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VRD 6002007654
Health Research group
20D0 P flREET. N. W. WASHINGTD'-!. D. . 2DD36
872-0320
February 21, 197^
Dr. Alexander M. Schmidt, Commissioner Food and Drug Administration 5oOO Fishers Lane Rockville, Maryland 20852
Dear Dr. Schmidt:
As you know, a rapidly rising number of cases of liver cancer (angiosarcoma) are being discovered in workers exposed to vinyl chloride. Combined with other human evidence of liver disease, an earlier study showing cancer in animals, and a recent study in animals demonstrating carcinogenicity with exposures as low as 250 parts per million, it appears that another common chemical has joined the growing list of environmental carcinogens.
Although the ma.jor use of vinyl chloride monomer is to make polyvinyl chloride (PVC), several percent of the billions of pounds of vinyl chloride manufactured each year goes into the production of other goods.
We have learned that a significant amount of vinyl chloride is used as an aerosol propellant- in consumer products including hair sprays. According to one published report (Aerosol Age, April 1964, p. 47), the levels of vinyl chloride, under conditions where hair spray was being used, can exceed 250 parts per million. (See petition, p. 2)
Several requests for action are detailed in the attached petition. In addition, we request that you make public the brand names of all aerosol cosmetic products presently marketed or marketed at any time in the past which contain vinyl chloride as a propellant. When matters of health and grave danger are at stake, the public has the right to be fully informed about the dangers it faces or has faced from using particular brand name products--rcgardless of the public relations damage that certain companies may suffer. All those people who have been exposed at any time to prod-i e containing vinyl chloride should be made aware of this so that they can inform their physicians.
Thank you for your consideration.
Sincerely yours,
VRIft 000 20 076 55
//
immediate
February 21, 1974
Further information: 572
Andrea Hricko Sidney VIolfe, M.D.
?U3LiC CITIZEN'S HEALTH RESEARCH GROUPS ASKS rCR 3AN OH VINYL CHLORIDE AS A PROPELLANT IM AEROSOLS
The Health Research Group today petitioned the Food ar.d Drug Administration, tho Consumer Product Safety Commission, and the Environmental Protection Agency to ban the use of vinyl chloride in aerosolized cosmetics, including r.airsprays , in aerosolized household products, and in pesticide products, since there is substantial -evidence that vinyl chloride is a carcinogen.
Vinyl chloride is known to be used as a propellant for aerosols. The chronic toxicity and evidence of carcinogenicity of vinyl chloride monomer for humans has been documented by scientific studies and clinical reports. Immediate action is necessary tc regulate the use of the chemical since there is no evidence tc sr.cw tr.at human beings can be safely exposed to the chemical.
Vinyl chloride monomer, `Which is used in. making polyvinyl chloride (PVC), has received much attention in the past few weeks since it has been linked with a rapidly rising number of liver cancer deaths among vinyl chloride workers at a single B.F. Goodrich plant in Louisville, Kentucky. In the past few days the sixth, case of the rare and invariably fatal cancer--angiosarcoma of the liver--nas been diagnosed in a worker at that plant.
Experimental studies have found production of the same type of liver cancer in rats after inhalation of vinyl chloride at doses as low as 2 5 C ppm [for 127 weeks'I > according tc an Italian study presented at a Department of Labor hearing on the chemical last Friday.
According to a published report, the levels of vinyl chloride-under conditions where hair spray is being ussd--can exceed 250 ppm (Aerosol Age, April 1364 , p. 47). Most industries--including B.F. Goodrich--say that it has been their practice in recent yot.rs
to try to keep industrial exposures down to 50 ppm over an 8 lour day.
