Document MxQ91pr6v64XdeZ8gVwgjOaV
JOSEPH E. HKixr.n JEUOHE H. UECICMAN CHARLES M. MEEHAN WILLIAM H. BORGJTNSANI, JR.
ROBERT R.TIERNAN WAYNE V. BLACK DAVID L. RILL MARTIN W. BERCOVICI EDWIN B. SPIEVACK PETER M. NEMKOV JOSEPH E. HADLET CAROLE C HARRIS WILLIAM W. POOH
s
LAW OFFICES Keller and Heckman
1130 17T? STREET, N. W. SUITE lOOO
WASHINGTON, D. C- 2003
May 14, 1974
r.oi-vc- pse-c&u
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TELEPHONE eoa eoo-2too CABLE ADDRESS "KELMAN"
TO: All Members of:
SPI Pood, Drug and Cosmetic Packaging Materials Committee;
General Polyvinyl^Chloride Interest-
Mailing List; / '
Ad Hoc Liquor Bottle Committee; PTastic Pipe Institute
(Executive Board); . Plastic Bottle Institute
(Voting Representatives); SPI Executive Committee; SPI Public Affairs Committee; VC and PVC Producers Ad Hoc
Committee
Gentlemen:
This week's updating of the status of regulatory and related activities affecting the vinyl chloride and polyvinyl chloride industries concerns mainly the publi cation by the Occupational Safety and Health Administra tion (OSHA) of its anticipated proposed permanent standard for vinyl chloride exposures. This proposal was published in the Federal Register on Friday, May 10 and, as anti cipated, looks towards the setting of a "no detectable" level of VC exposure. We are enclosing a copy for the
iiconvenience of any of you who do not receive the Federal
t&sRegister. Although we will be filing Comments oh this
proposed rulemaking and will be requesting a Hearing as the Notice provides, on behalf of SPI, those of you who so wish should certainly consider filing your own Comments with OSHA.
From a procedural standpoint, we anticipate that events will move somewhat as follows:
1. Comments will be filed on OSHA's Intention to File an Environmental Impact Statement in substantially the form that we circulated to you.
see
May 14, 1974 Page Two
2. In connection with the proposed standard for vinyl chloride, we will
request that the time for filing Comments on the rulemaking be extended for an additional thirty days.
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3. A request for a Hearingwill.be filed and will ask that the Hearing commence on or about August 1, 1974 .so ' -V- - v
as to allow us adequate time to prepare our case. It will be our intention to . * ! present expert witnesses to testify to the safety of a step-wise reduction of permitted ambient VCM levels, and engineering estimates of when the various steps can be achieved from an engineering standpoing.
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In connection with the Hearing, it will also be our intention to provide expert testimony regarding economic effects that could be anticipated if exposure standards are set so low as to require the cessation of PVC production.
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/ ;y *
In connection with the OSHA activity, you may already know that a working conference on vinyl chloride toxicology was held in New York on May 10 and 11 under the auspices of the New York Academy of Sciences and several other groups. A memorandum summarizing the conference reports and discussions is attached. Briefly, it can be stated that the scientific consensus of the conference was that vinyl monomer does pose an industrial hygiene problem but that its complete dimensions are not clearly understood, and that it does not appear to be an uncontrolled major problem. From a political point of view, however, it ap-. pears clear that certain groups are prepared to speculate about conceivable major threats to the world population and respond to these conceivable consequences as if they
were imminent dangers.
see 2-0176
May 14, 1974 Page Three
Nothing in a substantive way can be reported
at this time regarding Envirnomental Protection Agency
(EPA) actions, although a.variety of EPA taskgroups
are studying the vinyl chloride problem from an emissions
and disposal, point of view. It should be mentioned that
if any of you have hard data regarding the fate of.vinyl
chloride in any waste disposal streams (for example, air
or aqueous emissions), it might be helpful to provide
this information to EPA.
'
Regarding the anticipated Food and Drug Admin istration's actions, the Federal Register publications are still in the "within a few weeks" category. However, the Food and Drug Administration is now beginning to receive some of the requested information from a number of sources and we hope that all of you who have extraction and residue information are preparing and submitting it to the Food and Drug Administration.
~ We hope that this report and the enclosures will continue to keep you reasonably well informed. As you can see, our most immediate problems are associated
with OSHA activities. Nevertheless, we will continue to monitor all the various phases of the issue as best we can and will report to you as fully and promptly as is practical.
Enclosures
see 2-0177
* V\<.rr.& *. f\
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...
Report
Toxicity of Vinyl Chloride-Polyvinyl Chloride Working Group Conference ' May 10-11, 1974
A working .group dealing with the toxicity of vinyl chloride (VC) and polyvinyl chloride (PVC) was - assembled at the Delmonico.Hotel in New York City on May 10 and 11 under the sponsorship of the New York Academy of Sciences, the American Cancer Society, the National Institute of Environmental Health Sciences, the National Institute for Occupational Safety- and Health and the Society for Occupational and Environ mental Health. Although in its original concept the meeting was intended to involve only a selected group actively concerned with the problem of VC-PVC toxicity, the requests for admission became so numerous that it became an "open meeting." I believe that as many as 500 people may have attended. As you are by now aware, it received wide press coverage. \
The first portion of the conference concerned reports (including reports from Europe and Japan) of industrial hygiene and disease problems associated with worker exposure to VC. In general, reports ranged from general malaise, through loss of consciousness to the development of skin and bone malformations and damage to the spleen and liver. Many of the reported symptoms appear to be reversible, and in all cases the reduction of atmospheric concentrations of VC in the work areas appeared to eliminate the development of new cases.
