Document X7qyYeaqbn78MQYkBpq1ByVjJ

JOSEPH 1E KELLER JEROME H HECKMAN CHARLES M MEEHAN WILLIAM H BOROHESANI, JR ROBERT R TIEHNAN WAYNE V BT-ACK THOMAS J HTJOHES, JR DAVID L HILL MARTIN W BEHCOVTCI LAW OFFICES Kellee and Heckman 1713 N STEEET, N. W. WASHINGTON, B. C. 20036 fanuarv 19., 19 "0 TELEPHONE 302 BQ6* 2700 CABLE ADDRESS "KEENAN" Tis All Merrfcers of the SFI .-.cod, Drug and Cosmetic Packaging Materials Committee Gentlemens With further reference to cur continuing correspondence on the reorganization cf the Food and Drug Administration,, I thought ycu would be interested in seeing the enclosed copy of a Notice that appeared in the January 16, 19?0 Federal Register,, As you will note, the Notice refers tc the Reorganization Order issued by Secretary cf Health, Education and Welfare, Robert. H. Finch, and two Orders redelegating authority to the Ccitnnissiener of Feed and Drugs. Also enclosed herewith, is a copy of another very excellent article by Lou Rothschild, bearing on the FDA reorganization. "his latest article by Lou appeared in the January 19, l^/Q edition of Food Chemical News and 1 kn^w ycu will find the infc rtiaticn contained therein cf great interest. We look forward to seeing all cf you at -he ftrthrair.ing C"Tirittee meeting here in Wastiingttr. to February 26, 1970, Cordially ycuis. Ends ASI-PR 0000941 [ rrp - FEDERAL R^fclSTER - JANUARY Lb, 1970 \ c DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE ' Office of the Secretary REORGANIZATION ORDER Certain Functions of Department Under the authority of .seei .on e o. Reorganization Plan No. 1 of ii/.)5 ;.nr. section 2 of Reorganization Plan No 3 of 1966, I hereby order reorganize; .on of certain functions of the Depot iti.ent ,.s follows: Transfer of the Food and Ih mi Ad ministration. The Pood and Dm;: Ad ministration. currently constituted as tin organizational element of the Consumer Protection and Environmental Health - Service, is hereby transferred and es tablished within the Public Health Serv ice as an operating agency of the Depart ment under the direction of the Assistant Secretary for Health and Sci entific Affairs. Establishment of the Environmental Health Sendee. An Environmental Health Service Is hereby established within the Public Health Service os an operating agency of the Department to consist of the Environmental Control Administration and the National Air Pollution Control Administration and that portion of the Consumer PiotecLion and Environmental Health Service head. quarters which was devoted to their sup port, The Administrator, Environmental Health Service, will continue to exer cise the authorities currently delegated to the Administrator, Consumer Protect tion and Environmental Health Service, with the exception of the authorities delegated to the Commissioner of Food and Drugs. Abolishment of the Consumer Protect tion and Environmental Health Service. The Consumer Protection and Environ mental Health Service is hereby a' ollshed. Continuation of Regulations. Except as Inconsistent with this order, all regu lations, rules, orders, statements of pol icy, or interpretations with respect to the , Consumer Protection and Environmental Health Service and to the Pood and Drip Administration, heretofore issued, a:id either In effect Immediately prior to the date of this order or to become effective subsequent to said date, arc continued in full force and effect. Prior Statements of Organization, Functions, and Delegations of Authority. To the extent Inconsistent with this or der. all previous Statements of Organi zation, Functions, and Delegations of Authority, and chapters of the Depart ment's Organization Manual are super seded by this order, except that, pending further delegations, directives, or orders by flic A 1fc Sterol.ary for Health t.tiri Scici.tnic Affairs, all delegations it. the Surg. it: v;.l of ihe Public Heal::. Sey\;<v. ` ..nun.iffralor. Consumer Protectam i-nvirotunt r,uil Ilealtt) Setvuve. I '' .t..m.:,. gtr of Food and 1. .... , , elr . ins by thi" r ol - ...'.ah in , .r or employee of o........ite. outran, div; non, .'...or or or" ..i/iit.ioi.u! .tut in .the. ,,. l. u.1 ........... .or u> tot rneclivr date ol ............ ,.h. :i coni,mue m effect u .lam ... i;,e;r .suerrt.i.r.s. IN ... h . .of appt Ornate tulminis- ........ . .ma. , ,al n... it ret unit uuthor- . .r:, tl be .aide oy tilt1 Assistant i'rerrt,,ry tor .ami...stratum and tiie A. .'.aaa.it Srrretary, Comptroller, respec tively, to tlie Commissioner of Food and Dr.t'us. ...niafion, shellfish sanitation, and u a'n control. 4 Functions under Executive Or . 11001, section 3(f), and those pot ;!