[The Federal occupational health standard is currently 500 ppm.j
The Health Research Group also requested that tho Food and Drug Administration immediately prohibit the use of polyvinyl chloride (PVC) containers to package any cosmetic product which is capable cf leaching detectable amounts of vinyl chloride from its plastic container. Dn 1973 FDA and industry tests of alcoholic beverages packaged in PVC bottles determined that between 10-20 ppm of vinyl chloride had migrated out of the plastic bottles into the distilled spirits or wine they contained. To the Group's knowledge, no tests have been conducted to determine whether other alcohol-
containing or organic 5olvent-containing liquids (e.g. bath lotion
or perfume) can also leach detectable amounts of vinyl chloride from their PVC containers. Moreover, although the FDA proposed banning the use of PVC whiskey bottles in May 1973 because of the potential toxicity of vinyl chloride, the agency has failed to finalize the action.
lr. letters to the heads cf all three- agencies, the Group requested that the agency make public the brand names of all aerosol consumer products and cosmetics presently marketed--or marketed at any time in the past--which contain vinyl chloride as a propellant so that exposed people can inform, thair physicians. The public has the rizht to he fnllv in fnrr.pri about r.he hen~,er~ it faces or has faced--regardless cf the puoiic relations damage that certain companies may suffer.
U.S. DEPARTMr T OF LABOR
Occupational Safety and Health Administration WASHINGTON', D.C. 20210
INFORMAL FACT-FHIDING HEARING ON POSSIBLE
HAZARDS OF VINYL CHLORIDE MANUFACTURE
AND USE
'-Schedule of Appearances
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Friday, Feb, 15, 1974 Pre-hearing Conference- 9*30 a.m. Hearing - 10:00 a.m.
Conference Room B - Departmental Auditorium
Administrative Law Judge - Gordon J. Myatt
Office of Standards
- Joanne Goodell - Jeanne Ferr^ne
Office of the Solicitor - Evelyn Gholston
APPEARANCE
1. Mr. John O'Neill, Chief, Division of H;alth Standards 0SHA
2. Mr. Vernon E. Rose. Acting Assistant Institute Director for Research and Standards Development
NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH (NIOSH)
3. Dr. Irving J. Selikoff, Director Environmental Sciences Laboratory
MOUNT SINAI SCHOOL OF MEDICINE
4. Mr. Anthony Mazzocchi, Legislative Director OIL, CHEMICAL AND ATOMIC WORKERS INTERNATIONAL
5. Prof. Cesare Maltoni INSTITITUTO DI 0NC0L0GIA, Bologna, Italy
6. Mr. A.C. Clark, Vice President - Technical Director MANUFACTURING CHEMISTS ASSOCIATION
7. Mr. Anton Vittone, President Dr. Maurice M. Johnson, Medical Director Dr. Roger Strassburg, Director of Environmental Affairs Dr. L.B. Crider, Senior Scientist Mr. Harold J. Fast, Corporate Counsel and Assistant Secretary B.F. GOODRICH
8 Mr. Richard J. Reynolds, Manager Vinyl Chlobide SHELL CHEMICAL COMPANY
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9. Mr. Sheldon Samuels, Director
He.' 1th, Safety and Environmental Affairs
INDUSTRIAL UNION DEPARTMENT, AFL-CIO
Dr. Henry Anderson
MOUNT SINAI SCHOOL OF MEDICINE
Dr. Thomas F. Mancuso
UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH Mr. Louis Beliczky, Director of Industrial Hygiene
UNITED RUBBER, CORK, LINOLEUM AND PLASTIC WORKERS
10.
Dr. V.K. Rowe
Toxicologist DOW CHEMICAL COMPANY
11.
Mr. Herbert K. Carver, Jr. Design Engineer
'DOVE PACKAGING SYSTEMS DIVISION/FRANKLIN ELECTRIC
12. Professor R.J. Jaeger - Harvard
Occupational Safety and Health Services
ORGANIZATION RESOURCES COUNSELORS
13. Donald Holman, Industrial Hygienist CONTROL DATA CORPORATION - not oral - Exhibit 8
14 .
Dr. Roberts Brookman, Manager Research and Development
FIRESTONE Andrea Rickel Bertrand Cotteen
Health Research Group
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VRB 8002881662
MiK^Oijure ]
N10SU Recommended I'l'ccnut ionary Mnniiorinj', ami Contro] Procedures for Polymerization Processes Involving Vinyl Chloride
I. General Housekeeping Procedures
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A. The spilJage of Vinyl Chloride and Polyvinyl Chloride in and around the production facilities should be controlled as follows:
1. Housekeeping procedures should be implemented to assure immediate removal of VC and PVC material around polymerization operations including drying, packaging and loading operations.
