting 
that exemption and the basis for the employer's reliance on the data, as 
provided in the recordkeeping provision of paragraph (n) of this 
section.
    (b) Definitions. For the purpose of this section, the following 
definitions shall apply:
    Action level means a concentration of airborne MDA of 5 ppb as an 
eight (8)-hour time-weighted average.
    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 (o) of this section, or any 
other person authorized by the Act or regulations issued under the Act.
    Container means any barrel, bottle, can, cylinder, drum, reaction 
vessel, storage tank, commercial packaging or the like, but does not 
include piping systems.
    Dermal exposure to MDA occurs where employees are engaged in the 
handling, application or use of mixtures or materials containing MDA, 
with any of the following non-airborne forms of MDA:
    (i) Liquid, powdered, granular, or flaked mixtures containing MDA in 
concentrations greater than 0.1% by weight or volume; and
    (ii) Materials other than ``finished articles'' containing MDA in 
concentrations greater than 0.1% by weight or volume.
    Director means the Director of the National Institute for 
Occupational Safety and Health, U.S. Department of Health and Human 
Services, or designee.
    Emergency means any occurrence such as, but not limited to, 
equipment failure, rupture of containers, or failure of control 
equipment which results in an unexpected and potentially hazardous 
release of MDA.
    Employee exposure means exposure to MDA which would occur if the 
employee were not using respirators or protective work clothing and 
equipment.
    Finished article containing MDA is defined as a manufactured item:
    (i) Which is formed to a specific shape or design during 
manufacture;
    (ii) Which has end use function(s) dependent in whole or part upon 
its shape or design during end use; and
    (iii) Where applicable, is an item which is fully cured by virtue of 
having been subjected to the conditions (temperature, time) necessary to 
complete the desired chemical reaction.
    4,4' Methylenedianiline or MDA means the chemical, 4,4'-
diaminodiphenylmethane, Chemical Abstract Service Registry number 101-
77-9, in the form of a vapor, liquid, or solid. The definition also 
includes the salts of MDA.
    Regulated areas means areas where airborne concentrations of MDA 
exceed or can reasonably be expected to exceed, the permissible exposure 
limits, or where dermal exposure to MDA can occur.
    STEL means short term exposure limit as determined by any 15 minute 
sample period.
    (c) Permissible exposure limits (PEL). The employer shall assure 
that no employee is exposed to an airborne concentration of MDA in 
excess of ten parts per billion (10 ppb) as an 8-hour time-weighted 
average or a STEL of 100 ppb.

[[Page 428]]

    (d) Emergency situations--(1) Written plan. (i) A written plan for 
emergency situations shall be developed for each workplace where there 
is a possibility of an emergency. Appropriate portions of the plan shall 
be implemented in the event of an emergency.
    (ii) The plan shall specifically provide that employees engaged in 
correcting emergency conditions shall be equipped with the appropriate 
personal protective equipment and clothing as required in paragraphs (h) 
and (i) of this section until the emergency is abated.
    (iii) The plan shall specifically include provisions for alerting 
and evacuating affected employees as well as the elements prescribed in 
29 CFR 1910.38 and 29 CFR 1910.39, ``Emergency action plans'' and ``Fire 
prevention plans,'' respectively.
    (2) Alerting employees. Where there is the possibility of employee 
exposure to MDA due to an emergency, means shall be developed to alert 
promptly those employees who have the potential to be directly exposed. 
Affected employees not engaged in correcting emergency conditions shall 
be evacuated immediately in the event that an emergency occurs. Means 
shall also be developed and implemented for alerting other employees who 
may be exposed as a result of the emergency.
    (e) Exposure monitoring--(1) General. (i) Determinations of employee 
exposure shall be made from breathing zone air samples that are 
representative of each employee's exposure to airborne MDA over an eight 
(8) hour period. Determination of employee exposure to the STEL shall be 
made from breathing zone air samples collected over a 15 minute sampling 
period.
    (ii) Representative employee exposure shall be determined on the 
basis of one or more samples representing full shift exposure for each 
shift for each job classification in each work area where exposure to 
MDA may occur.
    (iii) Where the employer can document that exposure levels are 
equivalent for similar operations in different work shifts, the employer 
shall only be required to determine representative employee exposure for 
that operation during one shift.
    (2) Initial monitoring. Each employer who has a workplace or work 
operation covered by this standard shall perform initial monitoring to 
determine accurately the airborne concentrations of MDA to which 
employees may be exposed.
    (3) Periodic monitoring and monitoring frequency. (i) If the 
monitoring required by paragraph (e)(2) of this section reveals employee 
exposure at or above the action level, but at or below the PELs, the 
employer shall repeat such representative monitoring for each such 
employee at least every six (6) months.
    (ii) If the monitoring required by paragraph (e)(2) of this section 
reveals employee exposure above the PELs, the employer shall repeat such 
monitoring for each such employee at least every three (3) months.
    (iii) The employer may alter the monitoring schedule from every 
three months to every six months for any employee for whom two 
consecutive measurements taken at least 7 days apart indicate that the 
employee exposure has decreased to below the TWA but above the action 
level.
    (4) Termination of monitoring. (i) If the initial monitoring 
required by paragraph (e)(2) of this section reveals employee exposure 
to be below the action level, the employer may discontinue the 
monitoring for that employee, except as otherwise required by paragraph 
(e)(5) of this section.
    (ii) If the periodic monitoring required by paragraph (e)(3) of this 
section reveals that employee exposures, as indicated by at least two 
consecutive measurements taken at least 7 days apart, are below the 
action level the employer may discontinue the monitoring for that 
employee, except as otherwise required by paragraph (e)(5) of this 
section.
    (5) Additional monitoring. The employer shall institute the exposure 
monitoring required under paragraphs (e)(2) and (e)(3) of this section 
when there has been a change in production process, chemicals present, 
control equipment, personnel, or work practices which may result in new 
or additional exposures to MDA, or when the employer has any reason to 
suspect a

[[Page 429]]

change which may result in new or additional exposures.
    (6) Accuracy of monitoring. Monitoring shall be accurate, to a 
confidence level of 95 percent, to within plus or minus 25 percent for 
airborne concentrations of MDA.
    (7) Employee notification of monitoring results. (i) The employer 
shall, within 15 working days after the receipt of the results of any 
monitoring performed under this standard, notify each employee of these 
results, in writing, either individually or by posting of results in an 
appropriate location that is accessible to affected employees.
    (ii) The written notification required by paragraph (e)(7)(i) of 
this section shall contain the corrective action being taken by the 
employer to reduce the employee exposure to or below the PELs, wherever 
the PELs are exceeded.
    (8) Visual monitoring. The employer shall make routine inspections 
of employee hands, face and forearms potentially exposed to MDA. Other 
potential dermal exposures reported by the employee must be referred to 
the appropriate medical personnel for observation. If the employer 
determines that the employee has been exposed to MDA the employer shall:
    (i) Determine the source of exposure;
    (ii) Implement protective measures to correct the hazard; and
    (iii) Maintain records of the corrective actions in accordance with 
paragraph (n) of this section.
    (f) Regulated areas--(1) Establishment--(i) Airborne exposures. The 
employer shall establish regulated areas where airborne concentrations 
of MDA exceed or can reasonably be expected to exceed, the permissible 
exposure limits.
    (ii) Dermal exposures. Where employees are subject to dermal 
exposure to MDA the employer shall establish those work areas as 
regulated areas.
    (2) Demarcation. Regulated areas shall be demarcated from the rest 
of the workplace in a manner that minimizes the number of persons 
potentially exposed.
    (3) Access. Access to regulated areas shall be limited to authorized 
persons.
    (4) Personal protective equipment and clothing. Each person entering 
a regulated area shall be supplied with, and required to use, the 
appropriate personal protective clothing and equipment in accordance 
with paragraphs (h) and (i) 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 
regulated areas.
    (g) 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 MDA at or 
below the PELs except to the extent that the employer can establish that 
these controls are not feasible or where the provisions of paragraph 
(g)(1)(ii) or (h)(1) (i) through (iv) of this section apply.
    (ii) Wherever the feasible engineering controls and work practices 
which can be instituted are not sufficient to reduce employee exposure 
to or below the PELs, 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 protective devices which 
comply with the requirements of paragraph (h) of this section.
    (2) Compliance program. (i) The employer shall establish and 
implement a written program to reduce employee exposure to or below the 
PELs by means of engineering and work practice controls, as required by 
paragraph (g)(1) of this section, and by use of respiratory protection 
where permitted under this section. The program shall include a schedule 
for periodic maintenance (e.g., leak detection) and shall include the 
written plan for emergency situations as specified in paragraph (d) of 
this section.
    (ii) Upon request this written program shall be furnished for 
examination and copying to the Assistant Secretary, the Director, 
affected employees, and designated employee representatives. The 
employer shall review and, as necessary, update such plans at least once 
every 12 months to make certain they reflect the current status of the 
program.
    (3) Employee rotation. Employee rotation shall not be permitted as a 
means of reducing exposure.
    (h) Respiratory protection--(1) General. For employees who use 
respirators required by this section, the employer

[[Page 430]]

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 for which the employer establishes that 
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 PEL.
    (iv) Emergencies.
    (2) Respirator program. 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.
    (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 HEPA filters for powered and non-powered air-purifying 
respirators.
    (C) For escape, provide employees with one of the following 
respirator options: Any self-contained breathing apparatus with a full 
facepiece or hood operated in the positive-pressure or continuous-flow 
mode; or a full facepiece air-purifying respirator.
    (D) Provide a combination HEPA filter and organic vapor canister or 
cartridge with powered or non-powered air-purifying respirators when MDA 
is in liquid form or used as part of a process requiring heat.
    (ii) Any employee who cannot use a negative-pressure respirator must 
be given the option of using a positive-pressure respirator, or a 
supplied-air respirator operated in the continuous-flow or pressure-
demand mode.
    (i) Protective work clothing and equipment--(1) Provision and use. 
Where employees are subject to dermal exposure to MDA, where liquids 
containing MDA can be splashed into the eyes, or where airborne 
concentrations of MDA are in excess of the PEL, the employer shall 
provide, at no cost to the employee, and ensure that the employee uses, 
appropriate protective work clothing and equipment which prevent contact 
with MDA such as, but not limited to:
    (i) Aprons, coveralls or other full-body work clothing;
    (ii) Gloves, head coverings, and foot coverings; and
    (iii) Face shields, chemical goggles; or
    (iv) Other appropriate protective equipment which comply with Sec.  
1910.133.
    (2) Removal and storage. (i) The employer shall ensure that, at the 
end of their work shift, employees remove MDA-contaminated protective 
work clothing and equipment that is not routinely removed throughout the 
day in change rooms provided in accordance with the provisions 
established for change rooms.
    (ii) The employer shall ensure that, during their work shift, 
employees remove all other MDA-contaminated protective work clothing or 
equipment before leaving a regulated area.
    (iii) The employer shall ensure that no employee takes MDA-
contaminated work clothing or equipment out of the change room, except 
those employees authorized to do so for the purpose of laundering, 
maintenance, or disposal.
    (iv) MDA-contaminated work clothing or equipment shall be placed and 
stored in closed containers which prevent dispersion of the MDA outside 
the container.
    (v) Containers of MDA-contaminated protective work clothing or 
equipment which are to be taken out of change rooms or the workplace for 
cleaning, maintenance, or disposal, shall bear labels warning of the 
hazards of MDA.
    (3) Cleaning and replacement. (i) The employer shall provide the 
employee with clean protective clothing and equipment. The employer 
shall ensure that protective work clothing or equipment required by this 
paragraph is cleaned, laundered, repaired, or replaced at intervals 
appropriate to maintain its effectiveness.
    (ii) The employer shall prohibit the removal of MDA from protective 
work clothing or equipment by blowing, shaking, or any methods which 
allow MDA to re-enter the workplace.

[[Page 431]]

    (iii) The employer shall ensure that laundering of MDA-contaminated 
clothing shall be done so as to prevent the release of MDA in the 
workplace.
    (iv) Any employer who gives MDA-contaminated clothing to another 
person for laundering shall inform such person of the requirement to 
prevent the release of MDA.
    (v) The employer shall inform any person who launders or cleans 
protective clothing or equipment contaminated with MDA of the 
potentially harmful effects of exposure.
    (vi) MDA-contaminated clothing shall be transported in properly 
labeled, sealed, impermeable bags or containers.
    (j) Hygiene facilities and practices--(1) Change rooms. (i) The 
employer shall provide clean change rooms for employees, who must wear 
protective clothing, or who must use protective equipment because of 
their exposure to MDA.
    (ii) Change rooms must be equipped with separate storage for 
protective clothing and equipment and for street clothes which prevents 
MDA contamination of street clothes.
    (2) Showers. (i) The employer shall ensure that employees, who work 
in areas where there is the potential for exposure resulting from 
airborne MDA (e.g., particulates or vapors) above the action level, 
shower at the end of the work shift.
    (A) Shower facilities required by this paragraph shall comply with 
Sec.  1910.141(d)(3).
    (B) The employer shall ensure that employees who are required to 
shower pursuant to the provisions contained herein do not leave the 
workplace wearing any protective clothing or equipment worn during the 
work shift.
    (ii) Where dermal exposure to MDA occurs, the employer shall ensure 
that materials spilled or deposited on the skin are removed as soon as 
possible by methods which do not facilitate the dermal absorption of 
MDA.
    (3) Lunch facilities--(i) Availability and construction. (A) 
Whenever food or beverages are consumed at the worksite and employees 
are exposed to MDA at or above the PEL or are subject to dermal exposure 
to MDA the employer shall provide readily accessible lunch areas.
    (B) Lunch areas located within the workplace and in areas where 
there is the potential for airborne exposure to MDA at or above the PEL 
shall have a positive pressure, temperature controlled, filtered air 
supply.
    (C) Lunch areas may not be located in areas within the workplace 
where the potential for dermal exposure to MDA exists.
    (ii) The employer shall ensure that employees who have been 
subjected to dermal exposure to MDA or who have been exposed to MDA 
above the PEL wash their hands and faces with soap and water prior to 
eating, drinking, smoking, or applying cosmetics.
    (iii) The employer shall ensure that employees exposed to MDA do not 
enter lunch facilities with MDA-contaminated protective work clothing or 
equipment.
    (k) Communication of hazards--(1) Hazard communication--general.
    (i) Chemical manufacturers, importers, distributors and employers 
shall comply with all requirements of the Hazard Communication Standard 
(HCS) (Sec.  1910.1200) for MDA.
    (ii) In classifying the hazards of MDA at least the following 
hazards are to be addressed: Cancer; liver effects; and skin 
sensitization.
    (iii) Employers shall include MDA in the hazard communication 
program established to comply with the HCS (Sec.  1910.1200). Employers 
shall ensure that each employee has access to labels on containers of 
MDA and to safety data sheets, and is trained in accordance with the 
requirements of HCS and paragraph (k)(4) of this section.
    (2) Signs and labels--(i) Signs. (A) The employer shall post and 
maintain legible signs demarcating regulated areas and entrances or 
access ways to regulated areas that bear the following legend:

DANGER
MDA
MAY CAUSE CANCER
CAUSES DAMAGE TO THE LIVER
RESPIRATORY PROTECTION AND PROTECTIVE CLOTHING MAY BE REQUIRED IN THIS 
AREA
AUTHORIZED PERSONNEL ONLY


[[Page 432]]


    (B) Prior to June 1, 2016, employers may use the following legend in 
lieu of that specified in paragraph (k)(2)(i)(A) of this section:

DANGER
MDA
MAY CAUSE CANCER
LIVER TOXIN
AUTHORIZED PERSONNEL ONLY
RESPIRATORS AND PROTECTIVE CLOTHING MAY BE REQUIRED TO BE WORN IN THIS 
AREA

    (ii) Labels. Prior to June 1, 2015, employers may include the 
following information workplace labels in lieu of the labeling 
requirements in paragraph (k)(1) of this section:

    (A) For pure MDA:

DANGER
CONTAINS MDA
MAY CAUSE CANCER
LIVER TOXIN

    (B) For mixtures containing MDA:

DANGER
CONTAINS MDA
CONTAINS MATERIALS WHICH MAY CAUSE CANCER
LIVER TOXIN

    (3) Safety data sheets (SDS). In meeting the obligation to provide 
safety data sheets, employers shall make appropriate use of the 
information found in Appendices A and B to Sec.  1910.1050.
    (4) Information and training. (i) The employer shall provide 
employees with information and training on MDA, in accordance with 29 
CFR 1910.1200(h), at the time of initial assignment and at least 
annually thereafter.
    (ii) In addition to the information required under 29 CFR 1910.1200, 
the employer shall:
    (A) Provide an explanation of the contents of this section, 
including appendices A and B, and indicate to employees where a copy of 
the standard is available;
    (B) Describe the medical surveillance program required under 
paragraph (m) of this section, and explain the information contained in 
appendix C; and
    (C) Describe the medical removal provision required under paragraph 
(m) of this section.
    (5) Access to training materials. (i) The employer shall make 
readily available to all affected employees, without cost, all written 
materials relating to the employee training program, including a copy of 
this regulation.
    (ii) The employer shall provide to the Assistant Secretary and the 
Director, upon request, all information and training materials relating 
to the employee information and training program.
    (l) Housekeeping. (1) All surfaces shall be maintained as free as 
practicable of visible accumulations of MDA.
    (2) The employer shall institute a program for detecting MDA leaks, 
spills, and discharges, including regular visual inspections of 
operations involving liquid or solid MDA.
    (3) All leaks shall be repaired and liquid or dust spills cleaned up 
promptly.
    (4) Surfaces contaminated with MDA may not be cleaned by the use of 
compressed air.
    (5) Shoveling, dry sweeping, and other methods of dry clean-up of 
MDA may be used where HEPA-filtered vacuuming and/or wet cleaning are 
not feasible or practical.
    (6) Waste, scrap, debris, bags, containers, equipment, and clothing 
contaminated with MDA shall be collected and disposed of in a manner to 
prevent the re-entry of MDA into the workplace.
    (m) Medical surveillance--(1) General. (i) The employer shall make 
available a medical surveillance program for employees exposed to MDA:
    (A) Employees exposed at or above the action level for 30 or more 
days per year;
    (B) Employees who are subject to dermal exposure to MDA for 15 or 
more days per year;
    (C) Employees who have been exposed in an emergency situation;
    (D) Employees whom the employer, based on results from compliance 
with paragraph (e)(8) of this section, has reason to believe are being 
dermally exposed; and
    (E) Employees who show signs or symptoms of MDA exposure.
    (ii) The employer shall ensure that all medical examinations and 
procedures are performed by, or under the supervision of, a licensed 
physician, at a reasonable time and place, and provided without cost to 
the employee.

[[Page 433]]

    (2) Initial examinations. (i) Within 150 days of the effective date 
of this standard, or before the time of initial assignment, the employer 
shall provide each employee covered by paragraph (m)(1)(i) of this 
section with a medical examination including the following elements:
    (A) A detailed history which includes:
    (1) Past work exposure to MDA or any other toxic substances;
    (2) A history of drugs, alcohol, tobacco, and medication routinely 
taken (duration and quantity); and
    (3) A history of dermatitis, chemical skin sensitization, or 
previous hepatic disease.
    (B) A physical examination which includes all routine physical 
examination parameters, skin examination, and signs of liver disease.
    (C) Laboratory tests including:
    (1) Liver function tests and
    (2) Urinalysis.
    (D) Additional tests as necessary in the opinion of the physician.
    (ii) No initial medical examination is required if adequate records 
show that the employee has been examined in accordance with the 
requirements of this section within the previous six months prior to the 
effective date of this standard or prior to the date of initial 
assignment.
    (3) Periodic examinations. (i) The employer shall provide each 
employee covered by this section with a medical examination at least 
annually following the initial examination. These periodic examinations 
shall include at least the following elements:
    (A) A brief history regarding any new exposure to potential liver 
toxins, changes in drug, tobacco, and alcohol intake, and the appearance 
of physical signs relating to the liver, and the skin;
    (B) The appropriate tests and examinations including liver function 
tests and skin examinations; and
    (C) Appropriate additional tests or examinations as deemed necessary 
by the physician.
    (ii) If in the physicians' opinion the results of liver function 
tests indicate an abnormality, the employee shall be removed from 
further MDA exposure in accordance with paragraph (m)(9) of this 
section. Repeat liver function tests shall be conducted on advice of the 
physician.
    (4) Emergency examinations. If the employer determines that the 
employee has been exposed to a potentially hazardous amount of MDA in an 
emergency situation as addressed in paragraph (d) of this section, the 
employer shall provide medical examinations in accordance with 
paragraphs (m)(3)(i) and (ii) of this section. If the results of liver 
function testing indicate an abnormality, the employee shall be removed 
in accordance with paragraph (m)(9) of this section. Repeat liver 
function tests shall be conducted on the advice of the physician. If the 
results of the tests are normal, tests must be repeated two to three 
weeks from the initial testing. If the results of the second set of 
tests are normal and, on the advice of the physician, no additional 
testing is required.
    (5) Additional examinations. Where the employee develops signs and 
symptoms associated with exposure to MDA, the employer shall provide the 
employee with an additional medical examination including a liver 
function test. Repeat liver function tests shall be conducted on the 
advice of the physician. If the results of the tests are normal, tests 
must be repeated two to three weeks from the initial testing. If the 
results of the second set of tests are normal and, on the advice of the 
physician, no additional testing is required.
    (6) Multiple physician review mechanism. (i) If the employer selects 
the initial physician who conducts any medical examination or 
consultation provided to an employee under this section, and the 
employee has signs or symptoms of occupational exposure to MDA (which 
could include an abnormal liver function test), and the employee 
disagrees with the opinion of the examining physician, and this opinion 
could affect the employee's job status, the employee may designate an 
appropriate, mutually acceptable second physician:
    (A) To review any findings, determinations, or recommendations of 
the initial physician; and
    (B) To conduct such examinations, consultations, and laboratory 
tests as

[[Page 434]]

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 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:
    (A) The employee informing the employer that he or she intends to 
seek a second medical opinion, and
    (B) The employee 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 resolve quickly their 
disagreement, then the employer and the employee through their 
respective physicians shall designate a third physician;
    (A) To review any findings, determinations, or recommendations of 
the prior physicians; and
    (B) 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.
    (v) 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.
    (7) Information provided to the examining and consulting physicians. 
(i) The employer shall provide the following information to the 
examining physician:
    (A) A copy of this regulation and its appendices;
    (B) A description of the affected employee's duties as they relate 
to the employee's potential exposure to MDA;
    (C) The employee's current actual or representative MDA exposure 
level;
    (D) A description of any personal protective equipment used or to be 
used; and
    (E) Information from previous employment-related medical 
examinations of the affected employee.
    (ii) The employer shall provide the foregoing information to a 
second physician under this section upon request either by the second 
physician, or by the employee.
    (8) Physician's written opinion. (i) For each examination under this 
section, the employer shall obtain, and provide the employee with a copy 
of, the examining physician's written opinion within 15 days of its 
receipt. The written opinion shall include the following:
    (A) The occupationally-pertinent results of the medical examination 
and tests;
    (B) The physician's opinion concerning whether the employee has any 
detected medical conditions which would place the employee at increased 
risk of material impairment of health from exposure to MDA;
    (C) The physician's recommended limitations upon the employee's 
exposure to MDA or upon the employee's use of protective clothing or 
equipment and 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 
resulting from MDA exposure which require further explanation or 
treatment.
    (ii) The written opinion obtained by the employer shall not reveal 
specific findings or diagnoses unrelated to occupational exposures.
    (9) Medical removal--(i) Temporary medical removal of an employee--
(A) Temporary removal resulting from occupational exposure. The employee 
shall be removed from work environments in which exposure to MDA is at 
or above the action level or where dermal exposure to MDA may occur, 
following an initial examination (paragraph (m)(2) of this section), 
periodic examinations (paragraph (m)(3) of this section), an emergency 
situation paragraph (m)(4)

[[Page 435]]

of this section, or an additional examination (paragraph (m)(5) of this 
section) in the following circumstances:
    (1) When the employee exhibits signs and/or symptoms indicative of 
acute exposure to MDA; or
    (2) When the examining physician determines that an employee's 
abnormal liver function tests are not associated with MDA exposure but 
that the abnormalities may be exacerbated as a result of occupational 
exposure to MDA.
    (B) Temporary removal due to a final medical determination. (1) The 
employer shall remove an employee from work environments in which 
exposure to MDA is at or above the action level or where dermal exposure 
to MDA may occur, on each occasion that there is a final medical 
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 MDA.
    (2) For the purposes of this section, the phrase ``final medical 
determination'' shall mean the outcome of the physician review mechanism 
used pursuant to the medical surveillance provisions of this section.
    (3) Where a final medical determination results in any recommended 
special protective measures for an employee, or limitations on an 
employee's exposure to MDA, the employer shall implement and act 
consistent with the recommendation.
    (ii) Return of the employee to former job status. (A) The employer 
shall return an employee to his or her former job status:
    (1) When the employee no longer shows signs or symptoms of exposure 
to MDA, or upon the advice of the physician.
    (2) 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 MDA.
    (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.
    (iii) 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.
    (iv) Employer options pending a final medical determination. Where 
the physician review 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 
MDA, 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, and end any special protective measures provided to 
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.
    (1) If 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) If the employee has been on removal status for the preceding six 
months as a result of exposure to MDA, then the employer shall await a 
final medical determination.
    (v) Medical removal protection benefits--(A) Provisions of medical 
removal protection benefits. The employer shall provide to an employee 
up to six (6) months of medical removal protection benefits on each 
occasion that an employee is removed from exposure to

[[Page 436]]

MDA or otherwise limited pursuant to this section.
    (B) 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 MDA or otherwise limited.
    (C) Follow-up medical surveillance during the period of employee 
removal or limitations. During the period of time that an employee is 
removed from normal exposure to MDA 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.
    (D) Workers' compensation claims. If a removed employee files a 
claim for workers' compensation payments for a MDA-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.
    (E) 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 non-MDA-related employment 
with any employer made possible by virtue of the employee's removal.
    (F) Employees who do not recover within the 6 months of removal. The 
employer shall take the following measures with respect to any employee 
removed from exposure to MDA:
    (1) 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;
    (2) 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;
    (3) 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; and
    (4) 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 abnormal liver 
function test, 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 MDA removal 
criteria provided by this section.
    (vi) 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 MDA or otherwise places limitations on an 
employee due to the effects of MDA exposure on the employee's medical 
condition, the employer shall provide medical removal protection 
benefits to the employee equal to that required by paragraph (m)(9)(v) 
of this section.
    (n) Recordkeeping--(1) Monitoring data for exempted employers. (i) 
Where as a result of the initial monitoring the processing, use, or 
handling of products made from or containing MDA are exempted from other 
requirements of this section under paragraph (a)(2) of this section, the 
employer shall establish and maintain an accurate record of monitoring 
relied on in support of the exemption.

[[Page 437]]

    (ii) This record shall include at least the following information:
    (A) The product qualifying for exemption;
    (B) The source of the monitoring data (e.g., was monitoring 
performed by the employer or a private contractor);
    (C) The testing protocol, results of testing, and/or analysis of the 
material for the release of MDA;
    (D) A description of the operation exempted and how the data support 
the exemption (e.g., are the monitoring data representative of the 
conditions at the affected facility); 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.
    (2) Objective data for exempted employers. (i) Where the processing, 
use, or handling of products made from or containing MDA are exempted 
from other requirements of this section under paragraph (a) of this 
section, the employer shall establish and maintain an accurate record of 
objective data relied upon in support of the exemption.
    (ii) This record shall include at least the following information:
    (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 MDA;
    (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) Exposure measurements. (i) The employer shall establish and 
maintain an accurate record of all measurements required by paragraph 
(e) of this section, in accordance with 29 CFR 1910.1020.
    (ii) This record shall include:
    (A) The dates, number, duration, and results of each of the samples 
taken, including a description of the procedure used to determine 
representative employee exposures;
    (B) Identification of the sampling and analytical methods used;
    (C) A description of the type of respiratory protective devices 
worn, if any; and
    (D) The name, job classification and exposure levels of the employee 
monitored and all other employees whose exposure the measurement is 
intended to represent.
    (iii) The employer shall maintain this record for at least 30 years, 
in accordance with 29 CFR 1910.1020.
    (4) Medical surveillance. (i) The employer shall establish and 
maintain an accurate record for each employee subject to medical 
surveillance required by paragraph (m) of this section, in accordance 
with 29 CFR 1910.1020.
    (ii) This record shall include:
    (A) The name and description of the duties of the employee;
    (B) The employer's copy of the physician's written opinion on the 
initial, periodic, and any special examinations, including results of 
medical examination and all tests, opinions, and recommendations;
    (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 MDA;
    (iii) The employer shall keep, or assure that the examining 
physician keeps, the following medical records:
    (A) A copy of this standard and its appendices, except that the 
employer may keep one copy of the standard and its appendices for all 
employees provided the employer references the standard and its 
appendices in the medical surveillance record of each employee;
    (B) A copy of the information provided to the physician as required 
by any paragraphs in the regulatory text;
    (C) A description of the laboratory procedures and a copy of any 
standards or guidelines used to interpret the test results or references 
to the information;

[[Page 438]]

    (D) A copy of the employee's medical and work history related to 
exposure to MDA; and
    (iv) The employer shall maintain this record for at least the 
duration of employment plus 30 years, in accordance with 29 CFR 
1910.1020.
    (5) Medical removals. (i) The employer shall establish and maintain 
an accurate record for each employee removed from current exposure to 
MDA pursuant to paragraph (m) of this section.
    (ii) Each record shall include:
    (A) The name of the employee;
    (B) The date of each occasion that the employee was removed from 
current exposure to MDA 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 the reason 
for the removal.
    (iii) The employer shall maintain each medical removal record for at 
least the duration of an employee's employment plus 30 years.
    (6) Availability. (i) The employer shall assure that records 
required to be maintained by this section shall be made available, upon 
request, to the Assistant Secretary and the Director for examination and 
copying.
    (ii) Employee exposure monitoring records required by this section 
shall be provided upon request for examination and copying to employees, 
employee representatives, and the Assistant Secretary in accordance with 
29 CFR 1910.1020 (a)-(e) and (g)-(i).
    (iii) Employee medical records required by this section shall be 
provided upon request for examination and copying, to the subject 
employee, to anyone having the specific written consent of the subject 
employee, and to the Assistant Secretary in accordance with 29 CFR 
1910.1020.
    (7) Transfer of records. The employer shall comply with the 
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 the measuring or monitoring 
of employee exposure to MDA conducted pursuant to paragraph (e) of this 
section.
    (2) Observation procedures. When observation of the measuring or 
monitoring of employee exposure to MDA requires entry into areas where 
the use of protective clothing and equipment or respirators is required, 
the employer shall provide the observer with personal protective 
clothing and equipment or respirators required to be worn by employees 
working in the area, assure the use of such clothing and equipment or 
respirators, and require the observer to comply with all other 
applicable safety and health procedures.
    (p) [Reserved]
    (q) Appendices. The information contained in Appendices A, B, C, and 
D of 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.  1910.1050--Substance Data Sheet, for 4,4'-
                           Methylenedianiline

                       I. Substance Identification

    A. Substance: Methylenedianiline (MDA)
    B. Permissible Exposure:
    1. Airborne: Ten parts per billion parts of air (10 ppb), time-
weighted average (TWA) for an 8-hour workday and an action level of five 
parts per billion parts of air (5 ppb).
    2. Dermal: Eye contact and skin contact with MDA are not permitted.
    C. Appearance and odor: White to tan solid; amine odor

                         II. Health Hazard Data

    A. Ways in which MDA affects your health. MDA can affect your health 
if you inhale it, or if it comes in contact with your skin or eyes. MDA 
is also harmful if you happen to swallow it. Do not get MDA in eyes, on 
skin, or on clothing.
    B. Effects of overexposure. 1. Short-term (acute) overexposure: 
Overexposure to MDA may produce fever, chills, loss of appetite, 
vomiting, jaundice. Contact may irritate skin, eyes and mucous 
membranes. Sensitization may occur.
    2. Long-term (chronic) exposure. Repeated or prolonged exposure to 
MDA, even at relatively low concentrations, may cause cancer. In 
addition, damage to the liver, kidneys, blood, and spleen may occur with 
long term exposure.
    3. Reporting signs and symptoms. You should inform your employer if 
you develop any

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signs or symptoms which you suspect are caused by exposure to MDA 
including yellow staining of the skin.

                 III. Protective Clothing and Equipment

    A. Respirators. Respirators are required for those operations in 
which engineering controls or work-practice controls are not adequate or 
feasible to reduce exposure to the permissible limit. If respirators are 
worn, they must have a label issued by the National Institute for 
Occupational Safety and Health under the provisions of 42 CFR part 84 
stating that the respirators have been approved for this purpose, and 
cartridges and canisters must be replaced in accordance with the 
requirements of 29 CFR 1910.134. If you experience difficulty breathing 
while wearing a respirator, you can request a positive-pressure 
respirator from your employer. You must be thoroughly trained to use the 
assigned respirator, and the training must be provided by your employer.
    MDA does not have a detectable odor except at levels well above the 
permissible exposure limits. Do not depend on odor to warn you when a 
respirator canister is exhausted. If you can smell MDA while wearing a 
respirator, proceed immediately to fresh air. If you experience 
difficulty breathing while wearing a respirator, tell your employer.
    B. Protective Clothing. You may be required to wear coveralls, 
aprons, gloves, face shields, or other appropriate protective clothing 
to prevent skin contact with MDA. Where protective clothing is required, 
your employer is required to provide clean garments to you, as 
necessary, to assure that the clothing protects you adequately. Replace 
or repair impervious clothing that has developed leaks.
    MDA should never be allowed to remain on the skin. Clothing and 
shoes which are not impervious to MDA should not be allowed to become 
contaminated with MDA, and if they do, the clothing and shoes should be 
promptly removed and decontaminated. The clothing should be laundered to 
remove MDA or discarded. Once MDA penetrates shoes or other leather 
articles, they should not be worn again.
    C. Eye protection. You must wear splashproof safety goggles in areas 
where liquid MDA may contact your eyes. Contact lenses should not be 
worn in areas where eye contact with MDA can occur. In addition, you 
must wear a face shield if your face could be splashed with MDA liquid.

                 IV. Emergency and First Aid Procedures

    A. Eye and face exposure. If MDA is splashed into the eyes, wash the 
eyes for at least 15 minutes. See a doctor as soon as possible.
    B. Skin exposure. If MDA is spilled on your clothing or skin, remove 
the contaminated clothing and wash the exposed skin with large amounts 
of soap and water immediately. Wash contaminated clothing before you 
wear it again.
    C. Breathing. If you or any other person breathes in large amounts 
of MDA, get the exposed person to fresh air at once. Apply artificial 
respiration if breathing has stopped. Call for medical assistance or a 
doctor as soon as possible. Never enter any vessel or confined space 
where the MDA concentration might be high without proper safety 
equipment and at least one other person present who will stay outside. A 
life line should be used.
    D. Swallowing. If MDA has been swallowed and the patient is 
conscious, do not induce vomiting. Call for medical assistance or a 
doctor immediately.

                         V. Medical Requirements

    If you are exposed to MDA at a concentration at or above the action 
level for more than 30 days per year, or exposed to liquid mixtures more 
than 15 days per year, your employer is required to provide a medical 
examination, including a medical history and laboratory tests, within 60 
days of the effective date of this standard and annually thereafter. 
These tests shall be provided without cost to you. In addition, if you 
are accidentally exposed to MDA (either by ingestion, inhalation, or 
skin/eye contact) under conditions known or suspected to constitute 
toxic exposure to MDA, your employer is required to make special 
examinations and tests available to you.

                      VI. Observation of Monitoring

    Your employer is required to perform measurements that are 
representative of your exposure to MDA 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 and your representative must also 
be provided with, and must wear, the protective clothing and equipment.

                         VII. Access to Records

    You or your representative are entitled to see the records of 
measurements of your exposure to MDA upon written request to your 
employer. Your medical examination records can be furnished to your 
physician or designated representative upon request by you to your 
employer.

[[Page 440]]

          VIII. Precautions for Safe Use, Handling and Storage

    A. Material is combustible. Avoid strong acids and their anhydrides. 
Avoid strong oxidants. Consult supervisor for disposal requirements.
    B. Emergency clean-up. Wear self-contained breathing apparatus and 
fully clothe the body in the appropriate personal protective clothing 
and equipment.

   Appendix B to Sec.  1910.1050--Substance Technical Guidelines, MDA

                            I. Identification

    A. Substance identification.
    1. Synonyms: CAS No. 101-77-9. 
4,4'-methylenedianiline; 
4,4'-methylenebisaniline; methylenedianiline; dianilinomethane.
    2. Formula: C13 H14 N2

                            II. Physical Data

    1. Appearance and Odor: White to tan solid; amine odor
    2. Molecular Weight: 198.26
    3. Boiling Point: 398-399 degrees C at 760 mm Hg
    4. Melting Point: 88-93 degrees C (190-100 degrees F)
    5. Vapor Pressure: 9 mmHg at 232 degrees C
    6. Evaporation Rate (n-butyl acetate = 1): Negligible
    7. Vapor Density (Air = 1): Not Applicable
    8. Volatile Fraction by Weight: Negligible
    9. Specific Gravity (Water = 1): Slight
    10. Heat of Combustion: -8.40 kcal/g
    11. Solubility in Water: Slightly soluble in cold water, very 
soluble in alcohol, benzene, ether, and many organic solvents.

            III. Fire, Explosion, and Reactivity Hazard Data

    1. Flash Point: 190 degrees C (374 degrees F) Setaflash closed cup
    2. Flash Point: 226 degrees C (439 degrees F) Cleveland open cup
    3. Extinguishing Media: Water spray; Dry Chemical; Carbon dioxide.
    4. Special Fire Fighting Procedures: Wear self-contained breathing 
apparatus and protective clothing to prevent contact with skin and eyes.
    5. Unusual Fire and Explosion Hazards: Fire or excessive heat may 
cause production of hazardous decomposition products.

                           IV. Reactivity Data

    1. Stability: Stable
    2. Incompatibility: Strong oxidizers
    3. Hazardous Decomposition Products: As with any other organic 
material, combustion may produce carbon monoxide. Oxides of nitrogen may 
also be present.
    4. Hazardous Polymerization: Will not occur.

                      V. Spill and Leak Procedures

    1. Sweep material onto paper and place in fiber carton.
    2. Package appropriately for safe feed to an incinerator or dissolve 
in compatible waste solvents prior to incineration.
    3. Dispose of in an approved incinerator equipped with afterburner 
and scrubber or contract with licensed chemical waste disposal service.
    4. Discharge treatment or disposal may be subject to federal, state, 
or local laws.
    5. Wear appropriate personal protective equipment.

              VI. Special Storage and Handling Precautions

    A. High exposure to MDA can occur when transferring the substance 
from one container to another. Such operations should be well ventilated 
and good work practices must be established to avoid spills.
    B. Pure MDA is a solid with a low vapor pressure. Grinding or 
heating operations increase the potential for exposure.
    C. Store away from oxidizing materials.
    D. Employers shall advise employees of all areas and operations 
where exposure to MDA could occur.

                VII. Housekeeping and Hygiene Facilities

    A. The workplace should be kept clean, orderly, and in a sanitary 
condition.
    The employer should institute a leak and spill detection program for 
operations involving MDA in order to detect sources of fugitive MDA 
emissions.
    B. Adequate washing facilities with hot and cold water are to be 
provided and maintained in a sanitary condition. Suitable cleansing 
agents should also be provided to assure the effective removal of MDA 
from the skin.

                         VIII. Common Operations

    Common operations in which exposure to MDA is likely to occur 
include the following: Manufacture of MDA; Manufacture of Methylene 
diisocyanate; Curing agent for epoxy resin structures; Wire coating 
operations; and filament winding.

 Appendix C to Sec.  1910.1050--Medical Surveillance Guidelines for MDA

                            I. Route of Entry

    Inhalation; skin absorption; ingestion. MDA can be inhaled, absorbed 
through the skin, or ingested.

                             II. Toxicology

    MDA is a suspect carcinogen in humans. There are several reports of 
liver disease in humans and animals resulting from acute exposure to 
MDA. A well documented case of

[[Page 441]]

an acute cardiomyopathy secondary to exposure to MDA is on record. 
Numerous human cases of hepatitis secondary to MDA are known. Upon 
direct contact MDA may also cause damage to the eyes. Dermatitis and 
skin sensitization have been observed. Almost all forms of acute 
environmental hepatic injury in humans involve the hepatic parenchyma 
and produce hepatocellular jaundice. This agent produces intrahepatic 
cholestasis. The clinical picture consists of cholestatic jaundice, 
preceded or accompanied by abdominal pain, fever, and chills. Onset in 
about 60% of all observed cases is abrupt with severe abdominal pain. In 
about 30% of observed cases, the illness presented and evolved more 
slowly and less dramatically, with only slight abdominal pain. In about 
10% of the cases only jaundice was evident. The cholestatic nature of 
the jaundice is evident in the prominence of itching, the histologic 
predominance of bile stasis, and portal inflammatory infiltration, 
accompanied by only slight parenchymal injury in most cases, and by the 
moderately elevated transaminase values. Acute, high doses, however, 
have been known to cause hepatocellular damage resulting in elevated 
SGPT, SGOT, alkaline phosphatase and bilirubin.
    Absorption through the skin is rapid. MDA is metabolized and 
excreted over a 48-hour period. Direct contact may be irritating to the 
skin, causing dermatitis. Also MDA which is deposited on the skin is not 
thoroughly removed through washing.
    MDA may cause bladder cancer in humans. Animal data supporting this 
assumption is not available nor is conclusive human data. However, human 
data collected on workers at a helicopter manufacturing facility where 
MDA is used suggests a higher incidence of bladder cancer among exposed 
workers.

                         III. Signs and Symptoms

    Skin may become yellow from contact with MDA.
    Repeated or prolonged contact with MDA may result in recurring 
dermatitis (red-itchy, cracked skin) and eye irritation. Inhalation, 
ingestion or absorption through the skin at high concentrations may 
result in hepatitis, causing symptoms such as fever and chills, nausea 
and vomiting, dark urine, anorexia, rash, right upper quadrant pain and 
jaundice. Corneal burns may occur when MDA is splashed in the eyes.

        IV. Treatment of Acute Toxic Effects/Emergency Situation

    If MDA gets into the eyes, immediately wash eyes with large amounts 
of water. If MDA is splashed on the skin, immediately wash contaminated 
skin with mild soap or detergent. Employee should be removed from 
exposure and given proper medical treatment. Medical tests required 
under the emergency section of the medical surveillance section (M)(4) 
must be conducted.
    If the chemical is swallowed do not induce vomiting but remove by 
gastric lavage.

 Appendix D to Sec.  1910.1050--Sampling and Analytical Methods for MDA 
                  Monitoring and Measurement Procedures

    Measurements taken for the purpose of determining employee exposure 
to MDA are best taken so that the representative average 8-hour exposure 
may be determined from a single 8-hour sample or two (2) 4-hour samples. 
Short-time interval samples (or grab samples) may also be used to 
determine average exposure level if a minimum of five measurements are 
taken in a random manner over the 8-hour work shift. Random sampling 
means that any portion of the work shift has the same chance of being 
sampled as any other. The arithmetic average of all such random samples 
taken on one work shift is an estimate of an employee's average level of 
exposure for that work shift. Air samples should be taken in the 
employee's breathing zone (air that would most nearly represent that 
inhaled by the employee).
    There are a number of methods available for monitoring employee 
exposures to MDA. The method OSHA currently uses is included below.
    The employer, however, has the obligation of selecting any 
monitoring method which meets the accuracy and precision requirements of 
the standard under his unique field conditions. The standard requires 
that the method of monitoring must have an accuracy, to a 95 percent 
confidence level, of not less than plus or minus 25 percent for the 
select PEL.

                            OSHA Methodology

                           Sampling Procedure

                                Apparatus

    Samples are collected by use of a personal sampling pump that can be 
calibrated within 5% of the recommended flow rate 
with the sampling filter in line.
    Samples are collected on 37 mm Gelman type A/E glass fiber filters 
treated with sulfuric acid. The filters are prepared by soaking each 
filter with 0.5 mL of 0.26N H2 SO4. (0.26 N 
H2 SO4 can be prepared by diluting 1.5 mL of 36N 
H2 SO4 to 200 mL with deionized water.) The 
filters are dried in an oven at 100 degrees C for one hour and then 
assembled into two-piece 37 mm polystyrene cassettes with backup pads. 
The cassettes are sealed with shrink bands and the ends are plugged with 
plastic plugs.
    After sampling, the filters are carefully removed from the cassettes 
and individually transferred to small vials containing approximately 2 
mL deionized water. The vials

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must be tightly sealed. The water can be added before or after the 
filters are transferred. The vials must be sealable and capable of 
holding at least 7 mL of liquid. Small glass scintillation vials with 
caps containing Teflon liners are recommended.

                                Reagents

    Deionized water is needed for addition to the vials.

                           Sampling Technique

    Immediately before sampling, remove the plastic plugs from the 
filter cassettes.
    Attach the cassette to the sampling pump with flexible tubing and 
place the cassette in the employee's breathing zone.
    After sampling, seal the cassettes with plastic plugs until the 
filters are transferred to the vials containing deionized water.
    At some convenient time within 10 hours of sampling, transfer the 
sample filters to vials.
    Seal the small vials lengthwise.
    Submit at least one blank filter with each sample set. Blanks should 
be handled in the same manner as samples, but no air is drawn through 
them.
    Record sample volumes (in L of air) for each sample, along with any 
potential interferences.

                          Retention Efficiency

    A retention efficiency study was performed by drawing 100 L of air 
(80% relative humidity) at 1 L/min through sample filters that had been 
spiked with 0.814 [micro]g MDA. Instead of using backup pads, blank 
acid-treated filters were used as backups in each cassette. Upon 
analysis, the top filters were found to have an average of 91.8% of the 
spiked amount. There was no MDA found on the bottom filters, so the 
amount lost was probably due to the slight instability of the MDA salt.

                          Extraction Efficiency

    The average extraction efficiency for six filters spiked at the 
target concentration is 99.6%.
    The stability of extracted and derivatized samples was verified by 
reanalyzing the above six samples the next day using fresh standards. 
The average extraction efficiency for the reanalyzed samples is 98.7%.

                Recommended Air Volume and Sampling Rate

    The recommended air volume is 100 L.
    The recommended sampling rate is 1 L/min.

                        Interferences (Sampling)

    MDI appears to be a positive interference. It was found that when 
MDI was spiked onto an acid-treated filter, the MDI converted to MDA 
after air was drawn through it.
    Suspected interferences should be reported to the laboratory with 
submitted samples.

                      Safety Precautions (Sampling)

    Attach the sampling equipment to the employees so that it will not 
interfere with work performance or safety.
    Follow all safety procedures that apply to the work area being 
sampled.

                          Analytical Procedure

    Apparatus: The following are required for analysis.
    A GC equipped with an electron capture detector. For this evaluation 
a Tracor 222 Gas Chromatograph equipped with a Nickel 63 High 
Temperature Electron Capture Detector and a Linearizer was used.
    A GC column capable of separating the MDA derivative from the 
solvent and interferences. A 6 ft x 2 mm ID glass column packed with 3% 
OV-101 coated on 100/120 Gas Chrom Q was used in this evaluation.
    A electronic integrator or some other suitable means of measuring 
peak areas or heights.
    Small resealable vials with Teflon-lined caps capable of holding 4 
mL.
    A dispenser or pipet for toluene capable of delivering 2.0 mL.
    Pipets (or repipets with plastic or Teflon tips) capable of 
delivering 1 mL for the sodium hydroxide and buffer solutions.
    A repipet capable of delivering 25 [micro]L HFAA.
    Syringes for preparation of standards and injection of standards and 
samples into a GC.
    Volumetric flasks and pipets to dilute the pure MDA in preparation 
of standards.
    Disposable pipets to transfer the toluene layers after the samples 
are extracted.

                                Reagents

    0.5 NaOH prepared from reagent grade NaOH.
    Toluene, pesticide grade. Burdick and Jackson distilled in glass 
toluene was used.
    Heptafluorobutyric acid anhydride (HFAA). HFAA from Pierce Chemical 
Company was used.
    pH 7.0 phosphate buffer, prepared from 136 g potassium dihydrogen 
phosphate and 1 L deionized water. The pH is adjusted to 7.0 with 
saturated sodium hydroxide solution.
    4,4' -Methylenedianiline (MDA), reagent grade.

                          Standard Preparation

    Concentrated stock standards are prepared by diluting pure MDA with 
toluene. Analytical standards are prepared by injecting uL amounts of 
diluted stock standards into vials that contain 2.0 mL toluene.

[[Page 443]]

    25 uL HFAA are added to each vial and the vials are capped and 
shaken for 10 seconds.
    After 10 min, 1 mL of buffer is added to each vial.
    The vials are recapped and shaken for 10 seconds.
    After allowing the layers to separate, aliquots of the toluene 
(upper) layers are removed with a syringe and analyzed by GC.
    Analytical standard concentrations should bracket sample 
concentrations. Thus, if samples fall out of the range of prepared 
standards, additional standards must be prepared to ascertain detector 
response.

                           Sample Preparation

    The sample filters are received in vials containing deionized water.
    1 mL of 0.5N NaOH and 2.0 mL toluene are added to each vial.
    The vials are recapped and shaken for 10 min.
    After allowing the layers to separate, approximately 1 mL aliquots 
of the toluene (upper) layers are transferred to separate vials with 
clean disposable pipets.
    The toluene layers are treated and analyzed.

                                Analysis

                              GC conditions

Zone temperatures:
    Column--220 degrees C
    Injector--235 degrees C
    Detector--335 degrees C
Gas flows, Ar/CH4 Column--28 mL/min
    (95/5) Purge--40 mL/min
Injection volume: 5.0 uL
Column: 6 ft x \1/8\ in ID glass, 3% OV-101 on 100/120 Gas Chrom Q
Retention time of MDA derivative: 3.5 min

                              Chromatogram

    Peak areas or heights are measured by an integrator or other 
suitable means.
    A calibration curve is constructed by plotting response (peak areas 
or heights) of standard injections versus ug of MDA per sample. Sample 
concentrations must be bracketed by standards.

                       Interferences (Analytical)

    Any compound that gives an electron capture detector response and 
has the same general retention time as the HFAA derivative of MDA is a 
potential interference. Suspected interferences reported to the 
laboratory with submitted samples by the industrial hygienist must be 
considered before samples are derivatized.
    GC parameters may be changed to possibly circumvent interferences.
    Retention time on a single column is not considered proof of 
chemical identity. Analyte identity should be confirmed by GC/MS if 
possible.

                              Calculations

    The analyte concentration for samples is obtained from the 
calibration curve in terms of ug MDA per sample. The extraction 
efficiency is 100%. If any MDA is found on the blank, that amount is 
subtracted from the sample amounts. The air concentrations are 
calculated using the following formulae.
[micro]g/m\3\ = ([micro]g MDA per sample) (1000)/(L of air sampled)
ppb = ([micro]g/m\3\) (24.46) / (198.3) = ([micro]g/m\3\) (0.1233) where 
          24.46 is the molar volume at 25 degrees C and 760 mm Hg

                     Safety Precautions (Analytical)

    Avoid skin contact and inhalation of all chemicals.
    Restrict the use of all chemicals to a fume hood if possible.
    Wear safety glasses and a lab coat at all times while in the lab 
area.

[57 FR 35666, Aug. 10, 1992, as amended at 57 FR 49649, Nov. 3, 1992; 61 
FR 5508, Feb. 13, 1996; 63 FR 1293, Jan. 8, 1998; 67 FR 67965, Nov. 7, 
2002; 71 FR 16672, 16673, Apr. 3, 2006; 71 FR 50190, Aug. 24, 2006; 73 
FR 75586, Dec. 12, 2008; 76 FR 33609, June 8, 2011; 77 FR 17785, Mar. 
26, 2012]



Sec.  1910.1051  1,3-Butadiene.

    (a) Scope and application. (1) This section applies to all 
occupational exposures to 1,3-Butadiene (BD), Chemical Abstracts Service 
Registry No. 106-99-0, except as provided in paragraph (a)(2) of this 
section.
    (2)(i) Except for the recordkeeping provisions in paragraph (m)(1) 
of this section, this section does not apply to the processing, use, or 
handling of products containing BD or to other work operations and 
streams in which BD is present where objective data are reasonably 
relied upon that demonstrate the work operation or the product or the 
group of products or operations to which it belongs may not reasonably 
be foreseen to release BD in airborne concentrations at or above the 
action level or in excess of the STEL under the expected conditions of 
processing, use, or handling that will cause the greatest possible 
release or in any plausible accident.
    (ii) This section also does not apply to work operations, products 
or streams where the only exposure to BD is from liquid mixtures 
containing 0.1% or less of BD by volume or the vapors

[[Page 444]]

released from such liquids, unless objective data become available that 
show that airborne concentrations generated by such mixtures can exceed 
the action level or STEL under reasonably predictable conditions of 
processing, use or handling that will cause the greatest possible 
release.
    (iii) Except for labeling requirements and requirements for 
emergency response, this section does not apply to the storage, 
transportation, distribution or sale of BD or liquid mixtures in intact 
containers or in transportation pipelines sealed in such a manner as to 
fully contain BD vapors or liquid.
    (3) Where products or processes containing BD are exempted under 
paragraph (a)(2) of this section, the employer shall maintain records of 
the objective data supporting that exemption and the basis for the 
employer's reliance on the data, as provided in paragraph (m)(1) of this 
section.
    (b) Definitions: For the purpose of this section, the following 
definitions shall apply:
    Action level means a concentration of airborne BD of 0.5 ppm 
calculated as an eight (8)-hour time-weighted average.
    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 designated by the 
employer, whose duties require entrance into a regulated area, or a 
person entering such an area as a designated representative of employees 
to exercise the right to observe monitoring and measuring procedures 
under paragraph (d)(8) of this section, or a person designated under the 
Act or regulations issued under the Act to enter a regulated area.
    1,3-Butadiene means an organic compound with chemical formula 
CH2 = CH-CH = CH2 that has a molecular weight of 
approximately 54.15 gm/mole.
    Business day means any Monday through Friday, except those days 
designated as federal, state, local or company specific holidays.
    Complete Blood Count (CBC) means laboratory tests performed on whole 
blood specimens and includes the following: White blood cell count 
(WBC), hematocrit (Hct), red blood cell count (RBC), hemoglobin (Hgb), 
differential count of white blood cells, red blood cell morphology, red 
blood cell indices, and platelet count.
    Day means any part of a calendar day.
    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 situation means any occurrence such as, but not limited 
to, equipment failure, rupture of containers, or failure of control 
equipment that may or does result in an uncontrolled significant release 
of BD.
    Employee exposure means exposure of a worker to airborne 
concentrations of BD which would occur if the employee were not using 
respiratory protective equipment.
    Objective data means monitoring data, or mathematical modelling or 
calculations based on composition, chemical and physical properties of a 
material, stream or product.
    Permissible Exposure Limits, PELs means either the 8 hour Time 
Weighted Average (8-hr TWA) exposure or the Short-Term Exposure Limit 
(STEL).
    Physician or other licensed health care professional 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 one or more of the 
specific health care services required by paragraph (k) of this section.
    Regulated area means any area where airborne concentrations of BD 
exceed or can reasonably be expected to exceed the 8-hour time weighted 
average (8-hr TWA) exposure of 1 ppm or the short-term exposure limit 
(STEL) of 5 ppm for 15 minutes.
    This section means this 1,3-butadiene standard.
    (c) Permissible exposure limits (PELs)--(1) Time-weighted average 
(TWA) limit. The employer shall ensure that no employee is exposed to an 
airborne concentration of BD in excess of one (1) part BD per million 
parts of air (ppm) measured as an eight (8)-hour time-weighted average.

[[Page 445]]

    (2) Short-term exposure limit (STEL). The employer shall ensure that 
no employee is exposed to an airborne concentration of BD in excess of 
five parts of BD per million parts of air (5 ppm) as determined over a 
sampling period of fifteen (15) minutes.
    (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 15-minute short-term exposures of 
each employee.
    (ii) Representative 8-hour TWA employee exposure shall be determined 
on the basis of one or more samples representing full-shift exposure for 
each shift and for each job classification in each work area.
    (iii) Representative 15-minute short-term employee exposures shall 
be determined on the basis of one or more samples representing 15-minute 
exposures associated with operations that are most likely to produce 
exposures above the STEL for each shift and for each job classification 
in each work area.
    (iv) Except for the initial monitoring required under paragraph 
(d)(2) of this section, where the employer can document that exposure 
levels are equivalent for similar operations on different work shifts, 
the employer need only determine representative employee exposure for 
that operation from the shift during which the highest exposure is 
expected.
    (2) Initial monitoring. (i) Each employer who has a workplace or 
work operation covered by this section, shall perform initial monitoring 
to determine accurately the airborne concentrations of BD to which 
employees may be exposed, or shall rely on objective data pursuant to 
paragraph (a)(2)(i) of this section to fulfill this requirement. The 
initial monitoring required under this paragraph shall be completed 
within 60 days of the introduction of BD into the workplace.
    (ii) Where the employer has monitored within two years prior to the 
effective date of this section 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, provided that the conditions under which the initial 
monitoring was conducted have not changed in a manner that may result in 
new or additional exposures.
    (3) Periodic monitoring and its frequency. (i) If the initial 
monitoring required by paragraph (d)(2) of this section reveals employee 
exposure to be at or above the action level but at or below both the 8-
hour TWA limit and the STEL, the employer shall repeat the 
representative monitoring required by paragraph (d)(1) of this section 
every twelve months.
    (ii) If the initial monitoring required by paragraph (d)(2) of this 
section reveals employee exposure to be above the 8-hour TWA limit, the 
employer shall repeat the representative monitoring required by 
paragraph (d)(1)(ii) of this section at least every three months until 
the employer has collected two samples per quarter (each at least 7 days 
apart) within a two-year period, after which such monitoring must occur 
at least every six months.
    (iii) If the initial monitoring required by paragraph (d)(2) of this 
section reveals employee exposure to be above the STEL, the employer 
shall repeat the representative monitoring required by paragraph 
(d)(1)(iii) of this section at least every three months until the 
employer has collected two samples per quarter (each at least 7 days 
apart) within a two-year period, after which such monitoring must occur 
at least every six months.
    (iv) The employer may alter the monitoring schedule from every six 
months to annually for any required representative monitoring for which 
two consecutive measurements taken at least 7 days apart indicate that 
employee exposure has decreased to or below the 8-hour TWA, but is at or 
above the action level.
    (4) Termination of monitoring. (i) If the initial monitoring 
required by paragraph (d)(2) of this section reveals employee exposure 
to be below the action level and at or below the STEL, the employer may 
discontinue the monitoring for employees whose exposures are represented 
by the initial monitoring.

[[Page 446]]

    (ii) If the periodic monitoring required by paragraph (d)(3) of this 
section reveals that employee exposures, as indicated by at least two 
consecutive measurements taken at least 7 days apart, are below the 
action level and at or below the STEL, the employer may discontinue the 
monitoring for those employees who are represented by such monitoring.
    (5) Additional monitoring. (i) The employer shall institute the 
exposure monitoring required under paragraph (d) 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 to BD or when the employer has any reason to 
suspect that a change may result in new or additional exposures.
    (ii) Whenever spills, leaks, ruptures or other breakdowns occur that 
may lead to employee exposure above the 8-hr TWA limit or above the 
STEL, the employer shall monitor [using leak source, such as direct 
reading instruments, area or personal monitoring], after the cleanup of 
the spill or repair of the leak, rupture or other breakdown, to ensure 
that exposures have returned to the level that existed prior to the 
incident.
    (6) Accuracy of monitoring. Monitoring shall be accurate, at a 
confidence level of 95 percent, to within plus or minus 25 percent for 
airborne concentrations of BD at or above the 1 ppm TWA limit and to 
within plus or minus 35 percent for airborne concentrations of BD at or 
above the action level of 0.5 ppm and below the 1 ppm TWA limit.
    (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 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) The employer shall, within 15 business days after receipt of 
any monitoring performed under this section indicating the 8-hour TWA or 
STEL has been exceeded, provide the affected employees, in writing, with 
information on the corrective action being taken by the employer to 
reduce employee exposure to or below the 8-hour TWA or STEL and the 
schedule for completion of this action.
    (8) Observation of monitoring--(i) Employee observation. The 
employer shall provide affected employees or their designated 
representatives an opportunity to observe any monitoring of employee 
exposure to BD conducted in accordance with paragraph (d) of this 
section.
    (ii) Observation procedures. When observation of the monitoring of 
employee exposure to BD requires entry into an area where the use of 
protective clothing or equipment is required, the employer shall provide 
the observer at no cost with protective clothing and equipment, and 
shall ensure that the observer uses this equipment and complies with all 
other applicable safety and health procedures.
    (e) Regulated areas. (1) The employer shall establish a regulated 
area wherever occupational exposures to airborne concentrations of BD 
exceed or can reasonably be expected to exceed the permissible exposure 
limits, either the 8-hr TWA or the STEL.
    (2) Access to regulated areas shall be limited to authorized 
persons.
    (3) Regulated areas shall be demarcated from the rest of the 
workplace in any manner that minimizes the number of employees exposed 
to BD within the regulated area.
    (4) An employer at a multi-employer worksite who establishes a 
regulated area shall communicate the access restrictions and locations 
of these areas to other employers with work operations at that worksite 
whose employees may have access to these 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 
PELs, except to the extent that the employer can establish that these 
controls are not feasible or where paragraph (h)(1)(i) of this section 
applies.
    (ii) Wherever the feasible engineering controls and work practices 
which can be instituted are not sufficient to reduce employee exposure 
to or below the 8-hour TWA or STEL, the employer

[[Page 447]]

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 
(h) of this section.
    (2) Compliance plan. (i) Where any exposures are over the PELs, the 
employer shall establish and implement a written plan to reduce employee 
exposure to or below the PELs primarily 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 required or permitted under 
this section. No compliance plan is required if all exposures are under 
the PELs.
    (ii) The written compliance plan shall include a schedule for the 
development and implementation of the engineering controls and work 
practice controls including periodic leak detection surveys.
    (iii) Copies of the compliance plan required in paragraph (f)(2) of 
this section shall be furnished upon request for examination and copying 
to the Assistant Secretary, the Director, affected employees and 
designated employee representatives. Such plans shall be reviewed at 
least every 12 months, and shall be updated as necessary to reflect 
significant changes in the status of the employer's compliance program.
    (iv) The employer shall not implement a schedule of employee 
rotation as a means of compliance with the PELs.
    (g) Exposure Goal Program. (1) For those operations and job 
classifications where employee exposures are greater than the action 
level, in addition to compliance with the PELs, the employer shall have 
an exposure goal program that is intended to limit employee exposures to 
below the action level during normal operations.
    (2) Written plans for the exposure goal program shall be furnished 
upon request for examination and copying to the Assistant Secretary, the 
Director, affected employees and designated employee representatives.
    (3) Such plans shall be updated as necessary to reflect significant 
changes in the status of the exposure goal program.
    (4) Respirator use is not required in the exposure goal program.
    (5) The exposure goal program shall include the following items 
unless the employer can demonstrate that the item is not feasible, will 
have no significant effect in reducing employee exposures, or is not 
necessary to achieve exposures below the action level:
    (i) A leak prevention, detection, and repair program.
    (ii) A program for maintaining the effectiveness of local exhaust 
ventilation systems.
    (iii) The use of pump exposure control technology such as, but not 
limited to, mechanical double-sealed or seal-less pumps.
    (iv) Gauging devices designed to limit employee exposure, such as 
magnetic gauges on rail cars.
    (v) Unloading devices designed to limit employee exposure, such as a 
vapor return system.
    (vi) A program to maintain BD concentration below the action level 
in control rooms by use of engineering controls.
    (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 
and work-practice controls.
    (ii) Non-routine work operations that are performed infrequently and 
for which employee exposures are limited in duration.
    (iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposures to 
or below the PELs.
    (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), (d)(3)(iii)(B)(1), and (2)), and (f) 
through (m), which covers each employee required by this section to use 
a respirator.
    (ii) If air-purifying respirators are used, the employer must 
replace the

[[Page 448]]

air-purifying filter elements according to the replacement schedule set 
for the class of respirators listed in Table 1 of this section, and at 
the beginning of each work shift.
    (iii) Instead of using the replacement schedule listed in Table 1 of 
this section, the employer may replace cartridges or canisters at 90% of 
their expiration service life, provided the employer:
    (A) Demonstrates that employees will be adequately protected by this 
procedure.
    (B) Uses BD breakthrough data for this purpose that have been 
derived from tests conducted under worst-case conditions of humidity, 
temperature, and air-flow rate through the filter element, and the 
employer also describes the data supporting the cartridge-or canister-
change schedule, as well as the basis for using the data in the 
employer's respirator program.
    (iv) A label must be attached to each filter element to indicate the 
date and time it is first installed on the respirator.
    (v) If NIOSH approves an end-of-service-life indicator (ESLI) for an 
air-purifying filter element, the element may be used until the ESLI 
shows no further useful service life or until the element is replaced at 
the beginning of the next work shift, whichever occurs first.
    (vi) Regardless of the air-purifying element used, if an employee 
detects the odor of BD, the employer must replace the air-purifying 
element immediately.
    (3) Respirator selection. (i) The employer must select appropriate 
respirators from Table 1 of this section.

Table 1--Minimum Requirements for Respiratory Protection for Airborne BD
------------------------------------------------------------------------
 Concentration of airborne BD
  (ppm) or condition of use           Minimum required respirator
------------------------------------------------------------------------
Less than or equal to 5 ppm    (a) Air-purifying half mask or full
 (5 times PEL).                 facepiece respirator equipped with
                                approved BD or organic vapor cartridges
                                or canisters. Cartridges or canisters
                                shall be replaced every 4 hours.
Less than or equal to 10 ppm   (a) Air-purifying half mask or full
 (10 times PEL).                facepiece respirator equipped with
                                approved BD or organic vapor cartridges
                                or canisters. Cartridges or canisters
                                shall be replaced every 3 hours.
Less than or equal to 25 ppm   (a) Air-purifying full facepiece
 (25 times PEL).                respirator equipped with approved BD or
                                organic vapor cartridges or canisters.
                                Cartridges or canisters shall be
                                replaced every 2 hours.
                               (b) Any powered air-purifying respirator
                                equipped with approved BD or organic
                                vapor cartridges. PAPR cartridges shall
                                be replaced every 2 hours.
                               (c) Continuous flow supplied air
                                respirator equipped with a hood or
                                helmet.
Less than or equal to 50 ppm   (a) Air-purifying full facepiece
 (50 times PEL).                respirator equipped with approved BD or
                                organic vapor cartridges or canisters.
                                Cartridges or canisters shall be
                                replaced every (1) hour.
                               (b) Powered air-purifying respirator
                                equipped with a tight-fitting facepiece
                                and an approved BD or organic vapor
                                cartridges. PAPR cartridges shall be
                                replaced every (1) hour.
Less than or equal to 1,000    (a) Supplied air respirator equipped with
 ppm (1,000 times PEL).         a half mask of full facepiece and
                                operated in a pressure demand or other
                                positive pressure mode.
Greater than 1000 ppm unknown  (a) Self-contained breathing apparatus
 concentration, or              equipped with a full facepiece and
 firefighting.                  operated in a pressure demand or other
                                positive pressure mode.
                               (b) Any supplied air respirator equipped
                                with a full facepiece and operated in a
                                pressure demand or other positive
                                pressure mode in combination with an
                                auxiliary self-contained breathing
                                apparatus operated in a pressure demand
                                or other positive pressure mode.
Escape from IDLH conditions..  (a) Any positive pressure self-contained
                                breathing apparatus with an appropriate
                                service life.
                               (b) A air-purifying full facepiece
                                respirator equipped with a front or back
                                mounted BD or organic vapor canister.
------------------------------------------------------------------------
Notes: Respirators approved for use in higher concentrations are
  permitted to be used in lower concentrations. Full facepiece is
  required when eye irritation is anticipated.

    (ii) Air-purifying respirators must have filter elements approved by 
NIOSH for organic vapors or BD.
    (iii) When an employee whose job requires the use of a respirator 
cannot use a negative-pressure respirator, the employer must provide the 
employee with a respirator that has less breathing resistance than the 
negative-pressure respirator, such as a powered air-

[[Page 449]]

purifying respirator or supplied-air respirator, when the employee is 
able to use it and if it provides the employee adequate protection.
    (i) Protective clothing and equipment. Where appropriate to prevent 
eye contact and limit dermal exposure to BD, the employer shall provide 
protective clothing and equipment at no cost to the employee and shall 
ensure its use. Eye and face protection shall meet the requirements of 
29 CFR 1910.133.
    (j) Emergency situations. Written plan. A written plan for emergency 
situations shall be developed, or an existing plan shall be modified, to 
contain the applicable elements specified in 29 CFR 1910.38 and 29 CFR 
1910.39, ``Emergency action plans'' and ``Fire prevention plans,'' 
respectively, and in 29 CFR 1910.120, ``Hazardous Waste Operations and 
Emergency Response,'' for each workplace where there is the possibility 
of an emergency.
    (k) Medical screening and surveillance--(1) Employees covered. The 
employer shall institute a medical screening and surveillance program as 
specified in this paragraph for:
    (i) Each employee with exposure to BD at concentrations at or above 
the action level on 30 or more days or for employees who have or may 
have exposure to BD at or above the PELs on 10 or more days a year;
    (ii) Employers (including successor owners) shall continue to 
provide medical screening and surveillance for employees, even after 
transfer to a non-BD exposed job and regardless of when the employee is 
transferred, whose work histories suggest exposure to BD:
    (A) At or above the PELs on 30 or more days a year for 10 or more 
years;
    (B) At or above the action level on 60 or more days a year for 10 or 
more years; or
    (C) Above 10 ppm on 30 or more days in any past year; and
    (iii) Each employee exposed to BD following an emergency situation.
    (2) Program administration. (i) The employer shall ensure that the 
health questionnaire, physical examination and medical procedures are 
provided without cost to the employee, without loss of pay, and at a 
reasonable time and place.
    (ii) Physical examinations, health questionnaires, and medical 
procedures shall be performed or administered by a physician or other 
licensed health care professional.
    (iii) Laboratory tests shall be conducted by an accredited 
laboratory.
    (3) Frequency of medical screening activities. The employer shall 
make medical screening available on the following schedule:
    (i) For each employee covered under paragraphs (j)(1) (i)-(ii) of 
this section, a health questionnaire and complete blood count with 
differential and platelet count (CBC) every year, and a physical 
examination as specified below:
    (A) An initial physical examination that meets the requirements of 
this rule, if twelve months or more have elapsed since the last physical 
examination conducted as part of a medical screening program for BD 
exposure;
    (B) Before assumption of duties by the employee in a job with BD 
exposure;
    (C) Every 3 years after the initial physical examination;
    (D) At the discretion of the physician or other licensed health care 
professional reviewing the annual health questionnaire and CBC;
    (E) At the time of employee reassignment to an area where exposure 
to BD is below the action level, if the employee's past exposure history 
does not meet the criteria of paragraph (j)(1)(ii) of this section for 
continued coverage in the screening and surveillance program, and if 
twelve months or more have elapsed since the last physical examination; 
and
    (F) At termination of employment if twelve months or more have 
elapsed since the last physical examination.
    (ii) Following an emergency situation, medical screening shall be 
conducted as quickly as possible, but not later than 48 hours after the 
exposure.
    (iii) For each employee who must wear a respirator, physical ability 
to perform the work and use the respirator must be determined as 
required by 29 CFR 1910.134.
    (4) Content of medical screening. (i) Medical screening for 
employees covered by paragraphs (j)(1) (i)-(ii) of this section shall 
include:

[[Page 450]]

    (A) A baseline health questionnaire that includes a comprehensive 
occupational and health history and is updated annually. Particular 
emphasis shall be placed on the hematopoietic and reticuloendothelial 
systems, including exposure to chemicals, in addition to BD, that may 
have an adverse effect on these systems, the presence of signs and 
symptoms that might be related to disorders of these systems, and any 
other information determined by the examining physician or other 
licensed health care professional to be necessary to evaluate whether 
the employee is at increased risk of material impairment of health from 
BD exposure. Health questionnaires shall consist of the sample forms in 
appendix C to this section, or be equivalent to those samples;
    (B) A complete physical examination, with special emphasis on the 
liver, spleen, lymph nodes, and skin;
    (C) A CBC; and
    (D) Any other test which the examining physician or other licensed 
health care professional deems necessary to evaluate whether the 
employee may be at increased risk from exposure to BD.
    (ii) Medical screening for employees exposed to BD in an emergency 
situation shall focus on the acute effects of BD exposure and at a 
minimum include: A CBC within 48 hours of the exposure and then monthly 
for three months; and a physical examination if the employee reports 
irritation of the eyes, nose throat, lungs, or skin, blurred vision, 
coughing, drowsiness, nausea, or headache. Continued employee 
participation in the medical screening and surveillance program, beyond 
these minimum requirements, shall be at the discretion of the physician 
or other licensed health care professional.
    (5) Additional medical evaluations and referrals. (i) Where the 
results of medical screening indicate abnormalities of the hematopoietic 
or reticuloendothelial systems, for which a non-occupational cause is 
not readily apparent, the examining physician or other licensed health 
care professional shall refer the employee to an appropriate specialist 
for further evaluation and shall make available to the specialist the 
results of the medical screening.
    (ii) The specialist to whom the employee is referred under this 
paragraph shall determine the appropriate content for the medical 
evaluation, e.g., examinations, diagnostic tests and procedures, etc.
    (6) Information provided to the physician or other licensed health 
care professional. The employer shall provide the following information 
to the examining physician or other licensed health care professional 
involved in the evaluation:
    (i) A copy of this section including its appendices;
    (ii) A description of the affected employee's duties as they relate 
to the employee's BD exposure;
    (iii) The employee's actual or representative BD exposure level 
during employment tenure, including exposure incurred in an emergency 
situation;
    (iv) A description of pertinent personal protective equipment used 
or to be used; and
    (v) Information, when available, from previous employment-related 
medical evaluations of the affected employee which is not otherwise 
available to the physician or other licensed health care professional or 
the specialist.
    (7) The written medical opinion. (i) For each medical evaluation 
required by this section, the employer shall ensure that the physician 
or other licensed health care professional produces a written opinion 
and provides a copy to the employer and the employee within 15 business 
days of the evaluation. The written opinion shall be limited to the 
following information:
    (A) The occupationally pertinent results of the medical evaluation;
    (B) A medical opinion concerning whether the employee has any 
detected medical conditions which would place the employee's health at 
increased risk of material impairment from exposure to BD;
    (C) Any recommended limitations upon the employee's exposure to BD; 
and
    (D) A statement that the employee has been informed of the results 
of the medical evaluation and any medical conditions resulting from BD 
exposure

[[Page 451]]

that require further explanation or treatment.
    (ii) The written medical opinion provided to the employer shall not 
reveal specific records, findings, and diagnoses that have no bearing on 
the employee's ability to work with BD.

    Note: However, this provision does not negate the ethical obligation 
of the physician or other licensed health care professional to transmit 
any other adverse findings directly to the employee.

    (8) Medical surveillance. (i) The employer shall ensure that 
information obtained from the medical screening program activities is 
aggregated (with all personal identifiers removed) and periodically 
reviewed, to ascertain whether the health of the employee population of 
that employer is adversely affected by exposure to BD.
    (ii) Information learned from medical surveillance activities must 
be disseminated to covered employees, as defined in paragraph (k)(1) of 
this section, in a manner that ensures the confidentiality of individual 
medical information.
    (l) Communication of BD hazards to employees--(1) Hazard 
communication--general. (i) Chemical manufacturers, importers, 
distributors and employers shall comply with all requirements of the 
Hazard Communication Standard (HCS) (Sec.  1910.1200) for BD.
    (ii) In classifying the hazards of BD at least the following hazards 
are to be addressed: Cancer; eye and respiratory tract irritation; 
central nervous system effects; and flammability.
    (iii) Employers shall include BD in the hazard communication program 
established to comply with the HCS (Sec.  1910.1200). Employers shall 
ensure that each employee has access to labels on containers of BD and 
to safety data sheets, and is trained in accordance with the 
requirements of HCS and paragraph (l)(2) of this section.
    (2) Employee information and training. (i) The employer shall 
provide all employees exposed to BD with information and training in 
accordance with the requirements of the Hazard Communication Standard, 
29 CFR 1910.1200, 29 CFR 1915.1200, and 29 CFR 1926.59.
    (ii) The employer shall train each employee who is potentially 
exposed to BD at or above the action level or the STEL 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.
    (iii) Training shall be provided prior to or at the time of initial 
assignment to a job potentially involving exposure to BD at or above the 
action level or STEL and at least annually thereafter.
    (iv) The training program shall be conducted in a manner that the 
employee is able to understand. The employee shall ensure that each 
employee exposed to BD over the action level or STEL is informed of the 
following:
    (A) The health hazards associated with BD exposure, and the purpose 
and a description of the medical screening and surveillance program 
required by this section;
    (B) The quantity, location, manner of use, release, and storage of 
BD and the specific operations that could result in exposure to BD, 
especially exposures above the PEL or STEL;
    (C) The engineering controls and work practices associated with the 
employee's job assignment, and emergency procedures and personal 
protective equipment;
    (D) The measures employees can take to protect themselves from 
exposure to BD.
    (E) The contents of this standard and its appendices, and
    (F) The right of each employee exposed to BD at or above the action 
level or STEL to obtain:
    (1) medical examinations as required by paragraph (j) of this 
section at no cost to the employee;
    (2) the employee's medical records required to be maintained by 
paragraph (m)(4) of this section; and
    (3) all air monitoring results representing the employee's exposure 
to BD and required to be kept by paragraph (m)(2) of this section.
    (3) Access to information and training materials. (i) The employer 
shall make a copy of this standard and its appendices readily available 
without cost to all affected employees and their designated 
representatives and shall provide a copy if requested.
    (ii) The employer shall provide to the Assistant Secretary or the 
Director, or

[[Page 452]]

the designated employee representatives, upon request, all materials 
relating to the employee information and the training program.
    (m) Recordkeeping--(1) Objective data for exemption from initial 
monitoring. (i) Where the processing, use, or handling of products or 
streams made from or containing BD are exempted from other requirements 
of this section under paragraph (a)(2) of this section, or where 
objective data have been relied on in lieu of initial monitoring under 
paragraph (d)(2)(ii) of this section, the employer shall establish and 
maintain a record of the objective data reasonably relied upon in 
support of the exemption.
    (ii) This record shall include at least the following information:
    (A) The product or activity qualifying for exemption;
    (B) The source of the objective data;
    (C) The testing protocol, results of testing, and analysis of the 
material for the release of BD;
    (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.
    (2) Exposure measurements. (i) The employer shall establish and 
maintain an accurate record of all measurements taken to monitor 
employee exposure to BD as prescribed in paragraph (d) of this section.
    (ii) The record shall include at least the following information:
    (A) The date of measurement;
    (B) The operation involving exposure to BD 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 protective devices worn, if any; and
    (F) Name and exposure of the employees whose exposures are 
represented.
    (G) The written corrective action and the schedule for completion of 
this action required by paragraph (d)(7)(ii) of this section.
    (iii) The employer shall maintain this record for at least 30 years 
in accordance with 29 CFR 1910.1020.
    (3) [Reserved]
    (4) Medical screening and surveillance. (i) The employer shall 
establish and maintain an accurate record for each employee subject to 
medical screening and surveillance under this section.
    (ii) The record shall include at least the following information:
    (A) The name of the employee;
    (B) Physician's or other licensed health care professional's written 
opinions as described in paragraph (k)(7) of this section;
    (C) A copy of the information provided to the physician or other 
licensed health care professional as required by paragraphs (k)(7)(ii)-
(iv) of this section.
    (iii) Medical screening and surveillance records shall be maintained 
for each employee for the duration of employment plus 30 years, in 
accordance with 29 CFR 1910.1020.
    (5) Availability. (i) The employer, upon written request, shall make 
all records required to be maintained by this section available for 
examination and copying to the Assistant Secretary and the Director.
    (ii) Access to records required to be maintained by paragraphs 
(l)(1)-(3) of this section shall be granted in accordance with 29 CFR 
1910.1020(e).
    (6) Transfer of records. The employer shall transfer medical and 
exposure records as set forth in 29 CFR 1910.1020(h).
    (ii) The employer shall transfer medical and exposure records as set 
forth in 29 CFR 1910.1020(h).
    (n) [Reserved]
    (o) Appendices. (1) appendix E to this section is mandatory.
    (2) Appendices A, B, C, D, and F to this section are informational 
and are not intended to create any additional obligations not otherwise 
imposed or to detract from any existing obligations.

[[Page 453]]

   Appendix A to Sec.  1910.1051--Substance Safety Data Sheet For 1,3-
                        Butadiene (Non-Mandatory)

                       I. Substance Identification

    A. Substance: 1,3-Butadiene (CH2 = CH-CH = 
CH2).
    B. Synonyms: 1,3-Butadiene (BD); butadiene; biethylene; bi-vinyl; 
divinyl; butadiene-1,3; buta-1,3-diene; erythrene; NCI-C50602; CAS-106-
99-0.
    C. BD can be found as a gas or liquid.
    D. BD is used in production of styrene-butadiene rubber and 
polybutadiene rubber for the tire industry. Other uses include copolymer 
latexes for carpet backing and paper coating, as well as resins and 
polymers for pipes and automobile and appliance parts. It is also used 
as an intermediate in the production of such chemicals as fungicides.
    E. Appearance and odor: BD is a colorless, non-corrosive, flammable 
gas with a mild aromatic odor at standard ambient temperature and 
pressure.
    F. Permissible exposure: Exposure may not exceed 1 part BD per 
million parts of air averaged over the 8-hour workday, nor may short-
term exposure exceed 5 parts of BD per million parts of air averaged 
over any 15-minute period in the 8-hour workday.

                         II. Health Hazard Data

    A. BD can affect the body if the gas is inhaled or if the liquid 
form, which is very cold (cryogenic), comes in contact with the eyes or 
skin.
    B. Effects of overexposure: Breathing very high levels of BD for a 
short time can cause central nervous system effects, blurred vision, 
nausea, fatigue, headache, decreased blood pressure and pulse rate, and 
unconsciousness. There are no recorded cases of accidental exposures at 
high levels that have caused death in humans, but this could occur. 
Breathing lower levels of BD may cause irritation of the eyes, nose, and 
throat. Skin contact with liquefied BD can cause irritation and 
frostbite.
    C. Long-term (chronic) exposure: BD has been found to be a potent 
carcinogen in rodents, inducing neoplastic lesions at multiple target 
sites in mice and rats. A recent study of BD-exposed workers showed that 
exposed workers have an increased risk of developing leukemia. The risk 
of leukemia increases with increased exposure to BD. OSHA has concluded 
that there is strong evidence that workplace exposure to BD poses an 
increased risk of death from cancers of the lymphohematopoietic system.
    D. Reporting signs and symptoms: You should inform your supervisor 
if you develop any of these signs or symptoms and suspect that they are 
caused by exposure to BD.

                   III. Emergency First Aid Procedures

    In the event of an emergency, follow the emergency plan and 
procedures designated for your work area. If you have been trained in 
first aid procedures, provide the necessary first aid measures. If 
necessary, call for additional assistance from co-workers and emergency 
medical personnel.
    A. Eye and Skin Exposures: If there is a potential that liquefied BD 
can come in contact with eye or skin, face shields and skin protective 
equipment must be provided and used. If liquefied BD comes in contact 
with the eye, immediately flush the eyes with large amounts of water, 
occasionally lifting the lower and the upper lids. Flush repeatedly. Get 
medical attention immediately. Contact lenses should not be worn when 
working with this chemical. In the event of skin contact, which can 
cause frostbite, remove any contaminated clothing and flush the affected 
area repeatedly with large amounts of tepid water.
    B. Breathing: If a person breathes in large amounts of BD, move the 
exposed person to fresh air at once. If breathing has stopped, begin 
cardiopulmonary resuscitation (CPR) if you have been trained in this 
procedure. Keep the affected person warm and at rest. Get medical 
attention immediately.
    C. Rescue: Move the affected person from the hazardous exposure. If 
the exposed person has been overcome, call for help and begin emergency 
rescue procedures. Use extreme caution so that you do not become a 
casualty. Understand the plant's emergency rescue procedures and know 
the locations of rescue equipment before the need arises.

