Document e72M0xrgv9yv4kYdkqa19eeMM

TELEPHONE HUDSON 3-S12S Manufacturing Chemists' Association, Inc. (FOUNDED 1*73) 1825 Connecticut Avenue, N. W. Washington 9, D. C. L-277 Meeting of LABELS AMD PRECAUTIONARY INFORMATION COMMITTEE Wednesday, May 13 -- Meeting Gallery #2 Thursday, May l1)- -- Meeting Bersimis Salon Montreal, Canada The meeting came to order at 9:00 A.M. on Wednesday, May 13, 1959 1 MEMBERS PRESENT Nicholas M. Walker, Chairman Chester L. French, Vice Chairman Robert H. Dewey' J. H. Foulger, M.D. J. T. Fuess Sanford J.'Hill Edward J. Hogan Edward J. Masek H. H. McIntyre T. W. Nale, M.D. J. F. Osterritter, M.D. Richard F. Philpitt J. B. Tuttle L. J. Waldbauer N. E. Wendt N. G. White J. B. Williamson James D. Kittelton," Secretary Pennsalt Chemicals Corporation Mallinckrodt Chemical Works Commercial Solvents Corporation E. I. du Pont de Nemours & Co., Inc. Eastman Organic Chemicals Dept., Distillation Products Industries E. I. du Pont de Nemours & Co., Inc. Allied Chemical Corporation Diamond Alkali Company The Dow Chemical Company Union Carbide Corporation Celanese Corporation of America Olin Mathieson Chemical Corporation Ebso Standard Oil Company General Aniline & Film Corporation American Potash & Chemical Corporation Shell Chemical Corporation American Cyanamld Company Manufacturing Chemists' Association, Inc. MEMBERS ABSENT R. G. Troup J. T. Baker Chemical Co. GUESTS S. E. Bertsch C. H. Beuglet J. T. Gormally Warren Hull M. T. Miller J. A. Mooney A. Wllkenson Canadian Chemical Company.Limited Canadian Industries Limited Pennsalt Chemicals Corporation Canadian Chemical Company Limited Canadian Industries Limited Food Machinery and Chemical Corporation The Consolidated Mining and'. Smelting Company of Canada Limited The Chairman welcomed the guests who were present, including several representatives of Canadian Chemical Companies. iI i i 1.2 SUBCOMMITTEE ACTIVITIES (a) Pesticide In the absence of Mr. Dallas Sparre, it was reported that several pesticide meetings have been held and more are scheduled. At the present time, the Subcommittee is in the process of gathering data for labels. (b) Nominations Subcommittee The Chairman of the Nominations Subcommittee, Mr. John B. Williamson, reported that his group recommended the following new officers: Chairman Chester L. French Mallinckrodt Chemical Works Vice Chairman Edward J. Hogan Allied Chemical Corporation , Following this report. It was moved, seconded and voted THAT, the LAPI Committee elects Dr. Chester L. French, Chairman, and Mr-.-Edward-J. Hogan,--Vice Chairman for the term 1959-1961 and THAT, the'Rules of Organization and Procedure be amended to provide for election in odd-numbered years. Committee members paid tribute to the outgoing Chairman and It was moved, seconded and voted THAT, the Committee expresses its appreciation to the resigning Chairman, Mr. Nicholas M. Walker, for his fine work as a member and as Chairman of the LAPI Com mittee, expresses regret at his departure, and congratu lates him for his personal advancement. At this point in the meeting. Committee members expressed regret at the death of a long-time Committee member, Mr. Frank Low. Mr. James T. Fuess accepted contributions from members for a fund to be donated to the library of the Chemists' Club in New York City. (c) Dyestuffs The Chairman appointed a Dyestuffs Subcommittee consisting of Dr. L. J. Waldbauer, Chairman, and Messrs. Williamspn, Hill and Hogan as members. The Committee briefly discussed labeling of dyestuffs and the view was voiced also that this should be studied carefully. Some dyestuffs may be sensitizers and consideration should be given to how the chemicals should be labeled. L-279 (d) Rules of Organization and Procedure The Chairman of the Subcommittee, Mr. Edward Masek, reviewed for the Committee, suggested changes in the rules relating to new members. This was discussed and the Chairman requested that Mr. Masek and Dr. Waldbauer pre pare a statement on a method for qualifying individuals for membership on the LAPI Committee. This was done and the Chairman directed Mr. Masek to insert this in the appropriate place in the Rules. Formal changes in the Rules of Organization and Procedure will be considered at later meetings of the Committee. It was the feeling of the Committee that continued absence from Com mittee meetings or continued use of an alternate would constitute a basis for removing a Committee member as authorized by the Rules. (e) Model Industrial Regulations Dr. French reported that his Subcommittee reviewed the Federal House hold Hazardous Substances Act with a view to drafting a similar Federal act for industrial chemicals. It was agreed that the Subcommittee should also give thought to regula tions which might be issued by states which already have enabling legislation on the books. The Chairman appointed Mr. Ralph-Troup, Chairman of this Subcommittee with Messrs. Hogan, Masek, Tuttle and Wendt as members. 