< . of sections 3(b), 3(d), 3(e), 6, 7, 9 n- i 12 which relate to food, drugs, and i v lotteals. In the performance <ff these emergency functions the Commissioner shall coordinate his activities with the Administrator, Health Services and Mental Health Administration, in order iliat precinergency plans shall be devel oped in consonance with postattar k or ganizational plans and structure of the Department for the Emergency Health Service. 5 Function of issuing all regulations of the Food and Drug Administi a tton Tlie reservation of authority contained in Chapter 2-000 of the Department Or .'.s1, P.\s.innel. and Equipment. ganization Manual shall not apply T'anslr.-;, of o' ,am/,a, am and functions 6 Function of authorizing and ap eneeied by Lins order shall be accom proving miscellaneous and emergency panied in earn .nstanee by direct and expenses of enforcement activities, supporting Lunds, po.nuons, personnel- vested in the Secretary. records, equipment, supplies, and other These authorities may be redclegated. resources. Pending issuance of redelegations, all Effective date: This order shall be ef fective February 1, 1970. Dated: January 5, 1970. delegations or redelegations to any other officer or employee of any office, Insti tute. bureau, division, center, or other organization unit which were In effect [F.tt Doc. Rosert H. Finch, Secretary. 70-500: Filed, Jan 15, 1070; 8 -10 a.m. | immediately prior to the effective date of this redelegation shall continue in effect in them or their successors. This redelegation becomes effective February 1, 1970. COMMISSIONER OF FOOD AND DRUGS Recielcgcition by the Assistant Secre Dated: December 19, 1969. Roger O. Eceberc, Assistant Secretary for Health and Scientific Affairs. tary for rlealffi and Scientific Affairs IFR Doc. 70-597; Filed. Jan. 15. 1970: 8:46 a m.| I hereby delegate to the Commissioner of Pood and Diugs all authority dele gated by the Secretary of Health, Edu COMMISSIONER OF FOOD AND cation, and Welfare to me as follows: DRUGS 1. Functions vested in the Secretary end the Department under the Federal Food. Drug, and Cosmetic Act, as Redelegation by the Assistant Secretary for Administration amended (21 U.S C. 301 et seq.t, the Filled Milk Act (21 U.S.C. 61-631, the Federal import Milk Act (21 U.S.C. 141 ct seq.). the Tea Importation Act <21 U.S C. 41 et seq.t, the Federal Caustic Poison Act <445 Stat. 14061. the Fed eral Hazardous Substances Act cis amended by the Child Protection Act of 101.G and the Child Protection and Tov Safety Art of II,39) <15 U.S C 1201 et I hereby delegate to the Commissioner of Food and Drugs all the administra tive management authorities currently delegated on a common basis to heads of operating agencies within the Depart- meat. of Health, Education, and Welfare, These authorities may be redelegated within tlie restrictions specified in pertinent Department manual Instruc tions or other issuances. .'.ro.', the l-'.i.t i'srkipnp ano Lobelin" Fending issuance of rcdelegatlons. all \ct ml) ESC l ;51 et '.'fib, and t..c delegation.-, or rcdelegatlons to any other Flammable F,..i. ,cs Act . 15 U.S C. 120! 1 . oHirer or employee of any office. Institute, rntr-.u.im to see;, on 12 of Reorganization bureau, division, center, or other orga- - Flan No IV u-.d hvorganization Plan No. m/utional unit which were in effect Im 1 of 1953. inchidi.rT authority to admin mediately prior to the effective date of ister oaths vested in the Secretary of this redelegation shall continue in effect Agriculture by 7 U.S C. 2217. in them or their successors. 2, Functions vested in the Secretary This redelegation becomes effective by amendments to the foregoing stat February 1, 1970.- utes subsequent to Reorganization Plan No. 1 of 1953. 3. Functions pertaining to sections 301, 311, 314, and 361 of the Public Health Service Act (42 U.S.C. 241, 243, 246, and 264) which relate to pesticides, product safety, milk and food service Dated: December 22, 1969. IFR Sol Elson, Acting Deputy Assistant Secretary for Administration. Doc. 70-888: Filed, Jan. IS, 1970: i 8:48 a.m.] 4 nOEIAL RIOISTII, V L 35, N . 11--FRIDAY, JANUARY 16, 1970 ASI-PR 0000942 January 12, 1270 O Temporary Tolerances Set for Insecticide, Herbicide ^ i age ~~ FOOD CHEMICAL On Jan. 15, FDA established two temporary tolerances. The agency granted to the Stored-Product Insects Research Branch of the Agricultural Research Service a tolerance of 8 p.p.m. for residues of the insecticide malathlon in or on stored shelled pecans. The malathion is to be distributed under th Arqerican Cyanamid name. This temporary tolerance expires Jan. 5, 1971. The agency granted to Ciba Agrochemical a temporary tolerance of 0.2 p.p.m. for negligible residues of 3-(4-bromo-3-chlorophenyl)-l -methoxy-1 -methylurea in or on wheat (grain and straw). The temporary tolerance for the herbicide expires Jan. 7, 1971. Four Pesticide