                 IV. Respirators and Protective Clothing

    A. Respirators: Good industrial hygiene practices recommend that 
engineering and work practice controls be used to reduce environmental 
concentrations to the permissible exposure level. However, there are 
some exceptions where respirators may be used to control exposure. 
Respirators may be used when engineering and work practice controls are 
not technically feasible, when such controls are in the process of being 
installed, or when these controls fail and need to be supplemented or 
during brief, non-routine, intermittent exposure. Respirators may also 
be used in situations involving non-routine work operations which are 
performed infrequently and in which exposures are limited in duration, 
and in emergency situations. In some instances cartridge respirator use 
is allowed, but only with strict time constraints. For example, at 
exposure below 5 ppm BD, a cartridge (or canister) respirator, either 
full or half face, may be used, but the cartridge must be replaced at 
least every 4 hours, and it must be replaced every 3 hours when the 
exposure is between 5 and 10 ppm. If the use

[[Page 454]]

of respirators is necessary, the only respirators permitted are those 
that have been approved by the National Institute for Occupational 
Safety and Health (NIOSH). In addition to respirator selection, a 
complete respiratory protection program must be instituted which 
includes regular training, maintenance, fit testing, inspection, 
cleaning, and evaluation of respirators. If you can smell BD while 
wearing a respirator, proceed immediately to fresh air, and change 
cartridge (or canister) before re-entering an area where there is BD 
exposure. If you experience difficulty in breathing while wearing a 
respirator, tell your supervisor.
    B. Protective Clothing: Employees should be provided with and 
required to use impervious clothing, gloves, face shields (eight-inch 
minimum), and other appropriate protective clothing necessary to prevent 
the skin from becoming frozen by contact with liquefied BD (or a vessel 
containing liquid BD).
    Employees should be provided with and required to use splash-proof 
safety goggles where liquefied BD may contact the eyes.

           V. Precautions for Safe Use, Handling, and Storage

    A. Fire and Explosion Hazards: BD is a flammable gas and can easily 
form explosive mixtures in air. It has a lower explosive limit of 2%, 
and an upper explosive limit of 11.5%. It has an autoignition 
temperature of 420 [deg]C (788 [deg]F). Its vapor is heavier than air 
(vapor density, 1.9) and may travel a considerable distance to a source 
of ignition and flash back. Usually it contains inhibitors to prevent 
self-polymerization (which is accompanied by evolution of heat) and to 
prevent formation of explosive peroxides. At elevated temperatures, such 
as in fire conditions, polymerization may take place. If the 
polymerization takes place in a container, there is a possibility of 
violent rupture of the container.
    B. Hazard: Slightly toxic. Slight respiratory irritant. Direct 
contact of liquefied BD on skin may cause freeze burns and frostbite.
    C. Storage: Protect against physical damage to BD containers. 
Outside or detached storage of BD containers is preferred. Inside 
storage should be in a cool, dry, well-ventilated, noncombustible 
location, away from all possible sources of ignition. Store cylinders 
vertically and do not stack. Do not store with oxidizing material.
    D. Usual Shipping Containers: Liquefied BD is contained in steel 
pressure apparatus.
    E. Electrical Equipment: Electrical installations in Class I 
hazardous locations, as defined in Article 500 of the National 
Electrical Code, should be in accordance with Article 501 of the Code. 
If explosion-proof electrical equipment is necessary, it shall be 
suitable for use in Group B. Group D equipment may be used if such 
equipment is isolated in accordance with Section 501-5(a) by sealing all 
conduit \1/2\- inch size or larger. See Venting of Deflagrations (NFPA 
No. 68, 1994), National Electrical Code (NFPA No. 70, 1996), Static 
Electricity (NFPA No. 77, 1993), Lightning Protection Systems (NFPA No. 
780, 1995), and Fire Hazard Properties of Flammable Liquids, Gases and 
Volatile Solids (NFPA No. 325, 1994).
    F. Fire Fighting: Stop flow of gas. Use water to keep fire-exposed 
containers cool. Fire extinguishers and quick drenching facilities must 
be readily available, and you should know where they are and how to 
operate them.
    G. Spill and Leak: Persons not wearing protective equipment and 
clothing should be restricted from areas of spills or leaks until clean-
up has been completed. If BD is spilled or leaked, the following steps 
should be taken:
    1. Eliminate all ignition sources.
    2. Ventilate area of spill or leak.
    3. If in liquid form, for small quantities, allow to evaporate in a 
safe manner.
    4. Stop or control the leak if this can be done without risk. If 
source of leak is a cylinder and the leak cannot be stopped in place, 
remove the leaking cylinder to a safe place and repair the leak or allow 
the cylinder to empty.
    H. Disposal: This substance, when discarded or disposed of, is a 
hazardous waste according to Federal regulations (40 CFR part 261). It 
is listed as hazardous waste number D001 due to its ignitability. The 
transportation, storage, treatment, and disposal of this waste material 
must be conducted in compliance with 40 CFR parts 262, 263, 264, 268 and 
270. Disposal can occur only in properly permitted facilities. Check 
state and local regulation of any additional requirements as these may 
be more restrictive than federal laws and regulation.
    I. You should not keep food, beverages, or smoking materials in 
areas where there is BD exposure, nor should you eat or drink in such 
areas.
    J. Ask your supervisor where BD is used in your work area and ask 
for any additional plant safety and health rules.

                        VI. Medical Requirements

    Your employer is required to offer you the opportunity to 
participate in a medical screening and surveillance program if you are 
exposed to BD at concentrations exceeding the action level (0.5 ppm BD 
as an 8-hour TWA) on 30 days or more a year, or at or above the 8 hr TWA 
(1 ppm) or STEL (5 ppm for 15 minutes) on 10 days or more a year. 
Exposure for any part of a day counts. If you have had exposure to BD in 
the past, but have been transferred to another job, you may still be 
eligible to participate in the medical screening and surveillance 
program.

[[Page 455]]

The OSHA rule specifies the past exposures that would qualify you for 
participation in the program. These past exposure are work histories 
that suggest the following: (1) That you have been exposed at or above 
the PELs on 30 days a year for 10 or more years; (2) that you have been 
exposed at or above the action level on 60 days a year for 10 or more 
years; or (3) that you have been exposed above 10 ppm on 30 days in any 
past year. Additionally, if you are exposed to BD in an emergency 
situation, you are eligible for a medical examination within 48 hours. 
The basic medical screening program includes a health questionnaire, 
physical examination, and blood test. These medical evaluations must be 
offered to you at a reasonable time and place, and without cost or loss 
of pay.

                     VII. Observation of Monitoring

    Your employer is required to perform measurements that are 
representative of your exposure to BD 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.

                       VIII. Access to Information

    A. Each year, your employer is required to inform you of the 
information contained in this appendix. In addition, your employer must 
instruct you in the proper work practices for using BD, emergency 
procedures, and the correct use of protective equipment.
    B. Your employer is required to determine whether you are being 
exposed to BD. You or your representative has the right to observe 
employee measurements and to record the results obtained. Your employer 
is required to inform you of your exposure. If your employer determines 
that you are being overexposed, he or she is required to inform you of 
the actions which are being taken to reduce your exposure to within 
permissible exposure limits and of the schedule to implement these 
actions.
    C. Your employer is required to keep records of your exposures and 
medical examinations. These records must be kept by the employer for at 
least thirty (30) years.
    D. Your employer is required to release your exposure and medical 
records to you or your representative upon your request.

 Appendix B to Sec.  1910.1051--Substance Technical Guidelines for 1,3-
                        Butadiene (Non-Mandatory)

                      I. Physical and Chemical Data

    A. Substance identification:
    1. Synonyms: 1,3-Butadiene (BD); butadiene; biethylene; bivinyl; 
divinyl; butadiene-1,3; buta-1,3-diene; erythrene; NCI-C50620; CAS-106-
99-0.
    2. Formula: CH2 = CH-CH = CH2.
    3. Molecular weight: 54.1.
    B. Physical data:
    1. Boiling point (760 mm Hg): -4.7 [deg]C (23.5 [deg]F).
    2. Specific gravity (water = 1): 0.62 at 20 [deg]C (68 [deg]F).
    3. Vapor density (air = 1 at boiling point of BD): 1.87.
    4. Vapor pressure at 20 [deg]C (68 [deg]F): 910 mm Hg.
    5. Solubility in water, g/100 g water at 20 [deg]C (68 [deg]F): 
0.05.
    6. Appearance and odor: Colorless, flammable gas with a mildly 
aromatic odor. Liquefied BD is a colorless liquid with a mildly aromatic 
odor.

             II. Fire, Explosion, and Reactivity Hazard Data

    A. Fire:
    1. Flash point: -76 [deg]C (-105 [deg]F) for take out; liquefied BD; 
Not applicable to BD gas.
    2. Stability: A stabilizer is added to the monomer to inhibit 
formation of polymer during storage. Forms explosive peroxides in air in 
absence of inhibitor.
    3. Flammable limits in air, percent by volume: Lower: 2.0; Upper: 
11.5.
    4. Extinguishing media: Carbon dioxide for small fires, polymer or 
alcohol foams for large fires.
    5. Special fire fighting procedures: Fight fire from protected 
location or maximum possible distance. Stop flow of gas before 
extinguishing fire. Use water spray to keep fire-exposed cylinders cool.
    6. Unusual fire and explosion hazards: BD vapors are heavier than 
air and may travel to a source of ignition and flash back. Closed 
containers may rupture violently when heated.
    7. For purposes of compliance with the requirements of 29 CFR 
1910.106, BD is classified as a flammable gas. For example, 7,500 ppm, 
approximately one-fourth of the lower flammable limit, would be 
considered to pose a potential fire and explosion hazard.
    8. For purposes of compliance with 29 CFR 1910.155, BD is classified 
as a Class B fire hazard.
    9. For purposes of compliance with 29 CFR 1910.307, locations 
classified as hazardous due to the presence of BD shall be Class I.
    B. Reactivity:
    1. Conditions contributing to instability: Heat. Peroxides are 
formed when inhibitor

[[Page 456]]

concentration is not maintained at proper level. At elevated 
temperatures, such as in fire conditions, polymerization may take place.
    2. Incompatibilities: Contact with strong oxidizing agents may cause 
fires and explosions. The contacting of crude BD (not BD monomer) with 
copper and copper alloys may cause formations of explosive copper 
compounds.
    3. Hazardous decomposition products: Toxic gases (such as carbon 
monoxide) may be released in a fire involving BD.
    4. Special precautions: BD will attack some forms of plastics, 
rubber, and coatings. BD in storage should be checked for proper 
inhibitor content, for self-polymerization, and for formation of 
peroxides when in contact with air and iron. Piping carrying BD may 
become plugged by formation of rubbery polymer.
    C. Warning Properties:
    1. Odor Threshold: An odor threshold of 0.45 ppm has been reported 
in The American Industrial Hygiene Association (AIHA) Report, Odor 
Thresholds for Chemicals with Established Occupational Health Standards. 
(Ex. 32-28C)
    2. Eye Irritation Level: Workers exposed to vapors of BD 
(concentration or purity unspecified) have complained of irritation of 
eyes, nasal passages, throat, and lungs. Dogs and rabbits exposed 
experimentally to as much as 6700 ppm for 7\1/2\ hours a day for 8 
months have developed no histologically demonstrable abnormality of the 
eyes.
    3. Evaluation of Warning Properties: Since the mean odor threshold 
is about half of the 1 ppm PEL, and more than 10-fold below the 5 ppm 
STEL, most wearers of air purifying respirators should still be able to 
detect breakthrough before a significant overexposure to BD occurs.

                III. Spill, Leak, and Disposal Procedures

    A. Persons not wearing protective equipment and clothing should be 
restricted from areas of spills or leaks until cleanup has been 
completed. If BD is spilled or leaked, the following steps should be 
taken:
    1. Eliminate all ignition sources.
    2. Ventilate areas of spill or leak.
    3. If in liquid form, for small quantities, allow to evaporate in a 
safe manner.
    4. Stop or control the leak if this can be done without risk. If 
source of leak is a cylinder and the leak cannot be stopped in place, 
remove the leaking cylinder to a safe place and repair the leak or allow 
the cylinder to empty.
    B. Disposal: This substance, when discarded or disposed of, is a 
hazardous waste according to Federal regulations (40 CFR part 261). It 
is listed by the EPA as hazardous waste number D001 due to its 
ignitability. The transportation, storage, treatment, and disposal of 
this waste material must be conducted in compliance with 40 CFR parts 
262, 263, 264, 268 and 270. Disposal can occur only in properly 
permitted facilities. Check state and local regulations for any 
additional requirements because these may be more restrictive than 
federal laws and regulations.

                IV. Monitoring and Measurement Procedures

    A. Exposure above the Permissible Exposure Limit (8-hr TWA) or 
Short-Term Exposure Limit (STEL):
    1. 8-hr TWA exposure evaluation: Measurements taken for the purpose 
of determining employee exposure under this standard are best taken with 
consecutive samples covering the full shift. Air samples must be taken 
in the employee's breathing zone (air that would most nearly represent 
that inhaled by the employee).
    2. STEL exposure evaluation: Measurements must represent 15 minute 
exposures associated with operations most likely to exceed the STEL in 
each job and on each shift.
    3. Monitoring frequencies: Table 1 gives various exposure scenarios 
and their required monitoring frequencies, as required by the final 
standard for occupational exposure to butadiene.

    Table 1--Five Exposure Scenarios and Their Associated Monitoring
                               Frequencies
------------------------------------------------------------------------
 Action    8-hr
  level     TWA    STEL            Required monitoring activity
------------------------------------------------------------------------
     -*       -       -   No 8-hr TWA or STEL monitoring required.
    + *       -       -   No STEL monitoring required. Monitor 8-hr TWA
                           annually.
      +       +       -   No STEL monitoring required. Periodic
                           monitoring 8-hr TWA, in accordance with
                           (d)(3)(ii).**
      +       +       +   Periodic monitoring 8-hr TWA, in accordance
                           with (d)(3)(ii)**. Periodic monitoring STEL,
                           in accordance with (d)(3)(iii).
      +       -       +   Periodic monitoring STEL, in accordance with
                           (d)(3)(iii). Monitor 8-hr TWA, annually.
------------------------------------------------------------------------
* Exposure Scenario, Limit Exceeded: + = Yes, -= No.
** The employer may decrease the frequency of exposure monitoring to
  annually when at least 2 consecutive measurements taken at least 7
  days apart show exposures to be below the 8 hr TWA, but at or above
  the action level.

    4. Monitoring techniques: appendix D describes the validated method 
of sampling and analysis which has been tested by OSHA for use with BD. 
The employer has the obligation of selecting a monitoring method which 
meets the accuracy and precision requirements of the standard under his 
or her unique field conditions. The standard requires that the method of 
monitoring must be accurate, to a 95 percent confidence level, to plus 
or minus 25 percent for concentrations of BD at or above 1 ppm, and to 
plus or minus 35 percent for concentrations below 1 ppm.

[[Page 457]]

                    V. Personal Protective Equipment

    A. Employees should be provided with and required to use impervious 
clothing, gloves, face shields (eight-inch minimum), and other 
appropriate protective clothing necessary to prevent the skin from 
becoming frozen from contact with liquid BD.
    B. Any clothing which becomes wet with liquid BD should be removed 
immediately and not re-worn until the butadiene has evaporated.
    C. Employees should be provided with and required to use splash 
proof safety goggles where liquid BD may contact the eyes.

                 VI. Housekeeping and Hygiene Facilities

    For purposes of complying with 29 CFR 1910.141, the following items 
should be emphasized:
    A. The workplace should be kept clean, orderly, and in a sanitary 
condition.
    B. Adequate washing facilities with hot and cold water are to be 
provided and maintained in a sanitary condition.

                       VII. Additional Precautions

    A. Store BD in tightly closed containers in a cool, well-ventilated 
area and take all necessary precautions to avoid any explosion hazard.
    B. Non-sparking tools must be used to open and close metal 
containers. These containers must be effectively grounded.
    C. Do not incinerate BD cartridges, tanks or other containers.
    D. Employers must advise employees of all areas and operations where 
exposure to BD might occur.

 Appendix C to Sec.  1910.1051--Medical Screening and Surveillance for 
                      1,3-Butadiene (Non-Mandatory)

      I. Basis for Medical Screening and Surveillance Requirements

                      A. Route of Entry Inhalation

                              B. Toxicology

    Inhalation of BD has been linked to an increased risk of cancer, 
damage to the reproductive organs, and fetotoxicity. Butadiene can be 
converted via oxidation to epoxybutene and diepoxybutane, two genotoxic 
metabolites that may play a role in the expression of BD's toxic 
effects.
    BD has been tested for carcinogenicity in mice and rats. Both 
species responded to BD exposure by developing cancer at multiple 
primary organ sites. Early deaths in mice were caused by malignant 
lymphomas, primarily lymphocytic type, originating in the thymus.
    Mice exposed to BD have developed ovarian or testicular atrophy. 
Sperm head morphology tests also revealed abnormal sperm in mice exposed 
to BD; lethal mutations were found in a dominant lethal test. In light 
of these results in animals, the possibility that BD may adversely 
affect the reproductive systems of male and female workers must be 
considered.
    Additionally, anemia has been observed in animals exposed to 
butadiene. In some cases, this anemia appeared to be a primary response 
to exposure; in other cases, it may have been secondary to a neoplastic 
response.

                             C. Epidemiology

    Epidemiologic evidence demonstrates that BD exposure poses an 
increased risk of leukemia. Mild alterations of hematologic parameters 
have also been observed in synthetic rubber workers exposed to BD.

                  II. Potential Adverse Health Effects

                                A. Acute

    Skin contact with liquid BD causes characteristic burns or 
frostbite. BD is gaseous form can irritate the eyes, nasal passages, 
throat, and lungs. Blurred vision, coughing, and drowsiness may also 
occur. Effects are mild at 2,000 ppm and pronounced at 8,000 ppm for 
exposures occurring over the full workshift.
    At very high concentrations in air, BD is an anesthetic, causing 
narcosis, respiratory paralysis, unconsciousness, and death. Such 
concentrations are unlikely, however, except in an extreme emergency 
because BD poses an explosion hazard at these levels.

                               B. Chronic

    The principal adverse health effects of concern are BD-induced 
lymphoma, leukemia and potential reproductive toxicity. Anemia and other 
changes in the peripheral blood cells may be indicators of excessive 
exposure to BD.

                             C. Reproductive

    Workers may be concerned about the possibility that their BD 
exposure may be affecting their ability to procreate a healthy child. 
For workers with high exposures to BD, especially those who have 
experienced difficulties in conceiving, miscarriages, or stillbirths, 
appropriate medical and laboratory evaluation of fertility may be 
necessary to determine if BD is having any adverse effect on the 
reproductive system or on the health of the fetus.

              III. Medical Screening Components At-A-Glance

                         A. Health Questionnaire

    The most important goal of the health questionnaire is to elicit 
information from the worker regarding potential signs or symptoms 
generally related to leukemia or

[[Page 458]]

other blood abnormalities. Therefore, physicians or other licensed 
health care professionals should be aware of the presenting symptoms and 
signs of lymphohematopoietic disorders and cancers, as well as the 
procedures necessary to confirm or exclude such diagnoses. Additionally, 
the health questionnaire will assist with the identification of workers 
at greatest risk of developing leukemia or adverse reproductive effects 
from their exposures to BD.
    Workers with a history of reproductive difficulties or a personal or 
family history of immune deficiency syndromes, blood dyscrasias, 
lymphoma, or leukemia, and those who are or have been exposed to 
medicinal drugs or chemicals known to affect the hematopoietic or 
lymphatic systems may be at higher risk from their exposure to BD. After 
the initial administration, the health questionnaire must be updated 
annually.

                      B. Complete Blood Count (CBC)

    The medical screening and surveillance program requires an annual 
CBC, with differential and platelet count, to be provided for each 
employee with BD exposure. This test is to be performed on a blood 
sample obtained by phlebotomy of the venous system or, if technically 
feasible, from a fingerstick sample of capillary blood. The sample is to 
be analyzed by an accredited laboratory.
    Abnormalities in a CBC may be due to a number of different 
etiologies. The concern for workers exposed to BD includes, but is not 
limited to, timely identification of lymphohematopoietic cancers, such 
as leukemia and non-Hodgkin's lymphoma. Abnormalities of portions of the 
CBC are identified by comparing an individual's results to those of an 
established range of normal values for males and females. A substantial 
change in any individual employee's CBC may also be viewed as 
``abnormal'' for that individual even if all measurements fall within 
the population-based range of normal values. It is suggested that a 
flowsheet for laboratory values be included in each employee's medical 
record so that comparisons and trends in annual CBCs can be easily made.
    A determination of the clinical significance of an abnormal CBC 
shall be the responsibility of the examining physician, other licensed 
health care professional, or medical specialist to whom the employee is 
referred. Ideally, an abnormal CBC should be compared to previous CBC 
measurements for the same employee, when available. Clinical common 
sense may dictate that a CBC value that is very slightly outside the 
normal range does not warrant medical concern. A CBC abnormality may 
also be the result of a temporary physical stressor, such as a transient 
viral illness, blood donation, or menorrhagia, or laboratory error. In 
these cases, the CBC should be repeated in a timely fashion, i.e., 
within 6 weeks, to verify that return to the normal range has occurred. 
A clinically significant abnormal CBC should result in removal of the 
employee from further exposure to BD. Transfer of the employee to other 
work duties in a BD-free environment would be the preferred 
recommendation.

                         C. Physical Examination

    The medical screening and surveillance program requires an initial 
physical examination for workers exposed to BD; this examination is 
repeated once every three years. The initial physical examination should 
assess each worker's baseline general health and rule out clinical signs 
of medical conditions that may be caused by or aggravated by 
occupational BD exposure. The physical examination should be directed at 
identification of signs of lymphohematopoietic disorders, including 
lymph node enlargement, splenomegaly, and hepatomegaly.
    Repeated physical examinations should update objective clinical 
findings that could be indicative of interim development of a 
lymphohematopoietic disorder, such as lymphoma, leukemia, or other blood 
abnormality. Physical examinations may also be provided on an as needed 
basis in order to follow up on a positive answer on the health 
questionnaire, or in response to an abnormal CBC. Physical examination 
of workers who will no longer be working in jobs with BD exposure are 
intended to rule out lymphohematopoietic disorders.
    The need for physical examinations for workers concerned about 
adverse reproductive effects from their exposure to BD should be 
identified by the physician or other licensed health care professional 
and provided accordingly. For these workers, such consultations and 
examinations may relate to developmental toxicity and reproductive 
capacity.
    Physical examination of workers acutely exposed to significant 
levels of BD should be especially directed at the respiratory system, 
eyes, sinuses, skin, nervous system, and any region associated with 
particular complaints. If the worker has received a severe acute 
exposure, hospitalization may be required to assure proper medical 
management. Since this type of exposure may place workers at greater 
risk of blood abnormalities, a CBC must be obtained within 48 hours and 
repeated at one, two, and three months.

 Appendix D to Sec.  1910.1051--Sampling and Analytical Method for 1,3-
                        Butadiene (Non-Mandatory)

    OSHA Method No.: 56.
    Matrix: Air.
    Target concentration: 1 ppm (2.21 mg/m\3\)

[[Page 459]]

    Procedure: Air samples are collected by drawing known volumes of air 
through sampling tubes containing charcoal adsorbent which has been 
coated with 4-tert-butylcatechol. The samples are desorbed with carbon 
disulfide and then analyzed by gas chromatography using a flame 
ionization detector.
    Recommended sampling rate and air volume: 0.05 L/min and 3 L.
    Detection limit of the overall procedure: 90 ppb (200 ug/m\3\) 
(based on 3 L air volume).
    Reliable quantitation limit: 155 ppb (343 ug/m\3\) (based on 3 L air 
volume).
    Standard error of estimate at the target concentration: 6.5%.
    Special requirements: The sampling tubes must be coated with 4-tert-
butylcatechol. Collected samples should be stored in a freezer.
    Status of method: A sampling and analytical method has been 
subjected to the established evaluation procedures of the Organic 
Methods Evaluation Branch, OSHA Analytical Laboratory, Salt Lake City, 
Utah 84165.

                              1. Background

    This work was undertaken to develop a sampling and analytical 
procedure for BD at 1 ppm. The current method recommended by OSHA for 
collecting BD uses activated coconut shell charcoal as the sampling 
medium (Ref. 5.2). This method was found to be inadequate for use at low 
BD levels because of sample instability.
    The stability of samples has been significantly improved through the 
use of a specially cleaned charcoal which is coated with 4-tert-
butylcatechol (TBC). TBC is a polymerization inhibitor for BD (Ref. 
5.3).

                           1.1.1 Toxic effects

    Symptoms of human exposure to BD include irritation of the eyes, 
nose and throat. It can also cause coughing, drowsiness and fatigue. 
Dermatitis and frostbite can result from skin exposure to liquid BD. 
(Ref. 5.1)
    NIOSH recommends that BD be handled in the workplace as a potential 
occupational carcinogen. This recommendation is based on two inhalation 
studies that resulted in cancers at multiple sites in rats and in mice. 
BD has also demonstrated mutagenic activity in the presence of a liver 
microsomal activating system. It has also been reported to have adverse 
reproductive effects. (Ref. 5.1)

                   1.1.2. Potential workplace exposure

    About 90% of the annual production of BD is used to manufacture 
styrene-butadiene rubber and Polybutadiene rubber. Other uses include: 
Polychloroprene rubber, acrylonitrile butadiene-stryene resins, nylon 
intermediates, styrene-butadiene latexes, butadiene polymers, 
thermoplastic elastomers, nitrile resins, methyl methacrylate-butadiene 
styrene resins and chemical intermediates. (Ref. 5.1)

                  1.1.3. Physical properties (Ref. 5.1)

    CAS No.: 106-99-0
    Molecular weight: 54.1
    Appearance: Colorless gas
    Boiling point: -4.41 [deg]C (760 mm Hg)
    Freezing point: -108.9 [deg]C
    Vapor pressure: 2 atm @ 15.3 [deg]C; 5 atm @ 47 [deg]C
    Explosive limits: 2 to 11.5% (by volume in air)
    Odor threshold: 0.45 ppm
    Structural formula: H2 C:CHCH:CH2
    Synonyms: BD; biethylene; bivinyl; butadiene; divinyl; buta-1,3-
diene; alpha-gamma-butadiene; erythrene; NCI-C50602; pyrrolylene; 
vinylethylene.

                     1.2. Limit defining parameters

    The analyte air concentrations listed throughout this method are 
based on an air volume of 3 L and a desorption volume of 1 mL. Air 
concentrations listed in ppm are referenced to 25 [deg]C and 760 mm Hg.

           1.2.1. Detection limit of the analytical procedure

    The detection limit of the analytical procedure was 304 pg per 
injection. This was the amount of BD which gave a response relative to 
the interferences present in a standard.

             1.2.2. Detection limit of the overall procedure

    The detection limit of the overall procedure was 0.60 [micro]g per 
sample (90 ppb or 200 [micro]g/m\3\). This amount was determined 
graphically. It was the amount of analyte which, when spiked on the 
sampling device, would allow recovery approximately equal to the 
detection limit of the analytical procedure.

                   1.2.3. Reliable quantitation limit

    The reliable quantitation limit was 1.03 [micro]g per sample (155 
ppb or 343 [micro]g/m\3\). This was the smallest amount of analyte which 
could be quantitated within the limits of a recovery of at least 75% and 
a precision (1.96 SD) of 25% 
or better.

                         1.2.4. Sensitivity \1\
---------------------------------------------------------------------------

    \1\ The reliable quantitation limit and detection limits reported in 
the method are based upon optimization of the instrument for the 
smallest possible amount of analyte. When the target concentration of an 
analyte is exceptionally higher than these limits, they may not be 
attainable at the routine operation parameters.
---------------------------------------------------------------------------

    The sensitivity of the analytical procedure over a concentration 
range representing 0.6 to 2 times the target concentration, based on the 
recommended air volume, was 387 area

[[Page 460]]

units per [micro]g/mL. This value was determined from the slope of the 
calibration curve. The sensitivity may vary with the particular 
instrument used in the analysis.

                             1.2.5. Recovery

    The recovery of BD from samples used in storage tests remained above 
77% when the samples were stored at ambient temperature and above 94% 
when the samples were stored at refrigerated temperature. These values 
were determined from regression lines which were calculated from the 
storage data. The recovery of the analyte from the collection device 
must be at least 75% following storage.

                1.2.6. Precision (analytical method only)

    The pooled coefficient of variation obtained from replicate 
determinations of analytical standards over the range of 0.6 to 2 times 
the target concentration was 0.011.

                  1.2.7. Precision (overall procedure)

    The precision at the 95% confidence level for the refrigerated 
temperature storage test was 12.7%. This value 
includes an additional 5% for sampling error. The 
overall procedure must provide results at the target concentrations that 
are 25% at the 95% confidence level.

                         1.2.8. Reproducibility

    Samples collected from a controlled test atmosphere and a draft copy 
of this procedure were given to a chemist unassociated with this 
evaluation. The average recovery was 97.2% and the standard deviation 
was 6.2%.

                          2. Sampling procedure

                             2.1. Apparatus

    2.1.1. Samples are collected by use of a personal sampling pump that 
can be calibrated to within 5% of the recommended 
0.05 L/min sampling rate with the sampling tube in line.
    2.1.2. Samples are collected with laboratory prepared sampling 
tubes. The sampling tube is constructed of silane-treated glass and is 
about 5-cm long. The ID is 4 mm and the OD is 6 mm. One end of the tube 
is tapered so that a glass wool end plug will hold the contents of the 
tube in place during sampling. The opening in the tapered end of the 
sampling tube is at least one-half the ID of the tube (2 mm). The other 
end of the sampling tube is open to its full 4-mm ID to facilitate 
packing of the tube. Both ends of the tube are fire-polished for safety. 
The tube is packed with 2 sections of pretreated charcoal which has been 
coated with TBC. The tube is packed with a 50-mg backup section, located 
nearest the tapered end, and with a 100-mg sampling section of charcoal. 
The two sections of coated adsorbent are separated and retained with 
small plugs of silanized glass wool. Following packing, the sampling 
tubes are sealed with two \7/32\ inch OD plastic end caps. Instructions 
for the pretreatment and coating of the charcoal are presented in 
Section 4.1 of this method.

                              2.2. Reagents

    None required.

                             2.3. Technique

    2.3.1. Properly label the sampling tube before sampling and then 
remove the plastic end caps.
    2.3.2. Attach the sampling tube to the pump using a section of 
flexible plastic tubing such that the larger front section of the 
sampling tube is exposed directly to the atmosphere. Do not place any 
tubing ahead of the sampling tube. The sampling tube should be attached 
in the worker's breathing zone in a vertical manner such that it does 
not impede work performance.
    2.3.3. After sampling for the appropriate time, remove the sampling 
tube from the pump and then seal the tube with plastic end caps. Wrap 
the tube lengthwise.
    2.3.4. Include at least one blank for each sampling set. The blank 
should be handled in the same manner as the samples with the exception 
that air is not drawn through it.
    2.3.5. List any potential interferences on the sample data sheet.
    2.3.6. The samples require no special shipping precautions under 
normal conditions. The samples should be refrigerated if they are to be 
exposed to higher than normal ambient temperatures. If the samples are 
to be stored before they are shipped to the laboratory, they should be 
kept in a freezer. The samples should be placed in a freezer upon 
receipt at the laboratory.

                            2.4. Breakthrough

    (Breakthrough was defined as the relative amount of analyte found on 
the backup section of the tube in relation to the total amount of 
analyte collected on the sampling tube. Five-percent breakthrough 
occurred after sampling a test atmosphere containing 2.0 ppm BD for 90 
min at 0.05 L/min. At the end of this time 4.5 L of air had been sampled 
and 20.1 [micro]g of the analyte was collected. The relative humidity of 
the sampled air was 80% at 23 [deg]C.)
    Breakthrough studies have shown that the recommended sampling 
procedure can be used at air concentrations higher than the target 
concentration. The sampling time, however, should be reduced to 45 min 
if both the expected BD level and the relative humidity of the sampled 
air are high.

[[Page 461]]

                       2.5. Desorption efficiency

    The average desorption efficiency for BD from TBC coated charcoal 
over the range from 0.6 to 2 times the target concentration was 96.4%. 
The efficiency was essentially constant over the range studied.

              2.6. Recommended air volume and sampling rate

    2.6.1. The recommended air volume is 3L.
    2.6.2. The recommended sampling rate is 0.05 L/min for 1 hour.

                           2.7. Interferences

    There are no known interferences to the sampling method.

                         2.8. Safety precautions

    2.8.1. Attach the sampling equipment to the worker in such a manner 
that it will not interfere with work performance or safety.
    2.8.2. Follow all safety practices that apply to the work area being 
sampled.

                         3. Analytical procedure

                             3.1. Apparatus

    3.1.1. A gas chromatograph (GC), equipped with a flame ionization 
detector (FID). \2\
---------------------------------------------------------------------------

    \2\ A Hewlett-Packard Model 5840A GC was used for this evaluation. 
Injections were performed using a Hewlett-Packard Model 7671A automatic 
sampler.
---------------------------------------------------------------------------

    3.1.2. A GC column capable of resolving the analytes from any 
interference. \3\
---------------------------------------------------------------------------

    \3\ A 20-ft x \1/8\-inch OD stainless steel GC column containing 20% 
FFAP on 80/100 mesh Chromabsorb W-AW-DMCS was used for this evaluation.
---------------------------------------------------------------------------

    3.1.3. Vials, glass 2-mL with Teflon-lined caps.
    3.1.4. Disposable Pasteur-type pipets, volumetric flasks, pipets and 
syringes for preparing samples and standards, making dilutions and 
performing injections.

                              3.2. Reagents

    3.2.1. Carbon disulfide. \4\
---------------------------------------------------------------------------

    \4\ Fisher Scientific Company A.C.S. Reagent Grade solvent was used 
in this evaluation.
---------------------------------------------------------------------------

    The benzene contaminant that was present in the carbon disulfide was 
used as an internal standard (ISTD) in this evaluation.
    3.2.2. Nitrogen, hydrogen and air, GC grade.
    3.2.3. BD of known high purity. \5\
---------------------------------------------------------------------------

    \5\ Matheson Gas Products, CP Grade 1,3-butadiene was used in this 
study.
---------------------------------------------------------------------------

                        3.3. Standard preparation

    3.3.1. Prepare standards by diluting known volumes of BD gas with 
carbon disulfide. This can be accomplished by injecting the appropriate 
volume of BD into the headspace above the 1-mL of carbon disulfide 
contained in sealed 2-mL vial. Shake the vial after the needle is 
removed from the septum. \6\
---------------------------------------------------------------------------

    \6\ A standard containing 7.71 [micro]g/mL (at ambient temperature 
and pressure) was prepared by diluting 4 [micro]L of the gas with 1-mL 
of carbon disulfide.
---------------------------------------------------------------------------

    3.3.2. The mass of BD gas used to prepare standards can be 
determined by use of the following equations:

MV = (760/BP)(273 + t)/(273)(22.41)

Where:

MV = ambient molar volume
BP = ambient barometric pressure
T = ambient temperature
[micro]g/[micro]L = 54.09/MV
[micro]g/standard = ([micro]g/[micro]L)([micro]L) BD used to prepare the 
          standard

                         3.4. Sample preparation

    3.4.1. Transfer the 100-mg section of the sampling tube to a 2-mL 
vial. Place the 50-mg section in a separate vial. If the glass wool 
plugs contain a significant amount of charcoal, place them with the 
appropriate sampling tube section.
    3.4.2. Add 1-mL of carbon disulfide to each vial.
    3.4.3. Seal the vials with Teflon-lined caps and then allow them to 
desorb for one hour. Shake the vials by hand vigorously several times 
during the desorption period.
    3.4.4. If it is not possible to analyze the samples within 4 hours, 
separate the carbon disulfide from the charcoal, using a disposable 
Pasteur-type pipet, following the one hour. This separation will improve 
the stability of desorbed samples.
    3.4.5. Save the used sampling tubes to be cleaned and repacked with 
fresh adsorbent.

                              3.5. Analysis

    3.5.1. GC Conditions
    Column temperature: 95 [deg]C
    Injector temperature: 180 [deg]C
    Detector temperature: 275 [deg]C
    Carrier gas flow rate: 30 mL/min
    Injection volume: 0.80 [micro]L
    GC column: 20-ft x \1/8\-in OD stainless steel GC column containing 
20%
    FFAP on 80/100 Chromabsorb W-AW-DMCS.
    3.5.2. Chromatogram. See Section 4.2.
    3.5.3. Use a suitable method, such as electronic or peak heights, to 
measure detector response.
    3.5.4. Prepare a calibration curve using several standard solutions 
of different concentrations. Prepare the calibration curve daily. 
Program the integrator to report the results in [micro]g/mL.
    3.5.5. Bracket sample concentrations with standards.

[[Page 462]]

                     3.6. Interferences (analytical)

    3.6.1. Any compound with the same general retention time as the 
analyte and which also gives a detector response is a potential 
interference. Possible interferences should be reported by the 
industrial hygienist to the laboratory with submitted samples.
    3.6.2. GC parameters (temperature, column, etc.) may be changed to 
circumvent interferences.
    3.6.3. A useful means of structure designation is GC/MS. It is 
recommended that this procedure be used to confirm samples whenever 
possible.

                            3.7. Calculations

    3.7.1. Results are obtained by use of calibration curves. 
Calibration curves are prepared by plotting detector response against 
concentration for each standard. The best line through the data points 
is determined by curve fitting.
    3.7.2. The concentration, in ug/mL, for a particular sample is 
determined by comparing its detector response to the calibration curve. 
If any analyte is found on the backup section, this amount is added to 
the amount found on the front section. Blank corrections should be 
performed before adding the results together.
    3.7.3. The BD air concentration can be expressed using the following 
equation:

mg/m\3\ = (A)(B)/(C)(D)

Where:

A = [micro]g/mL from Section 3.7.2
B = volume
C = L of air sampled
D = efficiency

    3.7.4. The following equation can be used to convert results in mg/
m\3\ to ppm:

ppm = (mg/m\3\)(24.46)/54.09

Where:

mg/m\3\ = result from Section 3.7.3.
24.46 = molar volume of an ideal gas at 760 mm Hg and 25 [deg]C.

                  3.8. Safety precautions (analytical)

    3.8.1. Avoid skin contact and inhalation of all chemicals.
    3.8.2. Restrict the use of all chemicals to a fume hood whenever 
possible.
    3.8.3. Wear safety glasses and a lab coat in all laboratory areas.

                        4. Additional Information

 4.1. A procedure to prepare specially cleaned charcoal coated with TBC

                            4.1.1. Apparatus

    4.1.1.1. Magnetic stirrer and stir bar.
    4.1.1.2. Tube furnace capable of maintaining a temperature of 700 
[deg]C and equipped with a quartz tube that can hold 30 g of charcoal. 
\8\
---------------------------------------------------------------------------

    \8\ A Lindberg Type 55035 Tube furnace was used in this evaluation.
---------------------------------------------------------------------------

    4.1.1.3. A means to purge nitrogen gas through the charcoal inside 
the quartz tube.
    4.1.1.4. Water bath capable of maintaining a temperature of 60 
[deg]C.
    4.1.1.5. Miscellaneous laboratory equipment: One-liter vacuum flask, 
1-L Erlenmeyer flask, 350-M1 Buchner funnel with a coarse fitted disc, 
4-oz brown bottle, rubber stopper, Teflon tape etc.

                             4.1.2. Reagents

    4.1.2.1. Phosphoric acid, 10% by weight, in water. \9\
---------------------------------------------------------------------------

    \9\ Baker Analyzed'' Reagent grade was diluted with water for use in 
this evaluation.
---------------------------------------------------------------------------

    4.1.2.2. 4-tert-Butylcatechol (TBC). \10\
---------------------------------------------------------------------------

    \10\ The Aldrich Chemical Company 99% grade was used in this 
evaluation.
---------------------------------------------------------------------------

    4.1.2.3. Specially cleaned coconut shell charcoal, 20/40 mesh. \11\
---------------------------------------------------------------------------

    \11\ Specially cleaned charcoal was obtained from Supelco, Inc. for 
use in this evaluation. The cleaning process used by Supelco is 
proprietary.
---------------------------------------------------------------------------

    4.1.2.4. Nitrogen gas, GC grade.

                            4.1.3. Procedure

    Weigh 30g of charcoal into a 500-mL Erlenmeyer flask. Add about 250 
mL of 10% phosphoric acid to the flask and then swirl the mixture. Stir 
the mixture for 1 hour using a magnetic stirrer. Filter the mixture 
using a fitted Buchner funnel. Wash the charcoal several times with 250-
mL portions of deionized water to remove all traces of the acid. 
Transfer the washed charcoal to the tube furnace quartz tube. Place the 
quartz tube in the furnace and then connect the nitrogen gas purge to 
the tube. Fire the charcoal to 700 [deg]C. Maintain that temperature for 
at least 1 hour. After the charcoal has cooled to room temperature, 
transfer it to a tared beaker. Determine the weight of the charcoal and 
then add an amount of TBC which is 10% of the charcoal, by weight.
    CAUTION-TBC is toxic and should only be handled in a fume hood while 
wearing gloves.
    Carefully mix the contents of the beaker and then transfer the 
mixture to a 4-oz bottle. Stopper the bottle with a clean rubber stopper 
which has been wrapped with Teflon tape. Clamp the bottle in a water 
bath so that the water level is above the charcoal level. Gently heat 
the bath to 60 [deg]C and then maintain that temperature for 1 hour. 
Cool the charcoal to room temperature and then transfer the coated 
charcoal to a suitable container.
    The coated charcoal is now ready to be packed into sampling tubes. 
The sampling tubes should be stored in a sealed container

[[Page 463]]

to prevent contamination. Sampling tubes should be stored in the dark at 
room temperature. The sampling tubes should be segregated by coated 
adsorbent lot number.

                            4.2 Chromatograms

    The chromatograms were obtained using the recommended analytical 
method. The chart speed was set at 1 cm/min for the first three min and 
then at 0.2 cm/min for the time remaining in the analysis.
    The peak which elutes just before BD is a reaction product between 
an impurity on the charcoal and TBC. This peak is always present, but it 
is easily resolved from the analyte. The peak which elutes immediately 
before benzene is an oxidation product of TBC.

                              5. References

    5.1. ``Current Intelligence Bulletin 41, 1,3-Butadiene'', U.S. Dept. 
of Health and Human Services, Public Health Service, Center for Disease 
Control, NIOSH.
    5.2. ``NIOSH Manual of Analytical Methods'', 2nd ed; U.S. Dept. of 
Health Education and Welfare, National Institute for Occupational Safety 
and Health: Cincinnati, OH. 1977, Vol. 2, Method No. S91 DHEW (NIOSH) 
Publ. (US), No. 77-157-B.
    5.3. Hawley, G.C., Ed. ``The Condensed Chemical Dictionary'', 8th 
ed.; Van Nostrand Rienhold Company: New York, 1971; 139.5.4. Chem. Eng. 
News (June 10, 1985), (63), 22-66.

                Appendix E to Sec.  1910.1051 [Reserved]

  Appendix F to Sec.  1910.1051--Medical Questionnaires (Non-Mandatory)

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[61 FR 56831, Nov. 4, 1996, as amended at 63 FR 1294, Jan. 8, 1998; 67 
FR 67965, Nov. 7, 2002; 70 FR 1143, Jan. 5, 2005; 71 FR 16672, 16674, 
Apr. 3, 2006; 73 FR 75587, Dec. 12, 2008; 76 FR 33609, June 8, 2011; 77 
FR 17785, Mar. 26, 2012; 78 FR 9313, Feb. 8, 2013; 84 FR 21527, May 14, 
2019]



Sec.  1910.1052  Methylene chloride.

    This occupational health standard establishes requirements for 
employers to control occupational exposure to methylene chloride (MC). 
Employees exposed to MC are at increased risk of developing cancer, 
adverse effects on the heart, central nervous system and liver, and skin 
or eye irritation. Exposure may occur through inhalation, by absorption 
through the skin, or through contact with the skin. MC is a solvent 
which is used in many different types of work activities, such as paint 
stripping, polyurethane foam manufacturing, and cleaning and degreasing. 
Under the requirements of paragraph (d) of this section, each covered 
employer must make an initial determination of each employee's exposure 
to MC. If the employer determines that employees are exposed below the 
action level, the only other provisions of this section that apply are 
that a record must be made of the determination, the employees must 
receive information and training under paragraph (l) of this section 
and, where appropriate, employees must be protected from contact with 
liquid MC under paragraph (h) of this section. The provisions of the MC 
standard are as follows:
    (a) Scope and application. This section applies to all occupational 
exposures to methylene chloride (MC), Chemical Abstracts Service 
Registry Number 75-09-2, in general industry, construction and shipyard 
employment.
    (b) Definitions. For the purposes of this section, the following 
definitions shall apply:
    Action level means a concentration of airborne MC of 12.5 parts per 
million (ppm) calculated as an eight (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 specifically authorized by the 
employer and required by work duties to be present in regulated areas, 
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 (d) of this section, or any 
other person authorized by the OSH Act or regulations issued under the 
Act.
    Director means the Director of the National Institute for 
Occupational Safety and Health, U.S. Department of Health and Human 
Services, or designee.
    Emergency means any occurrence, such as, but not limited to, 
equipment failure, rupture of containers, or failure of control 
equipment, which results, or is likely to result in an uncontrolled 
release of MC. If an incidental release of MC can be controlled by 
employees such as maintenance personnel at the time of release and in 
accordance with the leak/spill provisions required by paragraph (f) of 
this section, it is not considered an emergency as defined by this 
standard.

[[Page 481]]

    Employee exposure means exposure to airborne MC which occurs or 
would occur if the employee were not using respiratory protection.
    Methylene chloride (MC) means an organic compound with chemical 
formula, CH2 Cl2. Its Chemical Abstracts Service 
Registry Number is 75-09-2. Its molecular weight is 84.9 g/mole.
    Physician or other licensed health care professional 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 
health care services required by paragraph (j) of this section.
    Regulated area means an area, demarcated by the employer, where an 
employee's exposure to airborne concentrations of MC exceeds or can 
reasonably be expected to exceed either the 8-hour TWA PEL or the STEL.
    Symptom means central nervous system effects such as headaches, 
disorientation, dizziness, fatigue, and decreased attention span; skin 
effects such as chapping, erythema, cracked skin, or skin burns; and 
cardiac effects such as chest pain or shortness of breath.
    This section means this methylene chloride standard.
    (c) Permissible exposure limits (PELs)--(1) Eight-hour time-weighted 
average (TWA) PEL. The employer shall ensure that no employee is exposed 
to an airborne concentration of MC in excess of twenty-five parts of MC 
per million parts of air (25 ppm) as an 8-hour TWA.
    (2) Short-term exposure limit (STEL). The employer shall ensure that 
no employee is exposed to an airborne concentration of MC in excess of 
one hundred and twenty-five parts of MC per million parts of air (125 
ppm) as determined over a sampling period of fifteen minutes.
    (d) Exposure monitoring--(1) Characterization of employee exposure. 
(i) Where MC is present in the workplace, the employer shall determine 
each employee's exposure by either:
    (A) Taking a personal breathing zone air sample of each employee's 
exposure; or
    (B) Taking personal breathing zone air samples that are 
representative of each employee's exposure.
    (ii) Representative samples. The employer may consider personal 
breathing zone air samples to be representative of employee exposures 
when they are taken as follows:
    (A) 8-hour TWA PEL. The employer has taken one or more personal 
breathing zone air samples for at least one employee in each job 
classification in a work area during every work shift, and the employee 
sampled is expected to have the highest MC exposure.
    (B) Short-term exposure limits. The employer has taken one or more 
personal breathing zone air samples which indicate the highest likely 
15-minute exposures during such operations for at least one employee in 
each job classification in the work area during every work shift, and 
the employee sampled is expected to have the highest MC exposure.
    (C) Exception. Personal breathing zone air samples taken during one 
work shift may be used to represent employee exposures on other work 
shifts where the employer can document that the tasks performed and 
conditions in the workplace are similar across shifts.
    (iii) Accuracy of monitoring. The employer shall ensure that the 
methods used to perform exposure monitoring produce results that are 
accurate to a confidence level of 95 percent, and are:
    (A) Within plus or minus 25 percent for airborne concentrations of 
MC above the 8-hour TWA PEL or the STEL; or
    (B) Within plus or minus 35 percent for airborne concentrations of 
MC at or above the action level but at or below the 8-hour TWA PEL.
    (2) Initial determination. Each employer whose employees are exposed 
to MC shall perform initial exposure monitoring to determine each 
affected employee's exposure, except under the following conditions:
    (i) Where objective data demonstrate that MC cannot be released in 
the workplace in airborne concentrations at or above the action level or 
above the STEL. The objective data shall represent the highest MC 
exposures likely to occur under reasonably foreseeable

[[Page 482]]

conditions of processing, use, or handling. The employer shall document 
the objective data exemption as specified in paragraph (m) of this 
section;
    (ii) Where the employer has performed exposure monitoring within 12 
months prior to April 10, 1997 and that exposure monitoring meets all 
other requirements of this section, and was conducted under conditions 
substantially equivalent to existing conditions; or
    (iii) Where employees are exposed to MC on fewer than 30 days per 
year (e.g., on a construction site), and the employer has measurements 
by direct-reading instruments which give immediate results (such as a 
detector tube) and which provide sufficient information regarding 
employee exposures to determine what control measures are necessary to 
reduce exposures to acceptable levels.
    (3) Periodic monitoring. Where the initial determination shows 
employee exposures at or above the action level or above the STEL, the 
employer shall establish an exposure monitoring program for periodic 
monitoring of employee exposure to MC in accordance with Table 1:

 Table 1--Initial Determination Exposure Scenarios and Their Associated
                         Monitoring Frequencies
------------------------------------------------------------------------
      Exposure scenario               Required monitoring activity
------------------------------------------------------------------------
Below the action level and at  No 8-hour TWA or STEL monitoring
 or below the STEL.             required.
Below the action level and     No 8-hour TWA monitoring required;
 above the STEL.                monitor STEL exposures every three
                                months.
At or above the action level,  Monitor 8-hour TWA exposures every six
 at or below the TWA, and at    months.
 or below the STEL.
At or above the action level,  Monitor 8-hour TWA exposures every six
 at or below the TWA, and       months and monitor STEL exposures every
 above the STEL.                three months.
Above the TWA and at or below  Monitor 8-hour TWA exposures every three
 the STEL.                      months. In addition, without regard to
                                the last sentence of the note to
                                paragraph (d)(3), the following
                                employers must monitor STEL exposures
                                every three months until either the date
                                by which they must achieve the 8-hour
                                TWA PEL under paragraph (n) of this
                                section or the date by which they in
                                fact achieve the 8-hour TWA PEL,
                                whichever comes first: employers engaged
                                in polyurethane foam manufacturing; foam
                                fabrication; furniture refinishing;
                                general aviation aircraft stripping;
                                product formulation; use of MC-based
                                adhesives for boat building and repair,
                                recreational vehicle manufacture, van
                                conversion, or upholstery; and use of MC
                                in construction work for restoration and
                                preservation of buildings, painting and
                                paint removal, cabinet making, or floor
                                refinishing and resurfacing.
Above the TWA and above the    Monitor 8-hour TWA exposures and STEL
 STEL.                          exposures every three months.
------------------------------------------------------------------------


    Note to paragraph (d)(3): The employer may decrease the frequency of 
8-hour TWA exposure monitoring to every six months when at least two 
consecutive measurements taken at least seven days apart show exposures 
to be at or below the 8-hour TWA PEL. The employer may discontinue the 
periodic 8-hour TWA monitoring for employees where at least two 
consecutive measurements taken at least seven days apart are below the 
action level. The employer may discontinue the periodic STEL monitoring 
for employees where at least two consecutive measurements taken at least 
7 days apart are at or below the STEL.

    (4) Additional monitoring. (i) The employer shall perform exposure 
monitoring when a change in workplace conditions indicates that employee 
exposure may have increased. Examples of situations that may require 
additional monitoring include changes in production, process, control 
equipment, or work practices, or a leak, rupture, or other breakdown.
    (ii) Where exposure monitoring is performed due to a spill, leak, 
rupture or equipment breakdown, the employer shall clean-up the MC and 
perform the appropriate repairs before monitoring.
    (5) Employee notification of monitoring results. (i) The employer 
shall, within 15 working days after the receipt of the results of any 
monitoring performed under this section, notify each affected employee 
of these results in writing, either individually or by posting of 
results in an appropriate location that is accessible to affected 
employees.
    (ii) Whenever monitoring results indicate that employee exposure is 
above the 8-hour TWA PEL or the STEL, the employer shall describe in the 
written

[[Page 483]]

notification the corrective action being taken to reduce employee 
exposure to or below the 8-hour TWA PEL or STEL and the schedule for 
completion of this action.
    (6) Observation of monitoring--(i) Employee observation. The 
employer shall provide affected employees or their designated 
representatives an opportunity to observe any monitoring of employee 
exposure to MC conducted in accordance with this section.
    (ii) Observation procedures. When observation of the monitoring of 
employee exposure to MC requires entry into an area where the use of 
protective clothing or equipment is required, the employer shall 
provide, at no cost to the observer(s), and the observer(s) shall be 
required to use such clothing and equipment and shall comply with all 
other applicable safety and health procedures.
    (e) Regulated areas. (1) The employer shall establish a regulated 
area wherever an employee's exposure to airborne concentrations of MC 
exceeds or can reasonably be expected to exceed either the 8-hour TWA 
PEL or the STEL.
    (2) The employer shall limit access to regulated areas to authorized 
persons.
    (3) The employer shall supply a respirator, selected in accordance 
with paragraph (h)(3) of this section, to each person who enters a 
regulated area and shall require each affected employee to use that 
respirator whenever MC exposures are likely to exceed the 8-hour TWA PEL 
or STEL.

    Note to paragraph (e)(3): An employer who has implemented all 
feasible engineering, work practice and administrative controls (as 
required in paragraph (f) of this section), and who has established a 
regulated area (as required by paragraph (e)(1) of this section) where 
MC exposure can be reliably predicted to exceed the 8-hour TWA PEL or 
the STEL only on certain days (for example, because of work or process 
schedule) would need to have affected employees use respirators in that 
regulated area only on those days.

    (4) The employer shall ensure that, within a regulated area, 
employees do not engage in non-work activities which may increase dermal 
or oral MC exposure.
    (5) The employer shall ensure that while employees are wearing 
respirators, they do not engage in activities (such as taking medication 
or chewing gum or tobacco) which interfere with respirator seal or 
performance.
    (6) The employer shall demarcate regulated areas from the rest of 
the workplace in any manner that adequately establishes and alerts 
employees to the boundaries of the area and minimizes the number of 
authorized employees exposed to MC within the regulated area.
    (7) An employer at a multi-employer worksite who establishes a 
regulated area shall communicate the access restrictions and locations 
of these areas to all other employers with work operations at that 
worksite.
    (f) Methods of compliance--(1) Engineering and work practice 
controls. The employer shall institute and maintain the effectiveness of 
engineering controls and work practices to reduce employee exposure to 
or below the PELs except to the extent that the employer can demonstrate 
that such controls are not feasible. Wherever the feasible engineering 
controls and work practices which can be instituted are not sufficient 
to reduce employee exposure to or below the 8-TWA PEL or STEL, 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.
    (2) Prohibition of rotation. The employer shall not implement a 
schedule of employee rotation as a means of compliance with the PELs.
    (3) Leak and spill detection. (i) The employer shall implement 
procedures to detect leaks of MC in the workplace. In work areas where 
spills may occur, the employer shall make provisions to contain any 
spills and to safely dispose of any MC-contaminated waste materials.
    (ii) The employer shall ensure that all incidental leaks are 
repaired and that incidental spills are cleaned promptly by employees 
who use the appropriate personal protective equipment and are trained in 
proper methods of cleanup.

    Note to paragraph (f)(3)(ii): See appendix A of this section for 
examples of procedures

[[Page 484]]

that satisfy this requirement. Employers covered by this standard may 
also be subject to the hazardous waste and emergency response provisions 
contained in 29 CFR 1910.120 (q).

    (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 when an employee's exposure to MC exceeds the 8-hour TWA 
PEL, or STEL (for example, when an employee is using MC in a regulated 
area).
    (ii) Periods necessary to install or implement feasible engineering 
and work-practice controls.
    (iii) A few work operations, such as some maintenance operations and 
repair activities, for which the employer demonstrates that engineering 
and work-practice controls are infeasible.
    (iv) Work operations for which feasible engineering and work-
practice controls are not sufficient to reduce employee exposures to or 
below the PELs.
    (v) Emergencies.
    (2) Respirator program. (i) The employer must implement a 
respiratory protection program in accordance with Sec.  1910.13(b) 
through (m) (except (d)(1)(iii)), which covers each employee required by 
this section to use a respirator.
    (ii) Employers who provide employees with gas masks with organic-
vapor canisters for the purpose of emergency escape must replace the 
canisters after any emergency use and before the gas masks are returned 
to service.
    (3) Respirator selection. Employers must:
    (i) Select, and provide to employees, the appropriate atmosphere-
supplying respirator specified in paragraph (d)(3)(i)(A) of 29 CFR 
1910.134; however, employers must not select or use half masks of any 
type because MC may cause eye irritation or damage.
    (ii) For emergency escape, provide employees with one of the 
following respirator options: A self-contained breathing apparatus 
operated in the continuous-flow or pressure-demand mode; or a gas mask 
with an organic vapor canister.
    (4) Medical evaluation. Before having an employee use a supplied-air 
respirator in the negative-pressure mode, or a gas mask with an organic-
vapor canister for emergency escape, the employer must:
    (i) Have a physician or other licensed health-care professional 
(PLHCP) evaluate the employee's ability to use such respiratory 
protection.
    (ii) Ensure that the PLHCP provides their findings in a written 
opinion to the employee and the employer.
    (h) Protective Work Clothing and Equipment. (1) Where needed to 
prevent MC-induced skin or eye irritation, the employer shall provide 
clean protective clothing and equipment which is resistant to MC, at no 
cost to the employee, and shall ensure that each affected employee uses 
it. Eye and face protection shall meet the requirements of 29 CFR 
1910.133 or 29 CFR 1915.153, as applicable.
    (2) The employer shall clean, launder, repair and replace all 
protective clothing and equipment required by this paragraph as needed 
to maintain their effectiveness.
    (3) The employer shall be responsible for the safe disposal of such 
clothing and equipment.

    Note to paragraph (h)(4): See appendix A for examples of disposal 
procedures that will satisfy this requirement.

    (i) Hygiene facilities. (1) If it is reasonably foreseeable that 
employees' skin may contact solutions containing 0.1 percent or greater 
MC (for example, through splashes, spills or improper work practices), 
the employer shall provide conveniently located washing facilities 
capable of removing the MC, and shall ensure that affected employees use 
these facilities as needed.
    (2) If it is reasonably foreseeable that an employee's eyes may 
contact solutions containing 0.1 percent or greater MC (for example 
through splashes, spills or improper work practices), the employer shall 
provide appropriate eyewash facilities within the immediate work area 
for emergency use, and shall ensure that affected employees use those 
facilities when necessary.
    (j) Medical surveillance--(1) Affected employees. The employer shall 
make

[[Page 485]]

medical surveillance available for employees who are or may be exposed 
to MC as follows:
    (i) At or above the action level on 30 or more days per year, or 
above the 8- hour TWA PEL or the STEL on 10 or more days per year;
    (ii) Above the 8-TWA PEL or STEL for any time period where an 
employee has been identified by a physician or other licensed health 
care professional as being at risk from cardiac disease or from some 
other serious MC-related health condition and such employee requests 
inclusion in the medical surveillance program;
    (iii) During an emergency.
    (2) Costs. The employer shall provide all required medical 
surveillance at no cost to affected employees, without loss of pay and 
at a reasonable time and place.
    (3) Medical personnel. The employer shall ensure that all medical 
surveillance procedures are performed by a physician or other licensed 
health care professional, as defined in paragraph (b) of this section.
    (4) Frequency of medical surveillance. The employer shall make 
medical surveillance available to each affected employee as follows:
    (i) Initial surveillance. The employer shall provide initial medical 
surveillance under the schedule provided by paragraph (n)(2)(iii) of 
this section, or before the time of initial assignment of the employee, 
whichever is later. The employer need not provide the initial 
surveillance if medical records show that an affected employee has been 
provided with medical surveillance that complies with this section 
within 12 months before April 10, 1997.
    (ii) Periodic medical surveillance. The employer shall update the 
medical and work history for each affected employee annually. The 
employer shall provide periodic physical examinations, including 
appropriate laboratory surveillance, as follows:
    (A) For employees 45 years of age or older, within 12 months of the 
initial surveillance or any subsequent medical surveillance; and
    (B) For employees younger than 45 years of age, within 36 months of 
the initial surveillance or any subsequent medical surveillance.
    (iii) Termination of employment or reassignment. When an employee 
leaves the employer's workplace, or is reassigned to an area where 
exposure to MC is consistently at or below the action level and STEL, 
medical surveillance shall be made available if six months or more have 
elapsed since the last medical surveillance.
    (iv) Additional surveillance. The employer shall provide additional 
medical surveillance at frequencies other than those listed above when 
recommended in the written medical opinion. (For example, the physician 
or other licensed health care professional may determine an examination 
is warranted in less than 36 months for employees younger than 45 years 
of age based upon evaluation of the results of the annual medical and 
work history.)
    (5) Content of medical surveillance--(i) Medical and work history. 
The comprehensive medical and work history shall emphasize neurological 
symptoms, skin conditions, history of hematologic or liver disease, 
signs or symptoms suggestive of heart disease (angina, coronary artery 
disease), risk factors for cardiac disease, MC exposures, and work 
practices and personal protective equipment used during such exposures.

    Note to paragraph (j)(5)(i): See appendix B of this section for an 
example of a medical and work history format that would satisfy this 
requirement.

    (ii) Physical examination. Where physical examinations are provided 
as required above, the physician or other licensed health care 
professional shall accord particular attention to the lungs, 
cardiovascular system (including blood pressure and pulse), liver, 
nervous system, and skin. The physician or other licensed health care 
professional shall determine the extent and nature of the physical 
examination based on the health status of the employee and analysis of 
the medical and work history.
    (iii) Laboratory surveillance. The physician or other licensed 
health care professional shall determine the extent of any required 
laboratory surveillance based on the employee's observed health status 
and the medical and work history.


[[Page 486]]


    Note to paragraph (j)(5)(iii): See appendix B of this section for 
information regarding medical tests. Laboratory surveillance may include 
before- and after-shift carboxyhemoglobin determinations, resting ECG, 
hematocrit, liver function tests and cholesterol levels.

    (iv) Other information or reports. The medical surveillance shall 
also include any other information or reports the physician or other 
licensed health care professional determines are necessary to assess the 
employee's health in relation to MC exposure.
    (6) Content of emergency medical surveillance. The employer shall 
ensure that medical surveillance made available when an employee has 
been exposed to MC in emergency situations includes, at a minimum:
    (i) Appropriate emergency treatment and decontamination of the 
exposed employee;
    (ii) Comprehensive physical examination with special emphasis on the 
nervous system, cardiovascular system, lungs, liver and skin, including 
blood pressure and pulse;
    (iii) Updated medical and work history, as appropriate for the 
medical condition of the employee; and
    (iv) Laboratory surveillance, as indicated by the employee's health 
status.

    Note to paragraph (j)(6)(iv): See appendix B for examples of tests 
which may be appropriate.

    (7) Additional examinations and referrals. Where the physician or 
other licensed health care professional determines it is necessary, the 
scope of the medical examination shall be expanded and the appropriate 
additional medical surveillance, such as referrals for consultation or 
examination, shall be provided.
    (8) Information provided to the physician or other licensed health 
care professional. The employer shall provide the following information 
to a physician or other licensed health care professional who is 
involved in the diagnosis of MC-induced health effects:
    (i) A copy of this section including its applicable appendices;
    (ii) A description of the affected employee's past, current and 
anticipated future duties as they relate to the employee's MC exposure;
    (iii) The employee's former or current exposure levels or, for 
employees not yet occupationally exposed to MC, the employee's 
anticipated exposure levels and the frequency and exposure levels 
anticipated to be associated with emergencies;
    (iv) A description of any personal protective equipment, such as 
respirators, used or to be used; and
    (v) Information from previous employment-related medical 
surveillance of the affected employee which is not otherwise available 
to the physician or other licensed health care professional.
    (9) Written medical opinions. (i) For each physical examination 
required by this section, the employer shall ensure that the physician 
or other licensed health care professional provides to the employer and 
to the affected employee a written opinion regarding the results of that 
examination within 15 days of completion of the evaluation of medical 
and laboratory findings, but not more than 30 days after the 
examination. The written medical opinion shall be limited to the 
following information:
    (A) The physician or other licensed health care professional's 
opinion concerning whether exposure to MC may contribute to or aggravate 
the employee's existing cardiac, hepatic, neurological (including 
stroke) or dermal disease or whether the employee has any other medical 
condition(s) that would place the employee's health at increased risk of 
material impairment from exposure to MC.
    (B) Any recommended limitations upon the employee's exposure to MC, 
including removal from MC exposure, or upon the employee's use of 
respirators, protective clothing, or other protective equipment.
    (C) A statement that the employee has been informed by the physician 
or other licensed health care professional that MC is a potential 
occupational carcinogen, of risk factors for heart disease, and the 
potential for exacerbation of underlying heart disease by exposure to MC 
through its metabolism to carbon monoxide; and
    (D) A statement that the employee has been informed by the physician 
or other licensed health care professional

[[Page 487]]

of the results of the medical examination and any medical conditions 
resulting from MC exposure which require further explanation or 
treatment.
    (ii) The employer shall instruct the physician or other licensed 
health care professional not to reveal to the employer, orally or in the 
written opinion, any specific records, findings, and diagnoses that have 
no bearing on occupational exposure to MC.

    Note to paragraph (j)(9)(ii): The written medical opinion may also 
include information and opinions generated to comply with other OSHA 
health standards.

    (10) Medical presumption. For purposes of this paragraph (j) of this 
section, the physician or other licensed health care professional shall 
presume, unless medical evidence indicates to the contrary, that a 
medical condition is unlikely to require medical removal from MC 
exposure if the employee is not exposed to MC above the 8-hour TWA PEL. 
If the physician or other licensed health care professional recommends 
removal for an employee exposed below the 8-hour TWA PEL, the physician 
or other licensed health care professional shall cite specific medical 
evidence, sufficient to rebut the presumption that exposure below the 8-
hour TWA PEL is unlikely to require removal, to support the 
recommendation. If such evidence is cited by the physician or other 
licensed health care professional, the employer must remove the 
employee. If such evidence is not cited by the physician or other 
licensed health care professional, the employer is not required to 
remove the employee.
    (11) Medical Removal Protection (MRP). (i) Temporary medical removal 
and return of an employee.
    (A) Except as provided in paragraph (j)(10) of this section, when a 
medical determination recommends removal because the employee's exposure 
to MC may contribute to or aggravate the employee's existing cardiac, 
hepatic, neurological (including stroke), or skin disease, the employer 
must provide medical removal protection benefits to the employee and 
either:
    (1) Transfer the employee to comparable work where methylene 
chloride exposure is below the action level; or
    (2) Remove the employee from MC exposure.
    (B) If comparable work is not available and the employer is able to 
demonstrate that removal and the costs of extending MRP benefits to an 
additional employee, considering feasibility in relation to the size of 
the employer's business and the other requirements of this standard, 
make further reliance on MRP an inappropriate remedy, the employer may 
retain the additional employee in the existing job until transfer or 
removal becomes appropriate, provided:
    (1) The employer ensures that the employee receives additional 
medical surveillance, including a physical examination at least every 60 
days until transfer or removal occurs; and
    (2) The employer or PLHCP informs the employee of the risk to the 
employee's health from continued MC exposure.
    (C) The employer shall maintain in effect any job-related protective 
measures or limitations, other than removal, for as long as a medical 
determination recommends them to be necessary.
    (ii) End of MRP benefits and return of the employee to former job 
status.
    (A) The employer may cease providing MRP benefits at the earliest of 
the following:
    (1) Six months;
    (2) Return of the employee to the employee's former job status 
following receipt of a medical determination concluding that the 
employee's exposure to MC no longer will aggravate any cardiac, hepatic, 
neurological (including stroke), or dermal disease;
    (3) Receipt of a medical determination concluding that the employee 
can never return to MC exposure.
    (B) For the purposes of this paragraph (j), the requirement that an 
employer return an employee to the employee's 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.
    (12) Medical removal protection benefits. (i) For purposes of this 
paragraph (j), the term medical removal protection benefits means that, 
for each removal, an employer must maintain for up to

[[Page 488]]

six months the earnings, seniority, and other employment rights and 
benefits of the employee as though the employee had not been removed 
from MC exposure or transferred to a comparable job.
    (ii) During the period of time that an employee is removed from 
exposure to MC, 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.
    (iii) If a removed employee files a workers' compensation claim for 
a MC-related disability, the employer shall continue the MRP benefits 
required by this paragraph until either the claim is resolved or the 6-
month period for payment f MRP benefits has passed, whichever occurs 
first. To the extent the employee is entitled to indemnity payments for 
earnings lost during the period of removal, the employer's obligation to 
provide medical removal protection benefits to the employee shall be 
reduced by the amount of such indemnity payments.
    (iv) 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 from either a publicly or an employer-funded compensation 
program, or receives income from employment with another employer made 
possible by virtue of the employee's removal.
    (13) 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 MC or otherwise places any limitation on an 
employee due to the effects of MC exposure on the employee's medical 
condition, the employer shall provide medical removal protection 
benefits to the employee equal to those required by paragraph (j)(12) of 
this section.
    (14) Multiple health care professional review mechanism. (i) If the 
employer selects the initial physician or licensed health care 
professional (PLHCP) to conduct any medical examination or consultation 
provided to an employee under this paragraph (j)(11), the employer shall 
notify the employee of the right to seek a second medical opinion each 
time the employer provides the employee with a copy of the written 
opinion of that PLHCP.
    (ii) If the employee does not agree with the opinion of the 
employer-selected PLHCP, notifies the employer of that fact, and takes 
steps to make an appointment with a second PLHCP within 15 days of 
receiving a copy of the written opinion of the initial PLHCP, the 
employer shall pay for the PLHCP chosen by the employee to perform at 
least the following:
    (A) Review any findings, determinations or recommendations of the 
initial PLHCP; and
    (B) Conduct such examinations, consultations, and laboratory tests 
as the PLHCP deems necessary to facilitate this review.
    (iii) If the findings, determinations or recommendations of the 
second PLHCP differ from those of the initial PLHCP, then the employer 
and the employee shall instruct the two health care professionals to 
resolve the disagreement.
    (iv) If the two health care professionals are unable to resolve 
their disagreement within 15 days, then those two health care 
professionals shall jointly designate a PLHCP who is a specialist in the 
field at issue. The employer shall pay for the specialist to perform at 
least the following:
    (A) Review the findings, determinations, and recommendations of the 
first two PLHCPs; and
    (B) Conduct such examinations, consultations, laboratory tests and 
discussions with the prior PLHCPs as the specialist deems necessary to 
resolve the disagreements of the prior health care professionals.
    (v) The written opinion of the specialist shall be the definitive 
medical determination. The employer shall act consistent with the 
definitive medical determination, unless the employer and employee agree 
that the written opinion of one of the other two PLHCPs shall be the 
definitive medical determination.
    (vi) The employer and the employee or authorized employee 
representative may agree upon the use of any expeditious alternate 
health care professional

[[Page 489]]

determination mechanism in lieu of the multiple health care professional 
review mechanism provided by this paragraph so long as the alternate 
mechanism otherwise satisfies the requirements contained in this 
paragraph.
    (k) Hazard communication--(1) Hazard communication--general. (i) 
Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for MC.
    (ii) In classifying the hazards of MC at least the following hazards 
are to be addressed: Cancer, cardiac effects (including elevation of 
carboxyhemoglobin), central nervous system effects, liver effects, and 
skin and eye irritation.
    (iii) Employers shall include MC in the hazard communication program 
established to comply with the HCS (Sec.  1910.1200). Employers shall 
ensure that each employee has access to labels on containers of MC and 
to safety data sheets, and is trained in accordance with the 
requirements of HCS and paragraph (l) of this section.
    (2) [Reserved]
    (l) Employee information and training. (1) The employer shall 
provide information and training for each affected employee prior to or 
at the time of initial assignment to a job involving potential exposure 
to MC.
    (2) The employer shall ensure that information and training is 
presented in a manner that is understandable to the employees.
    (3) In addition to the information required under the Hazard 
Communication Standard at 29 CFR 1910.1200, 29 CFR 1915.1200, or 29 CFR 
1926.59, as appropiate:
    (i) The employer shall inform each affected employee of the 
requirements of this section and information available in its 
appendices, as well as how to access or obtain a copy of it in the 
workplace;
    (ii) Wherever an employee's exposure to airborne concentrations of 
MC exceeds or can reasonably be expected to exceed the action level, the 
employer shall inform each affected employee of the quantity, location, 
manner of use, release, and storage of MC and the specific operations in 
the workplace that could result in exposure to MC, particularly noting 
where exposures may be above the 8-hour TWA PEL or STEL;
    (4) The employer shall train each affected employee as required 
under the Hazard Communication standard at 29 CFR 1910.1200, 29 CFR 
1915.1200, or 29 CFR 1926.59, as appropiate.
    (5) The employer shall re-train each affected employee as necessary 
to ensure that each employee exposed above the action level or the STEL 
maintains the requisite understanding of the principles of safe use and 
handling of MC in the workplace.
    (6) Whenever there are workplace changes, such as modifications of 
tasks or procedures or the institution of new tasks or procedures, which 
increase employee exposure, and where those exposures exceed or can 
reasonably be expected to exceed the action level, the employer shall 
update the training as necessary to ensure that each affected employee 
has the requisite proficiency.
    (7) An employer whose employees are exposed to MC at a multi-
employer worksite shall notify the other employers with work operations 
at that site in accordance with the requirements of the Hazard 
Communication Standard, 29 CFR 1910.1200, 29 CFR 1915.1200, or 29 CFR 
1926.59, as appropiate.
    (8) The employer shall provide to the Assistant Secretary or the 
Director, upon request, all available materials relating to employee 
information and training.
    (m) Recordkeeping--(1) Objective data. (i) Where an employer seeks 
to demonstrate that initial monitoring is unnecessary through reasonable 
reliance on objective data showing that any materials in the workplace 
containing MC will not release MC at levels which exceed the action 
level or the STEL under foreseeable conditions of exposure, the employer 
shall establish and maintain an accurate record of the objective data 
relied upon in support of the exemption.
    (ii) This record shall include at least the following information:
    (A) The MC-containing material in question;
    (B) The source of the objective data;

[[Page 490]]

    (C) The testing protocol, results of testing, and/or analysis of the 
material for the release of MC;
    (D) A description of the operation exempted under paragraph 
(d)(2)(i) of this section 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.
    (2) Exposure measurements. (i) The employer shall establish and keep 
an accurate record of all measurements taken to monitor employee 
exposure to MC as prescribed in paragraph (d) of this section.
    (ii) Where the employer has 20 or more employees, this record shall 
include at least the following information:
    (A) The date of measurement for each sample taken;
    (B) The operation involving exposure to MC 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 personal protective equipment, such as respiratory 
protective devices, worn, if any; and
    (F) Name, job classification and exposure of all of the employees 
represented by monitoring, indicating which employees were actually 
monitored.
    (iii) Where the employer has fewer than 20 employees, the record 
shall include at least the following information:
    (A) The date of measurement for each sample taken;
    (B) Number, duration, and results of samples taken; and
    (C) Name, job classification and exposure of all of the employees 
represented by monitoring, indicating which employees were actually 
monitored.
    (iv) The employer shall maintain this record for at least thirty 
(30) years, in accordance with 29 CFR 1910.1020.
    (3) Medical surveillance. (i) The employer shall establish and 
maintain an accurate record for each employee subject to medical 
surveillance under paragraph (j) of this section.
    (ii) The record shall include at least the following information:
    (A) The name and description of the duties of the employee;
    (B) Written medical opinions; and
    (C) Any employee medical conditions related to exposure to MC.
    (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) 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 in 
accordance with 29 CFR 1910.1020.

    Note to paragraph (m)(4)(i): All records required to be maintained 
by this section may be kept in the most administratively convenient form 
(for example, electronic or computer records would satisfy this 
requirement).

    (ii) The employer, upon request, shall make any employee exposure 
and objective data records required by this section available for 
examination and copying by affected employees, former employees, and 
designated representatives in accordance with 29 CFR 1910.1020.
    (iii) The employer, upon request, shall make employee medical 
records required to be kept by this section available for examination 
and copying by the subject employee and by anyone having the specific 
written consent of the subject employee in accordance with 29 CFR 
1910.1020.
    (5) Transfer of records. The employer shall comply with the 
requirements concerning transfer of records set forth in 29 CFR 
1910.1020(h).
    (n) [Reserved]
    (o) Appendices. The information contained in the appendices does 
not, by itself, create any additional obligations not otherwise imposed 
or detract from any existing obligation.

    Note to paragraph (o): The requirement of 29 CFR 1910.1052(g)(1) to 
use respiratory protection whenever an employee's exposure to methylene 
chloride exceeds or can reasonably be expected to exceed the 8-hour TWA

[[Page 491]]

PEL is hereby stayed until August 31, 1998 for employers engaged in 
polyurethane foam manufacturing; foam fabrication; furniture 
refinishing; general aviation aircraft stripping; formulation of 
products containing methylene chloride; boat building and repair; 
recreational vehicle manufacture; van conversion; upholstery; and use of 
methylene chloride in construction work for restoration and preservation 
of buildings, painting and paint removal, cabinet making and/or floor 
refinishing and resurfacing.
    The requirement of 29 CFR 1910.1052(f)(1) to implement engineering 
controls to achieve the 8-hour TWA PEL and STEL is hereby stayed until 
December 10, 1998 for employers with more than 100 employees engaged in 
polyurethane foam manufacturing and for employers with more than 20 
employees engaged in foam fabrication; furniture refinishing; general 
aviation aircraft stripping; formulation of products containing 
methylene chloride; boat building and repair; recreational vehicle 
manufacture; van conversion; upholstery; and use of methylene chloride 
in construction work for restoration and preservation of buildings, 
painting and paint removal, cabinet making and/or floor refinishing and 
resurfacing.

    Appendix A to Section 1910.1052--Substance Safety Data Sheet and 
               Technical Guidelines for Methylene Chloride

                       I. Substance Identification

    A. Substance: Methylene chloride (CH2 Cl2).
    B. Synonyms: MC, Dichloromethane (DCM); Methylene dichloride; 
Methylene bichloride; Methane dichloride; CAS: 75-09-2; NCI-C50102.
    C. Physical data:
    1. Molecular weight: 84.9.
    2. Boiling point (760 mm Hg): 39.8 [deg]C (104 [deg]F).
    3. Specific gravity (water = 1): 1.3.
    4. Vapor density (air = 1 at boiling point): 2.9.
    5. Vapor pressure at 20 [deg]C (68 [deg]F): 350 mm Hg.
    6. Solubility in water, g/100 g water at 20 [deg]C (68 [deg]F) = 
1.32.
    7. Appearance and odor: colorless liquid with a chloroform-like 
odor.
    D. Uses:
    MC is used as a solvent, especially where high volatility is 
required. It is a good solvent for oils, fats, waxes, resins, bitumen, 
rubber and cellulose acetate and is a useful paint stripper and 
degreaser. It is used in paint removers, in propellant mixtures for 
aerosol containers, as a solvent for plastics, as a degreasing agent, as 
an extracting agent in the pharmaceutical industry and as a blowing 
agent in polyurethane foams. Its solvent property is sometimes increased 
by mixing with methanol, petroleum naphtha or tetrachloroethylene.
    E. Appearance and odor:
    MC is a clear colorless liquid with a chloroform-like odor. It is 
slightly soluble in water and completely miscible with most organic 
solvents.
    F. Permissible exposure:
    Exposure may not exceed 25 parts MC per million parts of air (25 
ppm) as an eight-hour time-weighted average (8-hour TWA PEL) or 125 
parts of MC per million parts of air (125 ppm) averaged over a 15-minute 
period (STEL).

                         II. Health Hazard Data

    A. MC can affect the body if it is inhaled or if the liquid comes in 
contact with the eyes or skin. It can also affect the body if it is 
swallowed.
    B. Effects of overexposure:
    1. Short-term Exposure:
    MC is an anesthetic. Inhaling the vapor may cause mental confusion, 
light-headedness, nausea, vomiting, and headache. Continued exposure may 
cause increased light-headedness, staggering, unconsciousness, and even 
death. High vapor concentrations may also cause irritation of the eyes 
and respiratory tract. Exposure to MC may make the symptoms of angina 
(chest pains) worse. Skin exposure to liquid MC may cause irritation. If 
liquid MC remains on the skin, it may cause skin burns. Splashes of the 
liquid into the eyes may cause irritation.
    2. Long-term (chronic) exposure:
    The best evidence that MC causes cancer is from laboratory studies 
in which rats, mice and hamsters inhaled MC 6 hours per day, 5 days per 
week for 2 years. MC exposure produced lung and liver tumors in mice and 
mammary tumors in rats. No carcinogenic effects of MC were found in 
hamsters.
    There are also some human epidemiological studies which show an 
association between occupational exposure to MC and increases in biliary 
(bile duct) cancer and a type of brain cancer. Other epidemiological 
studies have not observed a relationship between MC exposure and cancer. 
OSHA interprets these results to mean that there is suggestive (but not 
absolute) evidence that MC is a human carcinogen.
    C. Reporting signs and symptoms:
    You should inform your employer if you develop any signs or symptoms 
and suspect that they are caused by exposure to MC.
    D. Warning Properties:
    1. Odor Threshold:
    Different authors have reported varying odor thresholds for MC. 
Kirk-Othmer and Sax both reported 25 to 50 ppm; Summer and May both 
reported 150 ppm; Spector reports 320 ppm. Patty, however, states that 
since one can become adapted to the odor, MC should not be considered to 
have adequate warning properties.

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    2. Eye Irritation Level:
    Kirk-Othmer reports that ``MC vapor is seriously damaging to the 
eyes.'' Sax agrees with Kirk-Othmer's statement. The ACGIH Documentation 
of TLVs states that irritation of the eyes has been observed in workers 
exposed to concentrations up to 5000 ppm.
    3. Evaluation of Warning Properties:
    Since a wide range of MC odor thresholds are reported (25-320 ppm), 
and human adaptation to the odor occurs, MC is considered to be a 
material with poor warning properties.

                   III. Emergency First Aid Procedures

    In the event of emergency, institute first aid procedures and send 
for first aid or medical assistance.
    A. Eye and Skin Exposures:
    If there is a potential for liquid MC to come in contact with eye or 
skin, face shields and skin protective equipment must be provided and 
used. If liquid MC comes in contact with the eye, get medical attention. 
Contact lenses should not be worn when working with this chemical.
    B. Breathing:
    If a person breathes in large amounts of MC, move the exposed person 
to fresh air at once. If breathing has stopped, perform cardiopulmorary 
resuscitation. Keep the affected person warm and at rest. Get medical 
attention as soon as possible.
    C. Rescue:
    Move the affected person from the hazardous exposure immediately. If 
the exposed person has been overcome, notify someone else and put into 
effect the established emergency rescue procedures. Understand the 
facility's emergency rescue procedures and know the locations of rescue 
equipment before the need arises. Do not become a casualty yourself.

