FDCC 71“1 Manufacturing Chemists’ Association, Inc, MINUTES OP MEETING POOD, DRUG, AND COSMETIC CHEMICALS COMMITTEE MCA Conference Room Washington, D.C. January 25, 1967 ***************** Members Present ''W. E. McCormick, Chairman V. H. Knoop, Vice Chairman -R. N. Bell •C. P. Carpenter -Prank Di Prima (for J. M. Stocker) James Hulse (for C. P. Hagan) -J. A. Korth (for J. T. Seawell) *W. H. Meyer Robert Miller (for J. G. Kuniholm) ^K. E. Mulford 0. H. Peterson A. M. Schnitzer (for R. P. Howard) H. C. Spencer G. J. Stopps (for T. W. Hanavan) G. P. Vincent Samuel Zuckerman A. R. Marusi, Board Liaison M. M. Hoover, Secretary B. P. Goodrich Company Mallinckrodt Chemical Works Stauffer Chemical Co. Union Carbide Corp. Merck & Co, Chas. Pfizer & Co. Com Products Co. Procter & Gamble Co. Hercules Inc. Atlas Chemical Industries, Inc. Salsbury Laboratories Phillips Petroleum Co. Dow Chemical Co. E. I. du Pont de Nemours & Co, Olin Mathleson Chemical Corp. H. Kohnstamm & Co, Borden Company MCA Staff Guests Present G. W. Piero John Kelly R. J. Kunz H. N. Reiman J. H. Yeager Humble Oil and Refining Co. Pharmaceutical Manufacturers Assn. Borden Co. Stauffer Chemical Co. Mallinckrodt Chemical Works Members Absent T. P. C. T. R. R. P. W. Aalto Barron, Jr. Hagan Hanavan Tenneco Chemicals, Inc. American Cyanamid Co. Chas. Pfizer and Co. E. I. du Pont de Nemours & Co. ASI 00002177 FDCC 71-2 Members Absent.... continued R. J, B. L. H. J. D. J. R. N. P. G T. A. L Howard Kuniholm McMillan Miller Schulman Seawell A. Seligman M. Stocker G Troup G. White Phillips Petroleum Co. Hercules Inc. Allied Chemical Corp. Monsanto Co. Washine Chemical Corp. Com Products Co. Hoffmann- La Roche Inc. Merck and Co. J. T. Baker Chemical Co Shell Chemical Co. . . J. • . *************** 1. Minutes of the Last Meeting The minutes of the October 11, 1966 meeting were approved as distributed with the exception of the identification in Item 7 of Dr. Stopps. He is with E. I. du Pont de Nemours and Company, 2, Membership The secretary reported that MCA has been advised by Corn Products Company that J. T. Seawell has been transferred to otner areas of operation. 3. Liaison with MCA Environmental Health Advisory Committee The chairman announced that he will appoint an FDCC Committee representative to EHAC to replace Mr. Hagan. 4. Cosmetics Legislation It was decided that the PDCC Committee should express to the Toilet Goods Association our interest in their activities in this area, and request that they keep us advised in the event they wish our support. The secretary was asked to make the contact. Mr. Miller reported that SPI has been and will be quite active in following the legislation. 5. Animal Care Legislation Dr. Stopps1 report on Animal Care Legislation is attached to these minutes as Exhibit A. Referred to in Dr. Stopps* report are the animal care law passed in August 1966 (together with the comments of the Joint House - Senate Conference Committee) and the proposed laboratory animal welfare rules as printed in the December 15, 1966 Federal Register, These were ASI 00002178 FDCC 71-3 distributed to the FDCC Committee at the January 25 meeting. Dr. Stopps stated that: "Most industrial laboratories would not find the intent of the law to be very different from their own guide lines for the conduct of testing and research procedures using animals. It is obviously in our own interest to have healthy, well-housed animals, and worthwhile research requires good record keeping--all of which are the stated aims of the law. Some discussion arises at the point when the methods by which these aims are to be achieved are published." 6. Medical Devices Legislation Mr. Kelly's report covering Medical Devices Legislation is attached to these minutes as Exhibit B. Mr. Kelly said that there will probably be no legislation this year, but possibly next year, and that PMA will oppose premarketing clearance. He said further that there are two schools of thought within FDA: (1) the only way to approach the regulation is through premarketing clearance procedures, and (2) devices should be classified as to those which must undergo premarketing clearance, those for which only standards must be promulgated, and those which require, neither standards nor premarketing clearance. 7. Indirect Food Additives Dr. Miller's report covering Dr. Frawley's proposal regarding Indirect Food Additives is attached to these minutes as Exhibit C. The committee commended Dr. Frawley for his proposal. Because of the potential benefit to the chemical industry, it was decided to request the secretary to obtain from MCA member companies data that will help establish or disprove the validity of the proposal. Dr. Miller agreed to supply the secretary with copies of Dr. Frawley's ACS paper which will help explain what data is required. It was also decided to discuss at the next meeting what stand might be taken by MCA with respect to the proposal, when the solicited data should be available for review. Mr. Zuckerman said that the proposal might run into difficulty with color additives. Mr. Marusi offered to get in touch