Document XRBY2EmJ47yqD9oEbQabRQDNw

FEB 1? ^69 THE SOCIETY OF THE PLASTICS INDUSTRY. INC. 250 PARK AVENUE NEW YORK. NEW YORK 10017 212/6B7-267S MINUTES MEETING OF SFI FOOD, DRUG AND COSMETIC PACKAGING MATERIALS COMMITTEE Hotel America Washington, D. C November 7, 1968 9:30 a.a. Present: Robert M. Miller, Chairman, Hercules, Inc., 910 Market St., Delaware Trust Bldg., Wilmington, Del. 19899 Taylor W. Hanavan, Vice Chairman, E. I. du Pont de Nemours 4 Co., Inc., 1007 Market St., Film Dept., Wilmington, Del. W. B. Ackart, Union Carbide Corporation, Chemicals & PlasticsOne River Rd., Bound Brook, N. J. 08805 R. C. Asam, The Goodyear Tire 4 Rubber Co., Chemical Materials Dept., Dept. 480D, 1485 E. Archwood Ave., Akron, Ohio 44316 Sal M. Cannavo, L. A. Dreyfus Company, P. 0. Bax 500, South Plainfield, N. J. K. C. Conley, Marbon Chemical, Development Division, Div. Borg-Warner Corp., P. 0. Box 68, Washington, W. Va. Paul F. Cundy, American Can Co., Research 4 Development Dept., Bcoc 702, Neenah, Wis. L. J. DeCorte, Sinclair-Koppers Co., Product Development, Frankfort Rd., Monaca, Pa. Barry R. Dittmar, Vyp&k Corp., Div. of Ethyl Coxp., 75th and Cleveland, Kansas City, Missouri Daniel S. Dixier, AIRCO, Air Reduction Co., Inc., Central Research Lab., Murray Hill, N. J. 07971 Andrew G. Engstrom, Glidden-Durkee Div., SCM Corp., 900 Union Commerce Bldg., Cleveland, Ohio 44115 George W. Ferner, The Goodyear Tire 4 Rubber Co., Research Div., 1144 East Market St., Akron, Ohio 44316 S. Walter Foulkrod, HI, Scott Paper Company, International Airport, Philadelphia, Pennsylvania 19113 Lawrence J. Friedman, Hooker Chemical Corp., Ruco Division, New South Rd., Hicksville, N. Y. Il802 Gerhard H. Fuchs, Allied Chemical Corp., P. 0. Box 405, Morristown, N. J. B. J. G&rce&u, ICI America, Inc., P. 0. Bax 1274, 151 South St., Stamford, Conn. Louis A. Guzaetti, Jr., Celanese Corporation, 522 Fifth Ave., New York, N. Y. R. H. Haas, The Goodyear lire 4 Rubber Co., 1144 East Market St., Akron, Ohio Ralph L. Harding, Jr., SFI, 250 Park Ave., New York, N. Y. 10017 Jerome H. Heckman, Keller and Heckman, 1712 "N" St., N. W.,Washington, D. C. 20036 Patrick L. Henry, Allied Chemical Corp., P. 0. Box 405, Morristown, N. J. 07960 Karl A. Hoehschwender, American Hoechst Corp., P. 0. Box 2500, Somerville, N. J. ^ bJk g) ASI 00000677 BFG61400 -2- George V. Ingle, Monsanto Co., 1101 17th St., N. W., Suite 604, Washington, D. C. John F. Janes, The Standard Oil Co., Midland Bldg., Cleveland, Ohio William A. Knapp, Allied Chemical Corp., F. 0. Bax 405, Morristown, H. J. 07960 Donald F. Krank, Armstrong Cork Co., Liberty and Charlotte Sts., Lancaster, Fa. Frank L. LaMotte, Jr., T. W. Winstead Co., Inc., 10830 Gilroy Rd., Cockeysville, Maryland 21030 F. S. Landers, Lily Tulip Cup Corp., 500 Comm&ck Bd., Comasck, Y. 11725 Walter L&nferman, Mobil Chemical Co., 150 East 42nd St., Hew York, N. Y. 10017 V. A. Larkin, M & T Chemicals, Inc., Woodbridge Ave., Rahway, If..J. 07065 James R. S. McCartney, Standard Packaging Corp., Ill Prospect St., Stamford, Conn. Thomas J. McGrath, SFI, 250 Park Ave., Hew York, H. Y. 10017 Gordon L. McIntyre, Columbian Carbon Co., P. 0. Box 975, Princeton, N. J. 06540 James A. Mitchell, S. 1. du Pont de Hemours & Co., Inc., Film Dept., 1007 Market St., Wilmington, Del. 19898 Kenneth Mcrgareidge, Food and Drug Besearch Laboratories, Inc., Maurice Ave., Maapeth, H. Y. 11378 Peter Morison, Eastman Chemical Products, Inc., Chemical Sales Dev. & Technical Service, B-230, Kingsport, Tern. 37662 Wendell P. Mxnro, American Cyanamid Co., Bound Brook, H. J. 08805 Stanley D. Nesmith, USI Chemicals Co., P. 0. Bax 218, Tuscola, HI. 61933 A. S. Nyquist, American Cyanamid Co., P. 0. Box 425, South Cherry St., Wallingford, Connecticut 06492 B. Newell Olson, Reynolds Metals Co., 10th and Byrd Sts., Richmond, Va. 23219 I. Frank Peake, E. I. du Pont de Hemours & Co., Inc., Film Dept., 1007 Market St., Wilmington, Del. 19898 Jules Pinsky, Monsanto Co., Packaging Div., P. 0. Bax 1019, Hartford, Conn. 06101 George A. Richter, Jr., Rohm & Haas Co., The Rohm & Haas Bldg., Independence Mall West, Philadelphia, Pa. 19105 Robert E. Rutherford, Gulf Oil Corporation, P. 0. Bax 1166, Fittsbrugh, Fa. A. Merrill Schnitzer, Phillips Petroleum Co., Research & Development Dept., 336 Chemical Laboratories, Bartlesville, Okla. George T. Scriba, Union Carbide Corp., Legal Dept., 270 Park Ave., New York, N. Y. A. W. Sheldon, M & T Chemicals, Inc., Woodbridge