        IV. Respirators, Protective Clothing, and Eye Protection

    A. Respirators:
    Good industrial hygiene practices recommend that engineering 
controls be used to reduce environmental concentrations to the 
permissible exposure level. However, there are some exceptions where 
respirators may be used to control exposure. Respirators may be used 
when engineering and work practice controls are not feasible, when such 
controls are in the process of being installed, or when these controls 
fail and need to be supplemented. Respirators may also be used for 
operations which require entry into tanks or closed vessels, and in 
emergency situations.
    If the use of respirators is necessary, the only respirators 
permitted are those that have been approved by the Mine Safety and 
Health Administration (MSHA) or the National Institute for Occupational 
Safety and Health (NIOSH). Supplied-air respirators are required because 
air-purifying respirators do not provide adequate respiratory protection 
against MC.
    In addition to respirator selection, a complete written respiratory 
protection program should be instituted which includes regular training, 
maintenance, inspection, cleaning, and evaluation. If you can smell MC 
while wearing a respirator, proceed immediately to fresh air. If you 
experience difficulty in breathing while wearing a respirator, tell your 
employer.
    B. Protective Clothing:
    Employees must be provided with and required to use impervious 
clothing, gloves, face shields (eight-inch minimum), and other 
appropriate protective clothing necessary to prevent repeated or 
prolonged skin contact with liquid MC or contact with vessels containing 
liquid MC. Any clothing which becomes wet with liquid MC should be 
removed immediately and not reworn until the employer has ensured that 
the protective clothing is fit for reuse. Contaminated protective 
clothing should be placed in a regulated area designated by the employer 
for removal of MC before the clothing is laundered or disposed of. 
Clothing and equipment should remain in the regulated area until all of 
the MC contamination has evaporated; clothing and equipment should then 
be laundered or disposed of as appropriate.
    C. Eye Protection:
    Employees should be provided with and required to use splash-proof 
safety goggles where liquid MC may contact the eyes.

                 V. Housekeeping and Hygiene Facilities

    For purposes of complying with 29 CFR 1910.141, the following items 
should be emphasized:
    A. The workplace should be kept clean, orderly, and in a sanitary 
condition. The employer should institute a leak and spill detection 
program for operations involving liquid MC in order to detect sources of 
fugitive MC emissions.
    B. Emergency drench showers and eyewash facilities are recommended. 
These should be maintained in a sanitary condition. Suitable cleansing 
agents should also be provided to assure the effective removal of MC 
from the skin.
    C. Because of the hazardous nature of MC, contaminated protective 
clothing should be placed in a regulated area designated by the employer 
for removal of MC before the clothing is laundered or disposed of.

           VI. Precautions for Safe Use, Handling, and Storage

    A. Fire and Explosion Hazards:
    MC has no flash point in a conventional closed tester, but it forms 
flammable vapor-air mixtures at approximately 100 [deg]C (212 [deg]F), 
or higher. It has a lower explosion limit of 12%, and an upper explosion 
limit of 19% in

[[Page 493]]

air. It has an autoignition temperature of 556.1 [deg]C (1033 [deg]F), 
and a boiling point of 39.8 [deg]C (104 [deg]F). It is heavier than 
water with a specific gravity of 1.3. It is slightly soluble in water.
    B. Reactivity Hazards:
    Conditions contributing to the instability of MC are heat and 
moisture. Contact with strong oxidizers, caustics, and chemically active 
metals such as aluminum or magnesium powder, sodium and potassium may 
cause fires and explosions.
    Special precautions: Liquid MC will attack some forms of plastics, 
rubber, and coatings.
    C. Toxicity:
    Liquid MC is painful and irritating if splashed in the eyes or if 
confined on the skin by gloves, clothing, or shoes. Vapors in high 
concentrations may cause narcosis and death. Prolonged exposure to 
vapors may cause cancer or exacerbate cardiac disease.
    D. Storage:
    Protect against physical damage. Because of its corrosive 
properties, and its high vapor pressure, MC should be stored in plain, 
galvanized or lead lined, mild steel containers in a cool, dry, well 
ventilated area away from direct sunlight, heat source and acute fire 
hazards.
    E. Piping Material:
    All piping and valves at the loading or unloading station should be 
of material that is resistant to MC and should be carefully inspected 
prior to connection to the transport vehicle and periodically during the 
operation.
    F. Usual Shipping Containers:
    Glass bottles, 5- and 55-gallon steel drums, tank cars, and tank 
trucks.

    Note: This section addresses MC exposure in marine terminal and 
longshore employment only where leaking or broken packages allow MC 
exposure that is not addressed through compliance with 29 CFR parts 1917 
and 1918, respectively.

    G. Electrical Equipment:
    Electrical installations in Class I hazardous locations as defined 
in Article 500 of the National Electrical Code, should be installed 
according to Article 501 of the code; and electrical equipment should be 
suitable for use in atmospheres containing MC vapors. See Flammable and 
Combustible Liquids Code (NFPA No. 325M), Chemical Safety Data Sheet SD-
86 (Manufacturing Chemists' Association, Inc.).
    H. Fire Fighting:
    When involved in fire, MC emits highly toxic and irritating fumes 
such as phosgene, hydrogen chloride and carbon monoxide. Wear breathing 
apparatus and use water spray to keep fire-exposed containers cool. 
Water spray may be used to flush spills away from exposures. 
Extinguishing media are dry chemical, carbon dioxide, foam. For purposes 
of compliance with 29 CFR 1910.307, locations classified as hazardous 
due to the presence of MC shall be Class I.
    I. Spills and Leaks:
    Persons not wearing protective equipment and clothing should be 
restricted from areas of spills or leaks until cleanup has been 
completed. If MC has spilled or leaked, the following steps should be 
taken:
    1. Remove all ignition sources.
    2. Ventilate area of spill or leak.
    3. Collect for reclamation or absorb in vermiculite, dry sand, 
earth, or a similar material.
    J. Methods of Waste Disposal:
    Small spills should be absorbed onto sand and taken to a safe area 
for atmospheric evaporation. Incineration is the preferred method for 
disposal of large quantities by mixing with a combustible solvent and 
spraying into an incinerator equipped with acid scrubbers to remove 
hydrogen chloride gases formed. Complete combustion will convert carbon 
monoxide to carbon dioxide. Care should be taken for the presence of 
phosgene.
    K. You should not keep food, beverage, or smoking materials, or eat 
or smoke in regulated areas where MC concentrations are above the 
permissible exposure limits.
    L. Portable heating units should not be used in confined areas where 
MC is used.
    M. Ask your supervisor where MC is used in your work area and for 
any additional plant safety and health rules.

                        VII. Medical Requirements

    Your employer is required to offer you the opportunity to 
participate in a medical surveillance program if you are exposed to MC 
at concentrations at or above the action level (12.5 ppm 8-hour TWA) for 
more than 30 days a year or at concentrations exceeding the PELs (25 ppm 
8-hour TWA or 125 ppm 15-minute STEL) for more than 10 days a year. If 
you are exposed to MC at concentrations over either of the PELs, your 
employer will also be required to have a physician or other licensed 
health care professional ensure that you are able to wear the respirator 
that you are assigned. Your employer must provide all medical 
examinations relating to your MC exposure at a reasonable time and place 
and at no cost to you.

               VIII. Monitoring and Measurement Procedures

    A. Exposure above the Permissible Exposure Limit:
    1. Eight-hour exposure evaluation: Measurements taken for the 
purpose of determining employee exposure under this section are best 
taken with consecutive samples covering the full shift. Air samples must 
be taken in the employee's breathing zone.

[[Page 494]]

    2. Monitoring techniques: The sampling and analysis under this 
section may be performed by collection of the MC vapor on two charcoal 
adsorption tubes in series or other composition adsorption tubes, with 
subsequent chemical analysis. Sampling and analysis may also be 
performed by instruments such as real-time continuous monitoring 
systems, portable direct reading instruments, or passive dosimeters as 
long as measurements taken using these methods accurately evaluate the 
concentration of MC in employees'' breathing zones.
    OSHA method 80 is an example of a validated method of sampling and 
analysis of MC. Copies of this method are available from OSHA or can be 
downloaded from the Internet at http://www.osha.gov. The employer has 
the obligation of selecting a monitoring method which meets the accuracy 
and precision requirements of the standard under his or her unique field 
conditions. The standard requires that the method of monitoring must be 
accurate, to a 95 percent confidence level, to plus or minus 25 percent 
for concentrations of MC at or above 25 ppm, and to plus or minus 35 
percent for concentrations at or below 25 ppm. In addition to OSHA 
method 80, there are numerous other methods available for monitoring for 
MC in the workplace.
    B. Since many of the duties relating to employee exposure are 
dependent on the results of measurement procedures, employers must 
assure that the evaluation of employee exposure is performed by a 
technically qualified person.

                      IX. Observation of Monitoring

    Your employer is required to perform measurements that are 
representative of your exposure to MC 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, protective clothing and equipment.

                        X. Access to Information

    A. Your employer is required to inform you of the information 
contained in this Appendix. In addition, your employer must instruct you 
in the proper work practices for using MC, emergency procedures, and the 
correct use of protective equipment.
    B. Your employer is required to determine whether you are being 
exposed to MC. You or your representative has the right to observe 
employee measurements and to record the results obtained. Your employer 
is required to inform you of your exposure. If your employer determines 
that you are being over exposed, he or she is required to inform you of 
the actions which are being taken to reduce your exposure to within 
permissible exposure limits.
    C. Your employer is required to keep records of your exposures and 
medical examinations. These records must be kept by the employer for at 
least thirty (30) years.
    D. Your employer is required to release your exposure and medical 
records to you or your representative upon your request.
    E. Your employer is required to provide labels and safety data 
sheets (SDSs) for all materials, mixtures or solutions composed of 
greater than 0.1 percent MC. These materials, mixtures or solutions 
would be classified and labeled in accordance with Sec.  1910.1200.

       Danger Contains Methylene Chloride Potential Cancer Hazard

    May worsen heart disease because methylene chloride is converted to 
carbon monoxide in the body.
    May cause dizziness, headache, irritation of the throat and lungs, 
loss of consciousness and death at high concentrations (for example, if 
used in a poorly ventilated room).
    Avoid Skin Contact. Contact with liquid causes skin and eye 
irritation.

                   XI. Common Operations and Controls

    The following list includes some common operations in which exposure 
to MC may occur and control methods which may be effective in each case:

------------------------------------------------------------------------
                Operations                            Controls
------------------------------------------------------------------------
Use as solvent in paint and varnish         General dilution
 removers; manufacture of aerosols; cold     ventilation; local exhaust
 cleaning and ultrasonic cleaning; and as    ventilation; personal
 a solvent in furniture stripping.           protective equipment;
                                             substitution.
Use as solvent in vapor degreasing........  Process enclosure; local
                                             exhaust ventilation;
                                             chilling coils;
                                             substitution.
Use as a secondary refrigerant in air       General dilution
 conditioning and scientific testing.        ventilation; local exhaust
                                             ventilation; personal
                                             protective equipment.
------------------------------------------------------------------------

  Appendix B to Section 1910.1052--Medical Surveillance for Methylene 
                                Chloride

                        I. Primary Route of Entry

    Inhalation.

                             II. Toxicology

    Methylene Chloride (MC) is primarily an inhalation hazard. The 
principal acute hazardous effects are the depressant action on the 
central nervous system, possible cardiac toxicity and possible liver 
toxicity. The range of CNS effects are from decreased eye/

[[Page 495]]

hand coordination and decreased performance in vigilance tasks to 
narcosis and even death of individuals exposed at very high doses. 
Cardiac toxicity is due to the metabolism of MC to carbon monoxide, and 
the effects of carbon monoxide on heart tissue. Carbon monoxide 
displaces oxygen in the blood, decreases the oxygen available to heart 
tissue, increasing the risk of damage to the heart, which may result in 
heart attacks in susceptible individuals. Susceptible individuals 
include persons with heart disease and those with risk factors for heart 
disease.
    Elevated liver enzymes and irritation to the respiratory passages 
and eyes have also been reported for both humans and experimental 
animals exposed to MC vapors.
    MC is metabolized to carbon monoxide and carbon dioxide via two 
separate pathways. Through the first pathway, MC is metabolized to 
carbon monoxide as an end-product via the P-450 mixed function oxidase 
pathway located in the microsomal fraction of the cell. This 
biotransformation of MC to carbon monoxide occurs through the process of 
microsomal oxidative dechlorination which takes place primarily in the 
liver. The amount of conversion to carbon monoxide is significant as 
measured by the concentration of carboxyhemoglobin, up to 12% measured 
in the blood following occupational exposure of up to 610 ppm. Through 
the second pathway, MC is metabolized to carbon dioxide as an end 
product (with formaldehyde and formic acid as metabolic intermediates) 
via the glutathione dependent enzyme found in the cytosolic fraction of 
the liver cell. Metabolites along this pathway are believed to be 
associated with the carcinogenic activity of MC.
    MC has been tested for carcinogenicity in several laboratory 
rodents. These rodent studies indicate that there is clear evidence that 
MC is carcinogenic to male and female mice and female rats. Based on 
epidemiologic studies, OSHA has concluded that there is suggestive 
evidence of increased cancer risk in MC-related worker populations. The 
epidemiological evidence is consistent with the finding of excess cancer 
in the experimental animal studies. NIOSH regards MC as a potential 
occupational carcinogen and the International Agency for Research Cancer 
(IARC) classifies MC as an animal carcinogen. OSHA considers MC as a 
suspected human carcinogen.

            III. Medical Signs and Symptoms of Acute Exposure

    Skin exposure to liquid MC may cause irritation or skin burns. 
Liquid MC can also be irritating to the eyes. MC is also absorbed 
through the skin and may contribute to the MC exposure by inhalation.
    At high concentrations in air, MC may cause nausea, vomiting, light-
headedness, numbness of the extremities, changes in blood enzyme levels, 
and breathing problems, leading to bronchitis and pulmonary edema, 
unconsciousness and even death.
    At lower concentrations in air, MC may cause irritation to the skin, 
eye, and respiratory tract and occasionally headache and nausea. Perhaps 
the greatest problem from exposure to low concentrations of MC is the 
CNS effects on coordination and alertness that may cause unsafe 
operations of machinery and equipment, leading to self-injury or 
accidents.
    Low levels and short duration exposures do not seem to produce 
permanent disability, but chronic exposures to MC have been demonstrated 
to produce liver toxicity in animals, and therefore, the evidence is 
suggestive for liver toxicity in humans after chronic exposure.
    Chronic exposure to MC may also cause cancer.

             IV. Surveillance and Preventive Considerations

    As discussed in sections II and III of this appendix, MC is 
classified as a suspect or potential human carcinogen. It is a central 
nervous system (CNS) depressant and a skin, eye and respiratory tract 
irritant. At extremely high concentrations, MC has caused liver damage 
in animals. MC principally affects the CNS, where it acts as a narcotic. 
The observation of the symptoms characteristic of CNS depression, along 
with a physical examination, provides the best detection of early 
neurological disorders. Since exposure to MC also increases the 
carboxyhemoglobin level in the blood, ambient carbon monoxide levels 
would have an additive effect on that carboxyhemoglobin level. Based on 
such information, a periodic post-shift carboxyhemoglobin test as an 
index of the presence of carbon monoxide in the blood is recommended, 
but not required, for medical surveillance.
    Based on the animal evidence and three epidemiologic studies 
previously mentioned, OSHA concludes that MC is a suspect human 
carcinogen. The medical surveillance program is designed to observe 
exposed workers on a regular basis. While the medical surveillance 
program cannot detect MC-induced cancer at a preneoplastic stage, OSHA 
anticipates that, as in the past, early detection and treatments of 
cancers leading to enhanced survival rates will continue to evolve.

                   A. Medical and Occupational History

    The medical and occupational work history plays an important role in 
the initial evaluation of workers exposed to MC. It is therefore 
extremely important for the examining physician or other licensed health 
care professional to evaluate the MC-exposed

[[Page 496]]

worker carefully and completely and to focus the examination on MC's 
potentially associated health hazards. The medical evaluation must 
include an annual detailed work and medical history with special 
emphasis on cardiac history and neurological symptoms.
    An important goal of the medical history is to elicit information 
from the worker regarding potential signs or symptoms associated with 
increased levels of carboxyhemoglobin due to the presence of carbon 
monoxide in the blood. Physicians or other licensed health care 
professionals should ensure that the smoking history of all MC exposed 
employees is known. Exposure to MC may cause a significant increase in 
carboxyhemoglobin level in all exposed persons. However, smokers as well 
as workers with anemia or heart disease and those concurrently exposed 
to carbon monoxide are at especially high risk of toxic effects because 
of an already reduced oxygen carrying capacity of the blood.
    A comprehensive or interim medical and work history should also 
include occurrence of headache, dizziness, fatigue, chest pain, 
shortness of breath, pain in the limbs, and irritation of the skin and 
eyes.
    In addition, it is important for the physician or other licensed 
health care professional to become familiar with the operating 
conditions in which exposure to MC is likely to occur. The physician or 
other licensed health care professional also must become familiar with 
the signs and symptoms that may indicate that a worker is receiving 
otherwise unrecognized and exceptionally high exposure levels of MC.
    An example of a medical and work history that would satisfy the 
requirement for a comprehensive or interim work history is represented 
by the following:
    The following is a list of recommended questions and issues for the 
self-administered questionnaire for methylene chloride exposure.

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   Appendix C to Section 1910.1052--Questions and Answers--Methylene 
                 Chloride Control in Furniture Stripping
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[62 FR 1601, Jan. 10, 1997, as amended at 62 FR 42667, Aug. 8, 1997; 62 
FR 54383, Oct. 20, 1997; 62 FR 66277, Dec. 18, 1997; 63 FR 1295, Jan. 8, 
1998; 63 FR 20099, Apr. 23, 1998; 63 FR 50729, Sept. 22, 1998; 71 FR 
16674, Apr. 3, 2006; 71 FR 50190, Aug. 24, 2006; 73 FR 75587, Dec. 12, 
2008; 77 FR 17785, Mar. 26, 2012; 78 FR 9313, Feb. 8, 2013; 84 FR 21555, 
May 14, 2019]

[[Page 514]]



Sec.  1910.1053  Respirable crystalline silica.

    (a) Scope and application. (1) This section applies to all 
occupational exposures to respirable crystalline silica, except:
    (i) Construction work as defined in 29 CFR 1910.12(b) (occupational 
exposures to respirable crystalline silica in construction work are 
covered under 29 CFR 1926.1153);
    (ii) Agricultural operations covered under 29 CFR part 1928; and
    (iii) Exposures that result from the processing of sorptive clays.
    (2) This section does not apply where the employer has objective 
data demonstrating that employee exposure to respirable crystalline 
silica will remain below 25 micrograms per cubic meter of air (25 
[micro]g/m\3\) as an 8-hour time-weighted average (TWA) under any 
foreseeable conditions.
    (3) This section does not apply if the employer complies with 29 CFR 
1926.1153 and:
    (i) The task performed is indistinguishable from a construction task 
listed on Table 1 in paragraph (c) of 29 CFR 1926.1153; and
    (ii) The task will not be performed regularly in the same 
environment and conditions.
    (b) Definitions. For the purposes of this section the following 
definitions apply:
    Action level means a concentration of airborne respirable 
crystalline silica of 25 [micro]g/m\3\, calculated as an 8-hour TWA.
    Assistant Secretary means the Assistant Secretary of Labor for 
Occupational Safety and Health, U.S. Department of Labor, or designee.
    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 means the exposure to airborne respirable 
crystalline silica 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.
    Objective data means information, such as air monitoring data from 
industry-wide surveys or calculations based on the composition of a 
substance, demonstrating employee exposure to respirable crystalline 
silica associated with a particular product or material or a specific 
process, task, or activity. The data must reflect workplace conditions 
closely resembling or with a higher exposure potential than 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] means 
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 (i) of this 
section.
    Regulated area means an area, demarcated by the employer, where an 
employee's exposure to airborne concentrations of respirable crystalline 
silica exceeds, or can reasonably be expected to exceed, the PEL.
    Respirable crystalline silica means quartz, cristobalite, and/or 
tridymite contained in airborne particles that are determined to be 
respirable by a sampling device designed to meet the characteristics for 
respirable-particle-size-selective samplers specified in the 
International Organization for Standardization (ISO) 7708:1995: Air 
Quality--Particle Size Fraction Definitions for Health-Related Sampling.
    Specialist means an American Board Certified Specialist in Pulmonary 
Disease or an American Board Certified Specialist in Occupational 
Medicine.
    This section means this respirable crystalline silica standard, 29 
CFR 1910.1053.
    (c) Permissible exposure limit (PEL). The employer shall ensure that 
no employee is exposed to an airborne concentration of respirable 
crystalline silica in excess of 50 [micro]g/m\3\, calculated as an 8-
hour TWA.
    (d) Exposure assessment--(1) General. The employer shall assess the 
exposure of each employee who is or may reasonably be expected to be 
exposed to respirable crystalline silica at or above

[[Page 515]]

the action level in accordance with either the performance option in 
paragraph (d)(2) or the scheduled monitoring option in paragraph (d)(3) 
of this section.
    (2) Performance option. The employer shall assess the 8-hour TWA 
exposure for each employee on the basis of any combination of air 
monitoring data or objective data sufficient to accurately characterize 
employee exposures to respirable crystalline silica.
    (3) Scheduled monitoring option. (i) The employer shall perform 
initial monitoring to assess the 8-hour TWA exposure for each employee 
on the basis of one or more personal breathing zone air samples that 
reflect the exposures of employees on each shift, for each job 
classification, in each work area. Where several employees perform the 
same tasks on the same shift and in the same work area, the employer may 
sample a representative fraction of these employees in order to meet 
this requirement. In representative sampling, the employer shall sample 
the employee(s) who are expected to have the highest exposure to 
respirable crystalline silica.
    (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) Where the most recent exposure monitoring indicates that 
employee exposures are at or above the action level but at or below the 
PEL, the employer shall repeat such monitoring within six months of the 
most recent monitoring.
    (iv) Where the most recent exposure monitoring indicates that 
employee exposures are above the PEL, the employer shall repeat such 
monitoring within three months of the most recent monitoring.
    (v) Where the most recent (non-initial) exposure monitoring 
indicates that employee exposures are below the action level, the 
employer shall repeat such monitoring within six months of the most 
recent monitoring until two consecutive measurements, taken 7 or more 
days apart, are below the action level, at which time the employer may 
discontinue monitoring for those employees whose exposures are 
represented by such monitoring, except as otherwise provided in 
paragraph (d)(4) of this section.
    (4) Reassessment of exposures. The employer shall reassess exposures 
whenever a change in the production, process, control equipment, 
personnel, or work practices may reasonably be expected to result in new 
or additional exposures at or above the action level, or when the 
employer has any reason to believe that new or additional exposures at 
or above the action level have occurred.
    (5) Methods of sample analysis. The employer shall ensure that all 
samples taken to satisfy the monitoring requirements of paragraph (d) of 
this section are evaluated by a laboratory that analyzes air samples for 
respirable crystalline silica in accordance with the procedures in 
Appendix A to this section.
    (6) Employee notification of assessment results. (i) Within 15 
working days after completing an exposure assessment in accordance with 
paragraph (d) of this section, the employer shall individually notify 
each affected employee in writing of the results of that assessment or 
post the results in an appropriate location accessible to all affected 
employees.
    (ii) Whenever an exposure assessment 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.
    (7) 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 respirable 
crystalline silica.
    (ii) When observation of monitoring requires entry into an area 
where the use of protective clothing or equipment is required for any 
workplace hazard, the employer shall provide the observer with 
protective clothing and equipment at no cost and shall ensure that the 
observer uses such clothing and equipment.

[[Page 516]]

    (e) Regulated areas--(1) Establishment. The employer shall establish 
a regulated area wherever an employee's exposure to airborne 
concentrations of respirable crystalline silica is, or can reasonably be 
expected to be, in excess of the PEL.
    (2) Demarcation. (i) The employer shall demarcate regulated areas 
from the rest of the workplace in a manner that minimizes the number of 
employees exposed to respirable crystalline silica within the regulated 
area.
    (ii) The employer shall post signs at all entrances to regulated 
areas that bear the legend specified in paragraph (j)(2) of this 
section.
    (3) Access. The employer shall limit access to regulated areas to:
    (A) Persons authorized by the employer and required by work duties 
to be present in the regulated area;
    (B) 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; and
    (C) Any person authorized by the Occupational Safety and Health Act 
or regulations issued under it to be in a regulated area.
    (4) Provision of respirators. The employer shall provide each 
employee and the employee's designated representative entering a 
regulated area with an appropriate respirator in accordance with 
paragraph (g) of this section and shall require each employee and the 
employee's designated representative to use the respirator while in a 
regulated area.
    (f) Methods of compliance--(1) Engineering and work practice 
controls. The employer shall use engineering and work practice controls 
to reduce and maintain employee exposure to respirable crystalline 
silica to or below the PEL, unless the employer can demonstrate that 
such controls are not feasible. Wherever such feasible engineering and 
work practice controls are not sufficient to reduce employee exposure to 
or below the PEL, the employer shall nonetheless use them to reduce 
employee exposure to the lowest feasible level and shall supplement them 
with the use of respiratory protection that complies with the 
requirements of paragraph (g) of this section.
    (2) Written exposure control plan. (i) The employer shall establish 
and implement a written exposure control plan that contains at least the 
following elements:
    (A) A description of the tasks in the workplace that involve 
exposure to respirable crystalline silica;
    (B) A description of the engineering controls, work practices, and 
respiratory protection used to limit employee exposure to respirable 
crystalline silica for each task; and
    (C) A description of the housekeeping measures used to limit 
employee exposure to respirable crystalline silica.
    (ii) The employer shall review and evaluate the effectiveness of the 
written exposure control plan at least annually and update it as 
necessary.
    (iii) The employer shall make the written exposure control plan 
readily available for examination and copying, upon request, to each 
employee covered by this section, their designated representatives, the 
Assistant Secretary and the Director.
    (3) Abrasive blasting. In addition to the requirements of paragraph 
(f)(1) of this section, the employer shall comply with other OSHA 
standards, when applicable, such as 29 CFR 1910.94 (Ventilation), 29 CFR 
1915.34 (Mechanical paint removers), and 29 CFR 1915 Subpart I (Personal 
Protective Equipment), where abrasive blasting is conducted using 
crystalline silica-containing blasting agents, or where abrasive 
blasting is conducted on substrates that contain crystalline silica.
    (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 and 29 CFR 1910.134. Respiratory protection is 
required:
    (i) Where exposures exceed the PEL during periods necessary to 
install or implement feasible engineering and work practice controls;
    (ii) Where exposures exceed the PEL during tasks, such as certain 
maintenance and repair tasks, for which engineering and work practice 
controls are not feasible;

[[Page 517]]

    (iii) During tasks 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; and
    (iv) During periods when the employee is in a regulated area.
    (2) Respiratory protection program. Where respirator use is required 
by this section, the employer shall institute a respiratory protection 
program in accordance with 29 CFR 1910.134.
    (h) Housekeeping. (1) The employer shall not allow dry sweeping or 
dry brushing where such activity could contribute to employee exposure 
to respirable crystalline silica unless wet sweeping, HEPA-filtered 
vacuuming or other methods that minimize the likelihood of exposure are 
not feasible.
    (2) The employer shall not allow compressed air to be used to clean 
clothing or surfaces where such activity could contribute to employee 
exposure to respirable crystalline silica unless:
    (i) The compressed air is used in conjunction with a ventilation 
system that effectively captures the dust cloud created by the 
compressed air; or
    (ii) No alternative method is feasible.
    (i) 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 each employee who will be occupationally 
exposed to respirable crystalline silica at or above the action level 
for 30 or more days per year.
    (ii) The employer shall ensure that all medical examinations and 
procedures required by this section are performed by a PLHCP as defined 
in paragraph (b) of this section.
    (2) Initial examination. The employer shall make available an 
initial (baseline) medical examination within 30 days after initial 
assignment, unless the employee has received a medical examination that 
meets the requirements of this section within the last three years. The 
examination shall consist of:
    (i) A medical and work history, with emphasis on: Past, present, and 
anticipated exposure to respirable crystalline silica, dust, and other 
agents affecting the respiratory system; any history of respiratory 
system dysfunction, including signs and symptoms of respiratory disease 
(e.g., shortness of breath, cough, wheezing); history of tuberculosis; 
and smoking status and history;
    (ii) A physical examination with special emphasis on the respiratory 
system;
    (iii) A chest X-ray (a single posteroanterior radiographic 
projection or radiograph of the chest at full inspiration recorded on 
either film (no less than 14 x 17 inches and no more than 16 x 17 
inches) or digital radiography systems), interpreted and classified 
according to the International Labour Office (ILO) International 
Classification of Radiographs of Pneumoconioses by a NIOSH-certified B 
Reader;
    (iv) A pulmonary function test to include forced vital capacity 
(FVC) and forced expiratory volume in one second (FEV1) and 
FEV1/FVC ratio, administered by a spirometry technician with 
a current certificate from a NIOSH-approved spirometry course;
    (v) Testing for latent tuberculosis infection; and
    (vi) Any other tests deemed appropriate by the PLHCP.
    (3) Periodic examinations. The employer shall make available medical 
examinations that include the procedures described in paragraph (i)(2) 
of this section (except paragraph (i)(2)(v)) at least every three years, 
or more frequently if recommended by the 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 PLHCP with the following information:
    (i) A description of the employee's former, current, and anticipated 
duties as they relate to the employee's occupational exposure to 
respirable crystalline silica;
    (ii) The employee's former, current, and anticipated levels of 
occupational exposure to respirable crystalline silica;
    (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 or will use that equipment; and

[[Page 518]]

    (iv) Information from records of employment-related medical 
examinations previously provided to the employee and currently within 
the control of the employer.
    (5) PLHCP's written medical report for the employee. The employer 
shall ensure that the PLHCP explains to the employee the results of the 
medical examination and provides each employee with a written medical 
report within 30 days of each medical examination performed. The written 
report shall contain:
    (i) A statement indicating the results of the medical examination, 
including any medical condition(s) that would place the employee at 
increased risk of material impairment to health from exposure to 
respirable crystalline silica and any medical conditions that require 
further evaluation or treatment;
    (ii) Any recommended limitations on the employee's use of 
respirators;
    (iii) Any recommended limitations on the employee's exposure to 
respirable crystalline silica; and
    (iv) A statement that the employee should be examined by a 
specialist (pursuant to paragraph (i)(7) of this section) if the chest 
X-ray provided in accordance with this section is classified as 1/0 or 
higher by the B Reader, or if referral to a specialist is otherwise 
deemed appropriate by the PLHCP.
    (6) PLHCP's written medical opinion for the employer. (i) The 
employer shall obtain a written medical opinion from the PLHCP within 30 
days of the medical examination. The written opinion shall contain only 
the following:
    (A) The date of the examination;
    (B) A statement that the examination has met the requirements of 
this section; and
    (C) Any recommended limitations on the employee's use of 
respirators.
    (ii) If the employee provides written authorization, the written 
opinion shall also contain either or both of the following:
    (A) Any recommended limitations on the employee's exposure to 
respirable crystalline silica;
    (B) A statement that the employee should be examined by a specialist 
(pursuant to paragraph (i)(7) of this section) if the chest X-ray 
provided in accordance with this section is classified as 1/0 or higher 
by the B Reader, or if referral to a specialist is otherwise deemed 
appropriate by the PLHCP.
    (iii) The employer shall ensure that each employee receives a copy 
of the written medical opinion described in paragraph (i)(6)(i) and (ii) 
of this section within 30 days of each medical examination performed.
    (7) Additional examinations. (i) If the PLHCP's written medical 
opinion indicates that an employee should be examined by a specialist, 
the employer shall make available a medical examination by a specialist 
within 30 days after receiving the PLHCP's written opinion.
    (ii) The employer shall ensure that the examining specialist is 
provided with all of the information that the employer is obligated to 
provide to the PLHCP in accordance with paragraph (i)(4) of this 
section.
    (iii) The employer shall ensure that the specialist explains to the 
employee the results of the medical examination and provides each 
employee with a written medical report within 30 days of the 
examination. The written report shall meet the requirements of paragraph 
(i)(5) (except paragraph (i)(5)(iv)) of this section.
    (iv) The employer shall obtain a written opinion from the specialist 
within 30 days of the medical examination. The written opinion shall 
meet the requirements of paragraph (i)(6) (except paragraph (i)(6)(i)(B) 
and (i)(6)(ii)(B)) of this section.
    (j) Communication of respirable crystalline silica hazards to 
employees--(1) Hazard communication. The employer shall include 
respirable crystalline silica in the program established to comply with 
the hazard communication standard (HCS) (29 CFR 1910.1200). The employer 
shall ensure that each employee has access to labels on containers of 
crystalline silica and safety data sheets, and is trained in accordance 
with the provisions of HCS and paragraph (j)(3) of this section. The 
employer shall ensure that at least the following hazards are addressed: 
Cancer, lung effects, immune system effects, and kidney effects.
    (2) Signs. The employer shall post signs at all entrances to 
regulated areas that bear the following legend:


[[Page 519]]


DANGER
RESPIRABLE CRYSTALLINE SILICA
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
WEAR RESPIRATORY PROTECTION IN THIS AREA
AUTHORIZED PERSONNEL ONLY

    (3) Employee information and training. (i) The employer shall ensure 
that each employee covered by this section can demonstrate knowledge and 
understanding of at least the following:
    (A) The health hazards associated with exposure to respirable 
crystalline silica;
    (B) Specific tasks in the workplace that could result in exposure to 
respirable crystalline silica;
    (C) Specific measures the employer has implemented to protect 
employees from exposure to respirable crystalline silica, including 
engineering controls, work practices, and respirators to be used;
    (D) The contents of this section; and
    (E) The purpose and a description of the medical surveillance 
program required by paragraph (i) of this section.
    (ii) The employer shall make a copy of this section readily 
available without cost to each employee covered by this section.
    (k) Recordkeeping--(1) Air monitoring data. (i) The employer shall 
make and maintain an accurate record of all exposure measurements taken 
to assess employee exposure to respirable crystalline silica, as 
prescribed in paragraph (d) of this section.
    (ii) This record shall include at least the following information:
    (A) The date of measurement for each sample taken;
    (B) The task monitored;
    (C) Sampling and analytical methods used;
    (D) Number, duration, and results of samples taken;
    (E) Identity of the laboratory that performed the analysis;
    (F) Type of personal protective equipment, such as respirators, worn 
by the employees monitored; and
    (G) Name 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) Objective data. (i) The employer shall make and 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 crystalline silica-containing material in question;
    (B) The source of the objective data;
    (C) The testing protocol and results of testing;
    (D) A description of the process, task, or activity on which the 
objective data were based; and
    (E) Other data relevant to the process, task, activity, material, or 
exposures on which the objective data were based.
    (iii) The employer shall ensure that objective data are maintained 
and made available in accordance with 29 CFR 1910.1020.
    (3) Medical surveillance. (i) The employer shall make and maintain 
an accurate record for each employee covered by medical surveillance 
under paragraph (i) of this section.
    (ii) The record shall include the following information about the 
employee:
    (A) Name;
    (B) A copy of the PLHCPs' and specialists' written medical opinions; 
and
    (C) A copy of the information provided to the PLHCPs and 
specialists.
    (iii) The employer shall ensure that medical records are maintained 
and made available in accordance with 29 CFR 1910.1020.
    (l) Dates. (1) This section is effective June 23, 2016.
    (2) Except as provided for in paragraphs (l)(3) and (4) of this 
section, all obligations of this section commence June 23, 2018.
    (3) For hydraulic fracturing operations in the oil and gas industry:
    (i) All obligations of this section, except obligations for medical 
surveillance in paragraph (i)(1)(i) and engineering controls in 
paragraph (f)(1) of this section, commence June 23, 2018;
    (ii) Obligations for engineering controls in paragraph (f)(1) of 
this section commence June 23, 2021; and

[[Page 520]]

    (iii) Obligations for medical surveillance in paragraph (i)(1)(i) 
commence in accordance with paragraph (l)(4) of this section.
    (4) The medical surveillance obligations in paragraph (i)(1)(i) 
commence on June 23, 2018, for employees who will be occupationally 
exposed to respirable crystalline silica above the PEL for 30 or more 
days per year. Those obligations commence June 23, 2020, for employees 
who will be occupationally exposed to respirable crystalline silica at 
or above the action level for 30 or more days per year.

        Appendix A to Sec.  1910.1053--Methods of Sample Analysis

    This appendix specifies the procedures for analyzing air samples for 
respirable crystalline silica, as well as the quality control procedures 
that employers must ensure that laboratories use when performing an 
analysis required under 29 CFR 1910.1053 (d)(5). Employers must ensure 
that such a laboratory:
    1. Evaluates all samples using the procedures specified in one of 
the following analytical methods: OSHA ID-142; NMAM 7500; NMAM 7602; 
NMAM 7603; MSHA P-2; or MSHA P-7;
    2. Is accredited to ANS/ISO/IEC Standard 17025:2005 with respect to 
crystalline silica analyses by a body that is compliant with ISO/IEC 
Standard 17011:2004 for implementation of quality assessment programs;
    3. Uses the most current National Institute of Standards and 
Technology (NIST) or NIST traceable standards for instrument calibration 
or instrument calibration verification;
    4. Implements an internal quality control (QC) program that 
evaluates analytical uncertainty and provides employers with estimates 
of sampling and analytical error;
    5. Characterizes the sample material by identifying polymorphs of 
respirable crystalline silica present, identifies the presence of any 
interfering compounds that might affect the analysis, and makes any 
corrections necessary in order to obtain accurate sample analysis; and
    6. Analyzes quantitatively for crystalline silica only after 
confirming that the sample matrix is free of uncorrectable analytical 
interferences, corrects for analytical interferences, and uses a method 
that meets the following performance specifications:
    6.1 Each day that samples are analyzed, performs instrument 
calibration checks with standards that bracket the sample 
concentrations;
    6.2 Uses five or more calibration standard levels to prepare 
calibration curves and ensures that standards are distributed through 
the calibration range in a manner that accurately reflects the 
underlying calibration curve; and
    6.3 Optimizes methods and instruments to obtain a quantitative limit 
of detection that represents a value no higher than 25 percent of the 
PEL based on sample air volume.

     Appendix B to Sec.  1910.1053--Medical Surveillance Guidelines

                              Introduction

    The purpose of this Appendix is to provide medical information and 
recommendations to aid physicians and other licensed health care 
professionals (PLHCPs) regarding compliance with the medical 
surveillance provisions of the respirable crystalline silica standard 
(29 CFR 1910.1053). Appendix B is for informational and guidance 
purposes only and none of the statements in Appendix B should be 
construed as imposing a mandatory requirement on employers that is not 
otherwise imposed by the standard.
    Medical screening and surveillance allow for early identification of 
exposure-related health effects in individual employee and groups of 
employees, so that actions can be taken to both avoid further exposure 
and prevent or address adverse health outcomes. Silica-related diseases 
can be fatal, encompass a variety of target organs, and may have public 
health consequences when considering the increased risk of a latent 
tuberculosis (TB) infection becoming active. Thus, medical surveillance 
of silica-exposed employees requires that PLHCPs have a thorough 
knowledge of silica-related health effects.
    This Appendix is divided into seven sections. Section 1 reviews 
silica-related diseases, medical responses, and public health responses. 
Section 2 outlines the components of the medical surveillance program 
for employees exposed to silica. Section 3 describes the roles and 
responsibilities of the PLHCP implementing the program and of other 
medical specialists and public health professionals. Section 4 provides 
a discussion of considerations, including confidentiality. Section 5 
provides a list of additional resources and Section 6 lists references. 
Section 7 provides sample forms for the written medical report for the 
employee, the written medical opinion for the employer and the written 
authorization.

                1. Recognition of Silica-Related Diseases

    1.1. Overview. The term ``silica'' refers specifically to the 
compound silicon dioxide (SiO2). Silica is a major component of sand, 
rock, and mineral ores. Exposure to fine (respirable size) particles of 
crystalline forms of silica is associated with adverse health effects, 
such as silicosis, lung cancer, chronic obstructive pulmonary disease 
(COPD), and activation of latent TB infections. Exposure to respirable 
crystalline silica can occur in

[[Page 521]]

industry settings such as foundries, abrasive blasting operations, paint 
manufacturing, glass and concrete product manufacturing, brick making, 
china and pottery manufacturing, manufacturing of plumbing fixtures, and 
many construction activities including highway repair, masonry, concrete 
work, rock drilling, and tuck-pointing. New uses of silica continue to 
emerge. These include countertop manufacturing, finishing, and 
installation (Kramer et al. 2012; OSHA 2015) and hydraulic fracturing in 
the oil and gas industry (OSHA 2012).
    Silicosis is an irreversible, often disabling, and sometimes fatal 
fibrotic lung disease. Progression of silicosis can occur despite 
removal from further exposure. Diagnosis of silicosis requires a history 
of exposure to silica and radiologic findings characteristic of silica 
exposure. Three different presentations of silicosis (chronic, 
accelerated, and acute) have been defined. Accelerated and acute 
silicosis are much less common than chronic silicosis. However, it is 
critical to recognize all cases of accelerated and acute silicosis 
because these are life-threatening illnesses and because they are caused 
by substantial overexposures to respirable crystalline silica. Although 
any case of silicosis indicates a breakdown in prevention, a case of 
acute or accelerated silicosis implies current high exposure and a very 
marked breakdown in prevention.
    In addition to silicosis, employees exposed to respirable 
crystalline silica, especially those with accelerated or acute 
silicosis, are at increased risks of contracting active TB and other 
infections (ATS 1997; Rees and Murray 2007). Exposure to respirable 
crystalline silica also increases an employee's risk of developing lung 
cancer, and the higher the cumulative exposure, the higher the risk 
(Steenland et al. 2001; Steenland and Ward 2014). Symptoms for these 
diseases and other respirable crystalline silica-related diseases are 
discussed below.
    1.2. Chronic Silicosis. Chronic silicosis is the most common 
presentation of silicosis and usually occurs after at least 10 years of 
exposure to respirable crystalline silica. The clinical presentation of 
chronic silicosis is:
    1.2.1. Symptoms--shortness of breath and cough, although employees 
may not notice any symptoms early in the disease. Constitutional 
symptoms, such as fever, loss of appetite and fatigue, may indicate 
other diseases associated with silica exposure, such as TB infection or 
lung cancer. Employees with these symptoms should immediately receive 
further evaluation and treatment.
    1.2.2. Physical Examination--may be normal or disclose dry rales or 
rhonchi on lung auscultation.
    1.2.3. Spirometry--may be normal or may show only a mild restrictive 
or obstructive pattern.
    1.2.4. Chest X-ray--classic findings are small, rounded opacities in 
the upper lung fields bilaterally. However, small irregular opacities 
and opacities in other lung areas can also occur. Rarely, ``eggshell 
calcifications'' in the hilar and mediastinal lymph nodes are seen.
    1.2.5. Clinical Course--chronic silicosis in most cases is a slowly 
progressive disease. Under the respirable crystalline silica standard, 
the PLHCP is to recommend that employees with a 1/0 category X-ray be 
referred to an American Board Certified Specialist in Pulmonary Disease 
or Occupational Medicine. The PLHCP and/or Specialist should counsel 
employees regarding work practices and personal habits that could affect 
employees' respiratory health.
    1.3. Accelerated Silicosis. Accelerated silicosis generally occurs 
within 5-10 years of exposure and results from high levels of exposure 
to respirable crystalline silica. The clinical presentation of 
accelerated silicosis is:
    1.3.1. Symptoms--shortness of breath, cough, and sometimes sputum 
production. Employees with exposure to respirable crystalline silica, 
and especially those with accelerated silicosis, are at high risk for 
activation of TB infections, atypical mycobacterial infections, and 
fungal superinfections. Constitutional symptoms, such as fever, weight 
loss, hemoptysis (coughing up blood), and fatigue may herald one of 
these infections or the onset of lung cancer.
    1.3.2. Physical Examination--rales, rhonchi, or other abnormal lung 
findings in relation to illnesses present. Clubbing of the digits, signs 
of heart failure, and cor pulmonale may be present in severe lung 
disease.
    1.3.3. Spirometry--restrictive or mixed restrictive/obstructive 
pattern.
    1.3.4. Chest X-ray--small rounded and/or irregular opacities 
bilaterally. Large opacities and lung abscesses may indicate infections, 
lung cancer, or progression to complicated silicosis, also termed 
progressive massive fibrosis.
    1.3.5. Clinical Course--accelerated silicosis has a rapid, severe 
course. Under the respirable crystalline silica standard, the PLHCP can 
recommend referral to a Board Certified Specialist in either Pulmonary 
Disease or Occupational Medicine, as deemed appropriate, and referral to 
a Specialist is recommended whenever the diagnosis of accelerated 
silicosis is being considered.
    1.4. Acute Silicosis. Acute silicosis is a rare disease caused by 
inhalation of extremely high levels of respirable crystalline silica 
particles. The pathology is similar to alveolar proteinosis with 
lipoproteinaceous material accumulating in the alveoli. Acute silicosis 
develops rapidly, often, within a few months to less than 2 years of 
exposure, and

[[Page 522]]

is almost always fatal. The clinical presentation of acute silicosis is 
as follows:
    1.4.1. Symptoms--sudden, progressive, and severe shortness of 
breath. Constitutional symptoms are frequently present and include 
fever, weight loss, fatigue, productive cough, hemoptysis (coughing up 
blood), and pleuritic chest pain.
    1.4.2. Physical Examination--dyspnea at rest, cyanosis, decreased 
breath sounds, inspiratory rales, clubbing of the digits, and fever.
    1.4.3. Spirometry--restrictive or mixed restrictive/obstructive 
pattern.
    1.4.4. Chest X-ray--diffuse haziness of the lungs bilaterally early 
in the disease. As the disease progresses, the ``ground glass'' 
appearance of interstitial fibrosis will appear.
    1.4.5. Clinical Course--employees with acute silicosis are at 
especially high risk of TB activation, nontuberculous mycobacterial 
infections, and fungal superinfections. Acute silicosis is immediately 
life-threatening. The employee should be urgently referred to a Board 
Certified Specialist in Pulmonary Disease or Occupational Medicine for 
evaluation and treatment. Although any case of silicosis indicates a 
breakdown in prevention, a case of acute or accelerated silicosis 
implies a profoundly high level of silica exposure and may mean that 
other employees are currently exposed to dangerous levels of silica.
    1.5. COPD. COPD, including chronic bronchitis and emphysema, has 
been documented in silica-exposed employees, including those who do not 
develop silicosis. Periodic spirometry tests are performed to evaluate 
each employee for progressive changes consistent with the development of 
COPD. In addition to evaluating spirometry results of individual 
employees over time, PLHCPs may want to be aware of general trends in 
spirometry results for groups of employees from the same workplace to 
identify possible problems that might exist at that workplace. (See 
Section 2 of this Appendix on Medical Surveillance for further 
discussion.) Heart disease may develop secondary to lung diseases such 
as COPD. A recent study by Liu et al. 2014 noted a significant exposure-
response trend between cumulative silica exposure and heart disease 
deaths, primarily due to pulmonary heart disease, such as cor pulmonale.
    1.6. Renal and Immune System. Silica exposure has been associated 
with several types of kidney disease, including glomerulonephritis, 
nephrotic syndrome, and end stage renal disease requiring dialysis. 
Silica exposure has also been associated with other autoimmune 
conditions, including progressive systemic sclerosis, systemic lupus 
erythematosus, and rheumatoid arthritis. Studies note an association 
between employees with silicosis and serologic markers for autoimmune 
diseases, including antinuclear antibodies, rheumatoid factor, and 
immune complexes (Jalloul and Banks 2007; Shtraichman et al. 2015).
    1.7. TB and Other Infections. Silica-exposed employees with latent 
TB are 3 to 30 times more likely to develop active pulmonary TB 
infection (ATS 1997; Rees and Murray 2007). Although respirable 
crystalline silica exposure does not cause TB infection, individuals 
with latent TB infection are at increased risk for activation of disease 
if they have higher levels of respirable crystalline silica exposure, 
greater profusion of radiographic abnormalities, or a diagnosis of 
silicosis. Demographic characteristics, such as immigration from some 
countries, are associated with increased rates of latent TB infection. 
PLHCPs can review the latest Centers for Disease Control and Prevention 
(CDC) information on TB incidence rates and high risk populations online 
(See Section 5 of this Appendix). Additionally, silica-exposed employees 
are at increased risk for contracting nontuberculous mycobacterial 
infections, including Mycobacterium avium-intracellulare and 
Mycobacterium kansaii.
    1.8. Lung Cancer. The National Toxicology Program has listed 
respirable crystalline silica as a known human carcinogen since 2000 
(NTP 2014). The International Agency for Research on Cancer (2012) has 
also classified silica as Group 1 (carcinogenic to humans). Several 
studies have indicated that the risk of lung cancer from exposure to 
respirable crystalline silica and smoking is greater than additive 
(Brown 2009; Liu et al. 2013). Employees should be counseled on smoking 
cessation.

                         2. Medical Surveillance

    PLHCPs who manage silica medical surveillance programs should have a 
thorough understanding of the many silica-related diseases and health 
effects outlined in Section 1 of this Appendix. At each clinical 
encounter, the PLHCP should consider silica-related health outcomes, 
with particular vigilance for acute and accelerated silicosis. In this 
Section, the required components of medical surveillance under the 
respirable crystalline silica standard are reviewed, along with 
additional guidance and recommendations for PLHCPs performing medical 
surveillance examinations for silica-exposed employees.

                              2.1. History

    2.1.1. The respirable crystalline silica standard requires the 
following: A medical and work history, with emphasis on: Past, present, 
and anticipated exposure to respirable crystalline silica, dust, and 
other agents affecting the respiratory system; any history of 
respiratory system dysfunction, including signs and symptoms of 
respiratory disease (e.g., shortness of breath, cough,

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wheezing); history of TB; and smoking status and history.
    2.1.2. Further, the employer must provide the PLHCP with the 
following information:
    2.1.2.1. A description of the employee's former, current, and 
anticipated duties as they relate to the employee's occupational 
exposure to respirable crystalline silica;
    2.1.2.2. The employee's former, current, and anticipated levels of 
occupational exposure to respirable crystalline silica;
    2.1.2.3. 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 or will use that equipment; and
    2.1.2.4. Information from records of employment-related medical 
examinations previously provided to the employee and currently within 
the control of the employer.
    2.1.3. Additional guidance and recommendations: A history is 
particularly important both in the initial evaluation and in periodic 
examinations. Information on past and current medical conditions 
(particularly a history of kidney disease, cardiac disease, connective 
tissue disease, and other immune diseases), medications, 
hospitalizations and surgeries may uncover health risks, such as immune 
suppression, that could put an employee at increased health risk from 
exposure to silica. This information is important when counseling the 
employee on risks and safe work practices related to silica exposure.

                        2.2. Physical Examination

    2.2.1. The respirable crystalline silica standard requires the 
following: A physical examination, with special emphasis on the 
respiratory system. The physical examination must be performed at the 
initial examination and every three years thereafter.
    2.2.2. Additional guidance and recommendations: Elements of the 
physical examination that can assist the PHLCP include: An examination 
of the cardiac system, an extremity examination (for clubbing, cyanosis, 
edema, or joint abnormalities), and an examination of other pertinent 
organ systems identified during the history.

                             2.3. TB Testing

    2.3.1. The respirable crystalline silica standard requires the 
following: Baseline testing for TB on initial examination.
    2.3.2. Additional guidance and recommendations:
    2.3.2.1. Current CDC guidelines (See Section 5 of this Appendix) 
should be followed for the application and interpretation of Tuberculin 
skin tests (TST). The interpretation and documentation of TST reactions 
should be performed within 48 to 72 hours of administration by trained 
PLHCPs.
    2.3.2.2. PLHCPs may use alternative TB tests, such as interferon-
[gamma] release assays (IGRAs), if sensitivity and specificity are 
comparable to TST (Mazurek et al. 2010; Slater et al. 2013). PLHCPs can 
consult the current CDC guidelines for acceptable tests for latent TB 
infection.
    2.3.2.3. The silica standard allows the PLHCP to order additional 
tests or test at a greater frequency than required by the standard, if 
deemed appropriate. Therefore, PLHCPs might perform periodic (e.g., 
annual) TB testing as appropriate, based on employees' risk factors. For 
example, according to the American Thoracic Society (ATS), the diagnosis 
of silicosis or exposure to silica for 25 years or more are indications 
for annual TB testing (ATS 1997). PLHCPs should consult the current CDC 
guidance on risk factors for TB (See Section 5 of this Appendix).
    2.3.2.4. Employees with positive TB tests and those with 
indeterminate test results should be referred to the appropriate agency 
or specialist, depending on the test results and clinical picture. 
Agencies, such as local public health departments, or specialists, such 
as a pulmonary or infectious disease specialist, may be the appropriate 
referral. Active TB is a nationally notifiable disease. PLHCPs should be 
aware of the reporting requirements for their region. All States have TB 
Control Offices that can be contacted for further information. (See 
Section 5 of this Appendix for links to CDC's TB resources and State TB 
Control Offices.)
    2.3.2.5. The following public health principles are key to TB 
control in the U.S. (ATS-CDC-IDSA 2005):
    (1) Prompt detection and reporting of persons who have contracted 
active TB;
    (2) Prevention of TB spread to close contacts of active TB cases;
    (3) Prevention of active TB in people with latent TB through 
targeted testing and treatment; and
    (4) Identification of settings at high risk for TB transmission so 
that appropriate infection-control measures can be implemented.

                     2.4. Pulmonary Function Testing

    2.4.1. The respirable crystalline silica standard requires the 
following: Pulmonary function testing must be performed on the initial 
examination and every three years thereafter. The required pulmonary 
function test is spirometry and must include forced vital capacity 
(FVC), forced expiratory volume in one second (FEV1), and 
FEV1/FVC ratio. Testing must be administered by a spirometry 
technician with a current certificate from a National Institute for 
Occupational Health and Safety (NIOSH)-approved spirometry course.

[[Page 524]]

    2.4.2. Additional guidance and recommendations: Spirometry provides 
information about individual respiratory status and can be used to track 
an employee's respiratory status over time or as a surveillance tool to 
follow individual and group respiratory function. For quality results, 
the ATS and the American College of Occupational and Environmental 
Medicine (ACOEM) recommend use of the third National Health and 
Nutrition Examination Survey (NHANES III) values, and ATS publishes 
recommendations for spirometry equipment (Miller et al. 2005; Townsend 
2011; Redlich et al. 2014). OSHA's publication, Spirometry Testing in 
Occupational Health Programs: Best Practices for Healthcare 
Professionals, provides helpful guidance (See Section 5 of this 
Appendix). Abnormal spirometry results may warrant further clinical 
evaluation and possible recommendations for limitations on the 
employee's exposure to respirable crystalline silica.

                            2.5. Chest X-ray

    2.5.1. The respirable crystalline silica standard requires the 
following: A single posteroanterior (PA) radiographic projection or 
radiograph of the chest at full inspiration recorded on either film (no 
less than 14 x 17 inches and no more than 16 x 17 inches) or digital 
radiography systems. A chest X-ray must be performed on the initial 
examination and every three years thereafter. The chest X-ray must be 
interpreted and classified according to the International Labour Office 
(ILO) International Classification of Radiographs of Pneumoconioses by a 
NIOSH-certified B Reader.
    Chest radiography is necessary to diagnose silicosis, monitor the 
progression of silicosis, and identify associated conditions such as TB. 
If the B reading indicates small opacities in a profusion of 1/0 or 
higher, the employee is to receive a recommendation for referral to a 
Board Certified Specialist in Pulmonary Disease or Occupational 
Medicine.
    2.5.2. Additional guidance and recommendations: Medical imaging has 
largely transitioned from conventional film-based radiography to digital 
radiography systems. The ILO Guidelines for the Classification of 
Pneumoconioses has historically provided film-based chest radiography as 
a referent standard for comparison to individual exams. However, in 
2011, the ILO revised the guidelines to include a digital set of 
referent standards that were derived from the prior film-based 
standards. To assist in assuring that digitally-acquired radiographs are 
at least as safe and effective as film radiographs, NIOSH has prepared 
guidelines, based upon accepted contemporary professional 
recommendations (See Section 5 of this Appendix). Current research from 
Laney et al. 2011 and Halldin et al. 2014 validate the use of the ILO 
digital referent images. Both studies conclude that the results of 
pneumoconiosis classification using digital references are comparable to 
film-based ILO classifications. Current ILO guidance on radiography for 
pneumoconioses and B-reading should be reviewed by the PLHCP 
periodically, as needed, on the ILO or NIOSH Web sites (See Section 5 of 
this Appendix).
    2.6. Other Testing. Under the respirable crystalline silica 
standards, the PLHCP has the option of ordering additional testing he or 
she deems appropriate. Additional tests can be ordered on a case-by-case 
basis depending on individual signs or symptoms and clinical judgment. 
For example, if an employee reports a history of abnormal kidney 
function tests, the PLHCP may want to order a baseline renal function 
tests (e.g., serum creatinine and urinalysis). As indicated above, the 
PLHCP may order annual TB testing for silica-exposed employees who are 
at high risk of developing active TB infections. Additional tests that 
PLHCPs may order based on findings of medical examinations include, but 
is not limited to, chest computerized tomography (CT) scan for lung 
cancer or COPD, testing for immunologic diseases, and cardiac testing 
for pulmonary-related heart disease, such as cor pulmonale.

                      3. Roles and Responsibilities

    3.1. PLHCP. The PLHCP designation refers to ``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 the respirable crystalline silica 
standard. The legally permitted scope of practice for the PLHCP is 
determined by each State. PLHCPs who perform clinical services for a 
silica medical surveillance program should have a thorough knowledge of 
respirable crystalline silica-related diseases and symptoms. Suspected 
cases of silicosis, advanced COPD, or other respiratory conditions 
causing impairment should be promptly referred to a Board Certified 
Specialist in Pulmonary Disease or Occupational Medicine.
    Once the medical surveillance examination is completed, the employer 
must ensure that the PLHCP explains to the employee the results of the 
medical examination and provides the employee with a written medical 
report within 30 days of the examination. The written medical report 
must contain a statement indicating the results of the medical 
examination, including any medical condition(s) that would place the 
employee at increased risk of material impairment to health from 
exposure to respirable crystalline silica and any medical conditions

[[Page 525]]

that require further evaluation or treatment. In addition, the PLHCP's 
written medical report must include any recommended limitations on the 
employee's use of respirators, any recommended limitations on the 
employee's exposure to respirable crystalline silica, and a statement 
that the employee should be examined by a Board Certified Specialist in 
Pulmonary Disease or Occupational medicine if the chest X-ray is 
classified as 1/0 or higher by the B Reader, or if referral to a 
Specialist is otherwise deemed appropriate by the PLHCP.
    The PLHCP should discuss all findings and test results and any 
recommendations regarding the employee's health, worksite safety and 
health practices, and medical referrals for further evaluation, if 
indicated. In addition, it is suggested that the PLHCP offer to provide 
the employee with a complete copy of their examination and test results, 
as some employees may want this information for their own records or to 
provide to their personal physician or a future PLHCP. Employees are 
entitled to access their medical records.
    Under the respirable crystalline silica standard, the employer must 
ensure that the PLHCP provides the employer with a written medical 
opinion within 30 days of the employee examination, and that the 
employee also gets a copy of the written medical opinion for the 
employer within 30 days. The PLHCP may choose to directly provide the 
employee a copy of the written medical opinion. This can be particularly 
helpful to employees, such as construction employees, who may change 
employers frequently. The written medical opinion can be used by the 
employee as proof of up-to-date medical surveillance. The following 
lists the elements of the written medical report for the employee and 
written medical opinion for the employer. (Sample forms for the written 
medical report for the employee, the written medical opinion for the 
employer, and the written authorization are provided in Section 7 of 
this Appendix.)
    3.1.1. The written medical report for the employee must include the 
following information:
    3.1.1.1. A statement indicating the results of the medical 
examination, including any medical condition(s) that would place the 
employee at increased risk of material impairment to health from 
exposure to respirable crystalline silica and any medical conditions 
that require further evaluation or treatment;
    3.1.1.2. Any recommended limitations upon the employee's use of a 
respirator;
    3.1.1.3. Any recommended limitations on the employee's exposure to 
respirable crystalline silica; and
    3.1.1.4. A statement that the employee should be examined by a Board 
Certified Specialist in Pulmonary Disease or Occupational Medicine, 
where the standard requires or where the PLHCP has determined such a 
referral is necessary. The standard requires referral to a Board 
Certified Specialist in Pulmonary Disease or Occupational Medicine for a 
chest X-ray B reading indicating small opacities in a profusion of 1/0 
or higher, or if the PHLCP determines that referral to a Specialist is 
necessary for other silica-related findings.
    3.1.2. The PLHCP's written medical opinion for the employer must 
include only the following information:
    3.1.2.1. The date of the examination;
    3.1.2.2. A statement that the examination has met the requirements 
of this section; and
    3.1.2.3. Any recommended limitations on the employee's use of 
respirators.
    3.1.2.4. If the employee provides the PLHCP with written 
authorization, the written opinion for the employer shall also contain 
either or both of the following:
    (1) Any recommended limitations on the employee's exposure to 
respirable crystalline silica; and
    (2) A statement that the employee should be examined by a Board 
Certified Specialist in Pulmonary Disease or Occupational Medicine if 
the chest X-ray provided in accordance with this section is classified 
as 1/0 or higher by the B Reader, or if referral to a Specialist is 
otherwise deemed appropriate.
    3.1.2.5. In addition to the above referral for abnormal chest X-ray, 
the PLHCP may refer an employee to a Board Certified Specialist in 
Pulmonary Disease or Occupational Medicine for other findings of concern 
during the medical surveillance examination if these findings are 
potentially related to silica exposure.
    3.1.2.6. Although the respirable crystalline silica standard 
requires the employer to ensure that the PLHCP explains the results of 
the medical examination to the employee, the standard does not mandate 
how this should be done. The written medical opinion for the employer 
could contain a statement that the PLHCP has explained the results of 
the medical examination to the employee.
    3.2. Medical Specialists. The silica standard requires that all 
employees with chest X-ray B readings of 1/0 or higher be referred to a 
Board Certified Specialist in Pulmonary Disease or Occupational 
Medicine. If the employee has given written authorization for the 
employer to be informed, then the employer shall make available a 
medical examination by a Specialist within 30 days after receiving the 
PLHCP's written medical opinion.
    3.2.1. The employer must provide the following information to the 
Board Certified Specialist in Pulmonary Disease or Occupational 
Medicine:
    3.2.1.1. A description of the employee's former, current, and 
anticipated duties as

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they relate to the employee's occupational exposure to respirable 
crystalline silica;
    3.2.1.2. The employee's former, current, and anticipated levels of 
occupational exposure to respirable crystalline silica;
    3.2.1.3. 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 or will use that equipment; and
    3.2.1.4. Information from records of employment-related medical 
examinations previously provided to the employee and currently within 
the control of the employer.
    3.2.2. The PLHCP should make certain that, with written 
authorization from the employee, the Board Certified Specialist in 
Pulmonary Disease or Occupational Medicine has any other pertinent 
medical and occupational information necessary for the specialist's 
evaluation of the employee's condition.
    3.2.3. Once the Board Certified Specialist in Pulmonary Disease or 
Occupational Medicine has evaluated the employee, the employer must 
ensure that the Specialist explains to the employee the results of the 
medical examination and provides the employee with a written medical 
report within 30 days of the examination. The employer must also ensure 
that the Specialist provides the employer with a written medical opinion 
within 30 days of the employee examination. (Sample forms for the 
written medical report for the employee, the written medical opinion for 
the employer and the written authorization are provided in Section 7 of 
this Appendix.)
    3.2.4. The Specialist's written medical report for the employee must 
include the following information:
    3.2.4.1. A statement indicating the results of the medical 
examination, including any medical condition(s) that would place the 
employee at increased risk of material impairment to health from 
exposure to respirable crystalline silica and any medical conditions 
that require further evaluation or treatment;
    3.2.4.2. Any recommended limitations upon the employee's use of a 
respirator; and
    3.2.4.3. Any recommended limitations on the employee's exposure to 
respirable crystalline silica.
    3.2.5. The Specialist's written medical opinion for the employer 
must include the following information:
    3.2.5.1. The date of the examination; and
    3.2.5.2. Any recommended limitations on the employee's use of 
respirators.
    3.2.5.3. If the employee provides the Board Certified Specialist in 
Pulmonary Disease or Occupational Medicine with written authorization, 
the written medical opinion for the employer shall also contain any 
recommended limitations on the employee's exposure to respirable 
crystalline silica.
    3.2.5.4. Although the respirable crystalline silica standard 
requires the employer to ensure that the Board Certified Specialist in 
Pulmonary Disease or Occupational Medicine explains the results of the 
medical examination to the employee, the standard does not mandate how 
this should be done. The written medical opinion for the employer could 
contain a statement that the Specialist has explained the results of the 
medical examination to the employee.
    3.2.6. After evaluating the employee, the Board Certified Specialist 
in Pulmonary Disease or Occupational Medicine should provide feedback to 
the PLHCP as appropriate, depending on the reason for the referral. OSHA 
believes that because the PLHCP has the primary relationship with the 
employer and employee, the Specialist may want to communicate his or her 
findings to the PLHCP and have the PLHCP simply update the original 
medical report for the employee and medical opinion for the employer. 
This is permitted under the standard, so long as all requirements and 
time deadlines are met.
    3.3. Public Health Professionals. PLHCPs might refer employees or 
consult with public health professionals as a result of silica medical 
surveillance. For instance, if individual cases of active TB are 
identified, public health professionals from state or local health 
departments may assist in diagnosis and treatment of individual cases 
and may evaluate other potentially affected persons, including 
coworkers. Because silica-exposed employees are at increased risk of 
progression from latent to active TB, treatment of latent infection is 
recommended. The diagnosis of active TB, acute or accelerated silicosis, 
or other silica-related diseases and infections should serve as sentinel 
events suggesting high levels of exposure to silica and may require 
consultation with the appropriate public health agencies to investigate 
potentially similarly exposed coworkers to assess for disease clusters. 
These agencies include local or state health departments or OSHA. In 
addition, NIOSH can provide assistance upon request through their Health 
Hazard Evaluation program. (See Section 5 of this Appendix)

               4. Confidentiality and Other Considerations

    The information that is provided from the PLHCP to the employee and 
employer under the medical surveillance section of OSHA's respirable 
crystalline silica standard differs from that of medical surveillance 
requirements in previous OSHA standards. The standard requires two 
separate written communications, a written medical report for the 
employee and a written medical opinion for the employer. The 
confidentiality requirements for the written medical opinion are more 
stringent than in past standards.

[[Page 527]]

For example, the information the PLHCP can (and must) include in his or 
her written medical opinion for the employer is limited to: The date of 
the examination, a statement that the examination has met the 
requirements of this section, and any recommended limitations on the 
employee's use of respirators. If the employee provides written 
authorization for the disclosure of any limitations on the employee's 
exposure to respirable crystalline silica, then the PLHCP can (and must) 
include that information in the written medical opinion for the employer 
as well. Likewise, with the employee's written authorization, the PLHCP 
can (and must) disclose the PLHCP's referral recommendation (if any) as 
part of the written medical opinion for the employer. However, the 
opinion to the employer must not include information regarding 
recommended limitations on the employee's exposure to respirable 
crystalline silica or any referral recommendations without the 
employee's written authorization.
    The standard also places limitations on the information that the 
Board Certified Specialist in Pulmonary Disease or Occupational Medicine 
can provide to the employer without the employee's written 
authorization. The Specialist's written medical opinion for the 
employer, like the PLHCP's opinion, is limited to (and must contain): 
The date of the examination and any recommended limitations on the 
employee's use of respirators. If the employee provides written 
authorization, the written medical opinion can (and must) also contain 
any limitations on the employee's exposure to respirable crystalline 
silica.
    The PLHCP should discuss the implication of signing or not signing 
the authorization with the employee (in a manner and language that he or 
she understands) so that the employee can make an informed decision 
regarding the written authorization and its consequences. The discussion 
should include the risk of ongoing silica exposure, personal risk 
factors, risk of disease progression, and possible health and economic 
consequences. For instance, written authorization is required for a 
PLHCP to advise an employer that an employee should be referred to a 
Board Certified Specialist in Pulmonary Disease or Occupational Medicine 
for evaluation of an abnormal chest X-ray (B-reading 1/0 or greater). If 
an employee does not sign an authorization, then the employer will not 
know and cannot facilitate the referral to a Specialist and is not 
required to pay for the Specialist's examination. In the rare case where 
an employee is diagnosed with acute or accelerated silicosis, co-workers 
are likely to be at significant risk of developing those diseases as a 
result of inadequate controls in the workplace. In this case, the PLHCP 
and/or Specialist should explain this concern to the affected employee 
and make a determined effort to obtain written authorization from the 
employee so that the PLHCP and/or Specialist can contact the employer.
    Finally, without written authorization from the employee, the PLHCP 
and/or Board Certified Specialist in Pulmonary Disease or Occupational 
Medicine cannot provide feedback to an employer regarding control of 
workplace silica exposure, at least in relation to an individual 
employee. However, the regulation does not prohibit a PLHCP and/or 
Specialist from providing an employer with general recommendations 
regarding exposure controls and prevention programs in relation to 
silica exposure and silica-related illnesses, based on the information 
that the PLHCP receives from the employer such as employees' duties and 
exposure levels. Recommendations may include increased frequency of 
medical surveillance examinations, additional medical surveillance 
components, engineering and work practice controls, exposure monitoring 
and personal protective equipment. For instance, more frequent medical 
surveillance examinations may be a recommendation to employers for 
employees who do abrasive blasting with silica because of the high 
exposures associated with that operation.
    ACOEM's Code of Ethics and discussion is a good resource to guide 
PLHCPs regarding the issues discussed in this section (See Section 5 of 
this Appendix).

                              5. Resources

    5.1. American College of Occupational and Environmental Medicine 
(ACOEM):

ACOEM Code of Ethics. Accessed at: http://www.acoem.org/
          codeofconduct.aspx
Raymond, L.W. and Wintermeyer, S. (2006) ACOEM evidenced-based statement 
          on medical surveillance of silica-exposed workers: Medical 
          surveillance of workers exposed to crystalline silica. J Occup 
          Environ Med, 48, 95-101.

    5.2. Center for Disease Control and Prevention (CDC)

Tuberculosis Web page: http://www.cdc.gov/tb/default.htm
State TB Control Offices Web page: http://www.cdc.gov/tb/links/
          tboffices.htm
Tuberculosis Laws and Policies Web page: http://www.cdc.gov/tb/programs/
          laws/default.htm
CDC. (2013). Latent Tuberculosis Infection: A Guide for Primary Health 
          Care Providers. Accessed at: http://www.cdc.gov/tb/
          publications/ltbi/pdf/targetedltbi.pdf

    5.3. International Labour Organization

International Labour Office (ILO). (2011) Guidelines for the use of the 
          ILO International Classification of Radiographs of 
          Pneumoconioses, Revised edition 2011. Occupational Safety and 
          Health Series No. 22: http://www.ilo.org/safework/info/

[[Page 528]]

          publications/WCMS_168260/lang-en/index.htm

    5.4. National Institute of Occupational Safety and Health (NIOSH)

NIOSH B Reader Program Web page. (Information on interpretation of X-
          rays for silicosis and a list of certified B-readers). 
          Accessed at: http://www.cdc.gov/niosh/topics/chestradiography/
          breader-info.html
NIOSH Guideline (2011). Application of Digital Radiography for the 
          Detection and Classification of Pneumoconiosis. NIOSH 
          publication number 2011-198. Accessed at: http://www.cdc.gov/
          niosh/docs/2011-198/.
NIOSH Hazard Review (2002), Health Effects of Occupational Exposure to 
          Respirable Crystalline Silica. NIOSH publication number 2002-
          129: Accessed at http://www.cdc.gov/niosh/docs/2002-129/
NIOSH Health Hazard Evaluations Programs. (Information on the NIOSH 
          Health Hazard Evaluation (HHE) program, how to request an HHE 
          and how to look up an HHE report). Accessed at: http://
          www.cdc.gov/niosh/hhe/

    5.5. National Industrial Sand Association:

Occupational Health Program for Exposure to Crystalline Silica in the 
          Industrial Sand Industry. National Industrial Sand 
          Association, 2nd ed. 2010. Can be ordered at: http://
          www.sand.org/silica-occupational-health-program

    5.6. Occupational Safety and Health Administration (OSHA)

Contacting OSHA: http://www.osha.gov/html/Feed_Back.html
OSHA's Clinicians Web page. (OSHA resources, regulations and links to 
          help clinicians navigate OSHA's Web site and aid clinicians in 
          caring for workers.) Accessed at: http://www.osha.gov/dts/oom/
          clinicians/index.html
OSHA's Safety and Health Topics Web page on Silica. Accessed at: http://
          www.osha.gov/dsg/topics/silicacrystalline/index.html
OSHA (2013). Spirometry Testing in Occupational Health Programs: Best 
          Practices for Healthcare Professionals. (OSHA 3637-03 2013). 
          Accessed at: http://www.osha.gov/Publications/OSHA3637.pdf
OSHA/NIOSH (2011). Spirometry: OSHA/NIOSH Spirometry InfoSheet (OSHA 
          3415-1-11). (Provides guidance to employers). Accessed at 
          http://www.osha.gov/Publications/osha3415.pdf
OSHA/NIOSH (2011) Spirometry: OSHA/NIOSH Spirometry Worker Info. (OSHA 
          3418-3-11). Accessed at http://www.osha.gov/Publications/
          osha3418.pdf

    5.7. Other
Steenland, K. and Ward E. (2014). Silica: A lung carcinogen. CA Cancer J 
          Clin, 64, 63-69. (This article reviews not only silica and 
          lung cancer but also all the known silica-related health 
          effects. Further, the authors provide guidance to clinicians 
          on medical surveillance of silica-exposed workers and worker 
          counselling on safety practices to minimize silica exposure.)

                              6. References

American Thoracic Society (ATS). Medical Section of the American Lung 
          Association (1997). Adverse effects of crystalline silica 
          exposure. Am J Respir Crit Care Med, 155, 761-765.
American Thoracic Society (ATS), Centers for Disease Control (CDC), 
          Infectious Diseases Society of America (IDSA) (2005). 
          Controlling Tuberculosis in the United States. Morbidity and 
          Mortality Weekly Report (MMWR), 54(RR12), 1-81. Accessed at: 
          http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5412a1.htm.
Brown, T. (2009). Silica exposure, smoking, silicosis and lung cancer--
          complex interactions. Occupational Medicine, 59, 89-95.
Halldin, C.N., Petsonk, E.L., and Laney, A.S. (2014). Validation of the 
          International Labour Office digitized standard images for 
          recognition and classification of radiographs of 
          pneumoconiosis. Acad Radiol, 21, 305-311.
International Agency for Research on Cancer. (2012). Monographs on the 
          evaluation of carcinogenic risks to humans: Arsenic, Metals, 
          Fibers, and Dusts Silica Dust, Crystalline, in the Form of 
          Quartz or Cristobalite. A Review of Human Carcinogens. Volume 
          100 C. Geneva, Switzerland: World Health Organization.
Jalloul, A.S. and Banks D.E. (2007). Chapter 23. The health effects of 
          silica exposure. In: Rom, W.N. and Markowitz, S.B. (Eds). 
          Environmental and Occupational Medicine, 4th edition. 
          Lippincott, Williams and Wilkins, Philadelphia, 365-387.
Kramer, M.R., Blanc, P.D., Fireman, E., Amital, A., Guber, A., Rahman, 
          N.A., and Shitrit, D. (2012). Artifical stone silicosis: 
          Disease resurgence among artificial stone workers. Chest, 142, 
          419-424.
Laney, A.S., Petsonk, E.L., and Attfield, M.D. (2011). Intramodality and 
          intermodality comparisons of storage phosphor computed 
          radiography and conventional film-screen radiography in the 
          recognition of small pneumonconiotic opacities. Chest, 140, 
          1574-1580.
Liu, Y., Steenland, K., Rong, Y., Hnizdo, E., Huang, X., Zhang, H., Shi, 
          T., Sun, Y., Wu, T., and Chen, W. (2013). Exposure-response 
          analysis and risk assessment for lung cancer in relationship 
          to silica exposure: A 44-year cohort study of 34,018 workers. 
          Am J Epi, 178, 1424-1433.
Liu, Y., Rong, Y., Steenland, K., Christiani, D.C., Huang, X., Wu, T., 
          and Chen, W. (2014). Long-term exposure to crystalline silica 
          and risk of heart disease mortality. Epidemiology, 25, 689-
          696.

[[Page 529]]

Mazurek, G.H., Jereb, J., Vernon, A., LoBue, P., Goldberg, S., Castro, 
          K. (2010). Updated guidelines for using interferon gamma 
          release assays to detect Mycobacterium tuberculosis 
          infection--United States. Morbidity and Mortality Weekly 
          Report (MMWR), 59(RR05), 1-25.
Miller, M.R., Hankinson, J., Brusasco, V., Burgos, F., Casaburi, R., 
          Coates, A., Crapo, R., Enright, P., van der Grinten, C.P., 
          Gustafsson, P., Jensen, R., Johnson, D.C., MacIntyre, N., 
          McKay, R., Navajas, D., Pedersen, O.F., Pellegrino, R., Viegi, 
          G., and Wanger, J. (2005).
American Thoracic Society/European Respiratory Society (ATS/ERS) Task 
          Force: Standardisation of Spirometry. Eur Respir J, 26, 319-
          338.
National Toxicology Program (NTP) (2014). Report on Carcinogens, 
          Thirteenth Edition. Silica, Crystalline (respirable Size). 
          Research Triangle Park, NC: U.S. Department of Health and 
          Human Services, Public Health Service. http://
          ntp.niehs.nih.gov/ntp/roc/content/profiles/silica.pdf.
Occupational Safety and Health Administration/National Institute for 
          Occupational Safety and Health (OSHA/NIOSH) (2012). Hazard 
          Alert. Worker exposure to silica during hydraulic fracturing.
Occupational Safety and Health Administration/National Institute for 
          Occupational Safety and Health (OSHA/NIOSH) (2015). Hazard 
          alert. Worker exposure to silica during countertop 
          manufacturing, finishing, and installation. (OSHA-HA-3768-
          2015).
Redlich, C.A., Tarlo, S.M., Hankinson, J.L., Townsend, M.C, 
          Eschenbacher, W.L., Von Essen, S.G., Sigsgaard, T., Weissman, 
          D.N. (2014). Official American Thoracic Society technical 
          standards: Spirometry in the occupational setting. Am J Respir 
          Crit Care Med; 189, 984-994.
Rees, D. and Murray, J. (2007). Silica, silicosis and tuberculosis. Int 
          J Tuberc Lung Dis, 11(5), 474-484.
Shtraichman, O., Blanc, P.D., Ollech, J.E., Fridel, L., Fuks, L., 
          Fireman, E., and Kramer, M.R. (2015). Outbreak of autoimmune 
          disease in silicosis linked to artificial stone. Occup Med, 
          65, 444-450.
Slater, M.L., Welland, G., Pai, M., Parsonnet, J., and Banaei, N. 
          (2013). Challenges with QuantiFERON-TB gold assay for large-
          scale, routine screening of U.S. healthcare workers. Am J 
          Respir Crit Care Med, 188, 1005-1010.
Steenland, K., Mannetje, A., Boffetta, P., Stayner, L., Attfield, M., 
          Chen, J., Dosemeci, M., DeKlerk, N., Hnizdo, E., Koskela, R., 
          and Checkoway, H. (2001). International Agency for Research on 
          Cancer. Pooled exposure-response analyses and risk assessment 
          for lung cancer in 10 cohorts of silica-exposed workers: An 
          IARC multicentre study. Cancer Causes Control, 12(9):773-84.
Steenland, K. and Ward E. (2014). Silica: A lung carcinogen. CA Cancer J 
          Clin, 64, 63-69.
Townsend, M.C. ACOEM Guidance Statement. (2011). Spirometry in the 
          occupational health setting--2011 Update. J Occup Environ Med, 
          53, 569-584.

                             7. Sample Forms

    Three sample forms are provided. The first is a sample written 
medical report for the employee. The second is a sample written medical 
opinion for the employer. And the third is a sample written 
authorization form that employees sign to clarify what information the 
employee is authorizing to be released to the employer.

[[Page 530]]

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[[Page 531]]


[GRAPHIC] [TIFF OMITTED] TR25MR16.173


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[GRAPHIC] [TIFF OMITTED] TR25MR16.174


[81 FR 16862, Mar. 25, 2016]



Sec.  1910.1096  Ionizing radiation.

    (a) Definitions applicable to this section--(1) Radiation includes 
alpha rays, beta rays, gamma rays, X-rays, neutrons, high-speed 
electrons, high-speed protons, and other atomic particles; but such term 
does not include sound or radio waves, or visible light, or infrared or 
ultraviolet light.
    (2) Radioactive material means any material which emits, by 
spontaneous nuclear disintegration, corpuscular or electromagnetic 
emanations.

[[Page 533]]

    (3) Restricted area means any area access to which is controlled by 
the employer for purposes of protection of individuals from exposure to 
radiation or radioactive materials.
    (4) Unrestricted area means any area access to which is not 
controlled by the employer for purposes of protection of individuals 
from exposure to radiation or radioactive materials.
    (5) Dose means the quantity of ionizing radiation absorbed, per unit 
of mass, by the body or by any portion of the body. When the provisions 
in this section specify a dose during a period of time, the dose is the 
total quantity of radiation absorbed, per unit of mass, by the body or 
by any portion of the body during such period of time. Several different 
units of dose are in current use. Definitions of units used in this 
section are set forth in paragraphs (a) (6) and (7) of this section.
    (6) Rad means a measure of the dose of any ionizing radiation to 
body tissues in terms of the energy absorbed per unit of mass of the 
tissue. One rad is the dose corresponding to the absorption of 100 ergs 
per gram of tissue (1 millirad (mrad) = 0.001 rad).
    (7) Rem means a measure of the dose of any ionizing radiation to 
body tissue in terms of its estimated biological effect relative to a 
dose of 1 roentgen (r) of X-rays (1 millirem (mrem) = 0.001 rem). The 
relation of the rem to other dose units depends upon the biological 
effect under consideration and upon the conditions for irradiation. Each 
of the following is considered to be equivalent to a dose of 1 rem:
    (i) A dose of 1 roentgen due to X- or gamma radiation;
    (ii) A dose of 1 rad due to X-, gamma, or beta radiation;
    (iii) A dose of 0.1 rad due to neutrons or high energy protons;
    (iv) A dose of 0.05 rad due to particles heavier than protons and 
with sufficient energy to reach the lens of the eye;
    (v) If it is more convenient to measure the neutron flux, or 
equivalent, than to determine the neutron dose in rads, as provided in 
paragraph (a)(7)(iii) of this section, 1 rem of neutron radiation may, 
for purposes of the provisions in this section be assumed to be 
equivalent to 14 million neutrons per square centimeter incident upon 
the body; or, if there is sufficient information to estimate with 
reasonable accuracy the approximate distribution in energy of the 
neutrons, the incident number of neutrons per square centimeter 
equivalent to 1 rem may be estimated from Table G-17:

                Table G-17--Neutron Flux Dose Equivalents
------------------------------------------------------------------------
                                                                Average
                                                 Number of      flux to
                                               neutrons per     deliver
                                                  square          100
   Neutron energy (million electron volts       centimeter     millirem
                   (Mev))                      equivalent to     in 40
                                                a dose of 1      hours
                                              rem (neutrons/  (neutrons/
                                                  cm\2\)       cm\2\ per
                                                                 sec.)
------------------------------------------------------------------------
Thermal.....................................     970 x 10\6\         670
0.0001......................................     720 x 10\6\         500
0.005.......................................     820 x 10\6\         570
0.02........................................     400 x 10\6\         280
0.1.........................................     120 x 10\6\          80
0.5.........................................      43 x 10\6\          30
1.0.........................................      26 x 10\6\          18
2.5.........................................      29 x 10\6\          20
5.0.........................................      26 x 10\6\          18
7.5.........................................      24 x 10\6\          17
10..........................................      24 x 10\6\          17
10 to 30....................................      14 x 10\6\          10
------------------------------------------------------------------------

    (8) For determining exposures to X- or gamma rays up to 3 Mev., the 
dose limits specified in this section may be assumed to be equivalent to 
the ``air dose''. For the purpose of this section air dose means that 
the dose is measured by a properly calibrated appropriate instrument in 
air at or near the body surface in the region of the highest dosage 
rate.
    (b) Exposure of individuals to radiation in restricted areas. (1) 
Except as provided in paragraph (b)(2) of this section, no employer 
shall possess, use, or transfer sources of ionizing radiation in such a 
manner as to cause any individual in a restricted area to receive in any 
period of one calendar quarter from sources in the employer's possession 
or control a dose in excess of the limits specified in Table G-18:

                               Table G-18
------------------------------------------------------------------------
                                                               Rems per
                                                               calendar
                                                                quarter
------------------------------------------------------------------------
Whole body: Head and trunk; active blood-forming organs;          1\1/4\
 lens of eyes; or gonads....................................
Hands and forearms; feet and ankles.........................     18\3/4\
Skin of whole body..........................................      7\1/2\
------------------------------------------------------------------------


[[Page 534]]

    (2) An employer may permit an individual in a restricted area to 
receive doses to the whole body greater than those permitted under 
subparagraph (1) of this paragraph, so long as:
    (i) During any calendar quarter the dose to the whole body shall not 
exceed 3 rems; and
    (ii) The dose to the whole body, when added to the accumulated 
occupational dose to the whole body, shall not exceed 5 (N-18) rems, 
where ``N'' equals the individual's age in years at his last birthday; 
and
    (iii) The employer maintains adequate past and current exposure 
records which show that the addition of such a dose will not cause the 
individual to exceed the amount authorized in this subparagraph. As used 
in this subparagraph Dose to the whole body shall be deemed to include 
any dose to the whole body, gonad, active bloodforming organs, head and 
trunk, or lens of the eye.
    (3) No employer shall permit any employee who is under 18 years of 
age to receive in any period of one calendar quarter a dose in excess of 
10 percent of the limits specified in Table G-18.
    (4) Calendar quarter means any 3-month period determined as follows:
    (i) The first period of any year may begin on any date in January: 
Provided, That the second, third, and fourth periods accordingly begin 
on the same date in April, July, and October, respectively, and that the 
fourth period extends into January of the succeeding year, if necessary 
to complete a 3-month quarter. During the first year of use of this 
method of determination, the first period for that year shall also 
include any additional days in January preceding the starting date for 
the first period; or
    (ii) The first period in a calendar year of 13 complete, consecutive 
calendar weeks; the second period in a calendar year of 13 complete, 
consecutive weeks; the third period in a calendar year of 13 complete, 
consecutive calendar weeks; the fourth period in a calendar year of 13 
complete, consecutive calendar weeks. If at the end of a calendar year 
there are any days not falling within a complete calendar week of that 
year, such days shall be included within the last complete calendar week 
of that year. If at the beginning of any calendar year there are days 
not falling within a complete calendar week of that year, such days 
shall be included within the last complete calendar week of the previous 
year; or
    (iii) The four periods in a calendar year may consist of the first 
14 complete, consecutive calendar weeks; the next 12 complete, 
consecutive calendar weeks, the next 14 complete, consecutive calendar 
weeks, and the last 12 complete, consecutive calendar weeks. If at the 
end of a calendar year there are any days not falling within a complete 
calendar week of that year, such days shall be included (for purposes of 
this section) within the last complete calendar week of the year. If at 
the beginning of any calendar year there are days not falling within a 
complete calendar week of that year, such days shall be included (for 
purposes of this section) within the last complete week of the previous 
year.
    (c) Exposure to airborne radioactive material. (1) No employer shall 
possess, use or transport radioactive material in such a manner as to 
cause any employee, within a restricted area, to be exposed to airborne 
radioactive material in an average concentration in excess of the limits 
specified in Table 1 of appendix B to 10 CFR part 20. The limits given 
in Table 1 are for exposure to the concentrations specified for 40 hours 
in any workweek of 7 consecutive days. In any such period where the 
number of hours of exposure is less than 40, the limits specified in the 
table may be increased proportionately. In any such period where the 
number of hours of exposure is greater than 40, the limits specified in 
the table shall be decreased proportionately.
    (2) No employer shall possess, use, or transfer radioactive material 
in such a manner as to cause any individual within a restricted area, 
who is under 18 years of age, to be exposed to airborne radioactive 
material in an average concentration in excess of the limits specified 
in Table II of appendix B to 10 CFR part 20. For purposes of this 
paragraph, concentrations may be averaged over periods not greater than 
1 week.