A second section of the conference concerned experimental observations and theories regarding the development of angiosarcoma as a "final" transformation of liver tissue resulting from a defined series of changes. In addition, interesting papers were presented concerning the pharmacology and biochemical transforma tions that VC might undergo after inhalation .
sec 2-0178
2
Still another portion of the conference was'.'
devoted to reports on the mortality studies and health .'
surveys being conducted by a number of different groups.' ' :
Of considerable direct interest was a preliminary re- '
^
port of the MCA-sponsored Tabershaw-Cooper study.' .In-'"1
particular, the group was able to follow up 85%.of the-:
cases. There appeared to be no excess cancer in the : " /
groups exposed to PVC but where cancers did occur, there'
appeared to be a positive correlation with time and in-
5
tensity of exposure although not of statistical signifi- '?
cance. A summary of the Tabershaw-Cooper report is -
.
attached hereto.
--
Still further, Professor Maltoni presented some V. additional data and indicated that at 50 parts per million exposure, his Sprague-Dawley rats showed tumors after one year (he also reported that Wistar rats are only onefifth as sensitive as the Sprague-Dawley strain). Professor Maltoni suggested that all the various effects he noted might be attributable to changes in vascular permeability.
'W. f-' *
The final section of the conference was devoted to problems and perspectives. Here, reports were pre sented concerning batteries of clinical tests being used to monitor workers in the VC-PVC producing industries. Still further, there was discussion of the general risk involved to the entire population and to those directly involved in VC handling. There was a marked divergence between expressions from the scientific community and representatives of labor unions and "public interest" groups. The scientific commentators seemed to be trying to assess the true risks associated with various levels of VC exposure and to strike a balance between the societal risks and benefits associated with specific levels of exposure to VC. The union and public interest groups tended to speculate more freely and to look upon their speculations as the justification for extreme responses.
Because the meeting was intended to be a forum for on-going, even preliminary work, no formal "Proceedings" will be published.
Respectfully submitted,
Daniel S. Dixler
see 2-0179
EPIDEMIOLOGICAL STUDY .OF VINYL CHLORIDE WORKERS Final Report - May 2, 1974
J. tV. >'CV
. I. SUMMARY
Eight thousand three hundred and eighty four men who had had at Least
one year of occupational exposure to vinyl chloride before December 31,
1972, were followed in a historical prospective mortality study; The
major findings of the study are:
1. The overall mortality of the study population was
approximately 75 percent of what would.be expected in a
comparable population of U. S. males*
2. No caiise of death showed a statistically significant
excess over what would be expected in a comparable U. S
-male population.
3. No new deaths identified as angiosarcoma of the liver were
found.
A
. *+.* *
4. .All previously known Angiosarcoma deaths in the study
population during the study period were found as part
of the routine study procedure. * ...
5. Cancers of the liver (primarily angiosarcoma), respiratory
.system, brain, and cancers of unknown primary site, as
well as lymphosarcoma, occurred more often than expected in
those members of the study population with the greatest
exposure. Even though the excesses were not statistically
significant, the findings warrant further study.
6. Other cancers occurred at lower levels than in the general
male population,* with the exception of cancers of the
buccal cavity and pharynx. There was an excess of these
see 2-0180
2 -' .cancers, which however was inversely related to exposure.' . The explanation for this finding is not apparent.
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t4 see
1C39G
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^
` PROPOSED RULES
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<c) The Deputy Administrator, Vet have been occupationally related.1 As a the level, from a ceiling of 500 ppm to 50
erinary Services, upon request to him. result of this notification and after con ppm ceiling. It was expressly recognized
may approve other identification systems sultation with the National Institute for that tiffs standard limiting exposures lo
in specific eases and under such condi Occupational - Safety and Health a 50 ppm level was Intended to be a ten
tions as lie may prescribe if he deter (NIOSH). and a joint inspection of the tative, Interim standard, to be in effect `
mines that, such systems provide the plant by OSHA, NIOSH. and the Ken no longer than six months, during which .
necessary information to allow for trace- tucky Department of Labor, a fact-find -time the whole question of possible safe
bach of the swine to 'their herd of origin. ing hearing on possible hazards involved exposure to VC would be reconsidered
Any person who wishes to submit writ with the manufacture and use of VC .more fully and In the light of more in-,
ten data, views or arguments concerning was announced on January 30, 1974 (39 formation, especially results of experi
the proposed amendment may do so by filing them with Deputy Administrator,
FR 3874) and held on February 15, 1974. 2. Carcinogenicity of VC. Information
ments wliich were known to be under- >
way at that time.
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Veterinary Services, Animal and Plant produced at this hearing demonstrated
4. Additional information. On April 15,
Health Inspection Sendee. U.S. Depart that exposure of laboratory animals 1974, Information and data were pre-v
ment of Agriculture. Hyattsville, Mary land 20782 before August 12. 1974.
(mostly Sprague-Dawley rats) to VC by inhalation at and below the then current
sented lo representatives of OSHA. '* NIOSH and the EPA by the Industrial ..-~
All written submissions made pursuant - OSHA standard of 500 ppm Induced Bio-Test Laboratories. Northbrook. 2111- '
to tliis notice will be made available for tumors, including angiosarcomas of the nois, concerning results of animal ex- ; -- -
public Inspection at the Federal Build liver. Professor Cesare Maltonl, of the posure studies with VC, sponsored by the
*
ing, 6505 Belcrest Road,' Room 870, Instituto di Oncologia,- Bologna, Italy, Manufacturing Chemists Association -5
Hyattsville, Maryland 20782, during reg reported on a series of experiments on (MCA) i1 Although only preliminary in v
ular hours of business (8 a.m. to 4:30 the effect of exposure of rats, mice, and nature, these results revealed that 2 out-rf-4
: pm., Monday to Friday, except holidays) in a manner convenient to the public
hamsters to VC at concentrations of 10,000: 6,000; 2,500; 500; 250; and 50
of 200 mice exposed to VC concentrations V-'-/of 50 ppm for 7 hours a day, five days a
business (7 CFR 1.27(b)).
ppm for varying periods of time (TB- week, for approximately 7 months, de- ---
Comments submitted should bear a 43-63). Some of the experiments have vcloped angiosarcomas of the liver. 1. --r
reference to the date and page number been concluded, and others are still on
The Industrial Bio-Test Lab data in-X" * <
of this issue In the Federal Register.
going. The experimental results reported' dicate that exposure lo VC at 50 ppm ' . -
Done at Washington, -D.C., this 7th were that tumors have been observed In may well constitute a serious health haz- ^
day of May1974.