Petitions Noted An American Cyanamid petition noted Jan. 13 would set a tolerance of 0.1 p.p.m. in or on cottonseed for negligible residues of the insecticide 0, 0, O', O'-tetramethyl 0, O'-thiodi-p-phenylene phosphorothioate and its sulfoxide (0, O.O'.O'tetramethyl 0, O'-sulfinyldi-p-phenylene phosphorothioate). A petition filed by Uniroyal Chemical, and noted Jan. 17, would set tolerances for residues of 2-(p-tert-butylphenoxy)cyclohexyl 2-propynyl sulfite of 15 p.p.m. in or on hops, 7 p.p.m. in or on apricots and strawberries, and 4 p.p.m. in or on nectarines. A Food Additive Petition was noted the same day to set a tolerance for residues of the insecticide in or on dried hops (See story. Page 30). Another Uniroyal petition, this one noted Jan. 13, would set tolerances for negligible residues of the herbicide sodium salt of N-l-naphthyl phthalamic acid, as follows; 0.2 p.p.m. in or on peanuts; and 0.1 p.p.m. in or on canta loupes, castor beans, cranberries, cucumbers, muskmelons, peaches, peanut forage, plums, potatoes, pumpkins, soybeans, soybean forage, squash, sweet potatoes, and watermelons. FMC's Niagara Chemical filed a petition, noted Jan. 17, to set a negligible residue tolerance of 0.05 p. p.m. for residues of the fungicide l-chloro-2nitropropane in or on cottonseed. ow EDWARDS SENDS NEW FDA REORGANIZATION TO SECRETARY FINCH Food and Drugs Commissioner Edwards last week met his self-imposed Jan. 15 deadline for reorganizing the Food and Drug Administration, and shipped his plans for a new three-bureau agency to Health, Education and Welfare Secretary Finch (See FOOD CHEMICAL NEWS, Jan. 12, Page 35). O Finch is expected to give the reorganization, which had already been previewed to Assistant Secretary for Health Roger Egeberg and Deputy Under Secretary Frederic Malek, quick approval, and allow Edwards to begin filling In the names. Official release to the staff is planned for Friday. ASI-PR 0000943 .1 > ur*ry 19, 1970 FOOD CDEMiCai_ Nii:vv> Several appointments have already been made quietly, but the Commissioner has kept these under wraps. * .Jew Assistant Commissioner for Program (''oordination Established The new organization also carries changes in the structure of the Commissioner's Office. Foremost is the appointment of a new Assistant Commissioner for Program Coordination, who is expected to "honcho" Edwards' special projects, and make sure that most elements of FDA are in communication with each other. One of Edwards' pet peeves has been the lack of communication within FDA. The new Assistant Commissioner will have, in addition to a special projects function, jurisdiction over FDA's scientific information and computer services, and policy management, the former inspector general or "spy" functions that were transferred to the Consumer Protection and Environmental Health Service. ,, /The Office of Policy Management will be part of the 150 or so former FDA-ers, representing about $2.5 million in operational funds, who are coming back to FDA as a result of Finch's decision to break FDA away from CPEHS. This loss of personnel, and CPEHS' interference with FDA operations prompted the so-called Malek study which resulted in the sbakeup at FDA, and the resultant split of the agency away from CPEHS (See FOOD CHEMICAL NEWS, Dec. 15, Pages 3 and 8). In other changes, the Assistant Commissioner for Field Coordination will pick up the States Relation Services, which are now part of the Office of Legislative and Governmental Services, to add to his laboratory, inspection, and program analysts services. The former OLGS willnow handle principally FDA's contacts on Capitol Hill, and will be renamed the Office of Legislative Services. The office of the Assistant Commissioner for Education and Information will pick up the Consumer Education Service operations of the Bureau of Compliance along with the newly established Training Institute in addition to the press services and publications it now operates. r i The functions of the Assistant Commissioner for Planning and Evaluation will be unchanged, with staffs charged with planning, evaluations, and operations research. Executive Officer Will Be Upgraded to Assistant Commissioner Again The Executive Officer will be restored to his former position of Assistant Commissioner for Administration, with Divisions of Financial Management, General Services, Management Systems, and Personnel Management. More power and personnel will be placed in the offices of the Associate Com missioners for Science and for Compliance, but organizationally these will remain much the same in the first phase of FDA's reorganization. ASI-PR 0000944 oW January 19, 1970 FOOD CHEMICAL N< f*) Edwards apparently plans additional changes as time goes on and he gains experience and