with Mr. Cruse of SPI to ascertain their position and contemplated action, so that this infor­ mation would be available to the committee before the next meeting. ASI 00002179 PDCC 71-4 8. Carcinogenicity of Food Additives and Cosmetics The chairman appointed Dr. Carpenter, Dr. Spencer, and Mr. Meyer as the task group to carry out the committee's project on carcinogenicity. Dr. Carpenter is to serve as chairman of this task group. During a brief discussion of Massachusetts House Bill No. 6^2, whicn proposes a commission to study cancer-producing in­ gredients in packaged goods, it was decided to request the secre­ tary to ascertain whether packaging materials or the products them­ selves are in question, what in general the objectives are, and what is being done with respect to the bill. 9. Plant Inspections The chairman appointed Messrs. Bell and Knoop as the task group to carry out the committee's project on plant inspections. Mr. Bell is to serve as chairman of this task group. 10. Codex Alimentarius Dr. Spencer reported briefly on the fourth session of the Codex Alimentarius Commission held in Rome, November 7-14, 1966. He referred the committee to the official report of the U. S. delegation to the session, and specifically to the following two paragraphs having to do with the need to strengthen communica­ tions between industry and government: "The working arrangements between U. S. government agencies and the food and chemical industries have proven to be effective and efficient. This fact is important in the development of the Codex Standards, but even more so in the deliberations of the commission. Because of the close consultation between industry and government, the U. S. delegation had available highly competent recommendations and suggestions in all of the fields under discussion. The U. S. delegation was able to participate effectively in the work of the commission in such a way that the United States position was understood and, in the main, received majority support. "As the number of Codex Standards being developed increases and as these standards advance in the step procedure toward accep­ tance, the cooperation between industry and government agencies will be even more important. Therefore, every opportunity should be taken by U. S. delegates to strengthen communications between parties interested in the various Codex Standards. This will strengthen the program by keeping more people informed about the progress and ramifications of the proposed standards." To acquaint the committee with established lines of communication Dr. Spencer made specific mention of the "Flow Diagram for Inter­ national Acceptance of Food Additives," and to "The Joint FAO/WHO Food Standards Program." A copy of the former is attached to these minutes as Exhibit D, and the latter as Exhibit E. ASI 00002180 FDCC 71-5 Dr. Spencer also referred the committee to two publications which will be particularly helpful to industry. One is a brochure telling what the Codex Alimentarius Commission is, why it is important to the U.S., the role of the U.S., and the names of the U.S. delegates to the various Codex Committees. It is published by the USDA, and is titled "Codex Alimentarius Commission." The other is the "1966 Yearbook of Agriculture" containing (in the chapter on international food standards) a highly useful section on the organization of the Codex Alimentarius Commission. The yearbook is available at $2.50 from the GPO, or through congressmen. The secretary was requested to inform the MCA membership of the list of flavoring materials to be considered at the eleventh meeting of the Joint FA0/WH0 Expert Committee on Food Additives, which is to be held in August 1967. This list is attached to these minutes as Exhibit F It is important that toxicological and related data from manu­ facturers of these substances be in the hands of committee members well in advance of the meeting. The information, including published articles and unpublished reports, should be sent to Dr. Frank C. Lu, Chief, Food, Additives, World Health Organization of the United Nations PaLais des Nations, Geneva, Switzerland. 11. Food Chemicals Codex Dr. Spencer reported that Dr. Paul E. Johnson at the NAS-NRC will head up further work on the Food Chemicals Codex, and that a meeting has been called for February 3 to discuss the mechanism of supplementation and revision. 