,,
PierrC A. Ciialoux. ' Acting Deputy Administrator, , / Veterinary Services, Animal
':,i'and Plant Health-Inspection .. .: Scrafce.-
groups of animals exposed to VC at con centrations as low as 250 ppm. No tumors were observed In the group of animals exposed to VC at a concentration of 50 ppm. It also appears that the total num ber of tumors, as well as the numbers of angiosarcomas of the liver, decreased
ard to employees. Also, the question of a safe level of exposure for humans can- ' -V1 not be determined at this time, and may . . -I continue as a matter for scientific de- "
liberation for many years. We therefore . t; \ conclude that it is now necessary to pro- *. * pose to change the 50 ppm level estab-
' ini Doe.74-10882 Filed. S-0-74;8:4S am] ; as the concentrations of VC were reduced fished in the ETS to as low a level as can ; ;
to 250 ppm. Another experiment by Pro be detected using methodologies outlined . :j
- -' .DEPARTMENT OF LABOR
~ Occupational Safety and Health . . Administration
fessor Mallohi was reported underway involving the exposure of 300 animals to VC at concentrations of 50 ppm, in order to assess In a more definitive way
In this proposal. (5) The proposed permanent standard.
The requirements for a complete stand ard under section 6(b) of the Occupa
. ' [29 CFR Part 1910] .
whether that level of exposure produces tional Safety and Health Act of 1970
[Docket OSK-3G] ,
tumors in animals. - Data reported by are much more comprehensive than the Torkelson, Oyea and Rowe (American. provisions of the ETS promulgated on
-VINYh CHLORIDE
rJ Industrial Hygiene Association J 22: 254- April 5. The following proposals are re
> Proposed Standard
- * 361 (1961)) Indicate that exposure to .VC-at concentrations of 50 ppm failed to
sponsive to the additional information _ on the carcinogenicity of VC, and the
i. Background. Vinyl chloride (chloror induce tumors in rats, hamsters, rabbits, requirements of the Act.
. ethene) Chemical Abstracts Service and dogs. *
A, Level of exposure. The proposed
. Registry No. 75015, is a synthetic chemi cal made by oxychlorlnation of ethylene or by hydrochlorination of acetylene. It
Is the parent compound of a series of tliemoplastlc resin polymers and co polymers which.are widely used for con tainers. wrapping film, electrical insula' tion, pipe, conduit, and a variety of other products. Vinyl chloride has been made
The employees of the B. F. Goodrich Chemical Company who died from angio
sarcoma of the liver had on average ex posure of approximately 19 years to vinyl chloride, at* unknown concentrations, and variable exposures to other volatile chemicals. (TR 93). Some employees of Union Carbide, Firestone Tire and Rub ber. and Goodyear were also reported in
standard for employee exposure is set, at no detectable level, as determined by a
sampling and analytical method capable
of detecting vinyl cliloridc at concentra tions of 1 ppm with an accuracy of 1
ppm-50 percent. Although more sensi
tive methods may be available now or In the future, the methodological sensitivity proposed appears to bo the most feasible
commercially in tills country since 1939 and present production Is in excess, of
post-hearing comments to have had ex posure to vinyl chloride and to have died
and generally available. A method of 1 ppm sensitivity has been recommended
- seven billion pounds per year.
from angiosarcoma of the liver. Finally, to OSHA by NIOSH. To minimize the
Vinyl chloride (VC) is a gas at am autopsies of four deceased employees re number of persons at risk, a require
bient temperature and pressure and Is a vealed their liver angiosarcoma tumors ment would be established for regulating
chlorinated hydrocarbon which has wero histologically indistinguishable areas where vinyl chloride is manufac
moderate liver toxicity. The previous from the angiosarcoma tumors observed tured, reacted, stored, handled, released,*
standard set a ceiling value of 500 parts in Professor Maltoni's experimental repackaged, or used, including opera
pcfmlUion (ppm) (29 CFR 1910.93, Table G-l).
On January 22,1974. the Occupational Safety and Health Administration (OSHA) was informed by the National Institute for Occupational Safety and Health (NIOSH) that the B. F. Good rich Chemical Company reported that
animals.
3. The Emergency Temporary Stand ard. On the basis of all information available at that time, and the fact that employees were being exposed at levels around the experimentally observed ef
fect level of 250 ppm. an Emergency Temporary Standard (ETS) was promul
tions with polyvinyl chloride containing detectable levels of vinyl chloride. Access lo the areas would be limited to author ized employees.
13. Monitoring. A program of monitor ing would be required lo establish
whether there are detectable levels in
regulated areas and to permit determina
deaths of several of its employees from gated on April 5, 1974 (39 FR 12342) as tion of employee exposures on an in
a rare liver cancer (angiosarcoma) may 29 CFR 1910.93q. This standard reduced dividual basis. Provision would also be
FEDERAL REGISTER, VOL 39, NO. 92--FRIDAY, MAY 10, 1974
see -0 18'
PROPOSED RULES
^
. *Y -1GS97 '
ft.;;^V:made for an opportunity to observe record to an employee's physician on the (5) "Decontamination"'means reduc- ' -/lirinonitoring by employees or' their clcsig- employee's request. Establishments con tion of vinyl chloride concentrations to : ft'r -na'.ed representatives, as required by sec- ducting VC operations would be required less than detectable levels.
, lion <c> (3) of the Act.
to Identify themselves to OSHA, and to (6) "Detectable level" means an air
I/*,:C Control methods. Where detectable report incidents (accidents) resulting in borne concentration of vinyl chloride
-^levels of VC are monitored, two pro- the release of vinyl chloride.
measurable by a sampling and analytical :
VjiiV*-grams would be triggered; an englncer-
Accordingly, pursuant to sections 6(b), method capable of measuring concentra-
.-5 -.0.-7;.- fog and work practice program to reduce. G(c), and 8(c) of the Occupational tlons of 1 ppm, with an accuracy of 1.