1.3 ALLIED COMMITTEE ACTIVITIES 1.3.1 CSMA Mr. Hill said that he believed CSMA and MCA were now working harmoniously together. He said the CSMA Labeling Committee would meet next week. Committee members were of the opinion that Mr. Ackerly did a fine job in California regarding California A. 1908. Mr. Hill suggested the permanent extentlon of the Joint Industry Com mittee consisting of CSMA, MCA, NPV&L and API representatives, who have been working on the Model Hazardous Substances Act. 1.3.2 API Mr. Tuttle said that Dr. Osborn and Dr. Gjerde would be API representa tives when hearings are held on the proposed Federal Hazardous Substances Labeling Bill. 1.3.3 NPV&L Dr. Foulger reported on NPV&L developments and said that a model paint bill, A. 531, had been introduced in the State of New Jersey. Introduction of this bill occurred as a result of recommendations from the Grand Jury of Passaic County which had been investigating the death of two children from paint. Committee members expressed regret at the death of Daniel L. Boland, Counsel for NPV&L. Mr. Daniel Ring has succeeded Mr. Boland. L-28o 1.3.k ACGIH Dr. Nale reported that Dr. Elkins had not replied to his recent invitat to discuss proposed ACGIH rules and regulations for the labeling of hazardous ma *01) terials . Dr. Osterritter said that he had talked to Dr. Stoklnger at the recent 1959 Industrial Health Conference and that Dr. S tokinger.: had sent him a copy of the latest draft of the ACGIH draft, "Guide to -Rules and Regulations for the Label ing of Hazardous Materials" The Secretary will reproduce this Guide and send it to Committee members. 1.3.6 HFPA Mr. McIntyre reviewed for Committee members, the activity of the JJFPA Committee on Fire Hazards of Materials. Canadian representatives inquired regarding the practice in the States when an accident happens while a chemical product Is being transported. It was stated that an information sheet is now being supplied to each driver of a Canadian tank truck giving instructions of what to do in case of accident. 1.3.8 AMA The activity of this group is discussed under 2.1 Federal Legislation. 1.3.9 AIHA Report on 1999 Industrial Health Conference Mr. Philpitt reported on the recent 1959 Industrial Health Conference and said that much favorable comment was received concerning MCA's Labeling Exhibit. Mr. Philpitt manned the Exhibit for the three days of the Conference and was aided one day by Dr. Osterritter. A large number of individuals stopped by the Exhibit, many of whom indicated that they were not familiar with MCA's work in the field of precautionary labeling. Commit+ee members agreed that it would be desirable to use this Exhibit at other meetings during the next few years. 1.3.10 Public Health Service Labeling Committee In the absence of Mr. Flanagan, there was nothing new to report. 2.1 FEDERAL LEGISLATION (a) Hazardous Substances Labeling Bill (l) Present Status Mr. Kittelton reported that he bad been informed by Mr. King that a hearing in the House on H. R. 5260 would -be',held, during June. Committee members discussed the phrase, "non-manufacturing use" as opposed to the coverage of the Model Industry Bill, "suitable or intended for household use." The members said that if the phrase "non-manufacturing use" were inserted in the labeling bill, products such as laboratory reagents, metal cleaning compounds, etc., would be covered. L-281 The Committee was of the opinion, that the phrase, "non-manufacturing use" is not one that you would be able to define with any amount of certainty. The coverage of the bill should be stated in positive terms sc that a manufacturer would know whether his product is covered, rather than stated in negative terms. The phrase, "suitable or intended for household use" is a clearly understood term. (2) Discussion