12. Economic Poison Disclaimers It was the feeling of the meeting that MCA has a stake in the current "war" on economic poison disclaimers being waged by USDA, and that a united industry front should be established. To assist in this, it was decided that close contact should be maintained with other industry groups, and that a report from each should be sent to the FDCC Committee. Dr. Flero agreed to do this for CSMA, Dr. Peterson for AHI, and Dr. Carpenter for NACA. 13. Next Meeting Subjects In addition to items in these minutes which will carry over to the next meeting, it was suggested that the secretary Invite Mr. Settl of the MCA Staff to discuss public relations activities of interest to the FDCC Committee, and to schedule a discussion on micro-organisms in foods and drugs with particular emphasis on salmonella. With regard to the latter, Mr. Zuckerman agreed to get in touch with Mr. Lee Harrow of General Foods to see if he will be willing to make a presentation, and to notify the secretary at which time an official invitation would be sent. ASI 00002181 /DCC 71-6 1^. Next Meeting Date and Place It was decided to hold the next meeting on Tuesday, June 13, 1967 In the MCA Conference Room In Washington, starting at 10:00 a„m. M. M. Hoover, Secretary Pood, Drug, and Cosmetic Chemicals Committee MMHssel February 20, 1967 ASI 00002182 HlSl i £* 1 of tT^) ANIMAL CAKE LEGISLATION By: Dr. G. J. Stopps Until 1966 the battle between the self-styled "humane movement" and the research community had been conducted as a series of sporadic skirmishes with the research workers regard­ ing the dog lobby as a nuisance rather than a threat. This situation altered in 1966 when nationwide exposes of pet stealing and of brutality among animal dealers caused a shift of emphasis by the humane movement. The focus of action now became animal procurement rather than the attempt to reduce and restrict animal experimentation which had always been a subject too sensitive for congressional action. Public interest rose to almost unprecedented heights. The House Agriculture Committee alone received over 20,000 letters following two days of hearings on "pet-napping" bills, and individual congressmen reported mail from constituents running far higher than the combined mail on Vietnam, inflation, poverty, and civil rights. This shift of emphasis away from the sensitive area of the regulation of experimentation to the more readily supported attempt to Improve animal care and handling resulted in Public Law 89“5^ which was signed in August 1966. Whether this is the end of further legislation in the realm of animal care for the immediate future is difficult to forecast, not because the "humane movement" will give up its struggle for what it con­ siders a just cause but because too many intangibles go into the building of the political climate to make the prediction of legislative events beyond one session of Congress worthwhile. The laboratory animal care law as passed in August 1966 is appended to these remarks, together with the comments of the Joint House-Senate Conference Committee. Most industrial laboratories would not find the intent of the law to be very different from their own guide lines for the conduct of testing and research procedures using animals. It is obviously in our own interest to have healthy, well-housed animals, and worth­ while research requires good record keeping - all of which are the stated alms of the law. Some discussion arises at the point when the methods by which these aims are to be achieved are published. On December 15, 1966, the proposed laboratory animal welfare rules were printed in the Federal Register. The usual 50-day period for the submission of views was allowed; but in this case, this period covered both the Christmas and New Year holiday which produced some inconvenience for those wishing to submit a statement. Part I of the proposed rules deals with definitions of terms. Part .II covers procedures for implementing the law such as dealer licensing and fees, registration of research facilities, identification of dogs and cats, and record keeping requirements, etc. ASI 00002183 t c ■K { £ >, J\ cn I 2 A research facility unlike an animal dealer is merely required to register with the Department of Agriculture, whereas the dealer obtains a license for which a fee is payable. The research facility applies for registration on forms provided for the purpose by the veterinarian in charge of the program. Along with the forms will be sent a copy of the standards to be followed, and acknowledgment of the receipt of the standards is included with the registration forms when the application is filed. Dogs and cats (but not other animals) obtained by research facilities must be identified by an aluminum tag embossed with the letters USDA and numbers and letters identifying the state, dealer, and animal. These tags are affixed to the animal's neck by the dealer; and if removed by the research facility, the tag must be retained until called for by a Department of Agriculture representative. In connection with all dogs and cats purchased or otherwise acquired, a research facility must keep the following Informa­ tion on forms to be supplied. 1. The name and address of the person from whom the animal was obtained, and the number of his license if he is a dealer. 