[[Page 535]]

    (3) Exposed as used in this paragraph means that the individual is 
present in an airborne concentration. No allowance shall be made for the 
use of protective clothing or equipment, or particle size.
    (d) Precautionary procedures and personal monitoring. (1) Every 
employer shall make such surveys as may be necessary for him to comply 
with the provisions in this section. Survey means an evaluation of the 
radiation hazards incident to the production, use, release, disposal, or 
presence of radioactive materials or other sources of radiation under a 
specific set of conditions. When appropriate, such evaluation includes a 
physical survey of the location of materials and equipment, and 
measurements of levels of radiation or concentrations of radioactive 
material present.
    (2) Every employer shall supply appropriate personnel monitoring 
equipment, such as film badges, pocket chambers, pocket dosimeters, or 
film rings, and shall require the use of such equipment by:
    (i) Each employee who enters a restricted area under such 
circumstances that he receives, or is likely to receive, a dose in any 
calendar quarter in excess of 25 percent of the applicable value 
specified in paragraph (b)(1) of this section; and
    (ii) Each employee under 18 years of age who enters a restricted 
area under such circumstances that he receives, or is likely to receive, 
a dose in any calendar quarter in excess of 5 percent of the applicable 
value specified in paragraph (b)(1) of this section; and
    (iii) Each employee who enters a high radiation area.
    (3) As used in this section:
    (i) Personnel monitoring equipment means devices designed to be worn 
or carried by an individual for the purpose of measuring the dose 
received (e.g., film badges, pocket chambers, pocket dosimeters, film 
rings, etc.);
    (ii) Radiation area means any area, accessible to personnel, in 
which there exists radiation at such levels that a major portion of the 
body could receive in any 1 hour a dose in excess of 5 millirem, or in 
any 5 consecutive days a dose in excess of 100 millirem; and
    (iii) High radiation area means any area, accessible to personnel, 
in which there exists radiation at such levels that a major portion of 
the body could receive in any one hour a dose in excess of 100 millirem.
    (e) Caution signs, labels, and signals--(1) General. (i) Symbols 
prescribed by this paragraph shall use the conventional radiation 
caution colors (magenta or purple on yellow background). The symbol 
prescribed by this paragraph is the conventional three-bladed design:
[GRAPHIC] [TIFF OMITTED] TC28OC91.041

                               Figure G-10
    (ii) [Reserved]
    (2) Radiation area. Each radiation area shall be conspicuously 
posted with a sign or signs bearing the radiation caution symbol 
described in subparagraph (1) of this paragraph and the words:

                                 CAUTION

                             RADIATION AREA

    (3) High radiation area. (i) Each high radiation area shall be 
conspicuously posted with a sign or signs bearing the radiation caution 
symbol and the words:

[[Page 536]]

                                 CAUTION

                           HIGH RADIATION AREA

    (ii) Each high radiation area shall be equipped with a control 
device which shall either cause the level of radiation to be reduced 
below that at which an individual might receive a dose of 100 millirems 
in 1 hour upon entry into the area or shall energize a conspicuous 
visible or audible alarm signal in such a manner that the individual 
entering and the employer or a supervisor of the activity are made aware 
of the entry. In the case of a high radiation area established for a 
period of 30 days or less, such control device is not required.
    (4) Airborne radioactivity area. (i) As used in the provisions of 
this section, airborne radioactivity area means:
    (a) Any room, enclosure, or operating area in which airborne 
radioactive materials, composed wholly or partly of radioactive 
material, exist in concentrations in excess of the amounts specified in 
column 1 of Table 1 of appendix B to 10 CFR part 20 or
    (b) Any room, enclosure, or operating area in which airborne 
radioactive materials exist in concentrations which, averaged over the 
number of hours in any week during which individuals are in the area, 
exceed 25 percent of the amounts specified in column 1 of Table 1 of 
appendix B to 10 CFR part 20.
    (ii) Each airborne radioactivity area shall be conspicuously posted 
with a sign or signs bearing the radiation caution symbol described in 
paragraph (e)(1) of this section and the words:

                                 CAUTION

                       AIRBORNE RADIOACTIVITY AREA

    (5) Additional requirements. (i) Each area or room in which 
radioactive material is used or stored and which contains any 
radioactive material (other than natural uranium or thorium) in any 
amount exceeding 10 times the quantity of such material specified in 
appendix C to 10 CFR part 20 shall be conspicuously posted with a sign 
or signs bearing the radiation caution symbol described in paragraph 
(e)(1) of this section and the words:

                                 CAUTION

                          RADIOACTIVE MATERIALS

    (ii) Each area or room in which natural uranium or thorium is used 
or stored in an amount exceeding 100 times the quantity of such material 
specified in 10 CFR part 20 shall be conspicuously posted with a sign or 
signs bearing the radiation caution symbol described in paragraph (e)(1) 
of this section and the words:

                                 CAUTION

                          RADIOACTIVE MATERIALS

    (6) Containers. (i) Each container in which is transported, stored, 
or used a quantity of any radioactive material (other than natural 
uranium or thorium) greater than the quantity of such material specified 
in appendix C to 10 CFR part 20 shall bear a durable, clearly visible 
label bearing the radiation caution symbol described in paragraph (e)(1) 
of this section and the words:

                                 CAUTION

                          RADIOACTIVE MATERIALS

    (ii) Each container in which natural uranium or thorium is 
transported, stored, or used in a quantity greater than 10 times the 
quantity specified in appendix C to 10 CFR part 20 shall bear a durable, 
clearly visible label bearing the radiation caution symbol described in 
paragraph (e)(1) of this section and the words:

                                 CAUTION

                          RADIOACTIVE MATERIALS

    (iii) Notwithstanding the provisions of paragraphs (e)(6) (i) and 
(ii) of this section a label shall not be required:
    (a) If the concentration of the material in the container does not 
exceed that specified in column 2 of Table 1 of appendix B to 10 CFR 
part 20, or
    (b) For laboratory containers, such as beakers, flasks, and test 
tubes, used transiently in laboratory procedures, when the user is 
present.
    (iv) Where containers are used for storage, the labels required in 
this subparagraph shall state also the quantities and kinds of 
radioactive materials in the containers and the date of measurement of 
the quantities.
    (f) Immediate evacuation warning signal--(1) Signal characteristics. 
(i) The signal shall be a midfrequency complex sound wave amplitude 
modulated at a subsonic frequency. The complex sound wave in free space 
shall have a fundamental frequency (f1) between 450 and

[[Page 537]]

500 hertz (Hz) modulated at a subsonic rate between 4 and 5 hertz.
    (ii) The signal generator shall not be less than 75 decibels at 
every location where an individual may be present whose immediate, 
rapid, and complete evacuation is essential.
    (iii) A sufficient number of signal units shall be installed such 
that the requirements of paragraph (f)(1)(ii) of this section are met at 
every location where an individual may be present whose immediate, 
rapid, and complete evacuation is essential.
    (iv) The signal shall be unique in the plant or facility in which it 
is installed.
    (v) The minimum duration of the signal shall be sufficient to insure 
that all affected persons hear the signal.
    (vi) The signal-generating system shall respond automatically to an 
initiating event without requiring any human action to sound the signal.
    (2) Design objectives. (i) The signal-generating system shall be 
designed to incorporate components which enable the system to produce 
the desired signal each time it is activated within one-half second of 
activation.
    (ii) The signal-generating system shall be provided with an 
automatically activated secondary power supply which is adequate to 
simultaneously power all emergency equipment to which it is connected, 
if operation during power failure is necessary, except in those systems 
using batteries as the primary source of power.
    (iii) All components of the signal-generating system shall be 
located to provide maximum practicable protection against damage in case 
of fire, explosion, corrosive atmosphere, or other environmental 
extremes consistent with adequate system performance.
    (iv) The signal-generating system shall be designed with the minimum 
number of components necessary to make it function as intended, and 
should utilize components which do not require frequent servicing such 
as lubrication or cleaning.
    (v) Where several activating devices feed activating information to 
a central signal generator, failure of any activating device shall not 
render the signal-generator system inoperable to activating information 
from the remaining devices.
    (vi) The signal-generating system shall be designed to enhance the 
probability that alarm occurs only when immediate evacuation is 
warranted. The number of false alarms shall not be so great that the 
signal will come to be disregarded and shall be low enough to minimize 
personal injuries or excessive property damage that might result from 
such evacuation.
    (3) Testing. (i) Initial tests, inspections, and checks of the 
signal-generating system shall be made to verify that the fabrication 
and installation were made in accordance with design plans and 
specifications and to develop a thorough knowledge of the performance of 
the system and all components under normal and hostile conditions.
    (ii) Once the system has been placed in service, periodic tests, 
inspections, and checks shall be made to minimize the possibility of 
malfunction.
    (iii) Following significant alterations or revisions to the system, 
tests and checks similar to the initial installation tests shall be 
made.
    (iv) Tests shall be designed to minimize hazards while conducting 
the tests.
    (v) Prior to normal operation the signal-generating system shall be 
checked physically and functionally to assure reliability and to 
demonstrate accuracy and performance. Specific tests shall include:
    (a) All power sources.
    (b) Calibration and calibration stability.
    (c) Trip levels and stability.
    (d) Continuity of function with loss and return of required services 
such as AC or DC power, air pressure, etc.
    (e) All indicators.
    (f) Trouble indicator circuits and signals, where used.
    (g) Air pressure (if used)
    (h) Determine that sound level of the signal is within the limit of 
paragraph (f)(1)(ii) of this section at all points that require 
immediate evacuation.
    (vi) In addition to the initial startup and operating tests, 
periodic scheduled performance tests and status checks must be made to 
insure that the system is at all times operating within design limits 
and capable of the required

[[Page 538]]

response. Specific periodic tests or checks or both shall include:
    (a) Adequacy of signal activation device.
    (b) All power sources.
    (c) Function of all alarm circuits and trouble indicator circuits 
including trip levels.
    (d) Air pressure (if used).
    (e) Function of entire system including operation without power 
where required.
    (f) Complete operational tests including sounding of the signal and 
determination that sound levels are adequate.
    (vii) Periodic tests shall be scheduled on the basis of need, 
experience, difficulty, and disruption of operations. The entire system 
should be operationally tested at least quarterly.
    (viii) All employees whose work may necessitate their presence in an 
area covered by the signal shall be made familiar with the actual sound 
of the signal--preferably as it sounds at their work location. Before 
placing the system into operation, all employees normally working in the 
area shall be made acquainted with the signal by actual demonstration at 
their work locations.
    (g) Exceptions from posting requirements. Notwithstanding the 
provisions of paragraph (e) of this section:
    (1) A room or area is not required to be posted with a caution sign 
because of the presence of a sealed source, provided the radiation level 
12 inches from the surface of the source container or housing does not 
exceed 5 millirem per hour.
    (2) Rooms or other areas in onsite medical facilities are not 
required to be posted with caution signs because of the presence of 
patients containing radioactive material, provided that there are 
personnel in attendance who shall take the precautions necessary to 
prevent the exposure of any individual to radiation or radioactive 
material in excess of the limits established in the provisions of this 
section.
    (3) Caution signs are not required to be posted at areas or rooms 
containing radioactive materials for periods of less than 8 hours: 
Provided, That
    (i) The materials are constantly attended during such periods by an 
individual who shall take the precautions necessary to prevent the 
exposure of any individual to radiation or radioactive materials in 
excess of the limits established in the provisions of this section; and
    (ii) Such area or room is subject to the employer's control.
    (h) Exemptions for radioactive materials packaged for shipment. 
Radioactive materials packaged and labeled in accordance with 
regulations of the Department of Transportation published in 49 CFR 
Chapter I, are exempt from the labeling and posting requirements of this 
subpart during shipment, provided that the inside containers are labeled 
in accordance with the provisions of paragraph (e) of this section.
    (i) Instruction of personnel, posting. (1) Employers regulated by 
the Nuclear Regulatory Commission shall be governed by 10 CFR part 20 
standards. Employers in a State named in paragraph (p)(3) of this 
section shall be governed by the requirements of the laws and 
regulations of that State. All other employers shall be regulated by the 
following:
    (2) All individuals working in or frequenting any portion of a 
radiation area shall be informed of the occurrence of radioactive 
materials or of radiation in such portions of the radiation area; shall 
be instructed in the safety problems associated with exposure to such 
materials or radiation and in precautions or devices to minimize 
exposure; shall be instructed in the applicable provisions of this 
section for the protection of employees from exposure to radiation or 
radioactive materials; and shall be advised of reports of radiation 
exposure which employees may request pursuant to the regulations in this 
section.
    (3) Each employer to whom this section applies shall post a current 
copy of its provisions and a copy of the operating procedures applicable 
to the work conspicuously in such locations as to insure that employees 
working in or frequenting radiation areas will observe these documents 
on the way to and from their place of employment, or shall keep such 
documents available for examination of employees upon request.

[[Page 539]]

    (j) Storage of radioactive materials. Radioactive materials stored 
in a nonradiation area shall be secured against unauthorized removal 
from the place of storage.
    (k) Waste disposal. No employer shall dispose of radioactive 
material except by transfer to an authorized recipient, or in a manner 
approved by the Nuclear Regulatory Commission or a State named in 
paragraph (p)(3) of this section.
    (l) Notification of incidents--(1) Immediate notification. Each 
employer shall immediately notify the Assistant Secretary of Labor or 
his duly authorized representative, for employees not protected by the 
Nuclear Regulatory Commission by means of 10 CFR part 20; paragraph 
(p)(2) of this section, or the requirements of the laws and regulations 
of States named in paragraph (p)(3) of this section, by telephone or 
telegraph of any incident involving radiation which may have caused or 
threatens to cause:
    (i) Exposure of the whole body of any individual to 25 rems or more 
of radiation; exposure of the skin of the whole body of any individual 
to 150 rems or more of radiation; or exposure of the feet, ankles, 
hands, or forearms of any individual to 375 rems or more of radiation; 
or
    (ii) The release of radioactive material in concentrations which, if 
averaged over a period of 24 hours, would exceed 5,000 times the limit 
specified for such materials in Table II of appendix B to 10 CFR part 
20.
    (2) Twenty-four hour notification. Each employer shall within 24 
hours following its occurrence notify the Assistant Secretary of Labor 
or his duly authorized representative for employees not protected by the 
Nuclear Regulatory Commission by means of 10 CFR part 20; paragraph 
(p)(2) of this section, or the requirements of the laws and applicable 
regulations of States named in paragraph (p)(3) of this section, by 
telephone or telegraph of any incident involving radiation which may 
have caused or threatens to cause:
    (i) Exposure of the whole body of any individual to 5 rems or more 
of radiation; exposure of the skin of the whole body of any individual 
to 30 rems or more of radiation; or exposure of the feet, ankles, hands, 
or forearms to 75 rems or more of radiation; or
    (ii) [Reserved]
    (m) Reports of overexposure and excessive levels and concentrations. 
(1) In addition to any notification required by paragraph (1) of this 
section each employer shall make a report in writing within 30 days to 
the Assistant Secretary of Labor or his duly authorized representative, 
for employees not protected by the Nuclear Regulatory Commission by 
means of 10 CFR part 20; or under paragraph (p)(2) of this section, or 
the requirements of the laws and regulations of States named in 
paragraph (p)(3) of this section, of each exposure of an individual to 
radiation or concentrations of radioactive material in excess of any 
applicable limit in this section. Each report required under this 
paragraph shall describe the extent of exposure of persons to radiation 
or to radioactive material; levels of radiation and concentration of 
radioactive material involved, the cause of the exposure, levels of 
concentrations; and corrective steps taken or planned to assure against 
a recurrence.
    (2) In any case where an employer is required pursuant to the 
provisions of this paragraph to report to the U.S. Department of Labor 
any exposure of an individual to radiation or to concentrations of 
radioactive material, the employer shall also notify such individual of 
the nature and extent of exposure. Such notice shall be in writing and 
shall contain the following statement: ``You should preserve this report 
for future reference.''
    (n) Records. (1) Every employer shall maintain records of the 
radiation exposure of all employees for whom personnel monitoring is 
required under paragraph (d) of this section and advise each of his 
employees of his individual exposure on at least an annual basis.
    (2) Every employer shall maintain records in the same units used in 
tables in paragraph (b) of this section and appendix B to 10 CFR part 
20.
    (o) Disclosure to former employee of individual employee's record. 
(1) At the request of a former employee an employer shall furnish to the 
employee a report of the employee's exposure to radiation as shown in 
records maintained by the employer pursuant to

[[Page 540]]

paragraph (n)(1) of this section. Such report shall be furnished within 
30 days from the time the request is made, and shall cover each calendar 
quarter of the individual's employment involving exposure to radiation 
or such lesser period as may be requested by the employee. The report 
shall also include the results of any calculations and analysis of 
radioactive material deposited in the body of the employee. The report 
shall be in writing and contain the following statement: ``You should 
preserve this report for future reference.''
    (2) [Reserved]
    (p) Nuclear Regulatory Commission licensees--NRC contractors 
operating NRC plants and facilities--NRC Agreement State licensees or 
registrants. (1) Any employer who possesses or uses source material, 
byproduct material, or special nuclear material, as defined in the 
Atomic Energy Act of 1954, as amended, under a license issued by the 
Nuclear Regulatory Commission and in accordance with the requirements of 
10 CFR part 20 shall be deemed to be in compliance with the requirements 
of this section with respect to such possession and use.
    (2) NRC contractors operating NRC plants and facilities: Any 
employer who possesses or uses source material, byproduct material, 
special nuclear material, or other radiation sources under a contract 
with the Nuclear Regulatory Commission for the operation of NRC plants 
and facilities and in accordance with the standards, procedures, and 
other requirements for radiation protection established by the 
Commission for such contract pursuant to the Atomic Energy Act of 1954 
as amended (42 U.S.C. 2011 et seq.), shall be deemed to be in compliance 
with the requirements of this section with respect to such possession 
and use.
    (3) NRC-agreement State licensees or registrants:
    (i) Atomic Energy Act sources. Any employer who possesses or uses 
source material, byproduct material, or special nuclear material, as 
defined in the Atomic Energy Act of 1954, as amended (42 U.S.C. 2011 et 
seq.), and has either registered such sources with, or is operating 
under a license issued by, a State which has an agreement in effect with 
the Nuclear Regulatory Commission pursuant to section 274(b) (42 U.S.C. 
2021(b)) of the Atomic Energy Act of 1954, as amended, and in accordance 
with the requirements of that State's laws and regulations shall be 
deemed to be in compliance with the radiation requirements of this 
section, insofar as his possession and use of such material is 
concerned, unless the Secretary of Labor, after conference with the 
Nuclear Regulatory Commission, shall determine that the State's program 
for control of these radiation sources is incompatible with the 
requirements of this section. Such agreements currently are in effect 
only in the States of Alabama, Arkansas, California, Kansas, Kentucky, 
Florida, Mississippi, New Hampshire, New York, North Carolina, Texas, 
Tennessee, Oregon, Idaho, Arizona, Colorado, Louisiana, Nebraska, 
Washington, Maryland, North Dakota, South Carolina, and Georgia.
    (ii) Other sources. Any employer who possesses or uses radiation 
sources other than source material, byproduct material, or special 
nuclear material, as defined in the Atomic Energy Act of 1954, as 
amended (42 U.S.C. 2011 et seq.), and has either registered such sources 
with, or is operating under a license issued by a State which has an 
agreement in effect with the Nuclear Regulatory Commission pursuant to 
section 274(b) (42 U.S.C. 2021(b)) of the Atomic Energy Act of 1954, as 
amended, and in accordance with the requirements of that State's laws 
and regulations shall be deemed to be in compliance with the radiation 
requirements of this section, insofar as his possession and use of such 
material is concerned, provided the State's program for control of these 
radiation sources is the subject of a currently effective determination 
by the Assistant Secretary of Labor that such program is compatible with 
the requirements of this section. Such determinations currently are in 
effect only in the States of Alabama, Arkansas, California, Kansas, 
Kentucky, Florida, Mississippi, New Hampshire,

[[Page 541]]

New York, North Carolina, Texas, Tennessee, Oregon, Idaho, Arizona, 
Colorado, Louisiana, Nebraska, Washington, Maryland, North Dakota, South 
Carolina, and Georgia.

[39 FR 23502, June 27, 1974, as amended at 43 FR 49746, Oct. 24, 1978; 
43 FR 51759, Nov. 7, 1978; 49 FR 18295, Apr. 30, 1984; 58 FR 35309, June 
30, 1993. Redesignated at 61 FR 31430, June 20, 1996]



Sec.  1910.1200  Hazard communication.

    (a) Purpose. (1) The purpose of this section is to ensure that the 
hazards of all chemicals produced or imported are classified, and that 
information concerning the classified hazards is transmitted to 
employers and employees. The requirements of this section are intended 
to be consistent with the provisions of the United Nations Globally 
Harmonized System of Classification and Labelling of Chemicals (GHS), 
Revision 3. The transmittal of information is to be accomplished by 
means of comprehensive hazard communication programs, which are to 
include container labeling and other forms of warning, safety data 
sheets and employee training.
    (2) This occupational safety and health standard is intended to 
address comprehensively the issue of classifying the potential hazards 
of chemicals, and communicating information concerning hazards and 
appropriate protective measures to employees, and to preempt any 
legislative or regulatory enactments of a state, or political 
subdivision of a state, pertaining to this subject. Classifying the 
potential hazards of chemicals and communicating information concerning 
hazards and appropriate protective measures to employees, may include, 
for example, but is not limited to, provisions for: developing and 
maintaining a written hazard communication program for the workplace, 
including lists of hazardous chemicals present; labeling of containers 
of chemicals in the workplace, as well as of containers of chemicals 
being shipped to other workplaces; preparation and distribution of 
safety data sheets to employees and downstream employers; and 
development and implementation of employee training programs regarding 
hazards of chemicals and protective measures. Under section 18 of the 
Act, no state or political subdivision of a state may adopt or enforce 
any requirement relating to the issue addressed by this Federal 
standard, except pursuant to a Federally-approved state plan.
    (b) Scope and application. (1) This section requires chemical 
manufacturers or importers to classify the hazards of chemicals which 
they produce or import, and all employers to provide information to 
their employees about the hazardous chemicals to which they are exposed, 
by means of a hazard communication program, labels and other forms of 
warning, safety data sheets, and information and training. In addition, 
this section requires distributors to transmit the required information 
to employers. (Employers who do not produce or import chemicals need 
only focus on those parts of this rule that deal with establishing a 
workplace program and communicating information to their workers.)
    (2) This section applies to any chemical which is known to be 
present in the workplace in such a manner that employees may be exposed 
under normal conditions of use or in a foreseeable emergency.
    (3) This section applies to laboratories only as follows:
    (i) Employers shall ensure that labels on incoming containers of 
hazardous chemicals are not removed or defaced;
    (ii) Employers shall maintain any safety data sheets that are 
received with incoming shipments of hazardous chemicals, and ensure that 
they are readily accessible during each workshift to laboratory 
employees when they are in their work areas;
    (iii) Employers shall ensure that laboratory employees are provided 
information and training in accordance with paragraph (h) of this 
section, except for the location and availability of the written hazard 
communication program under paragraph (h)(2)(iii) of this section; and,
    (iv) Laboratory employers that ship hazardous chemicals are 
considered to be either a chemical manufacturer or a distributor under 
this rule, and thus must ensure that any containers of hazardous 
chemicals leaving the laboratory are labeled in accordance with

[[Page 542]]

paragraph (f) of this section, and that a safety data sheet is provided 
to distributors and other employers in accordance with paragraphs (g)(6) 
and (g)(7) of this section.
    (4) In work operations where employees only handle chemicals in 
sealed containers which are not opened under normal conditions of use 
(such as are found in marine cargo handling, warehousing, or retail 
sales), this section applies to these operations only as follows:
    (i) Employers shall ensure that labels on incoming containers of 
hazardous chemicals are not removed or defaced;
    (ii) Employers shall maintain copies of any safety data sheets that 
are received with incoming shipments of the sealed containers of 
hazardous chemicals, shall obtain a safety data sheet as soon as 
possible for sealed containers of hazardous chemicals received without a 
safety data sheet if an employee requests the safety data sheet, and 
shall ensure that the safety data sheets are readily accessible during 
each work shift to employees when they are in their work area(s); and,
    (iii) Employers shall ensure that employees are provided with 
information and training in accordance with paragraph (h) of this 
section (except for the location and availability of the written hazard 
communication program under paragraph (h)(2)(iii) of this section), to 
the extent necessary to protect them in the event of a spill or leak of 
a hazardous chemical from a sealed container.
    (5) This section does not require labeling of the following 
chemicals:
    (i) Any pesticide as such term is defined in the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), when 
subject to the labeling requirements of that Act and labeling 
regulations issued under that Act by the Environmental Protection 
Agency;
    (ii) Any chemical substance or mixture as such terms are defined in 
the Toxic Substances Control Act (15 U.S.C. 2601 et seq.), when subject 
to the labeling requirements of that Act and labeling regulations issued 
under that Act by the Environmental Protection Agency.
    (iii) Any food, food additive, color additive, drug, cosmetic, or 
medical or veterinary device or product, including materials intended 
for use as ingredients in such products (e.g., flavors and fragrances), 
as such terms are defined in the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.) or the Virus-Serum-Toxin Act of 1913 (21 U.S.C. 
151 et seq.), and regulations issued under those Acts, when they are 
subject to the labeling requirements under those Acts by either the Food 
and Drug Administration or the Department of Agriculture;
    (iv) Any distilled spirits (beverage alcohols), wine, or malt 
beverage intended for nonindustrial use, as such terms are defined in 
the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) and 
regulations issued under that Act, when subject to the labeling 
requirements of that Act and labeling regulations issued under that Act 
by the Bureau of Alcohol, Tobacco, Firearms and Explosives;
    (v) Any consumer product or hazardous substance as those terms are 
defined in the Consumer Product Safety Act (15 U.S.C. 2051 et seq.) and 
Federal Hazardous Substances Act (15 U.S.C. 1261 et seq.) respectively, 
when subject to a consumer product safety standard or labeling 
requirement of those Acts, or regulations issued under those Acts by the 
Consumer Product Safety Commission; and,
    (vi) Agricultural or vegetable seed treated with pesticides and 
labeled in accordance with the Federal Seed Act (7 U.S.C. 1551 et seq.) 
and the labeling regulations issued under that Act by the Department of 
Agriculture.
    (6) This section does not apply to: (i) Any hazardous waste as such 
term is defined by the Solid Waste Disposal Act, as amended by the 
Resource Conservation and Recovery Act of 1976, as amended (42 U.S.C. 
6901 et seq.), when subject to regulations issued under that Act by the 
Environmental Protection Agency;
    (ii) Any hazardous substance as such term is defined by the 
Comprehensive Environmental Response, Compensation and Liability Act 
(CERCLA) (42 U.S.C. 9601 et seq.) when the hazardous substance is the 
focus of remedial or removal action being conducted under CERCLA in 
accordance with Environmental Protection Agency regulations.

[[Page 543]]

    (iii) Tobacco or tobacco products;
    (iv) Wood or wood products, including lumber which will not be 
processed, where the chemical manufacturer or importer can establish 
that the only hazard they pose to employees is the potential for 
flammability or combustibility (wood or wood products which have been 
treated with a hazardous chemical covered by this standard, and wood 
which may be subsequently sawed or cut, generating dust, are not 
exempted);
    (v) Articles (as that term is defined in paragraph (c) of this 
section);
    (vi) Food or alcoholic beverages which are sold, used, or prepared 
in a retail establishment (such as a grocery store, restaurant, or 
drinking place), and foods intended for personal consumption by 
employees while in the workplace;
    (vii) Any drug, as that term is defined in the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.), when it is in solid, final 
form for direct administration to the patient (e.g., tablets or pills); 
drugs which are packaged by the chemical manufacturer for sale to 
consumers in a retail establishment (e.g., over-the-counter drugs); and 
drugs intended for personal consumption by employees while in the 
workplace (e.g., first aid supplies);
    (viii) Cosmetics which are packaged for sale to consumers in a 
retail establishment, and cosmetics intended for personal consumption by 
employees while in the workplace;
    (ix) Any consumer product or hazardous substance, as those terms are 
defined in the Consumer Product Safety Act (15 U.S.C. 2051 et seq.) and 
Federal Hazardous Substances Act (15 U.S.C. 1261 et seq.) respectively, 
where the employer can show that it is used in the workplace for the 
purpose intended by the chemical manufacturer or importer of the 
product, and the use results in a duration and frequency of exposure 
which is not greater than the range of exposures that could reasonably 
be experienced by consumers when used for the purpose intended;
    (x) Nuisance particulates where the chemical manufacturer or 
importer can establish that they do not pose any physical or health 
hazard covered under this section;
    (xi) Ionizing and nonionizing radiation; and,
    (xii) Biological hazards.
    (c) Definitions. Article means a manufactured item other than a 
fluid or particle: (i) which is formed to a specific shape or design 
during manufacture; (ii) which has end use function(s) dependent in 
whole or in part upon its shape or design during end use; and (iii) 
which under normal conditions of use does not release more than very 
small quantities, e.g., minute or trace amounts of a hazardous chemical 
(as determined under paragraph (d) of this section), and does not pose a 
physical hazard or health risk to employees.
    Assistant Secretary means the Assistant Secretary of Labor for 
Occupational Safety and Health, U.S. Department of Labor, or designee.
    Chemical means any substance, or mixture of substances.
    Chemical manufacturer means an employer with a workplace where 
chemical(s) are produced for use or distribution.
    Chemical name means the scientific designation of a chemical in 
accordance with the nomenclature system developed by the International 
Union of Pure and Applied Chemistry (IUPAC) or the Chemical Abstracts 
Service (CAS) rules of nomenclature, or a name that will clearly 
identify the chemical for the purpose of conducting a hazard 
classification.
    Classification means to identify the relevant data regarding the 
hazards of a chemical; review those data to ascertain the hazards 
associated with the chemical; and decide whether the chemical will be 
classified as hazardous according to the definition of hazardous 
chemical in this section. In addition, classification for health and 
physical hazards includes the determination of the degree of hazard, 
where appropriate, by comparing the data with the criteria for health 
and physical hazards.
    Commercial account means an arrangement whereby a retail distributor 
sells hazardous chemicals to an employer, generally in large quantities 
over time and/or at costs that are below the regular retail price.
    Common name means any designation or identification such as code 
name,

[[Page 544]]

code number, trade name, brand name or generic name used to identify a 
chemical other than by its chemical name.
    Container means any bag, barrel, bottle, box, can, cylinder, drum, 
reaction vessel, storage tank, or the like that contains a hazardous 
chemical. For purposes of this section, pipes or piping systems, and 
engines, fuel tanks, or other operating systems in a vehicle, are not 
considered to be containers.
    Designated representative means any individual or organization to 
whom an employee gives written authorization to exercise such employee's 
rights under this section. A recognized or certified collective 
bargaining agent shall be treated automatically as a designated 
representative without regard to written employee authorization.
    Director means the Director, National Institute for Occupational 
Safety and Health, U.S. Department of Health and Human Services, or 
designee.
    Distributor means a business, other than a chemical manufacturer or 
importer, which supplies hazardous chemicals to other distributors or to 
employers.
    Employee means a worker who may be exposed to hazardous chemicals 
under normal operating conditions or in foreseeable emergencies. Workers 
such as office workers or bank tellers who encounter hazardous chemicals 
only in non-routine, isolated instances are not covered.
    Employer means a person engaged in a business where chemicals are 
either used, distributed, or are produced for use or distribution, 
including a contractor or subcontractor.
    Exposure or exposed means that an employee is subjected in the 
course of employment to a chemical that is a physical or health hazard, 
and includes potential (e.g., accidental or possible) exposure. 
``Subjected'' in terms of health hazards includes any route of entry 
(e.g., inhalation, ingestion, skin contact or absorption.)
    Foreseeable emergency means any potential occurrence such as, but 
not limited to, equipment failure, rupture of containers, or failure of 
control equipment which could result in an uncontrolled release of a 
hazardous chemical into the workplace.
    Hazard category means the division of criteria within each hazard 
class, e.g., oral acute toxicity and flammable liquids include four 
hazard categories. These categories compare hazard severity within a 
hazard class and should not be taken as a comparison of hazard 
categories more generally.
    Hazard class means the nature of the physical or health hazards, 
e.g., flammable solid, carcinogen, oral acute toxicity.
    Hazard not otherwise classified (HNOC) means an adverse physical or 
health effect identified through evaluation of scientific evidence 
during the classification process that does not meet the specified 
criteria for the physical and health hazard classes addressed in this 
section. This does not extend coverage to adverse physical and health 
effects for which there is a hazard class addressed in this section, but 
the effect either falls below the cut-off value/concentration limit of 
the hazard class or is under a GHS hazard category that has not been 
adopted by OSHA (e.g., acute toxicity Category 5).
    Hazard statement means a statement assigned to a hazard class and 
category that describes the nature of the hazard(s) of a chemical, 
including, where appropriate, the degree of hazard.
    Hazardous chemical means any chemical which is classified as a 
physical hazard or a health hazard, a simple asphyxiant, combustible 
dust, pyrophoric gas, or hazard not otherwise classified.
    Health hazard means a chemical which is classified as posing one of 
the following hazardous effects: acute toxicity (any route of exposure); 
skin corrosion or irritation; serious eye damage or eye irritation; 
respiratory or skin sensitization; germ cell mutagenicity; 
carcinogenicity; reproductive toxicity; specific target organ toxicity 
(single or repeated exposure); or aspiration hazard. The criteria for 
determining whether a chemical is classified as a health hazard are 
detailed in Appendix A to Sec.  1910.1200--Health Hazard Criteria.
    Immediate use means that the hazardous chemical will be under the 
control of and used only by the person who transfers it from a labeled 
container and only within the work shift in which it is transferred.

[[Page 545]]

    Importer means the first business with employees within the Customs 
Territory of the United States which receives hazardous chemicals 
produced in other countries for the purpose of supplying them to 
distributors or employers within the United States.
    Label means an appropriate group of written, printed or graphic 
information elements concerning a hazardous chemical that is affixed to, 
printed on, or attached to the immediate container of a hazardous 
chemical, or to the outside packaging.
    Label elements means the specified pictogram, hazard statement, 
signal word and precautionary statement for each hazard class and 
category.
    Mixture means a combination or a solution composed of two or more 
substances in which they do not react.
    Physical hazard means a chemical that is classified as posing one of 
the following hazardous effects: explosive; flammable (gases, aerosols, 
liquids, or solids); oxidizer (liquid, solid or gas); self-reactive; 
pyrophoric (liquid or solid); self-heating; organic peroxide; corrosive 
to metal; gas under pressure; or in contact with water emits flammable 
gas. See Appendix B to Sec.  1910.1200--Physical Hazard Criteria.
    Pictogram means a composition that may include a symbol plus other 
graphic elements, such as a border, background pattern, or color, that 
is intended to convey specific information about the hazards of a 
chemical. Eight pictograms are designated under this standard for 
application to a hazard category.
    Precautionary statement means a phrase that describes recommended 
measures that should be taken to minimize or prevent adverse effects 
resulting from exposure to a hazardous chemical, or improper storage or 
handling.
    Produce means to manufacture, process, formulate, blend, extract, 
generate, emit, or repackage.
    Product identifier means the name or number used for a hazardous 
chemical on a label or in the SDS. It provides a unique means by which 
the user can identify the chemical. The product identifier used shall 
permit cross-references to be made among the list of hazardous chemicals 
required in the written hazard communication program, the label and the 
SDS.
    Pyrophoric gas means a chemical in a gaseous state that will ignite 
spontaneously in air at a temperature of 130 degrees F (54.4 degrees C) 
or below.
    Responsible party means someone who can provide additional 
information on the hazardous chemical and appropriate emergency 
procedures, if necessary.
    Safety data sheet (SDS) means written or printed material concerning 
a hazardous chemical that is prepared in accordance with paragraph (g) 
of this section.
    Signal word means a word used to indicate the relative level of 
severity of hazard and alert the reader to a potential hazard on the 
label. The signal words used in this section are ``danger'' and 
``warning.'' ``Danger'' is used for the more severe hazards, while 
``warning'' is used for the less severe.
    Simple asphyxiant means a substance or mixture that displaces oxygen 
in the ambient atmosphere, and can thus cause oxygen deprivation in 
those who are exposed, leading to unconsciousness and death.
    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.
    Substance means chemical elements and their compounds in the natural 
state or obtained by any production process, including any additive 
necessary to preserve the stability of the product and any impurities 
deriving from the process used, but excluding any solvent which may be 
separated without affecting the stability of the substance or changing 
its composition.
    Trade secret means any confidential formula, pattern, process, 
device, 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. Appendix 
E to Sec.  1910.1200--Definition of Trade Secret, sets out the criteria 
to be used in evaluating trade secrets.
    Use means to package, handle, react, emit, extract, generate as a 
byproduct, or transfer.

[[Page 546]]

    Work area means a room or defined space in a workplace where 
hazardous chemicals are produced or used, and where employees are 
present.
    Workplace means an establishment, job site, or project, at one 
geographical location containing one or more work areas.
    (d) Hazard classification. (1) Chemical manufacturers and importers 
shall evaluate chemicals produced in their workplaces or imported by 
them to classify the chemicals in accordance with this section. For each 
chemical, the chemical manufacturer or importer shall determine the 
hazard classes, and, where appropriate, the category of each class that 
apply to the chemical being classified. Employers are not required to 
classify chemicals unless they choose not to rely on the classification 
performed by the chemical manufacturer or importer for the chemical to 
satisfy this requirement.
    (2) Chemical manufacturers, importers or employers classifying 
chemicals shall identify and consider the full range of available 
scientific literature and other evidence concerning the potential 
hazards. There is no requirement to test the chemical to determine how 
to classify its hazards. Appendix A to Sec.  1910.1200 shall be 
consulted for classification of health hazards, and Appendix B to Sec.  
1910.1200 shall be consulted for the classification of physical hazards.
    (3) Mixtures. (i) Chemical manufacturers, importers, or employers 
evaluating chemicals shall follow the procedures described in Appendices 
A and B to Sec.  1910.1200 to classify the hazards of the chemicals, 
including determinations regarding when mixtures of the classified 
chemicals are covered by this section.
    (ii) When classifying mixtures they produce or import, chemical 
manufacturers and importers of mixtures may rely on the information 
provided on the current safety data sheets of the individual 
ingredients, except where the chemical manufacturer or importer knows, 
or in the exercise of reasonable diligence should know, that the safety 
data sheet misstates or omits information required by this section.
    (e) Written hazard communication program. (1) Employers shall 
develop, implement, and maintain at each workplace, a written hazard 
communication program which at least describes how the criteria 
specified in paragraphs (f), (g), and (h) of this section for labels and 
other forms of warning, safety data sheets, and employee information and 
training will be met, and which also includes the following:
    (i) A list of the hazardous chemicals known to be present using a 
product identifier that is referenced on the appropriate safety data 
sheet (the list may be compiled for the workplace as a whole or for 
individual work areas); and,
    (ii) The methods the employer will use to inform employees of the 
hazards of non-routine tasks (for example, the cleaning of reactor 
vessels), and the hazards associated with chemicals contained in 
unlabeled pipes in their work areas.
    (2) Multi-employer workplaces. Employers who produce, use, or store 
hazardous chemicals at a workplace in such a way that the employees of 
other employer(s) may be exposed (for example, employees of a 
construction contractor working on-site) shall additionally ensure that 
the hazard communication programs developed and implemented under this 
paragraph (e) include the following:
    (i) The methods the employer will use to provide the other 
employer(s) on-site access to safety data sheets for each hazardous 
chemical the other employer(s)' employees may be exposed to while 
working;
    (ii) The methods the employer will use to inform the other 
employer(s) of any precautionary measures that need to be taken to 
protect employees during the workplace's normal operating conditions and 
in foreseeable emergencies; and,
    (iii) The methods the employer will use to inform the other 
employer(s) of the labeling system used in the workplace.
    (3) The employer may rely on an existing hazard communication 
program to comply with these requirements, provided that it meets the 
criteria established in this paragraph (e).

[[Page 547]]

    (4) The employer shall make the written hazard communication program 
available, upon request, to employees, their designated representatives, 
the Assistant Secretary and the Director, in accordance with the 
requirements of 29 CFR 1910.20 (e).
    (5) Where employees must travel between workplaces during a 
workshift, i.e., their work is carried out at more than one geographical 
location, the written hazard communication program may be kept at the 
primary workplace facility.
    (f) Labels and other forms of warning--(1) Labels on shipped 
containers. The chemical manufacturer, importer, or distributor shall 
ensure that each container of hazardous chemicals leaving the workplace 
is labeled, tagged, or marked. Hazards not otherwise classified do not 
have to be addressed on the container. Where the chemical manufacturer 
or importer is required to label, tag or mark the following information 
shall be provided:
    (i) Product identifier;
    (ii) Signal word;
    (iii) Hazard statement(s);
    (iv) Pictogram(s);
    (v) Precautionary statement(s); and,
    (vi) Name, address, and telephone number of the chemical 
manufacturer, importer, or other responsible party.
    (2) The chemical manufacturer, importer, or distributor shall ensure 
that the information provided under paragraphs (f)(1)(i) through (v) of 
this section is in accordance with Appendix C to Sec.  1910.1200, for 
each hazard class and associated hazard category for the hazardous 
chemical, prominently displayed, and in English (other languages may 
also be included if appropriate).
    (3) The chemical manufacturer, importer, or distributor shall ensure 
that the information provided under paragraphs (f)(1)(ii) through (iv) 
of this section is located together on the label, tag, or mark.
    (4) Solid materials. (i) For solid metal (such as a steel beam or a 
metal casting), solid wood, or plastic items that are not exempted as 
articles due to their downstream use, or shipments of whole grain, the 
required label may be transmitted to the customer at the time of the 
initial shipment, and need not be included with subsequent shipments to 
the same employer unless the information on the label changes;
    (ii) The label may be transmitted with the initial shipment itself, 
or with the safety data sheet that is to be provided prior to or at the 
time of the first shipment; and,
    (iii) This exception to requiring labels on every container of 
hazardous chemicals is only for the solid material itself, and does not 
apply to hazardous chemicals used in conjunction with, or known to be 
present with, the material and to which employees handling the items in 
transit may be exposed (for example, cutting fluids or pesticides in 
grains).
    (5) Chemical manufacturers, importers, or distributors shall ensure 
that each container of hazardous chemicals leaving the workplace is 
labeled, tagged, or marked in accordance with this section in a manner 
which does not conflict with the requirements of the Hazardous Materials 
Transportation Act (49 U.S.C. 1801 et seq.) and regulations issued under 
that Act by the Department of Transportation.
    (6) Workplace labeling. Except as provided in paragraphs (f)(7) and 
(f)(8) of this section, the employer shall ensure that each container of 
hazardous chemicals in the workplace is labeled, tagged or marked with 
either:
    (i) The information specified under paragraphs (f)(1)(i) through (v) 
of this section for labels on shipped containers; or,
    (ii) Product identifier and words, pictures, symbols, or combination 
thereof, which provide at least general information regarding the 
hazards of the chemicals, and which, in conjunction with the other 
information immediately available to employees under the hazard 
communication program, will provide employees with the specific 
information regarding the physical and health hazards of the hazardous 
chemical.
    (7) The employer may use signs, placards, process sheets, batch 
tickets, operating procedures, or other such written materials in lieu 
of affixing labels to individual stationary process containers, as long 
as the alternative method identifies the containers to which it is 
applicable and conveys the information required by paragraph

[[Page 548]]

(f)(6) of this section to be on a label. The employer shall ensure the 
written materials are readily accessible to the employees in their work 
area throughout each work shift.
    (8) The employer is not required to label portable containers into 
which hazardous chemicals are transferred from labeled containers, and 
which are intended only for the immediate use of the employee who 
performs the transfer. For purposes of this section, drugs which are 
dispensed by a pharmacy to a health care provider for direct 
administration to a patient are exempted from labeling.
    (9) The employer shall not remove or deface existing labels on 
incoming containers of hazardous chemicals, unless the container is 
immediately marked with the required information.
    (10) The employer shall ensure that workplace labels or other forms 
of warning are legible, in English, and prominently displayed on the 
container, or readily available in the work area throughout each work 
shift. Employers having employees who speak other languages may add the 
information in their language to the material presented, as long as the 
information is presented in English as well.
    (11) Chemical manufacturers, importers, distributors, or employers 
who become newly aware of any significant information regarding the 
hazards of a chemical shall revise the labels for the chemical within 
six months of becoming aware of the new information, and shall ensure 
that labels on containers of hazardous chemicals shipped after that time 
contain the new information. If the chemical is not currently produced 
or imported, the chemical manufacturer, importer, distributor, or 
employer shall add the information to the label before the chemical is 
shipped or introduced into the workplace again.
    (g) Safety data sheets. (1) Chemical manufacturers and importers 
shall obtain or develop a safety data sheet for each hazardous chemical 
they produce or import. Employers shall have a safety data sheet in the 
workplace for each hazardous chemical which they use.
    (2) The chemical manufacturer or importer preparing the safety data 
sheet shall ensure that it is in English (although the employer may 
maintain copies in other languages as well), and includes at least the 
following section numbers and headings, and associated information under 
each heading, in the order listed (See Appendix D to Sec.  1910.1200--
Safety Data Sheets, for the specific content of each section of the 
safety data sheet):
    (i) Section 1, Identification;
    (ii) Section 2, Hazard(s) identification;
    (iii) Section 3, Composition/information on ingredients;
    (iv) Section 4, First-aid measures;
    (v) Section 5, Fire-fighting measures;
    (vi) Section 6, Accidental release measures;
    (vii) Section 7, Handling and storage;
    (viii) Section 8, Exposure controls/personal protection;
    (ix) Section 9, Physical and chemical properties;
    (x) Section 10, Stability and reactivity;
    (xi) Section 11, Toxicological information;
    (xii) Section 12, Ecological information;
    (xiii) Section 13, Disposal considerations;
    (xiv) Section 14, Transport information;
    (xv) Section 15, Regulatory information; and
    (xvi) Section 16, Other information, including date of preparation 
or last revision.

    Note 1 to paragraph (g)(2): To be consistent with the GHS, an SDS 
must also include the headings in paragraphs (g)(2)(xii) through 
(g)(2)(xv) in order.
    Note 2 to paragraph (g)(2): OSHA will not be enforcing information 
requirements in sections 12 through 15, as these areas are not under its 
jurisdiction.

    (3) If no relevant information is found for any sub-heading within a 
section on the safety data sheet, the chemical manufacturer, importer or 
employer preparing the safety data sheet shall mark it to indicate that 
no applicable information was found.
    (4) Where complex mixtures have similar hazards and contents (i.e., 
the chemical ingredients are essentially the same, but the specific 
composition varies from mixture to mixture), the chemical manufacturer, 
importer or employer may prepare one safety data

[[Page 549]]

sheet to apply to all of these similar mixtures.
    (5) The chemical manufacturer, importer or employer preparing the 
safety data sheet shall ensure that the information provided accurately 
reflects the scientific evidence used in making the hazard 
classification. If the chemical manufacturer, importer or employer 
preparing the safety data sheet becomes newly aware of any significant 
information regarding the hazards of a chemical, or ways to protect 
against the hazards, this new information shall be added to the safety 
data sheet within three months. If the chemical is not currently being 
produced or imported, the chemical manufacturer or importer shall add 
the information to the safety data sheet before the chemical is 
introduced into the workplace again.
    (6)(i) Chemical manufacturers or importers shall ensure that 
distributors and employers are provided an appropriate safety data sheet 
with their initial shipment, and with the first shipment after a safety 
data sheet is updated;
    (ii) The chemical manufacturer or importer shall either provide 
safety data sheets with the shipped containers or send them to the 
distributor or employer prior to or at the time of the shipment;
    (iii) If the safety data sheet is not provided with a shipment that 
has been labeled as a hazardous chemical, the distributor or employer 
shall obtain one from the chemical manufacturer or importer as soon as 
possible; and,
    (iv) The chemical manufacturer or importer shall also provide 
distributors or employers with a safety data sheet upon request.
    (7)(i) Distributors shall ensure that material data sheets, and 
updated information, are provided to other distributors and employers 
with their initial shipment and with the first shipment after a safety 
data sheet is updated;
    (ii) The distributor shall either provide safety data sheets with 
the shipped containers, or send them to the other distributor or 
employer prior to or at the time of the shipment;
    (iii) Retail distributors selling hazardous chemicals to employers 
having a commercial account shall provide a safety data sheet to such 
employers upon request, and shall post a sign or otherwise inform them 
that a material safety data sheet is available;
    (iv) Wholesale distributors selling hazardous chemicals to employers 
over-the-counter may also provide safety data sheets upon the request of 
the employer at the time of the over-the-counter purchase, and shall 
post a sign or otherwise inform such employers that a material safety 
data sheet is available;
    (v) If an employer without a commercial account purchases a 
hazardous chemical from a retail distributor not required to have safety 
data sheets on file (i.e., the retail distributor does not have 
commercial accounts and does not use the materials), the retail 
distributor shall provide the employer, upon request, with the name, 
address, and telephone number of the chemical manufacturer, importer, or 
distributor from which a safety data sheet can be obtained;
    (vi) Wholesale distributors shall also provide safety data sheets to 
employers or other distributors upon request; and,
    (vii) Chemical manufacturers, importers, and distributors need not 
provide safety data sheets to retail distributors that have informed 
them that the retail distributor does not sell the product to commercial 
accounts or open the sealed container to use it in their own workplaces.
    (8) The employer shall maintain in the workplace copies of the 
required safety data sheets for each hazardous chemical, and shall 
ensure that they are readily accessible during each work shift to 
employees when they are in their work area(s). (Electronic access and 
other alternatives to maintaining paper copies of the safety data sheets 
are permitted as long as no barriers to immediate employee access in 
each workplace are created by such options.)
    (9) Where employees must travel between workplaces during a 
workshift, i.e., their work is carried out at more than one geographical 
location, the safety data sheets may be kept at the primary workplace 
facility. In this situation, the employer shall ensure that employees 
can immediately obtain the required information in an emergency.

[[Page 550]]

    (10) Safety data sheets may be kept in any form, including operating 
procedures, and may be designed to cover groups of hazardous chemicals 
in a work area where it may be more appropriate to address the hazards 
of a process rather than individual hazardous chemicals. However, the 
employer shall ensure that in all cases the required information is 
provided for each hazardous chemical, and is readily accessible during 
each work shift to employees when they are in their work area(s).
    (11) Safety data sheets shall also be made readily available, upon 
request, to designated representatives, the Assistant Secretary, and the 
Director, in accordance with the requirements of Sec.  1910.1020(e).
    (h) Employee information and training. (1) Employers shall provide 
employees with effective information and training on hazardous chemicals 
in their work area at the time of their initial assignment, and whenever 
a new chemical hazard the employees have not previously been trained 
about is introduced into their work area. Information and training may 
be designed to cover categories of hazards (e.g., flammability, 
carcinogenicity) or specific chemicals. Chemical-specific information 
must always be available through labels and safety data sheets.
    (2) Information. Employees shall be informed of:
    (i) The requirements of this section;
    (ii) Any operations in their work area where hazardous chemicals are 
present; and,
    (iii) The location and availability of the written hazard 
communication program, including the required list(s) of hazardous 
chemicals, and safety data sheets required by this section.
    (3) Training. Employee training shall include at least:
    (i) Methods and observations that may be used to detect the presence 
or release of a hazardous chemical in the work area (such as monitoring 
conducted by the employer, continuous monitoring devices, visual 
appearance or odor of hazardous chemicals when being released, etc.);
    (ii) The physical, health, simple asphyxiation, combustible dust, 
and pyrophoric gas hazards, as well as hazards not otherwise classified, 
of the chemicals in the work area;
    (iii) The measures employees can take to protect themselves from 
these hazards, including specific procedures the employer has 
implemented to protect employees from exposure to hazardous chemicals, 
such as appropriate work practices, emergency procedures, and personal 
protective equipment to be used; and,
    (iv) The details of the hazard communication program developed by 
the employer, including an explanation of the labels received on shipped 
containers and the workplace labeling system used by their employer; the 
safety data sheet, including the order of information and how employees 
can obtain and use the appropriate hazard information.
    (i) Trade secrets. (1) The chemical manufacturer, importer, or 
employer may withhold the specific chemical identity, including the 
chemical name, other specific identification of a hazardous chemical, or 
the exact percentage (concentration) of the substance in a mixture, from 
the safety data sheet, provided that:
    (i) The claim that the information withheld is a trade secret can be 
supported;
    (ii) Information contained in the safety data sheet concerning the 
properties and effects of the hazardous chemical is disclosed;
    (iii) The safety data sheet indicates that the specific chemical 
identity and/or percentage of composition is being withheld as a trade 
secret; and,
    (iv) The specific chemical identity and percentage is made available 
to health professionals, employees, and designated representatives in 
accordance with the applicable provisions of this paragraph (i).
    (2) Where a treating physician or nurse determines that a medical 
emergency exists and the specific chemical identity and/or specific 
percentage of composition of a hazardous chemical is necessary for 
emergency or first-aid treatment, the chemical manufacturer, importer, 
or employer shall immediately disclose the specific chemical identity or 
percentage composition of a trade secret chemical to that treating 
physician or nurse, regardless of the

[[Page 551]]

existence of a written statement of need or a confidentiality agreement. 
The chemical manufacturer, importer, or employer may require a written 
statement of need and confidentiality agreement, in accordance with the 
provisions of paragraphs (i)(3) and (4) of this section, as soon as 
circumstances permit.
    (3) In non-emergency situations, a chemical manufacturer, importer, 
or employer shall, upon request, disclose a specific chemical identity 
or percentage composition, otherwise permitted to be withheld under 
paragraph (i)(1) of this section, to a health professional (i.e., 
physician, industrial hygienist, toxicologist, epidemiologist, or 
occupational health nurse) providing medical or other occupational 
health services to exposed employee(s), and to employees or designated 
representatives, 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 or percentage composition is essential and 
that, in lieu thereof, the disclosure of the following information to 
the health professional, employee, or designated representative, would 
not satisfy the purposes described in paragraph (i)(3)(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, and the employer or contractor of the 
services of the health professional (i.e., downstream employer, labor 
organization, or individual employee), employee, 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 (i)(6) of 
this section, except as authorized by the terms of the agreement or by 
the chemical manufacturer, importer, or employer.
    (4) The confidentiality agreement authorized by paragraph (i)(3)(iv) 
of this section:
    (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.
    (5) Nothing in this standard is meant to preclude the parties from 
pursuing non-contractual remedies to the extent permitted by law.
    (6) 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 chemical manufacturer, importer, 
or employer who provided the information shall be informed by the health 
professional, employee, or designated representative prior to, or at the 
same time as, such disclosure.

[[Page 552]]

    (7) If the chemical manufacturer, importer, or employer denies a 
written request for disclosure of a specific chemical identity or 
percentage composition, 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 or percent of composition 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 trade 
secret.
    (8) The health professional, employee, or designated representative 
whose request for information is denied under paragraph (i)(3) of this 
section may refer the request and the written denial of the request to 
OSHA for consideration.
    (9) When a health professional, employee, or designated 
representative refers the denial to OSHA under paragraph (i)(8) of this 
section, OSHA shall consider the evidence to determine if:
    (i) The chemical manufacturer, importer, or employer has supported 
the claim that the specific chemical identity or percentage composition 
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.
    (10)(i) If OSHA determines that the specific chemical identity or 
percentage composition requested under paragraph (i)(3) 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 
representative has a legitimate medical or occupational health need for 
the information, has executed a written confidentiality agreement, and 
has shown adequate means to protect the confidentiality of the 
information, the chemical manufacturer, importer, or employer will be 
subject to citation by OSHA.
    (ii) If a chemical manufacturer, importer, or 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, 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 services are provided 
without an undue risk of harm to the chemical manufacturer, importer, or 
employer.
    (11) If a citation for a failure to release trade secret information 
is contested by the chemical manufacturer, importer, or employer, the 
matter will be adjudicated before the Occupational Safety and Health 
Review Commission in accordance with the Act's enforcement scheme and 
the applicable Commission rules of procedure. In accordance with the 
Commission rules, when a chemical manufacturer, importer, or employer 
continues to withhold the information during the contest, the 
Administrative Law Judge may review the citation and supporting 
documentation ``in camera'' or issue appropriate orders to protect the 
confidentiality of such matters.
    (12) Notwithstanding the existence of a trade secret claim, a 
chemical manufacturer, importer, or employer shall, upon request, 
disclose to the Assistant Secretary any information which this section 
requires the chemical manufacturer, importer, or 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 information which is a 
trade secret.
    (j) Effective dates. (1) Employers shall train employees regarding 
the new

[[Page 553]]

label elements and safety data sheets format by December 1, 2013.
    (2) Chemical manufacturers, importers, distributors, and employers 
shall be in compliance with all modified provisions of this section no 
later than June 1, 2015, except:
    (i) After December 1, 2015, the distributor shall not ship 
containers labeled by the chemical manufacturer or importer unless the 
label has been modified to comply with paragraph (f)(1) of this section.
    (ii) All employers shall, as necessary, update any alternative 
workplace labeling used under paragraph (f)(6) of this section, update 
the hazard communication program required by paragraph (h)(1), and 
provide any additional employee training in accordance with paragraph 
(h)(3) for newly identified physical or health hazards no later than 
June 1, 2016.
    (3) Chemical manufacturers, importers, distributors, and employers 
may comply with either Sec.  1910.1200 revised as of October 1, 2011, or 
the current version of this standard, or both during the transition 
period.

    Appendix A to Sec.  1910.1200--Health Hazard Criteria (Mandatory)

                A.0 GENERAL CLASSIFICATION CONSIDERATIONS

                          A.0.1 Classification

    A.0.1.1 The term ``hazard classification'' is used to indicate that 
only the intrinsic hazardous properties of chemicals are considered. 
Hazard classification incorporates three steps:
    (a) Identification of relevant data regarding the hazards of a 
chemical;
    (b) Subsequent review of those data to ascertain the hazards 
associated with the chemical;
    (c) Determination of whether the chemical will be classified as 
hazardous and the degree of hazard.
    A.0.1.2 For many hazard classes, the criteria are semi-quantitative 
or qualitative and expert judgment is required to interpret the data for 
classification purposes.

        A.0.2 Available Data, Test Methods and Test Data Quality

    A.0.2.1 There is no requirement for testing chemicals.
    A.0.2.2 The criteria for determining health hazards are test method 
neutral, i.e., they do not specify particular test methods, as long as 
the methods are scientifically validated.
    A.0.2.3 The term ``scientifically validated'' refers to the process 
by which the reliability and the relevance of a procedure are 
established for a particular purpose. Any test that determines hazardous 
properties, which is conducted according to recognized scientific 
principles, can be used for purposes of a hazard determination for 
health hazards. Test conditions need to be standardized so that the 
results are reproducible with a given substance, and the standardized 
test yields ``valid'' data for defining the hazard class of concern.
    A.0.2.4 Existing test data are acceptable for classifying chemicals, 
although expert judgment also may be needed for classification purposes.
    A.0.2.5 The effect of a chemical on biological systems is 
influenced, by the physico-chemical properties of the substance and/or 
ingredients of the mixture and the way in which ingredient substances 
are biologically available. A chemical need not be classified when it 
can be shown by conclusive experimental data from scientifically 
validated test methods that the chemical is not biologically available.
    A.0.2.6 For classification purposes, epidemiological data and 
experience on the effects of chemicals on humans (e.g., occupational 
data, data from accident databases) shall be taken into account in the 
evaluation of human health hazards of a chemical.

            A.0.3 Classification Based on Weight of Evidence

    A.0.3.1 For some hazard classes, classification results directly 
when the data satisfy the criteria. For others, classification of a 
chemical shall be determined on the basis of the total weight of 
evidence using expert judgment. This means that all available 
information bearing on the classification of hazard shall be considered 
together, including the results of valid in vitro tests, relevant animal 
data, and human experience such as epidemiological and clinical studies 
and well-documented case reports and observations.
    A.0.3.2 The quality and consistency of the data shall be considered. 
Information on chemicals related to the material being classified shall 
be considered as appropriate, as well as site of action and mechanism or 
mode of action study results. Both positive and negative results shall 
be considered together in a single weight-of-evidence determination.
    A.0.3.3 Positive effects which are consistent with the criteria for 
classification, whether seen in humans or animals, shall

[[Page 554]]

normally justify classification. Where evidence is available from both 
humans and animals and there is a conflict between the findings, the 
quality and reliability of the evidence from both sources shall be 
evaluated in order to resolve the question of classification. Reliable, 
good quality human data shall generally have precedence over other data. 
However, even well-designed and conducted epidemiological studies may 
lack a sufficient number of subjects to detect relatively rare but still 
significant effects, or to assess potentially confounding factors. 
Therefore, positive results from well-conducted animal studies are not 
necessarily negated by the lack of positive human experience but require 
an assessment of the robustness, quality and statistical power of both 
the human and animal data.
    A.0.3.4 Route of exposure, mechanistic information, and metabolism 
studies are pertinent to determining the relevance of an effect in 
humans. When such information raises doubt about relevance in humans, a 
lower classification may be warranted. When there is scientific evidence 
demonstrating that the mechanism or mode of action is not relevant to 
humans, the chemical should not be classified.
    A.0.3.5 Both positive and negative results are considered together 
in the weight of evidence determination. However, a single positive 
study performed according to good scientific principles and with 
statistically and biologically significant positive results may justify 
classification.

         A.0.4 Considerations for the Classification of Mixtures

    A.0.4.1 For most hazard classes, the recommended process of 
classification of mixtures is based on the following sequence:
    (a) Where test data are available for the complete mixture, the 
classification of the mixture will always be based on those data;
    (b) Where test data are not available for the mixture itself, the 
bridging principles designated in each health hazard chapter of this 
appendix shall be considered for classification of the mixture;
    (c) If test data are not available for the mixture itself, and the 
available information is not sufficient to allow application of the 
above-mentioned bridging principles, then the method(s) described in 
each chapter for estimating the hazards based on the information known 
will be applied to classify the mixture (e.g., application of cut-off 
values/concentration limits).
    A.0.4.2 An exception to the above order or precedence is made for 
Carcinogenicity, Germ Cell Mutagenicity, and Reproductive Toxicity. For 
these three hazard classes, mixtures shall be classified based upon 
information on the ingredient substances, unless on a case-by-case 
basis, justification can be provided for classifying based upon the 
mixture as a whole. See chapters A.5, A.6, and A.7 for further 
information on case-by-case bases.
    A.0.4.3 Use of cut-off values/concentration limits.
    A.0.4.3.1 When classifying an untested mixture based on the hazards 
of its ingredients, cut-off values/concentration limits for the 
classified ingredients of the mixture are used for several hazard 
classes. While the adopted cut-off values/concentration limits 
adequately identify the hazard for most mixtures, there may be some that 
contain hazardous ingredients at lower concentrations than the specified 
cut-off values/concentration limits that still pose an identifiable 
hazard. There may also be cases where the cut-off value/concentration 
limit is considerably lower than the established non-hazardous level for 
an ingredient.
    A.0.4.3.2 If the classifier has information that the hazard of an 
ingredient will be evident (i.e., it presents a health risk) below the 
specified cut-off value/concentration limit, the mixture containing that 
ingredient shall be classified accordingly.
    A.0.4.3.3 In exceptional cases, conclusive data may demonstrate that 
the hazard of an ingredient will not be evident (i.e., it does not 
present a health risk) when present at a level above the specified cut-
off value/concentration limit(s). In these cases the mixture may be 
classified according to those data. The data must exclude the 
possibility that the ingredient will behave in the mixture in a manner 
that would increase the hazard over that of the pure substance. 
Furthermore, the mixture must not contain ingredients that would affect 
that determination.
    A.0.4.4 Synergistic or antagonistic effects.
    When performing an assessment in accordance with these requirements, 
the evaluator must take into account all available information about the 
potential occurrence of synergistic effects among the ingredients of the 
mixture. Lowering classification of a mixture to a less hazardous 
category on the basis of antagonistic effects may be done only if the 
determination is supported by sufficient data.

A.0.5 Bridging Principles for the Classification of Mixtures Where Test 
             Data Are Not Available for the Complete Mixture

    A.0.5.1 Where the mixture itself has not been tested to determine 
its toxicity, but there are sufficient data on both the individual 
ingredients and similar tested mixtures to adequately characterize the 
hazards of the mixture, these data shall be used in accordance with the 
following bridging principles, subject to any specific provisions for 
mixtures for each hazard class. These principles ensure that the 
classification process

[[Page 555]]

uses the available data to the greatest extent possible in 
characterizing the hazards of the mixture.
    A.0.5.1.1 Dilution.
    For mixtures classified in accordance with A.1 through A.10 of this 
Appendix, if a tested mixture is diluted with a diluent that has an 
equivalent or lower toxicity classification than the least toxic 
original ingredient, and which is not expected to affect the toxicity of 
other ingredients, then:
    (a) The new diluted mixture shall be classified as equivalent to the 
original tested mixture; or
    (b) For classification of acute toxicity in accordance with A.1 of 
this Appendix, paragraph A.1.3.6 (the additivity formula) shall be 
applied.
    A.0.5.1.2 Batching.
    For mixtures classified in accordance with A.1 through A.10 of this 
Appendix, the toxicity of a tested production batch of a mixture can be 
assumed to be substantially equivalent to that of another untested 
production batch of the same mixture, when produced by or under the 
control of the same chemical manufacturer, unless there is reason to 
believe there is significant variation such that the toxicity of the 
untested batch has changed. If the latter occurs, a new classification 
is necessary.
    A.0.5.1.3 Concentration of mixtures.
    For mixtures classified in accordance with A.1, A.2, A.3, A.8, A.9, 
or A.10 of this Appendix, if a tested mixture is classified in Category 
1, and the concentration of the ingredients of the tested mixture that 
are in Category 1 is increased, the resulting untested mixture shall be 
classified in Category 1.
    A.0.5.1.4 Interpolation within one toxicity category.
    For mixtures classified in accordance with A.1, A.2, A.3, A.8, A.9, 
or A.10 of this Appendix, for three mixtures (A, B and C) with identical 
ingredients, where mixtures A and B have been tested and are in the same 
toxicity category, and where untested mixture C has the same 
toxicologically active ingredients as mixtures A and B but has 
concentrations of toxicologically active ingredients intermediate to the 
concentrations in mixtures A and B, then mixture C is assumed to be in 
the same toxicity category as A and B.
    A.0.5.1.5 Substantially similar mixtures.
    For mixtures classified in accordance with A.1 through A.10 of this 
Appendix, given the following set of conditions:
    (a) Where there are two mixtures:
    (i) A + B;
    (ii) C + B;
    (b) The concentration of ingredient B is essentially the same in 
both mixtures;
    (c) The concentration of ingredient A in mixture (i) equals that of 
ingredient C in mixture (ii);
    (d) And data on toxicity for A and C are available and substantially 
equivalent; i.e., they are in the same hazard category and are not 
expected to affect the toxicity of B; then
    If mixture (i) or (ii) is already classified based on test data, the 
other mixture can be assigned the same hazard category.
    A.0.5.1.6 Aerosols.
    For mixtures classified in accordance with A.1, A.2, A.3, A.4, A.8, 
or A.9 of this Appendix, an aerosol form of a mixture shall be 
classified in the same hazard category as the tested, non-aerosolized 
form of the mixture, provided the added propellant does not affect the 
toxicity of the mixture when spraying.

                           A.1 ACUTE TOXICITY

                            A.1.1 Definition

    Acute toxicity refers to those adverse effects occurring following 
oral or dermal administration of a single dose of a substance, or 
multiple doses given within 24 hours, or an inhalation exposure of 4 
hours.

              A.1.2 Classification Criteria for Substances

    A.1.2.1 Substances can be allocated to one of four toxicity 
categories based on acute toxicity by the oral, dermal or inhalation 
route according to the numeric cut-off criteria as shown in Table A.1.1. 
Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) 
or LC50 (inhalation) values or as acute toxicity estimates (ATE). See 
the footnotes following Table A.1.1 for further explanation on the 
application of these values.

 Table A.1.1--Acute Toxicity Hazard Categories and Acute Toxicity Estimate (ATE) Values Defining the Respective
                                                   Categories
----------------------------------------------------------------------------------------------------------------
          Exposure route             Category 1         Category 2           Category 3           Category 4
----------------------------------------------------------------------------------------------------------------
Oral (mg/kg bodyweight)
    see: Note (a)................             <=5  5 and     50 and    300 and
                                                    <=50.                <=300.               <=2000.
    Note (b)
Dermal (mg/kg bodyweight)
    see: Note (a)................            <=50  50 and    200 and   1000 and
                                                    <=200.               <=1000.              <=2000.
    Note (b)
Inhalation--Gases (ppmV)
    see: Note (a)................           <=100  100 and   500 and   2500 and
                                                    <=500.               <=2500.              <=20000.
    Note (b)
    Note (c)

[[Page 556]]

 
Inhalation--Vapors (mg/l)
    see: Note (a)................           <=0.5  0.5 and   2.0 and   10.0 and
                                                    <=2.0.               <=10.0.              <=20.0.
    Note (b)
    Note (c)
    Note (d)
Inhalation--Dusts and Mists (mg/
 l)
    see: Note (a)................          <=0.05  0.05 and  0.5 and   1.0 and
                                                    <=0.5.               <=1.0.               <=5.0.
    Note (b)
    Note (c)
----------------------------------------------------------------------------------------------------------------
Note: Gas concentrations are expressed in parts per million per volume (ppmV).
Notes to Table A.1.1:
(a) The acute toxicity estimate (ATE) for the classification of a substance is derived using the LD50/LC50 where
  available;
(b) The acute toxicity estimate (ATE) for the classification of a substance or ingredient in a mixture is
  derived using:
(i) the LD50/LC50 where available. Otherwise,
(ii) the appropriate conversion value from Table 1.2 that relates to the results of a range test, or
(iii) the appropriate conversion value from Table 1.2 that relates to a classification category;
(c) Inhalation cut-off values in the table are based on 4 hour testing exposures. Conversion of existing
  inhalation toxicity data which has been generated according to 1 hour exposure is achieved by dividing by a
  factor of 2 for gases and vapors and 4 for dusts and mists;
(d) For some substances the test atmosphere will be a vapor which consists of a combination of liquid and
  gaseous phases. For other substances the test atmosphere may consist of a vapor which is nearly all the
  gaseous phase. In these latter cases, classification is based on ppmV as follows: Category 1 (100 ppmV),
  Category 2 (500 ppmV), Category 3 (2500 ppmV), Category 4 (20000 ppmV).
The terms ``dust'', ``mist'' and ``vapor'' are defined as follows:
(i) Dust: solid particles of a substance or mixture suspended in a gas (usually air);
(ii) Mist: liquid droplets of a substance or mixture suspended in a gas (usually air);
(iii) Vapor: the gaseous form of a substance or mixture released from its liquid or solid state.

    A.1.2.3 The preferred test species for evaluation of acute toxicity 
by the oral and inhalation routes is the rat, while the rat or rabbit 
are preferred for evaluation of acute dermal toxicity. Test data already 
generated for the classification of chemicals under existing systems 
should be accepted when reclassifying these chemicals under the 
harmonized system. When experimental data for acute toxicity are 
available in several animal species, scientific judgment should be used 
in selecting the most appropriate LD50 value from among 
scientifically validated tests.

               A.1.3 Classification Criteria for Mixtures

    A.1.3.1 The approach to classification of mixtures for acute 
toxicity is tiered, and is dependent upon the amount of information 
available for the mixture itself and for its ingredients. The flow chart 
of Figure A.1.1 indicates the process that must be followed:

[[Page 557]]

[GRAPHIC] [TIFF OMITTED] TR26MR12.060

    A.1.3.2 Classification of mixtures for acute toxicity may be carried 
out for each route of exposure, but is only required for one route of 
exposure as long as this route is followed (estimated or tested) for all 
ingredients and there is no relevant evidence to suggest acute toxicity 
by multiple routes. When there is relevant evidence of acute toxicity by 
multiple routes of exposure, classification is to be conducted for all 
appropriate routes of exposure. All available information shall be 
considered. The pictogram and signal word used shall reflect the most 
severe hazard category; and all relevant hazard statements shall be 
used.
    A.1.3.3 For purposes of classifying the hazards of mixtures in the 
tiered approach:
    (a) The ``relevant ingredients'' of a mixture are those which are 
present in concentrations =1% (weight/weight for solids, 
liquids, dusts, mists and vapors and volume/volume for gases). If there 
is reason to suspect that an ingredient present at a concentration <1% 
will affect classification of the mixture for acute toxicity, that 
ingredient shall also be considered relevant. Consideration of 
ingredients present at a concentration <1% is particularly important 
when classifying untested mixtures which contain ingredients that are 
classified in Category 1 and Category 2;
    (b) Where a classified mixture is used as an ingredient of another 
mixture, the actual or derived acute toxicity estimate (ATE) for that 
mixture is used when calculating the classification of the new mixture 
using the formulas in A.1.3.6.1 and A.1.3.6.2.4.
    (c) If the converted acute toxicity point estimates for all 
ingredients of a mixture are within the same category, then the mixture 
should be classified in that category.
    (d) When only range data (or acute toxicity hazard category 
information) are available for ingredients in a mixture, they may be 
converted to point estimates in accordance with Table A.1.2 when 
calculating the classification of the new mixture using the formulas in 
A.1.3.6.1 and A.1.3.6.2.4.

 A.1.3.4 Classification of Mixtures Where Acute Toxicity Test Data Are 
                   Available for the Complete Mixture

    Where the mixture itself has been tested to determine its acute 
toxicity, it is classified according to the same criteria as those used 
for substances, presented in Table A.1.1. If test data for the mixture 
are not available, the procedures presented below must be followed.

 A.1.3.5 Classification of Mixtures Where Acute Toxicity Test Data Are 
       Not Available for the Complete Mixture: Bridging Principles

    A.1.3.5.1 Where the mixture itself has not been tested to determine 
its acute toxicity, but there are sufficient data on both the individual 
ingredients and similar tested mixtures to adequately characterize the 
hazards of the mixture, these data will be used in accordance with the 
following bridging principles as found in paragraph A.0.5 of this 
Appendix: Dilution, Batching, Concentration of mixtures, Interpolation 
within one toxicity category, Substantially similar mixtures, and 
Aerosols.

[[Page 558]]

 A.1.3.6 Classification of Mixtures Based on Ingredients of the Mixture 
                          (Additivity Formula)

    A.1.3.6.1 Data available for all ingredients.
    The acute toxicity estimate (ATE) of ingredients is considered as 
follows:
    (a) Include ingredients with a known acute toxicity, which fall into 
any of the acute toxicity categories, or have an oral or dermal 
LD50 greater than 2000 but less than or equal to 5000 mg/kg 
body weight (or the equivalent dose for inhalation);
    (b) Ignore ingredients that are presumed not acutely toxic (e.g., 
water, sugar);
    (c) Ignore ingredients if the data available are from a limit dose 
test (at the upper threshold for Category 4 for the appropriate route of 
exposure as provided in Table A.1.1) and do not show acute toxicity.
    Ingredients that fall within the scope of this paragraph are 
considered to be ingredients with a known acute toxicity estimate (ATE). 
See note (b) to Table A.1.1 and paragraph A.1.3.3 for appropriate 
application of available data to the equation below, and paragraph 
A.1.3.6.2.4.
    The ATE of the mixture is determined by calculation from the ATE 
values for all relevant ingredients according to the following formula 
below for oral, dermal or inhalation toxicity:
[GRAPHIC] [TIFF OMITTED] TR26MR12.061

Where:

Ci = concentration of ingredient i
n ingredients and i is running from 1 to n
ATEi = acute toxicity estimate of ingredient i.

    A.1.3.6.2 Data are not available for one or more ingredients of the 
mixture.
    A.1.3.6.2.1 Where an ATE is not available for an individual 
ingredient of the mixture, but available information provides a derived 
conversion value, the formula in A.1.3.6.1 may be applied. This 
information may include evaluation of:
    (a) Extrapolation between oral, dermal and inhalation acute toxicity 
estimates. Such an evaluation requires appropriate pharmacodynamic and 
pharmacokinetic data;
    (b) Evidence from human exposure that indicates toxic effects but 
does not provide lethal dose data;
    (c) Evidence from any other toxicity tests/assays available on the 
substance that indicates toxic acute effects but does not necessarily 
provide lethal dose data; or
    (d) Data from closely analogous substances using structure/activity 
relationships.
    A.1.3.6.2.2 This approach requires substantial supplemental 
technical information, and a highly trained and experienced expert, to 
reliably estimate acute toxicity. If sufficient information is not 
available to reliably estimate acute toxicity, proceed to the provisions 
of A.1.3.6.2.3.
    A.1.3.6.2.3 In the event that an ingredient with unknown acute 
toxicity is used in a mixture at a concentration =1%, and the 
mixture has not been classified based on testing of the mixture as a 
whole, the mixture cannot be attributed a definitive acute toxicity 
estimate. In this situation the mixture is classified based on the known 
ingredients only. (Note: A statement that x percent of the mixture 
consists of ingredient(s) of unknown toxicity is required on the label 
and safety data sheet in such cases; see Appendix C to this section, 
Allocation of Label Elements and Appendix D to this section, Safety Data 
Sheets.)
    Where an ingredient with unknown acute toxicity is used in a mixture 
at a concentration =1%, and the mixture is not classified 
based on testing of the mixture as a whole, a statement that X% of the 
mixture consists of ingredient(s) of unknown acute toxicity is required 
on the label and safety data sheet in such cases; see Appendix C to this 
section, Allocation of Label Elements and Appendix D to this section, 
Safety Data Sheets.)
    A.1.3.6.2.4 If the total concentration of the relevant ingredient(s) 
with unknown acute toxicity is <=10% then the formula presented in 
A.1.3.6.1 must be used. If the total concentration of the relevant 
ingredient(s) with unknown acute toxicity is 10%, the formula 
presented in A.1.3.6.1 is corrected to adjust for the percentage of the 
unknown ingredient(s) as follows:

[[Page 559]]

[GRAPHIC] [TIFF OMITTED] TR26MR12.062


   Table A.1.2--Conversion From Experimentally Obtained Acute Toxicity
  Range Values (or Acute Toxicity Hazard Categories) to Acute Toxicity
    Point Estimates for Use in the Formulas for the Classification of
                                Mixtures
------------------------------------------------------------------------
                                 Classification category
                                    or experimentally        Converted
        Exposure routes          obtained acute toxicity  acute toxicity
                                      range estimate      point estimate
------------------------------------------------------------------------
Oral (mg/kg bodyweight ).......  0 =1 of 3 animals
        Category 1: corrosive               Corrosive sub-     -------------------------------------------------
                                              categories                Exposure               Observation
----------------------------------------------------------------------------------------------------------------
                                       1A.....................  <=3 min................  <=1 h.
                                       1B.....................  3 min <=1 h.  <=14 days.
                                       1C.....................  1 h <=4 h...  <=14 days.
----------------------------------------------------------------------------------------------------------------

                           A.2.2.2 Irritation

    A.2.2.2.1 A single irritant category (Category 2) is presented in 
the Table A.2.2. The major criterion for the irritant category is that 
at least 2 tested animals have a mean score of =2.3 <=4.0.

                  Table A.2.2--Skin Irritation Category
------------------------------------------------------------------------
                                                Criteria
------------------------------------------------------------------------
Irritant (Category 2)........  (1) Mean value of =2.3 <=4.0
                                for erythema/eschar or for edema in at
                                least 2 of 3 tested animals from
                                gradings at 24, 48 and 72 hours after
                                patch removal or, if reactions are
                                delayed, from grades on 3 consecutive
                                days after the onset of skin reactions;
                                or
                               (2) Inflammation that persists to the end
                                of the observation period normally 14
                                days in at least 2 animals, particularly
                                taking into account alopecia (limited
                                area), hyperkeratosis, hyperplasia, and
                                scaling; or
                               (3) In some cases where there is
                                pronounced variability of response among
                                animals, with very definite positive
                                effects related to chemical exposure in
                                a single animal but less than the
                                criteria above.
------------------------------------------------------------------------

    A.2.2.2.2 Animal irritant responses within a test can be quite 
variable, as they are with corrosion. A separate irritant criterion 
accommodates cases when there is a significant irritant response but 
less than the mean score criterion for a positive test. For example, a 
substance might be designated as an irritant if at least 1 of 3 tested 
animals shows a very elevated mean score throughout the study, including 
lesions persisting at the end of an observation period of normally 14 
days. Other responses could also fulfil this criterion. However, it 
should be ascertained that the responses are the result of chemical 
exposure. Addition of this criterion increases the sensitivity of the 
classification system.
    A.2.2.2.3 Reversibility of skin lesions is another consideration in 
evaluating irritant responses. When inflammation persists to the end of 
the observation period in 2 or more test animals, taking into 
consideration alopecia (limited area), hyperkeratosis, hyperplasia and 
scaling, then a chemical should be considered to be an irritant.

