Document Dvbkg6odOZBnQ3Q3G94EZ43VB

JOSEPH E, KELLER JEHOME H HECKMAN CHARLES M MEEHAN WILLIAM IX. QOftOHESANI, JR, ROBERT li.TIKHNAN WAYNE V, BLACK DAVID L HILL MAHTIN W BERCOV1CI MARC K SHAYE LELAND tJ BLAIR PETER M NEMEOV LAW OFFICES Keu.ee and Heckman 1130 17TM STREET, S. W. SUITE lOOO WASHINGTON, T>. C. 20036 May 16, 1972 TELEPHONE 5302 296-2100 CABLE ADDRESS KELMAN Mr. Robert M. Miller Hercules, Inc. Delaware Trust Building Wilmington, Delaware 19898 Re: Food and Drug Administration's Proposed Rulemaking; Procedures for Affirmation of GRAS Status and Determination of Food Additive Status (37 Fed. Reg. 6207). Dear Bob: With sincere apologies for the short time I am allowing you and the others receiving copies of this letter to review the material, I am herewith en closing a draft of the Comments we would propose to file on behalf of The Society of the Plastics Industry in connection with the referenced Rulemaking. As you know, we have for some time felt that the FDA Proposal should be employed to at least raise a number of questions about the present handling of incidental food additives problems and, where possible, to make suggestions for changes. Our think ing in this respect is simply that, obviously, we must continue to raise these questions with FDA whenever an opportunity presents itself in the hope that someday, somehow, we will be able to obtain "high priority" consideration of our "low priority" food additives problem. We suspect that you will find the enclosed pleading a little unusual, and hope that perhaps FDA will ultimately feel the same way. Our objective, of course, is to try to bring about a restructuring of the incidental additives regulatory scheme so that some MAY 1 8 1972 ASI-PR 0001466 Mr. Robert M. Miller May 16, 1972 Page Two version of the old "Ramsey proposal" can be adopted to delimit the necessity for filing full-scale Food Additive Petitions on substances of obvious toxicolo gical insignificance. Bearing in mind that the Comment deadline date in the proceeding is May 26, and again with sincere apologies for the short notice, I am hereby asking that anyone who feels that the enclosed draft is inappropriate, or should be revised in any way, let my office know by telephone as promptly as possible. I will be here from May 22 through May 24 so sometime during this period would be the best tiitu. to give me your thoughts. We can then place the statement in final order and submit it on May 26. I will be looking forward to hearing from any of you with suggestions to offer. Enclosure cc: SPI Food, Drug and Cosmetic Packaging Materials Committee ASI-PR 0001467 [Please note: This May 16, 1972 draft is considered by us to be a working document only. The final comments will, we hope, properly reflect corrections, additions, and revisions oc casioned by FDCPMC members' reactions] Hearing Clerk Department of Health, Education, and Welfare Room 6-88 5600 Fishers Lane Rockville, Maryland 20852 Re: Food and Drug Administration's Proposed Rulemaking; Procedures for Affirmation of GRAS Status and Determination of Food Additive Status (37 Fed. Reg. 6207) Dear Sir: Pursuant to Section 4 of the Administrative Procedure Act, as amended, 5 U.S.C. 553 (c), and the referenced Food and Drug Administration Notice of Proposed Rulemaking pub lished on March 18, 1972, The Society of the Plastics Industry, Inc. (SPI), by its attorneys, and acting through 1/ its Food, Drug and Cosmetic Packaging Materials Committee, 1/ The Society of the Plastics Industry, Inc. (SPI) is a Corporation organized under the Membership Corporation Law of the State of New York. It is composed of approximately 1200 member companies and individuals who supply raw materials; process or manufacture plastics or plastics products; engineer or construct molds or similar accessory equipment for the plastics industry, and engage in the manufacture of machinery used to make plastics products or materials of all types. SPI is the major national trade association of the plastics in dustry, its membership being responsible for an estimated 75% of the total dollar volume of sales of plastics in this country. The Food and Drug Administration is quite familiar with the constitution and activities of the Society as a result of our many filings and participation in other proceedings of direct consequence to plastics producers. Copies of SPI membership directories, organization charts, and the like have been sup plied to FDA in connection with some of these filings. Any further background information desired can bo supplied (con't) 0001468 ASl"pR 2 hereby respectfully submits its views with regard to the abovereferenced proposed amendments to Part 121 of the Food and Drug Administration's Regulations. I INTRODUCTION AND GENERAL STATEMENT OF POSITION; REQUEST FOR ORAL ARGUMENT By means of the rulemaking proposal which is the subject of these Comments, the Food and Drug Administration appears to be looking towards a new approach to the handling of a segment of the general food additives regulatory problem which might well add a degree of rationality to what has been largely a maze of confusion and uncertainty since at least 1960. To the extent that this is the case, and bearing in mind that our primary interest here is in the indirect additive, or "food contact surface" area, we commend the Administration for making some effort to bring order out of chaos. At the same time, however, we are dismayed to note that the proposal raises many questions; so many that we have doubt as to the legal basis for parts of the proposal, and even more doubt as to how it will serve the useful purpose of