2. Recovered PVC material which is to be packaged should be stored in closed containers.
3. Waste PVC material should be sLured in closed containers and consideration should be given to the adequacy of its disposal and/or destruction. Care should be taken in the storage of closed containers to insure that unsafe conditions do not result from an internal build-up of pressure in the container.
B. Inventories of beginning and recovered quantities of VC ar.d quantities of PVC produced, packaged and recovered should be made to determine losses and probable areas affected.
C. PVC material should be removed from overhead structures and conduits where it tends to collect.
D. Consumption of food should be permitted only in separate facilities provided for this purpose, and no food products should be permitted elsewhere in the polymerization facility.
II. Protective Clothing
A. A daily change of protective clothing including full covcraJ1 a, or tlie equilva1out, should be provided each employee in areas wh re possible exposure to VC PVC could occur. Clothing contaminated j accidental spills should he changed as soon as feasible.
B. Protect ive gloves and footwear, or footcovers, sliould be wo: a a.s appropriate in those PVC operations where exposure to PVC material is possible.
C. Protective head reivers should he worn during, PVC operations as appropriate (c.g. hard hats in Lho.se areas where physical protect Lon of the head is necessary and hair coverings, or the oquilvnlenc, ...
VkD 0002007663
opcruL ions such us cleaning oi polymer j zat Lou reactor trunks and packaging operations),
b. Whore emp Joyces arc engaged in ip;i i ntonam.'' or cleaning operuL ions of poly-met ir.it ii.>n reactors tanks they should war lull iniperv: ous suits to guard against, skin contact of PVC male-rial and VC vapors. Procedures for .safe unity to confined spaces should bo observed.
ill. Showers
Showers al l lit* t o t mi n;i t i on of an eight-hour work shift should be mandatory lor all workers with possible contact with VC-I'VC.
IV. Monitoring
A. Environmental Monitoring
1. In-planl environmental monitoring programs should be i mpleinon Let!: and where workers are required to rni or polymerization tanks, a survey of the VC concentrations should be made in the reactors immediately after opening, immediately prior to entry of maintenance personnel and during the tank cleaning operation.
2. Data obtained from the environmental monitoring program should be used to indicate those areas where efforts should be directed to reduce airborne levels of VC.
3. Positive programs to initially control VC levels well below the present Federal Standard of 500 ppm should be developed (some companies ore targeting at 50 ppm) and efforts to further reduce levels should be given consideration concomitantly with the necessary modifications in engineering and design controls.
4. The concentration of VC in exhaust ventilation should be determined to estimate the amount of VC lost during operation and the possible exposure of personnel immediately outside th facility.5
5. Monitoring for J'Y'C particulate material should he accomplished to estimate: the degree of exposure to this subst :nce throughout Lhe facility.
B . Personal MoniLoring
1. I n togra t -d , o I gh t-i:uur personal ii.mi i tor i up s.a ,p L os snuc.i oblaincJ lro::i Liios.- i-mployeos considered lu receive the greai.--.-L exposure to VC or PVC.
VRD 0002001664
2. breathing xone samples should be obtained to complencmt environmental monitoring program for VC, and similar samples should be obtained for PVC.
V. Respiratory Protection
because VC is a gas under ambient conditions ami PVC is a solid under these conditions, it is recommended that respiratory protection for employees Lake these circumstances into consideration.
A. Where employees are engaged in cleaning and maintenance operations inside polymerization reactors they should be equipped with an atmosphere-supplied respirator in order to protect against both VC vapor and PVC particulates.
B. During housekeeping procedures and packaging operations where the possibility of PVC dust inhalation is a factor, it is recommended that an air-purifying respirator equipped with a mechanical filter designed to remove particulate material be worn. Respiratory protective devices which meet this requirement, as well as protect against VC vapors in concentrations less than 0.1% have been approved by the N10SH Testing and Certification Laboratory and bear the numbers: TC-23C-40, TC-23C-47, TC-23C-48.
C. Where employees are engaged in transfer operations of VC from railway tankcars to storage facilities or at any similar transfer point which requires manual operations, they should wear a selfcontained breathing apparatus (SCBA) during such operations to guard against unexpected release of VC during such operations.
