Appendix — Industrial Union Dept., AFL-CIO v. American Petroleum Institute
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~ Supreme Court US
| FILE a
APPENDIX | MAY 18 1979
MICHAL RODAK, JR., CLERK
Iu the Supreme Court of the United States
OCTOBER TERM, 1979
Nos. 78-911 and 78-1036
INDUSTRIAL UNION DEPARTMENT, AFL-CIO,
Petitioner
=f)
AMERICAN PETROLEUM INSTITUTE, ET AL.
RAY MARSHALL, SECRETARY OF LABOR,
Petitioner
|
AMERICAN PETROLEUM INSTITUTE, ET AL.
ON WRIT OF CERTIORARI TO THE UNITED STATES COURT
OF APPEALS FOR THE FIFTH CIRCUIT
PETITIONS FOR A WRIT OF CERTIORARI FILED DECEMBER 7,
1978 (NO. 78-911) AND DECEMBER 26, 1978 (NO. 78-1036)
CERTIORARI GRANTED FEBRUARY 21, 1979
Oe
“Se aaa Ywisntmae?
Iu the Supreme Court of the United States
OCTOBER TERM, 1979
Nos. 78-911 and 78-1036
INDUSTRIAL UNION DEPARTMENT, AFL-CIO,
Petitioner
—V_ —
AMERICAN PETROLEUM INSTITUTE, ET AL.
RAY MARSHALL, SECRETARY OF LABOR,
Petitioner
—
AMERICAN PETROLEUM INSTITUTE, ET AL.
ON WRIT OF CERTIORARI TO THE UNITED STATES COURT
OF APPEALS FOR THE FIFTH CIRCUIT
TABLE OF CONTENTS OF APPENDIX
Proceedings in the Court of Appeals and the Supreme Court *
Page
ETF aa ae) eRe IRN Cm er OTL mE Ne 1
Petition for Review Filed By The American Petroleum Insti-
tute In the Court of Appeals, No. 78-1253 (selected as a
representative example of the petitions filed) 000000000000... 12
Carcinogen Assessment Group, Preliminary Report on Popu-
lation Risk to Ambient Benzene Exposures (appended to
agency brief in court of appeals, June 8, 1978, as Adden-
yh ASTER BPE ERT OS ao (Es Melick Vee ene EBS NPE Bea 15
* The opinion of the court of appeals appears in the separate
appendix to the petition in No. 78-911. Copies of the briefs on the
merits filed in the court of appeals have been lodged with the Clerk.
ii TABLE OF CONTENTS OF APPENDIX
Page
Affidavit of Dr. Steven H. Lamm (appended to API’s reply
brief in the court of appeals, June 19, 1978, as Appendix
RRS ee A LL RTD EP A AE RO TR LNG ee AIR rd ome 30
Judgment of Court of panne 1 EES SARIE YL 2 Ret TRE SED Ro SP OT 37
ry: aE rs ss sepeagustibionsedecnenennes 38
Proceedings Before the Agency *
Excerpted Testimony of Drs. Douglas Smith and Laigo of
NIOSH, July 25, 1977 (Tr. 859-860) ..0....0..... ec eeeeeeeeeeeee 40
Excerpted Testimony of Dr, Richard Zeckhauser, July 29,
1977 (Tr. 2104-2112, 2141-2144, 2149-2154, 2156-2160,
2167-2169, 2180-2182, 2188-2190) 2... eee 40
Testimony of Dr. Howard Maibach, August 3, 1977 (Tr.
SCSI T CR A we Bee earner do Sead en Sy Gee ee EON UO 58
Excerpted Testimony of Dr. Richard Wilson, August 4, 1977
(Tr. 2701-2711, 2721-2723, 2732-2742, 2753-2755, 2772-
EERE IE RN R Oe EN E SE ETCEIN CR ON ORE 97
G. L. Conca and A. Maltagliati, “Study of the Percutaneous
Benzene Absorption,” Med Lavoro 46:194-198, 1955 (list
of references omitted) (OSHA translation) (Exh. 2-46) **.. 95
A. N. Cesaro, “Is Percutaneous Benzene Absorption Possi-
ble?”, Med Lavoro 37:151-156, 1946 (list of references
omitted) (OSHA translation) (Exh. 2-47) 2000000000... 101
J. Hanke, T. Dutkiewixz, and J. Piotrowski, “Absorption of
Benzene Through the Sxin in Man,” Med Pracy 12:413-426,
1961 (list of references omitted) (OSHA translation)
cos 5 Aaa a neee ds UPd orien Ue OY a reat NL FEES A ON a 107
Comments of the Council on Wage and Price Stability on the
Proposed Benzene Standard (Exh. 41-28) 00000000000... 121
Written Statement of Dr. Richard Zeckhauser (Exh.
RR RRIND, TALLER RENE AS has SERVER | Du SVR UREN AP AA PST CI aE 134
* The benzene standard and the Secretary’s statement of reasons
for adopting the standard, 43 Fed. Reg. 5918 (1978), appear in the
separate appendix to the petition in No. 78-911 at 34a-25la. The
materials printed in this appendix do not constitute the entire
administrative record compiled during the proceedings on the ben-
zene standard, now on file in the Clerk’s office. To facilitate its use,
the parties have lodged a typewritten index to the administrative
record with the Clerk.
** Diagrams and graphs in this and other studies were omitted
in printing but are available in the administrative record on file
with the Clerk.
———
TABLE OF CONTENTS OF APPENDIX
Written Statement of Dr. Howard I. Maibach, July 11, 1977
(omieiite omitted) CHEER. BRO) oon... cnc cscicciccescccessesscesseceise
Written Statement of Dr. Richard Wilson (Exh. 149.B)
DG ALI Lee Tr CA cd, A LD
(The following materials are from
the administrative record for the
amendment to the benzene standard )
Excerpted Cross-examination of Grover Wrenn, snd 23,
ge _ sR RENER LO ELCRN SUC FD AAaee Oe
Excerpted Testimony of Dr. Roger W. Strassburg (The B. F.
Goodrich Company), May 23, 1978 (Amend. Tr. 126-137,
iar ES Rtg MEAL ANE Lg inks SS 8 EL ASR SO Re ar
Excerpted Testimony of Mr. Roy N. Johnson (The General
Tire & Rubber Company), May 23, 1978 (Amend. Tr.
RE Ett iea TOaY TAPE UL Ss Me CALPE A WOR WANTS Lice: Oke USE RA ;
Rubber Manufacturers Association (“RMA”) Motion for
Stay, March 10, 1978, with attached OSHA statement
(omiates) CAmsené. Bum. SE-F-8) .......-2-.-....02..............-.......
Affidavit of James R. Sankey (The Goodyear Tire & Rubber
Company), March 8, 1978 (Amend. Exh. 32-F-2) 00000000...
Affidavit of Roger W. Strassburg (The B.F. Goodrich Com-
pany), March 9, 1978 (Amend. Exh. 32-F-2)
Affidavit of Robert E. Rehm (The General Tire & Rubber
Company), March 9, 1978 (Amend. Exh. 32-F-2)
Affidavit of Roy N. Johnson (The General Tire & Rubber
Company), March 9, 1978 (Amend. Exh. 32-F-2) 0...
Supplementary Affidavit of James R. Sankey (The Goodyear
Tire & Rubber ere March 28, 1979 (Amend. Exh.
EARNER ea ince Ay A APP OO Ob Se ERO Jane aT
Affidavit of Robert W. Laundrie (The General Tire & Rubber
Company), March 29, 1978 (Amend. Exh. 32-F-3)
Secretary of Labor’s Supplemental Opposition To Petitioners
Request For Stay Pending Judicial Review, April 12,
1978, cover page and page 67 (Amend. Exh. 32-A-3) .
Affidavit of N.A. Daigle (The Firestone Tire & Rubber
Company), April 13, 1978 (Amend. Exh. 32-F-4)
Second Supplemental Affidavit of Roger W. Strassburg (The
B. F. Goodrich Company), April 13, 1978) (exhibits
omitted) (Amend. Exh. 32-F-4) 0...
Amendment to Benzene Standard and Accompanying State-
ment of Reasons, 43 Fed. Reg. 27962 (June 27, 1978) _...
180
187
197
202
205
209
216
222
224
227
230
232
234
1 .
RELEVANT DOCKET ENTRIES
[Title of court omitted in printing]
AMERICAN PETROLEUM INSTITUTE ET AL.
v. OSHA ET AL., NO. 78-1253
Feb. 2, 1978 Petition for review
March 18, 1978 Order granting motion of Manufacturing
Chemists Association, The American Iron And Steel
Institute, and Chemical Specialties Manufacturers for
leave to intervene. (LRM) (Also filed in 78-1257).
March 21, 1978 Order granting motion of the Industrial
Union Department, AFL-CIO to intervene (Also filed in
78-1257).
April 18, 1978 Order continuing temporary stay entered on
3/13/78 pending disposition of petitions for review. Fur-
ther granting motion of Independent Petroleum Associa-
tion of America for leave to intervene. Further peti-
tioners’ motion to consolidate is granted.[*] Further the
motion to dismiss petition of review filed by Am. Petro-
leum in No. 77-1973, API, et al v. OSHRC is carried with
the case. Further the motion to correct captions in 78-
1253 and 78-1257 is granted.
June 22, 1978 Case argued.
June 23, 1978 Respondents’ letter dtd 6/22/78 with copy of
amendments to the benzene standard issued June 27,
1978. (CE) (Also filed in consolidated cases).
June 30, 1978 Petitioners’ letter dtd 6/30/78 with “pro-
ducer” petitioners’ supplemental memorandum which
addresses amendment to benzene standard and copy of
Federal Register notice announcing amendment. (CE)
(Also filed in consolidated cases).
[*] This order consolidated cases nos. 78-1253, 1257, 1486,
1676, 1677, 1707, 1745, and any other cases seeking review
of the benzene standard later transferred to the Fifth Circuit.
2
July 7, 1978 Order granting motion of petitioners, the Rub-
ber Manufacturers Association, Inc., et al and the Arm-
strong Rubber Company, et al. to filed amended petitions
for review. (JPC-CC-GBT).
July 11,1978 Filing Secretary of Labor’s motion to adjourn
present supplemental briefing schedule and to set new
briefing schedule on the merits of the amendment to the
benzene standard.
July 12,1978 Filing Response of Rubber Companies and Du
Pont in opposition to motion to adjourn briefing schedule,
etc.
July 14,1978 Order denying the Secretary of Labor’s motion
to adjourn present supplemental briefing schedule. Court
does not desire briefs designed to enable it to reach the
merits of the new standards. (CC) (Also filed in con-
solidated cases).
August 4, 1978 Filing Motion of Manufacturing Chemists
Association petitioner in No. 78-1988, to file amended
petition for review. (Filed in consolidated cases).
August 4, 1978 Filing contingent motion of Manufacturing
Chemists Association to defer briefing dates on the
merits of the liquid mixture exemption amendment to
the benzene standard. (Also filed in consolidated cases).
August 7, 1978 Filing motion of the American Iron and
Steel Institute to file amended petition for review in No.
78-1745. (Also filed in consolidated cases).
August 7, 1978 Filing motion of the American Iron and
Steel Institute to defer briefing on the merits of the
liquid mixture exemption amendment to the benzene
standard (Also filed in consolidated cases).
August 11, 1978 Order granting motion of the Manufactur-
ing Chemists Association to file an amended petition
for review; further order granting the contingent mo-
tion of Manufacturing Chemists Association to defer
briefing on the merits of the liquid mixture exemption
amendment to the benzene standard (CC) (Also filed
in consolidated cases).
3
August 11, 1978 Order granting motion of the American
Iron and Steel Institute to file amended petition for
review in No. 78-1745; further order granting motion
of American Iron and Steel Institute to defer briefing
on the merits of the liquid mixture exemption amend-
ment to the benzene standard. (CC) (Also filed in
consolidated cases).
August 14, 1978 Motion of E. I. Du Pont de Nemours & Co.
to file amended petition for review. (Also filed in con-
solidated cases).
August 18, 1978 Order granting motion of E.I. DuPont de
Nemours and Company to file an amended petition for
review.
October 5, 1978 Opinion and Judgment.
THE AMERICAN PETROLEUM INSTITUTE AND THE
NATIONAL PETROLEUM REFINERS, ET AL. v.
OSHA ET AL., NO. 78-1257
[The relevant docket entries for No. 78-1257 are the same
as'for No. 78-1253 except that the petition for review
was filed a day later (February 3, 1978) and the docket
for No. 78-1257 omits the entries for April 18 and July
7, 1978, shown above for No. 78-1253.]
THE RUBBER MANUFACTUERS ASSOCIATION, INC.,
ET AL. v. EULA BINGHAM, ET AL., NO. 78-1486
March 6, 1978 Petition to review and set aside an order of
the Assistant Secretary of Labor for OSHA filed [in the
Sixth Circuit, No. 78-3114].
March 9, 1978 Order granting motion of petitioners to
transfer this cause to the United States Court of Appeals
for the Fifth Circuit.
[After transfer, the Fifth Circuit renumbered the case
No. 78-1486 and made the following entries :]
March 13,1978 Filing order of the Sixth Circuit transferring
their docket No. 78-3114 to the 5th Circuit.
4
April 11, 1978 Order granting motion of the Industrial
Union Department, AFL-CIO, to intervene. (LRM)
(Also filed in 78-1676, 78-1677, and 78-1707).
May 5, 1978 Filing respondents’ motion to reschedule argu-
ment. Denied JPC.
June 22, 1978 Case argued.
June 23, 1978 Filing respondents’ letter dtd 6/22/78 with
copy of amendments to the benzene standard issued June
27, 1978. (CE) (Also filed in consolidated cases).
June 27, 1978 Filing motion of petitioners in Nos. 78-1486
and 78-1677 to file amended petitions for review.
June 30, 1978 Filing petitioners’ letter dtd 6/30/78 with
“producer” petitioners’ supplemental memorandum which
addresses amendment to benzene standard and copy of
Federal Register Notice announcing amendment. (CE)
(Also filed in consolidated cases).
July 7, 1978 Order granting motion of petitioners, the
Rubber Manufactuers Association, Inc, et al, and the
Armstrong Rubber Company et al, to file amended peti-
tions for review. (JPC-CC-GBT) (Also filed in 78-1677).
July 11,1978 Filing Secretary of Labor’s motion to adjourn
present supplemental briefing schedule, and to set new
briefing schedule on the merits of the amendment to the
benzene standard.
July 14,1978 Order denying the Secretary of Labor’s motion
to adjourn present supplemental briefing schedule. Court
does not desire briefs designed to enable it to reach the
merits of the new standards. (CC).
July 24, 1978 Order granting motion of Chemical Speciali-
ties Manufacturers Association for leave to intervene
(CC).
August 4, 1978 Filing motion of Manufacturing Chemists
Association, petitoner in No. 78-1988, to file amended
petition for review. (Also filed in consolidated cases).
August 4, 1978 Filing contingent motion of Manufacturing
Chemists Association to defer briefing dates on the merits
of the liquid mixture exemption amendment to the ben-
zene standard. (Also filed in consolidated cases).
5
August 7, 1978 Filing motion of the American Iron and
Steel Institute to file amended petition for review in No.
78-1745. (Also filed in consolidated cases).
August 7, 1978 Filing motion of American Iron and Steel
Institute to defer briefing on the merits of the liquid
mixture exemption amendment to the benzene standard.
(Also filed in consolidated cases).
August 11, 1978 Order granting motion of the Manufactur-
ing Chemists Association to file an amended petition for
review; further order granting the contingent. motion of
Manufacturing Chemists Association to defer briefing on
the merits of the liquid mixture amendment to the ben-
zene standard. (CC) (Also filed in consolidated cases).
August 11, 1978 Order granting motion of the American
Iron and Steel institute to file amended petition for re
view in No. 78-1745; further order granting motion
of American Iron and Steel Institute to defer briefing
on the merits of the liquid mixture exemption amendment
to the benzene standard. (CC) (Also filed in consolidated
cases).
August 18, 1978 Order granting motion of E.I. duPont de
Nemours and Company to file an amended petition for
review. (Also filed in consolidated cases).
October 5, 1978 Opinion and Judgment.
E. Il. DU PONT DE NEMOURS & CO. v. OSHA ET AL.,
NO. 78-1676
March 10, 1978 Petition for review of an order of the Occu-
pational Safety and Health Administration, U.S. Depart-
ment of Labor, received March 10, 1978, filed [in the
Third Circuit, No. 78-1290]. (10 cc) Service attached.
March 31, 1978 Order (Aldisert and Adams, C.J.) granting
the motions by petitioner for expedited consideration of
“petitioner’s Motion for Transfer” and to transfer Peti-
tion for Review to the United States Court of Appeals
for the Fifth Circuit filed.
6
[After transfer, the Fifth Circuit renumbered the case
No. 78-1676 and made the following entries: ]
April 3, 1978 Filing Order of the Third Circuit transferring
their docket No. 78-1290 to the 5th Circuit.
April 11, 1978 Order granting motion of the Industrial
Union Department, AFL-CIO, to intervene. (LRM).
(Also filed 78-1486, 78-1677 & 78-1707).
May 5, 1978 Filing Respondents’ motion to reschedule argu-
ment. Denied JPC.
June 22,1978 Case argued.
June 23, 1978 Filing respondents’ letter dtd 6/22/78 with
copy of amendments to the benzene standard issued
June 27, 1978. (CE) (Also filed in consolidated cases).
June 30, 1978 Filing petitioner’s letter dtd 6/30/78 with
“producer” petitioners’ supplemental memorandum which
addresses amendment to benzene standard and copy of
Federal Register Notice announcing amendment. (CE)
(Also filed in consolidated cases).
July 11,1978 Filing Secretary of Labor’s motion to adjourn
present supplemental briefing schedule, and to set new
briefing schedule on the merits of the amendment to the
benzene standard.