of Proposed FDA Amendments to Hazardous Substances Labeling Bill -- LAPI's Position where Opposed (a) The Committee discussed the PDA change in the term hazardous substance and took the following positions: (i) FDA would insert the ptoase "or as a result of" before "any customary or reasonably anticipated handling or use." The Committee felt this should read "or as a direct result of." (ii) FDA would add a new subsection to the term "hazardous substance" to read: (2) any "dangerous caustic, or corrosive substance" (or mixture of such substances) within the meaning of the Federal Caustic Poison Act (4k Stat. 1406) as in effect immediately prior to the enactment of this Act." This wording was confusing and the Committee requested that FDA be asked to explain the purpose. (iii) FDA has included radioactive substances and the Committee decided that it would not make an issue of this. (b) FDA desires to delete, "or the recognized generic name (not trade"name only)"and substitute "(if there be no common or usual name)." The Com mittee felt that this should be opposed. (c) FDA also wished to add "or twenty milligrams per liter by volume or less of" to line 11 of page 6 of H. R. 5260 after the word "vapor." The LAPI Committee voiced the opinion that MCA toxicologists should defend the LAPI standard with FDA. (d) FDA also wished to add a proviso to H. R. 5260 that the Secretary "may by regulation, establish such requirements as to size, typography, color and location of label information required by this Act as he finds are neces sary to make such information conspicuous and likely to be read." The Committee reiterated its traditional opposition to *udh a provision and urged that it be strongly opposed. (e) FDA would add a new section on "Variations and Exemptions" to read: "Sec. 3. (a). The Secretary may, by regulation, establish such variations from the labeling requirements established by section 2(p), or such additional labeling requirements, as he finds are necessary for the protection of the public health and safety in view of the special hazard presented by any hazardous substance; and any container of such hazardous substance, intended or suitable for household use, which fails to bear a label in accordance with such regulations shall be deemed to be a misbranded package of a hazardous substance. "(b). If the Secretary finds that, because of the size of the package involved or because of the minor hazard presented by the substance contained therein , full compliance, with the labeling requirements otherwise applicable under this Act would constitute an unreasonable burden upon the manufacturer. packer, or retailer of ary hazardous substance, the Secretary shall promulgate regulations exempting such substance from such 'requirements to such extent as he determines to be consistent with adequate pro tection of the public health and safety. "(c). The Secretary may exempt from the requirements established by or pursuant to this Act any-container of a hazardous substance with respect to which he finds that adequate requirements satisfying the purposes of this Act have been established by or pursuant to any other Act of Congress." (The Committee felt that section 3(a) and (c) should be opposed strongly.) (3) Toxicity Standards Dr. Osterritter`s Subcommittee reported their recommendations for a ment of the Model Hazardous Substances Labeling Bill. These recommendations are as follows: (1) Section 2 (f)(1)(b) of Model Industry Bill of January 5th is amended to read as follows: "Produces death in 14 days in half or more than half of a group of ten or more laboratory white rats, each, weighing 200 to 300 grams, when inhaled continuously for a period of one hour or less at an atmospheric concentration of 200 ppm by volume or less of a gas or vapor, or 0.2 of a milli gram per liter if_a_respirable mist, aerosol or dust, etc." (2) Section 2(m)(c)(2) is amended to read: "a period of one hour qe. less at an atmospheric concentration of 2000 ppm by volume or less of a gas or vapor or 2 milligrams per liter if a respirable' mist, aerosol or dust, etc." The recommendations were discussed by the Committee and Dr. White referred to a letter of March 31, 1959*. addressed to Dr. Osterritter. Attached to these minutes as Appendix A is a copy of the letter. The Committee agreed that for the present, the changes in the Toxicity Standards would not be incorporated into the MCA definition of poison. The Revision Subcommittee will look into this matter. After this discussion. It was moved, seconded and voted THAT, the Subcommittee.