providing in dustry and the public with a better understanding of the indirect food additive "ground rules." Among other things, there is nothing in the explanatory statement or the proposal to indicate the statutory basis for FDA's mention in several places of its intent to evaluate and 1/ (con't.) immediately upon request by the Food and Drug Administration. ASI-rr 0001469 3 pass on the "functionality" of indirect additives. If the term "functionality" is equatable to "efficacy" in the present con text, we respectfully submit that Congress specifically re jected giving FDA authority to pass on efficacy except in very unusual circumstances, i.e. whe a a tolerance must be 2/ established to protect the public health, and that these circumstances have never come into play, to the best of our knowledge, where indirect additives are concerned. Other points which we consider confusing, or especially significant because they are not discussed at all are exem plified by the following listing (discussed in more detail hereinafter): 1. How will the proposed new procedures/ which will necessarily bring about the filing of still more food additive petitions, be administered as a practical matter when FDA has thus far found it virtually impossible to act on any but a very few regular petitions (an estimated 50 to 70% of which relate to indirect food additives) within the 180 day 2/^c'f. Section 409 (c) (3) (A) and 409 (c) (4) of the Federal Food, Drug, and Cosmetic Act, as amended. A review of these provisions demonstrates that FDA, in dealing with food additives, must be convinced of their safety, but may only deal with the question of efficacy where a true "tolerance" is necessary to assure safety. The entire legislative history of the 1958 law confirms this view. ASI-PR 0001470 4 statutory deadline provided for promulgation of regulations or amendments responsive to Section 409 Petitions? 2. Is it intended that FDA will treat, and list as "generally recognized as safe" (GRAS), packaging materials or other food contact surface components when appropriate tests satisfy a seller or user that the substance involved may not reasonably be expected to become a component of foods, and, hence, is not a food additive under the basic Statute (Section 201 (s)) or FDA's Regulations (Section 121.1(e)). This may seem to be a question which answers itself,but fourteen years of very difficult experience indicates the contrary to be the case. This is pri marily because FDA's scientists have refused to concur in non-migrant, ergo non-food additive, status in all but a very few types of situations, and despite supporting data acquired under grossly exaggerated test con ditions. Such refusals have occurred somewhat erratically but often even when scientists of equal competence to FDA's, and with even more ASI-PR 0001471 5 experience as to specific packaging materials components, have concluded that there is no reasonable expectation of migration to foods. 3. Will the proposal require food additive or GRAS petitions to be filed in cases where test data is interpreted by the Bureau of Foods to indicate possible "insignificant levels" of migration to foods from packages or food contact surfaces? Indeed, this vexatious area has been the subject of the most prolonged and, thus far, fruitless debate between FDA and the packaging in dustries. If this rulemaking proceeding is intended to at least help deal with it forth rightly, and bring reason into play in the field of scientific judgment, as it would seem to purport to do, this should be made much clearer than is now the case. 4. Where a GRAS petition is filed, is it appropriate or proper to open the entire petition to public view if, among other things, FDA will require, under Section 121.40(c) (1) , that all details of past usage be included in the Petition? If this is done, many petitioners may ASI-PR 0001472 6 well have to lay open customer lists, and other important trade secrets now protected under Section 302 (j) of the Food, Drug and Cosmetic Act, and the Public Information seciion of the Administrative Procedure Act ("Freedom of Information Act"). This type of information would even be protected under the Agency's new proposal to release a great deal of other information now held confidential. (See 37 Fed. Reg. No. 88, pps. 9128 and 9129 and esp ecially the discussion of the trade secrets, etc. exemption plan.) For the sake of con sistency alone, the instant proposal should be revised to assure protection of such in formation. 5. In what specific ways will the new rules do anything to expedite clearances or rejections of GRAS or other substances, and help clarify product classifications for the packaging industries, or their customers? 6. Will there be time limits for final FDA action on GRAS petitions, or proposed interim food additive regulations, whether the same are instituted on the Commissioner's own ASI-Pp 0001473 7 initiative, or at the instance of outside parties ? At least as we view the situation, failure to consider these questions, and explain how they will be handled, casts serious doubt on the value of the rulemaking proposal. Here, as in all other instances in these Comments we are, of course, limiting our observations to indirect food additive problems. 