and Randolph Aves., Rahway, N. J. Matthew 2. Smith,Owens-Illinois, Plastic Products Div., Adams & l4th Sts., Toledo, Ohio 43601 Charles J. Spiegl, Continental Can Co., Inc., 7622 South Racine Ave., Chicago, HI. Donald F. Thompson, R & D Division, AviSun Corp., Post Rd., Marcus Hook, Pa. 19061 W. M. Westveer, The Dow Chemical Co., 433 Building, Midland, Mich. 48640 G. F. White, Jr., Reynolds Metals Co., 10th and Byrd Sts., Richmond, Va. 23219 Ambrose G. Whitney, W. R. Grace & Co., Research Div., Clarksville, Mi. 21029 Einar T. Wulfsberg, American Paper Institute, 1837 "K" St., N. W., Washington, D. C. Thomas J. Hughes, Acting Secretary. Keller and Heckman, 1712 TT" St., N. W., Washington, D. C. 20036 Under the direction of Robert M. Miller, Hercules, Inc., a meeting of the SFI Food, Drug and Cosmetic Packaging Materials Committee convened in Washington, D. C. at the Hotel America at 9*30 a.m. Referring to a detailed agenda circulated with the Secretary's meeting announcement, Mr. Miller, as a first order of business, asked for the usual self-introductions. BFG61401 ASI 00000678 tt'Z 9 T Q S 2 -3- Minutes Last Meeting Approved By way of reminder, Mr. Miller noted that the last overall meeting of the Committee was held in Nev York City on April 17, 1968. In the absence of comments as to corrections or additions to the minutes of the last meeting. Chairman Miller declared them approved as developed and circulated by SPX. Chairman's Remarks Chairman Miller first expressed the Committee's regrets and condolences at the passing of Joe Blanchette, Foster Grant, who had made great contributions to the Committee through his work on the Figments Task Group. Chairman Miller then called on former Committee Chairman, George W. Ingle, Monsanto Company, who presented the following resolution to the Committee bearing on the retirement of George T. Scriba from Union Carbide Corporation: WHEREAS, The Food, Drug and Cosmetic Packaging Materials Committee of The Society of the Plastics Industry, Inc., has been advised that George T. Scriba, Esquire, of Union Carbide Corporation, is now planning to retire from his present position on January 1, 1969: AHD WHEREAS, the said George T. Scriba has rendered outstanding service to the plastics industry in general, and this Committee in particular, by his having been a founder of the Committee in 1956; by his having served for lengthy periods as a Vice Chairman, Steering Committee member. Chairman of the Lawyers Advisory Sub committee, and in other capacities as one of the most distinguished Committee members; AHD WHEREAS, this Committee recognizes with deep appreciation the significant contributions Mr. Scriba has made in its work, but also in many areas of the greatest importance to the plastics industry; AHD WHEBEAS, this Committee is anxious to express, in a meaningful way, its respect and thanks to Mr. Scriba, and also its hope that he will continue to participate in the Committee's work; HOW THEREFORE EE IT HESOLVED, that the Food, Drug Cosmetic Packaging Materials Committee of The Society of the Plastics Industry, in appreciation for the invaluable contributions made by George T. Scriba over the past twelve years of the Committee's existence, hereby unanimously elects Mr. Scriba to lifetime honorary membership, and extends to him an invitation to attend all Committee meetings, and participate in the Committee's future work to the fullest possible extent; AHD BE IT FURTHER RESOLVED, that the Secretary of this Committee is hereby authorized and instructed to memorialize this Resolution in a permanent form, and present the same, duly executed by the Chairman of this Committee, and the Executive Vice President of the Society, to Mr. Scriba. ASI 00000679 BFG61402 -h- The Resolution was unanimously approved by the Committee and both Mr. Ingle and Chairman Miller further expressed the Committee1 s deep appreciation to Mr. Scriba for his many years of devoted service. Special Report of SPI Executive Vice President, Ralph L. Harding, Jr., On the ZTew York City Plastic Meat Tray Controversy Chairman Miller next called upon the Executive Vice President of the Society, Ralph 1. Harding, Jr., to report on the latest developments in what has come to be known as the 'Hew York City clear meat trays controversy." Mr. Harding began by noting that the relevant phase of the "controversy", as far as recent SPI activity is concerned, began when vord was received oa July 26, 1968 that