July 14,1978 Order denying the Secretary of Labor’s motion
to adjourn present supplemental briefing schedule. Court
does not desire briefs designed to enable it to reach the
merits of the new standards. (CC) (Also filed in consoli-
dated cases).
August 4, 1978 Filing motion of Manufacturing Chemists
Association, petitioner in No. 78-1988, to file amended
petition for review. (Also filed in consolidated cases).
August 4, 1978 Filing contingent motion of Manufacturing
Chemists Association to defer briefing dates on the merits
of the liquid mixture exemption amendment to the ben-
zene standard. (Also filed in consolidated cases).
7
August 7, 1978 Filing motion of the American Iron and
Steel Institute to file amended petition for review in No.
78-1745. (also filed in consolidated cases).
August 7, 1978 Filing motion of American Iron and Steel
Institute to defer briefing schedule on the merits of the
liquid mixture exemption to the benzene standard. (Also
filed in consolidated cases).
August 11, 1978 Order granting motion of the Manufactur-
ing Chemists Association to file an amended petition for
review; further order granting the contingent motion
of Manufacturing Chemists Association to defer briefing
on the merits of the liquid mixture exemption amend-
ment to the benzene standard (CC) (Also filed in con-
solidated cases).
August 11, 1978 Order granting motion of the American
Iron and Steel Institute to file amended petition for re-
view in No. 78-1745; further order granting motion of
American Iron and Steel Institute to defer briefing on
the merits of the liquid mixture exemption amendment
to the benzene standard (CC) (Also filed in consolidated
cases).
August 18, 1978 Order granting motion of E.I. Du Pont de
Nemours & Co. to file an amended petition for review.
(Also filed in consolidated cases).
October 5, 1978 Opinion and Judgment.
THE ARMSTRONG RUBBER COMPANY AND
UNIROYAL, INC. v. EULA BINGHAM, ET AL., NO. 78-1677
March 6, 1978 Filed Petition for review [in Second Circuit
No. 78-4034].
March 27, 1978 Filed Order granting motion to transfer
to the United States Court of Appeals for the Fifth
Circuit.
[After transfer, the Fifth Circuit renumbered the case
No. 78-1677 and made the following entries: ]
8
April 3,1978 Filing Order of the Second Circnit transferring
their docket No. 78-4034 to the 5th Circuit.
[The remainder of the relevant docket entries made by
the Fifth Circuit in No. 78-1677 are identical to those
beginning April 11, 1978, by the Fifth Circuit in No.
78-1676. ]
INDEPENDENT PETROLEUM ASSOCIATION OF
AMERICA v. OCCUPATIONAL SAFETY AND HEALTH
ADMINISTRATION, U.S. DEPARTMENT OF LABOR,
ET AL., NO. 78-1707
1978 Petition for review filed.
[The remainder of the relevant entries for No. 78-1707
are identical to those shown for No. 78-1676 beginning
with the entry for April 11, 1978, with the exception
that the docket in No. 78-1707 omits the entry for July
11, 1978.]
AMERICAN IRON AND STEEL INSTITUTE, ET AL. v.
OCCUPATIONAL SAFETY AND HEALTH ADMINISTRA-
TION, U.S. DEPARTMENT OF LABOR, ET AL., NO.
78-1745
April 3, 1978 Petition for Review of an order of the Occupa-
tional Safety and Health Administration United States
Department of Labor, received April 3, 1978, filed [in the
Third Circuit as No. 78-1388]. (6 cc) Service attached.
April 7, 1978 Order (Aldisert and Adams, C.J.) granting
petitioners’ motion for transfer of Petition for Review to
the United States Court of Appeals for the Fifth Circuit,
filed.
[After transfer, the Fifth Circuit renumbered the case
No. 78-1745 and made the following entries:]
April 10,1978 Filing Order of the Third Circuit transferring
their docket no. 78-1388 to the 5th Circuit.
{The remainder of the relevant entries for No. 78-1745
are identical to those shown for No. 78-1676, beginning
with the eutry for May 5, 1978, with the exception that
the docket in No. 78-1745 omits the entry for July 11,
1978. ]
9
MANUFACTURING CHEMISTS ASSOCIATION
v. OCCUPATIONAL SAFETY AND HEALTH
ADMINISTRATION, ET AL., NO. 78-1988
March 30, 1978 Petitioner’s petition for review of an order
of the Occupational Safety and Health Administration
(m-30) [filed in the United States Court of Appeals for
the District of Columbia Circuit, No. 1287].
May 5, 1978 Per curiam order granting petitioner’s motion
to transfer this case to the Fifth Circuit; Bazelon and
Leventhal, CJ’s.
[After transfer, the Fifth Circuit renumbered the case
No. 78-1988 and made the following entries :]
May 8, 1978 Filing order of the District of Columbia Circuit
transferring their docket No. 78-1287 to the Fifth Circuit.
June 22,1978 Case argued.
June 30, 1978 Filing petitioners’ letter dtd 6/30/78 with
“producers” petitioners’ supplemental memorandum
which addresses amendment to benzene standard and
copy of Federal Register Notice announcing amendment.
(CE) (Also filed in consolidated cases.)
July 14,1978 Order denying the Secretary of Labor’s motion
to adjourn present supplemental briefing schedule. Court
does not desire briefs designed to enable it to reach the
merits of the new standards. (CC) (Also filed in con-
solidated cases).
[The remainder of the entries for No. 78-1988 are identi-
cal to those beginning with August 4, 1978, for No. 78-
1676, except that the docket for No. 78-1988 omits the
entry for August 11, 1978, granting motion of AISI to
file amended petition and to defer briefing on amend-
ment. ]
10
INDEPENDENT PETROLEUM ASSOCIATION
OF AMERICA v. OCCUPATIONAL SAFETY AND
HEALTH ADMINISTRATION ET AL., NO. 78-1989
April 4, 1978 Petitioners’ petition for review of an order of
the OSHA (m-4) [filed in the United States Court of
Appeals for the District of Columbia Circuit, No. 1308].
May 3, 1978 Per Curiam Order granting Petitioners’ motion
for transfer and this case is transferred to the Fifth
Circuit: Bazelon and Leventhal, CJ’s.
[After transfer, the Fifth Circuit renumbered the case
No. 78-1989, and made the following entries:]
May 8, 1978 Filing Order of the District of Columbia Cir-
cuit transferring their docket no. 78-1308 to the 5th
Circuit.
June 22,1978 Case argued.
July 14,1978 Order denying the Secretary of Labor’s motion
to adjourn present supplemental briefing schedule. Court
does not desire briefs designed to enable it to reach the
merits of the new standards. (CC) (Also filed in con-
solidated cases).
August 18, 1978 Order granting motion of E.I. Du Pont de
Nemours & Co. to file an amended petition for review.
(Also filed in consolidated cases)
October 5,1978 Opinion and Judgment.
November 1, 1978 Order consolidating this appeal with 78-
1253, et al (CC).
INDUSTRIAL UNION DEPARTMENT, AFL-CIO v.
DR. EULA BINGHAM, ET AL., NO. 78-2642
July 11, 1978 Petitioner’s petition for review of order of
the Dept. of Labor (p-10) [filed in the United States
Court of Appeals for the District of Columbia Circuit,
No. 1644].
July 26, 1978 Per curiam order granting petitioner’s motion
to transfer and this case is to be transferred to the
USCA for the 5th Circuit as promptly as the business
of office permits; CJ Wright and McGowan, CJ.
POSTER GS see
11
[After transfer, the Fifth Circuit renumbered the case
No. 78-2642 and made the following entries :]
August 1, 1978 Filing order of the District of Columbia
Circuit transferring their docket no. 78-1644 to the
5th Circuit.
August 18, 1978 Order granting motion of E. I. Du Pont de
Nemours & Co. to file an amended petition for review.
(Also filed in consolidated cases).
October 5,1978 Opinion and judgment.
November 1, 1978 Order consolidating this appeal with 78-
1253 et al (CC).
THE AMERICAN PETROLEUM INSTITUTE AND THE
NATIONAL PETROLEUM REFINERS ASSOCIATION, ET
AL. v. OCCUPATIONAL SAFETY AND HEALTH
ADMINISTRATION UNITED STATES DEPARTMENT OF
LABOR, ET AL, NO. 78-2779
August 18,1978 Petition for review filed.
October 5,1978 Opinion and judgment.
THE ADHESIVE AND SEALANT COUNCIL, INC.
v. EULA BINGHAM, ET AL, NO. 78-3023
[This case was filed in the Fourth Circuit on August 18,
1978, and transferred to the Fifth Circuit on September
11, 1978. The record does not include the Fourth Circuit’s
docket entries but does disclose the filing and transfer
dates. After transfer, the Fifth Circuit renumbered the
case No. 78-3023, and made the following docket entries :]
Sept. 18, 1978 Filing Order of the Fourth Circuit transfer-
ring their docket no. 78-1544 to the Fifth Circuit.
October 5,1978 Opinion and Judgment.
November 1, 1978 Order consolidating this appeal with 78-
1253 et al. (CC).
12
UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT
No. 78-1253
THE AMERICAN PETROLEUM INSTITUTE, ET AL.,
PETITIONERS
Vv.
OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION,
RESPONDENTS
PETITION FOR REVIEW
Pursuant to Section 6(f) of the Occupational Safety
and Health Act of 1970, 29 U.S.C. § 655(f), The Ameri-
ean Petroleum ‘Institute, the National Petroleum Re-
finers Association on behalf of their respective members,
and American: Petrofina, Incorporated, Cities Service
Company, Continental Oil Company, Delta Oil Company,
Exxon Corporation, Gulf Oil Company, Husky Oil Com-
pany, Marathon Oil Company, Mobil Oil Corporation,
Phillips Petroleum Company, Shell Oil Company, South
Hampton Oil Company, Standard Oil Company (Indi-
ana), The Standard Oil Company (Ohio), Sun Oil Com-
pany of Pennsylvania, Sun Oil Company of Delaware,
Texaco Inc., Union Oil Company of California, U.S.A.
Petrochem Corporation, and Williams Pipe Line Com-
pany, hereby challenge the validity of, and petition this
Court for review of, the Permanent Standard for Oc-
cupational Exposure to Benzene released by the Occupa-
tional Safety and Health Administration, Department of
Labor, on February 2, 1978.
The Permanent Standard for Occupational Exposure
to Benzene challenged by this Petition supplants and
replaces the Emergency Temporary Standard for Occu-
pational Exposure to Benzene (42 Fed. Reg. 22516) pre-
viously challenged by the same petitioners in American
Petroleum Institute, et al. v. OSHA, et al., No. 77-1973,
presently pending before this Court.
13
By this Petition, the above captioned petitioners also
challenge OSHA’s procedural regulations dealing with the
official time for issuance of agency actions (29 C.F.R.
§ 1911.18(d), 42 Fed. Reg. 65166) on the ground that
such regulations may be invalid and inconsistent with
the D.C. Circuit’s opinion in Industrial Union Dept.
AFL-CIO, et al. v. Bingham, et al., Nos. 77-1395, 77-
1516 which retransferred API, et al. v. OSHA, et al.
(No. 77-1973) to this Court.
Respectfully submitted,
Gene W. Lafitte
J. Berry St. John, Jr.
John M. Wilson
of
Liskow & LEWIS
50th Floor—One Shell Square
New Orleans, Louisiana 70139
(504) 581-7979
Edward W. Warren
Robert F. Vanvoorhees
Arthur F. Sampson
of
KIRKLAND, ELLIS & ROWE
1776 K Street, N.W.
Washington, D.C. 20006
(202) 857-5000
Counsel for Petitioners
February 2, 1978.
14
[The following document was appended to
the agency brief in the court of appeals]
CARCINOGEN ASSESSMENT GROUP’S
PRELIMINARY REPORT ON
POPULATION RISK TO AMBIENT
BENZENE EXPOSURES
This document is being released by
EPA for external review
Roy E. ALBERT, M. D.
Chairman
wo ow ais esi
aed
~~ = """PARTICIPATING MEMBERS
Elizabeth L. Anderson, Ph. D.
I. Nathan Dubin, M. D.
Richard N. Hill, M.D., Ph. D.
Robert E. McGaughy, Ph. D.
Lakshmi C. Mishra, Ph. D.
Ruth Pertel, Ph. D.
Wade T. Richardson, J. D.
Todd W. Thorslund, Se. D.
STAFF ASSISTANT
Claudia Slacik
sia aol LS re ote
15
[Table of Contents Omitted in Printing]
PRELIMINARY ESTIMATE OF POPULATION RISK
TO AMBIENT BENZENE EXPOSURES
I Summary
There is substantial epidemiological evidence that ben-
zene is a human leukemogen. However, no validated ani-
mal model has yet been developed for benzene as a car-
cinogen. There are several large series of case reports
indicating a high risk of leukemia in individuals who
developed aplastic anemia consequent to benzene expo-
sure. In addition there are a number of epidemiological
studies in the rubber and shoe industries that demon-
strate an excess risk of leukemia. From the standpoint
of making quantitative estimates of the leukemia risk
- “associated with current general population exposures to
benzene in the United States there are only two epi-
demiological studies that provide some estimates of both
exposure to benzene and data on the occurence of leu-
kemia. These studies are by Infante (3) and by Ott,
et al. (5).
The Infante study, which showed an excess incidence
ia, is not yet completely analyzed. Hence, some
(ptions have had to be made about the average dura-
and magnitude of exposures. For this reason, this
w#eport should be considered as preliminary. The Ott
f study indicated no excess leukemia risk with relatively
- well-documented exposures.
The results of the Infante study were used as the basis
for an extrapolation of the leukemia risk to the low levels
of general population exposure, which averages one part
per billion (4). A linear non-threshhold model was used
for the extrapolation; such a model is expected to give
an upper limit to the estimated risk. Using this extra-
polation model, and using the leukemia rates observed
in the cohort of workers exposed to benzene over a period
of about 30 years (in the Infante study), we estimated
that the number of cases of acute myelogenous and my-
onocytic [2] leukemia per year in the general population
\
16
due to ambient atmospheric benzene is somewhere be-
tween 30 and 80 cases. The lifetime risk to an individual
continually exposed to benzene at a level of 1 ppb is
estimated to be between 10° and 2.5 x 10°, depending on
which exposure assumptions are made in the Infante
study. The risk from individual sources of benzene emis-
sions ranges from about 10° to 5 x 10°. The Ott study,
which reported no excess leukemia risk, is consistent with
the Infante study on statistical grounds given their rela-
tive exposures. However, the negative results of the Ott
study suggest that the level of calculated risk in the
general population is not likely to be higher than 10°
to 2.5 x 10°, but it could be lower.
[3] II Introduction
The Carcinogen Assessment Group (CAG) has been
asked by the Office of Air Quality Planning and Stand-
ards (OAQPS) to estimate the carcinogenic risk to the
United States population of ambient benzene concentra-
tions. This type of information is useful in judging the
overall contribution of benzene emissions to the national
rates of cancer mortality, and will be used by OAQPS
in the decision whether to regulate benzene.
As the primary basis for this estimation the CAG is
using the Infante (Infante, et al. 1977) mortality study
of workers exposed to benzene in the production of a
natural rubber cast film product. The reasons for this
choice are: (1) the worker exposures are said to have
_been almost exclusively restricted to benzene, since it is
used throughout the plant as the principal solvent in all
major processes; (2) the individuals in the cohort all
worked before 1950 and were followed until 1975, thus
allowing long latency diseases to be observed and (3)
acute myelogenous leukemia was observed, which is the
same cell type of leukemia observed in other studies
where workers have had known benzene exposures. The
disadvantages of relying on this study for determining
general population risks are (1) the authors essentially
give no estimate of worker exposures except to say that
the levels were less than the prevailing recommended oc-
17
cupational limits at the time various monitoring surveys
were made; (2) the cohort studied actually worked at
two separate plants (Akron and St. Mary’s, Ohio). Air
monitoring information in the former plant is almost
non-existent (Baier, 1977), and therefore the exposure
to half of the members of the cohort is almost completely
unknown. However, it is known (Young, 1977) that the
crude rates (leukemia cases/total people in the cohort)
are similar in the two [4] lecations; (3) Warren et al.
(1977) have claimed that over 400 workers known to be
exposed to low benzene levels were deliberately excluded
from the cohort.
In spite of these difficulties the Infante study is the
only one currently available which reports an excess rate
of leukemia among benzene-exposed populations. Another
occupational study (Ott, et al. 1977) of workers exposed
to benzene has documented the exposures relatively well
and reports no excess leukemia risk. The risk estimates
based on Infante’s study are used to calculate the num-
ber of cases expected in the cohort examined by Ott, et
al. If this is not significantly different than the observed
number of cases, the estimates are not grossly in error.
A more complete evaluation of the Infante study will be
possible after the authors have made a final evaluation
of their data. ,
III. Description of Infante Study
In a retrospective study of mortality among a cohort
of 748 white male workers in two Ohio plants manufac-
turing a natural rubber cast film product, Infante, et al.
(1977) observed a statistically significant higher rate of
leukemia than both of two control groups. The leukemia
mortality rate was 5.06 times higher than the general
U. S. white male population standardized for age and
time period of the cohort exposure, and 4.74 times higher
than a cohort of 1447 white males employed at an Ohio
fibrous-glass construction products factory. These results
were based on a 75% follow-up of the vital status of the
workers. A total of 160 deaths were observed and of
these there were 7 leukemia deaths four of which were
18
acute lyelogenous, one chronic myelogenous, and two
monocytic leukemia. The worker exposure information
is discussed in IV B below.
[5] IV. Analysis of Myelogenous and Monocytic Leu-
kemia Risks due to Benzene Exposures
A. General Approach
As was noted in the benzene health document (Gold-
stein, et al. 1977), very little information exists that
can be utilized to obtain a dose response relationship be-
tween benzene and leukemia in humans or animals.