3/ It is our position, just as it has been since 1956* that (1) indirect food additives present entirely different factual situations and questions than direct food additives; (2) sensible handling of these situations requires special and discrete, though far less demanding, treatment; and (3) there are means available to deal with the problem on bases which would allow most indirect additives to be cleared (yet made fully known to FDA and the public) without the procedural "folderol," waste of scarce scientific talent, time, and ex pense, and processing delays now involved with respect to what the Administration's staff has always declared to be its lowest priority concern vis-a-vis public health. /3 Statement of John G. Kuniholm on Behalf of The Society of the Plastics Industry, Inc.; Hearings Before a Subcommittee of the Committee on Interstate and Foreign Commerce, House of Representatives, Eighty-Fifth Congress, On Bills to Amend the Federal Food, Drug and Cosmetic Act With Respect to Chemical Additives in Food, (Pages 145-152). ASI-PR 0001474 8 Rather than burden this set of Comments with a repeti tion of information already in the Food and Drug Administra tion's hands, albeit apparently bypassed heretofore as far as definitive action is concerned, we respectfully request that the agency consider incorporated bv reference herein the 1/ following documents: 1. The lengthy Comments filed on behalf of The Society of the Plastics Industry, Inc. on November 6, 1967 in response to the FDA Notice of Proposed Rulemaking of August 8, 1967 (32 Fed. Reg. No. 152, p. 11443 et_. seg.) which looked towards amendment of the Food Additives procedural regulation:;. 2. The Transcript of the National Con ference on Indirect Food Additives held on February 13, 14, 1968. It would also be helpful if the Food and Drug Administration made reference to any exchanges of cor respondence between it and the Subcommittee on Regulatory Agencies of the House of Representatives Small Business Committee that led to or bore on the decision to call this 4/ Copies of all of the listed materials are readily available Tn our files and can be resubmitted to FDA if they cannot be found conveniently in the Agency's files. ASI-PR 0001475 9 Conference. It is our belief that this correspondence would clearly show that the Conference was called as a partial response to inquiries made of then Commissioner Goddard by Congressman John Dingell; that promises of prompt remedial action were made to Congressman Dingell; and that no such action has yet been taken despite these promises and others made "on the record" by Commissioner Goddard. 3. All correspondence and, where possible, any relevant FDA memoranda, relating to what industry has come to call the "Ramsey proposal," sent on an informal basis to industry rep resentatives on May 6, 1969. For reasons which still remain quite unclear to us, no further action has been taken on this proposal. We are of the view, based on our experience to date, that most of the questions and issues raised directly, or implied by the foregoing inquiries and the more specific comments that follow, are not susceptible of satisfactory resolution without a true exchange of opinions on the subject in a suitable, though not unduly burdensome forum. For this reason, we respectfully urge the Commissioner to hear oral argument on the entire indirect food additives "administrative ASI-pr 0001476 10 problem. Such oral argument is permissible under Section 4(b) of the Administrative Procedures Act, 5 U.S.C. 553 (c) although it is understood that conducting such legislative type pro ceedings is discretionary. Due to the importance, and long range impact of the questions we are raising, and the recommendations being made, we submit that such argument before the Commissioner, where all parties could be provided a reasonable time to explain- their positions and respond to the Commissioner's questions so as to make a full record, is the only sensible means by which essential issues can be brought into focus. We, there fore, urge that interested parties be allocated argument time before the Commissioner for this purpose and request that SPI be allotted one hour of the time provided for this purpose. In numerous instances, when other agencies are presented with public problems of significant import, their respective administrators do not hesitate to call for public hearings or oral presentations on their own initiative. For example, the Federal Trade Commission ordered open hearings to explore modern advertising practices and their impact on con- 57 sumers with special attention to television advertising. The Environmental Protection Agency made provision for a public hearing regarding the issue of lead and phosphorous additives 5/ 36 Fed. Reg. 16698, August 25, 1971; attached hereto as Appendix B. ASI-PR 0001477 11 6/ in motor vehicle gasoline; and the Federal Communications Commission has ordered oral argument regarding y Doctrine." / Even though the controlling law does the not "Fairness require oral argument, we believe this form of presentation will contribute substantially in '"his instance. It should be noted that we are specifically not requesting an evidentiary hearing pursuant to 5 U.S.C. 556. In the present case, in our opinion, a hearing is not required but we believe a leg islative type of oral argument is demanded to serve the public interest. THE II IN EFFECTUATING THE INSTANT PROPOSAL, IF IT IS ADOPTED, DUE CONCERN AND CAREFUL PLANNING SHOULD BE EMPLOYED TO ASSURE THAT REQUIRING "GRAS PETITIONS" WILL NOT FURTHER OVERBURDEN PRESENTLY UNSATISFACTORY PETITION PROCESSING SITUATION As we read the present proposal, it will most assuredly require the filing of a great number of additional petitions, albeit and hopefully, many of these petitions will require less 6/ 37 Fed. Reg. 3882, February 23, 1972; attached hereto as Appendix C. 7/ 37 Fed. Reg. 4978, March 8, 1972; attached hereto as Appendix D. 8/ The relevant part