a tele gram, reading in part as follows, had been sent to members of the press by the Pood, Tray and Board Association (FTBA): "On August 1, a new law is scheduled to go into effect in New Y:rk City that will require fresh or frozen meat, sold in food stores, to be prepackaged in so-called transparent trays. According to dramatic new evidence based on independent studies conducted for the Pood, Tray and Board Association, by a leading University, the new law inposes serious health threats that could effect every family in New York City." Mr. Harding went on to explain tut word of the telegram reached the Society late on Friday afternoon, July 26, and that, at the request of several companies in SPI, th< Society moved immediately to set the stage for an SPI press conference to be held the following Tuesday morning^promptly after the press conference called by FTBA. to expound on the statements made in its telegram. It was decided that such action on SPI's part was essential even though the Society had played absolutely no part ii the legislative, or any other phase of the controversy, as it had previously devel oped, because the FTBA telegram made it clear that, for the first time, this group had decided to raise or imply the existence of some health threat flowing from the use of plastic meat trays. Obviously, there was little time in which to consult with all SPI members to muster an "industry position" for purposes of countering thi FTBA allegations appropriately. The best that could be done, using the membership talent readily available, and the assistance of SPI Counsel, was to make the arrangements for our "counter press conference" and prepare a press release designee to deal appropriately with the health problem claims against both plastic foam and dear trays we anticipated. Mr. Harding continued to report that, at the FTBA press conference, which was held immediately prior to the SPI meeting with the press, a Hr. Elizabeth Bust of the faculty of the University of Massachusetts, gave a somewhat confused dissertation on a study that she had conducted demonstrating that the use of plastic meat trays results in losses of riboflavin and iron in packaged meat. The evidence against plastics on the riboflavin and iron questions was, as Mr. Harding noted, confusing at best. l..* O As a reaction to Dr. Rust's report, representatives of Monsanto Company promised that there would be independent research into the matter, sponsored by Monsanto. 03 Efforts were also made by Mr. Harding to obtain more detailed information on BFG61403 ASI 00000680 -5- Dr. Dust's report and the methodology used to obtain the results allegedly showing that plastic neat trays had a significant deleterious effect on the riboflavin and iron content of packaged meats. Mr. Harding noted that the FTBA flatly refused to release any information on the report other than what had already been given at the FTBA. press conference. Mr. Harding emphasised that SPI had tried to make it very clear at its press conference that it was not trying to promote the use or acceptance of any particular kind of plastic tray, but rather was defending the good name of plastics, in genera] against the pseudo-health threat charges leveled by the FTBA. With regard to the ordinance that had been adopted by the City of Hew York, Mr. Harding emphasized that SPI had, in no way, actively engaged in the sponsoring thereof, and that, in fact, the Society's policies are such that it never has, and never will endorse "restrictive" legislation of this type. Mr. Harding went on to report that on October 7, 1968, Monsanto Company called a press conference of its own to announce the results of tests it had subsequently conducted on the riboflavin and iron questions. Mr. Harding reported that,according to Monsanto representatives, the results of the test demonstrated that plastic meat trays bad no real significant deleterious effect on riboflavin and iron contest in meat. In conclusion, Mr. Harding again pointed out to the Committee that the Society in no way wishes to imply by any of its activities that it favors one segment of the plastics industry over another, nor any one plastic material over another for giver applications. The sole purpose of SPI's efforts in the meat tray controversy, as in all other controversies involving applications of plastics materials, was to defend the good name of plastics, in general, from an overall "industry" point of view. -At