Document gDvKk3yabXvxyk9yD30GrLywV
REVIEW
VCM STANDARD OF OCT 4, 1974
I Page 35890 - Background(2) The Emergency Temporary Standard - regarding Feb. 15 hearing/C. Maltoni "angiosarcoma in rats as low as 250 ppm, and . in other species at higher levels."
This is incorrect versus the records. Maltoni had no other species of animals under test with cancer diagnosed on Feb. 15, 1974.
"Experiments performed at lower levels of exposure were not complete at that time".
This is an incomplete statement versus records. The cited higher level exposures also were not complete either. There were still living animals at that time.
(2) + (3) documents a catastrophic drop in allowable VCM levels in 8 months, 500 ppm 1/30/74, 50 ppm 4/5/74, and 5/1 ppm 5/10/74 - 1/1/75.
The latter level is ipso facto unfeasible, even if technology were avail able, since procurement schedules are 12-36 months delivery on fundamental items of equipment.
II. Page 35891 - Carcinogenicity of Vinyl Chloride - the tone of this entire section is consistent with that of the regulation itself, e.g. there is no referencing to the fact that the rodert classes, and especially mice, are more susceptible to spontaneous angiosarcoma cancer than are homo sapiens. The statement to the contrary (page 15) is clearly erroneous. The dis cussion states that "three quarters of those employees with the longest exposure to VC (greater than 20 years since initial exposure) have not yet been located". Even if true, this does not dispute the above experimental fact. There is no statement concerning numbers here, yet they are liberally used with respect to animals. The record states that several thousand humans were exposed to VC at high levels for several years and less than 1% have been diagnosed with AS of the liver, a highly specific and rare human disease. The avoidance of a conscientious effort to weigh risk/benefit is not in the interest of the American worker and his industry, nor the American public and its economy in a one world environment.
This is written as an adversary document rather than a scientifically balanced analysis of an admittedly serious control problem. The proposed regulations are inconsistent with lack of OSHA regulations concerning the quoted smoking cancer hazards which have long been condoned in OSHA ' regulated plants via "smoke houses". Every effort is made to refute or minimize the facts in the record on the side of reason, moderation and feasibility -- in order to support the stringent and impractical standards of the regulation. This is a biased regulation which should be modified, pending receipt of "sufficient information". For example, Dow's significant epidemiology and metabolic experiments were both summarily dismissed as in significant. The regulation does not specify what will be accepted as significant, nor who will do it, nor when.
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III. Page 35892 - Feasibility. In refutation of a summary of industry state ments that "it is infeasible for the VC and PVC industries to remain below 1 ppm consistently, using engineering controls" and that "Labor union spokesmen and Health Group Research, Inc., however, have suggested that such a level is attainable", OSHA has chosen to give indefensible weight to spokesmen of political groups as opposed to that of qualified engineers in industry most closely associated with the problems of containing VC in a batch PVC process. This is not scientific judgment, this is patent bias.
OSHA admits this in the next sentence, since no evidence is available that either VC or PVC plants have been able to achieve this exposure level after a year and a half of dedicated industry effort (12 years in the case of Dow). Therefore, the statement "Likewise, the projections of Industry,' labor and others concerning feasibility are conjectural" is not valid - since industry has been trying and others have not. It is grossly unfair to weigh the real efforts of 23 companies in 37 plants during the last few months against theoreticians as to feasibility. This is further emphasized in the statement that "from an operating standpoint this ceiling (r ppm) level is realistic, because minor excursions up to the ceiling level are likely to occur on a regular basis". Further imple mentation will take 3 to 5 years of the best, but unproven technology now available. Therefore, if OSHA wishes to retain a viable PVC industry in the U.S.A., it must extend the compliance schedule far beyond January 1, 1976. This is in the real world "the near future".