of 4 of the Administrative Procedure Act, provides that: "...the agency shall give interested persons an opportunity to participate in the rulemaking through submission of written data, views, or arguments with or without opport unity for oral presentation." ASI-PR 0001478 12 preparation and FDA review time. Nonetheless, we question the advisability of adding to the over-all petition load at a time when it remains apparent that the petition-regulation system is by no means operating as Congress intended, nor as industry or the public have a right to expect. Indeed, it might be best to consider whether this system should be re9/ tained at all before an additional burden is placed upon it. The statutory time limitations placed on FDA require publications of Notices of Filings regarding Food Additive Petitions of any type within 30 days after filing (Federal Food, Drug and Cosmetic Act 409(b)(5)) and the adoption or denial of a proposed food additive regulation, 90 days or 180 days subsequent to the filing of the Petition. (409 (c) (2)). However, with few exceptions, the time limitations are con tinuously exceeded. This observation, which is a general w basis of complaint by industry, has been acknowledged by FDA 9/ In many ways the present regulatory scheme is much more akin to licensing than rulemaking. Perhaps it is time to acknowledge this frankly and proceed accordingly, accomplishing the neces sary public information function by publishing lists of "ap provals" given from time to time. This could expedite matters by allowing the FDA Staff to focus on specific substances for specific intended uses instead of requiring that Regulations be devised to anticipate broader coverages than Petitioners require, or can even know about. 10/ At an FDA-SPI Seminar, held in Washington, D.C., on June 18, 1971, Mr. Nathanial Geary, then Director of the Division of Petitions Processing of the Food and Drug Administration, stated that the average time to process a "perfect" petition was 184 days. ASI-PR 0001479 13 and was further quantified to a degree in a recent survey conducted by SPI's Food, Drug and Cosmetic Packaging Materials Committee. The SPI survey resulted in the receipt of responses from 19 petitioners covering 129 petitions relating to in direct food additives. Based upon these replies, it can be said prior to a 1966 internal FDA change in petition-processing procedures, there was an average delay of 13 1/2 months before regulations issued. The shortest times reported were onehalf month for acceptance, in one case, and two months for issuance in another, but these were not for the same petition. As to the post-1966 filings, the average processing time was 12 1/2 months per petition. The shortest time for promulga tion reported for a simple Regulation amendment was four months. Many responders reported petition-handling periods of over three years. Of the petitions reported on, 39 were filed since 1966, 51 prior to 1966, and the other 39 spanned the pre-and post-1966 years. Stated simply, this survey merely confirmed the common knowledge that the handling of Food Additive Petitions almost always involves delays which make a mockery of the statutory IV requirements. 11/ It is acknowledged that some of the delay is due to re quests by FDA for additional information but more often than not these requests are not even received until the "last hours" before a statutory deadline is due to expire. ASI-pr 0001480 14 The issue of time limitations naturally comes to mind in another sense in connection with the subject proposed rules since they will require petitioning for affirmation of GRAS status of a given food additive substance. In this case, the proposal does not mention time limitations so we must assume the plan is to follow the statutory procedures. This can only aggravate an already unacceptable situation and make further delays commonplace as to conventional petitions, as well as the new "GRAS" ones. According to the proposal, when affirmation of GRAS status is sought either on the initiative of the Commissioner or upon the petition of an "interested person," 60 days after a notice is placed in the Federal Register, the Commissioner must evaluate all comments received and make a determination. (121.40(b) (3) and 121.40(c) (4),) However, there is no time limitation placed on the Commissioner as regards the making of the evaluation, or as to the publishing of his decision in the Federal Register. Even though the already-existing processing time limits are so frequently exceeded, their presence at least serves as a reminder that a given regulatory proceeding should not continue indefinitely. Thus, at the very least, it is respectfully submitted that if the proposed rules are adopted, they should include the expression of a time limit upon the Commissioner in 121.40, especially with regard to petitions ASI-PR 0001481 15 initiated by an outside party. Accordingly, SPI recommends that 121.40 be revised as follows: 1. In 121.40(b)(3) on the fifth line, after the word "publish" insert the following phrase: "...within 90 days after publica tion of the notice in the Federal Register referred to in subsection (b)(1) of this Section,..," 2. In 121.40 (c) (4) , on the seventh line, after the word "publish" insert the following phrase: "..., within 90 days after publica tion of the notice in the Federal Register referred to in subsection (c)(2) of this Section,..." Ill THE FACT THAT SUBSTANCES WHICH ARE NOT DETECTED IN EXTRACTION STUDIES AT REASONABLE LEVELS OF METHOD SENSITIVITY SHOULD BE READILY DEEMED NON-ADDITIVES SHOULD BE MADE COMPLETELY CLEAR; MOREOVER