the conclusion of Mr. Harding's report, Jules Pinsky, Monsanto Chemical Company, noted for the record that Monsanto had not, and would not, promote any legislation, on any level, in favor of the use of clear plastic trays alone for any food packag ing applications. Jerome H. Heckman, SPI Counsel, commented that his office had been contacted by representatives of the United States Department of Agriculture the Food and Drug Administration for complete Information on the Hew York situation, and that he had supplied both USDA and FDA with substantially the same background information as had just been provided to the Committee by Mr. Harding. In concluding the discussion on the Hew York meat tray situation. Chairman Miller noted that the Food, Drug and Cosmetic Packaging Materials Committee had decided several years ago not to take any position on the use of any particular type of plastic for meat and poultry packaging applications, but had decided simply to follow the situation for informational purposes. At all times, however, it had been understood that SPI would be expected to move appropriately if any health problem issues were raised so as to give rise to a need for objective refutation. ASI 00000681 BFG6J404 - 10 - FMA Quality Control Section that the National Formulary baa agreed to publish a monograph containing methodology for containers for ophthalmic products."*/ Synthetic, Organic Chemical Manufacturers Association (SQCM/O Mr. W. P. I-imro, American Cyanamid Company, gave the following report on the status of the proposed "Synthetic Organic Colorants in Paper and Paperboard" Food Additive Begulation: "No actions in this area have been taken by the FDA in the past twelve months, i.e., since they received the objections to their Proposed Regulation of August b, 1967. "It has been reported very recently that any action awaits an internal policy decision stemming from the subject matter of the Conference on Indirect Food Additives of last February." Manufacturing Chemists Association (Food, Drug and Cosmetic Chemicals Committee) - Taylor Hanavan, E. I. du Pont de Nemours & Co., Inc., delivered the following report on MSA's efforts with regard to obtaining an exemption from the Good Manufacturing Practices Regulations for Food Additives, and its participation in investigation being conducted by -FDA's Advisory Committee Panel on Cancer Testing: "At the M2A Food, Drug and Cosmetic Chemicals Committee meeting on October 10, it was reported that MZA's request for an exemp tion from the GMP regulations for food additives was still open and that FDA is preparing a new proposal with thirty days for comments. If food additives are not exempted, the Committee agreed that it would renew MSA's request for such an exemption.**/ Prior to the publication of these minutes, arrangements are being made by Mr. Ackart to have representatives of the Committee meet with representatives of R4A to discuss the decision to have the methodology applied to ophthalmic products only. It is hoped that an agreement can be reached whereby the method ology will be referenced as applicable to dry powder and tablet form drugs. **/The new GMP proposal was published in the December 20, 1968 Federal Register The exemption request for plants making food additives was not granted in the proposal on which thirty days were allowed for comment. However, FDA noted that interested persons "... who believe circumstances warrant an exception and special regulation for his operation may submit a request for exemption together with a written justification in support of the request addressed to the Commissioner . . .". - continued - b?G6U05 C/l o O ASI 00000682 - 11 - The Committee's subcommittee on carcinogenicity has been offered an opportunity to appear before a November 12 open meeting of FDA's Advisory Committee Panel on Cancer Testing. In addition, the FDA Advisory Committee on Reproduction Studies is about to z'srward to FDA recommendations that go beyond MCA's recommenda tion of not more than a one-generation rat test. The specifics of this recommendation have not been disclosed. American Paper Institute Jim McCartney, Standard Packaging Corporation, reported briefly that API was still awaiting the outcome of events that occurred during and subsequent to the National Conference on Indirect Food Additives. Can Manufacturers Institute Charles J. Spiegl, Continental Can Co., reported that no developments of interest to the Committee