V4.Vf. y.levels below detectability; and while this Safety and Health Act of 1970 <84 Stat. ppm50 percent.
is on-goln^', a respiratory protection pro- 1593. 1596. 1599; 29 U.S.C. 655. 657), Sec
(7) "Director" means the Director, Na- `
`gram for employees In the regulated area. retary of Labor's Order No. 12-71 (36 FR llonal Institute for Occupational Safety ',
,^'vV' Engineering controls and work prac- 8754) and 29 CFR Part 1911, it Is here and Health, or any person directed by
tices arc favored methods of compliance by proposed to amend 29 CFR. Part 1910 him or the Secretary of Health, Educa- '
because they tend to avoid contdmina- by revising 1910.93q as set forth below. tion. and Welfare to act for the Director.
tion of the ambient air in the workplace. Written data, views, and arguments (8) "Emergency" means an unforseen.
^Accordingly,' it is proposed to require Lire concerning the proposals may be mailed circumstance or set of circumstances, re
v .r-S institution of engineering controls and to the Docket Officer, Docket OSH-3G, sulting in the release of vinyl chloride 'V'v,ivof workpractice methods as soon as feasi- Room 230, 1726 M Street, N.W., Occupa into areas occupied by employees. . ..
.^'KW-bie, and to require the use of.respirators tional Safety- and Health Administra ' (9) "Exposure" means actual contact v `ii'pending the institution of such controls, tion. Washington, D.C. -20210, post-, with vinyl cliloride when unprotected by
supplement such controls where they -frj-t are insufficient to reduce concentrations ^jcl'of vinyl chloride below the detectable $>'V level, in specified work situations, and
in cases of emergency. The proposal for . A* continuous flow and pressure demand
-.7 types of respirators is based on the rccSgK ;" ommendations of NIOSH, whicli lias ob-
marked not later than June 10, 1974. . Pursuant to 29 CFR 1911.11 (b) and (c), interested persons may file objec tions to the proposals, requesting an in formal hearing with respect thereto, in accordance with the following condi tions:
(1) The objections must include the
required personal protective equipment i
and clothing.
. ,':Z
(10) "Fabricated product"' means a
finished product or part of such product, -
made of polyvinyl chloride, entirely or in:
part, including semifinished `products-
such as film, sheet, block, bar, or extru- '
slon stock.
served leakage through chemical car- name and address of the objector;
trulge respirators at high concentrations
(2) The objections - must be post-
A- >ofVC. - '
. marked on or before June 10,1974;
A' requirement would also be estab-
(3) The objections must specify the
' v-l- llshed for the provision and use of pro- provisions of the proposed rule to which
-.'tective clothing for employees in tlie reg- objection is taken, .and must state the
. ulated areas. The protective clothing grounds therefor;
/.^rf-would minimize skin contact with VC
(4) Each objection must be separately
\. ' `vapor, and would provide some measure stated and numbered; and
; of protection from splash of liquid.in
(5) Tire objections must be accom
the event of a spill or rupture of equip- panied by a summary of the evidence
ment. Food, beverages, and like products proposed to be adduced at the requested
-7'. would be. prohibited in the regulated hearing.
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: area.
As revised, 1910.93q -would read as
,>*' Written operational and emergency follows:
plans would be required, along with em- 1910.93q Vinyl adoride. .. -
tir};-' ployee training in routine and emergency
(a) Scope and application. (1) This
? (11) "OSHA Area Director" means the
Director for the Occupational Safety and
Health Administration Area'Office hay-
ing jurisdiction over the geographic area -
in which the establishment is located.
(12) "Polyvinyl chloride" means poly
vinyl cliloride homopolymer or copol-'
ymer before such is converted to a fab-
ricated product.
..
(13) t ^Protective clothing" means-'
clothing protective against vinyl chlo
ride.
(14) "Vinyl cliloride" means vinyl
chloride monomer.
<15) "Waste resin" means any resin
or other .'reaction products removed in
the cleaning of equipment, such as ves
sels and piping.
B'i'section applies twoj a**n**y* area uoir operation
<c) iRvet/fte/reeinwcce.. ^CooulleeRgee oorf AAmmeerriiccaann
h -* Vtart cworid.
Pjtt***. 230 N. MU** A. CM-
manufactured, reacted, re
(4) Regulated areas. (1) A regulated
* *; hazards.;
leased, repackaged, stored; or used, in area shall be established where (1) vinyl cluding areas and operations Involving chloride is manufactured, reacted.' re
iy . The purposes of operational and emer polyvinyl chloride where detectable- leased, repackaged, stored, or used; or
gency plans and training are to apprise levels of vinyl chloride are released.
(U) polyvinyl chloride capable of re
employees of the hazards to which they
(2) This section does not apply to tlie leasing detectable levels of vinyl chlo
may be exposed, of the precautions they handling or use of fabricated products ride is manufactured, reacted, released,
must take to avoid such hazards, and to made entirely or in part of polyvinyl repackaged, stored, or used.
rehearse employees in the procedures they must follow in emergencies.'
chloride. (b> Definitions, (l) "Assistant Secre
(2) Access to regulated areas shall be ` limited to authorized employees.*
D. Medical surveillance, Comprehen sive requirements for employee medical examinations arc proposed, including necessary tests. Some additional guid ance is included for the convenience of . physicians. The proposed requirements have been recommended to OSHA by : NIOSH as reasonably appropriate to de tect liver dysfunction which may be in dicative of. or predisposing to, the de velopment of liver angiosarcomas.
E. Records and reports. Records of . monitoring, medical examinations, and
tary" means the Assistant Secretary of
Labor for Occupational Safety and
Health, U.S. Department of Labor or his designee.