GRAS STATUS SHOULD BE PROMLTLY AND EASILY GRANTED INDIRECT ADDITIVES USED IN AMOUNTS WHICH ARE OBVIOUSLY OF NO TOXICOLOGICAL SIGNIFICANCE The development of formal procedures to make GRAS status determinations proposed by this rulemaking should not be completed without resolving the long-pending issue of how to eliminate the excesses of full-scale regulation now afforded in cases where there is no detectable, or extremely low level migration of indirect food additives. More specifically, it is respectfully submitted that FDA should eliminate the costly, burdensome and needless requirement of filing food additive ASI- PR 0001482 16 petitions to establish GRAS or any other status with respect to substances (other than heavy metals, pesticides, and known carcinogens) which may become incidental food additives at very low concentrations. It is well recognized that even potentially harmful materials taken in minute enough amounts are harmless. It is on this basis that the National Academy 12/ of Sciences - National Research Council has developed its guidelines as to toxicological insignificance which FDA is already recognizing in determining the safe level of use of a food additive. Food additives that by law are required to be regulated have dietary levels below which they have no adverse effect, the "no-effect" level, and therefore, are permitted by regulations for use at that level and lower. It is an extension of this philosophy to very low concentrations that underlies the so-called "Ramsey Proposal," which SPI now formally requests that FDA re-examine, revise somewhat, and adopt. To review, this draft proposal affecting indirect additives was proposed to amend 121.2500 of the Food Additive Regulations and was issued on May 6, 1969 as an informal 12/ The Food Protection Committee-Food and Nutrition Board of NAS-NRC issued a pamphlet, "Guidelines for Estimating Toxicologically Insignificant Levels of Chemicals in Food," in 1969 wherein it was observed that: "for every chemical there is some finite level, sometimes called the 'safe level'"-that level which refers to the maximum acceptable daily intake in the total diet-- "at or below which it can be present in food without prejudicing safety." ASI-PR 0001483 17 statement for discussion purposes. The major provisions of the proposal would make it unnecessary to file Food Additive Petitions concerning components of (1) articles intended for use in contact with Type VIII dry foods (as defined in Table 1 of 121.2526 (c)), (2) articles intended for repeated use in contact with bulk quantities of food, (3) defoaming agents used in paper and paperboard, (4) food packaging adhesives complying with the good manufacturing practices requirements of 121.2520 and (5) those components (other than heavy metals, known carcinogens, and substances previously shown to be toxic at 40 ppm. or less) demonstrated by calculation, extractionstudies, or food analyses to result in a transfer to food of less than 0.05 ppm. As has already been indicated previously, the plastics and other packaging industries are in general agreement with the thrust of the Ramsey proposal because it was viewed as a good faith effort by the Food and Drug Administration to be responsive to some of the problems created by past administra tion of the Food Additives Amendment of 1958, as it relates to incidental food additives. Further, we believe FDA would agree that some means must be found for delineating between areas where potential hazards to health may be involved--and therefore warrant the careful attention and great expenditures of money, time, and expertise required to clear products by the food additive petition route--and those areas where there is ASI-Pr 0001484 18 no hazard to warrant such expenditures. Actually, it has long been our view that this type of delineation is precisely what Congress had in mind when, among other limitations, it de liberately restricted coverage of the Food Additives Amendment to any substance "the intended use of which results or may reasonably be expected to result, directly or indirectly in its becoming a component...of food..." This is why the packaging industries commended FDA , shortly after the May 6, 1969 proposal was circulated. We viewed this action as a true attempt to comply with the implied statutory mandate to clearly distinguish between sub stances which should be within the purview of the Food Additives Amendment and those so unlikely to become components of food, or otherwise so insignificant, as to demand that they receive only such attention as is necessary to exclude them from unduly complicated regulatory coverage. However, to our great dismay, the provisions in the draft proposal have never been effected despite FDA's continued acknowledgement of their scientific soundness. It is a fundamentally accepted proposition that "to provide assurance that any substance is absolutely safe for 13/ human or animal consumption is impossible. Because of the limitation of scientific manpower and the priority of other 13/ 21 CFR 121.3 (ah ASI-PR 0001485 19 national programs, health hazards should be assigned relative severity factors and available resources applied to those which pose the most significant problems to public health. On this basis, the public health protection achieved by the present procedure of regulation of indirect food additives has simply not justified the vast expenditures that have been required. In the fourteen years since the enactment of the Food Additives Amendment, millions of dollars have been spent on the toxicological testing of fc ;d packaging materials. How ever, the