However, if a number of simplifing assumptions are
made, it is possible to construct a crude dose response
model whose parameters can be estimated using vital
statistics, the Infante study, historical benzene workplace
standards, and a recent environmental benzene exposure
study. (Mara and Lee, 1977)
We assume that for low exposures the lifetime prob-
ability of death from leukemia may be represented by
the linear equation
P=a+ px
where a is the rate in the absence of benzene exposure
and x is the average lifetime exposure to atmospheric
benzene expressed in ppm. The term § is the change in
the leukemia rate for each increase of one ppm of ben-
zene in the air.
From the Infante, et al. study the relative risk of
leukemia for benzene workers compared to the general
population was obtained. We will denote this ratio as R
and niake the assumption that
R= R,=a+ B(x, +x,)
R, a+ BX,
where x, is the exposure of the general population to
benzene and x, is the industrial exposure to benzene.
19
[6] From our two assumptions we have the two linear
equations in two unknowns of the form
RR,=a~+ Bx, + BX,
R,=a~+ Bx,
so that
B=R, (R-1) /x,
and 8 x, is the average lifetime risk due to ambient
benzene exposures.
To utilize this technique to predict risk it is necessary
to obtain estimates of R,, R, X,, and X.. The estimation
of each of these quantities is discussed in a separate
section.
B. Estimation of Relative Risk R
Infante, et al. (1977) established as a lower bound a
total of seven acute myelogenous or monocytic cases of
leukemia in their studied cohort of 748 members. They
calculated an expected value of 1.3831 cases for all forms
of leukemia. From the 1971 U.S. Vital Statistics (U. S.
DHEW, 1971) we note that of 7,564 cases of leukemia
in white males, a total of 3,260 or 43% were myelogen-
ous or monocytic. Thus an estimate of the relative risk
for acute myelogenous and monocytic leukemia in white
males is
7
R= 1.3831 x0.43=11.77
[7] C. ESTIMATION OF BACKGROUND LEUKEMIA
RATE R,
The lifetime risk to a disease can be estimated from
age-specific deaths rates in the following manner. We
assume that during different segments of a lifespan the
total and disease specific death rates are constant. we
define the following terms:
aj=death rate due to a specific disease during the jt life-
time segment.
aj+ \j=total death rate during jt* lifetime segment.
S; length of j* lifetime segment.
=>
20
P,,=- ., = = probability of death due to the specific diseaes
4 aj*AJ given that death occurred during the jt life-
time segment.
P,,=1-e-(aj +Aj)S,= probability of death during the j®
lifetime segment given survival up
to the start of the jt lifetime seg-
ment.
Posed 1-P,,.) = probability of survival until the start of
k= the j' lifetime segment.
If we assume that the entire lifetime is divided into
m mutually exclusive segments then by definition P;,—1,
P.m==1 and the entire lifetime probability of the disease is
m
P=> P,; P.; Ps;
j=1
[8] The age specific rates for white males for myelo-
genous and monocytic leukemia were estimated from the
total leukemia rates by multiplying the entries in Table
I-13, disease categories 204-207, white male (U. S.
DHEW, 1971) by 0.43. This gives the entries j} shown
in Table 1. The total mortality aj + Aj is also obtained
from table I-13 and is shown in Table 1. The other terms
are calculated by the given definitions and the final result,
the lifetime risk of white males exposed to background
levels of benzene is found to be
R, =0.38987 x 102
TABLE 1
[9]
COMPUTATION OF LIFETIME RISK OF MYELOGENOUS-MONOCYTIC LEUKEMIA
.0000072_
.0000659
.0001348
.0000920
.0000983
.0001287
.0002287
.0005061
.00095 10
.0011108
0005752
Xs
.0038987
aj aj + Aj
Sj
Age
Intervals
rE
.9816
2
9785
9745
—
9621
9473
.9184
.8556
.7268
.5078
- -+- #+¢§ = + +
.3940x10-*
1,852.8
73
1.68
1.38
.2111x10"
79.6
1-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
74-85
85+
4042x10-
3407x100"
40.5
127.6
155.4
309.6
10
10
10
10
10
10
10
10
.7445x10
95
1.03
1.38
2.58
6.41
15.57
31.43
43.65
.6628x10-
.3049x10-
4457x107
.3640x10-2
708.7
1,632.0
3,586.1
.15058
30135
53919
3928x107
4342x107
4057x107
7,747.6
17,758.1
.2340
.2458x10
R, =0.0038987
22
[10] D. ESTIMATE OF AVERAGE AMBIENT BEN-
ZENE EXPOSURE
In a recent EPA contractor report (Mara and Lee,
1977), data relating to benzene exposure in the United
States was compiled. For each of several annual average
concentration ranges, the population exposed to seven
categories of benzene emissions was calculated. The seven
categories were: (1) chemical manufacturing, (2) coke
ovens, (3) gasoline service stations (separately for peo-
ple using self-service stations and for people living in the
vicinity of the stations), (4) petroleum refineries, (5)
solvent operations, (6) storage and distribution of ben-
zene and (7) urban exposures related to automobile tail-
pipe and gasoline tank emissions. The general procedure
used was to start with production data for benzene or its
major products, estimate emission factors (benzene re-
lease per kg of end product), apply an appropriate air
dispersion model to obtain concentrations as a function of
distance from the source, and to use population density
information for each location to calculate the number of
people exposed to each concentration range. Air monitor-
ing data were used whenever it was available. The re-
sults are summarized in Table 2. From this data one
can calculate that the annual average exposure of an indi-
vidual to ambient benzene from all sources is 1.03 ppb.
TABLE 2.
[11]
SUMMARY OF POPULATIONS EXPOSED (THOUSANDS) TO ATMOSPHERIC BENZENE EMISSIONS ¢
Gasoline Stations
Urban
Solvent
Operations Exposures
Petroleum
Vicinity Refineries
Coke Self
Mfg. Ovens Service
Chem.
Total
Population
(ppb)
Concen-
trations
0.042
0.50
37,000
7,497 15,726 87,000 6,529 208 68,337
45,353
37,000
185,297
23
31,000
301,684
0.5404 0.042 0.7627 0.5112 0.5465 0.8989
2.0885
0.7514
Population
Weighted
Averages
(ppb)
Average exposure to the population of 220 million is 0.7514 x 301,684=1.030 ppb
220,000
* Adapted from Mara and Lee (1977).
24
[12] E. ESTIMATION OF AVERAGE OCCUPATION-
AL EXPOSURE
Information about the plant benzene levels is contained
in the Appendix to the testimony of Baier at the OSHA
benzene hearings (Baier, 1977).
From the opening of the factory in 1940 until 1946,
no monitoring records were available. Following the in-
stallation of new ventilation equipment in 1946, a survey
showed that “most areas” in the plant ranged from 0 to
15 ppm and that all areas were less than the maximum
safe limit of 100 ppm which prevailed at that time. From
this information, one can guess that the average expo-
sure to all people in the plant before 1946 is probably
not much more than 100 ppm, and not less than 15 ppm.
Benzene levels were monitored after 1946 at various
plant locations but they were all instantaneous samples
and no reliable information is available about how many
man-hours were spent at those locations or whether pro-
tective masks were worn. These are case reports of ex-
posures of 1000 ppm for short time intervals. Since the
average levels were generally close to the occupational
standard, we will make the assumption that the average
worker exposure was the same as the prevailing recom-
mended occupational limits. These are tabulated below
along with the time weighted average for the 36 years
of the total exposure period.
Time Average Time-Weighted
Interval Exposure( ppm) Average(ppm)
1940-46 (7) 100-15
1947 (1) 50 39.9-23.3
1948-56 (9) 35
1957-68 (12) 25
1969-1975 (7) 10
[13] The actual levels to which the workers were ex-
posed was a subject of heated debate at the OSHA ben-
zene hearings. The CAG would like to see a realistic es-
timate of the population weighted average exposure and
its uncertainty limits. The time-weighted averages for
occupational exposure must be converted to a continuous
exposure life-time basis. It will be assumed that the
25
maximum likely lifetime exposure would result if a work-
er entered the factory in 1940 and was exposed to 82 ppm
for 10 years and 23.7 ppm for 25 years (which is equiva-
lent to an average of 40.36 ppm for 35 years) and the
least likely exposure would occur if a worker started in
1950 and was exposed to 23.7 ppm for 25 years. There-
fore the equivalent continuous lifetime exposures are:
High estimate: 40.36 x 240 x 1x 35=4.4 ppm
865 3 70
Low estimate: 23.7 x 240 x 1x 25=1.8 ppm
865 3 70
[14] F. CONCLUSIONS
Given the following derived estimates of our para-
meters of interest:
R =11.77
R, = 0.38987 x 10~
X, =1.030 x 10-** ppm
X,=1.8 to 4.4 ppm
the parameter @ and the resulting lifetime risks and ex-
pected number of acute myelogenous and monocytic leu-
kemia deaths can be derived in_the manner previously
indicated. In table 3 the average risk rates and expected
number of cases per lifetime and per year are shown for
total benzene exposure. In Table 4 the total rates and
cases are subdivided by source of exposure. We note that
about 85% of the total number of cases are directly re-
lated to the use of gasoline.
It should be emphasized that due to the very crude
methods that were necessarily employed in the estima-
tion of benzene exposures by both CAG for Infante’s
cohort and Mara and Lee (1977) for the U.S. population,
the estimates could easily be in error by several orders
of magnitude. This is true even if the form of the mathe-
matical response model used is a correct rescription of
benzene induced leukemia, which is also open to question.
However, an additional independent negative study of
workers exposed to benzene (Ott, et al. 1977, Dow Chemi-
26
cal Company) can be used to ascertain whether our
model, based on Infante’s data, grossly over-estimates
the leukemia risk to benzene exposure. They reported
the mortality [15] experience of a cohort of workers
whose exposure to benzene had been carefully documented
since 1940. No excess of leukemia was observed in the
cohort by 1973. Since the prediction model was previous-
ly discussed based upon workers with highly uncertain
exposures, it was felt to be important to estimate the
number of leukemia cases we might expect in Dow’s
cohort if our model was valid.
Using Dow’s exposure estimates and expected number
of cases for its workers, it was found that our model
predicted from 1.43 to 1.74 cases of leukemia where one
case was actually observed. Since this estimate is well
within the limits of normal statistical variability we can
be confident in claiming that the Dow study does not of-
fer any evidence upon which to question the validity of
our model.
of
Expected Number
Cases/Year
Lifetime
Exp. Leukemia
Cases in U.S.
2.177 ..
5,436
TABLE 8
TOTAL U.S. POPULATION RISKS TO BENZENE
Average Risk
BX,
.9897x10-"
.2471x10~
.4149x107/X,
.9609x107
.2399x10"
B
4.4 ppm
1.8 ppm
(X,)
Industrial
Exposure
* This represents about 1.2% of cases observed in 1971.
[16]
High
Low
1.8
499
211
37
81
2,456
**5 449
X,
85
15
865
32
1.2
982
Lifetime Expected
200
of Leukemia Cases
X,=4.4
**2,180
X,=1.8
5.00x10°°
1.30x10-°
1.01x10*
1.83x10-°
1.23x10-°
1.35x10°
2.16x10-°
Risk Rates
TABLE 4.
X,=4A4
2.x10°
5.19x10*
4.04x10°
7.33x10-°
4.91x10°°
5.41x10-°
8.64x10°
9.98
16.30
37.00
22
118.00
6.60
Population
Exposed
220.00*
113.69
* Does not sum due to multiple exposure.
Average
Level of
Exposure ppb. Millions
2.0885
5404
.042
.7627
5112
5465
8989
1.030
EXPOSURE FOR DIFFERENT SOURCES ~-
Source
of
Exposure
** This represents about 1% of the number of cases expected in a lifetime assuming current incidence
rates.
RISK AND LIFETIME EXPECTED NUMBER OF LEUKEMIA CASES DUE TO BENZENE
Self-Ser. Gas
Vicinity of
Gas Stations
Petroleum
Refineries
Solvent
Operations
Urban
Exposures
Coke Ovens
Stations
Chem. Mfg.
Total
[17]
29
[18] REFERENCES
1. Baier, E. J. “Statement of the National Institutes of
Occupational Safety and Health’, Exhibit 64A,
OSHA Benzene Hearings, July 19-Aug. 10, 1977.
2. Goldstein, B. D., C. A. Snyder, R. Snyder, R. and
S. R. Wolman, “Review of Benzene Toxicity,” pre-
pared for EPA, August 18, 1977.
3. Infante, P. F., J. K. Wagoner, R. A. Rinsky, R. J.
Young, ‘Leukemia in Benzene Workers,” Lancet, p.
76-78, July 9, 1977.
4. Mara, S. J. and Lee, S.S., “Human Exposures to At-
mospheric Benzene” EPA contract 68-01-4314 with
Stanford Research Institute, September, 1977.
5. Ott, M. G., J.C. Townsend, W. A. Fishbeck, R. A.
Langner, “Mortality Among Individuals Occupation-
ally Exposed to Benzene” Exhibit 154,,OSHA Ben-
zene Hearings, July 19-August 10, 1977.
6. U.S. Department of Health, Education and Welfare.
“Vital Statistics of the United States, 1971, Volume
II-Mortality, Part A’, Superintendent of Documents,
U.S. Government Printing Office, Stock No. 017-022-
00378-3.
Warren, E. W., R. F. Van Voorhee, A. F. Sampson,
“Post Hearing Brief of API, NPPA, and Individual
Member Companies Regarding the Proposed Revised
Permanent Standards for Occupational Exposure to
Benzene”, OSHA Docket No. H-059 September 22,
1977.
Young, R. J. National Institute of Occupational Safe-
ty and Health, Personal Communication, October,
1977.
39
[The following document was attached to the reply brief
of the American Petroleum Institute in the Court of
Appeals]
AFFIDAVIT OF DR. STEVEN H. LAMM
I, Dr. Steven H. Lamm, being duly sworn, do state
and depose as follows:
1. I was graduated from the University of Southern
California in 1968 with the degree of Doctor of Medi-
cine. From 1968 to 1969, I held a rotating internship
at the University of-Oregon. From 1969 to 1970, I held
a residency in pediatrics at the Montreal Children’s Hos-
pital. From 1970 to 1972, I was employed by the United
States Public Health Service as an epidemiologist at-
tached to the Connecticut State Department of Health.
From 1972 to 1973, I was Senior Pediatrie Resident at
the Bronx Memorial Hospital, Albert Einstein School of
Medicine. From 1973 to 1974, I attended the London
School of Hygiene and Tropical Medicine, in London,
England. From 1974 to 1976, I was Senior Epidemiolo-
gist at the National Institute of Child Health and Human
Development of the National Institutes of Health. From
1976 to 1977, I was in private practice as a pediatrician
and as a consultant in epidemiology. From 1977 to the
present time, I have been an associate with Tabershaw
Occupational Medicine Associates.
2. I appeared as a witness for the Manufacturing
Chemists Association during the hearing held last sum-
mer by the Occupational Safety and Health Administra-
tion (OSHA) on the proposed standard for occupational
exposure to benzene. In the course of preparing my
testimony and attending the hearing, I became thoroughly
familiar with the evidence associating occupational ex-
posure to benzene with leukemia, particularly the study
conducted by Infante, et al.’
3. In December of 1977, I prepared and presented
to the Environmental Protection Agency’s Science Ad-
1 Infante, Rinsky, Wagoner & Young, Lewkemia Among Workers
Exposed to Benzene (April 28, 1977) (OSHA Exhibit 40).
SELLA RPM te phe ED
2 ne a ee
°
31
visory Board a review and critique of the preliminary
report by EPA’s Carcinogen Assessment Group (CAG)
entitled “Population Risk to Ambient Benzene Expos-
ures.” * I have the following comments on the CAG re-
port as it compares to the risk estimate developed by
Dr. Richard Wilson, presented to OSHA during the 1977
benzene hearing.* I have reviewed and am thoroughly
familiar with both documents.
4. In its brief filed in the above-captioned case on
June 8, 1978, OSHA cites the CAG’s preliminary find-
ings of 30-80 cases of leukemia from exposure to ambient
levels of benzene as discrediting Dr. Wilson’s analysis,
which concluded that OSHA’s 1 ppm standard will pre-
vent, at most, 2 cases of cancer every six years.‘ OSHA’s
use of the CAG estimates, which are based on the lifetime
continuous exposure of a population of 220 million people,
is specious and seriously misleading as applied in the
occupational context. I have performed a series of cal-
culations (See Exhibit A) which show that the CAG’s
risk estimate, when translated to the occupational con-
text, is fully consistent with—indeed, somewhat lower
than—Dr. Wilson’s estimate.
5. The CAG and Wilson estimates are based on risk
estimates of two different populations with two different
sets of exposure assumptions. The CAG estimate of 30-
80 cases is an estimate of the number of cases of acute
non-lymphocytie leukemia deaths that might occur an-
nually if the USA total population of 220 million people
were exposed continually throughout their lifetime, 24
hours a day, 365 day a year, to a benzene concentration
of one part per billion in air.
6. The Wilson estimate of one leukemia case and one
additional cancer case in 6 years is based on the assump-
tion that for a year 30,000 workers exposed to benzene
at a level between 1-10 ppm are exposed 8 hours, 240
working days a year at an average level of 3 parts ner
2The CAG Preliminary Report is attached as Addendum C to
OSHA’s brief filed on June 8, 1978 in the above-captioned case.
3’ Testimony of Dr. Richard Wilson, Ex. 149.B.
* OSHA Brief 87 n.80.
32
million benzene in the air. The figure of 30,000 is ob-
tained from page 1-7 of the Economic Impact Study of
the proposed standard prepared by OSHA by Arthur D.
Little, Inc.