(2) "Authorized employee" means an employee whose duties require him to be in tlie regulated area and who has been specifically assigned by the employer;
and any employee who enters such an area as a designated representative of
employees to exercise an opportunity to observe monitoring and measuring of
vinyl cliloride.
(3) A daily roster of employees enter- ing regulated areas shall be made and maintained. The rosters, or summaries thereof, shall be kept for at least 20 years.
(c) Afoniforing. (1) Every regulated area shall be monitored for detectable levels of. vinyl chloride.
(2) The monitoring shall assure that any exposure may be determined for each authorized employee with a confi dence level of 95 percent.
entry to regulated areas arc proposed,
(3) "Closed container" means any
(3) Employees or their designated rep
with provision for access by appropriate container which prevents the release of resentatives shall be afforded an oppor
OSHA and NIOSH officials. Specific pro vinyl chloride to the environment.
tunity to observe monitoring and measur
visions for employee access to monitoring
<4> "Contaminated" means capable ing required by this paragraph.
' records are included, as well as the re of releasing a detectable level of vinyl (i) Where exercise of an opportunity
quirement to furnish a copy of a medical chloride.
; requires entry to an area where the use
No. 92--Pt. I- -10
FEOERAl RCCISTER, VOL. 39, NO. 92--FRIDAY, MAY 10, 1974
see 0183
1GS98
PROPOSED RULES
of protective clothing, equipment, .fa
(2) Tlfere shall be tests' made for
(J) Emergency situations, (l) A writ
cilities, or procedures is required, such process or equipment leaks and for emis ten operational plan -for' emergency -
clothing, equipment, facilities, and pro sion" of vinyl, chloride which may result situations shall be developed for each
cedures shall he provided to all persons from workpractices. The frequency of regulated area.
.. !
entitled to exercise the opportunity, at no tliesc tests shall be such as to Insure the
(2) In the event of an emergency. ap-i "
cost to any of them.
Integrity of equipment and adherence to propriatc portions of the plan shall be
<ii) Persons exercising the opportu proper workpractices.
..
put into operation. . .
'
nity shall be instructed regarding:
(g) Respiratory protection, (l) A res
(i) Hazardous conditions created b'v
(A) The toxicity and fire hazard of piratory protection program in accord the emergency shall be eliminated and
vinyl chloride; and
ance with $ 1910.134 shall be established the affected area shall be decontami- :
. - (B) The protective steps and measures and implemented where respirators are nated prior to the resumption of normal '-
necessary for their protection.
required to be used by this section.
operations.
-
(ill) Observers shall be permitted,
(2) Respirators shall be used only In (ii) Special medical surveillance by Vi
'.without interference to the persons per cases of emergency and where required physician shall be instituted within 24- '
forming the monitoring and measuring, by any other provision of this section. hours for employees present in the of- T
-to: :-
Respirators may cot be used in lieu of fected area at the time of the emergency. .
'(A) Observe all steps and procedures feasible engineering controls or work-
(ill) Where an employee has a known -
related to .the collecting, processing, and ~ practice meUiods.
contact with liquid vinyl,chloride such
' evaluation of particular monitoring and 'measurement samples;
(B) Record - quantities and. results
obtained;' (C) Observe the condition of monitor
ing and measuring equipment:
<D) Receive a demonstration of the . calibration and function tests of the
(3) Respirators or- combinations of respirators for protection against vinyl chloride shall* be selected. from among the following:
(D A positive pressure full facepiece self-contained breathing apparatus:
(ii) A pressure-demand full facepiece self-contained breathing apparatus op erating ip the pressure-demand mode;
employee shall be required to shower as '
soon as possible, unless contraindicated ^
by physical injuries. .
. (Iv). An incident report on the einer-^
gcncy shall be reported as required ln ` paragraph (q>(2) of this section.
. (3) Each authorized employee shall ?
be trained in a program relating to the =
hazards of vinyl chloride and the pre-2
monitoring and measuring equipment
(iii) A combination type "C" pressure- cautions for safe use. -
performed on site; and
demand full facepiece respirator oper
(1) The*program shall include:
' (E> Examine instructions and docu ating in the pressure-demand mode and
(A) The nature of the fire hazard, and "
ments related to the procedures and a pressure-demand self-contained the necessary protective steps;
equipment for monitoring and measur breathing apparatus operating in the (B) The nature of the toxic hazard. '
ing.
. >- pressure-demand mode; or
including local and systemic * effects,f
<4> Accurate and complete records of ' all required monitoring shall be made and maintained for not less than 20 . years. Such a record shall (I), state the date of.such monitoring and the levels determined; and (ii) identify the instru ments and methods used.
(f) Engineering controls and ioorkpractice methods. <1) Where detectable levels of vinyl chloride are measured, . immediate protection shall be provided against exposure to vinyl chloride by the .use of engineering controls, workpractice . methods, and respirators as follows:
* (iv) A combination type MC" continu ous flow respirator arid & pressuredemand self-contained breathing ap
paratus- operating in the pressure-de mand mode.
(h) Protective clothing. (1) Employees
'
acute and chronic effects Including : specifically the carcinogenic hazard;
<C) The specific nature of operations which could result in exposure to vinyl
chloride, and necessary protective steps:' (t The purpose for and application
of the medical surveillance program;
entering regulated areas shall be pro
(E) The purpose for `and application
vided full-body protective clothing, foot of decontamination practices;
wear or shoe covers, and gloves, at no
(F) The purpose for-and significance
cost to them, and required to-wear it of emergency practices; and procedures:
while in the regulated area.