had occurred within the CMI since this Committee's last meeting. SFI Food and Drug Bottling Committee of The Plastic Bottle Division Chairman Miller then called on Matt Smith, Owens-Illinois, to report on the latest developments of interest In the Food and Drug Bottling Committee of the SP1 Plastic Bottle Division. Mr. Smith reported that the Food and Drug Bottling Committee had supplied the Alcohol and Tobacco Tax Division, of the Internal Revenue Service, with a set of comments bearing on an ATTD proposal (industry Circular No. 68-21) to pro vide for the experimental use of FVC bottles, in certain sizes, for the packaging of distilled spirits. (Subsequent to the Committee's meeting, the ATTD issued a second Industry Circular (No. 68-32), which spelled out the procedures to be used by distillers in making application for the use of FVC liquor bottles in the packaging of distilled spirits.) Mr. Smith also reported that the U. S. Public Health Service apparently intended to begin publishing, on January 1, 1969, its first listing of single service milk con tainer and enclosure plants which have been properly inspected and found to comply with the U. S. Public Health Service Sanitation Standards. The listing will be published quarterly--January, April, July and October--and will cover containers and enclosures for interstate (not intrastate) milk shipments. Inspections would be under the jurisdiction of each State Milk Sanitation Rating Officer. Ifr. Smith went on to say that representatives of the Food and Drug Bottling Committee, as well as other interested parties, bad objected to such an early listing. However, the U. S. Public Health Service was apparently under a good deal of pressure to promulgate the listing. Other Matters of Interest At the conclusion of Mr. Smith's remarks. Chairman MLller asked if there were any other activities that might be of interest to the Committee. Ralph Harding called l000&83 AS! 00 BFG61406 - 12 - the Committee's attention to the fact that a conference will be held in Sweden ^ during April, 1969, on the subject of "The Corrosion Products of Burning Plastics." George Ingle, Monsanto, will represent SPI at this conference in his capacity as the Chairman of SPI's new Committee on Disposal. Mr. Harding also mentioned the fact that other new Committee's might be established from time to time within the SPI framework under a new organizational plan that had been devised for SPI, and a new set of SPI Bylaws that had been prepared by SPI Counsel. In response to a question raised by Jules Pinsky, Monsanto Company, concerning the source of news release on self-destructing PVC bottles that had apparently been aired on a Hartford, Connecticut radio station, and elsewhere, Mr. Harding indicated that the release had not been issued from the SPI office in spite of the fact that several news media sources may have given the impression that the release originated with the Society. Mr. Harding emphasized that SPI speaks as "one voice" for the plastics industry and does not engage in promotion for any one segment of the industry as opposed to others. Luncheon Conference At this point. Chairman Miller adjourned the meeting for & reception and luncheon conference with Mr. Lessel L. Ramsey, PDA Deputy Director of the Bureau of Scienti fic Standards and Evaluation. Mr. Ramsey had been invited to attend the luncheon session in the hope that he would be able to shed some light on the current FDA thinking as to what, if any, changes in the Food Additive regulatory scheme might be proposed as a direct follow. ~up to the views of industry expressed at the National Conference on Indirect Food ^Additives. Mr. Ramsey apologetically advised that he was unable to provide any "hard intelli gence" on this subject and could only report that FDA was "taking the matter seriously" and was giving very careful consideration to the proposals, comments, and arguments presented by industry at the National Conference on Indirect Food Additives. When asked if he could give some idea as to when industry might expect a response from FDA in this regard, Mr. Ramsey commented that, due to the change in personnel at the Commissioners level, (i.e., Commissioner Goddard having been replaced by Commissioner Ley), it would be impossible to predict when FDA might be forthcoming with a proposal on substantive changes directly responsive to the posi tions advanced and suggestions made at the National Conference