becomes more familiar with agency operations. At the Bureau levels, the Bureau of Veterinary Medicine remains virtually the same, with a few personnel additions from the former Bureau of Compliance, who have been handling work for BVM, and the prospect that some of the Bureau of Science personnel who have been working with BVM also will be transferred directly into the Bureau. The new Bureau of Foods, Pesticides, and Product Safety and the Bureau of Drugs will each have a Director, Assistant Directors for Planning and Scientific Coordination, and Executive Officers. The Bureau of Foods will have Offices of (1) Nutrition and Food Sciences, * (2) Compliance, and (3) Pesticides and Product Safety. < Under the Office of Compliance will be the Divisions of (1) Case Guidahce, (2) Industry Services, (3) Sanitation Control, (4) Regulations and Petitions Control; and (5) Compliance Programs. The Office of Nutrition and Food Sciences is virtually taken intact from the Bureau of Science and is composed of Divisions of (1) Food Chemistry and Technology, (2) Toxicology, (3) Nutrition, (4) Microbiology, (5) Colors and Cosmetics, and a new (6) Pathology Division. New Products Research Division to be Established The Office of Pesticides and Product Safety will be made up of Divisions of (1) Pesticide Chemistry and Toxicology; (2) Pesticide Community Studies; (3) Hazardous Substances; (4) Safety Services; (5) Poison Control; and <6) a new Product Research Division for which funds will be earmarked in FDA's 1971 fiscal year budget. In the Bureau of Drugs, FDA will establish Offices of (1) New Drugs, (2) Mar keted Drugs, (3) Pharmaceutical Sciences, and (4) Compliance. Pharmaceutical Sciences will be composed of a Division of Drug Chemistry and a Division of Drug Biology plus the National Center for Drug Analysis in St. Louis and the National Center for Antibiotic and Insulin Analysis in Washington. d The Office of Compliance will have Divisions of (1) Rx Drug Advertising, (2) Industry Services, (3) Case Guidance, (4) Regulations, (5) Compliance Programs, and (6) Medical Review. O The Offices of New Drugs and Marketed Drugs will be largely unchanged and will be set up along present lines of disease categories, and will include some elements of the former Offices of Medical Review and Medical Support. ASI-PR 0000945 January 19, 1970 FOOD CHEMICAL. wEWS Edwards plans a number of changes at all levels of the organization, and is considering bringing a number of FDA-ers from the field to fill key posts. He also has been interviewing outsiders for positions, and hopes to make as many appointments as quickly as possible. As a result of the reorganization, pare of the move from Virginia and elsewhere to new offices in the Parklawn Building in Rockville, Md. , will be delayed for several weeks. Edwards wants to put most of the reorganization into effect, and avoid additional relocations that might be necessary if the move goes on as scheduled. Most of the new Bureau of Foods operations willbe in FB 8 in Washing ton, and Edwards wants to locate as many as possible of the Bureau's personnel in Washington as soon as CPEHS lets go of the space it now holds there. j In an appearance at the National Press Club last week. Secretary Finch also ! talked of reorganization plans,, noting that he expects to propose further reor ganization of HEW early this year. He indicated that the job of Assistant Secre tary of Health will be upped to an Under Secretary level (See FOOD CHEMICAL NEWS, Dec. 22, Page 3). Finch Talks of Splitting HEW into Separate Departments, but Not Now He said he favors splitting HEW into separate Departments of Health and of Education some time in the future, but added that "now is not the time." Asked about rumors that HEW will replace its top public information officers, who are civil service employees, with political appointees. Finch replied that he has "no intention at this point" of changing "current policy." Finch was asked about comments by former FDA Commissioner Ley to the effect that he was placed under tremendous pressure from the drug industry. > Finch commented that FDA gets "pressure from all sides, " indicating that this is right. He said he will not "try to isolate" FDA from pressures. Expressing "great respect for Ley, " Finch said that "no one ever asked him to compromise his position. " Rogers Wants to Shift FDA's Scientific Responsibilities to NIH In other talk of reorganization. Rep. Rogers (D-Fla.), who headed a special House Commerce Committee study of the so-called Kinslow Report on FDA, told the annual convention of the Toilet Goods Association in Miami Beach that he favored a transfer of FDA's scientific responsibilities to the National Institutes of Health where they could be separated