*a.-report, is accepted and that the standard be inserted in the proposed Federal Act with the proviso that the Food and Drug Administration be consulted regarding the use of molecular weights. Dr.- White said that he would prepare overlay graphs to indicate the facts so that these might be used in the future as needed. (4) Letter from John G. Kuniholm of Hercules Powder The Committee considered the two points which were raised in Mr. Kuniholm1s letter. The Committee has not taken any position on the first point L-283 and the other second point, they did not feel that any food, drug or cosmetic drums would be identifiable by characteristic, shape or closure. (5) NFPA Letter It was the consensus of the Committee that the Model Bill should not be changed to reflect the objection raised by NFPA. (6) Letter from Liquefied Petroleum Gas Association The Committee discussed correspondence which the Secretary.has had with the Liquefied Petroleum Gas Association concerning exemption of LPG from the coverage of the bill. Following this discussion. It was moved, seconded and voted THAT, the LAPI Committee will not recommend exemption of specific chemical products from the coverage of the Model Hazardous Substances Labeling Act. (b) Bureau of Explosives -- Status of Definition Changes Committee members discussed the proposed Bureau changes and Mr. Walker stated he did not understand why. these ,changes..were necessary at all.- - The Com mittee agreed to continue to follow this matter by a vote of 11 to 2. The Chairman appointed Mr. Nelson Wendt as an additional member of Mr. Tuttle's Subcommittee and the Secretary was instructed to notify Mr. C. H. Mayhood of this fact. 2.2 STATS LEGISLATION 2.2.1 California Mr. Walker reported that Mr. Robert L. Ackerly had represented MCA, CSMA and NACA at a California hearing on Assembly Bill 1908, As a result of these efforts, the objectionable point-type requirements were eliminated from the bill. Committee members were pleased with arrangements which were made to have Mr. Ackerly jointly represent the three associations,. Mr. Walker appointed Sanford Hill, Chairman and E. J. Hogan as member to follow the situation in the State of California and to recommend future steps by MCA. 2.2.5 Massachusetts Mr. Tuttle relayed to the Committee the latest information which he had concerning H. 2402, a bill to require a pipison label on ethylene glycol anti-freeze. Dr. Foulger reported that he and another gentleman had paid a visit to the First Executive Secretary of the Governor of Massachusetts. They were informed that the Governor would not veto the bill. Three children had died from drinking green colored anti-freeze, thinking it was creme de menthe. Mr. Tuttle pointed out that when this bill was first discussed, he had talked to Dr. Hamilton of CSMA who informed him that CSMA was prepared to handle the situation in Massachusetts, and would attempt to have their "Model Bill introduced. The Chairman, Mr. N. M. Walker, said that he and the Secretary had also discussed L-284 this bill and that he had informed Mr. Kittelton that the bill was only of interest to a-few members of MCA and that if action were warranted,.these companies should -take such action. 2.2.6 Michigan Mr. McIntyre reported that he had talked to two representatives of the Michigan Medical Association regarding MCA labeling principles and that they had. been sent copies of the LAPI Manual and Proceedings of the 1957 and 1958 Precau tionary Labeling Conferences. Mr. McIntyre said he had also talked to a represents tive of the Grand Rapids Poison Control Center. Although no legislative action is taking place in Michigan,- the Chairnan congratulated Mr. McIntyre on the fine missionary work he is doing in the State. 2.2.9 Ohio Mr. Kittelton reported on his recent trip to Ohio at which time he conferred with Ohio Health Officials and also appeared at a hearing on Ohio S. 44o representing MCA. The Secretary said that he had a very good reception from Dr. Mancuso and the Ohio Health Department Staff and that the Senate Committee had substituted our Model Bill for the bill which was originally introduced and which would have been quite objectionable. 