 A.2.3 Classification Criteria for Substances Using Other Data Elements

    A.2.3.1 Existing human and animal data including information from 
single or repeated exposure should be the first line of analysis, as 
they give information directly relevant to effects on the skin. If a 
substance is highly toxic by the dermal route, a skin corrosion/
irritation study may not be practicable since the amount of test 
substance to be applied would considerably exceed the toxic dose and, 
consequently, would result in the death of the animals. When 
observations are made of skin corrosion/irritation in acute toxicity 
studies and are observed up through the limit dose, these data may be 
used for classification provided that the dilutions used and species 
tested are equivalent. In vitro alternatives that have been 
scientifically validated shall be used to make classification decisions. 
Solid substances (powders) may become corrosive or irritant when 
moistened or in contact with moist skin or mucous membranes. Likewise, 
pH extremes like <=2 and =11.5 may indicate skin effects, 
especially when associated with significant buffering capacity. 
Generally, such substances are expected to produce significant effects 
on the skin. In the absence of any other information, a substance is 
considered corrosive (Skin Category 1) if it has a pH <=2 or a pH 
=11.5. However, if consideration of alkali/acid reserve 
suggests the substance or mixture may not be corrosive despite the low 
or high pH value, then further evaluation may be necessary. In some 
cases enough information may be available from structurally related 
compounds to make classification decisions.
    A.2.3.2 A tiered approach to the evaluation of initial information 
shall be used (Figure A.2.1) recognizing that all elements may not be 
relevant in certain cases.
    A.2.3.3 The tiered approach explains how to organize information on 
a substance and to make a weight-of-evidence decision about hazard 
assessment and hazard classification.
    A.2.3.4 All the above information that is available on a substance 
shall be evaluated. Although information might be gained from

[[Page 561]]

the evaluation of single parameters within a tier, there is merit in 
considering the totality of existing information and making an overall 
weight of evidence determination. This is especially true when there is 
information available on some but not all parameters. Emphasis shall be 
placed upon existing human experience and data, followed by animal 
experience and testing data, followed by other sources of information, 
but case-by-case determinations are necessary.
[GRAPHIC] [TIFF OMITTED] TR26MR12.063


[[Page 562]]


[GRAPHIC] [TIFF OMITTED] TR26MR12.064

               A.2.4 Classification Criteria for Mixtures

   A.2.4.1 Classification of Mixtures When Data Are Available for the 
                            Complete Mixture

    A.2.4.1.1 The mixture shall be classified using the criteria for 
substances (See A.2.3).

 A.2.4.2 Classification of Mixtures When Data Are Not Available for the 
                  Complete Mixture: Bridging Principles

    A.2.4.2.1 Where the mixture itself has not been tested to determine 
its skin corrosion/irritation, but there are sufficient data on both the 
individual ingredients and similar tested mixtures to adequately 
characterize the hazards of the mixture, these data will be used in 
accordance with the following bridging principles, as found in paragraph 
A.0.5 of this Appendix: Dilution, Batching, Concentration of mixtures, 
Interpolation within one toxicity category, Substantially similar 
mixtures, and Aerosols.

   A.2.4.3 Classification of Mixtures When Data Are Available for All 
         Ingredients or Only for Some Ingredients of the Mixture

    A.2.4.3.1 For purposes of classifying the skin corrosion/irritation 
hazards of mixtures in the tiered approach:
    The ``relevant ingredients'' of a mixture are those which are 
present in concentrations =1% (weight/weight for solids, 
liquids, dusts, mists and vapors and volume/volume for gases.) If the 
classifier has reason to suspect that an ingredient present at a 
concentration <1% will affect classification of the mixture for skin 
corrosion/irritation, that ingredient shall also be considered relevant.
    A.2.4.3.2 In general, the approach to classification of mixtures as 
irritant or corrosive to skin when data are available on the 
ingredients, but not on the mixture as a whole, is based on the theory 
of additivity, such that each corrosive or irritant ingredient 
contributes to the overall irritant or corrosive properties of the 
mixture in proportion to its potency and concentration. A weighting 
factor of 10 is used for corrosive ingredients when they are present at 
a concentration below the concentration limit for classification with 
Category 1, but are at a concentration that will contribute to the 
classification of the mixture as an irritant. The mixture is classified 
as corrosive or irritant when the sum of the concentrations of such 
ingredients exceeds a cut-off value/concentration limit.
    A.2.4.3.3 Table A.2.3 below provides the cut-off value/concentration 
limits to be used to determine if the mixture is considered to be an 
irritant or a corrosive to the skin.
    A.2.4.3.4 Particular care shall be taken when classifying certain 
types of chemicals such as acids and bases, inorganic salts, aldehydes, 
phenols, and surfactants. The approach explained in A.2.4.3.1 and 
A.2.4.3.2 might not work given that many of such substances are 
corrosive or irritant at concentrations <1%. For mixtures containing 
strong acids or bases the pH should be used as classification criteria 
since pH will be a better indicator of corrosion than the concentration 
limits of Table A.2.3. A mixture

[[Page 563]]

containing corrosive or irritant ingredients that cannot be classified 
based on the additivity approach shown in Table A.2.3, due to chemical 
characteristics that make this approach unworkable, should be classified 
as Skin Category 1 if it contains =1% of a corrosive 
ingredient and as Skin Category 2 when it contains =3% of an 
irritant ingredient. Classification of mixtures with ingredients for 
which the approach in Table A.2.3 does not apply is summarized in Table 
A.2.4 below.
    A.2.4.3.5 On occasion, reliable data may show that the skin 
corrosion/irritation of an ingredient will not be evident when present 
at a level above the generic concentration cut-off values mentioned in 
Tables A.2.3 and A.2.4. In these cases the mixture could be classified 
according to those data (See Use of cut-off values/concentration limits, 
paragraph A.0.4.3 of this Appendix).
    A.2.4.3.6 If there are data showing that (an) ingredient(s) may be 
corrosive or irritant at a concentration of <1% (corrosive) or <3% 
(irritant), the mixture shall be classified accordingly (See Use of cut-
off values/concentration limits, paragraph A.0.4.3 of this Appendix).

  Table A.2.3--Concentration of Ingredients of a Mixture Classified as
Skin Category 1 or 2 That Would Trigger Classification of the Mixture as
                            Hazardous to Skin
                            [Category 1 or 2]
------------------------------------------------------------------------
                                Concentration triggering classification
                                            of a mixture as:
Sum of ingredients classified ------------------------------------------
             as:                 Skin corrosive        Skin irritant
                              ------------------------------------------
                                   Category 1            Category 2
------------------------------------------------------------------------
Skin Category 1..............      =5%  =1% but
                                                    <5%.
Skin Category 2..............  ..................  =10%.
(10 x Skin Category 1) + Skin  ..................  =10%.
 Category 2.
------------------------------------------------------------------------


  Table A.2.4--Concentration of Ingredients of a Mixture for Which the
Additivity Approach Does Not Apply, That Would Trigger Classification of
                    the Mixture as Hazardous to Skin
------------------------------------------------------------------------
                                                     Mixture classified
         Ingredient:             Concentration:           as: Skin
------------------------------------------------------------------------
Acid with pH <=2.............      =1%  Category 1.
Base with pH =11.5      =1%  Category 1.
Other corrosive (Category 1)       =1%  Category 1.
 ingredients for which
 additivity does not apply.
Other irritant (Category 2)        =3%  Category 2.
 ingredients for which
 additivity does not apply,
 including acids and bases.
------------------------------------------------------------------------

                  A.3 SERIOUS EYE DAMAGE/EYE IRRITATION

              A.3.1 Definitions and General Considerations

    A.3.1.1 Serious eye damage is the production of tissue damage in the 
eye, or serious physical decay of vision, following application of a 
test substance to the anterior surface of the eye, which is not fully 
reversible within 21 days of application.
    Eye irritation is the production of changes in the eye following the 
application of test substance to the anterior surface of the eye, which 
are fully reversible within 21 days of application.
    A.3.1.2 Serious eye damage/eye irritation shall be classified using 
a tiered approach as detailed in Figure A.3.1. Emphasis shall be placed 
upon existing human data (See A.0.2.6), followed by animal data, 
followed by other sources of information. Classification results 
directly when the data satisfy the criteria in this section. In case the 
criteria cannot be directly applied, classification of a substance or a 
mixture is made on the basis of the total weight of evidence (See 
A.0.3.1). This means that all available information bearing on the 
determination of serious eye damage/eye irritation is considered 
together, including the results of appropriate scientifically validated 
in vitro tests, relevant animal data, and human data such as 
epidemiological and clinical studies and well-documented case reports 
and observations.

   A.3.2 Classification Criteria for Substances Using Animal Test Data

    A.3.2.1 Irreversible effects on the eye/serious damage to eyes 
(Category 1).
    A single hazard category is provided in Table A.3.1, for substances 
that have the potential to seriously damage the eyes. Category 1, 
irreversible effects on the eye, includes the criteria listed below. 
These observations include animals with grade 4 cornea

[[Page 564]]

lesions and other severe reactions (e.g. destruction of cornea) observed 
at any time during the test, as well as persistent corneal opacity, 
discoloration of the cornea by a dye substance, adhesion, pannus, and 
interference with the function of the iris or other effects that impair 
sight. In this context, persistent lesions are considered those which 
are not fully reversible within an observation period of normally 21 
days. Category 1 also contains substances fulfilling the criteria of 
corneal opacity =3 and/or iritis 1.5 detected in a 
Draize eye test with rabbits, because severe lesions like these usually 
do not reverse within a 21-day observation period.

                  Table A.3.1--Irreversible Eye Effects
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
A substance is classified as Serious Eye Damage Category 1 (irreversible
 effects on the eye) when it produces:
    (a) at least in one tested animal, effects on the cornea, iris or
     conjunctiva that are not expected to reverse or have not fully
     reversed within an observation period of normally 21 days; and/or
    (b) at least in 2 of 3 tested animals, a positive response of:
        (i) corneal opacity =3; and/or
        (ii) iritis 1.5;
        calculated as the mean scores following grading at 24, 48 and 72
         hours after instillation of the substance.
------------------------------------------------------------------------

    A.3.2.2 Reversible effects on the eye (Category 2).
    A single category is provided in Table A.3.2 for substances that 
have the potential to induce reversible eye irritation.

                   Table A.3.2--Reversible Eye Effects
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
A substance is classified as Eye irritant Category 2A (irritating to
 eyes) when it produces in at least in 2 of 3 tested animals a positive
 response of:
    (i) corneal opacity =1; and/or
    (ii) iritis =1; and/or
    (iii) conjunctival redness =2; and/or
    (iv) conjunctival edema (chemosis) =2
    calculated as the mean scores following grading at 24, 48 and 72
     hours after instillation of the substance, and which fully reverses
     within an observation period of normally 21 days.
An eye irritant is considered mildly irritating to eyes (Category 2B)
 when the effects listed above are fully reversible within 7 days of
 observation.
------------------------------------------------------------------------

    A.3.2.3 For those chemicals where there is pronounced variability 
among animal responses, this information may be taken into account in 
determining the classification.

 A.3.3 Classification Criteria for Substances Using Other Data Elements

    A.3.3.1 Existing human and animal data should be the first line of 
analysis, as they give information directly relevant to effects on the 
eye. Possible skin corrosion shall be evaluated prior to consideration 
of serious eye damage/eye irritation in order to avoid testing for local 
effects on eyes with skin corrosive substances. In vitro alternatives 
that have been scientifically validated and accepted shall be used to 
make classification decisions. Likewise, pH extremes like <=2 and 
=11.5, may indicate serious eye damage, especially when 
associated with significant buffering capacity. Generally, such 
substances are expected to produce significant effects on the eyes. In 
the absence of any other information, a mixture/substance is considered 
to cause serious eye damage (Eye Category 1) if it has a pH <=2 or 
=11.5. However, if consideration of acid/alkaline reserve 
suggests the substance may not have the potential to cause serious eye 
damage despite the low or high pH value, then further evaluation may be 
necessary. In some cases enough information may be available from 
structurally related compounds to make classification decisions.
    A.3.3.2 A tiered approach to the evaluation of initial information 
shall be used

[[Page 565]]

where applicable, recognizing that all elements may not be relevant in 
certain cases (Figure A.3.1).
    A.3.3.3 The tiered approach explains how to organize existing 
information on a substance and to make a weight-of-evidence decision, 
where appropriate, about hazard assessment and hazard classification.
    A.3.3.4 All the above information that is available on a substance 
shall be evaluated. Although information might be gained from the 
evaluation of single parameters within a tier, consideration should be 
given to the totality of existing information and making an overall 
weight-of-evidence determination. This is especially true when there is 
conflict in information available on some parameters.
[GRAPHIC] [TIFF OMITTED] TR26MR12.065

[GRAPHIC] [TIFF OMITTED] TR26MR12.066


[[Page 566]]



               A.3.4 Classification Criteria for Mixtures

   A.3.4.1 Classification of Mixtures When Data Are Available for the 
                            Complete Mixture

    A.3.4.1.1 The mixture will be classified using the criteria for 
substances.
    A.3.4.1.2 Unlike other hazard classes, there are alternative tests 
available for skin corrosivity of certain types of chemicals that can 
give an accurate result for classification purposes, as well as being 
simple and relatively inexpensive to perform. When considering testing 
of the mixture, chemical manufacturers are encouraged to use a tiered 
weight of evidence strategy as included in the criteria for 
classification of substances for skin corrosion and serious eye damage 
and eye irritation to help ensure an accurate classification, as well as 
avoid unnecessary animal testing. In the absence of any other 
information, a mixture is considered to cause serious eye damage (Eye 
Category 1) if it has a pH <=2 or =11.5. However, if 
consideration of acid/alkaline reserve suggests the substance or mixture 
may not have the potential to cause serious eye damage despite the low 
or high pH value, then further evaluation may be necessary.

 A.3.4.2 Classification of Mixtures When Data Are Not Available for the 
                  Complete Mixture: Bridging Principles

    A.3.4.2.1 Where the mixture itself has not been tested to determine 
its skin corrosivity or potential to cause serious eye damage or eye 
irritation, but there are sufficient data on both the individual 
ingredients and similar tested mixtures to adequately characterize the 
hazards of the mixture, these data will be used in accordance with the 
following bridging principles, as found in paragraph A.0.5 of this 
Appendix: Dilution, Batching, Concentration of mixtures, Interpolation 
within one toxicity category, Substantially similar mixtures, and 
Aerosols.

   A.3.4.3 Classification of Mixtures When Data Are Available for All 
         Ingredients or Only for Some Ingredients of the Mixture

    A.3.4.3.1 For purposes of classifying the eye corrosion/irritation 
hazards of mixtures in the tiered approach:
    The ``relevant ingredients'' of a mixture are those which are 
present in concentrations =1% (weight/weight for solids, 
liquids, dusts, mists and vapors and volume/volume for gases.) If the 
classifier has reason to suspect that an ingredient present at a 
concentration <1% will affect classification of the mixture for eye 
corrosion/irritation, that ingredient shall also be considered relevant.
    A.3.4.3.2 In general, the approach to classification of mixtures as 
seriously damaging to the eye or eye irritant when data are available on 
the ingredients, but not on the mixture as a whole, is based on the 
theory of additivity, such that each corrosive or irritant ingredient 
contributes to the overall irritant or corrosive properties of the 
mixture in proportion to its potency and concentration. A weighting 
factor of 10 is used for corrosive ingredients when they are present at 
a concentration below the concentration limit for classification with 
Category 1, but are at a concentration that will contribute to the 
classification of the mixture as an irritant. The mixture is classified 
as seriously damaging to the eye or eye irritant when the sum of the 
concentrations of such ingredients exceeds a threshold cut-off value/
concentration limit.
    A.3.4.3.3 Table A.3.3 provides the cut-off value/concentration 
limits to be used to determine if the mixture should be classified as 
seriously damaging to the eye or an eye irritant.
    A.3.4.3.4 Particular care must be taken when classifying certain 
types of chemicals such as acids and bases, inorganic salts, aldehydes, 
phenols, and surfactants. The approach explained in A.3.4.3.1 and 
A.3.4.3.2 might not work given that many of such substances are 
corrosive or irritant at concentrations <1%. For mixtures containing 
strong acids or bases, the pH should be used as classification criteria 
(See A.3.4.1) since pH will be a better indicator of serious eye damage 
than the concentration limits of Table A.3.3. A mixture containing 
corrosive or irritant ingredients that cannot be classified based on the 
additivity approach applied in Table A.3.3 due to chemical 
characteristics that make this approach unworkable, should be classified 
as Eye Category 1 if it contains =1% of a corrosive 
ingredient and as Eye Category 2 when it contains =3% of an 
irritant ingredient. Classification of mixtures with ingredients for 
which the approach in Table A.3.3 does not apply is summarized in Table 
A.3.4.
    A.3.4.3.5 On occasion, reliable data may show that the reversible/
irreversible eye effects of an ingredient will not be evident when 
present at a level above the generic cut-off values/concentration limits 
mentioned in Tables A.3.3 and A.3.4. In these cases the mixture could be 
classified according to those data (See also A.0.4.3 Use of cut-off 
values/concentration limits''). On occasion, when it is expected that 
the skin corrosion/irritation or the reversible/irreversible eye effects 
of an ingredient will not be evident when present at a level above the 
generic concentration/cut-off levels mentioned in Tables A.3.3 and 
A.3.4, testing of the mixture may be considered. In those cases, the 
tiered weight of evidence strategy should be applied as referred to in 
section A.3.3, Figure A.3.1 and explained in detail in this chapter.

[[Page 567]]

    A.3.4.3.6 If there are data showing that (an) ingredient(s) may be 
corrosive or irritant at a concentration of <1% (corrosive) or <3% 
(irritant), the mixture should be classified accordingly (See also 
paragraph A.0.4.3, Use of cut-off values/concentration limits).

 Table A.3.3--Concentration of Ingredients of a Mixture Classified as Skin Category 1 and/or Eye Category 1 or 2
                    That Would Trigger Classification of the Mixtures as Hazardous to the Eye
----------------------------------------------------------------------------------------------------------------
                                                 Concentration triggering classification of a mixture as:
                                        ------------------------------------------------------------------------
   Sum of ingredients classified as:       Irreversible eye effects             Reversible eye effects
                                        ------------------------------------------------------------------------
                                                  Category 1                          Category 2
----------------------------------------------------------------------------------------------------------------
Eye or Skin Category 1.................               =3%  =1% but <3%.
Eye Category 2.........................  ...........................  =10%.
(10 x Eye Category 1) + Eye Category 2.  ...........................  =10%.
Skin Category 1 + Eye Category 1.......               =3%  =1% but <3%.
10 x (Skin Category 1 + Eye Category 1)  ...........................  =10%.
 + Eye Category 2.
----------------------------------------------------------------------------------------------------------------
Note: A mixture may be classified as Eye Category 2B in cases when all relevant ingredients are classified as
  Eye Category 2B.


  Table A.3.4--Concentration of Ingredients of a Mixture for Which the
Additivity Approach Does Not Apply, That Would Trigger Classification of
                   the Mixture as Hazardous to the Eye
------------------------------------------------------------------------
                                                     Mixture classified
          Ingredient              Concentration           as: Eye
------------------------------------------------------------------------
Acid with pH <=2..............     =1%  Category 1.
Base with pH =11.5.     =1%  Category 1.
Other corrosive (Category 1)       =1%  Category 1.
 ingredients for which
 additivity does not apply.
Other irritant (Category 2)        =3%  Category 2.
 ingredients for which
 additivity does not apply,
 including acids and bases.
------------------------------------------------------------------------

                  A.4 RESPIRATORY OR SKIN SENSITIZATION

              A.4.1 Definitions and General Considerations

    A.4.1.1 Respiratory sensitizer means a chemical that will lead to 
hypersensitivity of the airways following inhalation of the chemical.
    Skin sensitizer means a chemical that will lead to an allergic 
response following skin contact.
    A.4.1.2 For the purpose of this chapter, sensitization includes two 
phases: the first phase is induction of specialized immunological memory 
in an individual by exposure to an allergen. The second phase is 
elicitation, i.e., production of a cell-mediated or antibody-mediated 
allergic response by exposure of a sensitized individual to an allergen.
    A.4.1.3 For respiratory sensitization, the pattern of induction 
followed by elicitation phases is shared in common with skin 
sensitization. For skin sensitization, an induction phase is required in 
which the immune system learns to react; clinical symptoms can then 
arise when subsequent exposure is sufficient to elicit a visible skin 
reaction (elicitation phase). As a consequence, predictive tests usually 
follow this pattern in which there is an induction phase, the response 
to which is measured by a standardized elicitation phase, typically 
involving a patch test. The local lymph node assay is the exception, 
directly measuring the induction response. Evidence of skin 
sensitization in humans normally is assessed by a diagnostic patch test.
    A.4.1.4 Usually, for both skin and respiratory sensitization, lower 
levels are necessary for elicitation than are required for induction.
    A.4.1.5 The hazard class ``respiratory or skin sensitization'' is 
differentiated into:
    (a) Respiratory sensitization; and
    (b) Skin sensitization.

              A.4.2 Classification Criteria for Substances

                     A.4.2.1 Respiratory Sensitizers

    A.4.2.1.1 Hazard Categories.
    A.4.2.1.1.1 Effects seen in either humans or animals will normally 
justify classification in a weight of evidence approach for respiratory 
sensitizers. Substances may be allocated to one of the two sub-
categories 1A or 1B using a weight of evidence approach in accordance 
with the criteria given in Table A.4.1 and on the basis of reliable and 
good

[[Page 568]]

quality evidence from human cases or epidemiological studies and/or 
observations from appropriate studies in experimental animals.
    A.4.2.1.1.2 Where data are not sufficient for sub-categorization, 
respiratory sensitizers shall be classified in Category 1.

     Table A.4.1--Hazard Category and Sub-Categories for Respiratory
                               Sensitizers
------------------------------------------------------------------------
            Category 1                     Respiratory sensitizer
------------------------------------------------------------------------
                                    A substance is classified as a
                                     respiratory sensitizer.
                                    (a) if there is evidence in humans
                                     that the substance can lead to
                                     specific respiratory
                                     hypersensitivity and/or
                                    (b) if there are positive results
                                     from an appropriate animal test.
                                     \1\
Sub-category 1A...................  Substances showing a high frequency
                                     of occurrence in humans; or a
                                     probability of occurrence of a high
                                     sensitization rate in humans based
                                     on animal or other tests.\1\
                                     Severity of reaction may also be
                                     considered.
Sub-category 1B...................  Substances showing a low to moderate
                                     frequency of occurrence in humans;
                                     or a probability of occurrence of a
                                     low to moderate sensitization rate
                                     in humans based on animal or other
                                     tests. \1\ Severity of reaction may
                                     also be considered.
------------------------------------------------------------------------
\1\ At this writing, recognized and validated animal models for the
  testing of respiratory hypersensitivity are not available. Under
  certain circumstances, data from animal studies may provide valuable
  information in a weight of evidence assessment.

    A.4.2.1.2 Human evidence.
    A.4.2.1.2.1 Evidence that a substance can lead to specific 
respiratory hypersensitivity will normally be based on human experience. 
In this context, hypersensitivity is normally seen as asthma, but other 
hypersensitivity reactions such as rhinitis/conjunctivitis and 
alveolitis are also considered. The condition will have the clinical 
character of an allergic reaction. However, immunological mechanisms do 
not have to be demonstrated.
    A.4.2.1.2.2 When considering the human evidence, it is necessary 
that in addition to the evidence from the cases, the following be taken 
into account:
    (a) The size of the population exposed;
    (b) The extent of exposure.
    A.4.2.1.2.3 The evidence referred to above could be:
    (a) Clinical history and data from appropriate lung function tests 
related to exposure to the substance, confirmed by other supportive 
evidence which may include:
    (i) In vivo immunological test (e.g., skin prick test);
    (ii) In vitro immunological test (e.g., serological analysis);
    (iii) Studies that may indicate other specific hypersensitivity 
reactions where immunological mechanisms of action have not been proven, 
e.g., repeated low-level irritation, pharmacologically mediated effects;
    (iv) A chemical structure related to substances known to cause 
respiratory hypersensitivity;
    (b) Data from positive bronchial challenge tests with the substance 
conducted according to accepted guidelines for the determination of a 
specific hypersensitivity reaction.
    A.4.2.1.2.4 Clinical history should include both medical and 
occupational history to determine a relationship between exposure to a 
specific substance and development of respiratory hypersensitivity. 
Relevant information includes aggravating factors both in the home and 
workplace, the onset and progress of the disease, family history and 
medical history of the patient in question. The medical history should 
also include a note of other allergic or airway disorders from childhood 
and smoking history.
    A.4.2.1.2.5 The results of positive bronchial challenge tests are 
considered to provide sufficient evidence for classification on their 
own. It is, however, recognized that in practice many of the 
examinations listed above will already have been carried out.
    A.4.2.1.3 Animal studies.
    A.4.2.1.3.1 Data from appropriate animal studies \2\ which may be 
indicative of the potential of a substance to cause sensitization by 
inhalation in humans \3\ may include:
---------------------------------------------------------------------------

    \2\ At this writing, recognized and validated animal models for the 
testing of respiratory hypersensitivity are not available. Under certain 
circumstances, data from animal studies may provide valuable information 
in a weight of evidence assessment.
    \3\ The mechanisms by which substances induce symptoms of asthma are 
not yet fully known. For preventive measures, these substances are 
considered respiratory sensitizers. However, if on the basis of the 
evidence, it can be demonstrated that these substances induce symptoms 
of asthma by irritation only in people with bronchial hyperactivity, 
they should not be considered as respiratory sensitizers.
---------------------------------------------------------------------------

    (a) Measurements of Immunoglobulin E (IgE) and other specific 
immunological parameters, for example in mice
    (b) Specific pulmonary responses in guinea pigs.

                        A.4.2.2 Skin Sensitizers

    A.4.2.2.1 Hazard categories.
    A.4.2.2.1.1 Effects seen in either humans or animals will normally 
justify classification in a weight of evidence approach for skin 
sensitizers. Substances may be allocated to one of the two sub-
categories 1A or

[[Page 569]]

1B using a weight of evidence approach in accordance with the criteria 
given in Table A.4.2 and on the basis of reliable and good quality 
evidence from human cases or epidemiological studies and/or observations 
from appropriate studies in experimental animals according to the 
guidance values provided in A.4.2.2.2.1 and A.4.2.2.3.2 for sub-category 
1A and in A.4.2.2.2.2 and A.4.2.2.3.3 for sub-category 1B.
    A.4.2.2.1.2 Where data are not sufficient for sub-categorization, 
skin sensitizers shall be classified in Category 1.

  Table A.4.2--Hazard Category and Sub-Categories for Skin Sensitizers
------------------------------------------------------------------------
           Category 1                         Skin sensitizer
------------------------------------------------------------------------
                                  A substance is classified as a skin
                                   sensitizer.
                                  (a) if there is evidence in humans
                                   that the substance can lead to
                                   sensitization by skin contact in a
                                   substantial number of persons, or
                                  (b) if there are positive results from
                                   an appropriate animal test.
Sub-category 1A.................  Substances showing a high frequency of
                                   occurrence in humans and/or a high
                                   potency in animals can be presumed to
                                   have the potential to produce
                                   significant sensitization in humans.
                                   Severity of reaction may also be
                                   considered.
Sub-category 1B.................  Substances showing a low to moderate
                                   frequency of occurrence in humans and/
                                   or a low to moderate potency in
                                   animals can be presumed to have the
                                   potential to produce sensitization in
                                   humans. Severity of reaction may also
                                   be considered.
------------------------------------------------------------------------

    A.4.2.2.2 Human evidence.
    A.4.2.2.2.1 Human evidence for sub-category 1A may include:
    (a) Positive responses at <=500 [micro]g/cm\2\ (Human Repeat Insult 
Patch Test (HRIPT), Human Maximization Test (HMT)--induction threshold);
    (b) Diagnostic patch test data where there is a relatively high and 
substantial incidence of reactions in a defined population in relation 
to relatively low exposure;
    (c) Other epidemiological evidence where there is a relatively high 
and substantial incidence of allergic contact dermatitis in relation to 
relatively low exposure.
    A.4.2.2.2.2 Human evidence for sub-category 1B may include:
    (a) Positive responses at 500 [micro]g/cm\2\ (HRIPT, 
HMT--induction threshold);
    (b) Diagnostic patch test data where there is a relatively low but 
substantial incidence of reactions in a defined population in relation 
to relatively high exposure;
    (c) Other epidemiological evidence where there is a relatively low 
but substantial incidence of allergic contact dermatitis in relation to 
relatively high exposure.
    A.4.2.2.3 Animal studies
    A.4.2.2.3.1 For Category 1, when an adjuvant type test method for 
skin sensitization is used, a response of at least 30% of the animals is 
considered as positive. For a non-adjuvant Guinea pig test method a 
response of at least 15% of the animals is considered positive. For 
Category 1, a stimulation index of three or more is considered a 
positive response in the local lymph node assay.\4\
---------------------------------------------------------------------------

    \4\ Test methods for skin sensitization are described in OECD 
Guideline 406 (the Guinea Pig Maximization test and the Buehler guinea 
pig test) and Guideline 429 (Local Lymph Node Assay). Other methods may 
be used provided that they are scientifically validated. The Mouse Ear 
Swelling Test (MEST), appears to be a reliable screening test to detect 
moderate to strong sensitizers, and can be used, in accordance with 
professional judgment, as a first stage in the assessment of skin 
sensitization potential.
---------------------------------------------------------------------------

    A.4.2.2.3.2 Animal test results for sub-category 1A can include data 
with values indicated in Table A.4.3 below:

          Table A.4.3--Animal Test Results for Sub-Category 1A
------------------------------------------------------------------------
              Assay                               Criteria
------------------------------------------------------------------------
Local lymph node assay...........  EC3 value <=2%.
Guinea pig maximization test.....  =30% responding at <=0.1%
                                    intradermal induction dose or
                                   =60% responding at 0.1% to <=1% intradermal
                                    induction dose.
Buehler assay....................  =15% responding at <=0.2%
                                    topical induction dose or
                                   =60% responding at 0.2% to <=20% topical induction
                                    dose.
------------------------------------------------------------------------
Note: EC3 refers to the estimated concentration of test chemical
  required to induce a stimulation index of 3 in the local lymph node
  assay.

    A.4.2.2.3.3 Animal test results for sub-category 1B can include data 
with values indicated in Table A.4.4 below:

[[Page 570]]



          Table A.4.4--Animal Test Results for Sub-Category 1B
------------------------------------------------------------------------
            Assay                               Criteria
------------------------------------------------------------------------
Local lymph node assay.......  EC3 value 2%.
Guinea pig maximization test.  =30% to <60% responding at 0.1% to <=1% intradermal
                                induction dose or
                               =30% responding at 1% intradermal induction dose.
Buehler assay................  =15% to <60% responding at 0.2% to <=20% topical induction
                                dose or
                               =15% responding at 20% topical induction dose.
------------------------------------------------------------------------
Note: EC3 refers to the estimated concentration of test chemical
  required to induce a stimulation index of 3 in the local lymph node
  assay.

    A.4.2.2.4 Specific considerations.
    A.4.2.2.4.1 For classification of a substance, evidence shall 
include one or more of the following using a weight of evidence 
approach:
    (a) Positive data from patch testing, normally obtained in more than 
one dermatology clinic;
    (b) Epidemiological studies showing allergic contact dermatitis 
caused by the substance. Situations in which a high proportion of those 
exposed exhibit characteristic symptoms are to be looked at with special 
concern, even if the number of cases is small;
    (c) Positive data from appropriate animal studies;
    (d) Positive data from experimental studies in man (See paragraph 
A.0.2.6 of this Appendix);
    (e) Well documented episodes of allergic contact dermatitis, 
normally obtained in more than one dermatology clinic;
    (f) Severity of reaction.
    A.4.2.2.4.2 Evidence from animal studies is usually much more 
reliable than evidence from human exposure. However, in cases where 
evidence is available from both sources, and there is conflict between 
the results, the quality and reliability of the evidence from both 
sources must be assessed in order to resolve the question of 
classification on a case-by-case basis. Normally, human data are not 
generated in controlled experiments with volunteers for the purpose of 
hazard classification but rather as part of risk assessment to confirm 
lack of effects seen in animal tests. Consequently, positive human data 
on skin sensitization are usually derived from case-control or other, 
less defined studies. Evaluation of human data must, therefore, be 
carried out with caution as the frequency of cases reflect, in addition 
to the inherent properties of the substances, factors such as the 
exposure situation, bioavailability, individual predisposition and 
preventive measures taken. Negative human data should not normally be 
used to negate positive results from animal studies. For both animal and 
human data, consideration should be given to the impact of vehicle.
    A.4.2.2.4.3 If none of the above-mentioned conditions are met, the 
substance need not be classified as a skin sensitizer. However, a 
combination of two or more indicators of skin sensitization, as listed 
below, may alter the decision. This shall be considered on a case-by-
case basis.
    (a) Isolated episodes of allergic contact dermatitis;
    (b) Epidemiological studies of limited power, e.g., where chance, 
bias or confounders have not been ruled out fully with reasonable 
confidence;
    (c) Data from animal tests, performed according to existing 
guidelines, which do not meet the criteria for a positive result 
described in A.4.2.2.3, but which are sufficiently close to the limit to 
be considered significant;
    (d) Positive data from non-standard methods;
    (e) Positive results from close structural analogues.
    A.4.2.2.4.4 Immunological contact urticaria.
    A.4.2.2.4.4.1 Substances meeting the criteria for classification as 
respiratory sensitizers may, in addition, cause immunological contact 
urticaria. Consideration shall be given to classifying these substances 
as skin sensitizers.
    A.4.2.2.4.4.2 Substances which cause immunological contact urticaria 
without meeting the criteria for respiratory sensitizers shall be 
considered for classification as skin sensitizers.
    A.4.2.2.4.4.3 There is no recognized animal model available to 
identify substances which cause immunological contact urticaria. 
Therefore, classification will normally be based on human evidence, 
similar to that for skin sensitization.

               A.4.3 Classification Criteria for Mixtures

   A.4.3.1 Classification of Mixtures When Data Are Available for the 
                            Complete Mixture

    When reliable and good quality evidence, as described in the 
criteria for substances, from human experience or appropriate studies in 
experimental animals, is available for the mixture, then the mixture 
shall be classified by weight of evidence evaluation of these data. Care 
must be exercised in evaluating data on mixtures that the dose used does 
not render the results inconclusive.

[[Page 571]]

 A.4.3.2 Classification of Mixtures When Data Are Not Available for the 
                  Complete Mixture: Bridging Principles

    A.4.3.2.1 Where the mixture itself has not been tested to determine 
its sensitizing properties, but there are sufficient data on both the 
individual ingredients and similar tested mixtures to adequately 
characterize the hazards of the mixture, these data will be used in 
accordance with the following agreed bridging principles as found in 
paragraph A.0.5 of this Appendix: Dilution, Batching, Concentration of 
mixtures, Interpolation, Substantially similar mixtures, and Aerosols.

   A.4.3.3 Classification of Mixtures When Data Are Available for All 
         Ingredients or Only for Some Ingredients of the Mixture

    The mixture shall be classified as a respiratory or skin sensitizer 
when at least one ingredient has been classified as a respiratory or 
skin sensitizer and is present at or above the appropriate cut-off 
value/concentration limit for the specific endpoint as shown in Table 
A.4.5.

  Table A.4.5--Cut-Off Values/Concentration Limits of Ingredients of a Mixture Classified as Either Respiratory
                Sensitizers or Skin Sensitizers That Would Trigger Classification of the Mixture
----------------------------------------------------------------------------------------------------------------
                                           Cut-off values/concentration limits triggering classification of a
                                                                      mixture as:
                                      --------------------------------------------------------------------------
      Ingredient classified as:                Respiratory Sensitizer Category 1             Skin Sensitizer
                                      --------------------------------------------------        Category 1
                                                                                        ------------------------
                                             Solid/liquid                 Gas              All physical states
----------------------------------------------------------------------------------------------------------------
Respiratory Sensitizer, Category 1...         =0.1%         =0.1%
Respiratory Sensitizer, Sub-category          =0.1%         =0.1%
 1A..................................
Respiratory Sensitizer, Sub-category          =1.0%         =0.2%
 1B..................................
Skin Sensitizer, Category 1..........  .......................  .......................         =0.1%
Skin Sensitizer, Sub-category 1A.....  .......................  .......................         =0.1%
Skin Sensitizer, Sub-category 1B.....  .......................  .......................         =1.0%
----------------------------------------------------------------------------------------------------------------

                       A.5 GERM CELL MUTAGENICITY

              A.5.1 Definitions and General Considerations

    A.5.1.1 A mutation is defined as a permanent change in the amount or 
structure of the genetic material in a cell. The term mutation applies 
both to heritable genetic changes that may be manifested at the 
phenotypic level and to the underlying DNA modifications when known 
(including, for example, specific base pair changes and chromosomal 
translocations). The term mutagenic and mutagen will be used for agents 
giving rise to an increased occurrence of mutations in populations of 
cells and/or organisms.
    A.5.1.2 The more general terms genotoxic and genotoxicity apply to 
agents or processes which alter the structure, information content, or 
segregation of DNA, including those which cause DNA damage by 
interfering with normal replication processes, or which in a non-
physiological manner (temporarily) alter its replication. Genotoxicity 
test results are usually taken as indicators for mutagenic effects.
    A.5.1.3 This hazard class is primarily concerned with chemicals that 
may cause mutations in the germ cells of humans that can be transmitted 
to the progeny. However, mutagenicity/genotoxicity tests in vitro and in 
mammalian somatic cells in vivo are also considered in classifying 
substances and mixtures within this hazard class.

              A.5.2 Classification Criteria for Substances

    A.5.2.1 The classification system provides for two different 
categories of germ cell mutagens to accommodate the weight of evidence 
available. The two-category system is described in the Figure A.5.1.

         Figure A.5.1--Hazard Categories for Germ Cell Mutagens
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
CATEGORY 1: Substances known to induce heritable mutations or to be
 regarded as if they induce heritable mutations in the germ cells of
 humans.
Category 1A: Substances known to induce heritable mutations in germ
 cells of humans.
    Positive evidence from human epidemiological studies.
Category 1B: Substances which should be regarded as if they induce
 heritable mutations in the germ cells of humans.

[[Page 572]]

 
    (a) Positive result(s) from in vivo heritable germ cell mutagenicity
     tests in mammals; or
    (b) Positive result(s) from in vivo somatic cell mutagenicity tests
     in mammals, in combination with some evidence that the substance
     has potential to cause mutations to germ cells. This supporting
     evidence may, for example, be derived from mutagenicity/
     genotoxicity tests in germ cells in vivo, or by demonstrating the
     ability of the substance or its metabolite(s) to interact with the
     genetic material of germ cells; or
    (c) Positive results from tests showing mutagenic effects in the
     germ cells of humans, without demonstration of transmission to
     progeny; for example, an increase in the frequency of aneuploidy in
     sperm cells of exposed people.
CATEGORY 2: Substances which cause concern for humans owing to the
 possibility that they may induce heritable mutations in the germ cells
 of humans.
    Positive evidence obtained from experiments in mammals and/or in
     some cases from in vitro experiments, obtained from:
        (a) Somatic cell mutagenicity tests in vivo, in mammals; or
        (b) Other in vivo somatic cell genotoxicity tests which are
         supported by positive results from in vitro mutagenicity
         assays.
            Note: Substances which are positive in in vitro mammalian
             mutagenicity assays, and which also show chemical structure
             activity relationship to known germ cell mutagens, should
             be considered for classification as Category 2 mutagens.
------------------------------------------------------------------------

    A.5.2.2 Specific considerations for classification of substances as 
germ cell mutagens:
    A.5.2.2.1 To arrive at a classification, test results are considered 
from experiments determining mutagenic and/or genotoxic effects in germ 
and/or somatic cells of exposed animals. Mutagenic and/or genotoxic 
effects determined in in vitro tests shall also be considered.
    A.5.2.2.2 The system is hazard based, classifying chemicals on the 
basis of their intrinsic ability to induce mutations in germ cells. The 
scheme is, therefore, not meant for the (quantitative) risk assessment 
of chemical substances.
    A.5.2.2.3 Classification for heritable effects in human germ cells 
is made on the basis of scientifically validated tests. Evaluation of 
the test results shall be done using expert judgment and all the 
available evidence shall be weighed for classification.
    A.5.2.2.4 The classification of substances shall be based on the 
total weight of evidence available, using expert judgment. In those 
instances where a single well-conducted test is used for classification, 
it shall provide clear and unambiguously positive results. The relevance 
of the route of exposure used in the study of the substance compared to 
the route of human exposure should also be taken into account.

             A.5.3 Classification Criteria for Mixtures \5\
---------------------------------------------------------------------------

    \5\ It should be noted that the classification criteria for health 
hazards usually include a tiered scheme in which test data available on 
the complete mixture are considered as the first tier in the evaluation, 
followed by the applicable bridging principles, and lastly, cut-off 
values/concentration limits or additivity. However, this approach is not 
used for Germ Cell Mutagenicity. These criteria for Germ Cell 
Mutagenicity consider the cut-off values/concentration limits as the 
primary tier and allow the classification to be modified only on a case-
by-case evaluation based on available test data for the mixture as a 
whole.
---------------------------------------------------------------------------

   A.5.3.1 Classification of Mixtures When Data Are Available for All 
         Ingredients or Only for Some Ingredients of the Mixture

    A.5.3.1.1 Classification of mixtures shall be based on the available 
test data for the individual ingredients of the mixture using cut-off 
values/concentration limits for the ingredients classified as germ cell 
mutagens.
    A.5.3.1.2 The mixture will be classified as a mutagen when at least 
one ingredient has been classified as a Category 1A, Category 1B or 
Category 2 mutagen and is present at or above the appropriate cut-off 
value/concentration limit as shown in Table A.5.1 below for Category 1 
and 2 respectively.

[[Page 573]]



  Table A.5.1--Cut-Off Values/Concentration Limits of Ingredients of a Mixture Classified as Germ Cell Mutagens
                                That Would Trigger Classification of the Mixture
----------------------------------------------------------------------------------------------------------------
                                                                     Cut-off/concentration limits triggering
                                                                         classification of a mixture as:
                   Ingredient classified as:                   -------------------------------------------------
                                                                   Category 1 mutagen       Category 2 mutagen
----------------------------------------------------------------------------------------------------------------
Category 1A/B mutagen.........................................         =0.1%
Category 2 mutagen............................................  .......................         =1.0%
----------------------------------------------------------------------------------------------------------------
Note: The cut-off values/concentration limits in the table above apply to solids and liquids (w/w units) as well
  as gases (v/v units).

   A.5.3.2 Classification of Mixtures When Data Are Available for the 
                             Mixture Itself

    The classification may be modified on a case-by-case basis based on 
the available test data for the mixture as a whole. In such cases, the 
test results for the mixture as a whole must be shown to be conclusive 
taking into account dose and other factors such as duration, 
observations and analysis (e.g. statistical analysis, test sensitivity) 
of germ cell mutagenicity test systems.

 A.5.3.3 Classification of Mixtures When Data Are Not Available for the 
                  Complete Mixture: Bridging Principles

    A.5.3.3.1 Where the mixture itself has not been tested to determine 
its germ cell mutagenicity hazard, but there are sufficient data on both 
the individual ingredients and similar tested mixtures to adequately 
characterize the hazards of the mixture, these data will be used in 
accordance with the following bridging principles as found in paragraph 
A.0.5 of this Appendix: Dilution, Batching, and Substantially similar 
mixtures.

         A.5.4 Examples of Scientifically Validated Test Methods

A.5.4.1 Examples of in vivo heritable germ cell mutagenicity tests are:
    (a) Rodent dominant lethal mutation test (OECD 478)
    (b) Mouse heritable translocation assay (OECD 485)
    (c) Mouse specific locus test
A.5.4.2 Examples of in vivo somatic cell mutagenicity tests are:
    (a) Mammalian bone marrow chromosome aberration test (OECD 475)
    (b) Mouse spot test (OECD 484)
    (c) Mammalian erythrocyte micronucleus test (OECD 474)
A.5.4.3 Examples of mutagenicity/genotoxicity tests in germ cells are:
    (a) Mutagenicity tests:
    (i) Mammalian spermatogonial chromosome aberration test (OECD 483)
    (ii) Spermatid micronucleus assay
    (b) Genotoxicity tests:
    (i) Sister chromatid exchange analysis in spermatogonia
    (ii) Unscheduled DNA synthesis test (UDS) in testicular cells
A.5.4.4 Examples of genotoxicity tests in somatic cells are:
    (a) Liver Unscheduled DNA Synthesis (UDS) in vivo (OECD 486)
    (b) Mammalian bone marrow Sister Chromatid Exchanges (SCE)
A.5.4.5 Examples of in vitro mutagenicity tests are:
    (a) In vitro mammalian chromosome aberration test (OECD 473)
    (b) In vitro mammalian cell gene mutation test (OECD 476)
    (c) Bacterial reverse mutation tests (OECD 471)
A.5.4.6 As new, scientifically validated tests arise, these may also be 
          used in the total weight of evidence to be considered.

                           A.6 CARCINOGENICITY

                            A.6.1 Definitions

    Carcinogen means a substance or a mixture of substances which induce 
cancer or increase its incidence. Substances and mixtures which have 
induced benign and malignant tumors in well-performed experimental 
studies on animals are considered also to be presumed or suspected human 
carcinogens unless there is strong evidence that the mechanism of tumor 
formation is not relevant for humans.
    Classification of a substance or mixture as posing a carcinogenic 
hazard is based on its inherent properties and does not provide 
information on the level of the human cancer risk which the use of the 
substance or mixture may represent.

            A.6.2 Classification Criteria for Substances \6\

    A.6.2.1 For the purpose of classification for carcinogenicity, 
substances are allocated to

[[Page 574]]

one of two categories based on strength of evidence and additional 
weight of evidence considerations. In certain instances, route-specific 
classification may be warranted.
---------------------------------------------------------------------------

    \6\ See Non-mandatory Appendix F Part A for further guidance 
regarding hazard classification for carcinogenicity. This appendix is 
consistent with the GHS adn is provided as guidance excerpted from the 
International Agency for Research on Cancer (IARC) ``Monographs on the 
Evaluation of Carcinogenic Risks to Humans'' (2006).

             Figure A.6.1--Hazard Categories for Carcinogens
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
CATEGORY 1: Known or presumed human carcinogens.
    The classification of a substance as a Category 1 carcinogen is done
     on the basis of epidemiological and/or animal data. This
     classification is further distinguished on the basis of whether the
     evidence for classification is largely from human data (Category
     1A) or from animal data (Category 1B):
Category 1A: Known to have carcinogenic potential for humans.
 Classification in this category is largely based on human evidence.
Category 1B: Presumed to have carcinogenic potential for humans.
 Classification in this category is largely based on animal evidence.
    The classification of a substance in Category 1A and 1B is based on
     strength of evidence together with weight of evidence
     considerations (See paragraph A.6.2.5). Such evidence may be
     derived from:
        --human studies that establish a causal relationship between
         human exposure to a substance and the development of cancer
         (known human carcinogen); or
        --animal experiments for which there is sufficient evidence to
         demonstrate animal carcinogenicity (presumed human carcinogen).
    In addition, on a case by case basis, scientific judgment may
     warrant a decision of presumed human carcinogenicity derived from
     studies showing limited evidence of carcinogenicity in humans
     together with limited evidence of carcinogenicity in experimental
     animals.
CATEGORY 2: Suspected human carcinogens.
    The classification of a substance in Category 2 is done on the basis
     of evidence obtained from human and/or animal studies, but which is
     not sufficiently convincing to place the substance in Category 1A
     or B. This classification is based on strength of evidence together
     with weight of evidence considerations (See paragraph A.6.2.5).
     Such evidence may be from either limited evidence of
     carcinogenicity in human studies or from limited evidence of
     carcinogenicity in animal studies.
Other considerations: Where the weight of evidence for the
 carcinogenicity of a substance does not meet the above criteria, any
 positive study conducted in accordance with established scientific
 principles, and which reports statistically significant findings
 regarding the carcinogenic potential of the substance, must be noted on
 the safety data sheet.
------------------------------------------------------------------------

    A.6.2.2 Classification as a carcinogen is made on the basis of 
evidence from reliable and acceptable methods, and is intended to be 
used for substances which have an intrinsic property to produce such 
toxic effects. The evaluations are to be based on all existing data, 
peer-reviewed published studies and additional data accepted by 
regulatory agencies.
    A.6.2.3 Carcinogen classification is a one-step, criterion-based 
process that involves two interrelated determinations: evaluations of 
strength of evidence and consideration of all other relevant information 
to place substances with human cancer potential into hazard categories.
    A.6.2.4 Strength of evidence involves the enumeration of tumors in 
human and animal studies and determination of their level of statistical 
significance. Sufficient human evidence demonstrates causality between 
human exposure and the development of cancer, whereas sufficient 
evidence in animals shows a causal relationship between the agent and an 
increased incidence of tumors. Limited evidence in humans is 
demonstrated by a positive association between exposure and cancer, but 
a causal relationship cannot be stated. Limited evidence in animals is 
provided when data suggest a carcinogenic effect, but are less than 
sufficient. (Guidance on consideration of important factors in the 
classification of carcinogenicity and a more detailed description of the 
terms ``limited'' and ``sufficient'' have been developed by the 
International Agency for Research on Cancer (IARC) and are provided in 
non-mandatory Appendix F).

[[Page 575]]

    A.6.2.5 Weight of evidence: Beyond the determination of the strength 
of evidence for carcinogenicity, a number of other factors should be 
considered that influence the overall likelihood that an agent may pose 
a carcinogenic hazard in humans. The full list of factors that influence 
this determination is very lengthy, but some of the important ones are 
considered here.
    A.6.2.5.1 These factors can be viewed as either increasing or 
decreasing the level of concern for human carcinogenicity. The relative 
emphasis accorded to each factor depends upon the amount and coherence 
of evidence bearing on each. Generally there is a requirement for more 
complete information to decrease than to increase the level of concern. 
Additional considerations should be used in evaluating the tumor 
findings and the other factors in a case-by-case manner.
    A.6.2.5.2 Some important factors which may be taken into 
consideration, when assessing the overall level of concern are:
    (a) Tumor type and background incidence;
    (b) Multisite responses;
    (c) Progression of lesions to malignancy;
    (d) Reduced tumor latency;
    Additional factors which may increase or decrease the level of 
concern include:
    (e) Whether responses are in single or both sexes;
    (f) Whether responses are in a single species or several species;
    (g) Structural similarity or not to a substance(s) for which there 
is good evidence of carcinogenicity;
    (h) Routes of exposure;
    (i) Comparison of absorption, distribution, metabolism and excretion 
between test animals and humans;
    (j) The possibility of a confounding effect of excessive toxicity at 
test doses; and,
    (k) Mode of action and its relevance for humans, such as 
mutagenicity, cytotoxicity with growth stimulation, mitogenesis, 
immunosuppression.
    Mutagenicity: It is recognized that genetic events are central in 
the overall process of cancer development. Therefore evidence of 
mutagenic activity in vivo may indicate that a substance has a potential 
for carcinogenic effects.
    A.6.2.5.3 A substance that has not been tested for carcinogenicity 
may in certain instances be classified in Category 1A, Category 1B, or 
Category 2 based on tumor data from a structural analogue together with 
substantial support from consideration of other important factors such 
as formation of common significant metabolites, e.g., for benzidine 
congener dyes.
    A.6.2.5.4 The classification should also take into consideration 
whether or not the substance is absorbed by a given route(s); or whether 
there are only local tumors at the site of administration for the tested 
route(s), and adequate testing by other major route(s) show lack of 
carcinogenicity.
    A.6.2.5.5 It is important that whatever is known of the physico-
chemical, toxicokinetic and toxicodynamic properties of the substances, 
as well as any available relevant information on chemical analogues, 
i.e., structure activity relationship, is taken into consideration when 
undertaking classification.

             A.6.3 Classification Criteria for Mixtures \7\
---------------------------------------------------------------------------

    \7\ It should be noted that the classification criteria for health 
hazards usually include a tiered scheme in which test data available on 
the complete mixture are considered as the first tier in the evaluation, 
followed by the applicable bridging principles, and lastly, cut-off 
values/concentration limit or additivity. However, this approach is not 
used for Carcinogenicity. These criteria for Carcinogenicity consider 
the cut-off values/concentration limits as the primary tier and allow 
the classification to be modified only on a case-by-case evaluation 
based on available test data for the mixture as a whole.
---------------------------------------------------------------------------

    A.6.3.1 The mixture shall be classified as a carcinogen when at 
least one ingredient has been classified as a Category 1 or Category 2 
carcinogen and is present at or above the appropriate cut-off value/
concentration limit as shown in Table A.6.1.

Table A.6.1--Cut-Off Values/Concentration Limits of Ingredients of a Mixture Classified as Carcinogen That Would
                                      Trigger Classification of the Mixture
----------------------------------------------------------------------------------------------------------------
                                                    Category 1
           Ingredient classified as:                carcinogen                  Category 2 carcinogen
----------------------------------------------------------------------------------------------------------------
Category 1 carcinogen.........................    =0.1%
Category 2 carcinogen.........................  ..................  =0.1% (note 1).
----------------------------------------------------------------------------------------------------------------
Note: If a Category 2 carcinogen ingredient is present in the mixture at a concentration between 0.1% and 1%,
  information is required on the SDS for a product. However, a label warning is optional. If a Category 2
  carcinogen ingredient is present in the mixture at a concentration of =1%, both an SDS and a label
  is required and the information must be included on each.


[[Page 576]]

   A.6.3.2 Classification of Mixtures When Data Are Available for the 
                            Complete Mixture

    A mixture may be classified based on the available test data for the 
mixture as a whole. In such cases, the test results for the mixture as a 
whole must be shown to be conclusive taking into account dose and other 
factors such as duration, observations and analysis (e.g., statistical 
analysis, test sensitivity) of carcinogenicity test systems.

 A.6.3.3 Classification of Mixtures When Data Are Not Available for the 
                  Complete Mixture: Bridging Principles

    Where the mixture itself has not been tested to determine its 
carcinogenic hazard, but there are sufficient data on both the 
individual ingredients and similar tested mixtures to adequately 
characterize the hazards of the mixture, these data will be used in 
accordance with the following bridging principles as found in paragraph 
A.0.5 of this Appendix: Dilution; Batching; and Substantially similar 
mixtures.

               A.6.4 Classification of Carcinogenicity \8\
---------------------------------------------------------------------------

    \8\ See Non-mandatory Appendix F for further guidance regarding 
hazard classification for carcinogenicity and how to relate 
carcinogenicity classification information from IARC and NTP to GHS.
---------------------------------------------------------------------------

    A.6.4.1 Chemical manufacturers, importers and employers evaluating 
chemicals may treat the following sources as establishing that a 
substance is a carcinogen or potential carcinogen for hazard 
communication purposes in lieu of applying the criteria described 
herein:
    A.6.4.1.1 National Toxicology Program (NTP), ``Report on 
Carcinogens'' (latest edition);
    A.6.4.1.2 International Agency for Research on Cancer (IARC) 
``Monographs on the Evaluation of Carcinogenic Risks to Humans'' (latest 
editions)
    A.6.4.2 Where OSHA has included cancer as a health hazard to be 
considered by classifiers for a chemical covered by 29 CFR part 1910, 
Subpart Z, Toxic and Hazardous Substances, chemical manufacturers, 
importers, and employers shall classify the chemical as a carcinogen.

                        A.7 REPRODUCTIVE TOXICITY

              A.7.1 Definitions and General Considerations

    A.7.1.1 Reproductive toxicity includes adverse effects on sexual 
function and fertility in adult males and females, as well as adverse 
effects on development of the offspring. Some reproductive toxic effects 
cannot be clearly assigned to either impairment of sexual function and 
fertility or to developmental toxicity. Nonetheless, chemicals with 
these effects shall be classified as reproductive toxicants.
    For classification purposes, the known induction of genetically 
based inheritable effects in the offspring is addressed in Germ cell 
mutagenicity (See A.5).
    A.7.1.2 Adverse effects on sexual function and fertility means any 
effect of chemicals that interferes with reproductive ability or sexual 
capacity. This includes, but is not limited to, alterations to the 
female and male reproductive system, adverse effects on onset of 
puberty, gamete production and transport, reproductive cycle normality, 
sexual behaviour, fertility, parturition, pregnancy outcomes, premature 
reproductive senescence, or modifications in other functions that are 
dependent on the integrity of the reproductive systems.
    A.7.1.3 Adverse effects on development of the offspring means any 
effect of chemicals which interferes with normal development of the 
conceptus either before or after birth, which is induced during 
pregnancy or results from parental exposure. These effects can be 
manifested at any point in the life span of the organism. The major 
manifestations of developmental toxicity include death of the developing 
organism, structural abnormality, altered growth and functional 
deficiency.
    A.7.1.4 Adverse effects on or via lactation are also included in 
reproductive toxicity, but for classification purposes, such effects are 
treated separately (See A.7.2.1).

              A.7.2 Classification Criteria for Substances

    A.7.2.1 For the purpose of classification for reproductive toxicity, 
substances shall be classified in one of two categories in accordance 
with Figure A.7.1(a). Effects on sexual function and fertility, and on 
development, shall be considered. In addition, effects on or via 
lactation shall be classified in a separate hazard category in 
accordance with Figure A.7.1(b).

      Figure A.7.1(a)--Hazard Categories for Reproductive Toxicants
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
CATEGORY 1: Known or presumed human reproductive toxicant.

[[Page 577]]

 
    Substance shall be classified in Category 1 for reproductive
     toxicity when they are known to have produced an adverse effect on
     sexual function and fertility or on development in humans or when
     there is evidence from animal studies, possibly supplemented with
     other information, to provide a strong presumption that the
     substance has the capacity to interfere with reproduction in
     humans. The classification of a substance is further distinguished
     on the basis of whether the evidence for classification is
     primarily from human data (Category 1A) or from animal data
     (Category 1B).
Category 1A: Known human reproductive toxicant.
    The classification of a substance in this category is largely based
     on evidence from humans.
Category 1B: Presumed human reproductive toxicant.
    The classification of a substance in this category is largely based
     on evidence from experimental animals. Data from animal studies
     shall provide sufficient evidence of an adverse effect on sexual
     function and fertility or on development in the absence of other
     toxic effects, or if occurring together with other toxic effects
     the adverse effect on reproduction is considered not to be a
     secondary non-specific consequence of other toxic effects. However,
     when there is mechanistic information that raises doubt about the
     relevance of the effect for humans, classification in Category 2
     may be more appropriate.
CATEGORY 2: Suspected human reproductive toxicant.
    Substances shall be classified in Category 2 for reproductive
     toxicity when there is some evidence from humans or experimental
     animals, possibly supplemented with other information, of an
     adverse effect on sexual function and fertility, or on development,
     in the absence of other toxic effects, or if occurring together
     with other toxic effects the adverse effect on reproduction is
     considered not to be a secondary non-specific consequence of the
     other toxic effects, and where the evidence is not sufficiently
     convincing to place the substance in Category 1. For instance,
     deficiencies in the study may make the quality of evidence less
     convincing, and in view of this, Category 2 would be the more
     appropriate classification.
------------------------------------------------------------------------


    Figure A.7.1(b)--Hazard Category for Effects on or Via Lactation
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
EFFECTS ON OR VIA LACTATION
Effects on or via lactation shall be classified in a separate single
 category. Chemicals that are absorbed by women and have been shown to
 interfere with lactation or that may be present (including metabolites)
 in breast milk in amounts sufficient to cause concern for the health of
 a breastfed child, shall be classified to indicate this property
 hazardous to breastfed babies. This classification shall be assigned on
 the basis of:
    (a) absorption, metabolism, distribution and excretion studies that
     indicate the likelihood the substance would be present in
     potentially toxic levels in breast milk; and/or
    (b) results of one or two generation studies in animals which
     provide clear evidence of adverse effect in the offspring due to
     transfer in the milk or adverse effect on the quality of the milk;
     and/or
    (c) human evidence indicating a hazard to babies during the
     lactation period.
------------------------------------------------------------------------

                     A.7.2.2 Basis of Classification

    A.7.2.2.1 Classification is made on the basis of the criteria, 
outlined above, an assessment of the total weight of evidence, and the 
use of expert judgment. Classification as a reproductive toxicant is 
intended to be used for substances which have an intrinsic, specific 
property to produce an adverse effect on reproduction and substances 
should not be so classified if such an effect is produced solely as a 
non-specific secondary consequence of other toxic effects.
    A.7.2.2.2 In the evaluation of toxic effects on the developing 
offspring, it is important to consider the possible influence of 
maternal toxicity.

[[Page 578]]

    A.7.2.2.3 For human evidence to provide the primary basis for a 
Category 1A classification there must be reliable evidence of an adverse 
effect on reproduction in humans. Evidence used for classification shall 
be from well conducted epidemiological studies, if available, which 
include the use of appropriate controls, balanced assessment, and due 
consideration of bias or confounding factors. Less rigorous data from 
studies in humans may be sufficient for a Category 1A classification if 
supplemented with adequate data from studies in experimental animals, 
but classification in Category 1B may also be considered.

                       A.7.2.3 Weight of Evidence

    A.7.2.3.1 Classification as a reproductive toxicant is made on the 
basis of an assessment of the total weight of evidence using expert 
judgment. This means that all available information that bears on the 
determination of reproductive toxicity is considered together. Included 
is information such as epidemiological studies and case reports in 
humans and specific reproduction studies along with sub-chronic, chronic 
and special study results in animals that provide relevant information 
regarding toxicity to reproductive and related endocrine organs. 
Evaluation of substances chemically related to the material under study 
may also be included, particularly when information on the material is 
scarce. The weight given to the available evidence will be influenced by 
factors such as the quality of the studies, consistency of results, 
nature and severity of effects, level of statistical significance for 
intergroup differences, number of endpoints affected, relevance of route 
of administration to humans and freedom from bias. Both positive and 
negative results are considered together in a weight of evidence 
determination. However, a single, positive study performed according to 
good scientific principles and with statistically or biologically 
significant positive results may justify classification (See also 
A.7.2.2.3).
    A.7.2.3.2 Toxicokinetic studies in animals and humans, site of 
action and mechanism or mode of action study results may provide 
relevant information, which could reduce or increase concerns about the 
hazard to human health. If it is conclusively demonstrated that the 
clearly identified mechanism or mode of action has no relevance for 
humans or when the toxicokinetic differences are so marked that it is 
certain that the hazardous property will not be expressed in humans then 
a chemical which produces an adverse effect on reproduction in 
experimental animals should not be classified.
    A.7.2.3.3 In some reproductive toxicity studies in experimental 
animals the only effects recorded may be considered of low or minimal 
toxicological significance and classification may not necessarily be the 
outcome. These effects include, for example, small changes in semen 
parameters or in the incidence of spontaneous defects in the fetus, 
small changes in the proportions of common fetal variants such as are 
observed in skeletal examinations, or in fetal weights, or small 
differences in postnatal developmental assessments.
    A.7.2.3.4 Data from animal studies shall provide sufficient evidence 
of specific reproductive toxicity in the absence of other systemic toxic 
effects. However, if developmental toxicity occurs together with other 
toxic effects in the dam (mother), the potential influence of the 
generalized adverse effects should be assessed to the extent possible. 
The preferred approach is to consider adverse effects in the embryo/
fetus first, and then evaluate maternal toxicity, along with any other 
factors which are likely to have influenced these effects, as part of 
the weight of evidence. In general, developmental effects that are 
observed at maternally toxic doses should not be automatically 
discounted. Discounting developmental effects that are observed at 
maternally toxic doses can only be done on a case-by-case basis when a 
causal relationship is established or refuted.
    A.7.2.3.5 If appropriate information is available it is important to 
try to determine whether developmental toxicity is due to a specific 
maternally mediated mechanism or to a non-specific secondary mechanism, 
like maternal stress and the disruption of homeostasis. Generally, the 
presence of maternal toxicity should not be used to negate findings of 
embryo/fetal effects, unless it can be clearly demonstrated that the 
effects are secondary non-specific effects. This is especially the case 
when the effects in the offspring are significant, e.g., irreversible 
effects such as structural malformations. In some situations it is 
reasonable to assume that reproductive toxicity is due to a secondary 
consequence of maternal toxicity and discount the effects, for example 
if the chemical is so toxic that dams fail to thrive and there is severe 
inanition; they are incapable of nursing pups; or they are prostrate or 
dying.

                        A.7.2.4 Maternal Toxicity

    A.7.2.4.1 Development of the offspring throughout gestation and 
during the early postnatal stages can be influenced by toxic effects in 
the mother either through non-specific mechanisms related to stress and 
the disruption of maternal homeostasis, or by specific maternally-
mediated mechanisms. So, in the interpretation of the developmental 
outcome to decide classification for

[[Page 579]]

developmental effects it is important to consider the possible influence 
of maternal toxicity. This is a complex issue because of uncertainties 
surrounding the relationship between maternal toxicity and developmental 
outcome. Expert judgment and a weight of evidence approach, using all 
available studies, shall be used to determine the degree of influence to 
be attributed to maternal toxicity when interpreting the criteria for 
classification for developmental effects. The adverse effects in the 
embryo/fetus shall be first considered, and then maternal toxicity, 
along with any other factors which are likely to have influenced these 
effects, as weight of evidence, to help reach a conclusion about 
classification.
    A.7.2.4.2 Based on pragmatic observation, it is believed that 
maternal toxicity may, depending on severity, influence development via 
non-specific secondary mechanisms, producing effects such as depressed 
fetal weight, retarded ossification, and possibly resorptions and 
certain malformations in some strains of certain species. However, the 
limited numbers of studies which have investigated the relationship 
between developmental effects and general maternal toxicity have failed 
to demonstrate a consistent, reproducible relationship across species. 
Developmental effects which occur even in the presence of maternal 
toxicity are considered to be evidence of developmental toxicity, unless 
it can be unequivocally demonstrated on a case by case basis that the 
developmental effects are secondary to maternal toxicity. Moreover, 
classification shall be considered where there is a significant toxic 
effect in the offspring, e.g., irreversible effects such as structural 
malformations, embryo/fetal lethality, or significant post-natal 
functional deficiencies.
    A.7.2.4.3 Classification shall not automatically be discounted for 
chemicals that produce developmental toxicity only in association with 
maternal toxicity, even if a specific maternally-mediated mechanism has 
been demonstrated. In such a case, classification in Category 2 may be 
considered more appropriate than Category 1. However, when a chemical is 
so toxic that maternal death or severe inanition results, or the dams 
(mothers) are prostrate and incapable of nursing the pups, it is 
reasonable to assume that developmental toxicity is produced solely as a 
secondary consequence of maternal toxicity and discount the 
developmental effects. Classification is not necessarily the outcome in 
the case of minor developmental changes, e.g., a small reduction in 
fetal/pup body weight or retardation of ossification when seen in 
association with maternal toxicity.
    A.7.2.4.4 Some of the endpoints used to assess maternal toxicity are 
provided below. Data on these endpoints, if available, shall be 
evaluated in light of their statistical or biological significance and 
dose-response relationship.
    (a) Maternal mortality: An increased incidence of mortality among 
the treated dams over the controls shall be considered evidence of 
maternal toxicity if the increase occurs in a dose-related manner and 
can be attributed to the systemic toxicity of the test material. 
Maternal mortality greater than 10% is considered excessive and the data 
for that dose level shall not normally be considered to need further 
evaluation.
    (b) Mating index (Number of animals with seminal plugs or sperm/
Number of mated x 100)
    (c) Fertility index (Number of animals with implants/Number of 
matings x 100)
    (d) Gestation length (If allowed to deliver)
    (e) Body weight and body weight change: Consideration of the 
maternal body weight change and/or adjusted (corrected) maternal body 
weight shall be included in the evaluation of maternal toxicity whenever 
such data are available. The calculation of an adjusted (corrected) mean 
maternal body weight change, which is the difference between the initial 
and terminal body weight minus the gravid uterine weight (or 
alternatively, the sum of the weights of the fetuses), may indicate 
whether the effect is maternal or intrauterine. In rabbits, the body 
weight gain may not be a useful indicator of maternal toxicity because 
of normal fluctuations in body weight during pregnancy.
    (f) Food and water consumption (if relevant): The observation of a 
significant decrease in the average food or water consumption in treated 
dams (mothers) compared to the control group may be useful in evaluating 
maternal toxicity, particularly when the test material is administered 
in the diet or drinking water. Changes in food or water consumption must 
be evaluated in conjunction with maternal body weights when determining 
if the effects noted are reflective of maternal toxicity or more simply, 
unpalatability of the test material in feed or water.
    (g) Clinical evaluations (including clinical signs, markers, and 
hematology and clinical chemistry studies): The observation of increased 
incidence of significant clinical signs of toxicity in treated dams 
(mothers) relative to the control group is useful in evaluating maternal 
toxicity. If this is to be used as the basis for the assessment of 
maternal toxicity, the types, incidence, degree and duration of clinical 
signs shall be reported in the study. Clinical signs of maternal 
intoxication include, but are not limited to: coma, prostration, 
hyperactivity, loss of righting reflex, ataxia, or labored breathing.
    (h) Post-mortem data: Increased incidence and/or severity of post-
mortem findings may be indicative of maternal toxicity. This can include 
gross or microscopic pathological

[[Page 580]]

findings or organ weight data, including absolute organ weight, organ-
to-body weight ratio, or organ-to-brain weight ratio. When supported by 
findings of adverse histopathological effects in the affected organ(s), 
the observation of a significant change in the average weight of 
suspected target organ(s) of treated dams (mothers), compared to those 
in the control group, may be considered evidence of maternal toxicity.

                  A.7.2.5 Animal and Experimental Data

    A.7.2.5.1 A number of scientifically validated test methods are 
available, including methods for developmental toxicity testing (e.g., 
OECD Test Guideline 414, ICH Guideline S5A, 1993), methods for peri- and 
post-natal toxicity testing (e.g., ICH S5B, 1995), and methods for one 
or two-generation toxicity testing (e.g., OECD Test Guidelines 415, 416)
    A.7.2.5.2 Results obtained from screening tests (e.g., OECD 
Guidelines 421--Reproduction/Developmental Toxicity Screening Test, and 
422--Combined Repeated Dose Toxicity Study with Reproduction/Development 
Toxicity Screening Test) can also be used to justify classification, 
although the quality of this evidence is less reliable than that 
obtained through full studies.
    A.7.2.5.3 Adverse effects or changes, seen in short- or long-term 
repeated dose toxicity studies, which are judged likely to impair 
reproductive function and which occur in the absence of significant 
generalized toxicity, may be used as a basis for classification, e.g., 
histopathological changes in the gonads.
    A.7.2.5.4 Evidence from in vitro assays, or non-mammalian tests, and 
from analogous substances using structure-activity relationship (SAR), 
can contribute to the procedure for classification. In all cases of this 
nature, expert judgment must be used to assess the adequacy of the data. 
Inadequate data shall not be used as a primary support for 
classification.
    A.7.2.5.5 It is preferable that animal studies are conducted using 
appropriate routes of administration which relate to the potential route 
of human exposure. However, in practice, reproductive toxicity studies 
are commonly conducted using the oral route, and such studies will 
normally be suitable for evaluating the hazardous properties of the 
substance with respect to reproductive toxicity. However, if it can be 
conclusively demonstrated that the clearly identified mechanism or mode 
of action has no relevance for humans or when the toxicokinetic 
differences are so marked that it is certain that the hazardous property 
will not be expressed in humans then a substance which produces an 
adverse effect on reproduction in experimental animals should not be 
classified.
    A.7.2.5.6 Studies involving routes of administration such as 
intravenous or intraperitoneal injection, which may result in exposure 
of the reproductive organs to unrealistically high levels of the test 
substance, or elicit local damage to the reproductive organs, e.g., by 
irritation, must be interpreted with extreme caution and on their own 
are not normally the basis for classification.
    A.7.2.5.7 There is general agreement about the concept of a limit 
dose, above which the production of an adverse effect may be considered 
to be outside the criteria which lead to classification. Some test 
guidelines specify a limit dose, other test guidelines qualify the limit 
dose with a statement that higher doses may be necessary if anticipated 
human exposure is sufficiently high that an adequate margin of exposure 
would not be achieved. Also, due to species differences in 
toxicokinetics, establishing a specific limit dose may not be adequate 
for situations where humans are more sensitive than the animal model.
    A.7.2.5.8 In principle, adverse effects on reproduction seen only at 
very high dose levels in animal studies (for example doses that induce 
prostration, severe inappetence, excessive mortality) do not normally 
lead to classification, unless other information is available, for 
example, toxicokinetics information indicating that humans may be more 
susceptible than animals, to suggest that classification is appropriate.
    A.7.2.5.9 However, specification of the actual ``limit dose'' will 
depend upon the test method that has been employed to provide the test 
results.

             A.7.3 Classification Criteria for Mixtures \9\
---------------------------------------------------------------------------

    \9\ It should be noted that the classification criteria for health 
hazards usually include a tiered scheme in which test data available on 
the complete mixture are considered as the first tier in the evaluation, 
followed by the applicable bridging principles, and lastly, cut-off 
values/concentration limits or additivity. However, this approach is not 
used for Reproductive Toxicity. These criteria for Reproductive Toxicity 
consider the cut-off values/concentration limits as the primary tier and 
allow the classification to be modified only on a case-by-case 
evaluation based on available test data for the mixture as a whole.
---------------------------------------------------------------------------

   A.7.3.1 Classification of Mixtures When Data Are Available for All 
         Ingredients or Only for Some Ingredients of the Mixture

    A.7.3.1.1 The mixture shall be classified as a reproductive toxicant 
when at least one ingredient has been classified as a Category 1 or 
Category 2 reproductive toxicant and is present at or above the 
appropriate cut-off value/concentration limit specified in Table A.7.1 
for Category 1 and 2, respectively.

[[Page 581]]

    A.7.3.1.2 The mixture shall be classified for effects on or via 
lactation when at least one ingredient has been classified for effects 
on or via lactation and is present at or above the appropriate cut-off 
value/concentration limit specified in Table A.7.1 for the additional 
category for effects on or via lactation.

     Table A.7.1--Cut-Off Values/Concentration Limits of Ingredients of a Mixture Classified as Reproductive
             Toxicants or for Effects on or via Lactation That Trigger Classification of the Mixture
----------------------------------------------------------------------------------------------------------------
                                     Cut-off values/concentration limits triggering classification of a mixture
                                                                         as:
                                   -----------------------------------------------------------------------------
    Ingredients classified as:                                                           Additional category for
                                     Category 1 reproductive   Category 2 reproductive      effects on or via
                                            toxicant                  toxicant                  lactation
----------------------------------------------------------------------------------------------------------------
Category 1 reproductive toxicant..          =0.1%  ........................
Category 2 reproductive toxicant..  ........................          =0.1%
Additional category for effects on  ........................  ........................          =0.1%
 or via lactation.................
----------------------------------------------------------------------------------------------------------------

   A.7.3.2 Classification of Mixtures When Data Are Available for the 
                            Complete Mixture

    Available test data for the mixture as a whole may be used for 
classification on a case-by-case basis. In such cases, the test results 
for the mixture as a whole must be shown to be conclusive taking into 
account dose and other factors such as duration, observations and 
analysis (e.g., statistical analysis, test sensitivity) of reproduction 
test systems.

 A.7.3.3 Classification of Mixtures When Data Are Not Available for the 
                  Complete Mixture: Bridging Principles

    A.7.3.3.1 Where the mixture itself has not been tested to determine 
its reproductive toxicity, but there are sufficient data on both the 
individual ingredients and similar tested mixtures to adequately 
characterize the hazards of the mixture, these data shall be used in 
accordance with the following bridging principles as found in paragraph 
A.0.5 of this Appendix: Dilution, Batching, and Substantially similar 
mixtures.

           A.8 SPECIFIC TARGET ORGAN TOXICITY SINGLE EXPOSURE

              A.8.1 Definitions and General Considerations

    A.8.1.1 Specific target organ toxicity--single exposure, (STOT-SE) 
means specific, non-lethal target organ toxicity arising from a single 
exposure to a chemical. All significant health effects that can impair 
function, both reversible and irreversible, immediate and/or delayed and 
not specifically addressed in A.1 to A.7 and A.10 of this Appendix are 
included. Specific target organ toxicity following repeated exposure is 
classified in accordance with SPECIFIC TARGET ORGAN TOXICITY--REPEATED 
EXPOSURE (A.9 of this Appendix) and is therefore not included here.
    A.8.1.2 Classification identifies the chemical as being a specific 
target organ toxicant and, as such, it presents a potential for adverse 
health effects in people who are exposed to it.
    A.8.1.3 The adverse health effects produced by a single exposure 
include consistent and identifiable toxic effects in humans; or, in 
experimental animals, toxicologically significant changes which have 
affected the function or morphology of a tissue/organ, or have produced 
serious changes to the biochemistry or hematology of the organism, and 
these changes are relevant for human health. Human data is the primary 
source of evidence for this hazard class.
    A.8.1.4 Assessment shall take into consideration not only 
significant changes in a single organ or biological system but also 
generalized changes of a less severe nature involving several organs.
    A.8.1.5 Specific target organ toxicity can occur by any route that 
is relevant for humans, i.e., principally oral, dermal or inhalation.
    A.8.1.6 The classification criteria for specific organ systemic 
toxicity single exposure are organized as criteria for substances 
Categories 1 and 2 (See A.8.2.1), criteria for substances Category 3 
(See A.8.2.2) and criteria for mixtures (See A.8.3). See also Figure 
A.8.1.

              A.8.2 Classification Criteria for Substances

             A.8.2.1 Substances of Category 1 and Category 2

    A.8.2.1.1 Substances shall be classified for immediate or delayed 
effects separately, by the use of expert judgment on the basis of the 
weight of all evidence available, including the use of recommended 
guidance values (See A.8.2.1.9). Substances shall then be classified in 
Category 1 or 2, depending upon the nature and severity of the effect(s) 
observed, in accordance with Figure A.8.1.

[[Page 582]]



   Figure A.8.1--Hazard Categories for Specific Target Organ Toxicity
                        Following Single Exposure
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
CATEGORY 1: Substances that have produced significant toxicity in
 humans, or that, on the basis of evidence from studies in experimental
 animals can be presumed to have the potential to produce significant
 toxicity in humans following single exposure
Substances are classified in Category 1 for STOT-SE on the basis of:
(a) reliable and good quality evidence from human cases or
 epidemiological studies; or
(b) observations from appropriate studies in experimental animals in
 which significant and/or severe toxic effects of relevance to human
 health were produced at generally low exposure concentrations. Guidance
 dose/concentration values are provided below (See A.8.2.1.9) to be used
 as part of weight-of-evidence evaluation.
CATEGORY 2: Substances that, on the basis of evidence from studies in
 experimental animals, can be presumed to have the potential to be
 harmful to human health following single exposure
Substances are classified in Category 2 for STOT-SE on the basis of
 observations from appropriate studies in experimental animals in which
 significant toxic effects, of relevance to human health, were produced
 at generally moderate exposure concentrations. Guidance dose/
 concentration values are provided below (See A.8.2.1.9) in order to
 help in classification.
In exceptional cases, human evidence can also be used to place a
 substance in Category 2 (See A.8.2.1.6).
CATEGORY 3: Transient target organ effects
There are target organ effects for which a substance does not meet the
 criteria to be classified in Categories 1 or 2 indicated above. These
 are effects which adversely alter human function for a short duration
 after exposure and from which humans may recover in a reasonable period
 without leaving significant alteration of structure or function. This
 category only includes narcotic effects and respiratory tract
 irritation. Substances are classified specifically for these effects as
 discussed in A.8.2.2.
Note: The primary target organ/system shall be identified where
 possible, and where this is not possible, the substance shall be
 identified as a general toxicant. The data shall be evaluated and,
 where possible, shall not include secondary effects (e.g., a
 hepatotoxicant can produce secondary effects in the nervous or gastro-
 intestinal systems).
------------------------------------------------------------------------

    A.8.2.1.2 The relevant route(s) of exposure by which the classified 
substance produces damage shall be identified.
    A.8.2.1.3 Classification is determined by expert judgment, on the 
basis of the weight of all evidence available including the guidance 
presented below.
    A.8.2.1.4 Weight of evidence of all available data, including human 
incidents, epidemiology, and studies conducted in experimental animals 
is used to substantiate specific target organ toxic effects that merit 
classification.
    A.8.2.1.5 The information required to evaluate specific target organ 
toxicity comes either from single exposure in humans (e.g., exposure at 
home, in the workplace or environmentally), or from studies conducted in 
experimental animals. The standard animal studies in rats or mice that 
provide this information are acute toxicity studies which can include 
clinical observations and detailed macroscopic and microscopic 
examination to enable the toxic effects on target tissues/organs to be 
identified. Results of acute toxicity studies conducted in other species 
may also provide relevant information.
    A.8.2.1.6 In exceptional cases, based on expert judgment, it may be 
appropriate to place certain substances with human evidence of target 
organ toxicity in Category 2: (a) when the weight of human evidence is 
not sufficiently convincing to warrant Category 1 classification, and/or 
(b) based on the nature and severity of effects. Dose/concentration 
levels in humans shall not be considered in the classification and any 
available evidence from animal studies shall be consistent with the 
Category 2 classification. In other words, if there are also animal data 
available on the substance that warrant Category 1 classification, the 
chemical shall be classified as Category 1.
    A.8.2.1.7 Effects considered to support classification for Category 
1 and 2
    A.8.2.1.7.1 Classification is supported by evidence associating 
single exposure to the substance with a consistent and identifiable 
toxic effect.

[[Page 583]]

    A.8.2.1.7.2 Evidence from human experience/incidents is usually 
restricted to reports of adverse health consequences, often with 
uncertainty about exposure conditions, and may not provide the 
scientific detail that can be obtained from well-conducted studies in 
experimental animals.
    A.8.2.1.7.3 Evidence from appropriate studies in experimental 
animals can furnish much more detail, in the form of clinical 
observations, and macroscopic and microscopic pathological examination 
and this can often reveal hazards that may not be life-threatening but 
could indicate functional impairment. Consequently all available 
evidence, and evidence relevance to human health, must be taken into 
consideration in the classification process. Relevant toxic effects in 
humans and/or animals include, but are not limited to:
    (a) Morbidity resulting from single exposure;
    (b) Significant functional changes, more than transient in nature, 
in the respiratory system, central or peripheral nervous systems, other 
organs or other organ systems, including signs of central nervous system 
depression and effects on special senses (e.g., sight, hearing and sense 
of smell);
    (c) Any consistent and significant adverse change in clinical 
biochemistry, hematology, or urinalysis parameters;
    (d) Significant organ damage that may be noted at necropsy and/or 
subsequently seen or confirmed at microscopic examination;
    (e) Multi-focal or diffuse necrosis, fibrosis or granuloma formation 
in vital organs with regenerative capacity;
    (f) Morphological changes that are potentially reversible but 
provide clear evidence of marked organ dysfunction; and,
    (g) Evidence of appreciable cell death (including cell degeneration 
and reduced cell number) in vital organs incapable of regeneration.
    A.8.2.1.8 Effects considered not to support classification for 
Category 1 and 2
    Effects may be seen in humans and/or animals that do not justify 
classification. Such effects include, but are not limited to:
    (a) Clinical observations or small changes in bodyweight gain, food 
consumption or water intake that may have some toxicological importance 
but that do not, by themselves, indicate ``significant'' toxicity;
    (b) Small changes in clinical biochemistry, hematology or urinalysis 
parameters and/or transient effects, when such changes or effects are of 
doubtful or of minimal toxicological importance;
    (c) Changes in organ weights with no evidence of organ dysfunction;
    (d) Adaptive responses that are not considered toxicologically 
relevant; and,
    (e) Substance-induced species-specific mechanisms of toxicity, i.e., 
demonstrated with reasonable certainty to be not relevant for human 
health, shall not justify classification.
    A.8.2.1.9 Guidance values to assist with classification based on the 
results obtained from studies conducted in experimental animals for 
Category 1 and 2
    A.8.2.1.9.1 In order to help reach a decision about whether a 
substance shall be classified or not, and to what degree it shall be 
classified (Category 1 vs. Category 2), dose/concentration ``guidance 
values'' are provided for consideration of the dose/concentration which 
has been shown to produce significant health effects. The principal 
argument for proposing such guidance values is that all chemicals are 
potentially toxic and there has to be a reasonable dose/concentration 
above which a degree of toxic effect is acknowledged.
    A.8.2.1.9.2 Thus, in animal studies, when significant toxic effects 
are observed that indicate classification, consideration of the dose/
concentration at which these effects were seen, in relation to the 
suggested guidance values, provides useful information to help assess 
the need to classify (since the toxic effects are a consequence of the 
hazardous property(ies) and also the dose/concentration).
    A.8.2.1.9.3 The guidance value (C) ranges for single-dose exposure 
which has produced a significant non-lethal toxic effect are those 
applicable to acute toxicity testing, as indicated in Table A.8.1.