2. Date obtained. p. Description and identification of the animal. If animals are transported or disposed of to another person, suitable records must be maintained of these events and all records must be kept for at least two years. One of the more controversial portions of the proposed rules is that headed "Miscellaneous.'' "2.125 Information as to'business; furnishing of by dealers and research facilities. Each dealer and research facility shall furnish to authorized representatives of the Secretary any information concerning the business of the dealer or research facility which may be requested by them In connection with the enforcement of the provisions of the Act, the regulations and the Standards in this subchapter, within such reasonable time as may be specified in the request for such information. ASl 00002184 =XUl£lT A C Pe*c. 3 . The size of the cages. If these regulations are strictly enforced, most laboratories using animals would be forced into expensive reconstruction programs. 4. The phrasing of the lighting standard. 5. The abolition of open water containers for guinea pigs and hamsters. 6. It may be anticipated that any extra expenses incurred by the dealers in complying with the regulations will be passed on to the research facility thus resulting in more expensive animals. GJS/dyb Attachments (2) ASX 000021S7 EXKiB'T 3 - f -jf >x\ (' rZ' MORE PROPOSED FEDERAL REGULATION FOR MEDICAL DEVICES For the past few years, the Administration has sponsored legislation to bring medical devices under regulations now applicable to drugs. has caused our industries to share another mutual problem. This proposal Before this matter is finally resolved, many more industries will have discovered in it their own \ i grave concerns. ' The invitation to appear before you today to discuss this proposal is both flattering and pleasant. Flattering because it suggests that we can inform you about some of its aspects with which you may not be familiar, and pleasant because it brings me among friends. I have organized my discussion in three parts. First, to report briefly what the Administration's devices proposal is designed to do, as­ suming of course that it follows the same format it has since 1961. Second, to tell you how PMA views such provisions; and third, to report some -of the drug indus­ try's experiences under the 1962 Drug Amendments, which should give us some idea of what will happen if this proposal were enacted into law. I. * The principal new requirements of previous Administration proposals are these; 1. As is now the case with drugs, a device would also be deemed adulterated if manufacturing and control procedures do not conform with good manufac­ turing practice. Presented by John T. Kelly, Legislative Counsel, Pharmaceutical Manufacturers Association, January 25, 1967, before MCA's Food, Drug, and Cosmetic Chemicals Committee, "Washington, D. C. ASI 00002188 2- - 2. Ail new devices would be subject to the same premarketing require­ ments as new drugs, and Section 505 of the FDC Act would be amended to insert the words "or devices" after the word "drug" wherever it ap­ pears. Therefore, both safety and effectiveness would have to be shown, and all the types of information needed now to support a new drug appli­ cation would have to be furnished before a new device could be marketed. Clearance procedures would be identical, and denial of device applica­ tions and withdrawal of approvals would be based on the same grounds as for new drugs. Investigations of new devices could be conducted only by experts qualified to investigate the safety and effectiveness of devices, and the Secretary would be able to condition investigational exemptions on the same basis now allowed by the Act with regard to new drugs. 3. A new subsection to Section 501 (a) would be added to provide that a new drug or new device would be considered adulterated if there were no approved application in effect with respect to it for the uses recom­ mended in its labeling or it fails to conform to the approved application. Exemptions are provided for investigational drugs and devices, those exempted by regulation, and devices licensed by the A.E. C, The pro­ hibition under 3 01 (d) against introducing into interstate commerce an article in violation of Section 505 would also apply to devices because of the incorporation of devices in 505, and Section 301 (1) would be amended to prohibit representations that an application covering a new device or cosmetic has been approved. II. What in essence are the main objections to this proposal? In general, there is good reason to feel that this proposal is unrealistic, unworkable, and unneeded. Moreover, it will seriously interfere, without compensating benefit to the public, with the development and use in medicine of a wide variety of medi­ cal devices. Premarketing clearance of drugs under ihe present law is an expensive and lengthy process involving extensive tests, voluminous record keeping and frequent reports to FDA. Whatever its justification in the case of newly developed drugs, we know of no comparable evidence requiring such unusual controls for devices. 