7. In order to compare these estimates, they must be
related to the same exposure level and time and to the
same population. CAG indicates that their case numbers
are based on an estimation that the lifetime (70 year)
risk of leukemia due to lifetime (70 years), continuous
(24 hours/day, 365 days/year) exposure to 1 ppb ben-
zene in air is from 1 x 10° to 2.5 x 10°. Wilson’s case
numbers derive from the assumption that 1.8 x 10° is
the yearly risk of a worker dying from leukemia from
having been exposed for one work year of 8 hours/day,
240 days/year to a level of 1 part per million benzene.
Attached Exhibit A reviews the algebra necessary to com-
pare the two estimates.
8. Assuming an average lifetime of years, Equation 2
divides the CAG risk by 70 and identifies the lifetime
risk for 1 year, continuous exposure to 1 ppb of benzene
as [from 0.14 to 0.36] x 10, or [from 140 to 360] x
10°. In Equation 3, I again divide by 70 to produce
the annual risk of 1 year, continuous exposure to 1 ppb
of benzene, which is [from 2.0 to 5.1] x 10°.
9. Workers do not work 24 hours a day, which is the
exposure period assumed in the CAG model, but generally
work only one-third of a day (8 hours). Therefore, Equa-
tion 4 divides the CAG risk by 3, to produce a risk of
[from 0.7 to 1.7] x 10°, as the annual risk for 1 year
of eight-hour daily exposure to 1 ppb of benzene.
10. In addition, the CAG estimate assumes exposure
every day of the year, but workers do not work every
day. Therefore, weekends, holidays and _ vacations,
amounting to about one-third of the full year, must be
excluded. Equation 5 accomplishes this, and shows an
annual risk for 1 work-year of eight-hour workday ex-
posure to 1 ppb [from 0.45 to 1.1] x 10°.
11. Finally, the CAG assumes exposure to 1 part per
billion of benzene. To obtain the risk of exposure to 1
5 CAG Preliminary Report, Table 3.
33
part per million of benzene, the risk must be multiplied
by a factor of 1000, and Equation 6 reveals that, based
on the CAG’s risk estimate, the annual risk of 1 work
year of eight-hour workday exposures to 1 part per mil-
lion of benzene is [from 0.45 to 1.1] x 10”.
_12. Thus it is shown that CAG’s estimate of lifetime
risk of acute non-lymphocytic leukemia (ANLL) death
of [1.0 to 2.5] x 10° for lifetime continuous environ-
mental exposure to 1 ppb benzene is equivalent to a
[0.45-1.1] x 10° annual risk of ANLL death for 1 year
of occupational exposure (8 hours/day, 240 days/year)
to 1 ppm benzene.
13. Dr. Wilson has based his case count on an annual
risk of death from all types of leukemia (not just ANLL)
of 1.8 x 10° for one work year of occupational exposure
to 1 ppm benzene. Since only 43% of leukemia deaths are
due to acute nonlymphocytic leukemia, the Wilson risk
can be translated into a 0.77 x 10° risk of acute non-
lymphocytic leukemia death from one work year of oc-
cupational exposure to 1 ppm benzene.
14. Thus, Wilson and CAG have reached the same
estimate of the annual risk of acute non-lymphocytic
leukemia death due to one work year of occupational
exposure to 1 ppm benzene, to wit,
CAG estimate = [from 0.45 to 1.1] x 10°
Wilson estimate — 0.77 x 10°
15. Based on the data provided in the Arthur D. Little
Study, Dr. Wilson assumed that the 30,000 workers
exposed to between 1 and 10 ppm are exposed to an
average of 3 ppm benzene. It therefore follows, using the
CAG estimate, that a reduction in these workers’ ex-
posure to benzene from 3 ppm to 1 ppm might reduce
“sg ANLL mortality annually for each year of exposure
y
(0.45 to 1.1 x 10°) x (1 work year) x (3 ppm-l
ppm) x (30,000 people) = ([0.45 to 1.1] x 10°)
x 1 x 2 x 30,000 = (.027-.066) cases ANLL/year.
= one case every 15-3714 years
Use of the Wilson estimate of .77 x 10° would predict
046 excess cases ANLL each year or 1 case every 21
years.
34
16. Wilson’s estimate of one leukemia case and one
other cancer case in 6 years was based on three addi-
tional conservative assumptions.
a. All leukemias (not just ANLL) are benzene re-
lated.
b. For every benzene leukemia there would be an-
other cancer at another site in the body due to
benzene exposure.
ce. Benzene exposure of those currently exposed to
1 to 10 ppm benzene would be far less than 1
ppm if a new standard were introduced.
There is no reason to believe the need for any of these
pessimistic assumptions, but these assumptions account
for the different numbers derived from the Wilson risk
estimate.
17. It is concluded, based on the CAG estimate and
its underlying assumptions, that reduction of occupa-
tional benzene exposure from 10 ppm to 1 ppm for each
year of work might reduce the annual mortality for acute
non-lymphocytic leukemia by 1 case every 15-38 years.
18. The CAG estimated range was based on the
premise that the Infante cohort was exposed to a mean
occupational exposure of 24-40 ppm benzene. This was
based on the assumption that the exposure was at the
maximum permissible exposure level in effect from time
of hire in the forties to the end of study period 1975.
This assumption leads to an under-estimation of the levels
of exposure because: 1) industrial hygiene data show
that nearly half the surveys indicated levels greater than
the TLV at that time; and 2) the inclusion of exposure
estimates through 1975 is inappropriate since all the
leukemia deaths occurred prior to 1962 and the period
of exposure necessary to inclusion in the study ended
in 1949; and 3) the estimate ignores exposures prior to
1941 when no maximum exposure standard existed and
during which many employees worked. Evidence in the
hearing indicated that levels of exposure exceeded 100
ppm in the forties.’ If the CAG estimates was recal-
® See Brief of API, AISI, MCA and IPAA, the printed version
of which was filed in the above-captioned case on June 13, 1978,
at pp. 15-18, 26-37.
35
culated under the assumption that the exposure was at
100 ppm (rather than 24 or 40 ppm), the risk estimate
would be further reduced by 60% to a risk estimate of
about 0.20 x 10°, which would predict that OSHA’s 1
ppm standard would avoid .012 cases ANLL per year,
or about one case in 83 years.
19, The purpose of this exercise has been to indicate
the similarity between the risk estimates produced by
CAG and by Dr. Wilson. My purpose has not been to
prepare a new, independent estimate of the effect of
OSHA’s standard. As indicated by CAG’s acknowledge-
ment that its risk estimate may be off by several orders
of magnitude, risk estimates are necessarily imprecise
because of the large number of variables (such as eXpos-
ure levels, non-occupational exposures, etc.) for which
accurate information is not available. Nonetheless, it is
encouraging that the two different attempts to conserva-
tively address these issues compared here have reached
results so similar.
STEVEN H. LAMM
36
EXHIBIT
(1) [1.0 to 2.5] x 10-5
(2) [10 to 25] x 10
70
(3) [140 to 360] x 10°
70
(4) [2.0 to5.1] x 10-°
3
(5) 240 x [0.7 to 1.7] x 10°
365
(6) [0.45 to 1.1] x 10-® x 108
A
[10 to 25] x 10-°
CAG estimate of lifetime risk
of lifetime, continuous ex-
posure to 1 ppb of benzene
[0.14 to 0.36] x 10-°
140 to 360 x 10-°
lifetime risk for 1 year, con-
tinuous (24 hour) exposure
to 1 ppb
[2.0 to 5.1] x 10-°
annual risk for 1 year, con-
tinuous (24 hour) exposure
to 1 ppb
[0.7 to 1.7] x 10-*
annual risk for 1 year, 8 hour
daily exposure to 1 ppb
[0.45 to 1.1] x 10-°
annual risk for 1 work year
of 8 hour, workday exposure
to 1 ppb
[0.45 to 1.1] x 10-6
annual risk for 1 work year
of 8 hour workday exposure
to 1 part per million
37
UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT
Nos. 78-1253, 78-1257, 78-1486, 78-1676, 78-1677,
78-1707, 78-1745, 78-1988, 78-1989, 78-2642, 78-2779, ©
and 78-3023
OSHA No. 77-1395
Before Coleman, Clark and Tjoflat, Circuit Judges.
JUDGMENT
These causes came on to be heard on the petitions of
the American Petroleum Institute, et al., and were ar-
gued by counsel;
ON CONSIDERATION WHEREOF, It is now here
ordered and adjudged by this Court that the petitions
for review of an order of the American Petroleum
Institute, et al., in this cause be, and the same are
hereby granted; the provisions of the order reducing
the airborne permissable exposure limit and the dermal
contact prohibition are set aside and the remaining pro-
visions of the standard in this cause be and the same are
hereby vacated.
It is further ordered that respondents pay to peti-
tioners the costs on appeal to be taxed by the Clerk of
this Court.
October 5, 1978
Issued As Mandate:
38
SUPREME COURT OF THE UNITED STATES
No. 78-911
INDUSTRIAL UNION DEPARTMENT, AFL-CIO, PETITIONER
Vv.
AMERICAN PETROLEUM INSTITUTE, ET AL.
ORDER ALLOWING Cermionady) Filed February 21, 1979
The petition herein for a writ of certiorari to the
United States Court of Appeals for the Fifth Circuit is
granted. The case is consolidated with No. 78-1036 and
a total of one hour is allotted for oral argument.
39
SUPREME COURT OF THE UNITED STATES
No. 78-1036
RAY MARSHALL, SECRETARY OF LABOR, PETITIONER
| v.
AMERICAN PETROLEUM INSTITUTE, ET AL.
ORDER ALLOWING CERTIORARI. Filed February 21, 1979
The petition herein for a writ of certiorari to the
United States Court of Appeals for the Fifth Circuit
is granted. The case is consolidated with No. 78-911 and
a total of one hour is allotted for oral argument.
40
[The following testimony is from the reporter’s
transcript of the rulemaking hearing on the
proposed benzene standard]
* * * *
[859] MR. JACOBSON: Thank you. One other ques-
tion here and that is the employes that were cited here
had considerable dermal exposure as well as exposure in
the working atmosphere as far as inhalation. Does any-
one on the panel have any feeling as to whether this
dermal exposure is a contributing factor or [860] is the
addressing of the dermal problems with benzene in this
proposed standard for problems other than leukemia.
DR. DOUGLAS SMITH: I can start it off and then
if someone wants to continue it a little bit, they can.
Yes, the problem of dermal absorption is, I think, real.
Benzene in relation to other aromatic materials, by com-
paring it let’s say to toluene and xylene. Apparently it
is not absorbed through the skin at the same rate as
toluene and xylene but it nonetheless can be absorbed.
Even if you take and have a situation in which you
have got an inflamed skin or some abnormal situation,
or if you have got it contained in a mixture, I| believe
that a considerable amount can be absorbed. I believe
that this has been demonstrated in the past with meas-
urements of urinary phenol from dermal absorption of
benzene.
We don’t consider that it is absorbed as a clear com-
pound extensively. It can be. -
MR. BAIER: Maybe Blair or ;Bob would want to dis-
cuss it from a medical standpoint» .
DR. LAIGO: Well, it can be absorbed through the
skin, it is readily absorbed through -the skin. To what
extent it would be absorbed in any. particular exposure,
you don’t really know. You can’t mesure that. It cer-
tainly is a significant thing and if pele are getting it
on their skin, it certainly could be signi¥icant.
* * * «A
[2104] MR. WARREN: Dr. Zachauses?
DR. ZACHAUSER: I am Richard |
fessor of Political Economy at Harvard |
achauser, Pro-
niversity. My
41
fellow witnesses have testified on the adequacy and in
adequacy of the Arthur D. Little report. I will not focus
on that for two reasons: [2105] First, I think that the
Arthur D. Little Company, assuming that it was at all
responsive to its assigned task, was given the wrong
task. Second, I don’t think that the findings of the Ar-
thur D. Little study, whatever they might reasonably
have been, would likely have influenced the final deci-
sions that OSHA would make. This suggests that we
are in an unfortunate position where analysis is not
employed to affect decision making, but might be thought
of more as a charade.
Let me discuss the way an economist looks at this
problem, indeed, at any problem. The science of econom-
ics is basically devoted to a very simple problem. How
should we allocate resources to competing objectives. With
this problem there are two objectives: One is to have
economic resources available to accomplish other purposes.
The second one is to promote human health.
The economic resources that are involved here are
quite substantial accepting on face value the Arthur D.
Little report. We are talking about $267 million worth
of capital costs, $124 million worth of first year operat-
ing costs, $76 million of continuing operating costs. At
any reasonable rate of discount, this is a $1 billion deci-
sion. It would be reasonable to ask, under the circum-
stances, what are we accomplishing? What are we buy-
ing for our $1 billion expenditure or rather, what are
the people who are being forced to spend their money
buying for their $1 billion expenditure.
[2106] We have a little bit of information in the Ar-
thur D. Little report. For example, we know that there
are 30,000 who are at risk levels above one part per
million. We do not know, however, what happens to
these 30 thousand workers. We know they are to be
moved below a standard, but we don’t know whether we
are getting rid of 20 cases of leukemia, 10 cases of leu-
kemia, one case of leukemia, the expected vaiue of .001
cases of leukemia. I think that information is obviously
vital to our decision making process.
The objection might be raised that we do not want to
put a price tag on human lives. OSHA has continually
42
maintained that there is no legitimate procedure for put-
ting a price tag on human lives and I wouldn’t disagree
with that. I would say that we want full information
so that people in authority in the decision making process
will be able to see what trade off they are making.
Basically to adopt the notion that we don’t have to
quantify the health benefits. Not just saying that there
are health benefits, however small. There was testimony
earlier that they might be non existent. To say what the
actual health benefits are, I think, is essential and to
argue the contrary is to say that ignorance is better than
knowledge. I think that is not a very sensible thing to
do.
Is there anything that we can do where we don’t want
to put a price tag on human lives? I think the answer is
[2107] yes we can try to follow what economists refer
to as a cost-effectiveness approach. Basically, for what-
ever resource dollars we are going to spend for promot-
ing health, we try to achieve the maximum level of bene-
fits. In order to do this, you have to know what benefits
are going to come out of that type of expenditure.
All the time we are incurring risks because we think
we get other benefits. We let people drive cars even
though we know that if we put the speed limit down 20
miles pe. «r., we would have fewer accidents. At zero
miles per ‘cur, we would have no accidents. We allow
people to ec ich desserts, live in wooden houses instead
of brick houses which would be safer and I would say
in all of these areas the level of risk, even if you make
the most exagerated estimate of the leukemic affect of
the exposure to benzene and other health consequences
are much greater than the ones we are confronting here
today.
I say also that the government in its regulatory proc-
esses is getting into this problem in a very major way.
I was reading the Washington Post this morning and
there was an article on what is called CAT scanners,
computer assisted tomography which is a sophisticated
diagnostic technique that assists in various medical pro-
cedures. The Federal government is presently getting
into the position of regulating the use of these scanners
43
not that it doesn’t help in an occasional instance to diag-
nose a very difficult disease, but the benefits in terms of
improved diagnosis and medical treatment aren’t worth
the cost.
[2108] Here we know what the costs are, or at least
we know one estimate of costs. We have no notion of
what the benefits are. I should say, by the way, that
other areas of government have followed the approach
of putting a price tag on human lives. For example,
the National Highway Traffic Safety Administration
which is responsible for such things as tire standards or
air bags, uses a figure of $250,000 per life safed. I
would say that if you figure the $1 billion cost per 30,-
000 workers, that is $30,000 per worker. That would
mean that if we are being consistent with NHTSA, we
would have to save one out of every eight workers.
I don’t think that anybody would argue that one out
of every eight workers who is presently above the one
part per million standard is going to suffer from leu-
kemia, much less die of it.
Consumers Union, which is a consumer oriented pro-
tection group, uses a figure of $1 million. Various other
studies have cited numbers ranging from $150,000 to
perhaps $3 million. I think it is critical that we recog-
nize that trade off’s are being made here and that we
have to at least have the information as to what types
of benefits one part per million offers us.
Let me get to my point about it not mattering what
Arthur D. Little found. Let’s assume that all the costs
of the Arthur D. Little study were multiplied by three.
This becomes a $3 billion rather than a $1 billion ex-
penditure. Would any de- [2109] cision, would any of
the evidence presented today, vary in any way. Take
another hypothetical. Let us assume that the previous
witnesses had been able to quantify exactly how many
lives would have been saved. Then they corrected their
testimony and they said no, we are off by a factor of 10.
Only one tenth as many people would be affected as we
originally said. Is there anything that is part of this
decision making procedure that would reflect that change
in evidence?
44
I think that the answer is no. Unfortunately we
haven’t acquired the evidence so that we could even test
that particular hypothesis. I would like to make one
further point about how one should treat costs here. All
of the costs in the Arthur D. Little report and indeed
in virtually all of the OSHA standards that I have read
about, deal with average costs. They say how much will
it cost us to move from ten parts per million to one part
per million.
They don’t ask the question about the benefits, but
what we should like to know is not only how much does
it cost us to move from 10 to one but how much does
it cost us to move from 10 to two. We could always set
the standard at two parts per million. We don’t have to
deal with rounder numbers. Then we could see whether
the further reduction to one part per million was worth-
while.
For example, if 20 cases of leukemia per year would
be saved by this particular standard, then the cost of
saving one [2110] life would be $50 million. Let’s as-
sume, though, that we could save 19 of those cases for
half of the expenditures by moving to two parts per
million. Then that last life is costing us ten times as
much. I think that the point that should be recognized
is that when ADL or OSHA, when ADL conducts a
study or when OSHA formulates and promulgates a
standard, some attention should be marginal benefits and
costs to further reductions seems absolutely essential.
I would like to pose one disagreement I did have with
OSHA in general and its treatment of economic costs
which is that generally they only count when they get
above a threshold. This is surprising for an agency that
doesn’t accept thresholds going in the opposite direction
to say that only if something is above five percent or
only if an industry is closed down, in which case the
real resources spent are, as Professor Henderson and Dr.