                          Table A.8.1--Guidance Value Ranges for Single-Dose Exposures
----------------------------------------------------------------------------------------------------------------
                                                                      Guidance value ranges for:
        Route of exposure                Units       -----------------------------------------------------------
                                                          Category 1          Category 2          Category 3
----------------------------------------------------------------------------------------------------------------
Oral (rat)......................  mg/kg body weight.  C <=300...........  2000 =C  Guidance values do
                                                                           300.     not apply.
Dermal (rat or rabbit)..........  mg/kg body weight.  C <=1,000.........  2000 =C
                                                                           1,000.
Inhalation (rat) gas............  ppmV/4h...........  C <=2,500.........  20,000 =C 2,500.
Inhalation (rat) vapor..........  mg/1/4h...........  C <=10............  20 =C
                                                                           10.
Inhalation (rat) dust/mist/fume.  mg/l/4h...........  C <=1.0...........  5.0 =C
                                                                           1.0.
----------------------------------------------------------------------------------------------------------------


[[Page 584]]

    A.8.2.1.9.4 The guidance values and ranges mentioned in Table A.8.1 
are intended only for guidance purposes, i.e., to be used as part of the 
weight of evidence approach, and to assist with decisions about 
classification. They are not intended as strict demarcation values. 
Guidance values are not provided for Category 3 since this 
classification is primarily based on human data; animal data may be 
included in the weight of evidence evaluation.
    A.8.2.1.9.5 Thus, it is feasible that a specific profile of toxicity 
occurs at a dose/concentration below the guidance value, e.g., <2000 mg/
kg body weight by the oral route, however the nature of the effect may 
result in the decision not to classify. Conversely, a specific profile 
of toxicity may be seen in animal studies occurring at above a guidance 
value, e.g., =2000 mg/kg body weight by the oral route, and 
in addition there is supplementary information from other sources, e.g., 
other single dose studies, or human case experience, which supports a 
conclusion that, in view of the weight of evidence, classification is 
the prudent action to take.
    A.8.2.1.10 Other considerations
    A.8.2.1.10.1 When a substance is characterized only by use of animal 
data the classification process includes reference to dose/concentration 
guidance values as one of the elements that contribute to the weight of 
evidence approach.
    A.8.2.1.10.2 When well-substantiated human data are available 
showing a specific target organ toxic effect that can be reliably 
attributed to single exposure to a substance, the substance shall be 
classified. Positive human data, regardless of probable dose, 
predominates over animal data. Thus, if a substance is unclassified 
because specific target organ toxicity observed was considered not 
relevant or significant to humans, if subsequent human incident data 
become available showing a specific target organ toxic effect, the 
substance shall be classified.
    A.8.2.1.10.3 A substance that has not been tested for specific 
target organ toxicity shall, where appropriate, be classified on the 
basis of data from a scientifically validated structure activity 
relationship and expert judgment-based extrapolation from a structural 
analogue that has previously been classified together with substantial 
support from consideration of other important factors such as formation 
of common significant metabolites.

                    A.8.2.2 Substances of Category 3

    A.8.2.2.1 Criteria for respiratory tract irritation
    The criteria for classifying substances as Category 3 for 
respiratory tract irritation are:
    (a) Respiratory irritant effects (characterized by localized 
redness, edema, pruritis and/or pain) that impair function with symptoms 
such as cough, pain, choking, and breathing difficulties are included. 
It is recognized that this evaluation is based primarily on human data;
    (b) Subjective human observations supported by objective 
measurements of clear respiratory tract irritation (RTI) (e.g., 
electrophysiological responses, biomarkers of inflammation in nasal or 
bronchoalveolar lavage fluids);
    (c) The symptoms observed in humans shall also be typical of those 
that would be produced in the exposed population rather than being an 
isolated idiosyncratic reaction or response triggered only in 
individuals with hypersensitive airways. Ambiguous reports simply of 
``irritation'' should be excluded as this term is commonly used to 
describe a wide range of sensations including those such as smell, 
unpleasant taste, a tickling sensation, and dryness, which are outside 
the scope of classification for respiratory tract irritation;
    (d) There are currently no scientifically validated animal tests 
that deal specifically with RTI; however, useful information may be 
obtained from the single and repeated inhalation toxicity tests. For 
example, animal studies may provide useful information in terms of 
clinical signs of toxicity (dyspnoea, rhinitis etc) and histopathology 
(e.g., hyperemia, edema, minimal inflammation, thickened mucous layer) 
which are reversible and may be reflective of the characteristic 
clinical symptoms described above. Such animal studies can be used as 
part of weight of evidence evaluation; and,
    (e) This special classification will occur only when more severe 
organ effects including the respiratory system are not observed as those 
effects would require a higher classification.
    A.8.2.2.2 Criteria for narcotic effects
    The criteria for classifying substances in Category 3 for narcotic 
effects are:
    (a) Central nervous system depression including narcotic effects in 
humans such as drowsiness, narcosis, reduced alertness, loss of 
reflexes, lack of coordination, and vertigo are included. These effects 
can also be manifested as severe headache or nausea, and can lead to 
reduced judgment, dizziness, irritability, fatigue, impaired memory 
function, deficits in perception and coordination, reaction time, or 
sleepiness; and,
    (b) Narcotic effects observed in animal studies may include 
lethargy, lack of coordination righting reflex, narcosis, and ataxia. If 
these effects are not transient in nature, then they shall be considered 
for classification as Category 1 or 2.

[[Page 585]]

               A.8.3 Classification Criteria for Mixtures

    A.8.3.1 Mixtures are classified using the same criteria as for 
substances, or alternatively as described below. As with substances, 
mixtures may be classified for specific target organ toxicity following 
single exposure, repeated exposure, or both.

   A.8.3.2 Classification of Mixtures When Data Are Available for the 
                            Complete Mixture

    When reliable and good quality evidence from human experience or 
appropriate studies in experimental animals, as described in the 
criteria for substances, is available for the mixture, then the mixture 
shall be classified by weight of evidence evaluation of this data. Care 
shall be exercised in evaluating data on mixtures, that the dose, 
duration, observation or analysis, do not render the results 
inconclusive.

 A.8.3.3 Classification of Mixtures When Data Are Not Available for the 
                  Complete Mixture: Bridging Principles

    A.8.3.3.1 Where the mixture itself has not been tested to determine 
its specific target organ toxicity, but there are sufficient data on 
both the individual ingredients and similar tested mixtures to 
adequately characterize the hazards of the mixture, these data shall be 
used in accordance with the following bridging principles as found in 
paragraph A.0.5 of this Appendix: Dilution, Batching, Concentration of 
mixtures, Interpolation within one toxicity category, Substantially 
similar mixtures, or Aerosols.

   A.8.3.4 Classification of Mixtures When Data Are Available for All 
         Ingredients or Only for Some Ingredients of the Mixture

    A.8.3.4.1 Where there is no reliable evidence or test data for the 
specific mixture itself, and the bridging principles cannot be used to 
enable classification, then classification of the mixture is based on 
the classification of the ingredient substances. In this case, the 
mixture shall be classified as a specific target organ toxicant 
(specific organ specified), following single exposure, repeated 
exposure, or both when at least one ingredient has been classified as a 
Category 1 or Category 2 specific target organ toxicant and is present 
at or above the appropriate cut-off value/concentration limit specified 
in Table A.8.2 for Categories 1 and 2, respectively.

  Table A.8.2--Cut-Off Values/Concentration Limits of Ingredients of a
    Mixture Classified as a Specific Target Organ Toxicant That Would
        Trigger Classification of the Mixture as Category 1 or 2
------------------------------------------------------------------------
                                           Cut-off values/concentration
                                                 limits triggering
                                            classification of a mixture
        Ingredient classified as:                       as:
                                         -------------------------------
                                            Category 1      Category 2
------------------------------------------------------------------------
Category 1 Target organ toxicant........  =1.
                                                      0%
Category 2 Target organ toxicant........  ..............  =1.
                                                                      0%
------------------------------------------------------------------------

    A.8.3.4.2 These cut-off values and consequent classifications shall 
be applied equally and appropriately to both single- and repeated-dose 
target organ toxicants.
    A.8.3.4.3 Mixtures shall be classified for either or both single and 
repeated dose toxicity independently.
    A.8.3.4.4 Care shall be exercised when toxicants affecting more than 
one organ system are combined that the potentiation or synergistic 
interactions are considered, because certain substances can cause target 
organ toxicity at <1% concentration when other ingredients in the 
mixture are known to potentiate its toxic effect.
    A.8.3.4.5 Care shall be exercised when extrapolating the toxicity of 
a mixture that contains Category 3 ingredient(s). A cut-off value/
concentration limit of 20%, considered as an additive of all Category 3 
ingredients for each hazard endpoint, is appropriate; however, this cut-
off value/concentration limit may be higher or lower depending on the 
Category 3 ingredient(s) involved and the fact that some effects such as 
respiratory tract irritation may not occur below a certain concentration 
while other effects such as narcotic effects may occur below this 20% 
value. Expert judgment shall be exercised. Respiratory tract irritation 
and narcotic effects are to be evaluated separately in accordance with 
the criteria given in A.8.2.2. When conducting classifications for these 
hazards, the contribution of each ingredient should be considered 
additive, unless there is evidence that the effects are not additive.

    A.9 SPECIFIC TARGET ORGAN TOXICITY REPEATED OR PROLONGED EXPOSURE

              A.9.1 Definitions and general considerations

    A.9.1.1 Specific target organ toxicity--repeated exposure (STOT-RE) 
means specific

[[Page 586]]

target organ toxicity arising from repeated exposure to a substance or 
mixture. All significant health effects that can impair function, both 
reversible and irreversible, immediate and/or delayed and not 
specifically addressed in A.1 to A.7 and A.10 of this Appendix are 
included. Specific target organ toxicity following a single-event 
exposure is classified in accordance with SPECIFIC TARGET ORGAN 
TOXICITY--SINGLE EXPOSURE (A.8 of this Appendix) and is therefore not 
included here.
    A.9.1.2 Classification identifies the substance or mixture as being 
a specific target organ toxicant and, as such, it may present a 
potential for adverse health effects in people who are exposed to it.
    A.9.1.3 These adverse health effects produced by repeated exposure 
include consistent and identifiable toxic effects in humans, or, in 
experimental animals, toxicologically significant changes which have 
affected the function or morphology of a tissue/organ, or have produced 
serious changes to the biochemistry or hematology of the organism and 
these changes are relevant for human health. Human data will be the 
primary source of evidence for this hazard class.
    A.9.1.4 Assessment shall take into consideration not only 
significant changes in a single organ or biological system but also 
generalized changes of a less severe nature involving several organs.
    A.9.1.5 Specific target organ toxicity can occur by any route that 
is relevant for humans, e.g., principally oral, dermal or inhalation.

              A.9.2 Classification Criteria for Substances

    A.9.2.1 Substances shall be classified as STOT-RE by expert judgment 
on the basis of the weight of all evidence available, including the use 
of recommended guidance values which take into account the duration of 
exposure and the dose/concentration which produced the effect(s), (See 
A.9.2.9). Substances shall be placed in one of two categories, depending 
upon the nature and severity of the effect(s) observed, in accordance 
with Figure A.9.1.

   Figure A.9.1--Hazard Categories for Specific Target Organ Toxicity
                       Following Repeated Exposure
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
CATEGORY 1: Substances that have produced significant toxicity in
 humans, or that, on the basis of evidence from studies in experimental
 animals can be presumed to have the potential to produce significant
 toxicity in humans following repeated or prolonged exposure
    Substances are classified in Category 1 for specific target organ
     toxicity (repeated exposure) on the basis of:
    (a) reliable and good quality evidence from human cases or
     epidemiological studies; or,
    (b) observations from appropriate studies in experimental animals in
     which significant and/or severe toxic effects, of relevance to
     human health, were produced at generally low exposure
     concentrations. Guidance dose/concentration values are provided
     below (See A.9.2.9) to be used as part of weight-of-evidence
     evaluation.
CATEGORY 2: Substances that, on the basis of evidence from studies in
 experimental animals can be presumed to have the potential to be
 harmful to human health following repeated or prolonged exposure
    Substances are classified in Category 2 for specific target organ
     toxicity (repeated exposure) on the basis of observations from
     appropriate studies in experimental animals in which significant
     toxic effects, of relevance to human health, were produced at
     generally moderate exposure concentrations. Guidance dose/
     concentration values are provided below (See A.9.2.9) in order to
     help in classification.
    In exceptional cases human evidence can also be used to place a
     substance in Category 2 (See A.9.2.6).
Note: The primary target organ/system shall be identified where
 possible, or the substance shall be identified as a general toxicant.
 The data shall be carefully evaluated and, where possible, shall not
 include secondary effects (e.g., a hepatotoxicant can produce secondary
 effects in the nervous or gastro-intestinal systems).
------------------------------------------------------------------------

    A.9.2.2 The relevant route of exposure by which the classified 
substance produces damage shall be identified.
    A.9.2.3 Classification is determined by expert judgment, on the 
basis of the weight of all evidence available including the guidance 
presented below.

[[Page 587]]

    A.9.2.4 Weight of evidence of all data, including human incidents, 
epidemiology, and studies conducted in experimental animals, is used to 
substantiate specific target organ toxic effects that merit 
classification.
    A.9.2.5 The information required to evaluate specific target organ 
toxicity comes either from repeated exposure in humans, e.g., exposure 
at home, in the workplace or environmentally, or from studies conducted 
in experimental animals. The standard animal studies in rats or mice 
that provide this information are 28 day, 90 day or lifetime studies (up 
to 2 years) that include hematological, clinico-chemical and detailed 
macroscopic and microscopic examination to enable the toxic effects on 
target tissues/organs to be identified. Data from repeat dose studies 
performed in other species may also be used. Other long-term exposure 
studies, e.g., for carcinogenicity, neurotoxicity or reproductive 
toxicity, may also provide evidence of specific target organ toxicity 
that could be used in the assessment of classification.
    A.9.2.6 In exceptional cases, based on expert judgment, it may be 
appropriate to place certain substances with human evidence of specific 
target organ toxicity in Category 2: (a) when the weight of human 
evidence is not sufficiently convincing to warrant Category 1 
classification, and/or (b) based on the nature and severity of effects. 
Dose/concentration levels in humans shall not be considered in the 
classification and any available evidence from animal studies shall be 
consistent with the Category 2 classification. In other words, if there 
are also animal data available on the substance that warrant Category 1 
classification, the substance shall be classified as Category 1.

          A.9.2.7 Effects Considered To Support Classification

    A.9.2.7.1 Classification is supported by reliable evidence 
associating repeated exposure to the substance with a consistent and 
identifiable toxic effect.
    A.9.2.7.2 Evidence from human experience/incidents is usually 
restricted to reports of adverse health consequences, often with 
uncertainty about exposure conditions, and may not provide the 
scientific detail that can be obtained from well-conducted studies in 
experimental animals.
    A.9.2.7.3 Evidence from appropriate studies in experimental animals 
can furnish much more detail, in the form of clinical observations, 
hematology, clinical chemistry, macroscopic and microscopic pathological 
examination and this can often reveal hazards that may not be life-
threatening but could indicate functional impairment. Consequently all 
available evidence, and relevance to human health, must be taken into 
consideration in the classification process. Relevant toxic effects in 
humans and/or animals include, but are not limited to:
    (a) Morbidity or death resulting from repeated or long-term 
exposure. Morbidity or death may result from repeated exposure, even to 
relatively low doses/concentrations, due to bioaccumulation of the 
substance or its metabolites, or due to the overwhelming of the de-
toxification process by repeated exposure;
    (b) Significant functional changes in the central or peripheral 
nervous systems or other organ systems, including signs of central 
nervous system depression and effects on special senses (e.g., sight, 
hearing and sense of smell);
    (c) Any consistent and significant adverse change in clinical 
biochemistry, hematology, or urinalysis parameters;
    (d) Significant organ damage that may be noted at necropsy and/or 
subsequently seen or confirmed at microscopic examination;
    (e) Multi-focal or diffuse necrosis, fibrosis or granuloma formation 
in vital organs with regenerative capacity;
    (f) Morphological changes that are potentially reversible but 
provide clear evidence of marked organ dysfunction (e.g., severe fatty 
change in the liver); and,
    (g) Evidence of appreciable cell death (including cell degeneration 
and reduced cell number) in vital organs incapable of regeneration.

        A.9.2.8 Effects Considered Not To Support Classification

    Effects may be seen in humans and/or animals that do not justify 
classification. Such effects include, but are not limited to:
    (a) Clinical observations or small changes in bodyweight gain, food 
consumption or water intake that may have some toxicological importance 
but that do not, by themselves, indicate ``significant'' toxicity;
    (b) Small changes in clinical biochemistry, hematology or urinalysis 
parameters and/or transient effects, when such changes or effects are of 
doubtful or of minimal toxicological importance;
    (c) Changes in organ weights with no evidence of organ dysfunction;
    (d) Adaptive responses that are not considered toxicologically 
relevant;
    (e) Substance-induced species-specific mechanisms of toxicity, i.e., 
demonstrated with reasonable certainty to be not relevant for human 
health, shall not justify classification.

   A.9.2.9 Guidance Values To Assist With Classification Based on the 
     Results Obtained From Studies Conducted in Experimental Animals

    A.9.2.9.1 In studies conducted in experimental animals, reliance on 
observation of

[[Page 588]]

effects alone, without reference to the duration of experimental 
exposure and dose/concentration, omits a fundamental concept of 
toxicology, i.e., all substances are potentially toxic, and what 
determines the toxicity is a function of the dose/concentration and the 
duration of exposure. In most studies conducted in experimental animals 
the test guidelines use an upper limit dose value.
    A.9.2.9.2 In order to help reach a decision about whether a 
substance shall be classified or not, and to what degree it shall be 
classified (Category 1 vs. Category 2), dose/concentration ``guidance 
values'' are provided in Table A.9.1 for consideration of the dose/
concentration which has been shown to produce significant health 
effects. The principal argument for proposing such guidance values is 
that all chemicals are potentially toxic and there has to be a 
reasonable dose/concentration above which a degree of toxic effect is 
acknowledged. Also, repeated-dose studies conducted in experimental 
animals are designed to produce toxicity at the highest dose used in 
order to optimize the test objective and so most studies will reveal 
some toxic effect at least at this highest dose. What is therefore to be 
decided is not only what effects have been produced, but also at what 
dose/concentration they were produced and how relevant is that for 
humans.
    A.9.2.9.3 Thus, in animal studies, when significant toxic effects 
are observed that indicate classification, consideration of the duration 
of experimental exposure and the dose/concentration at which these 
effects were seen, in relation to the suggested guidance values, 
provides useful information to help assess the need to classify (since 
the toxic effects are a consequence of the hazardous property(ies) and 
also the duration of exposure and the dose/concentration).
    A.9.2.9.4 The decision to classify at all can be influenced by 
reference to the dose/concentration guidance values at or below which a 
significant toxic effect has been observed.
    A.9.2.9.5 The guidance values refer to effects seen in a standard 
90-day toxicity study conducted in rats. They can be used as a basis to 
extrapolate equivalent guidance values for toxicity studies of greater 
or lesser duration, using dose/exposure time extrapolation similar to 
Haber's rule for inhalation, which states essentially that the effective 
dose is directly proportional to the exposure concentration and the 
duration of exposure. The assessment should be done on a case-by-case 
basis; for example, for a 28-day study the guidance values below would 
be increased by a factor of three.
    A.9.2.9.6 Thus for Category 1 classification, significant toxic 
effects observed in a 90-day repeated-dose study conducted in 
experimental animals and seen to occur at or below the (suggested) 
guidance values (C) as indicated in Table A.9.1 would justify 
classification:

   Table A.9.1--Guidance Values To Assist in Category 1 Classification
                     [Applicable to a 90-day study]
------------------------------------------------------------------------
                                                       Guidance values
      Route of exposure               Units         (dose/concentration)
------------------------------------------------------------------------
Oral (rat)..................  mg/kg body weight/    C <=10.
                               day.
Dermal (rat or rabbit)......  mg/kg body weight/    C <=20.
                               day.
Inhalation (rat) gas........  ppmV/6h/day.........  C <=50.
Inhalation (rat) vapor......  mg/liter/6h/day.....  C <=0.2.
Inhalation (rat) dust/mist/   mg/liter/6h/day.....  C <=0.02.
 fume.
------------------------------------------------------------------------

    A.9.2.9.7 For Category 2 classification, significant toxic effects 
observed in a 90-day repeated-dose study conducted in experimental 
animals and seen to occur within the (suggested) guidance value ranges 
as indicated in Table A.9.2 would justify classification:

   Table A.9.2--Guidance Values To Assist in Category 2 Classification
                     [Applicable to a 90-day study]
------------------------------------------------------------------------
                                                       Guidance values
      Route of exposure               Units         (dose/concentration)
------------------------------------------------------------------------
Oral (rat)..................  mg/kg body weight/    10 =100 mg/kg body weight/day by the oral route, 
and in addition there is supplementary information from other sources, 
e.g., other long-term administration studies, or human case experience, 
which supports a conclusion that, in view of the weight of evidence, 
classification is prudent.

                      A.9.2.10 Other Considerations

    A.9.2.10.1 When a substance is characterized only by use of animal 
data the classification process includes reference to dose/concentration 
guidance values as one of the elements that contribute to the weight of 
evidence approach.
    A.9.2.10.2 When well-substantiated human data are available showing 
a specific target organ toxic effect that can be reliably attributed to 
repeated or prolonged exposure to a substance, the substance shall be 
classified. Positive human data, regardless of probable dose, 
predominates over animal data. Thus, if a substance is unclassified 
because no specific target organ toxicity was seen at or below the dose/
concentration guidance value for animal testing, if subsequent human 
incident data become available showing a specific target organ toxic 
effect, the substance shall be classified.
    A.9.2.10.3 A substance that has not been tested for specific target 
organ toxicity may in certain instances, where appropriate, be 
classified on the basis of data from a scientifically validated 
structure activity relationship and expert judgment-based extrapolation 
from a structural analogue that has previously been classified together 
with substantial support from consideration of other important factors 
such as formation of common significant metabolites.

               A.9.3 Classification Criteria for Mixtures

    A.9.3.1 Mixtures are classified using the same criteria as for 
substances, or alternatively as described below. As with substances, 
mixtures may be classified for specific target organ toxicity following 
single exposure, repeated exposure, or both.

   A.9.3.2 Classification of Mixtures When Data Are Available for the 
                            Complete Mixture

    When reliable and good quality evidence from human experience or 
appropriate studies in experimental animals, as described in the 
criteria for substances, is available for the mixture, then the mixture 
shall be classified by weight of evidence evaluation of these data. Care 
shall be exercised in evaluating data on mixtures, that the dose, 
duration, observation or analysis, do not render the results 
inconclusive.

 A.9.3.3 Classification of Mixtures When Data Are Not Available for the 
                  Complete Mixture: Bridging Principles

    A.9.3.3.1 Where the mixture itself has not been tested to determine 
its specific target organ toxicity, but there are sufficient data on 
both the individual ingredients and similar tested mixtures to 
adequately characterize the hazards of the mixture, these data shall be 
used in accordance with the following bridging principles as found in 
paragraph A.0.5 of this Appendix: Dilution; Batching; Concentration of 
mixtures; Interpolation within one toxicity category; Substantially 
similar mixtures; and Aerosols.

   A.9.3.4 Classification of Mixtures When Data Are Available for All 
         Ingredients or Only for Some Ingredients of the Mixture

    A.9.3.4.1 Where there is no reliable evidence or test data for the 
specific mixture itself, and the bridging principles cannot be used to 
enable classification, then classification of the mixture is based on 
the classification of the ingredient substances. In this case, the 
mixture shall be classified as a specific target organ toxicant 
(specific organ specified), following single exposure, repeated 
exposure, or both when at least one ingredient has been classified as a 
Category 1 or Category 2 specific target organ toxicant and is present 
at or above the appropriate cut-off value/concentration limit specified 
in Table A.9.3 for Category 1 and 2 respectively.

[[Page 590]]



   Table A.9.3--Cut-Off Value/Concentration Limits of Ingredients of a
    Mixture Classified as a Specific Target Organ Toxicant That Would
        Trigger Classification of the Mixture as Category 1 or 2
------------------------------------------------------------------------
                                           Cut-off values/concentration
                                                 limits triggering
                                            classification of a mixture
        Ingredient classified as:                       as:
                                         -------------------------------
                                            Category 1      Category 2
------------------------------------------------------------------------
Category 1 Target organ toxicant........  =1.
                                                      0%
Category 2 Target organ toxicant........  ..............  =1.
                                                                      0%
------------------------------------------------------------------------

    A.9.3.4.2 These cut-off values and consequent classifications shall 
be applied equally and appropriately to both single- and repeated-dose 
target organ toxicants.
    A.9.3.4.3 Mixtures shall be classified for either or both single- 
and repeated-dose toxicity independently.
    A.9.3.4.4 Care shall be exercised when toxicants affecting more than 
one organ system are combined that the potentiation or synergistic 
interactions are considered, because certain substances can cause 
specific target organ toxicity at <1% concentration when other 
ingredients in the mixture are known to potentiate its toxic effect.

                         A.10 ASPIRATION HAZARD

       A.10.1 Definitions and General and Specific Considerations

    A.10.1.1 Aspiration means the entry of a liquid or solid chemical 
directly through the oral or nasal cavity, or indirectly from vomiting, 
into the trachea and lower respiratory system.
    A.10.1.2 Aspiration toxicity includes severe acute effects such as 
chemical pneumonia, varying degrees of pulmonary injury or death 
following aspiration.
    A.10.1.3 Aspiration is initiated at the moment of inspiration, in 
the time required to take one breath, as the causative material lodges 
at the crossroad of the upper respiratory and digestive tracts in the 
laryngopharyngeal region.
    A.10.1.4 Aspiration of a substance or mixture can occur as it is 
vomited following ingestion. This may have consequences for labeling, 
particularly where, due to acute toxicity, a recommendation may be 
considered to induce vomiting after ingestion. However, if the 
substance/mixture also presents an aspiration toxicity hazard, the 
recommendation to induce vomiting may need to be modified.

                    A.10.1.5 Specific Considerations

    A.10.1.5.1 The classification criteria refer to kinematic viscosity. 
The following provides the conversion between dynamic and kinematic 
viscosity:
[GRAPHIC] [TIFF OMITTED] TR26MR12.130

    A.10.1.5.2 Although the definition of aspiration in A.10.1.1 
includes the entry of solids into the respiratory system, classification 
according to (b) in table A.10.1 for Category 1 is intended to apply to 
liquid substances and mixtures only.
    A.10.1.5.3 Classification of aerosol/mist products.
    Aerosol and mist products are usually dispensed in containers such 
as self-pressurized containers, trigger and pump sprayers. 
Classification for these products shall be considered if their use may 
form a pool of product in the mouth, which then may be aspirated. If the 
mist or aerosol from a pressurized container is fine, a pool may not be 
formed. On the other hand, if a pressurized container dispenses product 
in a stream, a pool may be formed that may then be aspirated. Usually, 
the mist produced by trigger and pump sprayers is coarse and therefore, 
a pool may be formed that then may be aspirated. When the pump mechanism 
may be removed and contents are available to be swallowed then the 
classification of the products should be considered.

              A.10.2 Classification Criteria for Substances

[[Page 591]]



             Table A.10.1--Criteria for Aspiration Toxicity
------------------------------------------------------------------------
                Category                             Criteria
------------------------------------------------------------------------
Category 1: Chemicals known to cause     A substance shall be classified
 human aspiration toxicity hazards or     in Category 1:
 to be regarded as if they cause human   (a) If reliable and good
 aspiration toxicity hazard.              quality human evidence
                                          indicates that it causes
                                          aspiration toxicity (See
                                          note); or
                                         (b) If it is a hydrocarbon and
                                          has a kinematic viscosity
                                          <=20.5 mm\2\/s, measured at 40
                                          [deg]C.
------------------------------------------------------------------------
Note: Examples of substances included in Category 1 are certain
  hydrocarbons, turpentine and pine oil.

               A.10.3 Classification Criteria for Mixtures

A.10.3.1 Classification When Data Are Available for the Complete Mixture

    A mixture shall be classified in Category 1 based on reliable and 
good quality human evidence.

A.10.3.2 Classification of Mixtures When Data Are Not Available for the 
                  Complete Mixture: Bridging Principles

    A.10.3.2.1 Where the mixture itself has not been tested to determine 
its aspiration toxicity, but there are sufficient data on both the 
individual ingredients and similar tested mixtures to adequately 
characterize the hazard of the mixture, these data shall be used in 
accordance with the following bridging principles as found in paragraph 
A.0.5 of this Appendix: Dilution; Batching; Concentration of mixtures; 
Interpolation within one toxicity category; and Substantially similar 
mixtures. For application of the dilution bridging principle, the 
concentration of aspiration toxicants shall not be less than 10%.

  A.10.3.3 Classification of Mixtures When Data Are Available for All 
         Ingredients or Only for Some Ingredients of the Mixture

    A.10.3.3.1 A mixture which contains =10% of an ingredient 
or ingredients classified in Category 1, and has a kinematic viscosity 
<=20.5 mm\2\/s, measured at 40 [deg]C, shall be classified in Category 
1.
    A.10.3.3.2 In the case of a mixture which separates into two or more 
distinct layers, one of which contains =10% of an ingredient 
or ingredients classified in Category 1 and has a kinematic viscosity 
<=20.5 mm\2\/s, measured at 40 [deg]C, then the entire mixture shall be 
classified in Category 1.

      Appendix B to Sec.  1910.1200--Physical Criteria (Mandatory)

                             B.1 EXPLOSIVES

              B.1.1 Definitions and General Considerations

    B.1.1.1 An explosive chemical is a solid or liquid chemical which is 
in itself capable by chemical reaction of producing gas at such a 
temperature and pressure and at such a speed as to cause damage to the 
surroundings. Pyrotechnic chemicals are included even when they do not 
evolve gases.
    A pyrotechnic chemical is a chemical designed to produce an effect 
by heat, light, sound, gas or smoke or a combination of these as the 
result of non-detonative self-sustaining exothermic chemical reactions.
    An explosive item is an item containing one or more explosive 
chemicals.
    A pyrotechnic item is an item containing one or more pyrotechnic 
chemicals.
    An unstable explosive is an explosive which is thermally unstable 
and/or too sensitive for normal handling, transport, or use.
    An intentional explosive is a chemical or item which is manufactured 
with a view to produce a practical explosive or pyrotechnic effect.
    B.1.1.2 The class of explosives comprises:
    (a) Explosive chemicals;
    (b) Explosive items, except devices containing explosive chemicals 
in such quantity or of such a character that their inadvertent or 
accidental ignition or initiation shall not cause any effect external to 
the device either by projection, fire, smoke, heat or loud noise; and
    (c) Chemicals and items not included under (a) and (b) above which 
are manufactured with the view to producing a practical explosive or 
pyrotechnic effect.

                      B.1.2 Classification Criteria

    Chemicals and items of this class shall be classified as unstable 
explosives or shall be assigned to one of the following six divisions 
depending on the type of hazard they present:
    (a) Division 1.1--Chemicals and items which have a mass explosion 
hazard (a mass explosion is one which affects almost the entire quantity 
present virtually instantaneously);
    (b) Division 1.2--Chemicals and items which have a projection hazard 
but not a mass explosion hazard;
    (c) Division 1.3--Chemicals and items which have a fire hazard and 
either a minor blast hazard or a minor projection hazard or both, but 
not a mass explosion hazard:
    (i) Combustion of which gives rise to considerable radiant heat; or

[[Page 592]]

    (ii) Which burn one after another, producing minor blast or 
projection effects or both;
    (d) Division 1.4--Chemicals and items which present no significant 
hazard: chemicals and items which present only a small hazard in the 
event of ignition or initiation. The effects are largely confined to the 
package and no projection of fragments of appreciable size or range is 
to be expected. An external fire shall not cause virtually instantaneous 
explosion of almost the entire contents of the package;
    (e) Division 1.5--Very insensitive chemicals which have a mass 
explosion hazard: chemicals which have a mass explosion hazard but are 
so insensitive that there is very little probability of initiation or of 
transition from burning to detonation under normal conditions;
    (f) Division 1.6--Extremely insensitive items which do not have a 
mass explosion hazard: items which contain only extremely insensitive 
detonating chemicals and which demonstrate a negligible probability of 
accidental initiation or propagation.

             B.1.3 Additional Classification Considerations

    B.1.3.1 Explosives shall be classified as unstable explosives or 
shall be assigned to one of the six divisions identified in B.1.2 in 
accordance with the three step procedure in Part I of the UN ST/SG/AC.10 
(incorporated by reference; See Sec.  1910.6). The first step is to 
ascertain whether the substance or mixture has explosive effects (Test 
Series 1). The second step is the acceptance procedure (Test Series 2 to 
4) and the third step is the assignment to a hazard division (Test 
Series 5 to 7). The assessment whether a candidate for ``ammonium 
nitrate emulsion or suspension or gel, intermediate for blasting 
explosives (ANE)'' is insensitive enough for inclusion as an oxidizing 
liquid (See B.13) or an oxidizing solid (See B.14) is determined by Test 
Series 8 tests.

    Note: Classification of solid chemicals shall be based on tests 
performed on the chemical as presented. If, for example, for the 
purposes of supply or transport, the same chemical is to be presented in 
a physical form different from that which was tested and which is 
considered likely to materially alter its performance in a 
classification test, classification must be based on testing of the 
chemical in the new form.

    B.1.3.2 Explosive properties are associated with the presence of 
certain chemical groups in a molecule which can react to produce very 
rapid increases in temperature or pressure. The screening procedure in 
B.1.3.1 is aimed at identifying the presence of such reactive groups and 
the potential for rapid energy release. If the screening procedure 
identifies the chemical as a potential explosive, the acceptance 
procedure (See section 10.3 of the UN ST/SG/AC.10 (incorporated by 
reference; See Sec.  1910.6)) is necessary for classification.

    Note: Neither a Series 1 type (a) propagation of detonation test nor 
a Series 2 type (a) test of sensitivity to detonative shock is necessary 
if the exothermic decomposition energy of organic materials is less than 
800 J/g.

    B.1.3.3 If a mixture contains any known explosives, the acceptance 
procedure is necessary for classification.
    B.1.3.4 A chemical is not classified as explosive if:
    (a) There are no chemical groups associated with explosive 
properties present in the molecule. Examples of groups which may 
indicate explosive properties are given in Table A6.1 in Appendix 6 of 
the UN ST/SG/AC.10 (incorporated by reference; See Sec.  1910.6); or
    (b) The substance contains chemical groups associated with explosive 
properties which include oxygen and the calculated oxygen balance is 
less than -200.
    The oxygen balance is calculated for the chemical reaction:

CXHyOz + [x + (y/4) - (z/2)] 
          O2 [rarr] x. CO2 + (y/2) H2O

using the formula:

oxygen balance = -1600 [2x + (y/2) -z]/molecular weight;
    or
    (c) The organic substance or a homogenous mixture of organic 
substances contains chemical groups associated with explosive properties 
but the exothermic decomposition energy is less than 500 J/g and the 
onset of exothermic decomposition is below 500 [deg]C (932 [deg]F). The 
exothermic decomposition energy may be determined using a suitable 
calorimetric technique; or
    (d) For mixtures of inorganic oxidizing substances with organic 
material(s), the concentration of the inorganic oxidizing substance is:
    (i) Less than 15%, by mass, if the oxidizing substance is assigned 
to Category 1 or 2;
    (ii) Less than 30%, by mass, if the oxidizing substance is assigned 
to Category 3.

                           B.2 FLAMMABLE GASES

                            B.2.1 Definition

    Flammable gas means a gas having a flammable range with air at 20 
[deg]C (68 [deg]F) and a standard pressure of 101.3 kPa (14.7 psi).

                      B.2.2 Classification Criteria

    A flammable gas shall be classified in one of the two categories for 
this class in accordance with Table B.2.1:

[[Page 593]]



                                    Table B.2.1--Criteria for Flammable Gases
----------------------------------------------------------------------------------------------------------------
                  Category                                                 Criteria
----------------------------------------------------------------------------------------------------------------
1...........................................  Gases, which at 20 [deg]C (68 [deg]F) and a standard pressure of
                                               101.3 kPa (14.7 psi):
                                               (a) are ignitable when in a mixture of 13% or less by volume in
                                               air; or
                                               (b) have a flammable range with air of at least 12 percentage
                                               points regardless of the lower flammable limit.
2...........................................  Gases, other than those of Category 1, which, at 20 [deg]C (68
                                               [deg]F) and a standard pressure of 101.3 kPa (14.7 psi), have a
                                               flammable range while mixed in air.
----------------------------------------------------------------------------------------------------------------

    Note: Aerosols should not be classified as flammable gases. See B.3.

             B.2.3 Additional Classification Considerations

    Flammability shall be determined by tests or by calculation in 
accordance with ISO 10156 (incorporated by reference; See Sec.  1910.6). 
Where insufficient data are available to use this method, equivalent 
validated methods may be used.

                         B.3 FLAMMABLE AEROSOLS

                            B.3.1 Definition

    Aerosol means any non-refillable receptacle containing a gas 
compressed, liquefied or dissolved under pressure, and fitted with a 
release device allowing the contents to be ejected as particles in 
suspension in a gas, or as a foam, paste, powder, liquid or gas.

                      B.3.2 Classification Criteria

    B.3.2.1 Aerosols shall be considered for classification as flammable 
if they contain any component which is classified as flammable in 
accordance with this Appendix, i.e.:

Flammable liquids (See B.6);
Flammable gases (See B.2);
Flammable solids (See B.7).

    Note 1: Flammable components do not include pyrophoric, self-heating 
or water-reactive chemicals.
    Note 2: Flammable aerosols do not fall additionally within the scope 
of flammable gases, flammable liquids, or flammable solids.
    B.3.2.2 A flammable aerosol shall be classified in one of the two 
categories for this class in accordance with Table B.3.1.

                                  Table B.3.1--Criteria for Flammable Aerosols
----------------------------------------------------------------------------------------------------------------
                  Category                                                 Criteria
----------------------------------------------------------------------------------------------------------------
1...........................................  Contains =85% flammable components and the chemical
                                               heat of combustion is =30 kJ/g; or
                                              (a) For spray aerosols, in the ignition distance test, ignition
                                               occurs at a distance =75 cm (29.5 in), or
                                              (b) For foam aerosols, in the aerosol foam flammability test
                                              (i) The flame height is =20 cm (7.87 in) and the flame
                                               duration =2 s; or
                                              (ii) The flame height is =4 cm (1.57 in) and the flame
                                               duration =7 s
2...........................................  Contains 1% flammable components, or the heat of
                                               combustion is =20 kJ/g; and
                                              (a) for spray aerosols, in the ignition distance test, ignition
                                               occurs at a distance =15 cm (5.9 in), or
                                              in the enclosed space ignition test, the
                                              (i) Time equivalent is <=300 s/m\3\; or
                                              (ii) Deflagration density is <=300 g/m\3\
                                              (b) For foam aerosols, in the aerosol foam flammability test, the
                                               flame height is =4 cm and the flame duration is =2 s
                                              and it does not meet the criteria for Category 1
----------------------------------------------------------------------------------------------------------------

    Note: Aerosols not submitted to the flammability classification 
procedures in this Appendix shall be classified as extremely flammable 
(Category 1).

             B.3.3 Additional Classification Considerations

    B.3.3.1 To classify a flammable aerosol, data on its flammable 
components, on its chemical heat of combustion and, if applicable, the 
results of the aerosol foam flammability test (for foam aerosols) and of 
the ignition distance test and enclosed space test (for spray aerosols) 
are necessary.
    B.3.3.2 The chemical heat of combustion ([Delta]Hc), in kilojoules 
per gram (kJ/g), is the product of the theoretical heat of combustion 
([Delta]Hcomb), and a combustion efficiency, usually less than 1.0 (a 
typical combustion efficiency is 0.95 or 95%).
    For a composite aerosol formulation, the chemical heat of combustion 
is the summation of the weighted heats of combustion for the individual 
components, as follows:

[[Page 594]]

[GRAPHIC] [TIFF OMITTED] TR26MR12.067

Where:

[Delta]Hc = chemical heat of combustion (kJ/g);
wi% = mass fraction of component i in the product;
[Delta]Hc(i) = specific heat of combustion (kJ/g) of component i in the 
          product;

    The chemical heats of combustion shall be found in literature, 
calculated or determined by tests (See ASTM D240-02, ISO 13943, Sections 
86.1 to 86.3, and NFPA 30B (incorporated by reference; See Sec.  
1910.6)).
    B.3.3.3 The Ignition Distance Test, Enclosed Space Ignition Test and 
Aerosol Foam Flammability Test shall be performed in accordance with 
sub-sections 31.4, 31.5 and 31.6 of the of the UN ST/SG/AC.10 
(incorporated by reference; See Sec.  1910.6).

                           B.4 OXIDIZING GASES

                            B.4.1 Definition

    Oxidizing gas means any gas which may, generally by providing 
oxygen, cause or contribute to the combustion of other material more 
than air does.

    Note: ``Gases which cause or contribute to the combustion of other 
material more than air does'' means pure gases or gas mixtures with an 
oxidizing power greater than 23.5% (as determined by a method specified 
in ISO 10156 or 10156-2 (incorporated by reference, See Sec.  1910.6) or 
an equivalent testing method.)

                      B.4.2 Classification Criteria

    An oxidizing gas shall be classified in a single category for this 
class in accordance with Table B.4.1:

                                    Table B.4.1--Criteria for Oxidizing Gases
----------------------------------------------------------------------------------------------------------------
                  Category                                                 Criteria
----------------------------------------------------------------------------------------------------------------
1...........................................  Any gas which may, generally by providing oxygen, cause or
                                               contribute to the combustion of other material more than air
                                               does.
----------------------------------------------------------------------------------------------------------------

             B.4.3 Additional Classification Considerations

    Classification shall be in accordance with tests or calculation 
methods as described in ISO 10156 (incorporated by reference; See Sec.  
1910.6) and ISO 10156-2 (incorporated by reference; See Sec.  1910.6).

                        B.5 GASES UNDER PRESSURE

                            B.5.1 Definition

    Gases under pressure are gases which are contained in a receptacle 
at a pressure of 200 kPa (29 psi) (gauge) or more, or which are 
liquefied or liquefied and refrigerated.
    They comprise compressed gases, liquefied gases, dissolved gases and 
refrigerated liquefied gases.

                      B.5.2 Classification Criteria

    Gases under pressure shall be classified in one of four groups in 
accordance with Table B.5.1:

                                 Table B.5.1--Criteria for Gases Under Pressure
----------------------------------------------------------------------------------------------------------------
                    Group                                                  Criteria
----------------------------------------------------------------------------------------------------------------
Compressed gas..............................  A gas which when under pressure is entirely gaseous at -50 [deg]C
                                               (-8 [deg]F), including all gases with a critical temperature\1\
                                               <=-50 [deg]C (-58 [deg]F).
Liquefied gas...............................  A gas which when under pressure is partially liquid at
                                               temperatures above -50 [deg]C (-58 [deg]F). A distinction is made
                                               between:
                                                 (a) High pressure liquefied gas: A gas with a critical
                                                  temperature \1\ between -50 [deg]C (-58 [deg]F) and + 65
                                                  [deg]C (149 [deg]F); and
                                                 (b) Low pressure liquefied gas: A gas with a critical
                                                  temperature \1\ above + 65 [deg]C (149 [deg]F).
Refrigerated liquefied gas..................  A gas which is made partially liquid because of its low
                                               temperature.
Dissolved gas...............................  A gas which when under pressure is dissolved in a liquid phase
                                               solvent.
----------------------------------------------------------------------------------------------------------------
\1\ The critical temperature is the temperature above which a pure gas cannot be liquefied, regardless of the
  degree of compression.


[[Page 595]]

                          B.6 FLAMMABLE LIQUIDS

                            B.6.1 Definition

    Flammable liquid means a liquid having a flash point of not more 
than 93 [deg]C (199.4 [deg]F).
    Flash point means the minimum temperature at which a liquid gives 
off vapor in sufficient concentration to form an ignitable mixture with 
air near the surface of the liquid, as determined by a method identified 
in Section B.6.3.

                      B.6.2 Classification Criteria

    A flammable liquid shall be classified in one of four categories in 
accordance with Table B.6.1:

                                                       Table B.6.1--Criteria for Flammable Liquids
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  Category                                                                     Criteria
--------------------------------------------------------------------------------------------------------------------------------------------------------
1...........................................  Flash point <23 [deg]C (73.4 [deg]F) and initial boiling point <=35 [deg]C (95 [deg]F).
2...........................................  Flash point <23 [deg]C (73.4 [deg]F) and initial boiling point 35 [deg]C (95 [deg]F).
3...........................................  Flash point =23 [deg]C (73.4 [deg]F) and <=60 [deg]C (140 [deg]F).
4...........................................  Flash point 60 [deg]C (140 [deg]F) and <=93 [deg]C (199.4 [deg]F).
--------------------------------------------------------------------------------------------------------------------------------------------------------

             B.6.3 Additional Classification Considerations

    The flash point shall be determined in accordance with ASTM D56-05, 
ASTM D3278, ASTM D3828, ASTM D93-08 (incorporated by reference; See 
Sec.  1910.6), or any other method specified in GHS Revision 3, Chapter 
2.6.
    The initial boiling point shall be determined in accordance with 
ASTM D86-07a or ASTM D1078 (incorporated by reference; See Sec.  
1910.6).

                          B.7 FLAMMABLE SOLIDS

                            B.7.1 Definitions

    Flammable solid means a solid which is a readily combustible solid, 
or which may cause or contribute to fire through friction.
    Readily combustible solids are powdered, granular, or pasty 
chemicals which are dangerous if they can be easily ignited by brief 
contact with an ignition source, such as a burning match, and if the 
flame spreads rapidly.

                      B.7.2 Classification Criteria

    B.7.2.1 Powdered, granular or pasty chemicals shall be classified as 
flammable solids when the time of burning of one or more of the test 
runs, performed in accordance with the test method described in the UN 
ST/SG/AC.10 (incorporated by reference; See Sec.  1910.6), Part III, 
sub-section 33.2.1, is less than 45 s or the rate of burning is more 
than 2.2 mm/s (0.0866 in/s).
    B.7.2.2 Powders of metals or metal alloys shall be classified as 
flammable solids when they can be ignited and the reaction spreads over 
the whole length of the sample in 10 min or less.
    B.7.2.3 Solids which may cause fire through friction shall be 
classified in this class by analogy with existing entries (e.g., 
matches) until definitive criteria are established.
    B.7.2.4 A flammable solid shall be classified in one of the two 
categories for this class using Method N.1 as described in Part III, 
sub-section 33.2.1 of the UN ST/SG/AC.10 (incorporated by reference; See 
Sec.  1910.6), in accordance with Table B.7.1:

               Table B.7.1--Criteria for Flammable Solids
------------------------------------------------------------------------
                Category                             Criteria
------------------------------------------------------------------------
1......................................  Burning rate test:
                                            Chemicals other than metal
                                             powders:
                                              (a) Wetted zone does not
                                               stop fire; and
                                              (b) Burning time <45 s or
                                               burning rate 2.2 mm/s.
                                            Metal powders: Burning time
                                             <=5 min.
2......................................  Burning rate test:
                                            Chemicals other than metal
                                             powders:
                                              (a) Wetted zone stops the
                                               fire for at least 4 min;
                                               and
                                              (b) Burning time <45 s or
                                               burning rate 2.2 mm/s.
                                            Metal powders: Burning time
                                             5 min and <=10
                                             min.
------------------------------------------------------------------------

    Note: Classification of solid chemicals shall be based on tests 
performed on the chemical as presented. If, for example, for the 
purposes of supply or transport, the same chemical is to be presented in 
a physical form different from that which was tested and which is 
considered likely to materially alter its performance in a 
classification test, classification must be based on testing of the 
chemical in the new form.

[[Page 596]]

                       B.8 SELF-REACTIVE CHEMICALS

                            B.8.1 Definitions

    Self-reactive chemicals are thermally unstable liquid or solid 
chemicals liable to undergo a strongly exothermic decomposition even 
without participation of oxygen (air). This definition excludes 
chemicals classified under this section as explosives, organic 
peroxides, oxidizing liquids or oxidizing solids.
    A self-reactive chemical is regarded as possessing explosive 
properties when in laboratory testing the formulation is liable to 
detonate, to deflagrate rapidly or to show a violent effect when heated 
under confinement.

                      B.8.2 Classification Criteria

    B.8.2.1 A self-reactive chemical shall be considered for 
classification in this class unless:
    (a) It is classified as an explosive according to B.1 of this 
appendix;
    (b) It is classified as an oxidizing liquid or an oxidizing solid 
according to B.13 or B.14 of this appendix, except that a mixture of 
oxidizing substances which contains 5% or more of combustible organic 
substances shall be classified as a self-reactive chemical according to 
the procedure defined in B.8.2.2;
    (c) It is classified as an organic peroxide according to B.15 of 
this appendix;
    (d) Its heat of decomposition is less than 300 J/g; or
    (e) Its self-accelerating decomposition temperature (SADT) is 
greater than 75 [deg]C (167 [deg]F) for a 50 kg (110 lb) package.
    B.8.2.2 Mixtures of oxidizing substances, meeting the criteria for 
classification as oxidizing liquids or oxidizing solids, which contain 
5% or more of combustible organic substances and which do not meet the 
criteria mentioned in B.8.2.1 (a), (c), (d) or (e), shall be subjected 
to the self-reactive chemicals classification procedure in B.8.2.3. Such 
a mixture showing the properties of a self-reactive chemical type B to F 
shall be classified as a self-reactive chemical.
    B.8.2.3 Self-reactive chemicals shall be classified in one of the 
seven categories of ``types A to G'' for this class, according to the 
following principles:
    (a) Any self-reactive chemical which can detonate or deflagrate 
rapidly, as packaged, will be defined as self-reactive chemical TYPE A;
    (b) Any self-reactive chemical possessing explosive properties and 
which, as packaged, neither detonates nor deflagrates rapidly, but is 
liable to undergo a thermal explosion in that package will be defined as 
self-reactive chemical TYPE B;
    (c) Any self-reactive chemical possessing explosive properties when 
the chemical as packaged cannot detonate or deflagrate rapidly or 
undergo a thermal explosion will be defined as self-reactive chemical 
TYPE C;
    (d) Any self-reactive chemical which in laboratory testing meets the 
criteria in (d)(i), (ii), or (iii) will be defined as self-reactive 
chemical TYPE D:
    (i) Detonates partially, does not deflagrate rapidly and shows no 
violent effect when heated under confinement; or
    (ii) Does not detonate at all, deflagrates slowly and shows no 
violent effect when heated under confinement; or
    (iii) Does not detonate or deflagrate at all and shows a medium 
effect when heated under confinement;
    (e) Any self-reactive chemical which, in laboratory testing, neither 
detonates nor deflagrates at all and shows low or no effect when heated 
under confinement will be defined as self-reactive chemical TYPE E;
    (f) Any self-reactive chemical which, in laboratory testing, neither 
detonates in the cavitated state nor deflagrates at all and shows only a 
low or no effect when heated under confinement as well as low or no 
explosive power will be defined as self-reactive chemical TYPE F;
    (g) Any self-reactive chemical which, in laboratory testing, neither 
detonates in the cavitated state nor deflagrates at all and shows no 
effect when heated under confinement nor any explosive power, provided 
that it is thermally stable (self-accelerating decomposition temperature 
is 60 [deg]C (140 [deg]F) to 75 [deg]C (167 [deg]F) for a 50 kg (110 lb) 
package), and, for liquid mixtures, a diluent having a boiling point 
greater than or equal to 150 [deg]C (302 [deg]F) is used for 
desensitization will be defined as self-reactive chemical TYPE G. If the 
mixture is not thermally stable or a diluent having a boiling point less 
than 150 [deg]C (302 [deg]F) is used for desensitization, the mixture 
shall be defined as self-reactive chemical TYPE F.

             B.8.3 Additional Classification Considerations

    B.8.3.1 For purposes of classification, the properties of self-
reactive chemicals shall be determined in accordance with test series A 
to H as described in Part II of the UN ST/SG/AC.10 (incorporated by 
reference; See Sec.  1910.6).
    B.8.3.2 Self-accelerating decomposition temperature (SADT) shall be 
determined in accordance with the UN ST/SG/AC.10, Part II, section 28 
(incorporated by reference; See Sec.  1910.6).
    B.8.3.3 The classification procedures for self-reactive substances 
and mixtures need not be applied if:
    (a) There are no chemical groups present in the molecule associated 
with explosive or self-reactive properties; examples of such groups are 
given in Tables A6.1 and A6.2 in the Appendix 6 of the UN ST/SG/AC.10 
(incorporated by reference; See Sec.  1910.6); or
    (b) For a single organic substance or a homogeneous mixture of 
organic substances,

[[Page 597]]

the estimated SADT is greater than 75 [deg]C (167 [deg]F) or the 
exothermic decomposition energy is less than 300 J/g. The onset 
temperature and decomposition energy may be estimated using a suitable 
calorimetric technique (See 20.3.3.3 in Part II of the UN ST/SG/AC.10 
(incorporated by reference; See Sec.  1910.6)).

                         B.9 PYROPHORIC LIQUIDS

                            B.9.1 Definition

    Pyrophoric liquid means a liquid which, even in small quantities, is 
liable to ignite within five minutes after coming into contact with air.

                      B.9.2 Classification Criteria

    A pyrophoric liquid shall be classified in a single category for 
this class using test N.3 in Part III, sub-section 33.3.1.5 of the UN 
ST/SG/AC.10 (incorporated by reference; See Sec.  1910.6), in accordance 
with Table B.9.1:

                                  Table B.9.1--Criteria for Pyrophoric Liquids
----------------------------------------------------------------------------------------------------------------
                  Category                                                 Criteria
----------------------------------------------------------------------------------------------------------------
1...........................................  The liquid ignites within 5 min when added to an inert carrier and
                                               exposed to air, or it ignites or chars a filter paper on contact
                                               with air within 5 min.
----------------------------------------------------------------------------------------------------------------

             B.9.3 Additional Classification Considerations

    The classification procedure for pyrophoric liquids need not be 
applied when experience in production or handling shows that the 
chemical does not ignite spontaneously on coming into contact with air 
at normal temperatures (i.e., the substance is known to be stable at 
room temperature for prolonged periods of time (days)).

                         B.10 PYROPHORIC SOLIDS

                            B.10.1 Definition

    Pyrophoric solid means a solid which, even in small quantities, is 
liable to ignite within five minutes after coming into contact with air.

                     B.10.2 Classification Criteria

    A pyrophoric solid shall be classified in a single category for this 
class using test N.2 in Part III, sub-section 33.3.1.4 of the UN ST/SG/
AC.10 (incorporated by reference; See Sec.  1910.6), in accordance with 
Table B.10.1:

                                                      Table B.10.1--Criteria for Pyrophoric Solids
--------------------------------------------------------------------------------------------------------------------------------------------------------
                   Category                                                                     Criteria
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.............................................  The solid ignites within 5 min of coming into contact with air.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Note: Classification of solid chemicals shall be based on tests 
performed on the chemical as presented. If, for example, for the 
purposes of supply or transport, the same chemical is to be presented in 
a physical form different from that which was tested and which is 
considered likely to materially alter its performance in a 
classification test, classification must be based on testing of the 
chemical in the new form.

             B.10.3 Additional Classification Considerations

    The classification procedure for pyrophoric solids need not be 
applied when experience in production or handling shows that the 
chemical does not ignite spontaneously on coming into contact with air 
at normal temperatures (i.e., the chemical is known to be stable at room 
temperature for prolonged periods of time (days)).

                       B.11 SELF-HEATING CHEMICALS

                            B.11.1 Definition

    A self-heating chemical is a solid or liquid chemical, other than a 
pyrophoric liquid or solid, which, by reaction with air and without 
energy supply, is liable to self-heat; this chemical differs from a 
pyrophoric liquid or solid in that it will ignite only when in large 
amounts (kilograms) and after long periods of time (hours or days).

    Note: Self-heating of a substance or mixture is a process where the 
gradual reaction of that substance or mixture with oxygen (in air) 
generates heat. If the rate of heat production exceeds the rate of heat 
loss, then the temperature of the substance or mixture will rise which, 
after an induction time, may lead to self-ignition and combustion.

[[Page 598]]

                     B.11.2 Classification Criteria

    B.11.2.1 A self-heating chemical shall be classified in one of the 
two categories for this class if, in tests performed in accordance with 
test method N.4 in Part III, sub-section 33.3.1.6 of the UN ST/SG/AC.10 
(incorporated by reference; See Sec.  1910.6), the result meets the 
criteria shown in Table B.11.1.

                                Table B.11.1--Criteria for Self-Heating Chemicals
----------------------------------------------------------------------------------------------------------------
                  Category                                                 Criteria
----------------------------------------------------------------------------------------------------------------
1...........................................  A positive result is obtained in a test using a 25 mm sample cube
                                               at 140 [deg]C (284 [deg]F).
2...........................................  A negative result is obtained in a test using a 25 mm cube sample
                                               at 140 [deg]C (284 [deg]F), a positive result is obtained in a
                                               test using a 100 mm sample cube at 140 [deg]C (284 [deg]F), and:
                                                 (a) The unit volume of the chemical is more than 3 m\3\; or
                                                 (b) A positive result is obtained in a test using a 100 mm cube
                                                  sample at 120 [deg]C (248 [deg]F) and the unit volume of the
                                                  chemical is more than 450 liters; or
                                                 (c) A positive result is obtained in a test using a 100 mm cube
                                                  sample at 100 [deg]C (212 [deg]F).
----------------------------------------------------------------------------------------------------------------

    B.11.2.2 Chemicals with a temperature of spontaneous combustion 
higher than 50 [deg]C (122 [deg]F) for a volume of 27 m\3\ shall not be 
classified as self-heating chemicals.
    B.11.2.3 Chemicals with a spontaneous ignition temperature higher 
than 50 [deg]C (122 [deg]F) for a volume of 450 liters shall not be 
classified in Category 1 of this class.

             B.11.3 Additional Classification Considerations

    B.11.3.1 The classification procedure for self-heating chemicals 
need not be applied if the results of a screening test can be adequately 
correlated with the classification test and an appropriate safety margin 
is applied.
    B.11.3.2 Examples of screening tests are:
    (a) The Grewer Oven test (VDI guideline 2263, part 1, 1990, Test 
methods for the Determination of the Safety Characteristics of Dusts) 
with an onset temperature 80[deg]K above the reference temperature for a 
volume of 1 l;
    (b) The Bulk Powder Screening Test (Gibson, N. Harper, D. J. Rogers, 
R. Evaluation of the fire and explosion risks in drying powders, Plant 
Operations Progress, 4 (3), 181-189, 1985) with an onset temperature 
60[deg]K above the reference temperature for a volume of 1 l.

    B.12 CHEMICALS WHICH, IN CONTACT WITH WATER, EMIT FLAMMABLE GASES

                            B.12.1 Definition

    Chemicals which, in contact with water, emit flammable gases are 
solid or liquid chemicals which, by interaction with water, are liable 
to become spontaneously flammable or to give off flammable gases in 
dangerous quantities.

                     B.12.2 Classification Criteria

    B.12.2.1 A chemical which, in contact with water, emits flammable 
gases shall be classified in one of the three categories for this class, 
using test N.5 in Part III, sub-section 33.4.1.4 of the UN ST/SG/AC.10 
(incorporated by reference; See Sec.  1910.6), in accordance with Table 
B.12.1:

             Table B.12.1--Criteria for Chemicals Which, in Contact With Water, Emit Flammable Gases
----------------------------------------------------------------------------------------------------------------
                  Category                                                 Criteria
----------------------------------------------------------------------------------------------------------------
1...........................................  Any chemical which reacts vigorously with water at ambient
                                               temperatures and demonstrates generally a tendency for the gas
                                               produced to ignite spontaneously, or which reacts readily with
                                               water at ambient temperatures such that the rate of evolution of
                                               flammable gas is equal to or greater than 10 liters per kilogram
                                               of chemical over any one minute.
2...........................................  Any chemical which reacts readily with water at ambient
                                               temperatures such that the maximum rate of evolution of flammable
                                               gas is equal to or greater than 20 liters per kilogram of
                                               chemical per hour, and which does not meet the criteria for
                                               Category 1.
3...........................................  Any chemical which reacts slowly with water at ambient
                                               temperatures such that the maximum rate of evolution of flammable
                                               gas is equal to or greater than 1 liter per kilogram of chemical
                                               per hour, and which does not meet the criteria for Categories 1
                                               and 2.
----------------------------------------------------------------------------------------------------------------

    Note: Classification of solid chemicals shall be based on tests 
performed on the chemical as presented. If, for example, for the 
purposes of supply or transport, the same chemical is to be presented in 
a physical form different from that which was tested and which is 
considered likely to materially alter its performance in a 
classification test, classification must be based on testing of the 
chemical in the new form.
    B.12.2.2 A chemical is classified as a chemical which, in contact 
with water emits

[[Page 599]]

flammable gases if spontaneous ignition takes place in any step of the 
test procedure.

             B.12.3 Additional Classification Considerations

    The classification procedure for this class need not be applied if:
    (a) The chemical structure of the chemical does not contain metals 
or metalloids;
    (b) Experience in production or handling shows that the chemical 
does not react with water, (e.g., the chemical is manufactured with 
water or washed with water); or
    (c) The chemical is known to be soluble in water to form a stable 
mixture.

                         B.13 OXIDIZING LIQUIDS

                            B.13.1 Definition

    Oxidizing liquid means a liquid which, while in itself not 
necessarily combustible, may, generally by yielding oxygen, cause, or 
contribute to, the combustion of other material.

                     B.13.2 Classification Criteria

    An oxidizing liquid shall be classified in one of the three 
categories for this class using test O.2 in Part III, sub-section 34.4.2 
of the UN ST/SG/AC.10 (incorporated by reference; See Sec.  1910.6), in 
accordance with Table B.13.1:

                                  Table B.13.1--Criteria for Oxidizing Liquids
----------------------------------------------------------------------------------------------------------------
                  Category                                                 Criteria
----------------------------------------------------------------------------------------------------------------
1...........................................  Any chemical which, in the 1:1 mixture, by mass, of chemical and
                                               cellulose tested, spontaneously ignites; or the mean pressure
                                               rise time of a 1:1 mixture, by mass, of chemical and cellulose is
                                               less than that of a 1:1 mixture, by mass, of 50% perchloric acid
                                               and cellulose;
2...........................................  Any chemical which, in the 1:1 mixture, by mass, of chemical and
                                               cellulose tested, exhibits a mean pressure rise time less than or
                                               equal to the mean pressure rise time of a 1:1 mixture, by mass,
                                               of 40% aqueous sodium chlorate solution and cellulose; and the
                                               criteria for Category 1 are not met;
3...........................................  Any chemical which, in the 1:1 mixture, by mass, of chemical and
                                               cellulose tested, exhibits a mean pressure rise time less than or
                                               equal to the mean pressure rise time of a 1:1 mixture, by mass,
                                               of 65% aqueous nitric acid and cellulose; and the criteria for
                                               Categories 1 and 2 are not met.
----------------------------------------------------------------------------------------------------------------

             B.13.3 Additional Classification Considerations

    B.13.3.1 For organic chemicals, the classification procedure for 
this class shall not be applied if:
    (a) The chemical does not contain oxygen, fluorine or chlorine; or
    (b) The chemical contains oxygen, fluorine or chlorine and these 
elements are chemically bonded only to carbon or hydrogen.
    B.13.3.2 For inorganic chemicals, the classification procedure for 
this class shall not be applied if the chemical does not contain oxygen 
or halogen atoms.
    B.13.3.3 In the event of divergence between test results and known 
experience in the handling and use of chemicals which shows them to be 
oxidizing, judgments based on known experience shall take precedence 
over test results.
    B.13.3.4 In cases where chemicals generate a pressure rise (too high 
or too low), caused by chemical reactions not characterizing the 
oxidizing properties of the chemical, the test described in Part III, 
sub-section 34.4.2 of the UN ST/SG/AC.10 (incorporated by reference; See 
Sec.  1910.6) shall be repeated with an inert substance (e.g., diatomite 
(kieselguhr)) in place of the cellulose in order to clarify the nature 
of the reaction.

                          B.14 OXIDIZING SOLIDS

                            B.14.1 Definition

    Oxidizing solid means a solid which, while in itself is not 
necessarily combustible, may, generally by yielding oxygen, cause, or 
contribute to, the combustion of other material.

                     B.14.2 Classification Criteria

    An oxidizing solid shall be classified in one of the three 
categories for this class using test O.1 in Part III, sub-section 34.4.1 
of the UN ST/SG/AC.10 (incorporated by reference; See Sec.  1910.6), in 
accordance with Table B.14.1:

                                   Table B.14.1--Criteria for Oxidizing Solids
----------------------------------------------------------------------------------------------------------------
                  Category                                                 Criteria
----------------------------------------------------------------------------------------------------------------
1...........................................  Any chemical which, in the 4:1 or 1:1 sample-to-cellulose ratio
                                               (by mass) tested, exhibits a mean burning time less than the mean
                                               burning time of a 3:2 mixture, by mass, of potassium bromate and
                                               cellulose.
2...........................................  Any chemical which, in the 4:1 or 1:1 sample-to-cellulose ratio
                                               (by mass) tested, exhibits a mean burning time equal to or less
                                               than the mean burning time of a 2:3 mixture (by mass) of
                                               potassium bromate and cellulose and the criteria for Category 1
                                               are not met.
3...........................................  Any chemical which, in the 4:1 or 1:1 sample-to-cellulose ratio
                                               (by mass) tested, exhibits a mean burning time equal to or less
                                               than the mean burning time of a 3:7 mixture (by mass) of
                                               potassium bromate and cellulose and the criteria for Categories 1
                                               and 2 are not met.
----------------------------------------------------------------------------------------------------------------


[[Page 600]]

    Note 1: Some oxidizing solids may present explosion hazards under 
certain conditions (e.g., when stored in large quantities). For example, 
some types of ammonium nitrate may give rise to an explosion hazard 
under extreme conditions and the ``Resistance to detonation test'' (IMO: 
Code of Safe Practice for Solid Bulk Cargoes, 2005, Annex 3, Test 5) may 
be used to assess this hazard. When information indicates that an 
oxidizing solid may present an explosion hazard, it shall be indicated 
on the Safety Data Sheet.
    Note 2: Classification of solid chemicals shall be based on tests 
performed on the chemical as presented. If, for example, for the 
purposes of supply or transport, the same chemical is to be presented in 
a physical form different from that which was tested and which is 
considered likely to materially alter its performance in a 
classification test, classification must be based on testing of the 
chemical in the new form.

             B.14.3 Additional Classification Considerations

    B.14.3.1 For organic chemicals, the classification procedure for 
this class shall not be applied if:
    (a) The chemical does not contain oxygen, fluorine or chlorine; or
    (b) The chemical contains oxygen, fluorine or chlorine and these 
elements are chemically bonded only to carbon or hydrogen.
    B.14.3.2 For inorganic chemicals, the classification procedure for 
this class shall not be applied if the chemical does not contain oxygen 
or halogen atoms.
    B.14.3.3 In the event of divergence between test results and known 
experience in the handling and use of chemicals which shows them to be 
oxidizing, judgements based on known experience shall take precedence 
over test results.

                         B.15 ORGANIC PEROXIDES

                            B.15.1 Definition

    B.15.1.1 Organic peroxide means a liquid or solid organic chemical 
which contains the bivalent -0-0- structure and as such is considered a 
derivative of hydrogen peroxide, where one or both of the hydrogen atoms 
have been replaced by organic radicals. The term organic peroxide 
includes organic peroxide mixtures containing at least one organic 
peroxide. Organic peroxides are thermally unstable chemicals, which may 
undergo exothermic self-accelerating decomposition. In addition, they 
may have one or more of the following properties:
    (a) Be liable to explosive decomposition;
    (b) Burn rapidly;
    (c) Be sensitive to impact or friction;
    (d) React dangerously with other substances.
    B.15.1.2 An organic peroxide is regarded as possessing explosive 
properties when in laboratory testing the formulation is liable to 
detonate, to deflagrate rapidly or to show a violent effect when heated 
under confinement.

                     B.15.2 Classification Criteria

    B.15.2.1 Any organic peroxide shall be considered for classification 
in this class, unless it contains:
    (a) Not more than 1.0% available oxygen from the organic peroxides 
when containing not more than 1.0% hydrogen peroxide; or
    (b) Not more than 0.5% available oxygen from the organic peroxides 
when containing more than 1.0% but not more than 7.0% hydrogen peroxide.

    Note: The available oxygen content (%) of an organic peroxide 
mixture is given by the formula:
[GRAPHIC] [TIFF OMITTED] TR26MR12.068

Where:

ni = number of peroxygen groups per molecule of organic peroxide i;
ci = concentration (mass %) of organic peroxide i;
mi = molecular mass of organic peroxide i.

    B.15.2.2 Organic peroxides shall be classified in one of the seven 
categories of ``Types A to G'' for this class, according to the 
following principles:
    (a) Any organic peroxide which, as packaged, can detonate or 
deflagrate rapidly shall be defined as organic peroxide TYPE A;
    (b) Any organic peroxide possessing explosive properties and which, 
as packaged, neither detonates nor deflagrates rapidly, but is liable to 
undergo a thermal explosion in that package shall be defined as organic 
peroxide TYPE B;
    (c) Any organic peroxide possessing explosive properties when the 
chemical as packaged cannot detonate or deflagrate rapidly or undergo a 
thermal explosion shall be defined as organic peroxide TYPE C;
    (d) Any organic peroxide which in laboratory testing meets the 
criteria in (d)(i), (ii),

[[Page 601]]

or (iii) shall be defined as organic peroxide TYPE D:
    (i) Detonates partially, does not deflagrate rapidly and shows no 
violent effect when heated under confinement; or
    (ii) Does not detonate at all, deflagrates slowly and shows no 
violent effect when heated under confinement; or
    (iii) Does not detonate or deflagrate at all and shows a medium 
effect when heated under confinement;
    (e) Any organic peroxide which, in laboratory testing, neither 
detonates nor deflagrates at all and shows low or no effect when heated 
under confinement shall be defined as organic peroxide TYPE E;
    (f) Any organic peroxide which, in laboratory testing, neither 
detonates in the cavitated state nor deflagrates at all and shows only a 
low or no effect when heated under confinement as well as low or no 
explosive power shall be defined as organic peroxide TYPE F;
    (g) Any organic peroxide which, in laboratory testing, neither 
detonates in the cavitated state nor deflagrates at all and shows no 
effect when heated under confinement nor any explosive power, provided 
that it is thermally stable (self-accelerating decomposition temperature 
is 60 [deg]C (140 [deg]F) or higher for a 50 kg (110 lb) package), and, 
for liquid mixtures, a diluent having a boiling point of not less than 
150 [deg]C (302 [deg]F) is used for desensitization, shall be defined as 
organic peroxide TYPE G. If the organic peroxide is not thermally stable 
or a diluent having a boiling point less than 150 [deg]C (302 [deg]F) is 
used for desensitization, it shall be defined as organic peroxide TYPE 
F.

             B.15.3 Additional Classification Considerations

    B.15.3.1 For purposes of classification, the properties of organic 
peroxides shall be determined in accordance with test series A to H as 
described in Part II of the UN ST/SG/AC.10 (incorporated by reference; 
See Sec.  1910.6).
    B.15.3.2 Self-accelerating decomposition temperature (SADT) shall be 
determined in accordance with the UN ST/SG/AC.10 (incorporated by 
reference; See Sec.  1910.6), Part II, section 28.
    B.15.3.3 Mixtures of organic peroxides may be classified as the same 
type of organic peroxide as that of the most dangerous ingredient. 
However, as two stable ingredients can form a thermally less stable 
mixture, the SADT of the mixture shall be determined.

                        B.16 CORROSIVE TO METALS

                            B.16.1 Definition

    A chemical which is corrosive to metals means a chemical which by 
chemical action will materially damage, or even destroy, metals.

                     B.16.2 Classification Criteria

    A chemical which is corrosive to metals shall be classified in a 
single category for this class, using the test in Part III, sub-section 
37.4 of the UN ST/SG/AC.10 (incorporated by reference; See Sec.  
1910.6), in accordance with Table B.16.1:

                             Table B.16.1--Criteria for Chemicals Corrosive to Metal
----------------------------------------------------------------------------------------------------------------
                  Category                                                 Criteria
----------------------------------------------------------------------------------------------------------------
1...........................................  Corrosion rate on either steel or aluminium surfaces exceeding
                                               6.25 mm per year at a test temperature of 55 [deg]C (131 [deg]F)
                                               when tested on both materials.
----------------------------------------------------------------------------------------------------------------

    Note: Where an initial test on either steel or aluminium indicates 
the chemical being tested is corrosive, the follow-up test on the other 
metal is not necessary.

             B.16.3 Additional Classification Considerations

    The specimen to be used for the test shall be made of the following 
materials:
    (a) For the purposes of testing steel, steel types S235JR + CR 
(1.0037 resp.St 37-2), S275J2G3 + CR (1.0144 resp.St 44-3), ISO 3574, 
Unified Numbering System (UNS) G 10200, or SAE 1020;
    (b) For the purposes of testing aluminium: Non-clad types 7075-T6 or 
AZ5GU-T6.

 Appendix C to Sec.  1910.1200--Allocation of Label Elements (Mandatory)

    C.1 The label for each hazardous chemical shall include the product 
identifier used on the safety data sheet.
    C.1.1 The labels on shipped containers shall also include the name, 
address, and telephone number of the chemical manufacturer, importer, or 
responsible party.
    C.2 The label for each hazardous chemical that is classified shall 
include the signal word, hazard statement(s), pictogram(s), and 
precautionary statement(s) specified in C.4 for each hazard class and 
associated hazard category, except as provided for in C.2.1 through 
C.2.4.

[[Page 602]]

                 C.2.1 Precedence of Hazard Information

    C.2.1.1 If the signal word ``Danger'' is included, the signal word 
``Warning'' shall not appear;
    C.2.1.2 If the skull and crossbones pictogram is included, the 
exclamation mark pictogram shall not appear where it is used for acute 
toxicity;
    C.2.1.3 If the corrosive pictogram is included, the exclamation mark 
pictogram shall not appear where it is used for skin or eye irritation;
    C.2.1.4 If the health hazard pictogram is included for respiratory 
sensitization, the exclamation mark pictogram shall not appear where it 
is used for skin sensitization or for skin or eye irritation.

                       C.2.2 Hazard Statement Text

    C.2.2.1 The text of all applicable hazard statements shall appear on 
the label, except as otherwise specified. The information in italics 
shall be included as part of the hazard statement as provided. For 
example: ``causes damage to organs (state all organs affected) through 
prolonged or repeated exposure (state route of exposure if no other 
routes of exposure cause the hazard)''. Hazard statements may be 
combined where appropriate to reduce the information on the label and 
improve readability, as long as all of the hazards are conveyed as 
required.
    C.2.2.2 If the chemical manufacturer, importer, or responsible party 
can demonstrate that all or part of the hazard statement is 
inappropriate to a specific substance or mixture, the corresponding 
statement may be omitted from the label.

                            C.2.3 Pictograms

    C.2.3.1 Pictograms shall be in the shape of a square set at a point 
and shall include a black hazard symbol on a white background with a red 
frame sufficiently wide to be clearly visible. A square red frame set at 
a point without a hazard symbol is not a pictogram and is not permitted 
on the label.

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                   C.2.4 Precautionary Statement Text

    C.2.4.1 There are four types of precautionary statements presented, 
``prevention,'' ``response,'' ``storage,'' and ``disposal.'' The core 
part of the precautionary statement is presented in bold print. This is 
the text, except as otherwise specified, that shall appear on the label. 
Where additional information is required, it is indicated in plain text.
    C.2.4.2 When a backslash or diagonal mark (/) appears in the 
precautionary statement text, it indicates that a choice has to be made 
between the separated phrases. In such cases, the chemical manufacturer, 
importer, or responsible party can choose the most appropriate 
phrase(s). For example, ``Wear protective gloves/protective clothing/eye 
protection/face protection'' could read ``wear eye protection''.
    C.2.4.3 When three full stops (* * *) appear in the precautionary 
statement text, they indicate that all applicable conditions are not 
listed. For example, in ``Use explosion-proof electrical/ventilating/
lighting/* * */equipment'', the use of ``* * *'' indicates that other 
equipment may need to be specified. In such cases, the chemical 
manufacturer, importer, or responsible party can choose the other 
conditions to be specified.
    C.2.4.4 When text in italics is used in a precautionary statement, 
this indicates specific conditions applying to the use or allocation of 
the precautionary statement. For example, ``Use explosion-proof 
electrical/ventilating/lighting/* * */equipment'' is only required for 
flammable solids ``if dust clouds can occur''. Text in italics is 
intended to be an explanatory, conditional note and is not intended to 
appear on the label.
    C.2.4.5 Where square brackets ([ ]) appear around text in a 
precautionary statement, this indicates that the text in square brackets 
is not appropriate in every case and should be used only in certain 
circumstances. In these cases, conditions for use explaining when the 
text should be used are provided. For example, one precautionary 
statement states: ``[In case of inadequate ventilation] wear respiratory 
protection.'' This statement is given with the condition for use ``- 
text in square brackets may be used if additional information is 
provided with the chemical at the point of use that explains what type 
of ventilation would be adequate for safe use''. This means that, if 
additional information is provided with the chemical explaining what 
type of ventilation would be adequate for safe use, the text in square 
brackets should be used and the statement would read: ``In case of 
inadequate ventilation wear respiratory protection.'' However, if the 
chemical is supplied without such ventilation information, the text in 
square brackets should not be used, and the precautionary statement 
should read: ``Wear respiratory protection.''
    C.2.4.6 Precautionary statements may be combined or consolidated to 
save label space and improve readability. For example, ``Keep away from 
heat, sparks and open flame,'' ``Store in a well-ventilated place'' and 
``Keep cool'' can be combined to read ``Keep away from heat, sparks and 
open flame and store in a cool, well-ventilated place.''
    C.2.4.7 In most cases, the precautionary statements are independent 
(e.g., the phrases for explosive hazards do not modify those related to 
certain health hazards, and products that are classified for both hazard 
classes shall bear appropriate precautionary statements for both). Where 
a chemical is classified for a number of hazards, and the precautionary 
statements are similar, the most stringent shall be included on the 
label (this will be applicable mainly to preventive measures). An order 
of precedence may be

[[Page 605]]

imposed by the chemical manufacturer, importer or responsible party in 
situations where phrases concern ``Response.'' Rapid action may be 
crucial. For example, if a chemical is carcinogenic and acutely toxic, 
rapid action may be crucial, and first aid measures for acute toxicity 
will take precedence over those for long-term effects. In addition, 
medical attention to delayed health effects may be required in cases of 
incidental exposure, even if not associated with immediate symptoms of 
intoxication.
    C.2.4.8 If the chemical manufacturer, importer, or responsible party 
can demonstrate that a precautionary statement is inappropriate to a 
specific substance or mixture, the precautionary statement may be 
omitted from the label.

                  C.3 Supplementary Hazard Information

    C.3.1 To ensure that non-standardized information does not lead to 
unnecessarily wide variation or undermine the required information, 
supplementary information on the label is limited to when it provides 
further detail and does not contradict or cast doubt on the validity of 
the standardized hazard information.
    C.3.2 Where the chemical manufacturer, importer, or distributor 
chooses to add supplementary information on the label, the placement of 
supplemental information shall not impede identification of information 
required by this section.
    C.3.3 Where an ingredient with unknown acute toxicity is used in a 
mixture at a concentration =1%, and the mixture is not 
classified based on testing of the mixture as a whole, a statement that 
X% of the mixture consists of ingredient(s) of unknown acute toxicity is 
required on the label.

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      Appendix D to Sec.  1910.1200--Safety Data Sheets (Mandatory)

    A safety data sheet (SDS) shall include the information specified in 
Table D.1 under the section number and heading indicated for sections 1-
11 and 16. If no relevant information is found for any given subheading 
within a section, the SDS shall clearly indicate

[[Page 663]]

that no applicable information is available. Sections 12-15 may be 
included in the SDS, but are not mandatory.