2.2.l6 Colorado . ..... Committee members did not know of any new developments in the State of Colorado. 2.2.18 Washington Mr. Hill reviewed developments in the State of Washington. The bill which had been introduced in that State was killed by the Legislature and it is probable that during the next Legislative Session,' a more favorable bill will be introduced, probably the Model Industry Bill of January 5th. 2.2.19 West Virginia The Secretary reported that the West Virginia Legislature only meets for 60 days and that there was not sufficient time to prepare a bill in proper form. Mr.'Wiseman of the West Virginia Manufacturers Association, suggested that work be started on a bill before the next Session of the Legislature. 2.2.22 Connecticut Mr. Tuttle stated that he had received a'letter from Mr. Frederick H. Waterhouse, Counsel far lie Manufacturers Association of Connecticut, in which Mr. Waterhouse said that the bills to require registration of hazardous substances were killed for this Legislative Session. 2.2.25 Indiana Mr. Dewey reported on developments leading up to passage of the new Indiana law, S. 103. Mr. Dewey said that Messrs. Walker and Hill did'a considerable amount of work on this bill. Both of these gentlemen traveled to Indiana and con ferred with Indiana officials. L-285 Mr. Dewey said that the new law was really in two parts, one relating to labeling and the other part relating to poisons and providing for registration of them. Committee members agreed that efforts in Indiana had been quite success ful in obtaining a limitation of the registration provision to poisons only. The Secretary promised to send a copy of the new law to the Committee. It is hoped that with a new law, Mr. Sullivan of Indiana,will observe the definition of poison and not attempt to place products under it which are not poisons. The Chairman expressed the gratitude of the Committee to Mr. Dewey for his efforts in the State of Indiana. 2.2.34 Florida The Chairman reported that Mr. Ackerly had met with Dr. Stewart in Tallahassee, Florida, regarding interest of the Association of Food and Drug Of ficials in proposing hazardous substance legislation. A copy of a letter Mr. Ackerly wrote to Dr. Hamilton setting out details of his visit is attached as Appendix B to these minutes. 2.2.35 Rhode Island Mr. Williamson reported that he and Mr. Kittelton had attended a meeting of the Rhode Island Industrial Codes Commission at the invitation of Mr. Frank Marcaccio, Industrial Inspector for Rhode Island. LAPI principles were discussed with the Codes Commission and the Com mission seemed to be quite favorably impressed with the efforts of the chemical industry to promote precautionary labeling. Copies of the LAPI Manual and of the New Jersey Industrial Regulations were left with the Codes Commission. Mr. Williamson said that it was his opinion that there might be a chance that Rhode Island would not take any action at this time. However, if they do, it appears likely that they will follow LAPI principles and will get in touch with MCA before taking any action. 2.2.36 Vermont The Committee discussed Vermont H. 360 which is actually a food and drug bill containing a section on the labeling of hazardous substances. Committee members discussed the advisability of having such a broad bill and concluded that It would be preferable to separate such legislation, but the Committee did not feel too strongly about this point. 2.3 CITY REGULATIONS (a) Revision of New York City Sanitary Code The Chairman reported that the City of New York had issued its revised Sanitary Code and that a copy of the Code might be obtained for the price of $2.00 from the following: City Record Office, 2213 Municipal Building, Manhattan 7- N.Y. L-286 Dr. Male said that George Scriba had analyzed the new Sanitary Code requirements relating to precautionary labeling. Mr. Scriba1s analysis will be sent to all members of the LAPI Committee by the Secretary. 3. LABELS -- SAFETY DATA SHEETS 3.65 Vinyl Acetate It was reported that the Medical Section of the Acetate Sheet had been prepared by Dr. Cranch. The Secretary also reported that the Chemical Packaging Committee ap proved the addition of the statement "Ground Drums and Equipment before Transferrhv, to Avoid Static Sparks." The Packaging Committee also suggested that it might be desirable to consider revision of statements on container handling and storage which appear on page 20 of the Fourth Revision of Manual L-l. The Chairman suggested that Dr. Nale and Dr. Osterritter agree on a label for Vinyl Acetate and that this label then be circulated for approval by letter ballot. 