D. Other operations involving possible exposure to VC or PVC should be evaluated as the individual situation exists and respiratory protection provided as appropriate.
VRD 0802007667
DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE
PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION
WASHINGTON. D C. 20204
January 31, 1974
Jerome Heckman, General Counsel The Society of the Plastics
Industry, Inc. Keller and Heckman 1150 17th Street, N.W. Washington, D. C. 20036
Re: PVC Prior Sanction Proposal
Dear Mr. Heckman:
We are enclosing a copy of the memo concerning our conference of
December 20, 1973. This memo is being sent to the Hearing Clerk, today
Sincerely yours,
*\
Gerad L. McCowin Assistant to the Director Division of Food and Color Additives, HFF-334
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Nearing Clerk, HFC-20
FEB 5 W4
Division of Food and Color Additives
Prior-sanctioned polyvinyl chloride (PVC) resin proposed rulemaking, 38 FR 12931 (May 17, 1973)
On December 20, 1973, we held a conference between FDA personnel and representatives of the Society of the Plastic Industry, Inc. (SPI). Present for SPI were J. H. Heckman, General Counsel for SPI, and D Dixler, Ph.D. of Mr. Heckman's office. Purpose of the conference was to advise SPI of that data which is considered necessary before a final decision can be made concerning the subject proposal.
We first discussed the toxicological aspects involving PVC and mentioned an article by Dr. Viola, A. Bigottl, and A. Caputo -- "Oncogenic Response of Rat Skin, Lungs and Bones to Vinyl Chloride," Cancer Research 31; 516522, May, 1971. We requested that they conduct an extensive review of the literature concerning the toxicity of PVC and prepare a treatise con cerning the applicability of the Viola study and inhalation data to the use of PVC as packaging materials. We also requested that they submit data from feeding studies of at least 90 day6 but possibly longer depen dent upon the results. We suggested that they determine if the monomer could be administered by encapsulation or freezing.
We next discussed the data contained in comments filed by SPI with the Hearing Clerk in their letters of October 16, 1973, and November 30, 1973.
In regards to the chemical data supplied by M&T Chemical Co. and Continental Can Co., we requested the following:
1. Provide a validated analytical method for the monomer sensitive to 50 ppb^ plus a mass spectrographic method of the specificity of VCM. The former method should be validated with recoveries of at least 902 and should yield a gas chromatograph peak response of at least 20 mm. The method would be validated by FDA laboratories.
2. Describe the procedures for handling the VCM sample before and during the analytical procedures.
In regards to the other data submitted by SPI in their comments and Schenley Distillers Inc. in their comments, we requested the following:
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Page 2
1. (a). Provide equilibrium extraction tests on the new PVC compound usin'* the other food simulating solvents in addition to ethyl alcohol.
(b). Provide data involving storage for longer periods of time to
show the relationship of VCM migration from the new PVC formulation as a function of time using 50% alcohol and edible oils. Such data should also be provided for the old PVC formulation.
2. Provide a method for the determination of VCM in the PVC resin and/or
compound.
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3. Provide a description of the new manufacturing process for PVC resin and/or compound.
4. Provide data on the VCM content of PVC bottles produced from a formu lation of 50% reground polymer with 50% virgin resin,
5. Provide data on Japanese manufacturers1' PVC compounds including descriptions of resin and compound preparation as well as VCM levels.
6. Provide more definitive data and discussion concerning the possibility of migration of VCM from cans and bottles which have coatings and plastisols containing PVC. It was noted that FDA's immediate reaction was that there appears to be no problem of monomer migration in this area but that more data would be desirable, particularly as to differences in resins used for these applications as compared to those for rigid containers.
Mr. Heckman stated that he would relay our requests to the SPI and its
members. It was agreed that the substance of the conference should be submitted to the Office of the Hearing Clerk for enclosure in the comment file for the subject proposed rulemaking.
Gerad L. McCowin
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Date 2/1/74
I have included only the Washington Post enclosure in the attached letter since you have already received the Goodrich release and the Wall Street Journal article.