from "police work. " He said he has legislation in mind that would make the transfer. Rogers also said the objective could be accomplished by the use of a "peer review committee composed of outside scientific experts. " "The scientific responsibilities of FDA should be separated from the inspection and enforcement functions by placing the scientific responsibilities under the umbrella of NIH so as to divorce scientific determinations from regulatory and political considerations, " he said, adding that this move "would also have the ASI-PR 0000946 January 19, 1970 - =-' FOOD CHEMICAL added benefits of attracting the caliber of scientists needed because of the high regard in which NIII is held by the scientific and academic community. " Rogers indicated he would call Edwards and Assistant Secretary Egeberg before the Interstate Health subcommittee "to explain in more detail the reasons behind the reorganization. " O NACA OPPOSES HEW VETO OVER PESTICIDE REGISTRATIONS The National Agricultural Chemicals Association, in a letter to Health, Educa tion and Welfare Secretary Finch, has urged against amendment of the Federal Insecticide, Fungicide and Rodenticide Act to give HEW and the Interior Depart ment veto powers over pesticide registrations. The point was made in comments submitted to Finch on the recommendations of the Mrak Commission on persistent pesticides (See FOOD CHEMICAL NEWS, Nov. 17, Pages 3, 6, 11, and 14; Nov. 24, Page 31; Dec. 29, Page 5; and Jan. 12, Page 19). The Mrak Commission recommended that HEW and CJSDI be given the right of approval before the Agriculture Department registers pesticides. Finch initially indicated that this could be worked out by a re-write of the Inter departmental Agreement, but more recently has called for amendment of FIFRA. The HEW change in position was based on CJSDA's contention that it bears sole legislative responsibility for pesticide registrations. NACA took the CJSDA position in the dispute. The Association said the recommendation of the Mrak Commission "compels two inferences: "(1) The registrant would be expected to submit directly to HEW the data to demonstrate that the proposed pesticide use would not produce untoward effects on two or more t species of animals which might indicate a hazard to health. Presumably, the registrant would be expected to deal directly with HEW personnel in discussing the data. Presumably, the registrant would likewise be expected to submit data relating to effects on wildlife directly to the Department of the Interior. "(2) The Secretary of HEW would make the decision on whether the proposed pesticide use presents an untoward hazard to the public health and the Secretary of CJSDI would make the decision on whether the proposed usage presents an untoward hazard to wildlife and the environment. " ASI-PR 0000947 4 Mr. Miller next noted that in January, 1969, Ralph L. Harding, Jr., Executive Vice President of SP1, received a communication from the Tea Association of the United States of America, Inc., expressing interest in knowing if SPI has facili ties fc" investigating the possibilities for transporting tea in plastic containers from growing areas overseas to blending plants in North America. Here again, Mr. Miller said he asked Mr. Heckman to send this particular communication from the Tea Association to all members of the Committee so that individual representa tives could communicate directly with the Tea Association if they so desired. In this particular case, Mr. Miller indicated that he did not know whether individuals have written directly to the Tea Association or not since he has not received any additional information in this connection. Concluding his remarks dealing with general interest items, Mr. Miller reminded everyone that, at the last meeting of the Committee, questions were raised con cerning reports about a Swedish company's development of an allegedly degradable plastic beer bottle. He then read an item from the Journal of Commerce plated January 8, 1968 to the effect that this particular beer container has been taken off the market because, as the article pointed out, "insufficiently founded claims regarding the degradability" were found. The Journal of Commerce article read, in toto, as follows: , "BEER CONTAINER TAKEN OFF MARKET "The so-called 'degradable' beer container announced last spring in Sweden by Warby Breweries has been withdrawn from the market because of 'insufficiently founded claims regarding degradability.' "Even as originally claimed the container was not degradable in the sense that the announcement implied or as reported in the American press. It was said to take two years to 'dissolve' and therefore could not be regarded as a valid answer to any part of the litter problem. "No