3.66 Benzoyl Peroxide Dr. Foulger said the Medical Advisory Committee is still undecided as to what-information,- if any.,- should-appear in the-Safety Data Sheets. Drs. Foulger and Nale seemed to feel that the compound definitely would react with liquid in the eye. It was the consensus of the LAPI Committee that no label could be drafted until a decision is made about the Medical Section. 3.71 Methyl and Ethyl Acrylates It was agreed that Mr. Dal las Sparre should submit to the LAPI Committee his recommendations for the label and that the Secretary should send such recom mendations out with a letter ballot together with a copy of the Medical Section of a Safety Data Sheet on Methyl and Ethyl Acrylates. 3.72 Dietbylenetriamine Mr. McIntyre said that his Subcommittee was "nol^eady to report on a proposed label for this chemical. Recommendations for a label will be later sub mitted for approval by letter ballot. 4.0 NEW AND REVISED LABELS 4.l4 Oxalic Acid The Committee discussed the material which had been distributed by Mr. Williamson. It was pointed out that Oxalic Acid is just above the border line for a "poison" based upon MCA suggested tests and that on the "basis of human tests the label possibly should be strengthened. Mr. McIntyre and Dr. Foulger reported on < evidence which they had available concerning this chemical. They agreed to supply the information to the Secretary for the files. L-287 Following this discussion. It was moved, seconded and voted THAT, the label as printed in the Manual be continued in force. REVISION OF MANUAL L-l (a) Report of Fifth Revision Subcommittee Mr. Edward J. Hogan, Chairman, reported that his Subcommittee had held a meeting and discussed the revision. Mr. Tuttle will prepare Part I of the Manual and he outlined for the Committee the arrangement he planned to make for Part I, which would also include a preface. Mr. Hogan discussed Part II in the absence of Mr. Troup. The point was raised whether all approved labels should be included in Part II. Dr. Nale raised the question whether each label carrying the word "poison" shouldn't also state the reasons why the LAPI Committee suggests the use of this term. It was also suggested that it might be desirable to have the phrase "Call a physician" in a more prominent position on the .label, Mr. Hogan said that an attempt will be made, to secure completed product data statements from principal manufacturers of each chemical for which there is a label in Part II. These state ments. should also be secured from the manufacturer whenever a new label is prepared .by the..LAPI Committee. It was also suggested that wherever a label requires an antidote state ment, the California antidote be used. In discussing this, it was agreed that the term "antidote" should not appear on suggested labels, but rather that the phrase, "First-aid procedure or treatment" be used. It was reported that Mr. Sparre will revise the Preface of Part III. Also, the U. S. Department of Agriculture is reviewing 30 chemicals and labels for these will be included in Part III. Mr. Hogan then discussed the printing of the Manual and the Secretary stated that this revision of the Manual would be published in Washington. Mr. Hogan said that the Subcommittee would have some ideas about type faces and also would be able to secure some free advice regarding make-up and style of the Manual. MISCELLANEOUS (a) International Conference on Industrial Health Dr. Nale said that the International Conference on Industrial Health would like to have two papers on precautionary labeling. Advance copies of the papers would have to be submitted sometime this Fall. The meeting, itself, is scheduled for the Waldorf in July i960. Arrangements have already been made to have the Labeling Exhibit used at this meeting. It was the consensus of the Committee that the LAPI Committee should participate fully in this conference. (b) Warning on Drugs The Committee discussed, recent FDA regulations in the Federal Register which were distributed by the Secretary and it was the general consensus that the Food and Drug Administration had taken a step