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VRD 0002007677
~1 COKTAui.: Jolxn J. Bell (21G) 379-3549
Cleveland L-vne (?.1G) 379-3410
703 73 ^MEDIATE nXEASE
iltnCCT, Jen. 22 -- The .?,Goodrich Cc-p^ay today reported that it Info" od ilentuchy health officials cad the Federal KaClensl Institute of Occupational Sr-fcty c.od `dealth that the Company is investigating whether the cmccir deaths of three employes in the polyvinyl chloride operations at its Louisville, 7*y. plant were related to occupational causes.
Br* Ksurice tf. John.? on* the Company's director of environnsatel health, stid ho lied recently received radical reports concernin'; the death of an ertploye Icte in December. A review of ctdical records uncovered chat fcvo other employes bed apparently died from the sane cause -- cae in Septurber, 1971 and one in Hatch. 1973. The reported causes of death are subject to verification, be added.
"Awarenass of this grouping," csid Dr. Johnson, "warranted a thorough investigation r*d prompt notification of the two government sgencicc nost directly concerned."
The 3.7.Goodrich Cor.pnny bro been co*-.ductir;g progress to reduce exposures to hydrocarbons, particularly vinyl chloride, throughout its operations, h^ilc 'h l plants wore operating at levels well below1 these preoevibou ly Fcdcnl goveuuronl* atce'erds, a successful effort has been u:-fa to reduce lev ole iu these plants to epprev. lately one-tenth those
npccifled.
(r-ore)
IL9LBBIBM 1ft A
These effort3 have included development of the cost rophlaticatcd
i^n.itori3 cystc^r- crj hnrjvm; ottfet: rule3 on procedures vhcre exposure
ir'ght hz Increased; a ccrnlete checking of All pipes, valves end clndlcr
equipment
pi'-vcat Icr/s, /red r::tcr.:;iva icprovr.r-ents In vont Hation
cysecras.
nTha death In December, considered in relation to the
previous
5f;.:ller cases, hr a cr-ur-c d uc to initiate intensive investigations
throughout the vinyl pro ducts cpercSiots of the Ccr'.pcny," Dr, Johnson caid.
{t7o bo. cute vfc sat the beat independent evaluation and guidance,
toe Ccrcpaay has engaged Tw.-ersha^-Ce'Oper Associates, Inc, of Berkeley,
Cslif* Dr. Irvins lu Ttberchsv, one of tbs country's foremost experts in the field of public end occupational health and safety,, is supervising
the t-orlt of this consultant fira," Dr. Johnson said. The Cc.cpfJty has instituted u prog/rara cf explaining the nev infortAtloa
c.rd steps tha Company iu taking to ail capI oy.ee involved in vinyl products
production. In addition, the Coup any has put into action a program, to reduce exposures to vinyl chloride and other hydrocarbons to the ninimm
possible in ell vinyl operations. Operations of the plants sre continuing
vender the program of rjir.lrrjai exposure levels.
(Vs are providing radical ca.v/.inscions to all employes involved in
r/.y phase of vinyl chloride or pol> vinyl chloride production and rcviovir.g
,17.able uicaj! records of any tk-ecac cd ferr-?.r or rot* red employes
Dr.. Johnson mid,
l,i;C h;AVC >!Vjsuted officials of UiOoH and tiag state of Kentucky that vill cor,'.: ir.ua to provide the:; '..liu oay ... / ilficanu sc\j infonccti.cn r.c it dc-valops,> t v1>~ r.nid.
"0-
1-2374
6L91BBISBB flil/l
1
A tetri of expert..'; from the National Institute for Occupational Safety am) Health of the Center for Disease Control will visit a Louisville, Ky. , plant of the 1*. F. Goodrich Co. tomorrow to begin an investigation of health hazards involved in the polymerization of vinyl chloride.
The team will begin its; work in response to an alert from the company vdiich reported one case of liver cancer and three cases of angio sarcoma, a rare type of liver cancer, among polymerization workers at the plant.
Dr. Marcus K. Key, director of UIOSH, said the institute also will step up its effort to determine the extent of the disease in the United States and in foreign countries with similar manufacturing processes.
At a later date, Dr. Key said, NIOSU wifi transmit criteria for a health standard to the Occupational Safety and Health'Administration in the Department of Labor.
Under a 1970 law, NI0SJ1 is responsible for health effects research and criteria used by OSHA to set and enforce standards for protecting health and safety at the workplace.
