Document zOyVOpdZG63a4DB09Krr5480

R&S 114109 bio-medical, research DOCUMENT DESCRIPTION FORM 63 68 69 76 Duplicate.in all cards:--> /fT-' year as--1961-- .'**0 ^77 File number [Right justify [Numeric only] Author(s), as Last Name FS (No Punctuation) and coden for journal as JAMA preceeded by one blank space r77_____ 78 7't? Sub-Index Code Title of Report; end with space-hyphen-hyphen-space. Follow with Index Terms. separated from each other with comma-space. Avoid other punctuation; do not abbreviate. 12 ,6,1 62 l -- ~ 21 7- ,u./s~ 7'X, --------, 7/ l/1 ^ '177 . 7//v'c^*y T'.pr'. 22 23 24 Source (Journal, Vol., Number,'Pages, Date^)' 12 / 7 SI 62 31 32 Brief Smisnary 12 10 SUMMARY: 61 62 61 62 63 64 hereto provide ents with a visit it would sit them all. consultation contused with : consultative lv organisations -,'s. They are of inspections, being given a n a citation. The *thepromises to tong, nut to 'fix to offer advice suggestions. In a a consultant ms, he would the employer d hygienist, to work out a program for the aii that os we, at r number of from :css than Woefully 1.000 by *cada_iha market kidustrial -- least 1 fact geometrically atl time, with 'JOO inspectors, "*250 hsalth. we vtflOO inspections l>Hn 10 percent in ** With a force of half in safety and " Utouid be able to * *any inspections _ "'tour times the " health. The 'rnn be higher Actors, by that ^oss-trained in the HA 37 vate fto ver CO tely, ssed othe must "* .`form O uvse.rn` y and ilmost j mix of willing d obe se often volatile and. usually need constant improvement We at OSHA feel we are a part of such a mix. and certainly are aware of a need for improvement OSHA and I, as an individual, would be .pleased and happy to discuss any specific suggestions along this line with Mr. Hertlein and the readers of the JOURNAL Joe Mancias, Jr. Director Office of Public end Consumer Affairs USDOL/OSHA Washington, DC 20210 Dear Sir: I would like to point out a redun dancy in the title of the paper of Pelfrene in American Ind. Hyg. Assoc. J. 37 (December), p. 706, 1976. Benzo(a)pyrene is what used to be termed 3.4-benzopyrene. If one uses the IUPAC nomenclature-- benzo(a)pyrene. the 3.4 is a redundancy. I note that the mistake was not repeated in the text. . There was a paper by Torkelson et al in the same issue es- referred to above. That covered tests of chloroform toxicity over six months'. It is of interest that the investigating laboratory did a six-month test on vinyl chloride in 1961 and missed its carcinogenicity (Amer. Ind. Hyg. Assoc. J. 22.354-361.1961). While the Journal cannot restrict authors to report on specified test periods, it can control through reviewers the interpretation placed on results for whatever period. In the six-month chloroform experiment as might be expected from what is known about chemical carcinogenesis, cancers did not develop. The report as it stands is really misleading to many concerned perofessionals because the question as to whether cancers might have developed over the longer exposure period used in the National Cancer Institute chloroform tests was not answered (notwithstanding that p. 698 contains a brief reference to the test duration as being inadequate to disclose carcinogenicity). The non-carcinogenic toxicity of chloroform in a six-month test may indeed be inconsequential in comparison with its carcinogen icityas was virtually the case with vinyl chloride which continued to be used in the trade on the wrong safety Hg- Am. Ind. Hyg. Assoc. J. (38) February. 1977 Jf basis for many years after the publication of the six-month test results. In effect, the toxicological reviewers of this paper (if there were toxicological reviewers) allowed a great deal more to be said about the applicability of the results to chloroform TLV levels than is warranted and in this respect the publication is also misleading. properly concluded that on the basis of the experimental data, workers' exposures should be controlled below 25 ppm with a time weighted average below 10 ppm. We did not state how much below 10 ppm the TWA should be because the data to do so were not available. Dr. Kay's comments about our laboratory's publication in 1961 on fei te; to> art do st; thi an us lat Kingsley Kay. Ph.D. vinyl chloride appear to reflect his Mount Sinai School of Medicine City University of New York New York. NY 10029 lack of understanding of the whole of the vinyl chloride problem. Had our recommendations base.d upon relatively simple toxicology been va hu th; ter Editor's note: Two of the leading . followed then, the difficulties of de toxicologists in the field ware the Today may never have occurred. Bi. reviewers. V. K. Rowe W. Toxicological Affairs Dii Dear Sir: We appreciate very much the opportunity to respond to the criticism leveled by Dr. Kingsley Kay at us and at the AIHA Journal for T. R. Torkelson Corporate Medical Dow Chemical U.S.A. Midland. Michigan 48640 AI Mi Ed en ref publishing the results of some ini toxicological studies we did quite a Dear Sir: Je number of years ago (AIHA Journal 37, 706, 1976). This work was not published earlier because it was not completed to our satisfaction; that is, a no-adverse-effect dose was not determined. However, at the time The December 1976 issue of the AMERICAN INDUSTRIAL HYGIENE ASSOCIATION JOURNAL contained a rather disappointing article entitled "Report on Carcinogenesis Bioassay of Technical Grade of Nt at Hi f Be NI0SH was preparing their Criteria Chlordecone (Kepone)." The Document on Chloroform, they were (anonymous) author has attempted aware of this work and they to paraphrase the official report, but D. requested that since there were no other similar data available, that we make our results available to all through publication. This we have done. failed to mention many of the original report's caveats nor any of the apparent failing in the underlying study. ,-- Insofar as the finding of animal Iv m G; ce S; Dr. Kay seems to feel that the carcinogenicity is concerned, the IE results of toxicological studies of less than some period greater than six months should not be accepted for publication. Frankly we vigor ously object to this. Unfortunately, in today's political climate, it appears to be difficult for some toxicologists to remember that there are other toxic effects, many of which are as important, or more important than cancer. We would not be surprised if for chloroform, liver injury other than cancer will be the limiting toxicological effect at low levels of exposure. We are anxiously await ing studies which can evaluate this. Dr. Kay states that our conclu sions are misleading with respect to carcinogenicity even though he acknowledges that we specifically reported "hepatocellular carcino mas" refer to cellular morphology.of liver nodules which are common in mice and rats and have no necessary connection with cancer as normally defined. The original report tacitly recognized the questions raised by such diagnostic terminology when it conceded that no evidence of invasion or metastasis was observed. Similarly, there are no indications that the liver lesions per se were the cause of death in any of the test animals. Indeed, most of the lesions were discovered only on terminal sacrifice, and the animals with lesions in general survived those who succumbed from the direct' toxic effects. Le in ac In M ti A In A H of tr in ai A S( iz ir d o address this point. We said, "None The conclusions drawn from the * of the studies were of sufficient duration to assess carcinogenicity". We wonder what more we could have said? Our paper states exactly what had been done, and we think tests are particularly suspect in light of the weaknesses in the test itself; e.g.: the unusually srhall number of matched controls (5-10) when compared to approximately 50 dose S A h American Industrial Hygiene Association JOURNAL (38) 2!T7