in the right direction. Dr. Nale pointed out that he had been following the statistics of the New York Poisons Control Center very carefully and that about two-thirds of the poisonings of children are from drugs. Also according to an AMA article, 55$ of child poison ings are due to drugs. The Committee decided not to take an official position on this matter at this time. (c) Proposed Seminar of American Management Association Mr. Tuttle stated that the .Packaging Coordinator of the American Manage ment Association was making plans for a Seminar on precautionary labeling. It vou^ be held around the second week in September. The Committee discussed this matter and concluded that it would not recommend to MCA that it participate as an Association, but that participation byMr. Tuttle as an individual would be at his discretion. (d) Next Meeting of Committee It was decided that the next meeting- of the Committee would be held on --Wednesday and Thursday, September 23 and 2k -in-the City of Washington at the Park Sheraton Hotel. Minutes Subject to Approval June 4, 1959 JDK/jmb James D. Kittelton, Secretary Labels and Precautionary Information Committee COPY SHELL CHEMICAL CORPORATION 50 West 50th Street New York 20, New York APPENDIX A March 31, 1959 Dr. John F. Osterritter Celanese Corporation of America 180 Madison Avenue New York 16, New York Dear Dr. Osterritter: Let us first review: Under the old I.C.C. standards a substance was classed as a poison and so labeled, if: LDjq rat LC^q rat LDijo rat 50 mg/kg or less 2 mg/L or less for gas, vapor, mist or dust 200 mg/kg or less on 24-hour contact. -- This classification was used and found to be quite-satisfactory as a warn ing for adults who might encounter unusual circumstances during shipment and the industrial use of chemicals. In all of the proposed bills everyone is generally in agreement with the oral and skin contact values and with the exception of the observation period (changed from 48 hours to 14 days) these values remain unchanged from the old I.C.C. classification. (Technically, this change in observa tion period means that all materials will have to be retestedI) The value under question, 2 mg/L for a gas, vapor, dust or mist is equivalent to 2,000 mg/meq3, or 2 grams. As a dust or mist, this is a h----- of a lot of dust and difficult to generate! I agree with Dr. Foulger -- I think it highly desirable to eliminate dust or mist from the standard. This can be justified because with the exception of insecticides which are already covered, dust and mist do not present a household hazard. I have converted all of the suggested values in the following table to an equivalentbasis. In addition, I have illustrated these values in a graph. If one examines these values critically, one can see, as depicted in the graph, that the use of the value 0.2 mols does not accomplish proper labeling. No one can dispute the fact that the greatest hazard from vapor exposure is present ed by the lower molecular weight, more volatile materials. Liquids of lower molecular weight present the greatest household hazard, high boiling liquids and solids present little if any. If we look at Columns IV and VI, we observe that the values recommended in Dr. Foulger's letter of March 26, will result in our recommendation that the level for the maximum test dose be lowered ten-fold in the case of a molecular weight material of 30. I, person ally, can see no justification for such a change and justification must be presented. Admitting that the red curve in the graph depicting hazard was drawn on an arbitrary basis which I personally can defend, it will be seen Dr. John F. Osterritter Page 2 that the 2 mg/-L value previously recommended by the MCA and used for years by the I.C.C.'actually conforms more closely to the hazard curve than any 1 other number one might select. An additional objection to the use of the millimole figure is en countered when one anticipates the evaluation of a mixture -- will it be based upon 2 millimoles of the most toxic, most volatile, highest percent age ingredient or an average of all components? ^ On a millimole basis any one of the above might be the most dangerous. I should like now to point out one factor to be considered in establish ing the base line for the dangerous category. X feel that a problem is presented in this area as well. Last week I had occasion to