on Indirect Food Additives. Mr. Ramsey concluded his remarks by suggesting that Commissioner Ley be questioned on this subject at the December 3 and 4 sessions of the FDA-FDLI Conference to be held in Washington. (By way of follow-up to Mr. Ramsey's remarks, Mr. Heckman and several other Committee members were in attendance at the referenced FDA-FDLI sessions and it can only be reported that Commissioner Ley was no more definitive in his response to questions on this subject asked at the Conference than was Mr. Ramsey at the Committee luncheon.) Cv c-; K* CD tO Ni BFG61407 ASI 00000684 - 13 - Chairman Miller reconvened the Committee Meeting at 2:30 p.m. Report of Technical Information Subcommittee As the first order of business for the afternoon's session. Chairman Miller called on Willard Westveer. Bow Chemical Company, who reported on Food Additive Regulations of interest that had been promulgated since the time of the last Committee Meeting. (Please Rote: Attached hereto as Exhibit C is a listing dated Hovember 1, 1968 prepared by Mr. Westveer and entitled "Recently Issued Food Additive Regulations.") Mr. Westveer discussed several of the Regulations which were of particular interest to the Committee, including an amendment to Section 121.1070 of the Food Additive Regulations which prescribes a method for determining the presence of chickedema in fatty acids. Arnold Finestone, Foster Grant, co-ordinator of the Committee's Pigments Task Group, was unable to attend the day's session and, in his absence, no report was forth coming relative to the Pigments Task Group activities. Report of Lawyers Advisory Subcommittee Chairman Miller next called on Taylor Hanavan, E. 1. du Pont de Hemours & Co., Inc., to give the customary Lawyers Advisory Subcommittee report on legislative and Judicial developments of interest to the Committee. Mr. Hanavan prefaced his remarks by paying special tribute to departing Chairman of the Lawyers Advisory Subcommittee, George Scriba. In commenting on Mr. Scriba's qualities as a "distinguished and dedicated lawyer and a true gentleman and pillar of strength" Mr. Hanavan observed that all of the industries with which Mr. Scriba has been involved, and on whose behalf he has labored, have been justly enriched, and that the SFI Food, Drug and Cosmetic Packaging Materials Committee will surely miss Mr. Scriba's vigilant counsel snd advice. Turning to his report, Mr. Hanavan first called attention to an article that had appeared in the October 23, 1968, edition of the Washington Evening Star, wherein FDA Associate Commissioner for Compliance, J. Kenneth Kirk, had been quoted on the possibility that more stringent regulatory controls might be proposed for cosmetics once the new session of congress convenes. Additionally, Mr. Hanavan noted that we might expect to see legislation offered in the next session of Congress bearing on regulatory control over medical and therapeutic devices, including those which involve plastics materials. Occupational Safety and Health Act Mr. Hanavan next commented on the status of the Occupational Safety and Health Act which had been introduced in both Houses of Congress during 1967* The proposed legislation, Mr. Hanavan reminded, would have required the Secretary of Labor to appoint various Committees to recommend Occupational Safety and Health Standards and to set up a Rational Advisory Committee on Occupational Safety and Health to administer the Act. Although bath the House and Senate bills have died in their respective Committees, Mr. Hanavan cautioned that the subject matter is by no means dormant. ASI 00000685 BFG61408 - 14 - With farther reference to this subject, it v&s pointed out that, under the WalahHealy Act, the Department of Labor bad proposed regulations which would require government contractors, or companies having government contracts, to comply with various safety standards. Among those areas which would be standardized would be noise, radiation, gas vapor,fume dust, etc. Mr. Hanavan speculated that perhaps through such regulatory procedures, the Department of Labor would be able to accom plish, without legislation, the ends which were being sought by means of the proposed Occupational Safety and Health Act. Mr. Hanavan noted that many companies and organizations, including the national Safety Counsel, had strongly objected to many of the aspects of the Department of Labor's proposed regulations, and that it was anybody's guess