Searbrough testified, are underestimated. Should we
count this as economic costs that conceivably should af-
fect our decision?
So let me summarize very briefly what I say in my
testimony. First, the proposed permanent standard: It
45
is not clear that any principal was used to set the stand-
ard. One part per million is just as good as two parts
per million or three parts per million. There is an avail-
able technology methodology widely accepted in economics,
widely accepted in the health care area, which is cost-
effectiveness where we attempt to achieve [2111] maxi-
mum benefits per dollar expenditure.
Second, no attempt was made to determine marginal
benefits. What will you gain if you tighten or lossen
control? Third, no attempt was made to measure bene-
fits. We get the same conclusion that I suggested ear-
lier. Do we have much greater benefits or much lower
benefits? Within the standard itself, there is little at-
tempt to direct resources to where they would do the
most good. It is noteworthy that this standard, one-
third of the operating costs during the first year are
directed to medical survailance, one third are directed
to monitoring of conditions and one third are directed
to reducing the risks.
Well, do we have the appropriate information as to
what gains we get out of either one of these different
areas? If we did, then we could use even $1 million
worth of resources to achieve substantially more health
benefits both within the benzene related industries and
in other industries.
I guess what I would recommend for action is to un-
derstand that we do not have the appropriate informa-
tion that would enable OSHA to adopt, to reject, or to
modify its standards. What is needed now are analyses
to compute the total benefits from various levels of stand-
ards and also information which was not provided on
marginal benefits and costs.
Unless we have this information, any decision taken
by OSHA now must reflect an emotional or political re-
sponse to an uncharted situation where the information
isn’t available. [2112] I would hope that intelligent and
well informed decision making should be giver a chance.
Thank you.
» * * _
[2141] MR. LE SOURD:
Let me turn to Dr. Zeckhauser’s testimony if I may.
Do I understand, Dr. Zeckhauser, that you are advocat-
46
ing the use of the techniques of the discipline called policy
analysis and specifically that the application of cost ef-
fectiveness analysis in the formulation of occupational
health standards? I am correct?
DR. ZECKHAUSER: I would say it is more than
policy analysis. It is basically the way most effective
government decisions are made and are sometimes put
under that head. It is part of economics. It is part of
government decision making.
MR. LE SOURD: You are recommending cost effec-
tiveness?
DR. ZECKHAUSER: Yes, I am.
MR. LE SOURD: Yes. Further, are you recommend-
ing that no action be taken to promulgate such a stan-
dard as this proposal?
DR. ZECKHAUSER: I wouldn’t make that recom-
mendation. The reason being all that I have learned
from reading the Arthur D. Little report and I have
not reviewed the medical evidence. I have heard a little
bit of it. I have discussed it with people at API and with
their legal counsel. All we know is the cost of [2142]
this information, It is $1 billion. We know nothing about
the benefits of this information. That strikes me as mak-
ing a decision in ignorance. I think we should get some
notion of what the effectiveness will be before we decide
to make a decision of this sort. So my answer would be
yes. We have no basis to make any possible decision.
However, there are some improvements we could make
even if we had to make a decision. I tried to be cost ef-
fective within the standard. Looked to see which expen-
ditures seemed most wasteful. But I would prefer to
get the basic information as to what level of protection,
if any, would be afforded.
MR. LE SOURD: Is cost effectiveness always of the
dr tn principal for use in regulatory action of this
sort?
DR. ZECKHAUSER: In protective regulation, it is
frequently very useful. There are some times where a
government regulatory agency may feel that it can
put a price on a level of protection that is afforded.
Otherwise it might chose to value a life.
47
I generally don’t think that that is very helpful. OSHA
has objected violently to it and has therefore stopped its
analysis more or less burrying its head in the sand.
Cost effectiveness analysis just gives you a way of
utilizing information to see, for example, that here maybe
we are saving a life at a cost of $50 million where as
we are failing to save lives, for example with the CAT
scanner that I [2143] mentioned earlier, that would cost
$500,000. We put more of our resources into CAT scan-
ners which has been identified as a rather wasteful!
technology by the government and less into protecting
workers in this way possibly offering very minimal bene-
fit, then we would be using cost effective analysis to do
that determination. The basic principal is that it high-
lights the trade off’s and allows decision makers at all
levels. As you know, the President of the United States
has expressed an interest in OSHA’s decision making
processes to learn what is being gained at what cost.
This is precisely the information, for example, that
the workers in the refineries themeselves and the other
establishments would use if they owned the refinery and
had to make the decision, should we protect ourselves?
My guess that if they did attempt to make that decision,
they might decide that it was worthwhile living with a
little more protective equipment. As you know, that is a
very cost effective way of protecting people, but as you
know that is also ruled out by traditional OSHA pro-
cedures.
I think that quantifying the effectiveness and the
costs of various types of impositions would immediately
inform decision makers within OSHA, within the govern-
ment and within the nation as a whole as to what is be-
ing gained at what cost and would enable OSHA to ration-
alize its interventions getting more occupational safety
and health for whatever level of re- [2144] sources that
are spent.
[2149] MR. LESOURD: Dr. Zeckhauser, you have said
that the guiding principle of cost effective analysis is
that for whatever level of resource expenditure we are
undertaking we should attempt the maximum possible
48
level of effectiveness. Is this a correct definition, then,
of cost effectiveness analysis?
DR. ZECKHAUSER: That is part of it. The other
part of it is that ultimately the decision maker should
look at cost and effectiveness and decide what level of
resources we want to spend. But, yes, that is an import-
ant component, and we want to get maximum effective-
ness for whatever level of resources we expend.
MR. LESOURD: Would you agree that it is OSHA’s
obligation to provide insofar as can be accomplished a
safe and healthful workplace for workers?
DR. ZECKHAUSER: As I remember the original
enabling legislation, it was insofar as possible. Also, in
the original legislation there was the term feasible, which
has generally been interpreted to include technologically
feasible. I think that any decision maker concerned for
the total resources of cur nation—and this is the lesson
of economics that you shouldn’t forget anything when you
make your decision— [2150] would want to interpret that
as being economically feasible as well. We shouldn’t
buy miniscule protection for an extra-ordinarily high
amount. The problem with saying safe and healthful is
how safe is safe? At what level? Why one part per mil-
lion? Why not .001 parts per million Why not zero parts
per million and put the petroleum industry maybe out of
business if we got an absolute zero because there is no
way you can assure nothing will creep through any mode
of protection?
So the problem with saying safe and healthful by it-
self, without qualification, is that there is no level that
is safe and healthful. OSHA has run into this problem
with regard to a number of its standards in that they
haven’t been able to define that level. We had a stand-
ard of ten parts per million. If that was safe and health-
ful, then it is still safe and healthful. It is not as though
the biology has changed at all. That was a decision we
chose to make at that time on the basis of not very good
information. We now it seems do not have much more
good information, and we are just changing our standard.
<a
49
I would like to have the information available so we
could provide insofar as seems feasible and desirable a
safe and healthful workplace, not meaning eliminating all
risks or we would close down all of American industry.
MR. LESOURD: Did I understand then that you are
[2151] equating cost effectiveness with economic feasi-
bility? That is how you define economically feasible?
DR. ZECKHAUSER: Economic feasibility would
mean that it was decided by the decision makers that the
benefits were worth the cost, the marginal benefits. When
we pushed it further, the marginal benefits were worth
the cost. Or you may say I might refer to that as econ-
omic feasibility, yes.
MR. LESOURD: Are you saying then that in the case
of this proposal for benzene that the cost effectiveness
of moving from 10 ppm to 1 ppm is not sufficient to justi-
fy this change? I am not sure that I followed you.
DR. ZECKHAUSER: No, what I would say is no in-
formation has been provided so that we could compute
the cost effectivenesss. We have the cost. Let us ac-
cept, subject to lowest limitations, the Arthur D. Little
report as an accurate reflection of costs. Then, we
would have to know—you said it yourself and you are an
economist as am I—economists look at al the outputs
of a process. Let us look at the costs that we are incur-
ring. Let us look at the benefits we are receiveing. There
is no discussion of the benefits. We don’t know how
many workers are getting protection, if any. All we
know is we are moving from 10 parts per million to 1
part per million.
I would like to know how many cases of leukemia are
[2152] we reducing? What other types of illness are
being avoided by moving from 10 parts per million to
1 part per million? And there is no information to that
effect. If we had that information, I think that a lot
of this debate would go away. We are arguing in a
vacuum. We know what the costs are. It is a remarkable
proceeding. We know what the costs are. The argument
is made that the costs aren’t excessive and therefore we
should have the standard. And nobody has even bothered
to say, “But what are we getting for it?”
50
I can’t say whether it is cost ineffective because no-
body has bothered to tell me what the benefits are in terms
of reduced healthfulness.
MR. LESOURD: Would you think that there is a
difference in dealing with carcinogens versus dealing with
non-carcinogenic toxic materials as to the decision that
would be made?
DR. ZECKHAUSER: I think that you would want to
worry about the health loss. I am as worried about
workers being run over by forklift trucks as I am by
workers dying of cancer. I am as worried about workers
dying of heart attacks as I am by workers dying of can-
cer. There are losts of other diseases. Black lung dis-
ease—it bothers me tremendously. I don’t like to see it,
and I am delighted that we have a regulatory effort that
protects miners. That is not carcinogenic.
[2153] MR. LESOURD: How difficult do you think
that it would be to get an adequate dose-response func-
tion or health benefit function that would answer this
question?
DR. ZECKHAUSER: I am not a doctor, but I think
that the testimony earlier today, the testimony that we
have been presented, put a clear upper bound on the level
of benefits that could be secured. Otherwise, the debate
that was going on before we came on to testify was is
there any, is it equivalent to one cigarette per year, one
cigarette in a life time, whatever else it might be? I
think that if somebody came in and said in the most
pessimistic view of the carcinogenic effects of benzene
this moving from 10 parts per million to 1 part per
million will save 200 lives over the next ten years and
the most optimistic view of the carcinogenic effects of
benzene, otherwise that it is not very carcinogenic, it
will save 30 lives. Then we would know. We are saving
between 30 and 200 lives, and we would say are there
other ways that society can spend resources, be it air
bags or mine safety or other modes of safety in the oil
refinery or within the coke oven plant that will offer
more health benefits for the cost?
I think we also could look for cost effectiveness even
within this present standard. For example, I noticed that
51
there were four medical inspections per year for all
sorts of different classes of workers, including some whose
exposure [2154] levels were very low. That can’t be cost
effective. Now, it may be that we should have four for
this class of workers and one per year for this class of
workers unless some statistical evidence tells us that
we should increase that level of surveillance. But there
is no attempt to do this. Jt is sort of the notion of you
provide absolute protection with absolute standards. As
a consequence, cost effectiveness is left out of the dis-
cussion. Effectiveness is left out of the discussion. Bene-
fits are left out of the discussion. Health is left out of
the discussion except that health is at risk, and that is
sufficient to set a standard.
* a x *
[2156] MR. LESOURD: You are saying then really, .
if I understand you, that the relative risk and probably
other matters such as latency period and the dose-re-
sponse function have to be known before you can make
these calculations of cost effectiveness?
DR. ZEKCHAUSER: I think that we should make
some [2157] effort to gather the information that we
have, to collect that information before we make a de-
cision. Yes, I would say that is the case. We can put
upper bounds. The discussion this afternoon suggested
that we can put upper bounds on the dose-response re-
lationship. You may argue that it is here, and I might
argue that it is here. But even if we accepted your esti-
mate the most tangential studies we would have an upper
bound of what it might be. And I think that informa-
tion should be part of the standard setting process.
MR. LESOURD: On page 8 of your written testi-
mony you stated that OSHA “should make every at-
tempt to be consistent across the broad sweep of problems
encompassed by occupational health and safety.” By con-
sistency do you mean the trade-off rates, which I believe
was your term?
DR. ZECKHAUSER: Yes. If that were done, then
we could be sure that the total level of impositions of
OSHA we would be getting the maximum health bene-
fits. So that if OSHA is, for example, with its cotton
52
dust standard, a very great health problem, sacrificing
lives at $500,000, otherwise for an additional $500,000 a
life could be saved, but with benzene saving a life at
$50 million, then what we should do is cut our expendi-
tures in benzene. And with that same $50 million we
could save I guess—I can’t remember my numbers ex-
actly, but I think it is 1,000 workers in the cotton dust
area. .
[2158] MR. LESOURD: But aren’t you—
DR. ZECKHAUSER: I don’t remember what the
numbers are—
MR. LESOURD: Isn’t it true that the expenditures
that the textile industry may make for compliance with
the regulation are not transferrable to some other in-
dustry for them to expend. So, you are not really com-
paring anything.
DR. ZECKHAUSER: But to the extent that most of
these expenditures are borne ultimately by consumers and
taxpayers at large. The textile industry raises its prices.
The benzene industry, petroleum industry, petrochemical
industry raises its prices. We bear the cost particularly
if demand is inelastic. So, too, if the companies lose
profits half those profits are absorbed by the taxpayer
at large so that an awful lot of the costs go back to,
you know, John Q. Public. So, I think from that stand-
point the costs are transferrable.
But I am only saying within the broad sweep. I don’t
mean that it has to be one to one. But let us not have
it 1,000 to one. Of course, here we don’t know what it
is at all because we have no notion as to what that ratio
is, although we can put a minimum on it.
MR. LESOURD: Then, you are not really saying that
they should be equal?
DR. ZECKHAUSER: In an ideal world maybe you
would [2159] have them equal. It is sufficient we are so
far from the optimum that it would be good to move
in the right direction. We could dramatically improve
occupational health and safety, save resources at the
same time, if we had a ratio where one was 100 to 1 and
one was 1 to i by moving so that one was 30 to 1 and one
was 15 to 1. As to whether they should move finally to
53
equality that is sort of a refinement that we can get to
later.
MR. LESOURD: How far do you think that OSHA
should go in comparing standards? Should it look at the
total range of all possible health and safety standards
and then examine the trade-off among all of these before
it acts on one?
DR. ZECKHAUSER: No, I don’t think it should. I
think they should come up with standards as they are
identified and as they come to the public view. I think
if we gather the appropriate information and fed it into
hearings such as this one and in its promulgation of regu-
lations it was made available in the newspapers and to
Congressmen, to the press, and the President, then very
shortly there would be forces pushing towards equaliza-
tion. But, I think that we should protect workers against
benzene now. The question is to what level should we do
that? We don’t have to worry as to what we are going
to be doing with cotton dust tomorrow or five years from
today. But we can look to other areas. NHTSA, which
I mentioned earlier, this Traffic Safety Agency, [2160]
is already proposing a lot of standards that are already
in effect. We can use that as a vague guideline.
We can look at OSHA’s other standards as a vague
guideline in terms of what we would do now. But the
main thing is that if we had the information then people
would comment. Congressmen would say this is outrage-
ous. No, we didn’t want to spend this amount of money.
When we passed the OSHA Act, we didn’t understand
what was really involved. Many Congressmen are say-
ing that.
* * * *
[2167] MR. LESOURD: Am I correct that you seem
to be assuming that you know the benefits, yet you are
telling us that the trouble is we don’t know the benefits?
Yet you are saying that the benefits of this change from
10 to 1 can’t justify the costs? It seems to me that you
are doing that.
DR. ZECKHAUSER: I don’t think I am being clear,
and I apologize. We know from earlier testimony. They
were quarreling this afternoon as to what the maximum
54
benefits could be. We can get a maximum estimate of
the benefits, and then we could say it is worthwhile. What
is the most number of workers that could be protected?
I think that we could provide some guess in that direc-
tion now. Maybe I am wrong. If I am wrong, that
information should have been generated.
I would like to use that information to decide what
we do right now. But I would also like to refine those
estimates, get estimates of marginal benefits, get not the
extreme valuation of the benefits but something more in
the middle of the range so we can know what sensible
action should [2168] be taken. So, I don’t claim that we
have the knowledge of the benefits.
My guess is, though, that medical witnesses would
give some maximum level. I think that is what they
were doing this afternoon.
MR. LESOURD: You do feel, do you, that even if
all that we could ever know was what some upper bound
might be on these benefits, there would still be a basis
for action at some time at least when we had determined
that that was all we could know?
DR. ZEKCHAUSER: Well, I don’t think that we will
ever determine that is all we can know. There have been
many other areas where we started off with a broad
guess. Eventually we refined it. I don’t think that would
be too hard to do. I think that it is quite possible in
this case that knowing the maximum benefit might tell
us what we shouldn’t do. It might tell us that this
present decision is wrong. It might not tell us exactly
where we should set the standard, whether we should
lower it as far as 5 parts per million. It might not tell
us whether we should have four medical inspections per
year or two medical inspections per year.
For example, in medical inspections I think we will
know within one year what sort of benefits come out of
four inspections per year as opposed to one inspection
per year. We might run a controlled experiment. It
would be very easy [2169] to do. That is not something
where we have to have new insights into epidemiology.
We can say, look, with these 1,000 workers we gave them
four examinations per year and we didn’t find anything,
55
with these workers we found an awful lot. You know an
awful lot more about the benefits of those medical exams.
I think that we could find out that information.
So, I think that the first question we should ask is,
“Without our present estimates of maximum benefits and
our estimates of costs, however good or bad they may
be, does it seem worthwhile just to move from 10 parts
per million to 1 part per million?” I think that is a
question that we can ask.
And that information is not provided, and that infor-
mation is not generally part of OSHA’s decision making.
[2180] DR. PARTRIDGE: Fine, given the time frame
available for a variety of analyses that might be under-
taken, if we were to take the approach that you are sug-
gesting to look at a variety of potential regulations,
what would we do in an interim situation where we have
a potential or a known carcinogen that requires regu-
lation?
DR. ZECKHAUSER: We would collect information
on the costs. That is what your organization has done.
[2181] DR. PARTRIDGE: Correct.