suiting beverage container material known to the packaging industry today, either in the U. S. or in Europe, has the quality of degradability envisioned by those concerned with the role of packaging in litter." Mr. Miller next called on Mr. Condit to discuss a recent move made by Ralph L. Harding, Jr., to set up within the Society a so-called "Medical Review Board" to assist in handling inquiries which the Society receives from time to time from the medical profession. Mr. Condit noted that, for the first time, a very success ful meeting on plastics and the human body was held by SPI at its major National Conference in November 1968 in Chicago during the National Plastics Exposition. The speakers at this particular meeting were eminently qualified to discuss such sub jects as disposable plastics in dentistry, plastics for the repair of war casual ties, plastics in the artificial kidney, plastics blood vessels, plastics for assisting the failing heart, plastic heart and heart valves, and other cardiovas cular uses of plastics. (Please Note: Although not all of the speakers at the National Conference provided the Society with complete copies of their talks, it has occurred to the Secretary that, if anyone is desirous of receiving copies of those papers that are available, he would be pleased to comply with requests for the same while the supply lasts.) ASI-PR 0000948 9 -5- At a special luncheon held in November for those from the medical profession who spoke at the National Conference, Mr. Harding was advised that it would be of immeasurable assistance if SPI could act as something of a clearinghouse for inquiries about plastics and their potential applications from physicians, hospi tals, and other medical personnel or Institutions. Thereafter, in May of this year, Mr. Harding communicated with the principal raw materials producers within the plastics Industry querying them on the names of individuals within their companies who might be willing and able to answer the sort of questions expected to be posed by physicians. In his communication he noted that, once a list was compiled, SPI would "then operate a reference service concerning the Inquiries sent to us, and in maintaining a listing of available sources of information, plan to send against this listing* from time* to time the various medical inquiries which the Society receives." Mr. Condit continued by saying that once the Society has compiled the amines of those within the materials producers companies who are receptive to receiving these medical questions, SPI will announce through an appropriate press release to various medical groups, the news media, and the medical publications, that SPI is prepared to consider answering appropriate inquiries about plastics for medical applications as they are received. Mr. Condit concluded his remarks by saying that, thus far, fine cooperation has been received from the materials companies in that several names of individuals have been provided to the Society, i.e., names of those who would be receptive to receiving the medical inquiries as they are received at the SPI headquarters. Report of SPI Counsel Chairman Miller then called upon Jerome H. Heckman, Esquire, Legal Counsel for SPI, to conduct his regular discussion on FDA regulatory matters. Mr. Heckman first reported on miscellaneous matters of general Interest concerning (1) changes in personnel at FDA; (2) the possibility that most of the FDA Staff (but not the Petitions Control Branch) of the FDA will be moving their offices to Rockville, Maryland; (3) the use which FDA officials are making of the so-called "Good Manufacturing Practices Manual" developed by this Committee some years ago and Issued through SPI; and (4) a detailed questionnaire sent by the so-called "Kennedy Subcommittee" to all administrative agencies of the government in order to generate answers to several broad questions about procedural policies. The major situation with which he dealt at length during his discussion was the socalled "Ramsey proposal" for amending Section 121.2500 of the Food Additive Regulations, and its implications as an aftermath to the National Conference on Indirect Food Additives. Due to the nature of Mr. Heckman's report, it was presented in a rather informal manner to permit considerable cross-questioning and explanations occasioned by the expressed Interests of the members of the Committee. For this reason. Instead of the usual type of formal report, there is attached to this set of Minutes, as Exhibit B, an edited transcript of Mr. Heckman's presentation, as interrupted from time to time, by questions and responses thereto, as well as comments from the floor. This material was taped during the course of the meeting so. In some ASI-pR 0000949