findings have established that potential health hazards from food packaging materials are extremely remote. Indeed the persuasive arguments put forth in 1966 by Dr. J. 14/ Frawley have only been further reinforced since then. For all of these reasons we urge adoption of the 1969 draft proposal or a reasonable modification thereof, as a sound method to reduce the needless expenditure of time and funds in this area. It is recognized that adoption of the said draft proposal affecting indirect additives in its present form would implicity require the categorical clearance in advance of substances with which FDA personnel may or may not be familiar. We further recognize that this aspect of the 14/ American Chemical Society Symposium on Safety Evaluation of Coatings and Plastics for Food Packaging, September 14, 1966. ASI-PR 0001486 20 proposal might be viewed with concern by FDA's toxicologists. To resolve this apparent roadblock we would propose the adoption of a system whereby indirect additive users or manufacturers could simply give official notice to FDA per sonnel prior to the use of a given indirect additive, when it is anticipated that the indirect additive will be used in concentrations falling within the range of "insignificance." By this means, FDA could raise any questions it might have, about such use if it has reason to do so; and categorical clearance without definition of what is being used would be avoided. With this provision for giving FDA an opportunity to review in advance any proposed use of a low level migrant, there would no longer be a real need to set the limit at 0.05 ppm. as was done in the 1969 draft proposal. This limit was set lower than safety or economy required in order to overcome FDA's reluctance to clear unknown substances in advance. Accordingly, the limit can now be safely raised, it is submitted, to 0*5 ppm. It is, therefore, our recommendation that the proposed regulations be revised now to include the following provision: Add the following subsection to proposed 121.40 Affirmation of GRAS Status: *** ASI-PR 0001487 21 "(d) (1) Persons seeking the affirmation of GRAS status of substances as provided for in 121.3(e) and based on the criteria set forth in subsection (d)(2) of this Section may obtain such by filing at least 90 days prior to intended use the Short Form Petition, Indirect Food AdditivesAffirmation of GRAS Status. The Short Form Petition shall contain: A. the names of the indirect additive, trade and generic, B. the proposed use of the indirect additive, C. the concentration in the resuJtant end products, D. the concentration of additive reasonably to be expected as a result of the intended conditions of use in the food, specifying the type or nature of each food, and the corresponding maximum concen tration reasonably expected, and E. other proposed limitations. "(d) (2) The Short Form Petition shall be filed for: A. components of articles intended for use in contact with Type VIII dry foods (as defined in Table 1 of 121.2526 (c)), B. components of articles intended for repeated use in contact with bulk quantities of food, C. defoaming agents used in paper and paperboard, D. food packaging adhesives complying with good manufacturing practices re quirement of 121.2520, and A$I~pR 0001488 22 E. components (other than heavy metals, known carcinogens, and sub stances previously shown to be toxic at 40 ppm or less) demonstrated by calculation based upon reasonable migration premises, extraction studies, or food analyses to result in a transfer to foods of less than 0.5 ppm."15/ **** It is our hope that these Comments will be received favorably and in the constructive light intended. The time is long overdue for the type of changes we are advocating. Moving in the directions indicated here will, we submit, serve the best interests of the public, the government and industry. Respectfully submitted. General Counsel for The Society of the Plastics Industry, Inc. of Counsel: Keller and Heckman 1150 17th Street, N.W. Washington, D. C. 20036 15/ A proposed draft of a Short Form Petition is attached here to as Appendix A. ASI-PR 0001489 DRAFT Appendix A 1. Name of Applicant FOOD AND DRUG ADMINISTRATION Short Form Petition Indirect Food AdditivesAffirmation of GRAS Status File Number 5. Concentration in Resultant Product o O' H o o 0 a a 1 w tn <r 2. Address of Applicant Name of Indirect Additive a. Trade Name b. Generic Name 6. Concentration in Food a. Type or Nature of Food b. Maximum concent ration reasonably expected 1. 2. 3. 7. Other Proposed Limitations 4. Proposed Use Signature of Applicant Date 16308 NOTICES APPENDIX B whether the suspension order should be vacated or made permanent, and it none was ordered by the Commission, the tem porary suspension would become per manent. The issuer filed a resnorue con taining denials of the allocations in the temporary suspension order, but there after, without admitting: or denying those allocations, the issuer stated that it did not desire to have and it did not request a heaiing, and further si ted that it un derstood that as a result of that decision on its part the suspension will become permanent. In view of the foregoing, it is appropri ate to enter an order permanently sus pending the exemption. Accordingly, it is ordered, Pursuant to rule 261 of regulation A under the Securi ties Act of 1933, that the exemption from registration with respect to the orlering of securities by Lov'n Leather, Inc. be, and it hereby is, permanently suspended. For the Commission, by the Office of Opinions and Review, pursuant to dele gated authority. [seal] _ Ronald F. Hunt, Acting