DR. ZECKHAUSER: We would collect information
on the benefits. There is some information that is not
presented. It was not presented in your report. I take it
that was not the charge to Arthur D. Little. It is nor-
mally not a charge that OSHA makes. We would pro-
vide that information, and we would make our decision
on the basis of the best information that we could gather.
Here we have not provided the best information that we
could gather.
I would like to see in your report or in the document
that promulgates OSHA standards a notion of using
this piece of epidemiological evidence we estimated that
these benefits would be provided, using this piece of
epidemiological evidence which is much more optimistic or
pessimistic or whatever else it is these would be the
benefits that would be provided. This was the range
that came out of the studies that we examined. That is
what I would like to do. In the interim if that informa-
tion were provided, I would like to compare it across
56
other areas. At least I would like to have it provided
so that OSHA for its own internal decision making pur-
poses would use it in a reasonable fashion.
DR. PARTRIDGE: Okay. In this type of situation
then would we be able to draw upon preceding studies as
a basis for future promulgation, where we are gradually
[2182] accumulating a body of literature and knowledge,
be it cost effectiveness or what have you.
DR. ZECKHAUSER: You certainly would, but we
couldn’t in the occupational health area given OSHA’s
refusal to quantify the benefits from its impositions.
We would have to look at this time to studies done in
other areas with the hope that since OSHA has been a
playing an increasing strong role in the occupational
health area that soon we will have broad enough studies
that would be able to inform us.
DR. PARTRIDGE: Begging the issue of whether or
not OSHA is willing to quantify benefits or not, would
you be prepared to utilize information that is now being
collected as a basis for quantifying the value of human
life for a variety of regulations?
DR. ZECKHAUSER: Well, there is a difference be-
tween quantifying the benefits in terms of how many
lives are saved and quantifying the value of a human
life. I think that quantifying the value of a human
life so turns off large groups of people that it is not
something that should be done. It doesn’t inform the de-
cision making process very much, and it just gets people
upset. Now I have actually seen some Arthur D. Little
studies that did do that, and I think they had precisely
that effect—the Pan American Health Organization wor-
rying about the benefits of mosquito eradication.
[2188] DR. PARTRIDGE: Fine. On page 13 you
make a statement more significant the uncertanties us-
ually the greater are the benefits for some sustained
study of the problem. If initial predictions of health
benefits range, say, over true orders of magnitude, several
months of investigation may narrow the prediction to
within a factor of 10. Extremely narrowing of this sort
may dramatically change both the form and severity of
57
the regulatory intervention that we wish to employ in
a particular case.
Would you briefly describe to my what types of ad-
ditional investigation you are advocating here?
DR. ZECKHAUSER: Well, what I would do is I
think I suggested earlier I would start off by asking our
medical witnesses to attempt to quantify the benefits,
and obviously we have got a range, with some people
suggesting that benzene causes more cases of leukemia
than others. I think that we would be most able to nar-
row uncertanties in something like the frequencies of
monitoring and surveillance, medical surveillance, where
I think a good control study within one year could tell
us an extraordinary amount, whether 50,000 exposed
workers will pick up—and nobody would know right now
—200 disturbing symptoms, sets of disturbing symptoms
or two. You gain an awful lot knowing that, and right
now if somebody were asked to testify they would have
an extra-ordinarily broad range. There is a study. We
could do it, [2189] do it in a year, and we would have
a much better standard in a year from today.
[2190] DR. PARTRIDGE: You are talking about an
almost after the fact evaluation of certain compliance ac-
tivities. I prefer to go back to perhaps issues of toxicology
and—
DR. ZECKHAUSER: I repeat my opinion with re-
gard to benzene. I don’t know what the level of un-
certainty is over the leukogenic consequences of benzene
exposure. I heard some discussion as to whether 10 parts
per million was safe or one part per million was safe,
and I guess we could find out something more about that.
I would like to see those studies conducted. It miglit take
some time. At the outset since I don’t think that it would
matter much for the standards, and certainly not the way
they are implemented, I would even be willing to live
with a reasonable maximum estimate of, the-benefits, and
make that information avaftable to Congress.
DR. PARTRIDGE: Have you participated in any of
these studies that you are advocating, these additional
studies? Are you aware of any such activities and the
results of such an activity?
58
DR. ZECKHAUSER: I haven’t done them in terms
of occupational health and safety. I have done them
however in other areas. For example, I participated
in a study that was published this spring on the risks,
costs, and benefits of surgery and when we started that
study we didn’t know whether various surgical proce-
dures were very effective or efficacious.
[2459] MR. VAN VOORHEES: Your Honor, first we
have Dr. Howard Maibach appearing on behalf of the
American Petroleum Institute.
JUDGE LAWRENCE: Present your testimony.
DR. MAIBACH: My comments will be very succinct
and limited to one simple issue, and that simple issue is
how much, if any benzene, applied to the skin of man
goes through the skin. In order to make some sense of
the recorded data that is present to you in the literature,
to anybody, I have taken the liberty of summarizing it
into two parts, with interpretations of each.
The first part starts in 1897, and the second part
starts in 1946. The first part in 1897 were attempts
[2460] to determine how much benzene goes through
your or my skin by applying the material to animals.
Now, in 1897 when this was done, there was essentially
no information available as to how the skin of a guinea
pig or a rabbit differed from our skin other than the
fact that we obviously share some dissimilarities in ap-
pearance.
The first observation was by Santeson in 1897. The
material was applied to the rabbits. The rabbits had had
their hair removed, and the skin of the rabbit changed
under observation, and they questioned whether the ma-
terial went through it.
The next observation was in 1925 when Morrow ap-
plied material to guinea pigs. The guinea pigs had their
hair removed. Again, there were no quantitative esti-
mates to determine how much went through, just to see
if there was a change in the physical appearance of the
skin.
For all practical purposes then, the first observation
to try to determine how much benzene goes through the
59
skin was in 1931 when Lazarev and his associates did a
simple experiment in which they immersed either the
ear or the paw of rabbits or mice into benzene for some
hours, and then they attempted to measure how much,
if any, of the material went through the skin by looking
for benzene in the breath with a colorimetric assay, and
they came up with a figure, which has been [2461] pub-
lished and quoted, stating that the amount of penetration
was several milligrams per centimeter per hour.
_ I think that it is very likely that for the rabbit this
is probably a very correct observation. The problems with
extrapilating that to your skin or my skin is simply that
the amount of benzene used was enough to “mummify”
the skin, which is a very different situation than you or
I working with benzene. Mainly they were dealing with
very abnormal skin.
Next Leeman attempted to measure the penetration
of benzene through the skin of animals and records that
he saw no penetration.
The last animal experiment was by Petrilli in which
benzene was applied to the skin of the guinea pig in a
pack, and I will get into the significance of a pack, and
“slight intoxication” was noted.
I think the most relevant experiments are those that
started right after World War II in Italy, leaving the
skin of animals and going directly to the skin of man,
and the reason that I believe that this is relevant is that
we now know that there are very grave differences and
very important differences with man being superior to
the animal.
If one wants to give it a teleological connotation,
maluly that man has a skin that is able to [2462] keep
chemicals out a great deal more effectively than many
animal species, and certainly much more effectively than
the rabbit.
The first experiment after World War II in man was
done in 1946 by Cesaro. He did a rather heroic experi-
ment, by many standards. He took some men who were
volunteers, he removed their clothing and placed them
in a tank. He then, in the tank, gave them a breathing
apparatus so that their skin could be exposed. He meas-
60
ured the amount of penetration of benzene by using a
technique of comparing the ratio of inorganic sulfates to
total sulfates. Now this is a relatively crude method in
1977, and using that technique and applying the benzene
both as a vapor and a liquid, and he doesn’t explain how
much he applied, he found that there was no penetra-
tion.
The next experiment was done by the people known as
the Research Association of British Rubber Manufac-
turers. They took a somewhat different tack. Instead of
just applying vapors they applied liquid benzene to the
chests of the volunteers, and they examined both the
sulfate ratios, the total sulfates, and they looked for
benzene in expired air, and they too came to the conclu-
sion that with their experimental technique and with the
analytic techniques available in 1947, that they found no
evidence of penetration.
[2463] We now go another few years. We go to 1956
when Konka and Maltigliotti did an immersion experi-
ment. Here they took the hands of workers, immersed
them, their hands and their forearms, in full strength
benzene for 25 to 35 minutes. Again, they used as their
analytic method the evaluation of breath, and they used
the sulfate ratio method, and they too, again, came to
the conclusion that under the circumstances of their ex-
perimental technique, in immersing the hands, they found
no evidence of penetration.
The last experiment and the one that is the most im-
portant, because here a postive result is equally as im-
portant as a negative result, Hanke and his associates
in 1961 did a somewhat different experiment. In 1961
they took some benzene, and unfortunately I have had
to read this in translation because I don’t read Czech
and I have read the official translation provided to me,
but what they did was they applied the benzene in cotton
pads and then they applied a plate over the cotton pads.
Using this, and using another technique for measuring
penetration now, or as an index of penetration, namely
the amount of phenol appearing in urine, they came to
the conclusion that there was penetration of benzene in
the subjects that they studied.
em
61
Now this experiment has two problems of [2464] in-
terpretation. The first problem is that they were not
measuring the penetration of benzene, they were meas-
uring the amount of phenol, and the people that they
were studying already had a fair bit of phenol in their
urine, so one is stuck with the problem of trying to
extrapolate how much of the phenol was present in these
people before they started out, and how much was due
to that added from the benzene.
The additional problem of interpretation here is very
simply that Hanke, in 1961, didn’t know that any time
you take a piece of anything and you cover the skin with
it and you wrap it with an impermeable dressing, such
as the glass plate, you greatly alter the permeability
characteristics of skin, and for those chemicals that we
have data on, which is unfortunately not benzene, we
know that it is one of the most potent methods of driv-
ing molecules to the skin.
You may know that dimethylsulfoxide is written up
in many of the lay journals and scientific journals as an
extremely efficient way of driving molecules into the skin.
Well, dimethylsulfoxide is not nearly as efficient at driv-
ing molecules into the skin as that little piece of plastic
or a piece of glass. So, the data that Hanke observed
has the one problem of interpretation, how much of the
phenol was due to the benzene, how much was due [2465]
to natural phenol from other metabolic pathways and
secondly, how does one extrapilate by his plate be applied
over the cotton to the situation of the worker.
I would like to summarize both the animal and the
human data by saying that in 1977 it is extremely diffi-
cult, if not impossible, to balance all of the information
that is available. Admittedly, the overwhelming major-
ity of the observations suggest that benzene does not
penetrate the skin. One observation suggests that it does.
Today we have a much simpler and a much more di-
rect way of answering this, and I would hope as the
result of the deliberations of this congregation of ob-
servers and official party that in a very short period of
time we could get a very specific answer because now
radioactive benzene is available, and one simply would
62
apply radioactive benzene, some Carbon 14: benzene, to
the skin of the arm of an appropriate animal that has
permeability characteristics similar to the people in this
room, and the monkey and the guinea pig, nor the rat
would fit into that category, and then would simply look
for the radioactivity excreted into the urine the feces
and the breath.
This is a simple technique. It has been done for over
100 organic compounds in the last decade, measuring the
amount of transport to the skin, and it would then tell
us definitively, without argument, and efficiently, [2466]
just how much of any benzene penetrates the skin.
Using the simple technique, it then would become
possible to answer a number of other very relevant ques-
tions for people like yourselves responsible for making
standards.
Question number one, is the material absorbed from
the palms the way it is from the forearm or from the
chest because there is a greater difference between the
absorption of-one part of your body to another than there
is in all of the people in this room.
For instance, for some of the chemicals that have been
measured, there is a 40-fold difference between one ana-
tomical site and the other in man, and so I think if we
are talking about standards for benzene, the site of the
workers skin that is exposed certainly is a site that
should be studied. :
Secondly, a very critical problem that must be answer-
ed, in all of the data that has been provided to me, it
is assumed that benzene applied to the skin has the same
or equal toxic potential compared to benzene inhaled which
is believed to be the major point of entry.
Well, I think in the 1940’s this was a very reasonable
assumption to make. In the 1970’s, we are aware of a
number of examples where the skin metabolizes compounds
in an entirely different fashion than any other part of the
body, and references are in my written testimony. So,
[2467| therefore, once you start to do this and use modern
analytic techniques, it should be possible to determine
is the skin detoxifying or is the skin handling this in
cll Mee NT et, oe TEs be
63
a way similar to the lung, or is it handling it in a dif-
ferent way.
Next, we didn’t know, until 1977 a very basic part
of this story. In 1976 we believed that if you splashed
a chemical on your skin once, or if you splashed a chemi-
eal on your skin ten times, we assumed that if you
applied once and IX went to the skin, if you splashed
it on ten times then 10X went through the skin. We now
know, at least for one chemical, it is the only chemical
that has been measured, that that, although it is a basic
assumption of all dermatologic therapy, happens not to be
correct, and the data for this is in my written testimony
for the one compound.
So, in setting standards for benzene for workers, one
would also want to know is there a difference in one
exposure versus multiple exposures, and again, with
modern analytic and biological technology, it should be
very simple, very quickly, and inexpensively to answer
this.
Another practical matter to be resolved is can one in
fact protect you or myself or any worker with protective
clothing. It is automatically ordinarily assumed that this
is in fact the case, but until you do an [2468] experiment
with the protective clothing, using appropriate method-
ology, one cannot make that assumption. It is very
possible that you may be, but it is equally possible that
it may not be, and it is something that can be demon-
strated.
The last two things that one could measure very ef-
fectively today, within a period, I would think, of 12
weeks, and that is is the amount of benzene that is ab-
sorbed through our skin concentration dependent. Cer-
tainly, in broad range, it must be concentration de-
pendent, but in the practical matter of setting standards,
we do not know whether there is a linear relationship
for all chemicals in terms of the amount of absorption.
Then lastly the thing that would be extremely ger-
mane to know in setting standards is that benzene is a
very volatile material. When it is splashed onto the skin,
is it going to evaporate more rapidly into the air or is it
going to go into the skin more rapidly. I think all of these
and several other questions could be very expeditously
64
answered if any of the appropriate agencies who are in-
terested in setting the standard wish to obtain the data.
JUDGE LAWRENCE: Thank you very much, Dr.
Maibach. Does the Solicitor have any questions?
MS. KALARIS: Yes, we have just a few questions.
Dr. Maibach, you said that the evidence was not clear
as to [2469] whether or not benzene is absorbed through
the skin. What is your personal view?
DR. MAIBACH: Well, I appreciate a direct question,
and I will give you an equally direct answer. I don’t
know.
MS. KALARIS: Thank you.
DR. MAIBACH: May I clarify you, because I think it
is important to be in the record.
MS. KALARIS: Certainly.
DR. MAIBACH: I think it should be emphasized
through normal skin of man rather than skin of rabbit.
I think we must separate those.
MS. KALARIS: Would the rate of absorption of
benzene be greater through the broken or the damaged
skin than through the intact skin?
DR. MAIBACH: It is ordinarily assumed that pene-
tration of any molecule will be greater through damaged
skin than undamaged skin, but unfortunately I have
to tell you that today that is usually as assumption rather
than a fact, namely in many dermatologic situations where
we are trying to drive molecules through the skin for
therapeutic purposes, we have almost no background data
to verify that assumption, and it could be that when
we get the data, it may be very surprising.
MS. KALARIS: What is the basis for the [2470]
assumption? |
DR. MAIBACH: The basis for the assumption is
that your skin is protected by an outermost barrier, the
dead skin, the stuff that you see in the bath tub inter-
ferring with the soap, on the side of the tub, the caro-
tene or stratum corneum. That barrier, that little dead
layer of cells in fact is a perfect membrane for allowing
you and I to get out of the seas. Namely, this is the
membrane that keeps water in us.
aS eter en
Martens
65
It has been assumed, and it is certainly true, that
if you remove that membrane, if you damage it, the
water comes right out of you. It has been assumed, in
fact, that it does the same thing for chemicals. Well,
the little bit of analytic data that we have done suggesis
that when we move that barrier we only increase penetra-
tion for the few chemicals, and I don’t want to generalize
on this, about three-fold, and I told you that a little
piece of Saran Wrap will increase penetration about 10-
fold.
Stripping off this barrier increases penetration about
as much as dimethylsulfoxide would, not as much as
occlusion, and certainly there seems—whoever created us
gave us other barriers to penetration, other barriers to
protect us for chemicals going in, other than just the stra-
tum corneum.
MS. KALARIS: Then liquid benzene could damage
[2471] that barrier?
DR. MAIBACH: Liquid benzene could damage that
barrier.
MS. KALARIS: Once the skin is broken, would multi-
ple applications produce more penetration than a single
application? G )
DR. MAIBACH: Last year I would have given the
answer yes. This year, on the basis of the one reference
of new data that I have given you, I don’t know.
MS.KALARIS: And your answer would apply whether
or not there was just splashing of the skin or there was
drenching?
DR. MAIBACH: Would you kindly repeat that?
MS. KALARIS: You said you don’t know, and this
year you said you do not know the effect of a multiple
application, and that would be the case whether or not
there was just splashing, the application was by splash-
ing, by intermittent contact with the skin, and would
also be the case if the skin was thoroughly drenched?
DR. MAIBACH: I would still say that I think that
experimental data must be obtained, because it is very
practical information.
MS. KALARIS: Is there any data which shows that
repeated skin contact does not result in absorption?
66
DR. MAIBACH: The only data that is available—
[2472] MR. VAN VOORHEES: Is that with benzene?
MS. KALARIS: With benzene, yes. Of course.
DR. MAIBACH: No, I don’t have that data.
MS. KALARIS: Okay. Is benzene absorbed more
readily if it is in another solvent such as to toluene or
xylene, does it penetrate the skin more readily?
DR. MAIBACH: I found no data for or against that.