as to what would came of this proposed regulatory effort. National Commission on Product Safety The next item in Mr. Hanavan's report concerned the National Commission on Product Safety, which, it was reminded, had been set up to undertake a two year study of tb scope and effectiveness of present means of protecting consumers from unsafe house hold products. The Commission's goals, Mr. Hanavan noted, were (l) the identifi cation of household products that present an unreasonable risk of injury to the consumer, (2) the study of the effectiveness of industry standards and industry self regulation in the field of -consumer protection and (3) a thorough review of existing Federal, State and local consumer protection laws, as well as the large body of common lav that has developed in nearly all of the separate states in this area. Of particular significance, Mr. Hanavan noted that the Cosmission is expecte to study closely the degree of legal protection afforded to consumers by product warrantees and guarantees. Mr. Hanavan went on to report that the Commission had held its initial hearings on October 21, 22, and 23, and that, of interest to the Committee might be the fact that Dr. Milton Helpern, the Chief Medical Examiner for New York City, did, in his testimony before the Cosmission, cite the efforts of the plastics industry during the "plastics bag crisis" as an excellent example of how some industries cooperate with Federal and State health agencies to remove and minimize health hazards in the home. Mr. Hanavan also noted that the Federal Trade Commission would be holding hearings, commencing on November 12, concerning factors relevant to national consumer protec tion education. AMP Company v. Gardner Mr. Hanavan then directed himself to a discussion of a recent case that could be of considerable significance to everyone concerned with food and drug regulatory matters. The case was AMP Company v. Gardner and involved two types of plastic devices used in surgery. The company involved, Mr. Hanavan reported, had apparently submitted a request to the Food and Drug Administration for an FDA opinion as to whether the plastic articles in question might be properly classified as "new drugs", or "devices" under the Federal Food, Drug and Cosmetic Act, as amended. FDA ruled tha BFG6H09 tO tn o 03 N CD ASI 00000686 15 - the products were properly classified as drugs and that as the products were not generally recognized as safe effective, they were also new drugs for which Hew Drug Applications would be required. Mr. Warmvan noted collaterally here that the Food, Drug and Cossetic Act, as amended, defines devices and drugs essentially the same way, the only difference being that a "device" is an instrument, apparatus or contrivance and a drug is an article. However, both statutory definitions cover use "in the diagnosis, cure, mitigation, treatment or prevention of disease," or a use that affects "the struc ture or any function of the body of man or other animal." Mr. Haaavan pointed out this gives a great di of flexibility to FDA, subject only to .the limitation that the definition of drugs expressly exempts devices. Xt can be assumed, however, Mr. Hanavan added that in light of the AMP case, this limitation will be given a very narrow construction. In the AMP Company case, the Court of Appeals in affirming the District Court in effect ruled that the Food and Drug Administration had properly classified AMP's products as "new drugs". The Supreme Court denied certiorari on October lb, 1968. Mr. Hanavan read the following quote from the District Court opinion in the case: "The remedial nature of the Food, Drug and Cosmetic Act warrants a liberal construction for the protection of the public health and thus, defines that the plaintiff's product is a drug. The public will be better protected by classifying plaintiff's product as a drug rather than device, so that proper testing controlled by the government, can be pursued. It would sees that where an item is capable of coming within two definitions, the definition affording the public the greatest protection should be accepted." As far as the plastics industry is concerned, Mr. Hanavan pointed out that the definition of drugs includes "articles intended for use as components of any (drug)" and that this Court decision may V rportant in terms of imposing a duty on plastics materials suppliers to know tha: their materials are being used for or as components