<G> The employee's specific role under
(2) Where polyvinyl chloride powder normal operating or emergency condi
containing detectable levels of vinyl tions;
chloride Is handled, employees ` shall
(H) Specific'information to aid the
(1) Feasible engineering controls and also be:
employee in recognition and evaluation
.workpractice methods shall immediately
(i) Provided - and Required to wear of conditions and situations which r**?
be used to reduce airborne concentra- headcoverings;
result in the release of vinyl chloric ;
. tlons of vinyl chloride below the detect able level;
(U) Required to remove all protective clothing at each exit from the regulated
(I) The purpose for and application of specific first aid procedures and prac
(ii) Wherever feasible engineering area: and
tices;
' `controls . and workpractice methods * which can be instituted immediately are
. not sufficient to reduce concentrations of vinyl chloride below the detectable level, they shall nonetheless be used to reduce the concentrations to the lowest prac-
ticable level, and shall be supplemented - by means of respirators in accordance
with paragraph (g) of this section;
(ill) Required to shower after the last
exit of the day.
(3) Clean protective clothing shall be provided whenever contaminated or soiled, but not less frequently than weekly. Contaminated clothing shall be decontaminated before reuse by removal for laundering or disposal.
(J) A review.of this standard at the employee's first training and indoctri
nation program and annually Iherealter.
(ii) All materials relating to the pro gram shall be provided upon request tc
authorized representatives of the Assisi' ant Secretary and the Director.
Oc> Signs and labels. (1) Entrances tc regulated areas shall be posted with signs
* (iii) Wherever no feasible engineering
(1) Hygiene facilities and practices. bearing the legend: -
control or workpractice method can be instituted immediately. Immediate res piratory protection shall be provided in accordance with paragraph (g) of this section; and
(iv) In any case covered by paragraph (f)(1) (il) or (iii) of this section, the
(1) Where employees are required by this section to wear protective clothing and equipment, change rooms shall bo provided in accordance with 1910.141(e).
(2) Where employees are required by this section to shower, shower facilities
CANCER-SUSPECT AGENT AREA .AUTHORIZED PERSONNEL ONLY
(2) Areas containing operations cov ered in paragraph <k) U) (4) of this sec tion shall be posted with signs bearing ilia legend:
employer shall also undertake as soon as shall be provided in accordance with CANCER-SUSPECT AGENT IN THIS ARE.-.
practicable a program to reduce airborne
concentrations of vinyl chloride below the detectable level, or to the greatest extent feasible, solely by means of engi
S 1910.141(d) (3).
(3) Storage or consumption of food or beverages, storage or use of smoking or non-food chewing products, and the
TULL IMPERVIOUS AIR-SUPPLIED EQUIP MENT required
AUTHORIZED PERSONNEL ONLY
(3) Containers of waste or other ma
neering controls and workpractice meth storage or application of cosmetics are terials contaminated with vinyl chlorid:
ods and as soon as feasible.
prohibited in regulated areas.
shall bo labeled:
FEDERAL REGISTER, VOL 39. NO. 92---FRIDAY, MAY 10, 1974
see
2-0134
PROPOSED RULES
1GS0D
..VINYL CHLORIDE CONTAMINATED
(ii) When vessels arc to be entered, all . (1) Alc'ohoVintakci
'
..; - '
MATERIAL
; : " CANCER-SUSPECT AGENT
:V DISPOSE OP OH DECONTAMINATE USING
. . ' AUTHORIZED PRECEDURES.
piping to such vessel shall be:
(A) Opened, blanked and tagged; or (B) Where welded piping is in use, not less than 2 valves in series, which isolate
(ii) Past history of hepatitis;" '
(iii) Past exposure to potential hepa-
totoxic agents, including drugs and chemicals; '
Containers of polyvinyl chloride tlic vessel from any other connection to
<iv) Past history of blood' transfu
7: ; containing detectable levels of vinyl such line, must be closed and secured. sions; and
V chloride shall be labeled: .
(iii) No employee shall enter a vessel,
(v> Past history of hospitalizations.
POLYVINYL CHLORIDE - CONTAINS VINYL CHLORIDE
except when another employee properly
<3) At the time of initial employment,
trained and equipped for entry is pres or upon institution of screening, a serum
. VINYL CHLORIDE IS A
ent and is observing the employee in the specimen shall be obtained for screening
./ CANCER-SUSPECT AGENT
vessel. The observer shall have means with respect to the following bio-cheoii- -*
ABSORBED BY BREATHING AND
for signalling for help in the event the cal determinations of liver function: V
' THROUGH SHIN
employee experiences problems. Under (i) Total bilirubin;
; - * \;
\ (5) Containers of vinyl chloride shall
be labeled:
' : ' VINYL CHLORIDE
danger
^ `EXTREMELY FLAMMABLE GAS
s 'I'-;-
UNDER PRESSURE
. ' MAY POLYMERIZE WITH
such conditions, the observer shall sig- - (ii) Alkaline phosphatase;-' -
2
nal for help, and shall not enter to assist
(iii) Serum glutamic oxalacetic trans
the employee until another .'person is aminase (SGOT); .
present to observed' (iv) Serum. glutamic pyruvic. trans-S
(m) Transportation loading and un aminase (SGPT); and
.' -
loading. (l) Facilities for the loading
(v) Gamma glust&myl transpeptidase
and unloading of vinyl chloride to and (GGTP). ;
EXPLOSIVE FORCE
from containers shall have each transfer (4) Additional tests that may option
Ja';
POISON
. " : :" CANCER SUSPECT AGENT AND
-
line and vapor-equalizing line equipped ally be considered for use in screening
with vent connections, and shall have' include:
:.;\V
' ANESTHETIC
` " ' 1. ABSORBED BY BREATHING
. and through skin .
(6) No statement shall appear on or
an inert gas purging system. Vent and . - (1) Lactic dehydrogenase; .
purge effluent sliall be returned to a proc-.. .(ii) Serum .protein determinations;
ess stream or flared in a safe location.
(iii) Serum protein electrophoresis;
(2) Procedures sliall be developed and and
;
near any required sign, label orinstruc-' Implemented for the transfer of vinyl
(lv) Plateletxeunt.
tion, which contradicts or detracts from chloride. Written copies of such proce " (5) Laboratory analyses for all biologi
- . "the effect of any required warning, ln- dures sliall be provided employees en cal specimens included in medical exam
>* formation or instruction.
gaged in such operations, and such em*,` inations sliall be performed in labora
(1) Afainfenance and' decontaniina- ployees sliall be fully trained and re tories accredited by the College of
vis tion(1) Emphasis shall be placed upon hearsed In all procedures.