00002189 -3- rpa. The new drug procedure was introduced into law by the 1938 Amend­ ments, and while Congress felt that it was necessary to regulate devices as well as drugs, it did not subject devices to premarketing clearance as it did drugs. It therefore concluded that the misbranding and adulteration provi­ sions of the 1938 law governing devices were adequate for them, but that be­ cause of the inherent differences in devices and drugs, new drugs should be fur­ ther regulated by premarketing clearance. Thus, in 1938, Congress made a decision that devices are not analogous to drugs and do not lend themselves to the same techniques of regulation as do drugs. This proposal, by trying to force device regulation into the same pattern as drug regulation, is seeking to overturn this prior decision of Congress. So far as we are aware, there are no particular problems in the field of devices which cannot be adequately handled under the provisions of existing laws which include seizure, injunctions, and criminal penalties for devices which are adulterated or misbranded, and action against manufacturers who falsely advertise devices. The laws are administered by the FDA and FTC which have never been bashful about vigorously enforcing all laws assigned to them. An attempt has been made to justify this proposal on the basis of the socalled "quack machines." There is adequate authority to meet this situation under present law as witness the FDA seizures in the field. There.seems to be ample evidence indicating that the public is adequately protected against the practice of quackery. Full exploration of the use of all enforcement techniques should be made, in any case, before extraordinary legislative remedies are pro­ posed. We do not believe this has been done. ASI 00002190 Furthermore, the proposal extends far beyond remedying any alleged enforcement problem that may exist with respect to unsafe or ineffective thera­ peutic devices. It would subject many thousands and various kinds or classes of devices to the same extensive premarketing clearance procedures which now apply to new drugs. These proposals would undoubtedly deter the improvement of many ex­ isting devices. For example, in the case of equipment for the administration of fluids or blood to humans, many improvements are made, such as changes in size or shape of the equipment or in its composition, which do not necessarily increase sales by the suppliers. The expense of premarketing clearance pro­ cedures would not be justified, and no need has been demonstrated for such a I procedure for these devices. Among other things, there are a limited number of suppliers of this kind of equipment, which is sold and used exclusively through professional channels. These proposals would also deter the development of new devices, many of which are developed by professional people for use in medical practice and made available to other experts. Such devices are not always sponsored by in­ dustrial concerns and the procedures which have been adopted by FDA are wholly inapplicable to the development and use of such devices. To apply these pro­ cedures to industrial concerns performing a service to the medical profession is to destroy the capacity of private industry to perform this valuable function. The term "device" presently has an extremely broad definition in Section 201 (h) of the Act which defines it to mean: "instruments, apparatus, and contrivances, including their components, parts, and accessaries, intended (1) for use in ASI 00002191 . EX+4IF-! -5- Cl CS~ o*f £ > the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or (2) to affect the structure of any function of the body of man or other animals. " As is clear, this definition covers a tremendously wide variety of articles. Some idea of its broad scope is gained from the fact that the FDA has ruled in the past that "devices11 include such diverse articles as ankle supports, athletic supporters, combs labeled "for dandruff and scale infections, " dental plates, dental supplies, sleep-inducing phonograph records, surgical instru­ ments (such as knives, forceps, saws, mallets, chisels, needles, drills, nails, and screwdrivers), suspensory bandages, syringes, clinical thermometers, rubber gloves sold for use by surgeons, tongue depressors and applicators, and elastic and leather wrist bands. Many different industries are involved in the manufacture of devices under the proposal. Actually, the pharmaceutical industry probably manufac­ tures only a small portion of the total devices embraced by the proposed defini­ tion. Some of the other industries which will be affected by the proposal are your industry, the surgical instrument industry, the dental supply industry, the optical supply industry,, the electronic industry, the electrical industry, the hos­ pital equipment industry, and even the shoe industry. The fact that so many different industries are involved in the production of devices emphasizes the differences which exist in devices themselves and the differences which exist between devices and drugs. There are different methods of production and distribution and of research and development. differences in methods of use. Some devices are developed by experts for their own use and made available to other experts. moted to the gullible public. There are wide A few are "quack" remedies pro­ All are now subject in one way or anothe r to the FDC ASI 00002192 6- - 3ecause of material differences within the device grouping and between devices and drugs, we are