Associate Secretary. [FR Doc.71-12107 Filed 3-24-71:8:48 cm) MODERN ADVERTISING PRACTICES Nonce of Public Hearing and Opportunity to Submit Data or Views Notice is hereby given that the Fed eral Trade Commission, pursuant to the Federal Trade Commission Act, as am-tided, 15 U.5.C. 41. et seq , will condUv t open hearings designed to explore modern advertising practices and their impact on consumers, with special at tention to television advertising. The hearings will involve neither re view nor evaluation of specific advertis ing representations or claims in terms of their possible violation of the law. Individual questions of advertising de ception cr misrepresentation will con tinue to be dealt with by complaint or rulemaking procedures. The hearings will attempt to i licit empirical informa tion from a wide variety of authorities regarding a number of aspects of ad vertising. The Commission's current pri mary interests are the following: Children. As a class, children have always been the subject of the special protection of law. Underlying this proposition is a recognition of the vul nerability of children to suggestion, and their immaturity of judgment. This spe cial protection afforded for children in cludes protecting them as consumers or television viewers. The unique aspects of television may provide compelling reasons for arguments that special standards should be developed in the regulation of advertising addressed to children. In order to better acquaint itself with the considerations involved in developing such standards, the Com mission desires to explore how children learn, perceive, and make decisions. Advertising themes. The Commission desires to infoim itself about the ex tent to which some advertising may appeal to such ft ts or anxieties as so cial acceptance or personal well-being. Technical aspects. The Commission desires to inform itself about whether and how certain photographic and other techniques used in making TV and other commercials may make use of nonverbal persuasion which may not be recognized by viewers. Physical, emtionat and psychological responses. New methods of advertising may be causing effects in viewers dif ferent from those customarily generated by advertising. The Commission desires to learn about consumers' physical, psychological, and emotional responses to advertising. The hearings will be for informational purposes only and will not be geared to the ad-: mn of a rule or other form of guici- tie. Whether future Commis sion act`on wall result from the infor mation developed will depend on the facts obtained from the record of these hearings. All interested persons, including the consuming public, having information based upon empirical date, or other ex pertise, are hereby notified that they may file written data or views concern ing modern advertising practices with the Director, Bureau of Consumer Pro tection, Federal Trade Commission, Pennsylvania Avenue and Sixth Street NW.. Washington, DC 20530. To the ex tent practicable, persons wishing to file written presentations m excess of two pages should submit 20 copies All interested parties are also given notice of opportunity to present data or views orally at the public hearings to be held 10 a.m., October 20, 21, and 28, 1971, in Room 532 of the Federal Trade Commission Building. Washington, D.C. Any person desiring to present his views orally at the hearing should so in form the Attorney-Advisor io the Chair man not later than September 15, 1971, and state the estimated time required for his oral presentation. Reasonable limita tions upon the length of time alloted to any person may be imposed. In addition, all parties desiring to deliver a prepared statement at the hearing should file such statement with the Director, Bureau of Consumer Protection, on or before October 1, 1971. Notes: (l) Depending oa the geographical location of tho-e persons desiring to present views or data orally, the Commission will consider holding hearing; in. location; other than Washington, D.C. Notice of hearings scheduled for locations other than Washing ton, D.C , will appear m the Fedskal Register. (2) Because the duration o! the hearings is contingent on the number of person; wish ing to express views cr data orally, the public record In this proceeding will remain, open until further notice appears in the FtossAa Register The data or views presented at the hearings or filed for the record will be available for examination by interested parties at the Office of the Assistant Sec retary for Legal and Public Records, Fed eral Trade Commusion, Waslungto.i D.C. By direction of the Commission dated August 17, 1971. [seal] Paul M. Trceslood, Acting Secretary. [FR Doc.7l-]2415 Filed S-24-71;8:49 am] TARIFF COMMISSION [TEA-I-22] CERAMIC ARTICLES, INCLUDING DINNERWARc Notice of Change in Scope of Investi gation end Rescheduling of Hearing Following receipt of cDmmu.iic'-i'jas filed by the American Dinners ate T.i.iergency Committee and the America. Fins China Guild on August 17 and 19, r* ..pectively, the U.S. Tariff Commission, on August 19. 