American Pathologists or licensed under
w' immediate clean up of spills, periodic in- _ (3) Employees engaged in transfer op 43 CFR Part 74.
v^y.' fipectlon, prompt repair of equipment and. erations shall be provided with and
(C) If-the results of screening required
v- leaks, and proper handling, storage and required to wear respirators in accord in paragraph (o) (3) of this section, are disposal or decontamination of materials ance with paragraph (g) of this section. normal, screening sliall be repeated:
to prevent airborne contamination and
(n) Polymer handling operations. (1)
accidental skin contact with vinyl chlo Containers of polyvinyl chloride releas
(i) Every six months for employees who have been employed in vinyl chlo
ride. Waste materials, equipment, and ing detectable levels of vinyl chloride ride related operations for 10 years' or
other sources of vinyl chloride in closed containers, may not be placed in areas of
shall be opened and transferred only under local exhaust ventilation which
more; and
*f
<il>. Annually for all other employees
... excessive temperature or sunlight since reduces the concentration of vinyl chlo entering regulated areas.
*' '-I &''build-up of. internal pressure may result " i';.'4^. in rupture of the container,, fire or
'fd'Vexplosion.
*,
,
tf - (2) waste resins or other materials
" * : .^ contaminated with vinyl chloride shall be
' placed in closed containers pending dis-
posal or decontamination.
(i--.Yj-'i- -(3) Appropriate procedures shall be y-'.yv developed and implemented for the de-
yy contamination or disposal of all such
'-.-waste material. (4) In maintenance or repair opera-
' tions on contaminated--systems or
equipment, including vessel entry, em
ployees engaged in such operations shall
. .be (i) provided with and required to
wear and use a whole-body air-suppUed
' suit impervious to vinyl chloride, and a
respirator in accordance with paragraph
- <g) of this section: and (it) required to
. shower after removing protective cquip-
' ment. (5) Protective clothing and equipment
.
ride below the detectable level.
<2) Hot operations, such as but not limited to milling, calendering and ex truding, which release detectable levels of vinyl chloride, shall be carried on only under local exhaust ventilation which reduces the concentration of vinyl chlo ride below the detectable level.
(o) Medical surveillance. Not later than --------------------- 1974, a program of medical surveillance shall be Insti tuted, and shall provide each authorized employee with an opportunity for ex aminations in accordance with this para graph. All medical examinations and procedures shall be performed *by or under the supervision of a licensed Doctor of Medicine (MD) or Doctor of Osteopathy (DO). All medical examina tions and tests shall be provided without cost to the employee.
(1) At the time of initial employment,
<7) If one or more liver function tests performed are abnormal, serum testing shall be repeated as soon as possible, preferably within two to four weeks. If no abnormalities are present upon re-
screenlng, serum testing shall be re peated In three months.
<&) If abnormalities persist upon rescrecnlng, the employee shall be with drawn from areas where contact with vinyl chloride is possible, and an individ ualized medical workshop shall be in stituted. Suggested* as initial steps are a complete physical examination and vari
ous special procedures such as hepatitis B antigen determination and liver scan ning. If liver function abnormalities are
determined to be unrelated to liver dis ease. the employee may be permitted to return to vinyl chloride-related employ
ment. subject to individual medical evaluation.
(9) A complete and accurate record of
' shall be clean and dry for each use.
or upon institution of screening, a physi the results of medical examinations shall
(6) When vessels or piping systems are cal examination shall be performed with be made and maintained for the dura
opened local exhaust ventilation shall be specific attention to detecting enlarge tion of employment plus five years, or
provided to remove the escaping vapor ment of liver or spleen* by abdominal for 20 years, whichever is longer.
from all occupied areas.
palpation.
(p) Records. (1) Records of monitor
(7) (i) Vessels to be entered shall first be ventilated and monitored so that the
` concentration of vinyl chloride is reduced
(2) At the time of initial employment
or upon institution of screening, and an nually thereafter, a medical history checklist shall be completed by the em
ing and measuring, medical records, and
regulated area entry rosters and sum maries, sliall be made available for ex amination and copying upon request to
to a level within the protection factor ployee. Tills list shall include questions authorized representatives of the Assist
capability of the protective equipment. concerning:
ant Secretary and the Director.
FEDERAL REGISTER, VOL. 39, NO. 92--FRIDAY, MAY 10, 1974
see 2-018S
' PROPOSED RULES ,
0
(2) Iji the event that the employer (Secs. C(b), G(c), and 8(c). M SUt. 1503.. conservative limitation may no longer*
ceases to do business and there is no suc 1S9G, 15S0 (29 U.S.C. CSS, C57); Sccicl&ry of
cessor to receive and retain ills records - Labor's Order Ko. 12-71 (3G PR 8754)) .
for the prescribed period, these records
shall be transmitted by registered mail
to the Director, and each, employee Indi
vidually notified In writing of this
transfer.,
*
' (3) Employees and their designated
Signed at Washington, D.C. this Gth day of May, 1974.
' JORN SlENDEK, , Assistant Secretary of Labor.
[Fit Doc.74-10748 Filed 5-9-74:8:45 am)
representatives shall be provided access
to examine and copy records of monitor
. . . . DEPARTMENT OF
ing and measuring. <4) Former employees shall be pro vided acces to examine and copy records .
TRANSPORTATION '
... Federal Aviation Administration
reflecting their own exposures.
- [ 14 CFR Part 25 ]
- (5) Upon written request of any em ployee, a copy of the medical record of such employee shall' be .furnished to a '
[Docket No. 13G9G; Notice 74-19]
TRANSPORT CATEGORY AIRPLANES
physician designated by the employee in Type A Passenger Emergency Exit Capacity
such request. (q) -Reports. (1) Not later than_____ -
-___:___the following information shall be reported to the OSHA Area Director. Any change in such information shall be reported to the OSHA Area Director within IS days of such change.