                Table D.1--Minimum Information for an SDS
------------------------------------------------------------------------
           Heading                             Subheading
------------------------------------------------------------------------
1. Identification............  (a) Product identifier used on the label;
                               (b) Other means of identification;
                               (c) Recommended use of the chemical and
                                restrictions on use;
                               (d) Name, address, and telephone number
                                of the chemical manufacturer, importer,
                                or other responsible party;
                               (e) Emergency phone number.
2. Hazard(s) identification..  (a) Classification of the chemical in
                                accordance with paragraph (d) of Sec.
                                1910.1200;
                               (b) Signal word, hazard statement(s),
                                symbol(s) and precautionary statement(s)
                                in accordance with paragraph (f) of Sec.
                                  1910.1200. (Hazard symbols may be
                                provided as graphical reproductions in
                                black and white or the name of the
                                symbol, e.g., flame, skull and
                                crossbones);
                               (c) Describe any hazards not otherwise
                                classified that have been identified
                                during the classification process;
                               (d) Where an ingredient with unknown
                                acute toxicity is used in a mixture at a
                                concentration =1% and the
                                mixture is not classified based on
                                testing of the mixture as a whole, a
                                statement that X% of the mixture
                                consists of ingredient(s) of unknown
                                acute toxicity is required.
3. Composition/information on  Except as provided for in paragraph (i)
 ingredients.                   of Sec.   1910.1200 on trade secrets:
                               For Substances
                               (a) Chemical name;
                               (b) Common name and synonyms;
                               (c) CAS number and other unique
                                identifiers;
                               (d) Impurities and stabilizing additives
                                which are themselves classified and
                                which contribute to the classification
                                of the substance.
                               For Mixtures
                               In addition to the information required
                                for substances:
                               (a) The chemical name and concentration
                                (exact percentage) or concentration
                                ranges of all ingredients which are
                                classified as health hazards in
                                accordance with paragraph (d) of Sec.
                                1910.1200 and
                               (1) Are present above their cut-off/
                                concentration limits; or
                               (2) Present a health risk below the cut-
                                off/concentration limits.
                               (b) The concentration (exact percentage)
                                shall be specified unless a trade secret
                                claim is made in accordance with
                                paragraph (i) of Sec.   1910.1200, when
                                there is batch-to-batch variability in
                                the production of a mixture, or for a
                                group of substantially similar mixtures
                                (See A.0.5.1.2) with similar chemical
                                composition. In these cases,
                                concentration ranges may be used.
                               For All Chemicals Where a Trade Secret is
                                Claimed
                               Where a trade secret is claimed in
                                accordance with paragraph (i) of Sec.
                                1910.1200, a statement that the specific
                                chemical identity and/or exact
                                percentage (concentration) of
                                composition has been withheld as a trade
                                secret is required.
4. First-aid measures........  (a) Description of necessary measures,
                                subdivided according to the different
                                routes of exposure, i.e., inhalation,
                                skin and eye contact, and ingestion;
                               (b) Most important symptoms/effects,
                                acute and delayed.
                               (c) Indication of immediate medical
                                attention and special treatment needed,
                                if necessary.
5. Fire-fighting measures....  (a) Suitable (and unsuitable)
                                extinguishing media.
                               (b) Specific hazards arising from the
                                chemical (e.g., nature of any hazardous
                                combustion products).
                               (c) Special protective equipment and
                                precautions for fire-fighters.
6. Accidental release          (a) Personal precautions, protective
 measures.                      equipment, and emergency procedures.
                               (b) Methods and materials for containment
                                and cleaning up.
7. Handling and storage......  (a) Precautions for safe handling.
                               (b) Conditions for safe storage,
                                including any incompatibilities.
8. Exposure controls/personal  (a) OSHA permissible exposure limit
 protection.                    (PEL), American Conference of
                                Governmental Industrial Hygienists
                                (ACGIH) Threshold Limit Value (TLV), and
                                any other exposure limit used or
                                recommended by the chemical
                                manufacturer, importer, or employer
                                preparing the safety data sheet, where
                                available.
                               (b) Appropriate engineering controls.
                               (c) Individual protection measures, such
                                as personal protective equipment.
9. Physical and chemical       (a) Appearance (physical state, color,
 properties.                    etc.);
                               (b) Odor;
                               (c) Odor threshold;
                               (d) pH;
                               (e) Melting point/freezing point;
                               (f) Initial boiling point and boiling
                                range;
                               (g) Flash point;
                               (h) Evaporation rate;
                               (i) Flammability (solid, gas);

[[Page 664]]

 
                               (j) Upper/lower flammability or explosive
                                limits;
                               (k) Vapor pressure;
                               (l) Vapor density;
                               (m) Relative density;
                               (n) Solubility(ies);
                               (o) Partition coefficient: n-octanol/
                                water;
                               (p) Auto-ignition temperature;
                               (q) Decomposition temperature;
                               (r) Viscosity.
10. Stability and reactivity.  (a) Reactivity;
                               (b) Chemical stability;
                               (c) Possibility of hazardous reactions;
                               (d) Conditions to avoid (e.g., static
                                discharge, shock, or vibration);
                               (e) Incompatible materials;
                               (f) Hazardous decomposition products.
11. Toxicological information  Description of the various toxicological
                                (health) effects and the available data
                                used to identify those effects,
                                including:
                               (a) Information on the likely routes of
                                exposure (inhalation, ingestion, skin
                                and eye contact);
                               (b) Symptoms related to the physical,
                                chemical and toxicological
                                characteristics;
                               (c) Delayed and immediate effects and
                                also chronic effects from short- and
                                long-term exposure;
                               (d) Numerical measures of toxicity (such
                                as acute toxicity estimates).
                               (e) Whether the hazardous chemical is
                                listed in the National Toxicology
                                Program (NTP) Report on Carcinogens
                                (latest edition) or has been found to be
                                a potential carcinogen in the
                                International Agency for Research on
                                Cancer (IARC) Monographs (latest
                                edition), or by OSHA.
12. Ecological information     (a) Ecotoxicity (aquatic and terrestrial,
 (Non-mandatory).               where available);
                               (b) Persistence and degradability;
                               (c) Bioaccumulative potential;
                               (d) Mobility in soil;
                               (e) Other adverse effects (such as
                                hazardous to the ozone layer).
13. Disposal considerations    Description of waste residues and
 (Non-mandatory).               information on their safe handling and
                                methods of disposal, including the
                                disposal of any contaminated packaging.
14. Transport information      (a) UN number;
 (Non-mandatory).
                               (b) UN proper shipping name;
                               (c) Transport hazard class(es);
                               (d) Packing group, if applicable;
                               (e) Environmental hazards (e.g., Marine
                                pollutant (Yes/No));
                               (f) Transport in bulk (according to Annex
                                II of MARPOL 73/78 and the IBC Code);
                               (g) Special precautions which a user
                                needs to be aware of, or needs to comply
                                with, in connection with transport or
                                conveyance either within or outside
                                their premises.
15. Regulatory information     Safety, health and environmental
 (Non-mandatory).               regulations specific for the product in
                                question.
16. Other information,         The date of preparation of the SDS or the
 including date of              last change to it.
 preparation or last revision.
------------------------------------------------------------------------

     Appendix E to Sec.  1910.1200--Definition of ``Trade Secret'' 
                               (Mandatory)

    The following is a reprint of the Restatement of Torts section 757, 
comment b (1939):
    b. Definition of trade secret. A trade secret may consist of any 
formula, pattern, device or compilation of information which is used in 
one's business, and which gives him an opportunity to obtain an 
advantage over competitors who do not know or use it. It may be a 
formula for a chemical compound, a process of manufacturing, treating or 
preserving materials, a pattern for a machine or other device, or a list 
of customers. It differs from other secret information in a business 
(see s759 of the Restatement of Torts which is not included in this 
Appendix) in that it is not simply information as to single or ephemeral 
events in the conduct of the business, as, for example, the amount or 
other terms of a secret bid for a contract or the salary of certain 
employees, or the security investments made or contemplated, or the date 
fixed for the announcement of a new policy or for bringing out a new 
model or the like. A trade secret is a process or device for continuous 
use in the operations of the business. Generally it relates to the 
production of goods, as, for example, a machine or formula for the 
production of an article. It may, however, relate to the sale of goods 
or to other operations in the business, such as a code for determining 
discounts, rebates or other concessions in a price list or catalogue, or 
a list of specialized customers, or a method of bookkeeping or other 
office management.

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    Secrecy. The subject matter of a trade secret must be secret. 
Matters of public knowledge or of general knowledge in an industry 
cannot be appropriated by one as his secret. Matters which are 
completely disclosed by the goods which one markets cannot be his 
secret. Substantially, a trade secret is known only in the particular 
business in which it is used. It is not requisite that only the 
proprietor of the business know it. He may, without losing his 
protection, communicate it to employees involved in its use. He may 
likewise communicate it to others pledged to secrecy. Others may also 
know of it independently, as, for example, when they have discovered the 
process or formula by independent invention and are keeping it secret. 
Nevertheless, a substantial element of secrecy must exist, so that, 
except by the use of improper means, there would be difficulty in 
acquiring the information. An exact definition of a trade secret is not 
possible. Some factors to be considered in determining whether given 
information is one's trade secret are: (1) The extent to which the 
information is known outside of his business; (2) the extent to which it 
is known by employees and others involved in his business; (3) the 
extent of measures taken by him to guard the secrecy of the information; 
(4) the value of the information to him and his competitors; (5) the 
amount of effort or money expended by him in developing the information; 
(6) the ease or difficulty with which the information could be properly 
acquired or duplicated by others.
    Novelty and prior art. A trade secret may be a device or process 
which is patentable; but it need not be that. It may be a device or 
process which is clearly anticipated in the prior art or one which is 
merely a mechanical improvement that a good mechanic can make. Novelty 
and invention are not requisite for a trade secret as they are for 
patentability. These requirements are essential to patentability because 
a patent protects against unlicensed use of the patented device or 
process even by one who discovers it properly through independent 
research. The patent monopoly is a reward to the inventor. But such is 
not the case with a trade secret. Its protection is not based on a 
policy of rewarding or otherwise encouraging the development of secret 
processes or devices. The protection is merely against breach of faith 
and reprehensible means of learning another's secret. For this limited 
protection it is not appropriate to require also the kind of novelty and 
invention which is a requisite of patentability. The nature of the 
secret is, however, an important factor in determining the kind of 
relief that is appropriate against one who is subject to liability under 
the rule stated in this Section. Thus, if the secret consists of a 
device or process which is a novel invention, one who acquires the 
secret wrongfully is ordinarily enjoined from further use of it and is 
required to account for the profits derived from his past use. If, on 
the other hand, the secret consists of mechanical improvements that a 
good mechanic can make without resort to the secret, the wrongdoer's 
liability may be limited to damages, and an injunction against future 
use of the improvements made with the aid of the secret may be 
inappropriate.

 Appendix F to Sec.  1910.1200--Guidance for Hazard Classifications Re: 
                     Carcinogenicity (Non-Mandatory)

    The mandatory criteria for classification of a chemical for 
carcinogenicity under HCS (Sec.  1910.1200) are found in Appendix A.6 to 
this section. This non-mandatory Appendix provides additional guidance 
on hazard classification for carcinogenicity. Part A of Appendix F 
includes background guidance provided by GHS based on the Preamble of 
the International Agency for Research on Cancer (IARC) ``Monographs on 
the Evaluation of Carcinogenic Risks to Humans'' (2006). Part B provides 
IARC classification information. Part C provides background guidance 
from the National Toxicology Program (NTP) ``Report on Carcinogens'' 
(RoC), and Part D is a table that compares GHS carcinogen hazard 
categories to carcinogen classifications under IARC and NTP, allowing 
classifiers to be able to use information from IARC and NTP RoC 
carcinogen classifications to complete their classifications under the 
GHS, and thus the HCS.

                     Part A: Background Guidance \1\
---------------------------------------------------------------------------

    \1\ The text of Appendix F, Part A, on the IARC Monographs, is 
paraphrased from the 2006 Preamble to the ``Monographs on the Evaluation 
of Carcinogenic Risks to Humans''; the Classifier is referred to the 
full IARC Preamble for the complete text. The text is not part of the 
agreed GHS text on the harmonized system developed by the OECD Task 
Force-HCL.
---------------------------------------------------------------------------

    As noted in Footnote 6 of Appendix A.6. to this section, the GHS 
includes as guidance for classifiers information taken from the Preamble 
of the International Agency for Research on Cancer (IARC) ``Monographs 
on the Evaluation of Carcinogenic Risks to Humans'' (2006), providing 
guidance on the evaluation of the strength and evidence of carcinogenic 
risks to humans. This guidance also discusses some additional 
considerations in classification and an approach to analysis, rather 
than hard-and-fast rules. Part A is consistent with Appendix A.6, and 
should help in evaluating information to determine carcinogenicity.
    Carcinogenicity in humans:
    The evidence relevant to carcinogenicity from studies in humans is 
classified into one of the following categories:

[[Page 666]]

    (a) Sufficient evidence of carcinogenicity: A causal relationship 
has been established between exposure to the agent and human cancer. 
That is, a positive relationship has been observed between the exposure 
and cancer in studies in which chance, bias and confounding could be 
ruled out with reasonable confidence.
    (b) Limited evidence of carcinogenicity: A positive association has 
been observed between exposure to the agent and cancer for which a 
causal interpretation is considered by the Working Group to be credible, 
but chance, bias or confounding could not be ruled out with reasonable 
confidence.
    In some instances, the above categories may be used to classify the 
degree of evidence related to carcinogenicity in specific organs or 
tissues.
    Carcinogenicity in experimental animals:
    The evidence relevant to carcinogenicity in experimental animals is 
classified into one of the following categories:
    (a) Sufficient evidence of carcinogenicity: A causal relationship 
has been established between the agent and an increased incidence of 
malignant neoplasms or of an appropriate combination of benign and 
malignant neoplasms in two or more species of animals or two or more 
independent studies in one species carried out at different times or in 
different laboratories or under different protocols. An increased 
incidence of tumors in both sexes of a single species in a well-
conducted study, ideally conducted under Good Laboratory Practices, can 
also provide sufficient evidence.
    Exceptionally, a single study in one species and sex might be 
considered to provide sufficient evidence of carcinogenicity when 
malignant neoplasms occur to an unusual degree with regard to incidence, 
site, type of tumor or age at onset, or when there are strong findings 
of tumors at multiple sites.
    (b) Limited evidence of carcinogenicity: The data suggest a 
carcinogenic effect but are limited for making a definitive evaluation 
because, e.g. the evidence of carcinogenicity is restricted to a single 
experiment; there are unresolved questions regarding the adequacy of the 
design, conduct or interpretation of the studies; the agent increases 
the incidence only of benign neoplasms or lesions of uncertain 
neoplastic potential; or the evidence of carcinogenicity is restricted 
to studies that demonstrate only promoting activity in a narrow range of 
tissues or organs.

   Guidance on How To Consider Important Factors in Classification of 
                 Carcinogenicity (See Reference Section)

    The weight of evidence analysis called for in GHS and the HCS (Sec.  
1910.1200) is an integrative approach that considers important factors 
in determining carcinogenic potential along with the strength of 
evidence analysis. The IPCS ``Conceptual Framework for Evaluating a Mode 
of Action for Chemical Carcinogenesis'' (2001), International Life 
Sciences Institute (ILSI) ``Framework for Human Relevance Analysis of 
Information on Carcinogenic Modes of Action'' (Meek, et al., 2003; Cohen 
et al., 2003, 2004), and Preamble to the IARC Monographs (2006; Section 
B.6. (Scientific Review and Evaluation; Evaluation and Rationale)) 
provide a basis for systematic assessments that may be performed in a 
consistent fashion. The IPCS also convened a panel in 2004 to further 
develop and clarify the human relevance framework. However, the above 
documents are not intended to dictate answers, nor provide lists of 
criteria to be checked off.

                             Mode of Action

    Various documents on carcinogen assessment all note that mode of 
action in and of itself, or consideration of comparative metabolism, 
should be evaluated on a case-by-case basis and are part of an analytic 
evaluative approach. One must look closely at any mode of action in 
animal experiments, taking into consideration comparative 
toxicokinetics/toxicodynamics between the animal test species and humans 
to determine the relevance of the results to humans. This may lead to 
the possibility of discounting very specific effects of certain types of 
substances. Life stage-dependent effects on cellular differentiation may 
also lead to qualitative differences between animals and humans. Only if 
a mode of action of tumor development is conclusively determined not to 
be operative in humans may the carcinogenic evidence for that tumor be 
discounted. However, a weight of evidence evaluation for a substance 
calls for any other tumorigenic activity to be evaluated, as well.

                Responses in Multiple Animal Experiments

    Positive responses in several species add to the weight of evidence 
that a substance is a carcinogen. Taking into account all of the factors 
listed in A.6.2.5.2 and more, such chemicals with positive outcomes in 
two or more species would be provisionally considered to be classified 
in GHS Category 1B until human relevance of animal results are assessed 
in their entirety. It should be noted, however, that positive results 
for one species in at least two independent studies, or a single 
positive study showing unusually strong evidence of malignancy may also 
lead to Category 1B.

                 Responses Are in One Sex or Both Sexes

    Any case of gender-specific tumors should be evaluated in light of 
the total tumorigenic response to the substance observed at other sites 
(multi-site responses or incidence above background) in determining the 
carcinogenic potential of the substance.

[[Page 667]]

    If tumors are seen only in one sex of an animal species, the mode of 
action should be carefully evaluated to see if the response is 
consistent with the postulated mode of action. Effects seen only in one 
sex in a test species may be less convincing than effects seen in both 
sexes, unless there is a clear patho-physiological difference consistent 
with the mode of action to explain the single sex response.

     Confounding Effects of Excessive Toxicity or Localized Effects

    Tumors occurring only at excessive doses associated with severe 
toxicity generally have doubtful potential for carcinogenicity in 
humans. In addition, tumors occurring only at sites of contact and/or 
only at excessive doses need to be carefully evaluated for human 
relevance for carcinogenic hazard. For example, forestomach tumors, 
following administration by gavage of an irritating or corrosive, non-
mutagenic chemical, may be of questionable relevance. However, such 
determinations must be evaluated carefully in justifying the 
carcinogenic potential for humans; any occurrence of other tumors at 
distant sites must also be considered.

                    Tumor Type, Reduced Tumor Latency

    Unusual tumor types or tumors occurring with reduced latency may add 
to the weight of evidence for the carcinogenic potential of a substance, 
even if the tumors are not statistically significant.
    Toxicokinetic behavior is normally assumed to be similar in animals 
and humans, at least from a qualitative perspective. On the other hand, 
certain tumor types in animals may be associated with toxicokinetics or 
toxicodynamics that are unique to the animal species tested and may not 
be predictive of carcinogenicity in humans. Very few such examples have 
been agreed internationally. However, one example is the lack of human 
relevance of kidney tumors in male rats associated with compounds 
causing [alpha]2u-globulin nephropathy (IARC, Scientific Publication 
N[deg] 147 \2\). Even when a particular tumor type may be discounted, 
expert judgment must be used in assessing the total tumor profile in any 
animal experiment.
---------------------------------------------------------------------------

    \2\ While most international agencies do not consider kidney tumors 
coincident with [alpha]2u-globulin nephropathy to be a predictor of risk 
in humans, this view is not universally held. (See: Doi et al., 2007).
---------------------------------------------------------------------------

     Part B: International Agency for Research on Cancer (IARC) \3\
---------------------------------------------------------------------------

    \3\ Preamble of the International Agency for Research on Cancer 
(IARC) ``Monographs on the Evaluation of Carcinogenic Risks to Humans'' 
(2006).
---------------------------------------------------------------------------

    IARC Carcinogen Classification Categories:
    Group 1: The agent is carcinogenic to humans
    This category is used when there is sufficient evidence of 
carcinogenicity in humans. Exceptionally, an agent may be placed in this 
category when evidence of carcinogenicity in humans is less than 
sufficient but there is sufficient evidence of carcinogenicity in 
experimental animals and strong evidence in exposed humans that the 
agent acts through a relevant mechanism of carcinogenicity.
    Group 2:
    This category includes agents for which, at one extreme, the degree 
of evidence of carcinogenicity in humans is almost sufficient, as well 
as those for which, at the other extreme, there are no human data but 
for which there is evidence of carcinogenicity in experimental animals. 
Agents are assigned to either Group 2A (probably carcinogenic to humans) 
or Group 2B (possibly carcinogenic to humans) on the basis of 
epidemiological and experimental evidence of carcinogenicity and 
mechanistic and other relevant data. The terms probably carcinogenic and 
possibly carcinogenic have no quantitative significance and are used 
simply as descriptors of different levels of evidence of human 
carcinogenicity, with probably carcinogenic signifying a higher level of 
evidence than possibly carcinogenic.
    Group 2A: The agent is probably carcinogenic to human.
    This category is used when there is limited evidence of 
carcinogenicity in humans and sufficient evidence of carcinogenicity in 
experimental animals. In some cases, an agent may be classified in this 
category when there is inadequate evidence of carcinogenicity in humans 
and sufficient evidence of carcinogenicity in experimental animals and 
strong evidence that the carcinogenesis is mediated by a mechanism that 
also operates in humans. Exceptionally, an agent may be classified in 
this category solely on the basis of limited evidence of carcinogenicity 
in humans. An agent may be assigned to this category if it clearly 
belongs, based on mechanistic considerations, to a class of agents for 
which one or more members have been classified in Group 1 or Group 2A.
    Group 2B: The agent is possibly carcinogenic to humans.
    This category is used for agents for which there is limited evidence 
of carcinogenicity in humans and less than sufficient evidence of 
carcinogenicity in experimental animals. It may also be used when there 
is inadequate evidence of carcinogenicity in humans but there is 
sufficient evidence of carcinogenicity in experimental animals. In some 
instances,

[[Page 668]]

an agent for which there is inadequate evidence of carcinogenicity in 
humans and less than sufficient evidence of carcinogenicity in 
experimental animals together with supporting evidence from mechanistic 
and other relevant data may be placed in this group. An agent may be 
classified in this category solely on the basis of strong evidence from 
mechanistic and other relevant data.

 Part C: National Toxicology Program (NTP), ``Report on Carcinogens'', 
                           Background Guidance

                        NTP Listing Criteria \4\
---------------------------------------------------------------------------

    \4\ See: http://ntp.niehs.nih.gov/go/15209.
---------------------------------------------------------------------------

    The criteria for listing an agent, substance, mixture, or exposure 
circumstance in the Report on Carcinogens (RoC) are as follows:
    Known To Be A Human Carcinogen: There is sufficient evidence of 
carcinogenicity from studies in humans \5\ that indicates a causal 
relationship between exposure to the agent, substance, or mixture, and 
human cancer.
---------------------------------------------------------------------------

    \5\ This evidence can include traditional cancer epidemiology 
studies, data from clinical studies, and/or data derived from the study 
of tissues or cells from humans exposed to the substance in question 
that can be useful for evaluating whether a relevant cancer mechanism is 
operating in people.
---------------------------------------------------------------------------

    Reasonably Anticipated To Be A Human Carcinogen: There is limited 
evidence of carcinogenicity from studies in humans that indicates that a 
causal interpretation is credible, but that alternative explanations, 
such as chance, bias, or confounding factors, could not adequately be 
excluded,

or

there is sufficient evidence of carcinogenicity from studies in 
experimental animals that indicates there is an increased incidence of 
malignant and/or a combination of malignant and benign tumors in 
multiple species or at multiple tissue sites, or by multiple routes of 
exposure, or to an unusual degree with regard to incidence, site, or 
type of tumor, or age at onset,

or

there is less than sufficient evidence of carcinogenicity in humans or 
laboratory animals; however, the agent, substance, or mixture belongs to 
a well-defined, structurally-related class of substances whose members 
are listed in a previous Report on Carcinogens as either known to be a 
human carcinogen or reasonably anticipated to be a human carcinogen, or 
there is convincing relevant information that the agent acts through 
mechanisms indicating it would likely cause cancer in humans.
    Conclusions regarding carcinogenicity in humans or experimental 
animals are based on scientific judgment, with consideration given to 
all relevant information. Relevant information includes, but is not 
limited to, dose response, route of exposure, chemical structure, 
metabolism, pharmacokinetics, sensitive sub-populations, genetic 
effects, or other data relating to mechanism of action or factors that 
may be unique to a given substance. For example, there may be substances 
for which there is evidence of carcinogenicity in laboratory animals, 
but there are compelling data indicating that the agent acts through 
mechanisms that do not operate in humans and would therefore not 
reasonably be anticipated to cause cancer in humans.

Part D: Table Relating Approximate Equivalences Among IARC, NTP RoC, and 
                   GHS Carcinogenicity Classifications

    The following table may be used to perform hazard classifications 
for carcinogenicity under the HCS (Sec.  1910.1200). It relates the 
approximated GHS hazard categories for carcinogenicity to the 
classifications provided by IARC and NTP, as described in Parts B and C 
of this Appendix.

    Approximate Equivalences Among Carcinogen Classification Schemes
------------------------------------------------------------------------
             IARC                      GHS                NTP RoC
------------------------------------------------------------------------
Group 1.......................  Category 1A......  Known.
Group 2A......................  Category 1B......  Reasonably
                                                    Anticipated (See
                                                    Note 1).
Group 2B......................  Category 2.......  Reasonably
                                                    Anticipated (See
                                                    Note 1).
------------------------------------------------------------------------

    Note 1:
    1. Limited evidence of carcinogenicity from studies in humans 
(corresponding to IARC 2A/GHS 1B);
    2. Sufficient evidence of carcinogenicity from studies in 
experimental animals (again, essentially corresponding to IARC 2A/GHS 
1B);
    3. Less than sufficient evidence of carcinogenicity in humans or 
laboratory animals; however:
    a. The agent, substance, or mixture belongs to a well-defined, 
structurally-related class of substances whose members are listed in a 
previous RoC as either ``Known'' or ``Reasonably Anticipated'' to be a 
human carcinogen, or

[[Page 669]]

    b. There is convincing relevant information that the agent acts 
through mechanisms indicating it would likely cause cancer in humans.

                               *References

Cohen, S.M., J. Klaunig, M.E. Meek, R.N. Hill, T. Pastoor, L. Lehman-
          McKeeman, J. Bucher, D.G. Longfellow, J. Seed, V. Dellarco, P. 
          Fenner-Crisp, and D. Patton. 2004. Evaluating the human 
          relevance of chemically induced animal tumors. Toxicol. Sci. 
          78(2):181-186.
Cohen, S.M., M.E. Meek, J.E. Klaunig, D.E. Patton, P.A. Fenner-Crisp. 
          2003. The human relevance of information on carcinogenic modes 
          of action: Overview. Crit. Rev. Toxicol. 33(6):581-9.
Meek, M.E., J.R. Bucher, S.M. Cohen, V. Dellarco, R.N. Hill, L. Lehman-
          McKeeman, D.G. Longfellow, T. Pastoor, J. Seed, D.E. Patton. 
          2003. A framework for human relevance analysis of information 
          on carcinogenic modes of action. Crit. Rev. Toxicol. 
          33(6):591-653.
Sonich-Mullin, C., R. Fielder, J. Wiltse, K. Baetcke, J. Dempsey, P. 
          Fenner-Crisp, D. Grant, M. Hartley, A. Knapp, D. Kroese, I. 
          Mangelsdorf, E. Meek, J.M. Rice, and M. Younes. 2001. The 
          conceptual framework for evaluating a mode of action for 
          chemical carcinogenesis. Reg. Toxicol. Pharm. 34:146-152.
International Programme on Chemical Safety Harmonization Group. 2004. 
          Report of the First Meeting of the Cancer Working Group. World 
          Health Organization. Report IPCS/HSC-CWG-1/04. Geneva.
International Agency for Research on Cancer. IARC Monographs on the 
          Evaluation of Carcinogenic Risks to Human. Preambles to 
          Volumes. World Health Organization. Lyon, France.
Cohen, S.M., P.A. Fenner-Crisp, and D.E. Patton. 2003. Special Issue: 
          Cancer Modes of Action and Human Relevance. Critical Reviews 
          in Toxicology, R.O. McClellan, ed., Volume 33/Issue 6. CRC 
          Press.
Capen, C.C., E. Dybing, and J.D. Wilbourn. 1999. Species differences in 
          thyroid, kidney and urinary bladder carcinogenesis. 
          International Agency for Research on Cancer, Scientific 
          Publication N[deg] 147.
Doi, A.M., G. Hill, J. Seely, J.R. Hailey, G. Kissling, and J.R. 
          Buchera. 2007. [alpha]2u-Globulin nephropathy and renal tumors 
          in National Toxicology Program studies. Toxicol. Pathol. 
          35:533-540.

[59 FR 6170, Feb. 9, 1994, as amended at 59 FR 17479, Apr. 13, 1994; 59 
FR 65948, Dec. 22, 1994; 61 FR 9245, Mar. 7, 1996; 77 FR 17785, Mar. 26, 
2012; 78 FR 9313, Feb. 8, 2013]



Sec.  1910.1201  Retention of DOT markings, placards and labels.

    (a) Any employer who receives a package of hazardous material which 
is required to be marked, labeled or placarded in accordance with the U. 
S. Department of Transportation's Hazardous Materials Regulations (49 
CFR Parts 171 through 180) shall retain those markings, labels and 
placards on the package until the packaging is sufficiently cleaned of 
residue and purged of vapors to remove any potential hazards.
    (b) Any employer who receives a freight container, rail freight car, 
motor vehicle, or transport vehicle that is required to be marked or 
placarded in accordance with the Hazardous Materials Regulations shall 
retain those markings and placards on the freight container, rail 
freight car, motor vehicle or transport vehicle until the hazardous 
materials which require the marking or placarding are sufficiently 
removed to prevent any potential hazards.
    (c) Markings, placards and labels shall be maintained in a manner 
that ensures that they are readily visible.
    (d) For non-bulk packages which will not be reshipped, the 
provisions of this section are met if a label or other acceptable 
marking is affixed in accordance with the Hazard Communication Standard 
(29 CFR 1910.1200).
    (e) For the purposes of this section, the term ``hazardous 
material'' and any other terms not defined in this section have the same 
definition as in the Hazardous Materials Regulations (49 CFR Parts 171 
through 180).

[59 FR 36700, July 19, 1994]



Sec.  1910.1450  Occupational exposure to hazardous chemicals in laboratories.

    (a) Scope and application. (1) This section shall apply to all 
employers engaged in the laboratory use of hazardous chemicals as 
defined below.
    (2) Where this section applies, it shall supersede, for 
laboratories, the requirements of all other OSHA health standards in 29 
CFR part 1910, subpart Z, except as follows:

[[Page 670]]

    (i) For any OSHA health standard, only the requirement to limit 
employee exposure to the specific permissible exposure limit shall apply 
for laboratories, unless that particular standard states otherwise or 
unless the conditions of paragraph (a)(2)(iii) of this section apply.
    (ii) Prohibition of eye and skin contact where specified by any OSHA 
health standard shall be observed.
    (iii) Where the action level (or in the absence of an action level, 
the permissible exposure limit) is routinely exceeded for an OSHA 
regulated substance with exposure monitoring and medical surveillance 
requirements, paragraphs (d) and (g)(1)(ii) of this section shall apply.
    (3) This section shall not apply to:
    (i) Uses of hazardous chemicals which do not meet the definition of 
laboratory use, and in such cases, the employer shall comply with the 
relevant standard in 29 CFR part 1910, subpart Z, even if such use 
occurs in a laboratory.
    (ii) Laboratory uses of hazardous chemicals which provide no 
potential for employee exposure. Examples of such conditions might 
include:
    (A) Procedures using chemically-impregnated test media such as Dip-
and-Read tests where a reagent strip is dipped into the specimen to be 
tested and the results are interpreted by comparing the color reaction 
to a color chart supplied by the manufacturer of the test strip; and
    (B) Commercially prepared kits such as those used in performing 
pregnancy tests in which all of the reagents needed to conduct the test 
are contained in the kit.
    (b) Definitions--
    Action level means a concentration designated in 29 CFR part 1910 
for a specific substance, calculated as an eight (8)-hour time-weighted 
average, which initiates certain required activities such as exposure 
monitoring and medical surveillance.
    Assistant Secretary means the Assistant Secretary of Labor for 
Occupational Safety and Health, U.S. Department of Labor, or designee.
    Carcinogen (see select carcinogen).
    Chemical Hygiene Officer means an employee who is designated by the 
employer, and who is qualified by training or experience, to provide 
technical guidance in the development and implementation of the 
provisions of the Chemical Hygiene Plan. This definition is not intended 
to place limitations on the position description or job classification 
that the designated indvidual shall hold within the employer's 
organizational structure.
    Chemical Hygiene Plan means a written program developed and 
implemented by the employer which sets forth procedures, equipment, 
personal protective equipment and work practices that (i) are capable of 
protecting employees from the health hazards presented by hazardous 
chemicals used in that particular workplace and (ii) meets the 
requirements of paragraph (e) of this section.
    Designated area means an area which may be used for work with 
``select carcinogens,'' reproductive toxins or substances which have a 
high degree of acute toxicity. A designated area may be the entire 
laboratory, an area of a laboratory or a device such as a laboratory 
hood.
    Emergency means any occurrence such as, but not limited to, 
equipment failure, rupture of containers or failure of control equipment 
which results in an uncontrolled release of a hazardous chemical into 
the workplace.
    Employee means an individual employed in a laboratory workplace who 
may be exposed to hazardous chemicals in the course of his or her 
assignments.
    Hazardous chemical means any chemical which is classified as health 
hazard or simple asphyxiant in accordance with the Hazard Communication 
Standard (Sec.  1910.1200).
    Health hazard means a chemical that is classified as posing one of 
the following hazardous effects: Acute toxicity (any route of exposure); 
skin corrosion or irritation; serious eye damage or eye irritation; 
respiratory or skin sensitization; germ cell mutagenicity; 
carcinogenity; reproductive toxicity; specific target organ toxicity 
(single or repeated exposure); aspiration hazard. The criteria for 
determining whether a chemical is classified as a health hazard are 
detailed in appendix A of the Hazard Communication Standard (Sec.  
1910.1200) and Sec.  1910.1200(c) (definition of ``simple asphyxiant'').

[[Page 671]]

    Laboratory means a facility where the ``laboratory use of hazardous 
chemicals'' occurs. It is a workplace where relatively small quantities 
of hazardous chemicals are used on a non-production basis.
    Laboratory scale means work with substances in which the containers 
used for reactions, transfers, and other handling of substances are 
designed to be easily and safely manipulated by one person. ``Laboratory 
scale'' excludes those workplaces whose function is to produce 
commercial quantities of materials.
    Laboratory-type hood means a device located in a laboratory, 
enclosure on five sides with a moveable sash or fixed partial enclosed 
on the remaining side; constructed and maintained to draw air from the 
laboratory and to prevent or minimize the escape of air contaminants 
into the laboratory; and allows chemical manipulations to be conducted 
in the enclosure without insertion of any portion of the employee's body 
other than hands and arms.
    Walk-in hoods with adjustable sashes meet the above definition 
provided that the sashes are adjusted during use so that the airflow and 
the exhaust of air contaminants are not compromised and employees do not 
work inside the enclosure during the release of airborne hazardous 
chemicals.
    Laboratory use of hazardous chemicals means handling or use of such 
chemicals in which all of the following conditions are met:
    (i) Chemical manipulations are carried out on a ``laboratory 
scale;''
    (ii) Multiple chemical procedures or chemicals are used;
    (iii) The procedures involved are not part of a production process, 
nor in any way simulate a production process; and
    (iv) ``Protective laboratory practices and equipment'' are available 
and in common use to minimize the potential for employee exposure to 
hazardous chemicals.
    Medical consultation means a consultation which takes place between 
an employee and a licensed physician for the purpose of determining what 
medical examinations or procedures, if any, are appropriate in cases 
where a significant exposure to a hazardous chemical may have taken 
place.
    Mutagen means chemicals that cause permanent changes in the amount 
or structure of the genetic material in a cell. Chemicals classified as 
mutagens in accordance with the Hazard Communication Standard (Sec.  
1910.1200) shall be considered mutagens for purposes of this section.
    Physical hazard means a chemical that is classified as posing one of 
the following hazardous effects: Explosive; flammable (gases, aerosols, 
liquids, or solids); oxidizer (liquid, solid, or gas); self reactive; 
pyrophoric (gas, liquid or solid); self-heating; organic peroxide; 
corrosive to metal; gas under pressure; in contact with water emits 
flammable gas; or combustible dust. The criteria for determining whether 
a chemical is classified as a physical hazard are in appendix B of the 
Hazard Communication Standard (Sec.  1910.1200) and Sec.  1910.1200(c) 
(definitions of ``combustible dust'' and ``pyrophoric gas'').
    Protective laboratory practices and equipment means those laboratory 
procedures, practices and equipment accepted by laboratory health and 
safety experts as effective, or that the employer can show to be 
effective, in minimizing the potential for employee exposure to 
hazardous chemicals.
    Reproductive toxins mean chemicals that affect the reproductive 
capabilities including adverse effects on sexual function and fertility 
in adult males and females, as well as adverse effects on the 
development of the offspring. Chemicals classified as reproductive 
toxins in accordance with the Hazard Communication Standard (Sec.  
1910.1200) shall be considered reproductive toxins for purposes of this 
section.
    Select carcinogen means any substance which meets one of the 
following criteria:
    (i) It is regulated by OSHA as a carcinogen; or
    (ii) It is listed under the category, ``known to be carcinogens,'' 
in the Annual Report on Carcinogens published by the National Toxicology 
Program (NTP) (latest edition); or
    (iii) It is listed under Group 1 (``carcinogenic to humans'') by the 
International Agency for Research on Cancer Monographs (IARC) (latest 
editions); or

[[Page 672]]

    (iv) It is listed in either Group 2A or 2B by IARC or under the 
category, ``reasonably anticipated to be carcinogens'' by NTP, and 
causes statistically significant tumor incidence in experimental animals 
in accordance with any of the following criteria:
    (A) After inhalation exposure of 6-7 hours per day, 5 days per week, 
for a significant portion of a lifetime to dosages of less than 10 mg/
m\3\;
    (B) After repeated skin application of less than 300 (mg/kg of body 
weight) per week; or
    (C) After oral dosages of less than 50 mg/kg of body weight per day.
    (c) Permissible exposure limits. For laboratory uses of OSHA 
regulated substances, the employer shall assure that laboratory 
employees' exposures to such substances do not exceed the permissible 
exposure limits specified in 29 CFR part 1910, subpart Z.
    (d) Employee exposure determination--(1) Initial monitoring. The 
employer shall measure the employee's exposure to any substance 
regulated by a standard which requires monitoring if there is reason to 
believe that exposure levels for that substance routinely exceed the 
action level (or in the absence of an action level, the PEL).
    (2) Periodic monitoring. If the initial monitoring prescribed by 
paragraph (d)(1) of this section discloses employee exposure over the 
action level (or in the absence of an action level, the PEL), the 
employer shall immediately comply with the exposure monitoring 
provisions of the relevant standard.
    (3) Termination of monitoring. Monitoring may be terminated in 
accordance with the relevant standard.
    (4) Employee notification of monitoring results. The employer shall, 
within 15 working days after the receipt of any monitoring results, 
notify the employee of these results in writing either individually or 
by posting results in an appropriate location that is accessible to 
employees.
    (e) Chemical hygiene plan--General. (Appendix A of this section is 
non-mandatory but provides guidance to assist employers in the 
development of the Chemical Hygiene Plan.)
    (1) Where hazardous chemicals as defined by this standard are used 
in the workplace, the employer shall develop and carry out the 
provisions of a written Chemical Hygiene Plan which is:
    (i) Capable of protecting employees from health hazards associated 
with hazardous chemicals in that laboratory and
    (ii) Capable of keeping exposures below the limits specified in 
paragraph (c) of this section.
    (2) The Chemical Hygiene Plan shall be readily available to 
employees, employee representatives and, upon request, to the Assistant 
Secretary.
    (3) The Chemical Hygiene Plan shall include each of the following 
elements and shall indicate specific measures that the employer will 
take to ensure laboratory employee protection:
    (i) Standard operating procedures relevant to safety and health 
considerations to be followed when laboratory work involves the use of 
hazardous chemicals;
    (ii) Criteria that the employer will use to determine and implement 
control measures to reduce employee exposure to hazardous chemicals 
including engineering controls, the use of personal protective equipment 
and hygiene practices; particular attention shall be given to the 
selection of control measures for chemicals that are known to be 
extremely hazardous;
    (iii) A requirement that fume hoods and other protective equipment 
are functioning properly and specific measures that shall be taken to 
ensure proper and adequate performance of such equipment;
    (iv) Provisions for employee information and training as prescribed 
in paragraph (f) of this section;
    (v) The circumstances under which a particular laboratory operation, 
procedure or activity shall require prior approval from the employer or 
the employer's designee before implementation;
    (vi) Provisions for medical consultation and medical examinations in 
accordance with paragraph (g) of this section;
    (vii) Designation of personnel responsible for implementation of the 
Chemical Hygiene Plan including the assignment of a Chemical Hygiene 
Officer and, if appropriate, establishment of a Chemical Hygiene 
Committee; and

[[Page 673]]

    (viii) Provisions for additional employee protection for work with 
particularly hazardous substances. These include ``select carcinogens,'' 
reproductive toxins and substances which have a high degree of acute 
toxicity. Specific consideration shall be given to the following 
provisions which shall be included where appropriate:
    (A) Establishment of a designated area;
    (B) Use of containment devices such as fume hoods or glove boxes;
    (C) Procedures for safe removal of contaminated waste; and
    (D) Decontamination procedures.
    (4) The employer shall review and evaluate the effectiveness of the 
Chemical Hygiene Plan at least annually and update it as necessary.
    (f) Employee information and training. (1) The employer shall 
provide employees with information and training to ensure that they are 
apprised of the hazards of chemicals present in their work area.
    (2) Such information shall be provided at the time of an employee's 
initial assignment to a work area where hazardous chemicals are present 
and prior to assignments involving new exposure situations. The 
frequency of refresher information and training shall be determined by 
the employer.
    (3) Information. Employees shall be informed of:
    (i) The contents of this standard and its appendices which shall be 
made available to employees;
    (ii) The location and availability of the employer's Chemical 
Hygiene Plan;
    (iii) The permissible exposure limits for OSHA regulated substances 
or recommended exposure limits for other hazardous chemicals where there 
is no applicable OSHA standard;
    (iv) Signs and symptoms associated with exposures to hazardous 
chemicals used in the laboratory; and
    (v) The location and availability of known reference material on the 
hazards, safe handling, storage and disposal of hazardous chemicals 
found in the laboratory including, but not limited to, safety data 
sheets received from the chemical supplier.
    (4) Training. (i) Employee training shall include:
    (A) Methods and observations that may be used to detect the presence 
or release of a hazardous chemical (such as monitoring conducted by the 
employer, continuous monitoring devices, visual appearance or odor of 
hazardous chemicals when being released, etc.);
    (B) The physical and health hazards of chemicals in the work area; 
and
    (C) The measures employees can take to protect themselves from these 
hazards, including specific procedures the employer has implemented to 
protect employees from exposure to hazardous chemicals, such as 
appropriate work practices, emergency procedures, and personal 
protective equipment to be used.
    (ii) The employee shall be trained on the applicable details of the 
employer's written Chemical Hygiene Plan.
    (g) Medical consultation and medical examinations. (1) The employer 
shall provide all employees who work with hazardous chemicals an 
opportunity to receive medical attention, including any follow-up 
examinations which the examining physician determines to be necessary, 
under the following circumstances:
    (i) Whenever an employee develops signs or symptoms associated with 
a hazardous chemical to which the employee may have been exposed in the 
laboratory, the employee shall be provided an opportunity to receive an 
appropriate medical examination.
    (ii) Where exposure monitoring reveals an exposure level routinely 
above the action level (or in the absence of an action level, the PEL) 
for an OSHA regulated substance for which there are exposure monitoring 
and medical surveillance requirements, medical surveillance shall be 
established for the affected employee as prescribed by the particular 
standard.
    (iii) Whenever an event takes place in the work area such as a 
spill, leak, explosion or other occurrence resulting in the likelihood 
of a hazardous exposure, the affected employee shall be provided an 
opportunity for a medical consultation. Such consultation shall be for 
the purpose of determining the need for a medical examination.
    (2) All medical examinations and consultations shall be performed by 
or

[[Page 674]]

under the direct 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.
    (3) Information provided to the physician. The employer shall 
provide the following information to the physician:
    (i) The identity of the hazardous chemical(s) to which the employee 
may have been exposed;
    (ii) A description of the conditions under which the exposure 
occurred including quantitative exposure data, if available; and
    (iii) A description of the signs and symptoms of exposure that the 
employee is experiencing, if any.
    (4) Physician's written opinion. (i) For examination or consultation 
required under this standard, the employer shall obtain a written 
opinion from the examining physician which shall include the following:
    (A) Any recommendation for further medical follow-up;
    (B) The results of the medical examination and any associated tests;
    (C) Any medical condition which may be revealed in the course of the 
examination which may place the employee at increased risk as a result 
of exposure to a hazardous chemical found in the workplace; and
    (D) A statement that the employee has been informed by the physician 
of the results of the consultation or medical examination and any 
medical condition that may require further examination or treatment.
    (ii) The written opinion shall not reveal specific findings of 
diagnoses unrelated to occupational exposure.
    (h) Hazard identification. (1) With respect to labels and safety 
data sheets:
    (i) Employers shall ensure that labels on incoming containers of 
hazardous chemicals are not removed or defaced.
    (ii) Employers shall maintain any safety data sheets that are 
received with incoming shipments of hazardous chemicals, and ensure that 
they are readily accessible to laboratory employees.
    (2) The following provisions shall apply to chemical substances 
developed in the laboratory:
    (i) If the composition of the chemical substance which is produced 
exclusively for the laboratory's use is known, the employer shall 
determine if it is a hazardous chemical as defined in paragraph (b) of 
this section. If the chemical is determined to be hazardous, the 
employer shall provide appropriate training as required under paragraph 
(f) of this section.
    (ii) If the chemical produced is a byproduct whose composition is 
not known, the employer shall assume that the substance is hazardous and 
shall implement paragraph (e) of this section.
    (iii) If the chemical substance is produced for another user outside 
of the laboratory, the employer shall comply with the Hazard 
Communication Standard (29 CFR 1910.1200) including the requirements for 
preparation of safety data sheets and labeling.
    (i) Use of respirators. Where the use of respirators is necessary to 
maintain exposure below permissible exposure limits, the employer shall 
provide, at no cost to the employee, the proper respiratory equipment. 
Respirators shall be selected and used in accordance with the 
requirements of 29 CFR 1910.134.
    (j) Recordkeeping. (1) The employer shall establish and maintain for 
each employee an accurate record of any measurements taken to monitor 
employee exposures and any medical consultation and examinations 
including tests or written opinions required by this standard.
    (2) The employer shall assure that such records are kept, 
transferred, and made available in accordance with 29 CFR 1910.20.
    (k) [Reserved]
    (l) Appendices. The information contained in the appendices is not 
intended, by itself, to create any additional obligations not otherwise 
imposed or to detract from any existing obligation.

Appendix A to Sec.  1910.1450--National Research Council Recommendations 
       Concerning Chemical Hygiene In Laboratories (Non-Mandatory)

    To assist employers in developing an appropriate laboratory Chemical 
Hygiene Plan (CHP), the following non-mandatory recommendations were 
based on the National Research Council's (NRC) 2011 edition of

[[Page 675]]

``Prudent Practices in the Laboratory: Handling and Management of 
Chemical Hazards.'' This reference, henceforth referred to as ``Prudent 
Practices,'' is available from the National Academies Press, 500 Fifth 
Street NW., Washington DC 20001 (www.nap.edu). ``Prudent Practices'' is 
cited because of its wide distribution and acceptance and because of its 
preparation by recognized authorities in the laboratory community 
through the sponsorship of the NRC. However, these recommendations do 
not modify any requirements of the OSHA Laboratory standard. This 
appendix presents pertinent recommendations from ``Prudent Practices,'' 
organized into a form convenient for quick reference during operation of 
a laboratory and during development and application of a CHP. For a 
detailed explanation and justification for each recommendation, consult 
``Prudent Practices.''
    ``Prudent Practices'' deals with both general laboratory safety and 
many types of chemical hazards, while the Laboratory standard is 
concerned primarily with chemical health hazards as a result of chemical 
exposures. The recommendations from ``Prudent Practices'' have been 
paraphrased, combined, or otherwise reorganized in order to adapt them 
for this purpose. However, their sense has not been changed.
    Section F contains information from the U.S. Chemical Safety Board's 
(CSB) Fiscal Year 2011 Annual Performance and Accountability report and 
Section F contains recommendations extracted from the CSB's 2011 case 
study, ``Texas Tech University Laboratory Explosion,'' available from: 
http://www.csb.gov/.

                            Culture of Safety

    With the promulgation of the Occupational Safety and Health 
Administration (OSHA) Laboratory standard (29 CFR 1910.1450), a culture 
of safety consciousness, accountability, organization, and education has 
developed in industrial, governmental, and academic laboratories. Safety 
and training programs have been implemented to promote the safe handling 
of chemicals from ordering to disposal, and to train laboratory 
personnel in safe practices. Laboratory personnel must realize that the 
welfare and safety of each individual depends on clearly defined 
attitudes of teamwork and personal responsibility. Learning to 
participate in this culture of habitual risk assessment, experiment 
planning, and consideration of worst-case possibilities--for oneself and 
one's fellow workers--is as much part of a scientific education as 
learning the theoretical background of experiments or the step-by-step 
protocols for doing them in a professional manner. A crucial component 
of chemical education for all personnel is to nurture basic attitudes 
and habits of prudent behavior so that safety is a valued and 
inseparable part of all laboratory activities throughout their career.
    Over the years, special techniques have been developed for handling 
chemicals safely. Local, state, and federal regulations hold 
institutions that sponsor chemical laboratories accountable for 
providing safe working environments. Beyond regulation, employers and 
scientists also hold themselves personally responsible for their own 
safety, the safety of their colleagues and the safety of the general 
public. A sound safety organization that is respected by all requires 
the participation and support of laboratory administrators, workers, and 
students. A successful health and safety program requires a daily 
commitment from everyone in the organization. To be most effective, 
safety and health must be balanced with, and incorporated into, 
laboratory processes. A strong safety and health culture is the result 
of positive workplace attitudes--from the chief executive officer to the 
newest hire; involvement and buy-in of all members of the workforce; 
mutual, meaningful, and measurable safety and health improvement goals; 
and policies and procedures that serve as reference tools, rather than 
obscure rules.
    In order to perform their work in a prudent manner, laboratory 
personnel must consider the health, physical, and environmental hazards 
of the chemicals they plan to use in an experiment. However, the ability 
to accurately identify and assess laboratory hazards must be taught and 
encouraged through training and ongoing organizational support. This 
training must be at the core of every good health and safety program. 
For management to lead, personnel to assess worksite hazards, and 
hazards to be eliminated or controlled, everyone involved must be 
trained.

                          A. General Principles

              1. Minimize All Chemical Exposures and Risks

    Because few laboratory chemicals are without hazards, general 
precautions for handling all laboratory chemicals should be adopted. In 
addition to these general guidelines, specific guidelines for chemicals 
that are used frequently or are particularly hazardous should be 
adopted.
    Laboratory personnel should conduct their work under conditions that 
minimize the risks from both known and unknown hazardous substances. 
Before beginning any laboratory work, the hazards and risks associated 
with an experiment or activity should be determined and the necessary 
safety precautions implemented. Every laboratory should develop 
facility-specific policies and procedures for the highest-risk materials 
and procedures used in their laboratory. To identify these, 
consideration should be given to

[[Page 676]]

past accidents, process conditions, chemicals used in large volumes, and 
particularly hazardous chemicals.
    Perform Risk Assessments for Hazardous Chemicals and Procedures 
Prior to Laboratory Work:
    (a) Identify chemicals to be used, amounts required, and 
circumstances of use in the experiment. Consider any special employee or 
laboratory conditions that could create or increase a hazard. Consult 
sources of safety and health information and experienced scientists to 
ensure that those conducting the risk assessment have sufficient 
expertise.
    (b) Evaluate the hazards posed by the chemicals and the experimental 
conditions. The evaluation should cover toxic, physical, reactive, 
flammable, explosive, radiation, and biological hazards, as well as any 
other potential hazards posed by the chemicals.
    (c) For a variety of physical and chemical reasons, reaction scale-
ups pose special risks, which merit additional prior review and 
precautions.
    (d) Select appropriate controls to minimize risk, including use of 
engineering controls, administrative controls, and personal protective 
equipment (PPE) to protect workers from hazards. The controls must 
ensure that OSHA's Permissible Exposure Limits (PELs) are not exceeded. 
Prepare for contingencies and be aware of the institutional procedures 
in the event of emergencies and accidents.
    One sample approach to risk assessment is to answer these five 
questions:
    (a) What are the hazards?
    (b) What is the worst thing that could happen?
    (c) What can be done to prevent this from happening?
    (d) What can be done to protect from these hazards?
    (e) What should be done if something goes wrong?

                    2. Avoid Underestimation of Risk

    Even for substances of no known significant hazard, exposure should 
be minimized; when working with substances that present special hazards, 
special precautions should be taken. Reference should be made to the 
safety data sheet (SDS) that is provided for each chemical. Unless 
otherwise known, one should assume that any mixture will be more toxic 
than its most toxic component and that all substances of unknown 
toxicity are toxic.
    Determine the physical and health hazards associated with chemicals 
before working with them. This determination may involve consulting 
literature references, laboratory chemical safety summaries (LCSSs), 
SDSs, or other reference materials. Consider how the chemicals will be 
processed and determine whether the changing states or forms will change 
the nature of the hazard. Review your plan, operating limits, chemical 
evaluations and detailed risk assessment with other chemists, especially 
those with experience with similar materials and protocols.
    Before working with chemicals, know your facility's policies and 
procedures for how to handle an accidental spill or fire. Emergency 
telephone numbers should be posted in a prominent area. Know the 
location of all safety equipment and the nearest fire alarm and 
telephone.

                 3. Adhere to the Hierarchy of Controls

    The hierarchy of controls prioritizes intervention strategies based 
on the premise that the best way to control a hazard is to 
systematically remove it from the workplace, rather than relying on 
employees to reduce their exposure. The types of measures that may be 
used to protect employees (listed from most effective to least 
effective) are: engineering controls, administrative controls, work 
practices, and PPE. Engineering controls, such as chemical hoods, 
physically separate the employee from the hazard. Administrative 
controls, such as employee scheduling, are established by management to 
help minimize the employees' exposure time to hazardous chemicals. Work 
practice controls are tasks that are performed in a designated way to 
minimize or eliminate hazards. Personal protective equipment and apparel 
are additional protection provided under special circumstances and when 
exposure is unavoidable.
    Face and eye protection is necessary to prevent ingestion and skin 
absorption of hazardous chemicals. At a minimum, safety glasses, with 
side shields, should be used for all laboratory work. Chemical splash 
goggles are more appropriate than regular safety glasses to protect 
against hazards such as projectiles, as well as when working with 
glassware under reduced or elevated pressures (e.g., sealed tube 
reactions), when handling potentially explosive compounds (particularly 
during distillations), and when using glassware in high-temperature 
operations. Do not allow laboratory chemicals to come in contact with 
skin. Select gloves carefully to ensure that they are impervious to the 
chemicals being used and are of correct thickness to allow reasonable 
dexterity while also ensuring adequate barrier protection.
    Lab coats and gloves should be worn when working with hazardous 
materials in a laboratory. Wear closed-toe shoes and long pants or other 
clothing that covers the legs when in a laboratory where hazardous 
chemicals are used. Additional protective clothing should be used when 
there is significant potential for skin-contact exposure to chemicals. 
The protective characteristics of this clothing must be matched to the 
hazard. Never wear gloves or laboratory coats outside the laboratory or 
into areas where food is stored and consumed.

[[Page 677]]

                    4. Provide Laboratory Ventilation

    The best way to prevent exposure to airborne substances is to 
prevent their escape into the working atmosphere by the use of hoods and 
other ventilation devices. To determine the best choice for laboratory 
ventilation using engineering controls for personal protection, 
employers are referred to Table 9.3 of the 2011 edition of ``Prudent 
Practices.'' Laboratory chemical hoods are the most important components 
used to protect laboratory personnel from exposure to hazardous 
chemicals.
    (a) Toxic or corrosive chemicals that require vented storage should 
be stored in vented cabinets instead of in a chemical hood.
    (b) Chemical waste should not be disposed of by evaporation in a 
chemical hood.
    (c) Keep chemical hood areas clean and free of debris at all times.
    (d) Solid objects and materials, such as paper, should be prevented 
from entering the exhaust ducts as they can reduce the air flow.
    (e) Chemical hoods should be maintained, monitored and routinely 
tested for proper performance.
    A laboratory ventilation system should include the following 
characteristics and practices:
    (a) Heating and cooling should be adequate for the comfort of 
workers and operation of equipment. Before modification of any building 
HVAC, the impact on laboratory or hood ventilation should be considered, 
as well as how laboratory ventilation changes may affect the building 
HVAC.
    (b) A negative pressure differential should exist between the amount 
of air exhausted from the laboratory and the amount supplied to the 
laboratory to prevent uncontrolled chemical vapors from leaving the 
laboratory.
    (c) Local exhaust ventilation devices should be appropriate to the 
materials and operations in the laboratory.
    (d) The air in chemical laboratories should be continuously replaced 
so that concentrations of odoriferous or toxic substances do not 
increase during the workday.
    (e) Laboratory air should not be recirculated but exhausted directly 
outdoors.
    (f) Air pressure should be negative with respect to the rest of the 
building. Local capture equipment and systems should be designed only by 
an experienced engineer or industrial hygienist.
    (g) Ventilation systems should be inspected and maintained on a 
regular basis. There should be no areas where air remains static or 
areas that have unusually high airflow velocities.
    Before work begins, laboratory workers should be provided with 
proper training that includes how to use the ventilation equipment, how 
to ensure that it is functioning properly, the consequences of improper 
use, what to do in the event of a system failure or power outage, 
special considerations, and the importance of signage and postings.

                 5. Institute a Chemical Hygiene Program

    A comprehensive chemical hygiene program is required. It should be 
designed to minimize exposures, injuries, illnesses and incidents. There 
should be a regular, continuing effort that includes program oversight, 
safe facilities, chemical hygiene planning, training, emergency 
preparedness and chemical security. The chemical hygiene program must be 
reviewed annually and updated as necessary whenever new processes, 
chemicals, or equipment is implemented. Its recommendations should be 
followed in all laboratories.

                      6. Observe the PELs and TLVs

    OSHA's Permissible Exposure Limits (PELs) must not be exceeded. The 
American Conference of Governmental Industrial Hygienists' Threshold 
Limit Values (TLVs) should also not be exceeded.

                           B. Responsibilities

    Persons responsible for chemical hygiene include, but are not 
limited to, the following:

                       1. Chemical Hygiene Officer

    (a) Establishes, maintains, and revises the chemical hygiene plan 
(CHP).
    (b) Creates and revises safety rules and regulations.
    (c) Monitors procurement, use, storage, and disposal of chemicals.
    (d) Conducts regular inspections of the laboratories, preparations 
rooms, and chemical storage rooms, and submits detailed laboratory 
inspection reports to administration.
    (e) Maintains inspection, personnel training, and inventory records.
    (f) Assists laboratory supervisors in developing and maintaining 
adequate facilities.
    (g) Seeks ways to improve the chemical hygiene program.

                  2. Department Chairperson or Director

    (a) Assumes responsibility for personnel engaged in the laboratory 
use of hazardous chemicals.
    (b) Provides the chemical hygiene officer (CHO) with the support 
necessary to implement and maintain the CHP.
    (c) After receipt of laboratory inspection report from the CHO, 
meets with laboratory supervisors to discuss cited violations and to 
ensure timely actions to protect trained laboratory personnel and 
facilities and to ensure that the department remains in compliance with 
all applicable federal, state, university, local and departmental codes 
and regulations.

[[Page 678]]

    (d) Provides budgetary arrangements to ensure the health and safety 
of the departmental personnel, visitors, and students.
    3. Departmental Safety Committee reviews accident reports and makes 
appropriate recommendations to the department chairperson regarding 
proposed changes in the laboratory procedures.
    4. Laboratory Supervisor or Principal Investigator has overall 
responsibility for chemical hygiene in the laboratory, including 
responsibility to:
    (a) Ensure that laboratory personnel comply with the departmental 
CHP and do not operate equipment or handle hazardous chemicals without 
proper training and authorization.
    (b) Always wear personal protective equipment (PPE) that is 
compatible to the degree of hazard of the chemical.
    (c) Follow all pertinent safety rules when working in the laboratory 
to set an example.
    (d) Review laboratory procedures for potential safety problems 
before assigning to other laboratory personnel.
    (e) Ensure that visitors follow the laboratory rules and assumes 
responsibility for laboratory visitors.
    (f) Ensure that PPE is available and properly used by each 
laboratory employee and visitor.
    (g) Maintain and implement safe laboratory practices.
    (h) Provide regular, formal chemical hygiene and housekeeping 
inspections, including routine inspections of emergency equipment;
    (i) Monitor the facilities and the chemical fume hoods to ensure 
that they are maintained and function properly. Contact the appropriate 
person, as designated by the department chairperson, to report problems 
with the facilities or the chemical fume hoods.

                         5. Laboratory Personnel

    (a) Read, understand, and follow all safety rules and regulations 
that apply to the work area;
    (b) Plan and conduct each operation in accordance with the 
institutional chemical hygiene procedures;
    (c) Promote good housekeeping practices in the laboratory or work 
area.
    (d) Notify the supervisor of any hazardous conditions or unsafe work 
practices in the work area.
    (e) Use PPE as appropriate for each procedure that involves 
hazardous chemicals.

                       C. The Laboratory Facility

                General Laboratory Design Considerations

    Wet chemical spaces and those with a higher degree of hazard should 
be separated from other spaces by a wall or protective barrier wherever 
possible. If the areas cannot be separated, then workers in lower hazard 
spaces may require additional protection from the hazards in connected 
spaces.

                   1. Laboratory Layout and Furnishing

    (a) Work surfaces should be chemically resistant, smooth, and easy 
to clean.
    (b) Hand washing sinks for hazardous materials may require elbow, 
foot, or electronic controls for safe operation.
    (c) Wet laboratory areas should have chemically resistant, 
impermeable, slip-resistant flooring.
    (d) Walls should be finished with a material that is easy to clean 
and maintain.
    (e) Doors should have view panels to prevent accidents and should 
open in the direction of egress.
    (f) Operable windows should not be present in laboratories, 
particularly if there are chemical hoods or other local ventilation 
systems present.

                    2. Safety Equipment and Utilities

    (a) An adequate number and placement of safety showers, eyewash 
units, and fire extinguishers should be provided for the laboratory.
    (b) Use of water sprinkler systems is resisted by some laboratories 
because of the presence of electrical equipment or water-reactive 
materials, but it is still generally safer to have sprinkler systems 
installed. A fire large enough to trigger the sprinkler system would 
have the potential to cause far more destruction than the local water 
damage.

                     D. Chemical Hygiene Plan (CHP)

    The OSHA Laboratory standard defines a CHP as ``a written program 
developed and implemented by the employer which sets forth procedures, 
equipment, personal protective equipment and work practices that are 
capable of protecting employees from the health hazards presented by 
hazardous chemicals used in that particular workplace.'' (29 CFR 
1910.1450(b)). The Laboratory Standard requires a CHP: ``Where hazardous 
chemicals as defined by this standard are used in the workplace, the 
employer shall develop and carry out the provisions of a written 
Chemical Hygiene Plan.'' (29 CFR 1910.1450(e)(1)). The CHP is the 
foundation of the laboratory safety program and must be reviewed and 
updated, as needed, and at least on an annual basis to reflect changes 
in policies and personnel. A CHP should be facility specific and can 
assist in promoting a culture of safety to protect workers from exposure 
to hazardous materials.
    1. The Laboratory's CHP must be readily available to workers and 
capable of protecting workers from health hazards and minimizing 
exposure. Include the following topics in the CHP:

[[Page 679]]

    (a) Individual chemical hygiene responsibilities;
    (b) Standard operating procedures;
    (c) Personal protective equipment, engineering controls and apparel;
    (d) Laboratory equipment;
    (e) Safety equipment;
    (f) Chemical management;
    (g) Housekeeping;
    (h) Emergency procedures for accidents and spills;
    (i) Chemical waste;
    (j) Training;
    (k) Safety rules and regulations;
    (l) Laboratory design and ventilation;
    (m) Exposure monitoring;
    (n) Compressed gas safety;
    (o) Medical consultation and examination.
    It should be noted that the nature of laboratory work may 
necessitate addressing biological safety, radiation safety and security 
issues.

           2. Chemical Procurement, Distribution, and Storage

    Prudent chemical management includes the following processes:
    Chemical Procurement:
    (a) Information on proper handling, storage, and disposal should be 
known to those who will be involved before a substance is received.
    (b) Only containers with adequate identifying labels should be 
accepted.
    (c) Ideally, a central location should be used for receiving all 
chemical shipments.
    (d) Shipments with breakage or leakage should be refused or opened 
in a chemical hood.
    (e) Only the minimum amount of the chemical needed to perform the 
planned work should be ordered.
    (f) Purchases of high risk chemicals should be reviewed and approved 
by the CHO.
    (g) Proper protective equipment and handling and storage procedures 
should be in place before receiving a shipment.
    Chemical Storage:
    (a) Chemicals should be separated and stored according to hazard 
category and compatibility.
    (b) SDS and label information should be followed for storage 
requirements.
    (c) Maintain existing labels on incoming containers of chemicals and 
other materials.
    (d) Labels on containers used for storing hazardous chemicals must 
include the chemical identification and appropriate hazard warnings.
    (e) The contents of all other chemical containers and transfer 
vessels, including, but not limited to, beakers, flasks, reaction 
vessels, and process equipment, should be properly identified.
    (f) Chemical shipments should be dated upon receipt and stock 
rotated.
    (g) Peroxide formers should be dated upon receipt, again dated upon 
opening, and stored away from heat and light with tight-fitting, 
nonmetal lids.
    (h) Open shelves used for chemical storage should be secured to the 
wall and contain \3/4\-inch lips. Secondary containment devices should 
be used as necessary.
    (i) Consult the SDS and keep incompatibles separate during 
transport, storage, use, and disposal.
    (j) Oxidizers, reducing agents, and fuels should be stored 
separately to prevent contact in the event of an accident.
    (k) Chemicals should not be stored in the chemical hood, on the 
floor, in areas of egress, on the benchtop, or in areas near heat or in 
direct sunlight.
    (l) Laboratory-grade, flammable-rated refrigerators and freezers 
should be used to store sealed chemical containers of flammable liquids 
that require cool storage. Do not store food or beverages in the 
laboratory refrigerator.
    (m) Highly hazardous chemicals should be stored in a well-ventilated 
and secure area designated for that purpose.
    (n) Flammable chemicals should be stored in a spark-free environment 
and in approved flammable-liquid containers and storage cabinets. 
Grounding and bonding should be used to prevent static charge buildups 
when dispensing solvents.
    (o) Chemical storage and handling rooms should be controlled-access 
areas. They should have proper ventilation, appropriate signage, diked 
floors, and fire suppression systems.
    Chemical Handling:
    (a) As described above, a risk assessment should be conducted prior 
to beginning work with any hazardous chemical for the first time.
    (b) All SDS and label information should be read before using a 
chemical for the first time.
    (c) Trained laboratory workers should ensure that proper engineering 
controls (ventilation) and PPE are in place.
    Chemical Inventory:
    (a) Prudent management of chemicals in any laboratory is greatly 
facilitated by keeping an accurate inventory of the chemicals stored.
    (b) Unneeded items should be discarded or returned to the storeroom.
    Transporting Chemicals:
    (a) Secondary containment devices should be used when transporting 
chemicals.
    (b) When transporting chemicals outside of the laboratory or between 
stockrooms and laboratories, the transport container should be break-
resistant.
    (c) High-traffic areas should be avoided.
    Transferring Chemicals:
    (a) Use adequate ventilation (such as a fume hood) when transferring 
even a small

[[Page 680]]

amount of a particularly hazardous substance (PHS).
    (b) While drum storage is not appropriate for laboratories, chemical 
stockrooms may purchase drum quantities of solvents used in high 
volumes. Ground and bond the drum and receiving vessel when transferring 
flammable liquids from a drum to prevent static charge buildup.
    (c) If chemicals from commercial sources are repackaged into 
transfer vessels, the new containers should be labeled with all 
essential information on the original container.
    Shipping Chemicals: Outgoing chemical shipments must meet all 
applicable Department of Transportation (DOT) regulations and should be 
authorized and handled by the institutional shipper.

                           3. Waste Management

    A waste management plan should be in place before work begins on any 
laboratory activity. The plan should utilize the following hierarchy of 
practices:
    (a) Reduce waste sources. The best approach to minimize waste 
generation is by reducing the scale of operations, reducing its 
formation during operations, and, if possible, substituting less 
hazardous chemicals for a particular operation.
    (b) Reuse surplus materials. Only the amount of material necessary 
for an experiment should be purchased, and, if possible, materials 
should be reused.
    (c) Recycle waste. If waste cannot be prevented or minimized, the 
organization should consider recycling chemicals that can be safely 
recovered or used as fuel.
    (d) Dispose of waste properly. Sink disposal may not be appropriate. 
Proper waste disposal methods include incineration, treatment, and land 
disposal. The organization's environmental health and safety (EHS) 
office should be consulted in determining which methods are appropriate 
for different types of waste.
    Collection and Storage of Waste:
    (a) Chemical waste should be accumulated at or near the point of 
generation, under the control of laboratory workers.
    (b) Each waste type should be stored in a compatible container 
pending transfer or disposal. Waste containers should be clearly labeled 
and kept sealed when not in use.
    (c) Incompatible waste types should be kept separate to ensure that 
heat generation, gas evolution, or another reaction does not occur.
    (d) Waste containers should be segregated by how they will be 
managed. Waste containers should be stored in a designated location that 
does not interfere with normal laboratory operations. Ventilated storage 
and secondary containment may be appropriate for certain waste types.
    (e) Waste containers should be clearly labeled and kept sealed when 
not in use. Labels should include the accumulation start date and hazard 
warnings as appropriate.
    (f) Non-explosive electrical systems, grounding and bonding between 
floors and containers, and non-sparking conductive floors and containers 
should be used in the central waste accumulation area to minimize fire 
and explosion hazards. Fire suppression systems, specialized ventilation 
systems, and dikes should be installed in the central waste accumulation 
area. Waste management workers should be trained in proper waste 
handling procedures as well as contingency planning and emergency 
response. Trained laboratory workers most familiar with the waste should 
be actively involved in waste management decisions to ensure that the 
waste is managed safely and efficiently. Engineering controls should be 
implemented as necessary, and personal protective equipment should be 
worn by workers involved in waste management.

                          4. Inspection Program

    Maintenance and regular inspection of laboratory equipment are 
essential parts of the laboratory safety program. Management should 
participate in the design of a laboratory inspection program to ensure 
that the facility is safe and healthy, workers are adequately trained, 
and proper procedures are being followed.
    Types of inspections: The program should include an appropriate 
combination of routine inspections, self-audits, program audits, peer 
inspections, EHS inspections, and inspections by external entities.
    Elements of an inspection:
    (a) Inspectors should bring a checklist to ensure that all issues 
are covered and a camera to document issues that require correction.
    (b) Conversations with workers should occur during the inspection, 
as they can provide valuable information and allow inspectors an 
opportunity to show workers how to fix problems.
    (c) Issues resolved during the inspection should be noted.
    (d) An inspection report containing all findings and recommendations 
should be prepared for management and other appropriate workers.
    (e) Management should follow-up on the inspection to ensure that all 
corrections are implemented.

                 5. Medical Consultation and Examination

    The employer must provide all employees who work with hazardous 
chemicals an opportunity to receive medical attention, including any 
follow-up examinations that the examining physician determines to be 
necessary, whenever an employee develops signs or symptoms associated 
with a hazardous chemical to which the employee may have

[[Page 681]]

been exposed in the laboratory. If an employee encounters a spill, leak, 
explosion or other occurrence resulting in the likelihood of a hazardous 
exposure, the affected employee must be provided an opportunity for a 
medical consultation by a licensed physician. All medical examinations 
and consultations must be performed by or under the direct supervision 
of a licensed physician and must be provided without cost to the 
employee, without loss of pay and at a reasonable time and place. The 
identity of the hazardous chemical, a description of the incident, and 
any signs and symptoms that the employee may experience must be relayed 
to the physician.

                               6. Records

    All accident, fatality, illness, injury, and medical records and 
exposure monitoring records must be retained by the institution in 
accordance with the requirements of state and federal regulations (see 
29 CFR part 1904 and Sec.  1910.1450(j)). Any exposure monitoring 
results must be provided to affected laboratory staff within 15 working 
days after receipt of the results (29 CFR 1910.1450(d)(4)).

                                7. Signs

    Prominent signs of the following types should be posted:
    (a) Emergency telephone numbers of emergency personnel/facilities, 
supervisors, and laboratory workers;
    (b) Location signs for safety showers, eyewash stations, other 
safety and first aid equipment, and exits; and
    (c) Warnings at areas or equipment where special or unusual hazards 
exist.

                         8. Spills and Accidents

    Before beginning an experiment, know your facility's policies and 
procedures for how to handle an accidental release of a hazardous 
substance, a spill or a fire. Emergency response planning and training 
are especially important when working with highly toxic compounds. 
Emergency telephone numbers should be posted in a prominent area. Know 
the location of all safety equipment and the nearest fire alarm and 
telephone. Know who to notify in the event of an emergency. Be prepared 
to provide basic emergency treatment. Keep your co-workers informed of 
your activities so they can respond appropriately. Safety equipment, 
including spill control kits, safety shields, fire safety equipment, 
PPE, safety showers and eyewash units, and emergency equipment should be 
available in well-marked highly visible locations in all chemical 
laboratories. The laboratory supervisor or CHO is responsible for 
ensuring that all personnel are aware of the locations of fire 
extinguishers and are trained in their use. After an extinguisher has 
been used, designated personnel must promptly recharge or replace it (29 
CFR 1910.157(c)(4)). The laboratory supervisor or CHO is also 
responsible for ensuring proper training and providing supplementary 
equipment as needed.
    Special care must be used when handling solutions of chemicals in 
syringes with needles. Do not recap needles, especially when they have 
been in contact with chemicals. Remove the needle and discard it 
immediately after use in the appropriate sharps containers. Blunt-tip 
needles are available from a number of commercial sources and should be 
used unless a sharp needle is required to puncture rubber septa or for 
subcutaneous injection.
    For unattended operations, laboratory lights should be left on, and 
signs should be posted to identify the nature of the experiment and the 
hazardous substances in use. Arrangements should be made, if possible, 
for other workers to periodically inspect the operation. Information 
should be clearly posted indicating who to contact in the event of an 
emergency. Depending on the nature of the hazard, special rules, 
precautions, and alert systems may be necessary.

                       9. Training and Information

    Personnel training at all levels within the organization, is 
essential. Responsibility and accountability throughout the organization 
are key elements in a strong safety and health program. The employer is 
required to provide employees with information and training to ensure 
that they are apprised of the hazards of chemicals present in their work 
area (29 CFR 1910.1450(f)). This information must be provided at the 
time of an employee's initial assignment to a work area where hazardous 
chemicals are present and prior to assignments involving new exposure 
situations. The frequency of refresher information and training should 
be determined by the employer. At a minimum, laboratory personnel should 
be trained on their facility's specific CHP, methods and observations 
that may be used to detect the presence or release of a hazardous 
chemical (such as monitoring conducted by the employer, continuous 
monitoring devices, visual appearance or odor of hazardous chemicals 
when being released), the physical and health hazards of chemicals in 
the work area and means to protect themselves from these hazards. 
Trained laboratory personnel must know shut-off procedures in case of an 
emergency. All SDSs must be made available to the employees.

            E. General Procedures for Working With Chemicals

    The risk of laboratory injuries can be reduced through adequate 
training, improved engineering, good housekeeping, safe work practice 
and personal behavior.

[[Page 682]]

           1. General Rules for Laboratory Work With Chemicals

    (a) Assigned work schedules should be followed unless a deviation is 
authorized by the laboratory supervisor.
    (b) Unauthorized experiments should not be performed.
    (c) Plan safety procedures before beginning any operation.
    (d) Follow standard operating procedures at all times.
    (e) Always read the SDS and label before using a chemical.
    (f) Wear appropriate PPE at all times.
    (g) To protect your skin from splashes, spills and drips, always 
wear long pants and closed-toe shoes.
    (h) Use appropriate ventilation when working with hazardous 
chemicals.
    (i) Pipetting should never be done by mouth.
    (j) Hands should be washed with soap and water immediately after 
working with any laboratory chemicals, even if gloves have been worn.
    (k) Eating, drinking, smoking, gum chewing, applying cosmetics, and 
taking medicine in laboratories where hazardous chemicals are used or 
stored should be strictly prohibited.
    (l) Food, beverages, cups, and other drinking and eating utensils 
should not be stored in areas where hazardous chemicals are handled or 
stored.
    (m) Laboratory refrigerators, ice chests, cold rooms, and ovens 
should not be used for food storage or preparation.
    (n) Contact the laboratory supervisor, Principal Investigator, CHO 
or EHS office with all safety questions or concerns.
    (o) Know the location and proper use of safety equipment.
    (p) Maintain situational awareness.
    (q) Make others aware of special hazards associated with your work.
    (r) Notify supervisors of chemical sensitivities or allergies.
    (s) Report all injuries, accidents, incidents, and near misses.
    (t) Unauthorized persons should not be allowed in the laboratory.
    (u) Report unsafe conditions to the laboratory supervisor or CHO.
    (v) Properly dispose of chemical wastes.

                     Working Alone in the Laboratory

    Working alone in a laboratory is dangerous and should be strictly 
avoided. There have been many tragic accidents that illustrate this 
danger. Accidents are unexpected by definition, which is why coworkers 
should always be present. Workers should coordinate schedules to avoid 
working alone.

                              Housekeeping

    Housekeeping can help reduce or eliminate a number of laboratory 
hazards. Proper housekeeping includes appropriate labeling and storage 
of chemicals, safe and regular cleaning of the facility, and proper 
arrangement of laboratory equipment.

                   2. Nanoparticles and Nanomaterials

    Nanoparticles and nanomaterials have different reactivities and 
interactions with biological systems than bulk materials, and 
understanding and exploiting these differences is an active area of 
research. However, these differences also mean that the risks and 
hazards associated with exposure to engineered nanomaterials are not 
well known. Because this is an area of ongoing research, consult trusted 
sources for the most up to date information available. Note that the 
higher reactivity of many nanoscale materials suggests that they should 
be treated as potential sources of ignition, accelerants, and fuel that 
could result in fire or explosion. Easily dispersed dry nanomaterials 
may pose the greatest health hazard because of the risk of inhalation. 
Operations involving these nanomaterials deserve more attention and more 
stringent controls than those where the nanomaterials are embedded in 
solid or suspended in liquid matrixes.
    Consideration should be given to all possible routes of exposure to 
nanomaterials including inhalation, ingestion, injection, and dermal 
contact (including eye and mucous membranes). Avoid handling 
nanomaterials in the open air in a free-particle state. Whenever 
possible, handle and store dispersible nanomaterials, whether suspended 
in liquids or in a dry particle form, in closed (tightly-sealed) 
containers. Unless cutting or grinding occurs, nanomaterials that are 
not in a free form (encapsulated in a solid or a nanocomposite) 
typically will not require engineering controls. If a synthesis is being 
performed to create nanomaterials, it is not enough to only consider the 
final material in the risk assessment, but consider the hazardous 
properties of the precursor materials as well.
    To minimize laboratory personnel exposure, conduct any work that 
could generate engineered nanoparticles in an enclosure that operates at 
a negative pressure differential compared to the laboratory personnel 
breathing zone. Limited data exist regarding the efficacy of PPE and 
ventilation systems against exposure to nanoparticles. However, until 
further information is available, it is prudent to follow standard 
chemical hygiene practices. Conduct a hazard evaluation to determine PPE 
appropriate for the level of hazard according to the requirements set 
forth in OSHA's Personal Protective Equipment standard (29 CFR 
1910.132).

[[Page 683]]

       3. Highly Toxic and Explosive/Reactive Chemicals/Materials

    The use of highly toxic and explosive/reactive chemicals and 
materials has been an area of growing concern. The frequency of academic 
laboratory incidents in the U.S. is an area of significant concern for 
the Chemical Safety Board (CSB). The CSB issued a case study on an 
explosion at Texas Tech University in Lubbock, Texas, which severely 
injured a graduate student handling a high-energy metal compound. Since 
2001, the CSB has gathered preliminary information on 120 different 
university laboratory incidents that resulted in 87 evacuations, 96 
injuries, and three deaths.
    It is recommended that each facility keep a detailed inventory of 
highly toxic chemicals and explosive/reactive materials. There should be 
a record of the date of receipt, amount, location, and responsible 
individual for all acquisitions, syntheses, and disposal of these 
chemicals. A physical inventory should be performed annually to verify 
active inventory records. There should be a procedure in place to report 
security breaches, inventory discrepancies, losses, diversions, or 
suspected thefts.
    Procedures for disposal of highly toxic materials should be 
established before any experiments begin, possibly even before the 
chemicals are ordered. The procedures should address methods for 
decontamination of any laboratory equipment that comes into contact with 
highly toxic chemicals. All waste should be accumulated in clearly 
labeled impervious containers that are stored in unbreakable secondary 
containment.
    Highly reactive and explosive materials that may be used in the 
laboratory require appropriate procedures and training. An explosion can 
occur when a material undergoes a rapid reaction that results in a 
violent release of energy. Such reactions can happen spontaneously and 
can produce pressures, gases, and fumes that are hazardous. Some 
reagents pose a risk on contact with the atmosphere. It is prudent 
laboratory practice to use a safer alternative whenever possible.
    If at all possible, substitutes for highly acute, chronic, 
explosive, or reactive chemicals should be considered prior to beginning 
work and used whenever possible.

                            4. Compressed Gas

    Compressed gases expose laboratory personnel to both chemical and 
physical hazards. It is essential that these are monitored for leaks and 
have the proper labeling. By monitoring compressed gas inventories and 
disposing of or returning gases for which there is no immediate need, 
the laboratory can substantially reduce these risks. Leaking gas 
cylinders can cause serious hazards that may require an immediate 
evacuation of the area and activation of the emergency response system. 
Only appropriately trained hazmat responders may respond to stop a 
leaking gas cylinder under this situation.

               F. Safety Recommendations--Physical Hazards

    Physical hazards in the laboratory include combustible liquids, 
compressed gases, reactives, explosives and flammable chemicals, as well 
as high pressure/energy procedures, sharp objects and moving equipment. 
Injuries can result from bodily contact with rotating or moving objects, 
including mechanical equipment, parts, and devices. Personnel should not 
wear loose-fitting clothing, jewelry, or unrestrained long hair around 
machinery with moving parts.
    The Chemical Safety Board has identified the following key lessons 
for laboratories that address both physical and other hazards:
    (1) Ensure that research-specific hazards are evaluated and then 
controlled by developing specific written protocols and training.
    (2) Expand existing laboratory safety plans to ensure that all 
safety hazards, including physical hazards of chemicals, are addressed.
    (3) Ensure that the organization's EHS office reports directly to an 
identified individual/office with organizational authority to implement 
safety improvements.
    (4) Develop a verification program that ensures that the safety 
provisions of the CHP are communicated, followed, and enforced at all 
levels within the organization.
    (5) Document and communicate all laboratory near-misses and previous 
incidents to track safety, provide opportunities for education and 
improvement to drive safety changes at the university.
    (6) Manage the hazards unique to laboratory chemical research in the 
academic environment. Utilize available practice guidance that 
identifies and describes methodologies to assess and control hazards.
    (7) Written safety protocols and training are necessary to manage 
laboratory risk.

                          G. Emergency Planning

    In addition to laboratory safety issues, laboratory personnel should 
be familiar with established facility policies and procedures regarding 
emergency situations. Topics may include, but are not limited to:
    (1) Evacuation procedures--when it is appropriate and alternate 
routes;
    (2) Emergency shutdown procedures--equipment shutdown and materials 
that should be stored safely;
    (3) Communications during an emergency--what to expect, how to 
report, where to call or look for information;
    (4) How and when to use a fire extinguisher;
    (5) Security issues--preventing tailgating and unauthorized access;

[[Page 684]]

    (6) Protocol for absences due to travel restrictions or illness;
    (7) Safe practices for power outage;
    (8) Shelter in place--when it is appropriate;
    (9) Handling suspicious mail or phone calls;
    (10) Laboratory-specific protocols relating to emergency planning 
and response;
    (11) Handling violent behavior in the workplace; and
    (12) First-aid and CPR training, including automated external 
defibrillator training if available.
    It is prudent that laboratory personnel are also trained in how to 
respond to short-term, long-term and large-scale emergencies. Laboratory 
security can play a role in reducing the likelihood of some emergencies 
and assisting in preparation and response for others. Every institution, 
department, and individual laboratory should consider having an 
emergency preparedness plan. The level of detail of the plan will vary 
depending on the function of the group and institutional planning 
efforts already in place.
    Emergency planning is a dynamic process. As personnel, operations, 
and events change, plans will need to be updated and modified. To 
determine the type and level of emergency planning needed, laboratory 
personnel need to perform a vulnerability assessment. Periodic drills to 
assist in training and evaluation of the emergency plan are recommended 
as part of the training program.

                         H. Emergency Procedures

    (1) Fire alarm policy. Most organizations use fire alarms whenever a 
building needs to be evacuated--for any reason. When a fire alarm sounds 
in the facility, evacuate immediately after extinguishing all equipment 
flames. Check on and assist others who may require help evacuating.
    (2) Emergency safety equipment. The following safety elements should 
be met:
    a. A written emergency action plan has been provided to workers;
    b. Fire extinguishers, eyewash units, and safety showers are 
available and tested on a regular basis; and
    c. Fire blankets, first-aid equipment, fire alarms, and telephones 
are available and accessible.
    (3) Chemical spills. Workers should contact the CHO or EHS office 
for instructions before cleaning up a chemical spill. All SDS and label 
instructions should be followed, and appropriate PPE should be worn 
during spill cleanup.
    (4) Accident procedures. In the event of an accident, immediately 
notify appropriate personnel and local emergency responders. Provide an 
SDS of any chemical involved to the attending physician. Complete an 
accident report and submit it to the appropriate office or individual 
within 24 hours.
    (5) Employee safety training program. New workers should attend 
safety training before they begin any activities. Additional training 
should be provided when they advance in their duties or are required to 
perform a task for the first time. Training documents should be recorded 
and maintained. Training should include hands-on instruction of how to 
use safety equipment appropriately.
    (6) Conduct drills. Practice building evacuations, including the use 
of alternate routes. Practice shelter-in-place, including plans for 
extended stays. Walk the fastest route from your work area to the 
nearest fire alarm, emergency eye wash and emergency shower. Learn how 
each is activated. In the excitement of an actual emergency, people rely 
on what they learned from drills, practice and training.
    (7) Contingency plans. All laboratories should have long-term 
contingency plans in place (e.g., for pandemics). Scheduling, workload, 
utilities and alternate work sites may need to be considered.