Again, very easily measured in 1977. ;
MS. KALARIS: You mentioned a 40-fold increase
in certain anatomical regions for some chemicals. What
part of the body were you referring to?
DR. MAIBACH: Well, I was specifically referring to
the scrotum. Every chemical that we have studied to
date, using radio isotopes, and using man, suggests that
the scrotum has essentially no barrier to penetration
for many chemicals.
For instance, the first one that we studied was hy-
drocortisone. Hydrocortisone is very poorly absorbed, very
minimally absorbed in the forearm. About 40 percent of
the dose is absorbed in the scrotum.
Some of the pesticides that we have applied, 100
percent of the dose is absorbed in the scrotum.
MS. KALARIS: So other parts of the body would be
less sensitive?
DR. MAIBACH: Generally speaking, we know of
[2473] no area other than the scrotum that is com-
pletely permeable. I might add that the female genitalia
have not been studied so we don’t know the answer.
MS. KALARIS: You mentioned Saran Wrap increas-
ing absorption from three-fold to ten-fold. If you are
wearing a shirt, for example, would that shirt, if it is
splashed or drenched with benzene, act as a Saran Wrap
and increase the absorption?
DR. MAIBACH: The only data that we have bearing
on this is with totally inclusive materials.
MS. KALARIS: Such as?
DR. MAIBACH: Such as plastics, rather than shirt-
ing. Shirting would be an entirely different—it would be
a very relevant question to ask, but we have no background
data to date.
MS. KALARIS: Thank you.
at ln. a at
67
JUDGE LAWRENCE: Do we have any questions
from the floor? Mr. Alexander?
MR. ALEXANDER: Thank you, Your Honor. My
name is Victor Alexander, I am here on behalf of che
Industrial Union Department of the AFL-CIO.
JUDGE LAWRENCE: Would you estimate your
time? .
MR. ALEXANDER: I will try to keep it within a
half an hour, Your Honor.
Dr. Maibach, is there some standard way that [2474]
experimenters use to apply an occlusive dressing? Can
you describe that to us, in an animal experiment?
For instance, if you apply a piece of plastic or Saran
Wrap, are the edges sealed?
DR. MAIBACH: Could you clarify a little bit? If
I knew what you were driving at, I might be able to
answer that.
MR. ALEXANDER: On page five of your statement,
you say it is not clear whether the watch glass was used
as an occlusive dressing, and I am just trying to get
out if the fact that it was held down by an elastic which
might have left the edges open for evaporation, if that
would qualify as a standard type of occlusive dressing,
as you understand it.
Ae sn MAIBACH: I don’t have any ready answer for
at.
MR. ALEXANDER: On page six of your statement,
five and six, at the bottom, and then going over, you
talk about them having performed 52 tests for the concen-
tration of phenol, and that they found an average of 7.2
milligrams of phenol per liter of urine, and that this was
the baseline observation.
Further down the page you say that the maximum
concentration observed in the controls was 16 milligrams.
Do you have any idea how those data were distributed?
For [2475] instance, how many of them had values, say,
above ten?
DR. MAIBACH: I don’t really have a specific idea.
I can give you the exact data.
MR. ALEXANDER: Good.
DR. MAIBACH: In translation.
68
MR. ALEXANDER: I don’t read Czech either.
DR. MAIBACH: Here we are. This is page 10 of
their Table Two, and it is entitled, “Maximum Values
of Phenol Excretion in Urine in Unexposed Persons, and
Persons Who Absorb Liquid Benzene Through the Skin”,
and the maximum concentration of what they call, in this
particular table, “physiologic excretion”, and it is 16.0
milligrams. One of their exposed subjects had 15.8.
MR. ALEXANDER: Excuse me a second Doctor, I
was interested specifically in the controls.
DR. MAIBACH: Okay, they give, as the controls,
16.0, in this particular table.
MR. ALEXANDER: That was the maximum value?
DR. MAIBACH: Maximum concentration in milli-
grams per liter.
MR. ALEXANDER: You reported, on page six, that
the average was 7.2 milligrams.
DR. MAIBACH: Ox«ay, that could be a different
table. The table that we are referring to there is their
Table One, “Physiological Values of Phenol Excretion in
[2476] Different Unexposed Individuals”, and there were
52 tests with a result that they say test results from
3.0 to 16.0 with an average of 7.2.
MR. ALEXANDER: My question really relates to, in
one case, at the top of page six here, you are referring
to 7.2 as a baseline, and further on in your comparisons,
you use 16 which is the maximum observed value for con-
trols, and I ask you if it really wouldn’t be more ap-
propriate to consider 7.2 the baseline rather than 16.
DR. MAIBACH: It is a very germane question. I
chose to use what the authors chose in their discussions.
MR. ALEXANDER: If, in fact, one were to do that,
then the five values you report for the exposed sub-
jects would then have concentrations of phenol in the
urine on the order of two to three times as much as
what I might call the baseline.
. DR. MAIBACH: For that reason, I think if you
and I were doing this, in light of standard experimental
design, neither one of us would do it this way, would we?
We would take each person as his own control because
you would have to worry about outlyers, and if you
69
notice their table in which he gives his physiological
excretion of 16, 3 of the 5 subjects were at baseline level.
I think 2 were above it.
MR. ALEXANDER: At the maximum level for con-
trols [2477] when you say baseline.
DR. MAIBACH: Right. So, obviously that made him
a little uncomfortable too.
MR. ALEXANDER: On page 7 you state that the
authors do not appear to eliminate the possibility that
these two subjects, meaning the two that are above the
so-called baseline represent a contamination from an-
other source. I wonder if we were to apply the other
version of baseline, if, in fact, it might not be a ques-
tion whether or not the 16 vaiue that was observed might
not have been from contamination of another source. If
you might turn that phrase on it’s head, so to speak.
DR. MAIBACH: It is an interesting question, I
don’t have a good answer for it.
MR. ALEXANDER: /You have written several papers
about using a standard technique, which apparently you
developed for studying both pesticides and other organic
_ compounds. Is that correct?
DR. MAIBACH: Yes.
MR. ALEXANDER: If I can refer to one paper in
particular, which is called “Absorption of Organic Com-
pounds Through Skin in Man”, it contains several in-
teresting things, one of which, on this question of recov-
ery in urine, after IV administration, two compounds
which have some reasonable similarity to benzene, that is
[2478] dinitrochloro benzene, and nitro benzene, those
would be benzene compounds wiih some substitutions. In
those cases, something on the order of 60 percent was
recovered in the urine, and do I take it to mean that if
a similar situation occurred with respect to measuring
phenol, that we might be talking about an actual ab-
sorbed dose, something on the order of twice as much
as they were actually measuring?
DR. MAIBACH: Yes, that is a very easy question
to answer. If you measure—if I put some benzene on
my—if I put some melathion on my forehead, and if I
accounted for one percent of that being excreted in the
70
urine and stools, there could still be a very significant
underestimate.
If I didn’t know what happened when you put mela-
thion into the body to be sure that in fact you could find
it in the urine and stool, so we therefore correct or in-
complete excretion after foreheadal dose.
MR. ALEXANDER: I wonder next what the effect
of worker sweating would be on the absorption of a
compound. Is it likely to be increased?
DR. MAIBACH: Unfortunately we only have one ob-
jective documented study on this work we did with a
pesticide. It was either parathion or melathion, and it
is unpublished work, but I can provide the experimental
data. We found surprisingly no difference with the one
[2479] pesticide we studied and one anatomical site, in
one statistically significant experiment. The statistical
significance was we could show no difference.
MR. ALEXANDER: That is a-little bit surprising?
DR. MAIBACH: Like many things in membrane
transport, once you get the data, it is often very surpris-
ing. 7
MR. ALEXANDER: Based on that, do you have any
idea what the mechanism for the increased transport,
when you are using an occlusive dressing would be?
DR. MAIBACH: We have pat answers that we give
to students who are not very questioning. Do you want
those or do you want the real answer which is I am not
sure that we know?
MR. ALEXANDER: I wonder if some of the experi-
ments that are described were conducted at 25 degrees
Centigrade. I wonder if, for instance, in a working
environment where the temperature might be 40 degrees,
if that might have an effect to increase the transport.
DR. MAIBACH: If I understand your question, it
is two parts. One, does the occlusion—
MR. ALEXANDER: No, I am not talking about oc-
clusion. I am speaking about temperature.
DR. MAIBACH: There is every reason to believe on
the basis of invitro studies, that increasing [2480] tem-
perature will increase penetration, but again, as in all
of these things, that is going to have to be documented
with in vivo studies.
71
MR. ALEXANDER: How about the humidity? The
experiments described discuss 35 percent humidity. It is
relatively common to find an environment where the
humidity might be 70 percent or higher. What would
that do to the rate of transport?
DR. MAIBACH: I think that is going to have to be
measured in vivo before I will be comfortable enough to
answer.
MR. ALEXANDER: Now most of these experiments
relate to compounds applied to the forearm skin, and in
some of your published work, for instance, you say that
skin, such as the angle of the jaw or the face would have
a, based on the experiments that have been done, trans-
port factor some four times greater. Is that correct?
DR. MAIBACH: The chemicals that we have studied,
it is the general rule that the face is more permeable
than the forearm.
MR. ALEXANDER: And the back of the hand, com-
pared to the forearm, is perhaps twice as great?
DR. MAIBACH: We have very little data on that,
unfortunately.
MR. ALEXANDER: In one of your papers also, you
[2481] site an individual variation from person to per-
son of five times in the amount of a compound. I think
it was specifically pesticides absorbed. Do you have any
reason to suspect that same sort of variation might not
apply to the case of benzene?
DR. MAIBACH: I think we need the simple experi-
ment to answer that.
MR. ALEXANDER: You also talk about—I under-
stand the caution you are giving us about whether one
dose or multiple doses, but you mention, again, in your
paper, something about the effect that it is possible to
have sort of an overwhelming dose in which there may
be a linear relationship of absorption to concentration
to a certain point, and then much more of the compound
would be absorbed.
In the case, say, of a mechanic, who opens a pipe and
is inadvertently soaked in the stuff, might not that be a
case where you have this overwhelming event?
12
DR. MAIBACH: I don’t recall having made a state-
ment about overwhelming absorption. I wonder if you
could clarify that for me.
MR. ALEXANDER: No, I didn’t mean overwhelm-
ing absorption, I meant that there seems to be a rela-
tively linear relationship between concentration and ab-
sorption up to a certain point, and then after that, more
compound [2482] applied, a greater proportion of it
might go through the skin.
DR. MAIBACH: Okay, I understand now.
MR. ALEXANDER: I was just trying to give a prac-
tical application of this concept.
DR. MAIBACH: There are purported examples in
which the opposite occurs, namely at very high concen-
trations one gets less absorption thun one gets at lower
amounts, and I think you would have to obtain the data
to know what would happen with benzene.
MR. ALEXANDER: Now, as I understand it, your
standard protocol is to do a complete urine collection for
five days, and you report for several different compounds,
the pesticides for instance, half lives ranging from up
to 28 to 30 some odd hours. Now, as I understand it,
the standard practice would be to collect urine for at
least three half lives to be certain of a reasonable col-
lection over 90 percent, and based on that, since in the
experiments you report, there seems to be an incomplete
urine collection for a period of 24 hours, if in fact that
might not be a significant understatement or the total
absorbed dose.
DR. MAIBACH: One can plot that out mathematic-
ally, and we do, and in fact, on certain compounds, we
have collected as long as 20 days. Hexochlorophene is
one [2483] of them because of it’s slow, half life in
excretion. ‘
MR. ALEXANDER: Also, if I understand some of
your work correctly, you also speak about the fact that
various layers of the skin can act sort of as depots, stor-
age depots for the compound, and that this may explain
some of this delayed absorption, but in fact, the com-
pound may be stored in one or another of the layers,
only to be released very slowly later on. Is that a fair ©
representation of—
eg
73
DR. MAIBACH: As a general rule, I would nct know
if that would hold with something like benzene.
MR. ALEXANDER: I guess I just have a couple
more questions then. Again, in that paper that I was
referring to earlier, you mention on page 400 that three
compounds, possibly two toxic to test intraveneously in
man or administered instead intraperitoneally in guinea
pigs.
I wonder if you could tell us why you chose not to
administer those compounds to man. The compounds, I
believe, if I am reading correctly are butter yellow,
malathion, and methylcholanthrene.
DR. MAIBACH: Butter yellow we chose not to apply,
and I am thinking back a decade, and I would have to
look at my notes.
MR. ALEXANDER: I appreciate that.
[2484] DR. MAIBACH: Butter yellow is a low grade
carcinogen. Methylcholanthrene is the same, for the same
reason. Malathion has, we subsequently realized, to be
very easily administered to me intravenously, —
MR. ALEXANDER: So your concern with two of
those compounds, at least, was the possibility of their
having some carcinogenic risk.
DR. MAIBACH: Yes.
MR. ALEXANDER: Now, on page 11, your last com-
ment is that similar studies could be safely done in man
because the chemical and radiologic exposures are ex-
tremely small.
I wonder if based on this prior work of yours, and
if in fact benzene has a carcinogenic risk, whether or
not you might be concerned about conducting an experi-
ment of that sort.
DR. MAIBACH: Well, at the time we wrote this, we
were unaware of the fact that there is a very good animal
model now for this, and so I would be very happy to
run it as an animal model.
Secondly, we have learned a great deal more general
toxicology than we knew then, and would feel very com-
fortable about injecting tracer quantities into myself
for instance.
MR. ALEXANDER: The final question is, I [2485]
understand that these experiments are done on human
74
volunteers, and I wonder whether the protocol for such
a study has been submitted and approved by the human
experimentation—
DR. MAIBACH: For benzene?
MR. ALEXANDER: Of your medical school. ,
MR. MAIBACH: These experiments have, but not for
benzene. We have suggested in this that studies like this
should certainly be done for benzene, either in an i
propriate animal model, which would be the one of the
species, monkeys, that we have correlated data with
other compounds from animal to man, or certain—I sus-
pect that this would probably clear many committees for
the use because of the very small doses needed because of
the exquisiteness of the analytic methodology available
today.
MR. ALEXANDER: Thank you, Doctor. Thank you,
Your Honor.
JUDGE LAWRENCE: Do we have any further ques-
tions from the floor? Mr. Wodka?
MR. WODKA: Five minutes, Your Honor. Dr. Mai-
bach, the National Institute for Occupational Safety and
Health has placed into the record here a 1972 German
study by Hartwich. Are you familiar with that one?
DR. MAIBACH: May I take a look at it please?
MR. WODKA: Sure. Well, let me read to you [2486]
this part of it. I don’t have the entire study. I have
a reference to it. What they did was this, they found
an increased incidence of structural chromosomal ab-
errations in a group of nine refinery workers who did
not have clinical hematological or biochemical abnormali-
ties.
The concentrations of benzene measured in the in-
dividual outdoor working areas had at no time exceeded
25 parts per million. However, there had been prolonged
skin contact with benzene with all the workers, and I
would like to know if you think this observation is sig-
nificant?
DR. MAIBACH: I am afraid that I am not familiar
with that paper and would have to study it before I
would comment.
MR. WODKA: Let me just show you this. This is the
—one of the NIOSH references that was “Considera-
75
tions Bearing on the Question of Safe Concentrations of
Benzene in the Work Environment”, the MAK-WERT
paper.
DR. MAIBACH: Thank you.
MR. WODKA: I have just excerpted some of the—
DR. MAIBACH: I would be very happy to step out-
side and read it and return after I have studied it, but
I have not studied it before.
MR. WODKA: I just have one other question. [2487]
I have listened here to your oral presentation, and I
have noticed that in several places you stated that more
work is needed in order to explore the question of skin
absorption of benzene, and I think you expressed several
places where more research is needed, more tests need
to be done, and so on.
Don’t you think, therefore, that it would be prudent
for workers who are exposed to liquid benzene to wear
gloves, impervious gloves, during this period of time
while we don’t have all the data?
DR. MAIBACH: That is a very direct question and
the face, of it is so simplistic is to be silly, and I don’t
think you meant it that way. Obviously, it makes a
great deal of sense to protect all of us from all of the
risks of the world, and I, like motherhood, must endorse
it. However, I think the specific question that I am
addressing myself to here is that whoever makes these
standards does have a lot of practical issues to deal with,
and this is one practical issue which is perhaps the
most straightforward, namely how much of this ma-
terial goes through skin, it could be answered before this
committee’s deliberations are finished. We are talking
of a relatively short term experiment. In six to twelve
weeks, one could have an enormous amount of data that
could allow one to make some reasonable judgements
without having to resort to the [2488] motherhood type
of principle.
MR. WODKA: Well, I understand that, and I saw
that in your testimony, but my question is if I, as a
Union representative, came to you and said that I had a
group of workers exposed to liquid benzene, and I was
going to ask you, in your expert opinion, do you think
76
it would be prudent for me, as a Union representative,
to insure that these workers wear impervious gloves when
they handle up the benzene, what would you tell me?
DR. MAIBACH: I would tell you what I have been
told by the people, the Union people who speak to me,
and the workers who speak to me, and the State agencies
that speak to me, namely that you must preserve your
warnings with bothyyou and me, whether it Is smoking
or anything else, t6 the most relevant warnings, and so
I am saying that in the six weeks necessary to do these
experiments, you will have your answer.
I don’t think it is particularly effective to make a
generic warning for everything, because then I think
everything is disregarded.
MR. WODKA: So, in essence then, you would want
to conduct your experiments first before you give me
an answer?
DR. MAIBACH: I would like to, again, remove the
first person from that answer, saying that I would be
[2489] for you or anybody in this room who is inter-
“ested in doing it, the techniques are straightforward and
reliable,.and it/could be done by anybody having the
analytic facilities available.
MR. WODKA: Thank you.
JUDGE LAWRENCE: Anybody have any further—
MR. WODKA: Do you want to hold on to that?