convinced that the proposed requirement that all devices generally be integrated under the drug control law and be pretested and cleared for safety and effectiveness would impair the development and use of many important devices and for others would require work which, insofar as we are aware, is not necessary, for the public interest, with resulting waste of time, money and effort on the part of both theGovernment and the industries involved ■ * At a time when the FDA is still struggling to digest the Drug Amendments of 1962 and is still attempting to expand its staff sufficiently to meet the added work load imposed by those Amendments, one can only guess as to the enormous j additional demands which would be imposed upon the FDA were the premarketing clearance of all devices to be required. In light of what has gone before, the capacity of FDA to administer the proposed devices legislation should be care­ fully evaluated. III. If the experience gained under the 1962 Drug Amendments can provide realistic guide lines as to what we may expect if the devices proposal is enacted-andwe believe it does--here are some things like to happen. Since the passage of the 1962 Amendments, there has been a steady decline in the introduction of new drugs, and their development and production costs have greatly increased. In 1959, the introduction of new single chemical entities in the United States prescription drug market reached a high of 63. This compares with 23 in 1965, 17 in 1964, 18 in 1963, 28 in 1962, and 41 in 1961. ASX 00002193 And this year there EXWifclT ^ L^ -b __‘ W- i / £>t J were only 11. Data concerning the submission of new drug applications is much the same. In fiscal year 1959, 369 were submitted and 230 approved; in fiscal year 1963, 179 and 67; in fiscal year 1964, 160 and 84; and in fiscal year 1965, 203 and 53. The approval picture is a little brighter in 1966 with 108. I do not presently have the figures on the number of applications submitted. During this same period, industry spending on research has soared. In 1959 it was $197 million; in 1960, $212 million; in 1961, $238 million; in 1962, $251 million; in 1963, $282 million; in 1964, $298 million; in 1965, $339 million; and in 1966, about $400 million. More time for processing individual applications has also been very evident, thus adding to the delay and increasing the manufac­ turer's over-all premarketing expenditures. times what it was in I960, is invented. The average is now two or three Consider what is involved when a new drug product From the time a new chemical is isolated until its clinical trial has been completed, a minimum of 4, and possibly as much as 6 or 7, years have elapsed. During this time, a minimum of $1 million, and as much as $5 or $6 million, have been invested, and if the information collected reflects that the product justifies marketing, an application must be made to the FDA for ap­ proval to do so. From this point another time lapse of from 6 months to 2 y ars or more takes place. We recognize that some of our sad experiences under the 1962 Drug Amendments are due to lack of facilities and a shortage of qualified personnel. We are the first to acknowledge that FDA has its dedicated people--there are not enough of them to meet the burdens this law has thrust upon it, or the additional ASI 00002194 8- - ones it seeks. Certainly, the myriad of new responsibilities, accompanied by the need to recruit more qualified people in admittedly short supply argue most dramatically against hasty, unneeded and potentially harmful legislation. 3efore legislation proposing additional controls on devices is enacted, it would seem to us that a thorough study is badly needed. done. This has not been Such a study should facus on (1) whether there is a need for additional controls, (2) what kind of devices should be further controlled, and (3) what kind of controls should be used and whether different types of devices require different controls. Only when all of this,information is available and carefully analyzed, and any problems revealed thereby have been delineated and understood, will it be possible to legislate intelligently concerning the wide, complex and hetero­ geneous field of devices. As we have all heard, the FDA has been meeting with various groups, individuals, and organizations on a new study it is making of the regulatory controls it feels are required in the field of devices. gestions and approaches will be offered. No doubt numerous sug­ Whether FDA remains wedded to the premarketing clearance approach, in light of the overwhelming evidence we be­ lieve militates against it, remains to be seen. ASI 00002195 EAUl‘i. i- ^ •' Ch "'7 CSjrro / '5- J-<> ^v>\. ✓* FOOD ADui*>VES 24 Ar j/^/'C ^f( - 'V , C'‘-T't''~ '2; , ,■ ,.,.^y. (,<> y L CPci^’l o-C " 0 Annex 5 FLOW DIAGRAM FOR INTERNATIONAL ACCEPTANCE OF FOOD ADDITIVES Request tot consideration Comraidity Committees of the Codex Alimentanus ---------- Supply ol dote Requests lot consideration Decisions reached ASI 00002199 F A 0/ ;7 :i 0 'OQD STANDARtJ PROGRAM (IJ0VtlL133^ 1905) t ASI 00002200