of drugs or new drugs. Because certain materials may not be appro priate for such drug use,for reasons known perhaps only to the materials manufac turer or supplier, the questions of civil product liability make it encumbent upon the manufacturer and/or supplier to be extremely careful in making an effort to determine the end use for its product. If nothing else, the AMP Company decision emphasizes the need for the plastics industry to proceed with caution in this area. In conclusion, Mr. Hanavan noted as further evidence of the passible implications of the AMP case that Mr. William Goodrich, Assistant General Counsel for the Department of Health, Education and Welfare, assigned to FDA, has been quoted in a local Washington newspaper as stating that, in his opinion, the AMP Company decision now gives FDA the means by which to regulate, before sale, intra-uterine birth control devices. Again, Mr. Hanavan expressed the opinion that the AMP Company case, especially as viewed by Mr. Goodrich, gives rise to a stronger than ever need for the plasties industry to take a good hard look at where it is going, and what it is doing in the medical and therapeutic devices area. SI 00000687 i bFG614' ! 16 - la consenting on Mr. Hanavan's report. Dr. Mcrgareidge, Food and Drug Research Laboratories, Inc., called the Committee's attention to the fact that there is in existence an AS3M Standard for medical devices; namely, ASTM Fh. George Ingle, Monsanto Congtany, also noted that USA Standard Institute Committee Z79 was working on the drafting of a standard for PVC and other plasties for tissue contact applications. Mr. Ingle went on to state his personal conviction tbat plastic manufacturers who plan to enter the field of supplying PVC and other plastic materials for tissue contact are going to have to do a great deal more than is presently being done with their quality control procedures,^because, for example the evidence to date is that there is extreme variability in thel.tissue contact toxicity of anyone of the "garden type variety" of PVC ingredients which are customarily used. As an example, Mr. Ingle pointed out that there are many com mercial grades of epaxidized soybean oil, and preliminary data that baa come to the attention of the USASI Z79 Committee indicates that there is considerable vari ation in the response of various grades of epaxidized soybean oil from one grade to another, and from one batch of one grade to another batch of the same grade, insofar as tissue contact toxicity is concerned. Mr. Ingle concluded by stating that the proposed USASI Standard was anticipated to be distributed within the next several months and that there would, undoubtedly, be ample occasion for comment on the proposed Standard. Report on International Developments Chairman Miller next called upon Mr. Hughes, of the law firm of Keller and Heckman, to deliver a report on the latest international developments of interest to the Committee (Please Rote; Attached hereto as Exhibit D is a copy of Mr.Hughes * pre pared remarks.) In giving his report, Mr. Hughes invited open discussion and comment from the Committee members. During Mr. Hughes' report on the developments in the United Kingdom and the current status of the British Food Additives and Contaminants Committee proposal for the establishment of a food packaging regulatory scheme in the UK, Newell Olson, Reynolds Metals Company, moved that the ad hoc Subcommittee, established during th April 17, 1968 Committee Meeting to deal with the British situation, be formally dissolved as there apparently was no further need for the Subcommittee to deliberat the British situation. Accordingly, the ad hoc Subcommittee was dissolved by Chair man Miller. With further reference to the British situation, Mr. Hughes, also pointed out, during his discussion, that the British Plastics Federation had recently published a new list of polymer specifications, which, as is customary in the UK, had been submitted to the British Industrial Biological Research Association (BIBRA). C/T o CD ro hi* ASI 00000688 - 17 Hew Business There was no further business offered for discussion at the day's meeting. Heart Meeting Mr. Miller announced that, as usual, the dates and site for the next meeting of the full Committee will be left up to the Steering Committee. The day's session was adjourned at 3:30 p.m. Respectfully submitted, Thomas J. Hughes Acting Secretary TJH:vw Sues. As X 00000689 BFG61412