JUDGE LAWRENCE: Do you want to answer that
question?
DR. MAIBACH: Would you like me to then write
you or go out in the hall?
MR. WODKA: You could write me.
DR. MAIBACH: Okay. Fine.
JUDGE'LAWRENCE: Do we have any further ques-
tions from the floor? \
MS. KALARIS: Dr. Maibach, would you submit your
opinion on that article for the record please?
DR. MAIBACH: Yes, I certainly will.
JUDGE LAWRENCE: Mr. VanVoorhees, do you have
any questions?
MR. VAN VORHEES: I have just one question, Dr.
Maibach. If an employee were wearing impermeable
17
clothing or gloves, and in the process of handling benzene,
liquid benzene got underneath the gloves, would that
increase the absorption potential of the benzene? |
[2490] DR. MAIBACH: If benzene is like other
chemicals that have been studied, and that must be
demonstrated, the occlusiveness of the glove would be a
very potent way of increasing penetration.
MR. VAN VOORHEES: I have no further questions.
JUDGE LAWRENCE: Thank you. Thank you very
much, Dr. Maibach. Mr. MacDonald, do you want to be
second?
[2701] DR. WILSON: The corrections I have to make
are mostly typographical. On page 18 of my testimony
on line three the word “most” is typed and it should have
been “worst”. It is “under the worst case”’.
On page 24—
MS. KALARIS: Would you go a little bit slower,
please?
[2702] DR. WILSON: Page 18 there is a typo and
line three. It should be, “suggests that benzene is at
worst a weak mutagen,” not “at most”’.
MS. KALARIS: Yes.
DR. WILSON: On page 24, in the various tables,
in all of these tables, that should read, for example,
on page 24, it should read on the first number, it should
be 10 to the power of minus 6. The minus 6 is put on the
same line as the 10 in all of these typings and it should
be read as a superscript.
On page 25, the third entry in the table, it is incor-
rectly typed. It should read five times 10-*.
On page 29, line nine, there is a correction because
here I was referring to the draft study, the Arthur D.
Little, which was done for OSHA, and the final study
has slightly different numbers in it. So that I will have
to correct these statements here.
On line nine it said “Calculated in the above OSHA
study,” it is $75 million for 12 months plus $250 mil-
lion capital cost, which, if I amortize at 10 percent,
corrected for inflation, it gives a total of $100 million
a year.
78
Then I would go on, “Corresponding to a cost of
$300 million for every hypothetical life saved”. Those
are the corrections, the ones that I found.
[2703] I will give you a brief summary and try and
put this in the framework that has already been men-
tioned. I would like to—well, I want to point out in my
testimony what I believe is a necessity of making a risk
estimate in any situation involving either the workplace
or an environment, whether it is a carcinogen or not.
It seems to me that,anyone who claims that benzene
is a leukemogen or a ¢arcinogen must put numbers into
a statement and preferably numbers into the dose so that
that automatically will give him some estimate of a risk
no matter how r gh it is‘and peoples’ reluctance to make
‘this estimate is’ in some sénses, to my mind, synonymous
with a reluctance to believe that benzene is in fact a
carcinogen.
Likewise, I believe that it should not make much dif-
ference to OSHA action whether benzene is found to be
a carcinogen or not or merely a suspected carcinogen.
OSHA, in its regulations, should be careful if it is a sus-
pected carcinogen and should put reasonable limits on
the dosage.
If it is found to be a carcinogen, there is no reason,
in my view, and I can’t see anything in the law either,
that there should be a sudden switch in what it does
and even though the emergency standard, the proposed
emergency standard, in the preamble, said something
about [2704] having to reduce to zero emissions, I be-
lieve that is not reasonable and one should make a risk
estimate in both cases in order to properly protect the
worker and if one insists on too low a risk, then one is
not protecting other workers enough because one may be
spending too much on protecting that one group and
without any benefit to that group.
Now. the dominant .feature, it seems to me, in the
emergency standard as promulgated and as I have heard
just a little bit of the questioning is the failure of OSHA
to put numbers into a risk and to state what relation
this proposed standard has to public health and par-
ticularly to health of the workers.
79
Without such a relation I don’t quite see how one
can usefully make a new standard.
Also, I want to emphasize that there seems to be
no emergency involved here. We have been using benzene
for 50 years. Indeed, we were using it at those levels far
higher than we are now using it. There have been no
dramatic cases of leukemia that have been standing out
all over the place and in fact, as the evidence has shown,
it is hard to prove that the cases of leukemia that have
been seen are indeed attributable to benzene.
Therefore, a short delay, while we try and understand
the situation, should not have catastrophic [2705] sig-
nificance. This is not a new chemical and it should not
be treated as such.
An emphasis has been placed on a simple yes or no on
whether it is carcinogenic or not. This by itself I be-
lieve is nonsense, particularly in today’s framework. 30
years ago when you had three carcinogens, radiation,
cigarette smoking, and beta-naphthalamene, I think.
Now we have about 150 known human carcinogens and
1,000 animal carcinogens and if we were able to look with
human beings with the sensitivity we can look in animal
experiments, most of these animal carcinogens would,
I think, be found to be human carcinogens.
Yet, the laws of science haven’t changed. These things
haven’t suddenly become carcinogens. They were carcino-
gens before. That is just what they are now.
I suspect that if we improve our techniques we will
find more suspected animal carcinogens and we have to
be careful about that.
We can put them on a scale now and in fact table
C of my testimony I put such a testimony which came
from a paper of Mr. Meselson and I put some limits of
benzene on that scale. We will see that at a worst it is
a very weak carcinogen compared with the strong ones
that we know how to deal with. We have examples. It
is also a weak mutagen.
[2706] On a direct carcinogen, which we have heard
about, mutagenesis, carcinogenesis, are usually related,
and that was the point, of course, of Meselson’s paper.
Benzene is at least 100,000 times weaker than aflatoxin
80
us a carcinogen. Aflatoxin we regularly eat with the
peanuts offered on American Airlines and Allegany Air-
lines and so on, and even available in the FDA cafeteria.
It is also a thousand times weaker than benzoapyrine
which we regularly pour at our workplace and environ-
ments and kitchens and fossil fuel burning, from our
ears and from charcoal burning foods.
Even if benzene is found to be a carcinogen in the
end, at the level of the limits I took, I believe that
OSHA should tackle the bigger hazard first. If indeed
it is correct that OSHA wants to have a policy of stop-
ping all carcinogens, they should stop smoking in the
workplace, particularly all hearing rooms, OSHA cafe-
terias, and anywhere where people work.
They should also stop people working anywhere within
a quarter of a mile of a car so that we don’t have—
which can be done. It is quite feasible. Maybe we should
wear gas masks. I worked several days with a gas mask
in the second world war as an air raid warden. For-
tunately only in practice.
It is possible for us all to wear gas masks in [2707]
the cities and it is feasible and that might be the tech-
nical meaning of the Act.
However, I think the right thing to do is to evaluate
the risk, see if the risk is sensible. It is indeed, as I
can testify. Wearing a gas mask does reduce one’s avail-
ability to do work. I have done it in order to show that
I could carry out my duties as an air raid warden while
still wearing a gas mask. It was possible but a lot harder.
Moreover, you know, we can measure these substances
and control them better than ever before. 30 years ago
if we found a substance that was found to be carcinogenic
it was not only potent but it was present’ in high con-
centrations.
The sort of policy that OSHA seems to be talking about
today might have made sense 30 years ago. Nowadays
we are finding weak carcinogens. We are finding them
in low concentrations. To make an absolute statement,
it is a carcinogen or not and making a change in rules
in accordance is to my mind wrong.
81
So that we have to do—now early in the hearing Pro-
fessor Zeckhauser testified and he quite correctly re-
jected putting a value on human life and his way of
talking about cost effectiveness analysis. In my testi-
mony I gave an example of how on a reasonable basis,
pessimistic [2708] basis, on how benzene might be a
carcinogen, this proposed standard, using the Arthur D.
Little study, will cost about $300 million for every hy-
pothetical life saved.
Spending that $300 million is not done without a waste
of life. We know that every time you build a building
lives are spent, about one for every $20 million spent in
construction. Now, that $300 million won’t all be in con-
struction but a rough estimate suggests that the $300
million, three other lives will be lost. So for saving one
hypothetical one we will have spent three. I believe that
1s not correct.
Now, the question therefore is we have to have a
yardstick in order to compare risks and benefits. The
public interest lobbying organization called The Federa-
tion of American Scientists in a study of carcinogenesis
a year ago called for such a yardstick.
The Federal Register on May the 22nd last year
Russell Train, Director of EPA, said one should com-
pare risks and benefits and said that is what they were
supposed to do and mentioned it was the new change in
policy. I hope they follow it.
It has been said—so, I think that is what OSHA
should be trying to do in the hearing and unfortunately,
it didn’t come in the preamble to the proposed state-
ment. The risk analysis that I try and present and the
comparison [2709] with other testimony are rough ones
because, as we have heard, the data on possible carcino-
genesis is rather rough.
gigs I think it is about the best one knows how
0 do.
So on the—if we take this conservative hypothesis one
would then come to a feeling, I would come to a feeling,
that although there may be some, a more careful study
might show it in some places, one could reduce this
standard below 10 parts per million without this huge
expenditure which is in the Arthur D. Little report.
82
neidentally, I would point out that is not an industry
be It “age Gait heanelnieaed report. One would
normally expect industry to be more pessimistic about
how much it costs and an OSHA-commissioned report to
be more optimistic. But this is the OSHA one.
So, in the Arthur D. Little report they do mention
something in the latest copy about the possible benefits
of this. But only in extremely rough terms. They make
no estimate about making a risk study, no attempt to
compare these risks with any other risks in society so as
to give one perspective, and so that I believe this is a
major defect in that Arthur D. Little study and in that
I completely agree with Dr. Zeckhauser that these defects,
although omissions in the Arthur D. Little study, are so
(2710] great that some of the details which he and other
people were also concerned about in that study are com-
tively irrelevant.
nl ee to make one more comment. The Arthur D.
Little study comments that the OSHA policy is that
putting dollar costs on risks is arbitrary. I would cer-
tainly agree it is somewhat arbitrary. It is, however,
done, as Dr. Zeckhauser commented in his testimony and
I would just add on one more place where it has been
suggested, and that is in the Nuclear Regulatory Com-
mission hearings, the so-called “as low as practicable
hearings” which lasted a period of two to three years
and was finally ruled on last year where they suggested
$1,000 for a man-rem of exposure which has a possible
level below which one should reduce radiation exposure.
They reached this by taking the most conservative
number that anyone had suggested to them and rounding
it on upwards to be as safe as possible. If you take the
same linear projection on cancer incidence that I took
in my study, this corresponds to a number roughly of
$10 million every hypothetical life saved and that is
somewhat less than $300 million which I estimate that
this proposed OSHA standard would take, according to
the Arthur D. Little study.
So that I believe, in fact, that such numbers have
[2711] been done in the Government, should be done
again, in fact, should be done very much more than they
have been in the past.
SE ~~
83
JUDGE LAWRENCE: Thank you, Dr. Wilson. Off
the record.
(Off the record discussion. )
MS. KALARIS: I would like to advise everybody
that we have in the back copies of page four, page five,
page eight and page 10 of Professor Wilson’s presenta-
tion.
JUDGE LAWRENCE: Page 30.
MS. KALARIS: Oh, that is page 30 of Professor
Wilson’s statement. Those pages were missing from
some of the copies obtained through the Technical Data
Center. So if you need them, they are out there in the
back.
JUDGE LAWRENCE: All right, any further busi-
ness? All right, there being nothing further, the hear-
ing stands adjourned and we will resume tomorrow morn-
ing at 8:30 a.m. Thank you very much.
* * * +
[2721] MS. KALARIS: Would you explain please what
you mean by a weak carcinogen?
DR. WILSON: Yes. If we look at my Figure 3 in
my testimony, this comes from the work of a colleague
of mine, Matthew Meselson at Harvard University. Now
he was very much impressed, as a lot of people have
been, that in a very large number of carcinogens, which
were found to be animal carcinogens, there is a direct
proportic-al relationship between the ability of this
chemical to produce revertance in a mutagenic test of
the type of Bruce Ames at the University of California.
The relationship between if you do a study on animals
where you do a lifetime study of feeding of this particular
carcinogen, and this graph is taking to those cases where
a lifetime study is available on animals, and there is also
a mutagenic study available.
It is quite significant in my mind that over a range
of approximately 10,000, some chemicals produce more
[2722] mutation activities than others by a factor of 10
to 100,000. Those same chemicals that are more potent
in producing mutations are also more potent in producing
cancer.
84
For example, on this curve the most potent one on the
curve, I am not sure it is the most potent carcinogen we
have—I don’t think so, is aflatoxin B, That is in very
small quantities it is known to produce cancer in animals.
Two parts per billion will cause according to the NIT
of that study by Jerry Wogan, will give 10 percent of the
rats cancer. Whereas if you do similar tests, for ex-
ample, on benzopyrene, whereas a test here is on Chinese
hamsters, you would find you would have to have a 30
to 40 times the concentration of the chemical to get the
same number of rats dying. If you do the same test on
saccharine, you will up the curve at the top right hand
corner, you will have to have a dose of 7'% percent of
saccharine in the diet, fed continuously, in order to pro-
duce 15 percent cancers.
So there is a very wide range, well over 100,000 into
the factor between the potency of some carcinogens and
others. These are, I would like to note, what one might
call direct carcinogens.
If benzene is a direct carcinogen, I put on this graph
where it might lie because if it is a direct carcinogen, it
would presumably show up on an Ames Test. It hasn’t
[2723] according to the information I have from the peo-
ple in Bruce Ames’ lab. It has been tested, and they
haven’t found anything. They haven’t found anything, I
don’t accept a yes or no as an answer to this sort of
question. :
[2732] MS. KALARIS: How do you define an insig-
nificant risk, Dr. Wilson?
DR. WILSON: Oh, the only way of regarding a risk
as insignificant, in my view, is very much a personal
question, and it has to be by comparison with others.
That is why I have always, in my own mind, I have not
been content with calculating risks of anything until I
have compared it with something else. Something else
particularly without getting involved with personally if
possible and something else which I can calculate on as
nearly as similar basis as possible. Then if one risk is
very much smailer than the other, say it was less than
10 percent, then I would tend to regard it as insignificant.
85
MS. KALARIS: On Table I you have calculated risks
for certain occurrences.
DR. WILSON: Table I? Yes, there it is.
MS. KALARIS: All right. What relevancy does that
sampling of ris have to the risk of developing leukemia
from occupational exposure to benzene?
[2733] DR. WILSON: That has less relevancy than
some of the later tables, but it—incidentally I have just
realized there is a misprint on line 2 of that, my division
can’t possibly be correct. Excuse me, I have line 2 with a
risk from falls of 17,000 people must be 9 times 10-° and
not 9 times 10°°. I must beg your pardon because it is
clearly the total number divided by.
The relevancy, to go back to the relevancy question,
these are risks which various elements are exposed to it
in various ways. Some are exposed to some and some are
exposed to the other. I personally try to avoid the risk of
firearms, I am never able to avoid the motor vehicles or
the falls or the fires or the eletrocution for example.
Those are risks to which we are all exposed to in life.
Now I would normally, the two aspects of which this is a
risk we ought to expose to whether we work on a subject
or not. If benzene work on an ordinary person, you would
have that risk.
Now risk of benzene is a risk in the working place.
A risk that is usually accepted, and I would think it
reasonable to continue, that if a limited number of people
in a limited occupation can be exposed to slightly higher
risk due to that occupation, than the general public.
There are a wide number of cases; otherwise without that
you would clearly have the obvious cases, climbing a scaf-
fold, [2734] fix a building. That is clearly a very risky
thing to do. You clearly stop the general public from
doing it, you don’t let them get up there. But you none-
theless ask a worker to do it. So that is not directly
applicable to worker, but it is so that should in general
those risks that you would expect you would allow a
worker have a sightly larger risk than those ones that he
is generally exposed to in that sense.
But those are just to give a perspective and nothing
much else.
86
MS. KALARIS: Thank you.
(Pause)
MS. KALARIS: Isn’t the significance of a risk rela-
tive? For example, in your written testimony, you cite
the example of no one reasonably worrying ®>dout being
killed in a hurricane. Now this might be true in the
United States, but it may not be true in another country
where hurricanes are an annual hazard. So isn’t it a
question of selection of priorities?
DR. WILSON: Oh, absolutely. Risk is certainly right
to question. Of course, there are numbers on hurricanes
in the United States which is also very important to note
that although a hurricane is widely defined to be an act
of God and of course in that sense it is. Nonetheless you
can protect against it and reduce your risk, and a [2735]
cautious person would look, in fact it is quite notable the
people who calculate risks in this business of calculating
risks, calculating them will in fact start avoiding hurri-
canes and choosing their airlines rather carefully and
so on.
MS. KALARIS: Would you agree, then, if one’s prime
objective is to protect as many workers as possible, one
may not be willing to accept a risk which entails a few
workers being exposed to a hazard?
DR. WILSON: I am sorry, I don’t understand the
question.
MS. KALARIS: We said that, if I understood you
correctly, you agreed that risks are relative.
DR. WILSON: Correct.
MS. KALARIS: Ok. If one’s primary objective is
to protect as many workers as possible from a particular
risk, one may not be willing to accept the risk which
entails few workers being exposed to the hazard. In that
case doesn’t the risk become a significant risk rather than
an insignificant one?
DR. WILSON: I am still not quite sure to understand
it but let me try to answer and see if I have got it
correctly.
There is a prime objective for protecting human life,
that is correct. In the framework of this hearing, [2736]
re
87
one can talk about that limit that particular groups of
people who are working people. Now indeed risk is a
variable question and as I said, it is somewhat an in-
dividual question. It is important not only to make sure
that the risk to all of society be s
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