<i) The address and location, of each
establishment which has one or more regulated areas; and (ii) The number of employees in each regulated area'during normal operations,' including maintenance.
(2) Incidents which result la the re lease of vinyl chloride into any area where employees may be exposed shall be 'reported in accordance with this para graph. .
(i) A report of the occurrence of the incident and the facts obtainable at that time including a report on any medical treatment of affected employees shall be made within 24 hours to the OSHA Area Director.
(ii) A written report shall be filed with the OSHA Area Director within IS calendar days thereafter and shall in clude: V (A) A specification of the amount of -material released; .
(B) A description of the area involved : and the extent of known and potential
employee exposure and a;*: a affected; _ <C) A report on any medical treat ment of affected employees and any
.medical surveillance program imple mented; and
<D> An analysis of the circumstances
' The PAA is considering rule making to revise the passenger seating configura tion limit that is applicable to Type A
exits on transport category airplanes. Sections 25.807(c) (2) and (3) of the
Federal Aviation Regulations (TARs) currently provide that for each pair of Type A exits (consisting of one on cadi side of the fuselage) the airplane may
have a maximum passenger seating con-figuration of 100. ' This advance notice of proposed rule
making is being issued in accordance with the FAA's policy for early institu
tion of public proceedings in actions re lated to rule mailing. An "advance" no tice is issued to Invite early public par ticipation in the identification and sc-
lection of, a course or alternate courses of action with respect to a particular rule making problem.
Interested persons are invited to par ticipate in the rule making by submitting such written data, views, or arguments as they may desire. Communications should identify the regulatory docket or notice number and be submitted in duplicate
-to; Federal Aviation Administration, Of fice of the Chief Counsel. Attention: Rules Docket, AGC-24, 800 Independence Avenue, SW., Washington, D.C. 20591.
Communications should be received on or before July 9, 1974, to assure proper consideration. All comments submitted will be available, both before and after
the closing date for comments, for ex amination by interested persons.
of the incident, and measures taken or Tho regulatory provisions relating to
to be taken, with specific completion Type A exits that arc contained in S 25.-
-dates, to'avoid further similar releases. 807 of the Federal Aviation Regulations
<3) Upon completion of any monitoring were adopted by Amendment 25-15, ef
-
be applicable, the FAA has instituted a.:
regulatory study project to reevaluate
tho limitation. The study wfll Include the factors originally considered in estab-
lishlng tlie limitation as well as any other'- '
factors found to bo pertinent. Those-
factors originally considered include per- -
tinent evacuation tests and demonstra- ;
tions. exterior slides, the number, loca-
tion, and size of, aisles and passageways
and evacuation system reliability.
'
Data available to the FAA on in-serv- "
ico evacuations, slide deployments, and -:
evacuation demonstrations indicate that '.:
more than 100 passengers have been. .
evacuated through a Type A exit within ` -
90 seconds. The data further. indicate- -
that Type A exit systems may haver-
higher in-service reliability than was an- .*
tiejpated at the time the limitation was
established in the regulations. However --i
the FAA believes it is important to re- -
view all relevant data on safety and cost '
considerations that may be applicable to
any proposed change in the Type A exit _i passenger seating limitation. To this end, '
tho FAA solicits data, views, and argu- ' ments from all interested persons on the - questions'set forth below. Data support-
lug an answer should'be submitted or
identified sufficiently that the FAA may v obtain or develop It.
1. Do the data available on evacuation
tests and in-service incidents that relate to the evacuation capacity of Type A '
exits under emergency conditions indl- -
cate that the 100 passenger limitations .
may safely be increased? 2. What reliability has been.jdemon-
strated for Type A exit system^ by serv
ice experience and tests?
3. What, relationships may :be. estab lished between reliability and passenger
emergency evacuation capability of Type
A exits?
4. How would the emergency evacua
tion capability of Type A exits be af
fected by specific increases in passenger seating capacity and by. specific passen
ger seating configuration consideration*
5. If there are other factors Ih x should be considered, how should the rel
evant data be related to the emergency
evacuation capability of Type A exits?
6. If the commentator recommends specific passenger capacities for consid
eration, what economic ar.d safety bene fits or penalties would be associated with
them?
-and measuring which discloses that any fective October 24, 1907. That amend
Issued in Washington, D.C., on Mnv 2.
.employee has actually been exposed to ment also established the provision. In J974.
-
detectable levels of vinyl chloride, each such employee shall be individually noti fied in writing. The notice shall:
(i) Be delivered not later than 10
25.803(c) , that manufacturers show by demonstration that the maximum seat ing capacity of nil airplane having a ca pacity of more than 44 passengers can be evacuated to the ground within 90
C. R. Melugix, Jr., Acting Director,
Flight Standards Service.
[Fit Doc.74-10787 Filed 5-9-74:8:45 am]
'working days after completion of the seconds, under conditions prescribed in
monitoring and measuring;
the regulation. As discussed in the pre
(ii) State the actual exposure in terms amble to Amendment 25-15. the allow
[14CFR Part 39]
of concentration and time; and
able passenger seating limit of 100 that
[Docket No. 74-NW-4-AD] '
(iii) State the steps which have been taken, are being taken, and will be taken, with specific completion dates, to tcrml-
was established for each pair of Type A exists was less than the evacuation ca
pacity that had been demonstrated by test. As a result of receiving data and
AIRWORTHINESS DIRECTIVES
Boeing Model 737-100/200 Series Airplanes
. nalc the exposure and prevent a recur information tending to indicate that The Federal Aviation Administration
rence.
some of the considerations leading to the Is considering amending Part 39 of the
FEOERAl REGISTCft, VOL 39. NO. 92--FRIOAY, MAY 10, 1974
bCL
2-0186