OSHA admits that "it is apparent that reaching such levels may require some new technology and work practices". It, in fact, substantiates this by quoting B.F.Goodrich (TR 1120) ability to reduce average exposure levels from 35-40 ppm to 12-13 ppm by July 1. This ignores the data in the record that excursions above 50 ppm did not recede correspondingly, nor that the reduction rate was plateauing with available technology, nor that summer has an easier ventilation time than winter, nor that blowing VCM outside creates an irreducible recycle air situation which must also be recognized as an EPA economic and time impact for implementation of the OSHA ruling. Therefore, the arguments for the (4) conclusions (Pg 35892) are invalid per se, and especially that "from an operational standpoint this ceiling level (5 ppm for not to exceed 15 minutes) is realistic because minor excurisons up to the ceiling level are likely to occur on a regular basis".
We find the preamble to be an adversarial position, best expressed by "the overriding consideration has been the protection of employees, even those who may have regular exposure to VC through their working lives". In other words, discriminatory, anti-PVC workers and anti-industry judg ments were made concerning this industry in comparison to other earlier demonstrated carcinogen exposures, such as asbestos, smoking, benzene in gasoline, the 14 carcinogens, etc. Finally, there is an implication that there is technology being used in other industries that could be used in VC-PVC. The implied availability of this technology should be made abundantly clear to the PVC industry, and it has not.
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Ill -(Page 35892) The Final Standard.
Referring to regulations on the 14 carcinogens, the statement was made "The record did not include information that reliable monitoring and measuring techniques were available". The Final Standard goes on to presume that analytical procedures are available to promptly identify the "action level" of 0.5 ppm TWA and "limit of 1 ppm TWA" and "ceiling of 5 ppm" averaged over any period not exceeding 15 minutes. In fact, the standard itself quotes (Page 35896) a confidence level of 95% and "an accuracy of not less than * 507. from 0.25 through 0.5 ppm, 35% from over 0.5 ppm through 1.0 ppm, and 25% over 1.0 ppm. (Methods meeting these accuracy requirements are available in the "NIOSH Manual of Analytical Methods")". Our careful perusal of this manual on October 5, 1974 disclosed no method for VCM and the interest ing statement that the accuracy of their method for organic chemicals "is not known". This makes it rather difficult to advise our customers on their analytical laboratory requirements on October 7.
(Page 35896) - Methods of Compliance.
The tenor of this whole section implies that 0SHA knows how industry can reduce its employee exposure level below the "permissable exposure limit". They must be instituted "immediately". Industry is on record that it doesn't know the answers. How can OSHA fail to withhold them? Please reveal your plan for engineering and work practices that can meet these regulations. Our logic says you do not have these answers for "we have not established any deadlines for full compliance through engineer ing controls because we are presently unable to determine when it will be feasible for most (sic any) establishments to reduce exposure levels to the permissible level".
(Page 35896) - Respiratory Protection.
This standard admits that "respirators have many drawbacks". Also, "The record shows that the PVC industry particularly may need several years before plant environmental levels can be reduced so that respirators are necessary only occasionally." However, OSHA now says 8 hour/day use of canister and air-supplied respirators is suddenly acceptable. They give the employees and employers a year to educate themselves to this new concept. Meanwhile OSHA recognizes that 25 ppm VCM is "relatively safe". Why not 10 ppm instead of 1 ppm on January 1, 1976?
(Page 35897) - Monitoring (6) (ii) of the regulation - "A continuous monitoring and alarm system shall be provided where concentrations of vinyl chloride could reasonably exceed the allowable concentrations for the devices in use. Such systems shall be used to alert employees when vinyl chloride concentrations exceed the allowable concentrations for the devices in use". This is either a meaningless statement, or OSHA knows something B. F. Goodrich doesn't. We have been diligently searching for a device that will monitor area vinyl chloride concentrations accurately below 10 ppm so far without success.
cc: A. Vittone W. C. Becker P. J. Weaver J. L. Nelson R. D. Scott D/5004 File
B. M. G. Zwicker
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