visit Dr. Harold Hodge at Rochester. This subject came up for discussion. Dr. Hodge gave me some figures which are rather disconcerting. I think you are familiar with "Clinical Toxicology of Commercial Products" by Gleason, Gosselin and Hodge. As a follow-up of this work they published an article in a rather recent issue of the A.M.A. Journal (sorry I do not have the reference). They did a statis tical break-down of household products falling into their classification as presented in the toxicity rating chart on the inside cover of their book. Five thousand household products were classified and on the basis of total product toxicity, 28.1$ fell within classes 4, 5> and 6, or were materials with a probable lethal dose to humans of less than 500 millimoles per kilo gram. Based upon 1002 ingredients, 52$ of all household products were in volved. In other words., 52$..of all household.products contained one or more of the 1002 ingredients, said ingredients probably having a lethal dose to humans of less than 500 millimoles per kilogram. This fact must be consider ed very seriously before Ve entertain any thoughts of "bargaining" for a I higher value. I have spent many hours attempting to arrive, at a satisfactory number for classifying "highly toxic" from vapor exposure and I am convinced that it is not possible. I continually come back to the fact that the old 2 mg/L is the least objectionable and most desirable benchmark if a finite number is considered the only acceptable standard. I still feel that if we want uniformity and a true evaluation of the actual hazard to life it must be done upon the basis of -- will the amount of vapor actually generated in a confined space cause death or seriously impair the health of man -- not upon some number that we were finally able to agree upon. I urgently suggest that steps be taken to reach an understanding and agreement on this matter in preparation for Congressional and State hearings. Very truly yours. cc: J. H. Foulger, M.D. H. M. Walker J. D. Kittelton J. T. Fuess T. W. Nale, M.D. /s/ N. G. White, Manager Industrial Hygiene j !i J I = ?. in PPM i i I? I 38 a CM -=t CM li -p HaC>O i ^ S 8S& o co a $i |# mHH w w ad H Cvi CM as HM S\ 8 8 5\ CM CM Copied by HCA June- U, 1959 I s 34 <n S 8 8 S 3 CM CM tf\ COPY CUMMINGS, SELLERS, REEVES & CONNER Attorneys and Counselors Commonwealth Building 1625- K Street, Northwest Washington 6, D. C. April 3, 1959 APPENDIX B Mr. H. W. Hamilton Chemical Specialties Manufacturers Association 50 East 4lst Street New York 17, New York Dear Doc: Last Monday I met with' Dr. Vincent E. Stewart in Tallahassee. Dr. Stewart, of course, is Chairman of the Committee of the Association of Food and Drug Officials charged with the responsibility for recommending to the Association some action on hazardous substances legislation. Dr. Stewart seemed to be favorably impressed with the pending federal legisla tion. He was qqite .interested in learning the reaction of AMA to the federal bills and unfortunately, I cannot enlighten him very much on this point. ^ Dr.- Stewart indicated that he had received some expression from among the membership of the Association to the effect that this legislation could not be enforced adequately without registration. . I believe that I persuaded him that registration would be a mistake. ' I urged him to have his Committee consider recommending that the Associa tion of Food and Drug Officials support the two pending federal bills and he indicated that his Committee would take this approach when it meets in Boston in June in conjunction with the annual meeting of the Association. I told Dr. Stewart that representatives of industry would be in attendance at the Boston meeting and would be available to discuss the federal bills with the Committee if they so desired. I feel'that Dr. Stewart will support the federal bills, but I think it advisable that at least one person or perhaps two from industry be available to discuss the proposals with, his Committee during the June meeting. Since Sanford Hill usually attends these meetings, he might be willing to undertake this responsibility. If anyone attends on behalf of CSMA, I think that they should also make themselves available. i ' Best regards. RLA/ras cc: Dr. E. G. Klarmann /s/ i Nicholas M. Walker, Esq. Sanford J. Hill ----------------------------------- Sincerely, Robert L. Ackerly