In the interim, Key added, NTOSH will work v*ith OSHA, the Kentucky Occupational Safety and health Administration, the industry and involved workers to develop stringent work practices for use i.n the polymerization pvoeci
VRD 06020076 84
N.
DEPARTMENT OF LABOR
Office of the Secretary
POSSIBLE HAZARDS OF VINYL CHLORIDE MANUFACTURE AND USE
Request for Information and Notice of Fact-Finding Hearing
Notice Is hereby given that the Oc cupational Safely and Health Admin istration is requesting information on possible hazards associated with the manufacture and/or use of vinyl chlo ride (chloroethene, Chemical Abstracts Service Registry Number 75014).
The Administration requests informa tion Including, but not necessarily lim ited to:
(1) The toxicity of vinyl chloride; (2) The toxicity of other chemicals in volved in the manufacture and use of vinyl chloride;
(3) The tccluiolop.ics Involved in the production and use of vinyl chloride:
(4) Employee populations potentially or actually exposed to vinyl chloride or other chemicals, and involved in the pro duction and/or use of vinyl cliloridc;
(5) Epidemiological studies of eifccLs of vinyl diloride and other chemicals used in the manufacture or use of vinyl chloride on populations, employee or otherwise; and
NOTICES
(6) Whether ...c available Information warrants the issuance of an Emergency Temporary Standard, or the commence ment of a regular rulemaking under sec tion G(b) of the Occupational Safely and Health Act.
Written data may be mailed or deliv ered to the Office of Standards, Attn: Docket OSH-3C, Occupational Safety and Health Administration, Room 203, 1720 M Street NW,, Washington, D.C. 20210, not later than February 28. 1974.
The data will be available for public in spection and copying at the OSI1A Public Reading Room, Room 203,1720 M Street NW,, Washington. D.C. 20210.
Oral'presentation of data will also be received by an administrative law judge at an informal fact-finding hearing be ginning at 10 a.m.. c.d.t., on Friday, Feb ruary 15, 1974, Conference Room B, Detmental Auditorium, Constitution Avepartmental Auditorium, Constitution Avenue NW,, between 12th and 14th Streets. Washington, D.C.
Persons desiring to appear at the hear ing must file with J. Goodell, Attn: Dock et OSH-36, Office of Standards. Occupa tional Safety and Health Administration, Room 203, 172G M Street NW,, Washing ton, D.C. 20210, a written notice of in tention to appear, in triplicate. Notice should be filed as soon as possible, but will be accepted by the Management Offi cer at the hearing until the pre-hearing conference begins. The notice should state: The name and address of the person wishing to appear; the capacity in which he will appear; and the approx imate amount of time required for the presentation. The notice should also in clude, or be accompanied by, a brief statement of the presentation to be made.
Beginning at 9:30 a.m.t e.d.t., on Feb ruary 15, 1974, the presiding Adminis trative Law Judge will hold a pre-hearing conference in order to establish the order and time lor the presentations, and in order to settle any other matter relat ing to the proceedings.
The oral proceedings shall be reported verbatim. The use of prepared statements by witnesses is encouraged. All documents that arc intended to be submitted should be submitted In triplicate (original and two copies).
The administrative law judge shall have all the powers necessary or appro
priate to conduct a fair and full informal hearing, including the powers:
<a) To regulate the course of the hear ing;
(b) To dispose of procedural requests, objections, and comparable matters;
(c) To confine the presentations to matters pertinent to the requested in formation;
(d) To regulate the conduct of those present at the hearing by appropriate means;
(e) In his discretion, to question and permit questioning of any witness; and
(f) In his discretion, to keep the record open for a reasonable stated time to rccclvo written data from any person who
has participated in the oral proceeding.
Following the close of the hearing, the
lA
presiding officer shall certify the record thereof to the Assistant Secretary of Labor for Occupational Safety and Health.
6igncd,at Washington. D.C., this 28th' day of January 1974.
John II. Stenper,
Assistant Secretary of Labor.
I Fit Doc. 74-2604 Filed l-20-74;8:45 am]
FEDERAL REGISTER, VOL 39, NO. 21--WEDNESDAY, JANUARY 30, 1974