                         I. Laboratory Security

    Laboratory security has evolved in the past decade, reducing the 
likelihood of some emergencies and assisting in preparation and response 
for others. Most security measures are based on the laboratory's 
vulnerability. Risks to laboratory security include, but are not limited 
to:
    (1) Theft or diversion of chemicals, biologicals, and radioactive or 
proprietary materials, mission-critical or high-value equipment;
    (2) Threats from activist groups;
    (3) Intentional release of, or exposure to, hazardous materials;
    (4) Sabotage or vandalism of chemicals or high-value equipment;
    (5) Loss or release of sensitive information; and
    (6) Rogue work or unauthorized laboratory experimentation. Security 
systems in the laboratory are used to detect and respond to a security 
breach, or a potential security breach, as well as to delay criminal 
activity by imposing multiple layered barriers of increasing stringency. 
A good laboratory security system will increase overall safety for 
laboratory personnel and the public, improve emergency preparedness by 
assisting with preplanning, and lower the organization's liability by 
incorporating more rigorous planning, staffing, training, and command 
systems and implementing emergency communications protocols, drills, 
background checks, card access systems, video surveillance, and other 
measures. The security plan should clearly delineate response to 
security issues, including the coordination of institution and 
laboratory personnel with both internal and external responders.

[[Page 685]]

        Appendix B to Sec.  1910.1450--References (Non-Mandatory)

    The following references are provided to assist the employer in the 
development of a Chemical Hygiene Plan. The materials listed below are 
offered as non-mandatory guidance. References listed here do not imply 
specific endorsement of a book, opinion, technique, policy or a specific 
solution for a safety or health problem. Other references not listed 
here may better meet the needs of a specific laboratory. (a) Materials 
for the development of the Chemical Hygiene Plan:
    1. American Chemical Society, Safety in Academic Chemistry 
Laboratories, 4th edition, 1985.
    2. Fawcett, H.H. and W. S. Wood, Safety and Accident Prevention in 
Chemical Operations, 2nd edition, Wiley-Interscience, New York, 1982.
    3. Flury, Patricia A., Environmental Health and Safety in the 
Hospital Laboratory, Charles C. Thomas Publisher, Springfield IL, 1978.
    4. Green, Michael E. and Turk, Amos, Safety in Working with 
Chemicals, Macmillan Publishing Co., NY, 1978.
    5. Kaufman, James A., Laboratory Safety Guidelines, Dow Chemical 
Co., Box 1713, Midland, MI 48640, 1977.
    6. National Institutes of Health, NIH Guidelines for the Laboratory 
use of Chemical Carcinogens, NIH Pub. No. 81-2385, GPO, Washington, DC 
20402, 1981.
    7. National Research Council, Prudent Practices for Disposal of 
Chemicals from Laboratories, National Academy Press, Washington, DC, 
1983.
    8. National Research Council, Prudent Practices for Handling 
Hazardous Chemicals in Laboratories, National Academy Press, Washington, 
DC, 1981.
    9. Renfrew, Malcolm, Ed., Safety in the Chemical Laboratory, Vol. 
IV, J. Chem. Ed., American Chemical Society, Easlon, PA, 1981.
    10. Steere, Norman V., Ed., Safety in the Chemical Laboratory, J. 
Chem. Ed. American Chemical Society, Easlon, PA, 18042, Vol. I, 1967, 
Vol. II, 1971, Vol. III 1974.
    11. Steere, Norman V., Handbook of Laboratory Safety, the Chemical 
Rubber Company Cleveland, OH, 1971.
    12. Young, Jay A., Ed., Improving Safety in the Chemical Laboratory, 
John Wiley & Sons, Inc. New York, 1987.
    (b) Hazardous Substances Information:
    1. American Conference of Governmental Industrial Hygienists, 
Threshold Limit Values for Chemical Substances and Physical Agents in 
the Workroom Environment with Intended Changes, 6500 Glenway Avenue, 
Bldg. D-7 Cincinnati, OH 45211-4438 (latest edition).
    2. Annual Report on Carcinogens, National Toxicology Program U.S. 
Department of Health and Human Services, Public Health Service, U.S. 
Government Printing Office, Washington, DC, (latest edition).
    3. Best Company, Best Safety Directory, Vols. I and II, Oldwick, 
N.J., 1981.
    4. Bretherick, L., Handbook of Reactive Chemical Hazards, 2nd 
edition, Butterworths, London, 1979.
    5. Bretherick, L., Hazards in the Chemical Laboratory, 3rd edition, 
Royal Society of Chemistry, London, 1986.
    6. Code of Federal Regulations, 29 CFR part 1910 subpart Z. U.S. 
Govt. Printing Office, Washington, DC 20402 (latest edition).
    7. IARC Monographs on the Evaluation of the Carcinogenic Risk of 
Chemicals to Man, World Health Organization Publications Center, 49 
Sheridan Avenue, Albany, New York 12210 (latest editions).
    8. NIOSH/OSHA Pocket Guide to Chemical Hazards. NIOSH Pub. No. 85-
114, U.S. Government Printing Office, Washington, DC, 1985 (or latest 
edition).
    9. Occupational Health Guidelines, NIOSH/OSHA NIOSH Pub. No. 81-123 
U.S. Government Printing Office, Washington, DC, 1981.
    10. Patty, F.A., Industrial Hygiene and Toxicology, John Wiley & 
Sons, Inc., New York, NY (Five Volumes).
    11. Registry of Toxic Effects of Chemical Substances, U.S. 
Department of Health and Human Services, Public Health Service, Centers 
for Disease Control, National Institute for Occupational Safety and 
Health, Revised Annually, for sale from Superintendent of Documents U.S. 
Govt. Printing Office, Washington, DC 20402.
    12. The Merck Index: An Encyclopedia of Chemicals and Drugs. Merck 
and Company Inc. Rahway, N.J., 1976 (or latest edition).
    13. Sax, N.I. Dangerous Properties of Industrial Materials, 5th 
edition, Van Nostrand Reinhold, NY., 1979.
    14. Sittig, Marshall, Handbook of Toxic and Hazardous Chemicals, 
Noyes Publications, Park Ridge, NJ, 1981.
    (c) Information on Ventilation:
    1. American Conference of Governmental Industrial Hygienists 
Industrial Ventilation (latest edition), 6500 Glenway Avenue, Bldg. D-7, 
Cincinnati, Ohio 45211-4438.
    2. American National Standards Institute, Inc. American National 
Standards Fundamentals Governing the Design and Operation of Local 
Exhaust Systems ANSI Z 9.2-1979 American National Standards Institute, 
N.Y. 1979.
    3. Imad, A.P. and Watson, C.L. Ventilation Index: An Easy Way to 
Decide about Hazardous Liquids, Professional Safety pp 15-18, April 
1980.
    4. National Fire Protection Association, Fire Protection for 
Laboratories Using Chemicals NFPA-45, 1982.
    Safety Standard for Laboratories in Health Related Institutions, 
NFPA, 56c, 1980.

[[Page 686]]

    Fire Protection Guide on Hazardous Materials, 7th edition, 1978.
    National Fire Protection Association, Batterymarch Park, Quincy, MA 
02269.
    5. Scientific Apparatus Makers Association (SAMA), Standard for 
Laboratory Fume Hoods, SAMA LF7-1980, 1101 16th Street, NW., Washington, 
DC 20036.
    (d) Information on Availability of Referenced Material:
    1. American National Standards Institute (ANSI), 1430 Broadway, New 
York, NY 10018.
    2. American Society for Testing and Materials (ASTM), 1916 Race 
Street, Philadelphia, PA 19103.

[55 FR 3327, Jan. 31, 1990; 55 FR 7967, Mar. 6, 1990; 55 FR 12111, Mar. 
30, 1990; 57 FR 29204, July 1, 1992; 61 FR 5508, Feb. 13, 1996; 71 FR 
16674, Apr. 3, 2006; 76 FR 33609, June 8, 2011; 77 FR 17887, Mar. 26, 
2012; 78 FR 4325, Jan. 22, 2013]



Sec. Sec.  1910.1451-1910.1499  [Reserved]

[[Page 687]]



                              FINDING AIDS




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

  A list of CFR titles, subtitles, chapters, subchapters and parts and 
an alphabetical list of agencies publishing in the CFR are included in 
the CFR Index and Finding Aids volume to the Code of Federal Regulations 
which is published separately and revised annually.

  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  Table of OMB Control Numbers
  List of CFR Sections Affected

[[Page 689]]



                    Table of CFR Titles and Chapters




                      (Revised as of July 1, 2021)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
       III  Administrative Conference of the United States (Parts 
                300--399)
        IV  Miscellaneous Agencies (Parts 400--599)
        VI  National Capital Planning Commission (Parts 600--699)

                    Title 2--Grants and Agreements

            Subtitle A--Office of Management and Budget Guidance 
                for Grants and Agreements
         I  Office of Management and Budget Governmentwide 
                Guidance for Grants and Agreements (Parts 2--199)
        II  Office of Management and Budget Guidance (Parts 200--
                299)
            Subtitle B--Federal Agency Regulations for Grants and 
                Agreements
       III  Department of Health and Human Services (Parts 300--
                399)
        IV  Department of Agriculture (Parts 400--499)
        VI  Department of State (Parts 600--699)
       VII  Agency for International Development (Parts 700--799)
      VIII  Department of Veterans Affairs (Parts 800--899)
        IX  Department of Energy (Parts 900--999)
         X  Department of the Treasury (Parts 1000--1099)
        XI  Department of Defense (Parts 1100--1199)
       XII  Department of Transportation (Parts 1200--1299)
      XIII  Department of Commerce (Parts 1300--1399)
       XIV  Department of the Interior (Parts 1400--1499)
        XV  Environmental Protection Agency (Parts 1500--1599)
     XVIII  National Aeronautics and Space Administration (Parts 
                1800--1899)
        XX  United States Nuclear Regulatory Commission (Parts 
                2000--2099)
      XXII  Corporation for National and Community Service (Parts 
                2200--2299)
     XXIII  Social Security Administration (Parts 2300--2399)
      XXIV  Department of Housing and Urban Development (Parts 
                2400--2499)
       XXV  National Science Foundation (Parts 2500--2599)
      XXVI  National Archives and Records Administration (Parts 
                2600--2699)

[[Page 690]]

     XXVII  Small Business Administration (Parts 2700--2799)
    XXVIII  Department of Justice (Parts 2800--2899)
      XXIX  Department of Labor (Parts 2900--2999)
       XXX  Department of Homeland Security (Parts 3000--3099)
      XXXI  Institute of Museum and Library Services (Parts 3100--
                3199)
     XXXII  National Endowment for the Arts (Parts 3200--3299)
    XXXIII  National Endowment for the Humanities (Parts 3300--
                3399)
     XXXIV  Department of Education (Parts 3400--3499)
      XXXV  Export-Import Bank of the United States (Parts 3500--
                3599)
     XXXVI  Office of National Drug Control Policy, Executive 
                Office of the President (Parts 3600--3699)
    XXXVII  Peace Corps (Parts 3700--3799)
     LVIII  Election Assistance Commission (Parts 5800--5899)
       LIX  Gulf Coast Ecosystem Restoration Council (Parts 5900--
                5999)

                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  Government Accountability Office (Parts 1--199)

                   Title 5--Administrative Personnel

         I  Office of Personnel Management (Parts 1--1199)
        II  Merit Systems Protection Board (Parts 1200--1299)
       III  Office of Management and Budget (Parts 1300--1399)
        IV  Office of Personnel Management and Office of the 
                Director of National Intelligence (Parts 1400--
                1499)
         V  The International Organizations Employees Loyalty 
                Board (Parts 1500--1599)
        VI  Federal Retirement Thrift Investment Board (Parts 
                1600--1699)
      VIII  Office of Special Counsel (Parts 1800--1899)
        IX  Appalachian Regional Commission (Parts 1900--1999)
        XI  Armed Forces Retirement Home (Parts 2100--2199)
       XIV  Federal Labor Relations Authority, General Counsel of 
                the Federal Labor Relations Authority and Federal 
                Service Impasses Panel (Parts 2400--2499)
       XVI  Office of Government Ethics (Parts 2600--2699)
       XXI  Department of the Treasury (Parts 3100--3199)
      XXII  Federal Deposit Insurance Corporation (Parts 3200--
                3299)
     XXIII  Department of Energy (Parts 3300--3399)
      XXIV  Federal Energy Regulatory Commission (Parts 3400--
                3499)
       XXV  Department of the Interior (Parts 3500--3599)
      XXVI  Department of Defense (Parts 3600--3699)

[[Page 691]]

    XXVIII  Department of Justice (Parts 3800--3899)
      XXIX  Federal Communications Commission (Parts 3900--3999)
       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)
    XXXIII  U.S. International Development Finance Corporation 
                (Parts 4300--4399)
     XXXIV  Securities and Exchange Commission (Parts 4400--4499)
      XXXV  Office of Personnel Management (Parts 4500--4599)
     XXXVI  Department of Homeland Security (Parts 4600--4699)
    XXXVII  Federal Election Commission (Parts 4700--4799)
        XL  Interstate Commerce Commission (Parts 5000--5099)
       XLI  Commodity Futures Trading Commission (Parts 5100--
                5199)
      XLII  Department of Labor (Parts 5200--5299)
     XLIII  National Science Foundation (Parts 5300--5399)
       XLV  Department of Health and Human Services (Parts 5500--
                5599)
      XLVI  Postal Rate Commission (Parts 5600--5699)
     XLVII  Federal Trade Commission (Parts 5700--5799)
    XLVIII  Nuclear Regulatory Commission (Parts 5800--5899)
      XLIX  Federal Labor Relations Authority (Parts 5900--5999)
         L  Department of Transportation (Parts 6000--6099)
       LII  Export-Import Bank of the United States (Parts 6200--
                6299)
      LIII  Department of Education (Parts 6300--6399)
       LIV  Environmental Protection Agency (Parts 6400--6499)
        LV  National Endowment for the Arts (Parts 6500--6599)
       LVI  National Endowment for the Humanities (Parts 6600--
                6699)
      LVII  General Services Administration (Parts 6700--6799)
     LVIII  Board of Governors of the Federal Reserve System 
                (Parts 6800--6899)
       LIX  National Aeronautics and Space Administration (Parts 
                6900--6999)
        LX  United States Postal Service (Parts 7000--7099)
       LXI  National Labor Relations Board (Parts 7100--7199)
      LXII  Equal Employment Opportunity Commission (Parts 7200--
                7299)
     LXIII  Inter-American Foundation (Parts 7300--7399)
      LXIV  Merit Systems Protection Board (Parts 7400--7499)
       LXV  Department of Housing and Urban Development (Parts 
                7500--7599)
      LXVI  National Archives and Records Administration (Parts 
                7600--7699)
     LXVII  Institute of Museum and Library Services (Parts 7700--
                7799)
    LXVIII  Commission on Civil Rights (Parts 7800--7899)
      LXIX  Tennessee Valley Authority (Parts 7900--7999)
       LXX  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 8000--8099)
      LXXI  Consumer Product Safety Commission (Parts 8100--8199)
    LXXIII  Department of Agriculture (Parts 8300--8399)

[[Page 692]]

     LXXIV  Federal Mine Safety and Health Review Commission 
                (Parts 8400--8499)
     LXXVI  Federal Retirement Thrift Investment Board (Parts 
                8600--8699)
    LXXVII  Office of Management and Budget (Parts 8700--8799)
      LXXX  Federal Housing Finance Agency (Parts 9000--9099)
   LXXXIII  Special Inspector General for Afghanistan 
                Reconstruction (Parts 9300--9399)
    LXXXIV  Bureau of Consumer Financial Protection (Parts 9400--
                9499)
    LXXXVI  National Credit Union Administration (Parts 9600--
                9699)
     XCVII  Department of Homeland Security Human Resources 
                Management System (Department of Homeland 
                Security--Office of Personnel Management) (Parts 
                9700--9799)
    XCVIII  Council of the Inspectors General on Integrity and 
                Efficiency (Parts 9800--9899)
      XCIX  Military Compensation and Retirement Modernization 
                Commission (Parts 9900--9999)
         C  National Council on Disability (Parts 10000--10049)
        CI  National Mediation Board (Parts 10100--10199)
       CII  U.S. Office of Special Counsel (Parts 10200--10299)

                      Title 6--Domestic Security

         I  Department of Homeland Security, Office of the 
                Secretary (Parts 1--199)
         X  Privacy and Civil Liberties Oversight Board (Parts 
                1000--1099)

                         Title 7--Agriculture

            Subtitle A--Office of the Secretary of Agriculture 
                (Parts 0--26)
            Subtitle B--Regulations of the Department of 
                Agriculture
         I  Agricultural Marketing Service (Standards, 
                Inspections, Marketing Practices), Department of 
                Agriculture (Parts 27--209)
        II  Food and Nutrition Service, Department of Agriculture 
                (Parts 210--299)
       III  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 300--399)
        IV  Federal Crop Insurance Corporation, Department of 
                Agriculture (Parts 400--499)
         V  Agricultural Research Service, Department of 
                Agriculture (Parts 500--599)
        VI  Natural Resources Conservation Service, Department of 
                Agriculture (Parts 600--699)
       VII  Farm Service Agency, Department of Agriculture (Parts 
                700--799)
      VIII  Agricultural Marketing Service (Federal Grain 
                Inspection Service, Fair Trade Practices Program), 
                Department of Agriculture (Parts 800--899)

[[Page 693]]

        IX  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Fruits, Vegetables, Nuts), Department 
                of Agriculture (Parts 900--999)
         X  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Milk), Department of Agriculture 
                (Parts 1000--1199)
        XI  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Miscellaneous Commodities), Department 
                of Agriculture (Parts 1200--1299)
       XIV  Commodity Credit Corporation, Department of 
                Agriculture (Parts 1400--1499)
        XV  Foreign Agricultural Service, Department of 
                Agriculture (Parts 1500--1599)
       XVI  (Parts 1600--1699) [Reserved]
      XVII  Rural Utilities Service, Department of Agriculture 
                (Parts 1700--1799)
     XVIII  Rural Housing Service, Rural Business-Cooperative 
                Service, Rural Utilities Service, and Farm Service 
                Agency, Department of Agriculture (Parts 1800--
                2099)
        XX  (Parts 2200--2299) [Reserved]
       XXV  Office of Advocacy and Outreach, Department of 
                Agriculture (Parts 2500--2599)
      XXVI  Office of Inspector General, Department of Agriculture 
                (Parts 2600--2699)
     XXVII  Office of Information Resources Management, Department 
                of Agriculture (Parts 2700--2799)
    XXVIII  Office of Operations, Department of Agriculture (Parts 
                2800--2899)
      XXIX  Office of Energy Policy and New Uses, Department of 
                Agriculture (Parts 2900--2999)
       XXX  Office of the Chief Financial Officer, Department of 
                Agriculture (Parts 3000--3099)
      XXXI  Office of Environmental Quality, Department of 
                Agriculture (Parts 3100--3199)
     XXXII  Office of Procurement and Property Management, 
                Department of Agriculture (Parts 3200--3299)
    XXXIII  Office of Transportation, Department of Agriculture 
                (Parts 3300--3399)
     XXXIV  National Institute of Food and Agriculture (Parts 
                3400--3499)
      XXXV  Rural Housing Service, Department of Agriculture 
                (Parts 3500--3599)
     XXXVI  National Agricultural Statistics Service, Department 
                of Agriculture (Parts 3600--3699)
    XXXVII  Economic Research Service, Department of Agriculture 
                (Parts 3700--3799)
   XXXVIII  World Agricultural Outlook Board, Department of 
                Agriculture (Parts 3800--3899)
       XLI  [Reserved]
      XLII  Rural Business-Cooperative Service and Rural Utilities 
                Service, Department of Agriculture (Parts 4200--
                4299)

[[Page 694]]

         L  Rural Business-Cooperative Service, and Rural 
                Utilities Service, Department of Agriculture 
                (Parts 5000--5099)

                    Title 8--Aliens and Nationality

         I  Department of Homeland Security (Parts 1--499)
         V  Executive Office for Immigration Review, Department of 
                Justice (Parts 1000--1399)

                 Title 9--Animals and Animal Products

         I  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 1--199)
        II  Agricultural Marketing Service (Fair Trade Practices 
                Program), Department of Agriculture (Parts 200--
                299)
       III  Food Safety and Inspection Service, Department of 
                Agriculture (Parts 300--599)

                           Title 10--Energy

         I  Nuclear Regulatory Commission (Parts 0--199)
        II  Department of Energy (Parts 200--699)
       III  Department of Energy (Parts 700--999)
         X  Department of Energy (General Provisions) (Parts 
                1000--1099)
      XIII  Nuclear Waste Technical Review Board (Parts 1300--
                1399)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)
     XVIII  Northeast Interstate Low-Level Radioactive Waste 
                Commission (Parts 1800--1899)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)
        II  Election Assistance Commission (Parts 9400--9499)

                      Title 12--Banks and Banking

         I  Comptroller of the Currency, Department of the 
                Treasury (Parts 1--199)
        II  Federal Reserve System (Parts 200--299)
       III  Federal Deposit Insurance Corporation (Parts 300--399)
        IV  Export-Import Bank of the United States (Parts 400--
                499)
         V  (Parts 500--599) [Reserved]
        VI  Farm Credit Administration (Parts 600--699)
       VII  National Credit Union Administration (Parts 700--799)
      VIII  Federal Financing Bank (Parts 800--899)
        IX  (Parts 900--999) [Reserved]
         X  Bureau of Consumer Financial Protection (Parts 1000--
                1099)

[[Page 695]]

        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XII  Federal Housing Finance Agency (Parts 1200--1299)
      XIII  Financial Stability Oversight Council (Parts 1300--
                1399)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Department of the Treasury (Parts 1500--1599)
       XVI  Office of Financial Research, Department of the 
                Treasury (Parts 1600--1699)
      XVII  Office of Federal Housing Enterprise Oversight, 
                Department of Housing and Urban Development (Parts 
                1700--1799)
     XVIII  Community Development Financial Institutions Fund, 
                Department of the Treasury (Parts 1800--1899)

               Title 13--Business Credit and Assistance

         I  Small Business Administration (Parts 1--199)
       III  Economic Development Administration, Department of 
                Commerce (Parts 300--399)
        IV  Emergency Steel Guarantee Loan Board (Parts 400--499)
         V  Emergency Oil and Gas Guaranteed Loan Board (Parts 
                500--599)

                    Title 14--Aeronautics and Space

         I  Federal Aviation Administration, Department of 
                Transportation (Parts 1--199)
        II  Office of the Secretary, Department of Transportation 
                (Aviation Proceedings) (Parts 200--399)
       III  Commercial Space Transportation, Federal Aviation 
                Administration, Department of Transportation 
                (Parts 400--1199)
         V  National Aeronautics and Space Administration (Parts 
                1200--1299)
        VI  Air Transportation System Stabilization (Parts 1300--
                1399)

                 Title 15--Commerce and Foreign Trade

            Subtitle A--Office of the Secretary of Commerce (Parts 
                0--29)
            Subtitle B--Regulations Relating to Commerce and 
                Foreign Trade
         I  Bureau of the Census, Department of Commerce (Parts 
                30--199)
        II  National Institute of Standards and Technology, 
                Department of Commerce (Parts 200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  Foreign-Trade Zones Board, Department of Commerce 
                (Parts 400--499)
       VII  Bureau of Industry and Security, Department of 
                Commerce (Parts 700--799)

[[Page 696]]

      VIII  Bureau of Economic Analysis, Department of Commerce 
                (Parts 800--899)
        IX  National Oceanic and Atmospheric Administration, 
                Department of Commerce (Parts 900--999)
        XI  National Technical Information Service, Department of 
                Commerce (Parts 1100--1199)
      XIII  East-West Foreign Trade Board (Parts 1300--1399)
       XIV  Minority Business Development Agency (Parts 1400--
                1499)
        XV  Office of the Under-Secretary for Economic Affairs, 
                Department of Commerce (Parts 1500--1599)
            Subtitle C--Regulations Relating to Foreign Trade 
                Agreements
        XX  Office of the United States Trade Representative 
                (Parts 2000--2099)
            Subtitle D--Regulations Relating to Telecommunications 
                and Information
     XXIII  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                2300--2399) [Reserved]

                    Title 16--Commercial Practices

         I  Federal Trade Commission (Parts 0--999)
        II  Consumer Product Safety Commission (Parts 1000--1799)

             Title 17--Commodity and Securities Exchanges

         I  Commodity Futures Trading Commission (Parts 1--199)
        II  Securities and Exchange Commission (Parts 200--399)
        IV  Department of the Treasury (Parts 400--499)

          Title 18--Conservation of Power and Water Resources

         I  Federal Energy Regulatory Commission, Department of 
                Energy (Parts 1--399)
       III  Delaware River Basin Commission (Parts 400--499)
        VI  Water Resources Council (Parts 700--799)
      VIII  Susquehanna River Basin Commission (Parts 800--899)
      XIII  Tennessee Valley Authority (Parts 1300--1399)

                       Title 19--Customs Duties

         I  U.S. Customs and Border Protection, Department of 
                Homeland Security; Department of the Treasury 
                (Parts 0--199)
        II  United States International Trade Commission (Parts 
                200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  U.S. Immigration and Customs Enforcement, Department 
                of Homeland Security (Parts 400--599) [Reserved]

[[Page 697]]

                     Title 20--Employees' Benefits

         I  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 1--199)
        II  Railroad Retirement Board (Parts 200--399)
       III  Social Security Administration (Parts 400--499)
        IV  Employees' Compensation Appeals Board, Department of 
                Labor (Parts 500--599)
         V  Employment and Training Administration, Department of 
                Labor (Parts 600--699)
        VI  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 700--799)
       VII  Benefits Review Board, Department of Labor (Parts 
                800--899)
      VIII  Joint Board for the Enrollment of Actuaries (Parts 
                900--999)
        IX  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 1000--1099)

                       Title 21--Food and Drugs

         I  Food and Drug Administration, Department of Health and 
                Human Services (Parts 1--1299)
        II  Drug Enforcement Administration, Department of Justice 
                (Parts 1300--1399)
       III  Office of National Drug Control Policy (Parts 1400--
                1499)

                      Title 22--Foreign Relations

         I  Department of State (Parts 1--199)
        II  Agency for International Development (Parts 200--299)
       III  Peace Corps (Parts 300--399)
        IV  International Joint Commission, United States and 
                Canada (Parts 400--499)
         V  United States Agency for Global Media (Parts 500--599)
       VII  U.S. International Development Finance Corporation 
                (Parts 700--799)
        IX  Foreign Service Grievance Board (Parts 900--999)
         X  Inter-American Foundation (Parts 1000--1099)
        XI  International Boundary and Water Commission, United 
                States and Mexico, United States Section (Parts 
                1100--1199)
       XII  United States International Development Cooperation 
                Agency (Parts 1200--1299)
      XIII  Millennium Challenge Corporation (Parts 1300--1399)
       XIV  Foreign Service Labor Relations Board; Federal Labor 
                Relations Authority; General Counsel of the 
                Federal Labor Relations Authority; and the Foreign 
                Service Impasse Disputes Panel (Parts 1400--1499)
        XV  African Development Foundation (Parts 1500--1599)
       XVI  Japan-United States Friendship Commission (Parts 
                1600--1699)
      XVII  United States Institute of Peace (Parts 1700--1799)

[[Page 698]]

                          Title 23--Highways

         I  Federal Highway Administration, Department of 
                Transportation (Parts 1--999)
        II  National Highway Traffic Safety Administration and 
                Federal Highway Administration, Department of 
                Transportation (Parts 1200--1299)
       III  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 1300--1399)

                Title 24--Housing and Urban Development

            Subtitle A--Office of the Secretary, Department of 
                Housing and Urban Development (Parts 0--99)
            Subtitle B--Regulations Relating to Housing and Urban 
                Development
         I  Office of Assistant Secretary for Equal Opportunity, 
                Department of Housing and Urban Development (Parts 
                100--199)
        II  Office of Assistant Secretary for Housing-Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 200--299)
       III  Government National Mortgage Association, Department 
                of Housing and Urban Development (Parts 300--399)
        IV  Office of Housing and Office of Multifamily Housing 
                Assistance Restructuring, Department of Housing 
                and Urban Development (Parts 400--499)
         V  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 500--599)
        VI  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 600--699) [Reserved]
       VII  Office of the Secretary, Department of Housing and 
                Urban Development (Housing Assistance Programs and 
                Public and Indian Housing Programs) (Parts 700--
                799)
      VIII  Office of the Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Section 8 Housing Assistance 
                Programs, Section 202 Direct Loan Program, Section 
                202 Supportive Housing for the Elderly Program and 
                Section 811 Supportive Housing for Persons With 
                Disabilities Program) (Parts 800--899)
        IX  Office of Assistant Secretary for Public and Indian 
                Housing, Department of Housing and Urban 
                Development (Parts 900--1699)
         X  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Interstate Land Sales 
                Registration Program) (Parts 1700--1799) 
                [Reserved]
       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XV  Emergency Mortgage Insurance and Loan Programs, 
                Department of Housing and Urban Development (Parts 
                2700--2799) [Reserved]

[[Page 699]]

        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3899)
      XXIV  Board of Directors of the HOPE for Homeowners Program 
                (Parts 4000--4099) [Reserved]
       XXV  Neighborhood Reinvestment Corporation (Parts 4100--
                4199)

                           Title 25--Indians

         I  Bureau of Indian Affairs, Department of the Interior 
                (Parts 1--299)
        II  Indian Arts and Crafts Board, Department of the 
                Interior (Parts 300--399)
       III  National Indian Gaming Commission, Department of the 
                Interior (Parts 500--599)
        IV  Office of Navajo and Hopi Indian Relocation (Parts 
                700--899)
         V  Bureau of Indian Affairs, Department of the Interior, 
                and Indian Health Service, Department of Health 
                and Human Services (Part 900--999)
        VI  Office of the Assistant Secretary, Indian Affairs, 
                Department of the Interior (Parts 1000--1199)
       VII  Office of the Special Trustee for American Indians, 
                Department of the Interior (Parts 1200--1299)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--End)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Alcohol and Tobacco Tax and Trade Bureau, Department 
                of the Treasury (Parts 1--399)
        II  Bureau of Alcohol, Tobacco, Firearms, and Explosives, 
                Department of Justice (Parts 400--799)

                   Title 28--Judicial Administration

         I  Department of Justice (Parts 0--299)
       III  Federal Prison Industries, Inc., Department of Justice 
                (Parts 300--399)
         V  Bureau of Prisons, Department of Justice (Parts 500--
                599)
        VI  Offices of Independent Counsel, Department of Justice 
                (Parts 600--699)
       VII  Office of Independent Counsel (Parts 700--799)
      VIII  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 800--899)
        IX  National Crime Prevention and Privacy Compact Council 
                (Parts 900--999)

[[Page 700]]

        XI  Department of Justice and Department of State (Parts 
                1100--1199)

                            Title 29--Labor

            Subtitle A--Office of the Secretary of Labor (Parts 
                0--99)
            Subtitle B--Regulations Relating to Labor
         I  National Labor Relations Board (Parts 100--199)
        II  Office of Labor-Management Standards, Department of 
                Labor (Parts 200--299)
       III  National Railroad Adjustment Board (Parts 300--399)
        IV  Office of Labor-Management Standards, Department of 
                Labor (Parts 400--499)
         V  Wage and Hour Division, Department of Labor (Parts 
                500--899)
        IX  Construction Industry Collective Bargaining Commission 
                (Parts 900--999)
         X  National Mediation Board (Parts 1200--1299)
       XII  Federal Mediation and Conciliation Service (Parts 
                1400--1499)
       XIV  Equal Employment Opportunity Commission (Parts 1600--
                1699)
      XVII  Occupational Safety and Health Administration, 
                Department of Labor (Parts 1900--1999)
        XX  Occupational Safety and Health Review Commission 
                (Parts 2200--2499)
       XXV  Employee Benefits Security Administration, Department 
                of Labor (Parts 2500--2599)
     XXVII  Federal Mine Safety and Health Review Commission 
                (Parts 2700--2799)
        XL  Pension Benefit Guaranty Corporation (Parts 4000--
                4999)

                      Title 30--Mineral Resources

         I  Mine Safety and Health Administration, Department of 
                Labor (Parts 1--199)
        II  Bureau of Safety and Environmental Enforcement, 
                Department of the Interior (Parts 200--299)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
         V  Bureau of Ocean Energy Management, Department of the 
                Interior (Parts 500--599)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)
       XII  Office of Natural Resources Revenue, Department of the 
                Interior (Parts 1200--1299)

                 Title 31--Money and Finance: Treasury

            Subtitle A--Office of the Secretary of the Treasury 
                (Parts 0--50)
            Subtitle B--Regulations Relating to Money and Finance

[[Page 701]]

         I  Monetary Offices, Department of the Treasury (Parts 
                51--199)
        II  Fiscal Service, Department of the Treasury (Parts 
                200--399)
        IV  Secret Service, Department of the Treasury (Parts 
                400--499)
         V  Office of Foreign Assets Control, Department of the 
                Treasury (Parts 500--599)
        VI  Bureau of Engraving and Printing, Department of the 
                Treasury (Parts 600--699)
       VII  Federal Law Enforcement Training Center, Department of 
                the Treasury (Parts 700--799)
      VIII  Office of Investment Security, Department of the 
                Treasury (Parts 800--899)
        IX  Federal Claims Collection Standards (Department of the 
                Treasury--Department of Justice) (Parts 900--999)
         X  Financial Crimes Enforcement Network, Department of 
                the Treasury (Parts 1000--1099)

                      Title 32--National Defense

            Subtitle A--Department of Defense
         I  Office of the Secretary of Defense (Parts 1--399)
         V  Department of the Army (Parts 400--699)
        VI  Department of the Navy (Parts 700--799)
       VII  Department of the Air Force (Parts 800--1099)
            Subtitle B--Other Regulations Relating to National 
                Defense
       XII  Department of Defense, Defense Logistics Agency (Parts 
                1200--1299)
       XVI  Selective Service System (Parts 1600--1699)
      XVII  Office of the Director of National Intelligence (Parts 
                1700--1799)
     XVIII  National Counterintelligence Center (Parts 1800--1899)
       XIX  Central Intelligence Agency (Parts 1900--1999)
        XX  Information Security Oversight Office, National 
                Archives and Records Administration (Parts 2000--
                2099)
       XXI  National Security Council (Parts 2100--2199)
      XXIV  Office of Science and Technology Policy (Parts 2400--
                2499)
     XXVII  Office for Micronesian Status Negotiations (Parts 
                2700--2799)
    XXVIII  Office of the Vice President of the United States 
                (Parts 2800--2899)

               Title 33--Navigation and Navigable Waters

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Corps of Engineers, Department of the Army, Department 
                of Defense (Parts 200--399)
        IV  Great Lakes St. Lawrence Seaway Development 
                Corporation, Department of Transportation (Parts 
                400--499)

[[Page 702]]

                          Title 34--Education

            Subtitle A--Office of the Secretary, Department of 
                Education (Parts 1--99)
            Subtitle B--Regulations of the Offices of the 
                Department of Education
         I  Office for Civil Rights, Department of Education 
                (Parts 100--199)
        II  Office of Elementary and Secondary Education, 
                Department of Education (Parts 200--299)
       III  Office of Special Education and Rehabilitative 
                Services, Department of Education (Parts 300--399)
        IV  Office of Career, Technical, and Adult Education, 
                Department of Education (Parts 400--499)
         V  Office of Bilingual Education and Minority Languages 
                Affairs, Department of Education (Parts 500--599) 
                [Reserved]
        VI  Office of Postsecondary Education, Department of 
                Education (Parts 600--699)
       VII  Office of Educational Research and Improvement, 
                Department of Education (Parts 700--799) 
                [Reserved]
            Subtitle C--Regulations Relating to Education
        XI  (Parts 1100--1199) [Reserved]
       XII  National Council on Disability (Parts 1200--1299)

                          Title 35 [Reserved]

             Title 36--Parks, Forests, and Public Property

         I  National Park Service, Department of the Interior 
                (Parts 1--199)
        II  Forest Service, Department of Agriculture (Parts 200--
                299)
       III  Corps of Engineers, Department of the Army (Parts 
                300--399)
        IV  American Battle Monuments Commission (Parts 400--499)
         V  Smithsonian Institution (Parts 500--599)
        VI  [Reserved]
       VII  Library of Congress (Parts 700--799)
      VIII  Advisory Council on Historic Preservation (Parts 800--
                899)
        IX  Pennsylvania Avenue Development Corporation (Parts 
                900--999)
         X  Presidio Trust (Parts 1000--1099)
        XI  Architectural and Transportation Barriers Compliance 
                Board (Parts 1100--1199)
       XII  National Archives and Records Administration (Parts 
                1200--1299)
        XV  Oklahoma City National Memorial Trust (Parts 1500--
                1599)
       XVI  Morris K. Udall Scholarship and Excellence in National 
                Environmental Policy Foundation (Parts 1600--1699)

             Title 37--Patents, Trademarks, and Copyrights

         I  United States Patent and Trademark Office, Department 
                of Commerce (Parts 1--199)
        II  U.S. Copyright Office, Library of Congress (Parts 
                200--299)

[[Page 703]]

       III  Copyright Royalty Board, Library of Congress (Parts 
                300--399)
        IV  National Institute of Standards and Technology, 
                Department of Commerce (Parts 400--599)

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--199)
        II  Armed Forces Retirement Home (Parts 200--299)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Regulatory Commission (Parts 3000--3099)

                  Title 40--Protection of Environment

         I  Environmental Protection Agency (Parts 1--1099)
        IV  Environmental Protection Agency and Department of 
                Justice (Parts 1400--1499)
         V  Council on Environmental Quality (Parts 1500--1599)
        VI  Chemical Safety and Hazard Investigation Board (Parts 
                1600--1699)
       VII  Environmental Protection Agency and Department of 
                Defense; Uniform National Discharge Standards for 
                Vessels of the Armed Forces (Parts 1700--1799)
      VIII  Gulf Coast Ecosystem Restoration Council (Parts 1800--
                1899)
        IX  Federal Permitting Improvement Steering Council (Part 
                1900)

          Title 41--Public Contracts and Property Management

            Subtitle A--Federal Procurement Regulations System 
                [Note]
            Subtitle B--Other Provisions Relating to Public 
                Contracts
        50  Public Contracts, Department of Labor (Parts 50-1--50-
                999)
        51  Committee for Purchase From People Who Are Blind or 
                Severely Disabled (Parts 51-1--51-99)
        60  Office of Federal Contract Compliance Programs, Equal 
                Employment Opportunity, Department of Labor (Parts 
                60-1--60-999)
        61  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 61-1--61-999)
   62--100  [Reserved]
            Subtitle C--Federal Property Management Regulations 
                System
       101  Federal Property Management Regulations (Parts 101-1--
                101-99)
       102  Federal Management Regulation (Parts 102-1--102-299)
  103--104  [Reserved]
       105  General Services Administration (Parts 105-1--105-999)

[[Page 704]]

       109  Department of Energy Property Management Regulations 
                (Parts 109-1--109-99)
       114  Department of the Interior (Parts 114-1--114-99)
       115  Environmental Protection Agency (Parts 115-1--115-99)
       128  Department of Justice (Parts 128-1--128-99)
  129--200  [Reserved]
            Subtitle D--Other Provisions Relating to Property 
                Management [Reserved]
            Subtitle E--Federal Information Resources Management 
                Regulations System [Reserved]
            Subtitle F--Federal Travel Regulation System
       300  General (Parts 300-1--300-99)
       301  Temporary Duty (TDY) Travel Allowances (Parts 301-1--
                301-99)
       302  Relocation Allowances (Parts 302-1--302-99)
       303  Payment of Expenses Connected with the Death of 
                Certain Employees (Part 303-1--303-99)
       304  Payment of Travel Expenses from a Non-Federal Source 
                (Parts 304-1--304-99)

                        Title 42--Public Health

         I  Public Health Service, Department of Health and Human 
                Services (Parts 1--199)
   II--III  [Reserved]
        IV  Centers for Medicare & Medicaid Services, Department 
                of Health and Human Services (Parts 400--699)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1099)

                   Title 43--Public Lands: Interior

            Subtitle A--Office of the Secretary of the Interior 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Lands
         I  Bureau of Reclamation, Department of the Interior 
                (Parts 400--999)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10099)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency, Department of 
                Homeland Security (Parts 0--399)
        IV  Department of Commerce and Department of 
                Transportation (Parts 400--499)

[[Page 705]]

                       Title 45--Public Welfare

            Subtitle A--Department of Health and Human Services 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Welfare
        II  Office of Family Assistance (Assistance Programs), 
                Administration for Children and Families, 
                Department of Health and Human Services (Parts 
                200--299)
       III  Office of Child Support Enforcement (Child Support 
                Enforcement Program), Administration for Children 
                and Families, Department of Health and Human 
                Services (Parts 300--399)
        IV  Office of Refugee Resettlement, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 400--499)
         V  Foreign Claims Settlement Commission of the United 
                States, Department of Justice (Parts 500--599)
        VI  National Science Foundation (Parts 600--699)
       VII  Commission on Civil Rights (Parts 700--799)
      VIII  Office of Personnel Management (Parts 800--899)
        IX  Denali Commission (Parts 900--999)
         X  Office of Community Services, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 1000--1099)
        XI  National Foundation on the Arts and the Humanities 
                (Parts 1100--1199)
       XII  Corporation for National and Community Service (Parts 
                1200--1299)
      XIII  Administration for Children and Families, Department 
                of Health and Human Services (Parts 1300--1399)
       XVI  Legal Services Corporation (Parts 1600--1699)
      XVII  National Commission on Libraries and Information 
                Science (Parts 1700--1799)
     XVIII  Harry S. Truman Scholarship Foundation (Parts 1800--
                1899)
       XXI  Commission of Fine Arts (Parts 2100--2199)
     XXIII  Arctic Research Commission (Parts 2300--2399)
      XXIV  James Madison Memorial Fellowship Foundation (Parts 
                2400--2499)
       XXV  Corporation for National and Community Service (Parts 
                2500--2599)

                          Title 46--Shipping

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Maritime Administration, Department of Transportation 
                (Parts 200--399)
       III  Coast Guard (Great Lakes Pilotage), Department of 
                Homeland Security (Parts 400--499)
        IV  Federal Maritime Commission (Parts 500--599)

[[Page 706]]

                      Title 47--Telecommunication

         I  Federal Communications Commission (Parts 0--199)
        II  Office of Science and Technology Policy and National 
                Security Council (Parts 200--299)
       III  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                300--399)
        IV  National Telecommunications and Information 
                Administration, Department of Commerce, and 
                National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 400--499)
         V  The First Responder Network Authority (Parts 500--599)

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  Defense Acquisition Regulations System, Department of 
                Defense (Parts 200--299)
         3  Department of Health and Human Services (Parts 300--
                399)
         4  Department of Agriculture (Parts 400--499)
         5  General Services Administration (Parts 500--599)
         6  Department of State (Parts 600--699)
         7  Agency for International Development (Parts 700--799)
         8  Department of Veterans Affairs (Parts 800--899)
         9  Department of Energy (Parts 900--999)
        10  Department of the Treasury (Parts 1000--1099)
        12  Department of Transportation (Parts 1200--1299)
        13  Department of Commerce (Parts 1300--1399)
        14  Department of the Interior (Parts 1400--1499)
        15  Environmental Protection Agency (Parts 1500--1599)
        16  Office of Personnel Management Federal Employees 
                Health Benefits Acquisition Regulation (Parts 
                1600--1699)
        17  Office of Personnel Management (Parts 1700--1799)
        18  National Aeronautics and Space Administration (Parts 
                1800--1899)
        19  Broadcasting Board of Governors (Parts 1900--1999)
        20  Nuclear Regulatory Commission (Parts 2000--2099)
        21  Office of Personnel Management, Federal Employees 
                Group Life Insurance Federal Acquisition 
                Regulation (Parts 2100--2199)
        23  Social Security Administration (Parts 2300--2399)
        24  Department of Housing and Urban Development (Parts 
                2400--2499)
        25  National Science Foundation (Parts 2500--2599)
        28  Department of Justice (Parts 2800--2899)
        29  Department of Labor (Parts 2900--2999)
        30  Department of Homeland Security, Homeland Security 
                Acquisition Regulation (HSAR) (Parts 3000--3099)
        34  Department of Education Acquisition Regulation (Parts 
                3400--3499)

[[Page 707]]

        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199) [Reserved]
        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)
        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399) 
                [Reserved]
        54  Defense Logistics Agency, Department of Defense (Parts 
                5400--5499)
        57  African Development Foundation (Parts 5700--5799)
        61  Civilian Board of Contract Appeals, General Services 
                Administration (Parts 6100--6199)
        99  Cost Accounting Standards Board, Office of Federal 
                Procurement Policy, Office of Management and 
                Budget (Parts 9900--9999)

                       Title 49--Transportation

            Subtitle A--Office of the Secretary of Transportation 
                (Parts 1--99)
            Subtitle B--Other Regulations Relating to 
                Transportation
         I  Pipeline and Hazardous Materials Safety 
                Administration, Department of Transportation 
                (Parts 100--199)
        II  Federal Railroad Administration, Department of 
                Transportation (Parts 200--299)
       III  Federal Motor Carrier Safety Administration, 
                Department of Transportation (Parts 300--399)
        IV  Coast Guard, Department of Homeland Security (Parts 
                400--499)
         V  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 500--599)
        VI  Federal Transit Administration, Department of 
                Transportation (Parts 600--699)
       VII  National Railroad Passenger Corporation (AMTRAK) 
                (Parts 700--799)
      VIII  National Transportation Safety Board (Parts 800--999)
         X  Surface Transportation Board (Parts 1000--1399)
        XI  Research and Innovative Technology Administration, 
                Department of Transportation (Parts 1400--1499) 
                [Reserved]
       XII  Transportation Security Administration, Department of 
                Homeland Security (Parts 1500--1699)

                   Title 50--Wildlife and Fisheries

         I  United States Fish and Wildlife Service, Department of 
                the Interior (Parts 1--199)
        II  National Marine Fisheries Service, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 200--299)
       III  International Fishing and Related Activities (Parts 
                300--399)

[[Page 708]]

        IV  Joint Regulations (United States Fish and Wildlife 
                Service, Department of the Interior and National 
                Marine Fisheries Service, National Oceanic and 
                Atmospheric Administration, Department of 
                Commerce); Endangered Species Committee 
                Regulations (Parts 400--499)
         V  Marine Mammal Commission (Parts 500--599)
        VI  Fishery Conservation and Management, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 600--699)

[[Page 709]]





           Alphabetical List of Agencies Appearing in the CFR




                      (Revised as of July 1, 2021)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

Administrative Conference of the United States    1, III
Advisory Council on Historic Preservation         36, VIII
Advocacy and Outreach, Office of                  7, XXV
Afghanistan Reconstruction, Special Inspector     5, LXXXIII
     General for
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development              2, VII; 22, II
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, VIII, IX, X, XI; 9, 
                                                  II
Agricultural Research Service                     7, V
Agriculture, Department of                        2, IV; 5, LXXIII
  Advocacy and Outreach, Office of                7, XXV
  Agricultural Marketing Service                  7, I, VIII, IX, X, XI; 9, 
                                                  II
  Agricultural Research Service                   7, V
  Animal and Plant Health Inspection Service      7, III; 9, I
  Chief Financial Officer, Office of              7, XXX
  Commodity Credit Corporation                    7, XIV
  Economic Research Service                       7, XXXVII
  Energy Policy and New Uses, Office of           2, IX; 7, XXIX
  Environmental Quality, Office of                7, XXXI
  Farm Service Agency                             7, VII, XVIII
  Federal Acquisition Regulation                  48, 4
  Federal Crop Insurance Corporation              7, IV
  Food and Nutrition Service                      7, II
  Food Safety and Inspection Service              9, III
  Foreign Agricultural Service                    7, XV
  Forest Service                                  36, II
  Information Resources Management, Office of     7, XXVII
  Inspector General, Office of                    7, XXVI
  National Agricultural Library                   7, XLI
  National Agricultural Statistics Service        7, XXXVI
  National Institute of Food and Agriculture      7, XXXIV
  Natural Resources Conservation Service          7, VI
  Operations, Office of                           7, XXVIII
  Procurement and Property Management, Office of  7, XXXII
  Rural Business-Cooperative Service              7, XVIII, XLII
  Rural Development Administration                7, XLII
  Rural Housing Service                           7, XVIII, XXXV
  Rural Utilities Service                         7, XVII, XVIII, XLII
  Secretary of Agriculture, Office of             7, Subtitle A
  Transportation, Office of                       7, XXXIII
  World Agricultural Outlook Board                7, XXXVIII
Air Force, Department of                          32, VII
  Federal Acquisition Regulation Supplement       48, 53
Air Transportation Stabilization Board            14, VI
Alcohol and Tobacco Tax and Trade Bureau          27, I
Alcohol, Tobacco, Firearms, and Explosives,       27, II
     Bureau of
AMTRAK                                            49, VII
American Battle Monuments Commission              36, IV
American Indians, Office of the Special Trustee   25, VII
Animal and Plant Health Inspection Service        7, III; 9, I
Appalachian Regional Commission                   5, IX
Architectural and Transportation Barriers         36, XI
   Compliance Board
[[Page 710]]

Arctic Research Commission                        45, XXIII
Armed Forces Retirement Home                      5, XI; 38, II
Army, Department of                               32, V
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 51
Benefits Review Board                             20, VII
Bilingual Education and Minority Languages        34, V
     Affairs, Office of
Blind or Severely Disabled, Committee for         41, 51
     Purchase from People Who Are
  Federal Acquisition Regulation                  48, 19
Career, Technical, and Adult Education, Office    34, IV
     of
Census Bureau                                     15, I
Centers for Medicare & Medicaid Services          42, IV
Central Intelligence Agency                       32, XIX
Chemical Safety and Hazard Investigation Board    40, VI
Chief Financial Officer, Office of                7, XXX
Child Support Enforcement, Office of              45, III
Children and Families, Administration for         45, II, III, IV, X, XIII
Civil Rights, Commission on                       5, LXVIII; 45, VII
Civil Rights, Office for                          34, I
Coast Guard                                       33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage)                46, III
Commerce, Department of                           2, XIII; 44, IV; 50, VI
  Census Bureau                                   15, I
  Economic Affairs, Office of the Under-          15, XV
       Secretary for
  Economic Analysis, Bureau of                    15, VIII
  Economic Development Administration             13, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 13
  Foreign-Trade Zones Board                       15, IV
  Industry and Security, Bureau of                15, VII
  International Trade Administration              15, III; 19, III
  National Institute of Standards and Technology  15, II; 37, IV
  National Marine Fisheries Service               50, II, IV
  National Oceanic and Atmospheric                15, IX; 50, II, III, IV, 
       Administration                             VI
  National Technical Information Service          15, XI
  National Telecommunications and Information     15, XXIII; 47, III, IV
       Administration
  National Weather Service                        15, IX
  Patent and Trademark Office, United States      37, I
  Secretary of Commerce, Office of                15, Subtitle A
Commercial Space Transportation                   14, III
Commodity Credit Corporation                      7, XIV
Commodity Futures Trading Commission              5, XLI; 17, I
Community Planning and Development, Office of     24, V, VI
     Assistant Secretary for
Community Services, Office of                     45, X
Comptroller of the Currency                       12, I
Construction Industry Collective Bargaining       29, IX
     Commission
Consumer Financial Protection Bureau              5, LXXXIV; 12, X
Consumer Product Safety Commission                5, LXXI; 16, II
Copyright Royalty Board                           37, III
Corporation for National and Community Service    2, XXII; 45, XII, XXV
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Council of the Inspectors General on Integrity    5, XCVIII
     and Efficiency
Court Services and Offender Supervision Agency    5, LXX; 28, VIII
     for the District of Columbia
Customs and Border Protection                     19, I
Defense, Department of                            2, XI; 5, XXVI; 32, 
                                                  Subtitle A; 40, VII
  Advanced Research Projects Agency               32, I
  Air Force Department                            32, VII
  Army Department                                 32, V; 33, II; 36, III; 
                                                  48, 51
  Defense Acquisition Regulations System          48, 2
  Defense Intelligence Agency                     32, I

[[Page 711]]

  Defense Logistics Agency                        32, I, XII; 48, 54
  Engineers, Corps of                             33, II; 36, III
  National Imagery and Mapping Agency             32, I
  Navy, Department of                             32, VI; 48, 52
  Secretary of Defense, Office of                 2, XI; 32, I
Defense Contract Audit Agency                     32, I
Defense Intelligence Agency                       32, I
Defense Logistics Agency                          32, XII; 48, 54
Defense Nuclear Facilities Safety Board           10, XVII
Delaware River Basin Commission                   18, III
Denali Commission                                 45, IX
Disability, National Council on                   5, C; 34, XII
District of Columbia, Court Services and          5, LXX; 28, VIII
     Offender Supervision Agency for the
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Affairs, Office of the Under-Secretary   15, XV
     for
Economic Analysis, Bureau of                      15, VIII
Economic Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          2, XXXIV; 5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office of
  Career, Technical, and Adult Education, Office  34, IV
       of
  Civil Rights, Office for                        34, I
  Educational Research and Improvement, Office    34, VII
       of
  Elementary and Secondary Education, Office of   34, II
  Federal Acquisition Regulation                  48, 34
  Postsecondary Education, Office of              34, VI
  Secretary of Education, Office of               34, Subtitle A
  Special Education and Rehabilitative Services,  34, III
       Office of
Educational Research and Improvement, Office of   34, VII
Election Assistance Commission                    2, LVIII; 11, II
Elementary and Secondary Education, Office of     34, II
Emergency Oil and Gas Guaranteed Loan Board       13, V
Emergency Steel Guarantee Loan Board              13, IV
Employee Benefits Security Administration         29, XXV
Employees' Compensation Appeals Board             20, IV
Employees Loyalty Board                           5, V
Employment and Training Administration            20, V
Employment Policy, National Commission for        1, IV
Employment Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             2, IX; 5, XXIII; 10, II, 
                                                  III, X
  Federal Acquisition Regulation                  48, 9
  Federal Energy Regulatory Commission            5, XXIV; 18, I
  Property Management Regulations                 41, 109
Energy, Office of                                 7, XXIX
Engineers, Corps of                               33, II; 36, III
Engraving and Printing, Bureau of                 31, VI
Environmental Protection Agency                   2, XV; 5, LIV; 40, I, IV, 
                                                  VII
  Federal Acquisition Regulation                  48, 15
  Property Management Regulations                 41, 115
Environmental Quality, Office of                  7, XXXI
Equal Employment Opportunity Commission           5, LXII; 29, XIV
Equal Opportunity, Office of Assistant Secretary  24, I
     for
Executive Office of the President                 3, I
  Environmental Quality, Council on               40, V
  Management and Budget, Office of                2, Subtitle A; 5, III, 
                                                  LXXVII; 14, VI; 48, 99
  National Drug Control Policy, Office of         2, XXXVI; 21, III
  National Security Council                       32, XXI; 47, II
  Presidential Documents                          3
  Science and Technology Policy, Office of        32, XXIV; 47, II
  Trade Representative, Office of the United      15, XX
     States
[[Page 712]]

Export-Import Bank of the United States           2, XXXV; 5, LII; 12, IV
Family Assistance, Office of                      45, II
Farm Credit Administration                        5, XXXI; 12, VI
Farm Credit System Insurance Corporation          5, XXX; 12, XIV
Farm Service Agency                               7, VII, XVIII
Federal Acquisition Regulation                    48, 1
Federal Aviation Administration                   14, I
  Commercial Space Transportation                 14, III
Federal Claims Collection Standards               31, IX
Federal Communications Commission                 5, XXIX; 47, I
Federal Contract Compliance Programs, Office of   41, 60
Federal Crop Insurance Corporation                7, IV
Federal Deposit Insurance Corporation             5, XXII; 12, III
Federal Election Commission                       5, XXXVII; 11, I
Federal Emergency Management Agency               44, I
Federal Employees Group Life Insurance Federal    48, 21
     Acquisition Regulation
Federal Employees Health Benefits Acquisition     48, 16
     Regulation
Federal Energy Regulatory Commission              5, XXIV; 18, I
Federal Financial Institutions Examination        12, XI
     Council
Federal Financing Bank                            12, VIII
Federal Highway Administration                    23, I, II
Federal Home Loan Mortgage Corporation            1, IV
Federal Housing Enterprise Oversight Office       12, XVII
Federal Housing Finance Agency                    5, LXXX; 12, XII
Federal Labor Relations Authority                 5, XIV, XLIX; 22, XIV
Federal Law Enforcement Training Center           31, VII
Federal Management Regulation                     41, 102
Federal Maritime Commission                       46, IV
Federal Mediation and Conciliation Service        29, XII
Federal Mine Safety and Health Review Commission  5, LXXIV; 29, XXVII
Federal Motor Carrier Safety Administration       49, III
Federal Permitting Improvement Steering Council   40, IX
Federal Prison Industries, Inc.                   28, III
Federal Procurement Policy Office                 48, 99
Federal Property Management Regulations           41, 101
Federal Railroad Administration                   49, II
Federal Register, Administrative Committee of     1, I
Federal Register, Office of                       1, II
Federal Reserve System                            12, II
  Board of Governors                              5, LVIII
Federal Retirement Thrift Investment Board        5, VI, LXXVI
Federal Service Impasses Panel                    5, XIV
Federal Trade Commission                          5, XLVII; 16, I
Federal Transit Administration                    49, VI
Federal Travel Regulation System                  41, Subtitle F
Financial Crimes Enforcement Network              31, X
Financial Research Office                         12, XVI
Financial Stability Oversight Council             12, XIII
Fine Arts, Commission of                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
Food and Drug Administration                      21, I
Food and Nutrition Service                        7, II
Food Safety and Inspection Service                9, III
Foreign Agricultural Service                      7, XV
Foreign Assets Control, Office of                 31, V
Foreign Claims Settlement Commission of the       45, V
     United States
Foreign Service Grievance Board                   22, IX
Foreign Service Impasse Disputes Panel            22, XIV
Foreign Service Labor Relations Board             22, XIV
Foreign-Trade Zones Board                         15, IV
Forest Service                                    36, II
General Services Administration                   5, LVII; 41, 105
  Contract Appeals, Board of                      48, 61
  Federal Acquisition Regulation                  48, 5
  Federal Management Regulation                   41, 102

[[Page 713]]

  Federal Property Management Regulations         41, 101
  Federal Travel Regulation System                41, Subtitle F
  General                                         41, 300
  Payment From a Non-Federal Source for Travel    41, 304
       Expenses
  Payment of Expenses Connected With the Death    41, 303
       of Certain Employees
  Relocation Allowances                           41, 302
  Temporary Duty (TDY) Travel Allowances          41, 301
Geological Survey                                 30, IV
Government Accountability Office                  4, I
Government Ethics, Office of                      5, XVI
Government National Mortgage Association          24, III
Grain Inspection, Packers and Stockyards          7, VIII; 9, II
     Administration
Great Lakes St. Lawrence Seaway Development       33, IV
     Corporation
Gulf Coast Ecosystem Restoration Council          2, LIX; 40, VIII
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          2, III; 5, XLV; 45, 
                                                  Subtitle A
  Centers for Medicare & Medicaid Services        42, IV
  Child Support Enforcement, Office of            45, III
  Children and Families, Administration for       45, II, III, IV, X, XIII
  Community Services, Office of                   45, X
  Family Assistance, Office of                    45, II
  Federal Acquisition Regulation                  48, 3
  Food and Drug Administration                    21, I
  Indian Health Service                           25, V
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Homeland Security, Department of                  2, XXX; 5, XXXVI; 6, I; 8, 
                                                  I
  Coast Guard                                     33, I; 46, I; 49, IV
  Coast Guard (Great Lakes Pilotage)              46, III
  Customs and Border Protection                   19, I
  Federal Emergency Management Agency             44, I
  Human Resources Management and Labor Relations  5, XCVII
       Systems
  Immigration and Customs Enforcement Bureau      19, IV
  Transportation Security Administration          49, XII
HOPE for Homeowners Program, Board of Directors   24, XXIV
     of
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Housing and Urban Development, Department of      2, XXIV; 5, LXV; 24, 
                                                  Subtitle B
  Community Planning and Development, Office of   24, V, VI
       Assistant Secretary for
  Equal Opportunity, Office of Assistant          24, I
       Secretary for
  Federal Acquisition Regulation                  48, 24
  Federal Housing Enterprise Oversight, Office    12, XVII
       of
  Government National Mortgage Association        24, III
  Housing--Federal Housing Commissioner, Office   24, II, VIII, X, XX
       of Assistant Secretary for
  Housing, Office of, and Multifamily Housing     24, IV
       Assistance Restructuring, Office of
  Inspector General, Office of                    24, XII
  Public and Indian Housing, Office of Assistant  24, IX
       Secretary for
  Secretary, Office of                            24, Subtitle A, VII
Housing--Federal Housing Commissioner, Office of  24, II, VIII, X, XX
     Assistant Secretary for
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Immigration and Customs Enforcement Bureau        19, IV
Immigration Review, Executive Office for          8, V
Independent Counsel, Office of                    28, VII
Independent Counsel, Offices of                   28, VI
Indian Affairs, Bureau of                         25, I, V
Indian Affairs, Office of the Assistant           25, VI
   Secretary
[[Page 714]]

Indian Arts and Crafts Board                      25, II
Indian Health Service                             25, V
Industry and Security, Bureau of                  15, VII
Information Resources Management, Office of       7, XXVII
Information Security Oversight Office, National   32, XX
     Archives and Records Administration
Inspector General
  Agriculture Department                          7, XXVI
  Health and Human Services Department            42, V
  Housing and Urban Development Department        24, XII, XV
Institute of Peace, United States                 22, XVII
Inter-American Foundation                         5, LXIII; 22, X
Interior, Department of                           2, XIV
  American Indians, Office of the Special         25, VII
       Trustee
  Endangered Species Committee                    50, IV
  Federal Acquisition Regulation                  48, 14
  Federal Property Management Regulations System  41, 114
  Fish and Wildlife Service, United States        50, I, IV
  Geological Survey                               30, IV
  Indian Affairs, Bureau of                       25, I, V
  Indian Affairs, Office of the Assistant         25, VI
       Secretary
  Indian Arts and Crafts Board                    25, II
  Land Management, Bureau of                      43, II
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Natural Resource Revenue, Office of             30, XII
  Ocean Energy Management, Bureau of              30, V
  Reclamation, Bureau of                          43, I
  Safety and Environmental Enforcement, Bureau    30, II
       of
  Secretary of the Interior, Office of            2, XIV; 43, Subtitle A
  Surface Mining Reclamation and Enforcement,     30, VII
       Office of
Internal Revenue Service                          26, I
International Boundary and Water Commission,      22, XI
     United States and Mexico, United States 
     Section
International Development, United States Agency   22, II
     for
  Federal Acquisition Regulation                  48, 7
International Development Cooperation Agency,     22, XII
     United States
International Development Finance Corporation,    5, XXXIII; 22, VII
     U.S.
International Joint Commission, United States     22, IV
     and Canada
International Organizations Employees Loyalty     5, V
     Board
International Trade Administration                15, III; 19, III
International Trade Commission, United States     19, II
Interstate Commerce Commission                    5, XL
Investment Security, Office of                    31, VIII
James Madison Memorial Fellowship Foundation      45, XXIV
Japan-United States Friendship Commission         22, XVI
Joint Board for the Enrollment of Actuaries       20, VIII
Justice, Department of                            2, XXVIII; 5, XXVIII; 28, 
                                                  I, XI; 40, IV
  Alcohol, Tobacco, Firearms, and Explosives,     27, II
       Bureau of
  Drug Enforcement Administration                 21, II
  Federal Acquisition Regulation                  48, 28
  Federal Claims Collection Standards             31, IX
  Federal Prison Industries, Inc.                 28, III
  Foreign Claims Settlement Commission of the     45, V
       United States
  Immigration Review, Executive Office for        8, V
  Independent Counsel, Offices of                 28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor, Department of                              2, XXIX; 5, XLII
  Benefits Review Board                           20, VII
  Employee Benefits Security Administration       29, XXV
  Employees' Compensation Appeals Board           20, IV
  Employment and Training Administration          20, V
  Federal Acquisition Regulation                  48, 29

[[Page 715]]

  Federal Contract Compliance Programs, Office    41, 60
       of
  Federal Procurement Regulations System          41, 50
  Labor-Management Standards, Office of           29, II, IV
  Mine Safety and Health Administration           30, I
  Occupational Safety and Health Administration   29, XVII
  Public Contracts                                41, 50
  Secretary of Labor, Office of                   29, Subtitle A
  Veterans' Employment and Training Service,      41, 61; 20, IX
       Office of the Assistant Secretary for
  Wage and Hour Division                          29, V
  Workers' Compensation Programs, Office of       20, I, VI
Labor-Management Standards, Office of             29, II, IV
Land Management, Bureau of                        43, II
Legal Services Corporation                        45, XVI
Libraries and Information Science, National       45, XVII
     Commission on
Library of Congress                               36, VII
  Copyright Royalty Board                         37, III
  U.S. Copyright Office                           37, II
Management and Budget, Office of                  5, III, LXXVII; 14, VI; 
                                                  48, 99
Marine Mammal Commission                          50, V
Maritime Administration                           46, II
Merit Systems Protection Board                    5, II, LXIV
Micronesian Status Negotiations, Office for       32, XXVII
Military Compensation and Retirement              5, XCIX
     Modernization Commission
Millennium Challenge Corporation                  22, XIII
Mine Safety and Health Administration             30, I
Minority Business Development Agency              15, XIV
Miscellaneous Agencies                            1, IV
Monetary Offices                                  31, I
Morris K. Udall Scholarship and Excellence in     36, XVI
     National Environmental Policy Foundation
Museum and Library Services, Institute of         2, XXXI
National Aeronautics and Space Administration     2, XVIII; 5, LIX; 14, V
  Federal Acquisition Regulation                  48, 18
National Agricultural Library                     7, XLI
National Agricultural Statistics Service          7, XXXVI
National and Community Service, Corporation for   2, XXII; 45, XII, XXV
National Archives and Records Administration      2, XXVI; 5, LXVI; 36, XII
  Information Security Oversight Office           32, XX
National Capital Planning Commission              1, IV, VI
National Counterintelligence Center               32, XVIII
National Credit Union Administration              5, LXXXVI; 12, VII
National Crime Prevention and Privacy Compact     28, IX
     Council
National Drug Control Policy, Office of           2, XXXVI; 21, III
National Endowment for the Arts                   2, XXXII
National Endowment for the Humanities             2, XXXIII
National Foundation on the Arts and the           45, XI
     Humanities
National Geospatial-Intelligence Agency           32, I
National Highway Traffic Safety Administration    23, II, III; 47, VI; 49, V
National Imagery and Mapping Agency               32, I
National Indian Gaming Commission                 25, III
National Institute of Food and Agriculture        7, XXXIV
National Institute of Standards and Technology    15, II; 37, IV
National Intelligence, Office of Director of      5, IV; 32, XVII
National Labor Relations Board                    5, LXI; 29, I
National Marine Fisheries Service                 50, II, IV
National Mediation Board                          5, CI; 29, X
National Oceanic and Atmospheric Administration   15, IX; 50, II, III, IV, 
                                                  VI
National Park Service                             36, I
National Railroad Adjustment Board                29, III
National Railroad Passenger Corporation (AMTRAK)  49, VII
National Science Foundation                       2, XXV; 5, XLIII; 45, VI
  Federal Acquisition Regulation                  48, 25
National Security Council                         32, XXI; 47, II

[[Page 716]]

National Technical Information Service            15, XI
National Telecommunications and Information       15, XXIII; 47, III, IV, V
     Administration
National Transportation Safety Board              49, VIII
Natural Resource Revenue, Office of               30, XII
Natural Resources Conservation Service            7, VI
Navajo and Hopi Indian Relocation, Office of      25, IV
Navy, Department of                               32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Northeast Interstate Low-Level Radioactive Waste  10, XVIII
     Commission
Nuclear Regulatory Commission                     2, XX; 5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Ocean Energy Management, Bureau of                30, V
Oklahoma City National Memorial Trust             36, XV
Operations Office                                 7, XXVIII
Patent and Trademark Office, United States        37, I
Payment From a Non-Federal Source for Travel      41, 304
     Expenses
Payment of Expenses Connected With the Death of   41, 303
     Certain Employees
Peace Corps                                       2, XXXVII; 22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, IV, XXXV; 45, VIII
  Federal Acquisition Regulation                  48, 17
  Federal Employees Group Life Insurance Federal  48, 21
       Acquisition Regulation
  Federal Employees Health Benefits Acquisition   48, 16
       Regulation
  Human Resources Management and Labor Relations  5, XCVII
       Systems, Department of Homeland Security
Pipeline and Hazardous Materials Safety           49, I
     Administration
Postal Regulatory Commission                      5, XLVI; 39, III
Postal Service, United States                     5, LX; 39, I
Postsecondary Education, Office of                34, VI
President's Commission on White House             1, IV
     Fellowships
Presidential Documents                            3
Presidio Trust                                    36, X
Prisons, Bureau of                                28, V
Privacy and Civil Liberties Oversight Board       6, X
Procurement and Property Management, Office of    7, XXXII
Public and Indian Housing, Office of Assistant    24, IX
     Secretary for
Public Contracts, Department of Labor             41, 50
Public Health Service                             42, I
Railroad Retirement Board                         20, II
Reclamation, Bureau of                            43, I
Refugee Resettlement, Office of                   45, IV
Relocation Allowances                             41, 302
Research and Innovative Technology                49, XI
     Administration
Rural Business-Cooperative Service                7, XVIII, XLII
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII, XXXV
Rural Utilities Service                           7, XVII, XVIII, XLII
Safety and Environmental Enforcement, Bureau of   30, II
Science and Technology Policy, Office of, and     32, XXIV; 47, II
     National Security Council
Secret Service                                    31, IV
Securities and Exchange Commission                5, XXXIV; 17, II
Selective Service System                          32, XVI
Small Business Administration                     2, XXVII; 13, I
Smithsonian Institution                           36, V
Social Security Administration                    2, XXIII; 20, III; 48, 23
Soldiers' and Airmen's Home, United States        5, XI
Special Counsel, Office of                        5, VIII
Special Education and Rehabilitative Services,    34, III
   Office of
[[Page 717]]

State, Department of                              2, VI; 22, I; 28, XI
  Federal Acquisition Regulation                  48, 6
Surface Mining Reclamation and Enforcement,       30, VII
     Office of
Surface Transportation Board                      49, X
Susquehanna River Basin Commission                18, VIII
Tennessee Valley Authority                        5, LXIX; 18, XIII
Trade Representative, United States, Office of    15, XX
Transportation, Department of                     2, XII; 5, L
  Commercial Space Transportation                 14, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 12
  Federal Aviation Administration                 14, I
  Federal Highway Administration                  23, I, II
  Federal Motor Carrier Safety Administration     49, III
  Federal Railroad Administration                 49, II
  Federal Transit Administration                  49, VI
  Great Lakes St. Lawrence Seaway Development     33, IV
       Corporation
  Maritime Administration                         46, II
  National Highway Traffic Safety Administration  23, II, III; 47, IV; 49, V
  Pipeline and Hazardous Materials Safety         49, I
       Administration
  Secretary of Transportation, Office of          14, II; 49, Subtitle A
  Transportation Statistics Bureau                49, XI
Transportation, Office of                         7, XXXIII
Transportation Security Administration            49, XII
Transportation Statistics Bureau                  49, XI
Travel Allowances, Temporary Duty (TDY)           41, 301
Treasury, Department of the                       2, X; 5, XXI; 12, XV; 17, 
                                                  IV; 31, IX
  Alcohol and Tobacco Tax and Trade Bureau        27, I
  Community Development Financial Institutions    12, XVIII
       Fund
  Comptroller of the Currency                     12, I
  Customs and Border Protection                   19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Claims Collection Standards             31, IX
  Federal Law Enforcement Training Center         31, VII
  Financial Crimes Enforcement Network            31, X
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  Investment Security, Office of                  31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
Truman, Harry S. Scholarship Foundation           45, XVIII
United States Agency for Global Media             22, V
United States and Canada, International Joint     22, IV
     Commission
United States and Mexico, International Boundary  22, XI
     and Water Commission, United States Section
U.S. Copyright Office                             37, II
U.S. Office of Special Counsel                    5, CII
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs, Department of                   2, VIII; 38, I
  Federal Acquisition Regulation                  48, 8
Veterans' Employment and Training Service,        41, 61; 20, IX
     Office of the Assistant Secretary for
Vice President of the United States, Office of    32, XXVIII
Wage and Hour Division                            29, V
Water Resources Council                           18, VI
Workers' Compensation Programs, Office of         20, I, VII
World Agricultural Outlook Board                  7, XXXVIII

[[Page 719]]







                      Table of OMB Control Numbers



The OMB control numbers for part 1910 of title 29 were consolidated into 
Sec.  1910.8 at 61 FR 5508, Feb. 13, 1996. Section 1910.8 is reprinted 
below for the convenience of the user.



Sec.  1910.8  OMB control numbers under the Paperwork Reduction Act.

    The following sections or paragraphs each contain a collection of 
information requirement which has been approved by the Office of 
Management and Budget under the control number listed.

------------------------------------------------------------------------
                                                                  OMB
                       29 CFR citation                          control
                                                                  No.
------------------------------------------------------------------------
1910.7......................................................   1218-0147
1910.23.....................................................   1218-0199
1910.27.....................................................   1218-0199
1910.28.....................................................   1218-0199
1910.66.....................................................   1218-0121
1910.67(b)..................................................   1218-0230
1910.68.....................................................   1218-0226
1910.95.....................................................   1218-0048
1910.111....................................................   1218-0208
1910.119....................................................   1218-0200
1910.120....................................................   1218-0202
1910.132....................................................   1218-0205
1910.134....................................................   1218-0099
1910.137....................................................   1218-0190
1910.142....................................................   1218-0096
1910.145....................................................   1218-0132
1910.146....................................................   1218-0203
1910.147....................................................   1218-0150
1910.156....................................................   1218-0075
1910.157(e)(3)..............................................   1218-0210
1910.157(f)(16).............................................   1218-0218
1910.177(d)(3)(iv)..........................................   1218-0219
1910.179(j)(2)(iii) and (iv)................................   1218-0224
1910.179(m)(1) and (m)(2)...................................   1218-0224
1910.180(d)(6)..............................................   1218-0221
1910.180(g)(1) and (g)(2)(ii)...............................   1218-0221
1910.181(g)(1) and (g)(3)...................................   1218-0222
1910.184(e)(4), (f)(4) and (i)(8)(ii).......................   1218-0223
1910.217(e)(1)(i) and (ii)..................................   1218-0229
1910.217(g).................................................   1218-0070
1910.217(h).................................................   1218-0143
1910.218(a)(2)(i) and (ii)..................................   1218-0228
1910.252(a)(2)(xiii)(c).....................................   1218-0207
1910.255(e).................................................   1218-0207
1910.266....................................................   1218-0198
1910.268....................................................   1218-0225
1910.269....................................................   1218-0190
1910.272....................................................   1218-0206
1910.302....................................................   1218-0256
1910.303....................................................   1218-0256
1910.304....................................................   1218-0256
1910.305....................................................   1218-0256
1910.306....................................................   1218-0256
1910.307....................................................   1218-0256
1910.308....................................................   1218-0256
1910.420....................................................   1218-0069
1910.421....................................................   1218-0069
1910.423....................................................   1218-0069
1910.430....................................................   1218-0069
1910.440....................................................   1218-0069
1910.1001...................................................   1218-0133
1910.1003...................................................   1218-0085
1910.1004...................................................   1218-0084
1910.1006...................................................   1218-0086
1910.1007...................................................   1218-0083
1910.1008...................................................   1218-0087
1910.1009...................................................   1218-0089
1910.1010...................................................   1218-0082
1910.1011...................................................   1218-0090
1910.1012...................................................   1218-0080
1910.1013...................................................   1218-0079
1910.1014...................................................   1218-0088
1910.1015...................................................   1218-0044
1910.1016...................................................   1218-0081
1910.1017...................................................   1218-0010
1910.1018...................................................   1218-0104
1910.1020...................................................   1218-0065
1910.1024...................................................   1218-0267
1910.1025...................................................   1218-0092
1910.1026...................................................   1218-0252
1910.1027...................................................   1218-0185
1910.1028...................................................   1218-0129
1910.1029...................................................   1218-0128
1910.1030...................................................   1218-0180
1910.1043...................................................   1218-0061
1910.1044...................................................   1218-0101
1910.1045...................................................   1218-0126
1910.1047...................................................   1218-0108
1910.1048...................................................   1218-0145
1910.1050...................................................   1218-0184
1910.1051...................................................   1218-0170
1910.1052...................................................   1218-0179
1910.1053...................................................   1218-0266
1910.1096...................................................   1218-0103
1910.1200...................................................   1218-0072
1910.1450...................................................   1218-0131
------------------------------------------------------------------------


[61 FR 5508, Feb. 13, 1996, as amended at 62 FR 29668, June 2, 1997; 62 
FR 42666, Aug. 8, 1997; 62 FR 43581, Aug. 14, 1997; 62 FR 65203, Dec. 
11, 1997; 63 FR 13340, Mar. 19, 1998; 63 FR 17093, Apr. 8, 1998; 71 FR 
38086, July 5, 2006; 72 FR 40075, July 23, 2007; 81 FR 48710, July 26, 
2016; 82 FR 31253, July 6, 2017; 83 FR 9702, Mar. 7, 2018]

[[Page 721]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations (CFR) that 
were made by documents published in the Federal Register since January 
1, 2016 are enumerated in the following list. Entries indicate the 
nature of the changes effected. Page numbers refer to Federal Register 
pages. The user should consult the entries for chapters, parts and 
subparts as well as sections for revisions.
For changes to this volume of the CFR prior to this listing, consult the 
annual edition of the monthly List of CFR Sections Affected (LSA). The 
LSA is available at www.govinfo.gov. For changes to this volume of the 
CFR prior to 2001, see the ``List of CFR Sections Affected, 1949-1963, 
1964-1972, 1973-1985, and 1986-2000'' published in 11 separate volumes. 
The ``List of CFR Sections Affected 1986-2000'' is available at 
www.govinfo.gov.

                                  2016

29 CFR
                                                                   81 FR
                                                                    Page
Chapter XVII
1910.1000--1910.1499 (Subpart Z) Authority citation revised........16861
1910.1000 (e) Tables Z-1 and Z-3 amended...........................16861
    (e) Table Z-3 corrected........................................31167
    (e) Table Z-3 correctly amended................................60272
1910.1053 Added....................................................16862

                                  2017

29 CFR
                                                                   82 FR
                                                                    Page
Chapter XVII
1910.1000--1910.1499 (Subpart Z) Authority citation revised.........2735
    Regulation at 82 FR 2735 eff. date delayed to 3-21-17...........8901
    Regulation at 82 FR 2735 eff. date further delayed to 5-20-17 
                                                                   14439
1910.1000 (e) Table Z-1 and Table Z-2 amended.......................2735
    Regulation at 82 FR 2735 eff. date delayed to 3-21-17...........8901
    Regulation at 82 FR 2735 eff. date further delayed to 5-20-17 
                                                                   14439
1910.1024 Added.....................................................2736
    Regulation at 82 FR 2736 eff. date delayed to 3-21-17...........8901
    Regulation at 82 FR 2736 eff. date further delayed to 5-20-17 
                                                                   14439

                                  2018

29 CFR
                                                                   83 FR
                                                                    Page
Chapter XVII
1910.1000--1910.1499 (Subpart Z) Authority citation revised........39360
1910.1017 (n) reinstated; CFR correction...........................11413
1910.1024 (b) amended; (f)(2), (h)(3)(ii), (i)(3)(i)(B), 
        (i)(3)(ii)(B), (i)(4)(i), (ii), (j)(1)(i), (j)(2)(i), 
        (ii), and (j)(3) revised; eff. 7-6-18......................19948
    (o)(2) revised.................................................39360
1910.1043 (i)(1)(i)(A) through (F) removed; CFR correction.........30035

                                  2019

29 CFR
                                                                   84 FR
                                                                    Page
Chapter XVII
1910.1000--1910.1499 (Subpart Z) Authority citation revised........21458
1910.1001 (l)(2)(ii), (3)(ii), Table 1 heading, Appendix D, 
        Appendix E, and Appendix H revised; eff. 7-15-19...........21458
    (m)(1)(ii)(F) and (3)(ii)(A) amended; eff. 7-15-19.............21597
1910.1017 (m)(1) amended; eff. 7-15-19.............................21597
1910.1018 (n)(2)(ii)(A), (3)(i), (ii), Appendix A, and Appendix C 
        revised; eff. 7-15-19......................................21476

[[Page 722]]

    (q)(1)(ii)(D) and (2)(ii)(A) amended; eff. 7-15-19.............21597
1910.1025 (d)(5), (n)(1)(ii)(D), (2)(ii)(A), (3)(ii)(A), and 
        Appendix B amended; eff. 7-15-19...........................21597
1910.1026 (m)(1)(ii)(F) and (4)(ii)(A) amended; eff. 7-15-19.......21597
1910.1027 (l)(4)(ii)(C) and Appendix D revised; eff. 7-15-19.......21477
    (n)(1)(ii)(B) and (3)(ii)(A) amended; eff. 7-15-19.............21597
1910.1028 (k)(1)(ii)(D) and (2)(ii)(A) amended; eff. 7-15-19.......21597
1910.1029 (j)(2)(ii), (3), Appendix A, and Appendix B amended; 
        eff. 7-15-19...............................................21490
    (m)(1)(i)(a) and (2)(i)(a) amended; eff. 7-15-19...............21597
1910.1030 (h)(1)(ii)(A) amended; eff. 7-15-19......................21597
1910.1043 (h)(2)(iii), (3)(ii), (n)(1), Appendix B-I, Appendix B-
        II, Appendix B-III, and Appendix D revised; Appendix C 
        removed; eff. 7-15-19......................................21490
    (k)(1)(ii)(C) and (2)(ii)(A) amended; eff. 7-15-19.............21597
1910.1044 (p)(1)(ii)(d) and (2)(ii)(a) amended; eff. 7-15-19.......21597
1910.1045 (n)(2)(iii), (3)(i), and (ii) revised; eff. 7-15-19......21518
    (q)(2)(ii)(D) amended; eff. 7-15-19............................21597
1910.1047 (k)(2)(ii)(F) and (3)(ii)(A) amended; eff. 7-15-19.......21597
1910.1048 Appendix D revised; eff. 7-15-19.........................21518
    (o)(1)(vi), (3)(i), and (4)(ii)(D) amended; eff. 7-15-19.......21597
1910.1050 (n)(3)(ii)(D), (4)(ii)(A), (5)(ii)(A) amended; eff. 7-
        15-19......................................................21597
1910.1051 Appendix F revised; eff. 7-15-19.........................21527
    (m)(2)(ii)(F) and (4)(ii)(A) amended; eff. 7-15-19.............21597
1910.1052 Appendix B revised; eff. 7-15-19.........................21544
    (m)(2)(ii)(F), (iii)(C), and (3)(ii)(A) amended; eff. 7-15-19 
                                                                   21597
1910.1053 (k)(1)(ii)(G) and (3)(ii)(A) amended; eff. 7-15-19.......21597

                                  2020

29 CFR
                                                                   85 FR
                                                                    Page
Chapter XVII
1910.1024 (f)(1)(i)(D), (ii)(B), (h)(2)(i), (3)(iii), (i)(1) 
        introductory text, (2), (4)(ii), (j)(3), (k)(2)(i)(B), 
        (iii), (iv), (7)(i) introductory text, (ii) through (vi), 
        (l)(1)(i)(B), (ii), (m)(3), (4)(ii)(A), (E), 
        (n)(1)(ii)(F), (3)(ii)(A), (4)(i), and Appendix A revised; 
        section amended............................................42625
1910.1025 Correction: (e)(3)(ii)(G) revised.........................8732
1910.1027 Correction: (n)(6) removed................................8732

                                  2021

   (Regulations published from January 1, 2021, through July 1, 2021)

29 CFR
                                                                   86 FR
                                                                    Page
Subtitle A
1910.502--1910.509 (Subpart U) Added...............................32620


                                  [all]