1971, amended the scope of investigation No. TEA-I-22 under sec tion 301(b) of the Trade Expansion Act of 1962 (36 F.R. 11617). The investigation, as amended, is to determine whether, as a result in majo part of concessions granted under trade agreements-- articles chiefly used for preparing, serv ing, or storing food or beverages, or food or beverage ingredients, ail the foregoing of fine-grained earthenware, of fine grained stoneware, of chinaware, or of subporcelain, and provided for in items 533.14 through 533.77 of the Tariff Sched ules of the United States, inclusive, but excluding item 533.51 thereof, are being imported into the United States in such increased quantities as to cause, or threaten to cause, serious injury to the domestic industry or industries produc ing articles which are like or directly competitive with the imported articles. Notice of the investigation was published in the Fsdss.vl Regists?, of June 16, 1971 (36'F.R. 11617). Public hearing rescheduled. The public hearing ordered to be held beginning September 14, 1971 136 F.R. 14632), is rescheduled to begin at 10 a.m., e.s.t., on November 30, 1971, in the Hearing Room, Tariff Commission Building, Eighth and E Streets NW , Washington. DC. Appear ances at the hearing should be entered in accordance with 5 201.13 of the Tariff Commission's rules of practice and procedure. Requests to appear must contain a careful estimate of the aggregate tune desired for presentation of oral testi mony by all witnesses for whose appear ances the request is filed. Issued: August 2(1.1971. By order of the Commission. 1 seal 1 Kenneth R. Mason, Secretary 1 FR Doc 71-12410 Filed 8-24-7t;S.4D ami F;Q;3Al. REGISTER, VOL. 36, NO. 165--WEDNESDAY, AUGUST 25, 1771 ASI-PR 0001491 APPENDIX C 3SS2 PROPOSED RULE MAKING EM0ift3E:iTAI PROTECTION AGENCY t 40 CFR Part 80 ] REGULATION OF FUELS AND FUEL ADDITIVES Lead and Phos .'lorus Additives in Motor Vehicle Gusoliri" On January 30, 1971, advance notice of proposed rule mi!:ir,; was published in the Federal Regis .'Er (3G F.R. I486) to inform the public that tile Agency, in accordance with the reqmremeiv of sec tion ' 11 of the Clean Air Act, as . lended <42 U.S.C. 1857 et sen.), was r< isidering available relevant scienti So, meuical, eco nomic, and technolor.ii,.' data concern ing the uve of lead and: cs in motor ve hicle r.aso'.nes, with tue intention of proposing use of the " -jr prohibitions on the dud.' es on the earliest date possible. After considering available scientific and economic data, including a costbern.r.; analj-vis comparing motor vehicle emission < ruitrol devices or systems which are or will be in gemr. 1 , -,e and require control or prohibition of !-ad additives in gaso'nes with eimrsion i .iiol devices or sysi as which are or will be in gen eral tin '.nd do not require such control or prod tion o` tho.' additives, the Admin,.-, ior he d, 1 i mined that emis sion proclu.' of 1c. ... additives wall im pair to a sn 1 ilcjnt, degree the perform ance of etnissi, centre' systems that include catalytic converters which motor vehicle manufacturers are developing to meet 1975-78 motor vehicle emission standards and are likely to be in general use if lead additives are controlled or pro hibited for me in certain motor vehicle gasolines. The same considerations were given, and the same determination was made regarding the use of phosphorus- containing additives in motor vehicle gasolines. Therefore, It is proposed to provide for general availability by July 1, 1974, of essentially lead-free and phosphorus-' free gasolines of an octane quality suit able for 1975 and subsequent model year light-duty vehicles. Copies of the costbenefit analysis referred to above, en titled Aerospace Report, PB-205-981, are available for $4.50 each from National Technical Information Service, Depart ment of Commerce, 5285 Port Royal Road, Springfield, VA 22151. Based on the available evidence, the Administrator has concluded that air borne lead levels exceeding 2 micrograms per cubic meter, averaged over a period of 3 months or longer, aie associated with a sufficient risk of adverse physiologic effects to constitute endangerment of public health. Since airborne lead levels in many major urban areas currently range from 2 to somewhat over 5 micro- grains, and since motor vehicles are the predominant source of airborne lead in such areas, attainment of a 2-micro- gram level will require a GO to 65 percent reduction in lead emissions irom moLor vehicles. The Administiator proposes to regulate the lead content of "regular" and "premium" lead'-d gasolines by pro viding for the reduction of lead over a 4-year period, beginning January 1, 1974. It Is the Agency's judgment that these reductions, together with the introduc tion of one grade of lead-free gasoline, as proposed herein, v.ill provide for the protection of health m mr.ior urban areas v. ithin the shortest time reasonably pos sible. Copies of'a summary and analysis of evidence on health hazards of air borne lead, entitled "Health Hazards of Lead," are available from the Publica tions Section, Environmental Protection Agency, 5600 Fishers Lane, Room 18B03, Rockville, MD 20352. The Administrator has considered whether it would be more economically and technologically feasible to provide for the protection of public health by means of a rew motor vehicle emission standard for lead particles than by means of the proposed reduction of gaso line lead content. It is considered uc likely, however, that new motor vehicles could be equipped with lead emission control devices prior to V ' 1975 model year, it is anticipated tlr new vehicles will be equipped with ei. ion control systems requiring the u.: of lead-free gasoline; thus, imposing a lead emission standard would produce no benefit, in terms of lead emissions. Furthermore, the Administiator does not have author ity to prescribe a lead emission standard applicable to other-than-nsw vehicles. Accordingly, the Administrator has de termined that providing for the protec tion of public health by means of a new motor vehicle emission standard for lead is not feasible. The Administrator finds that prohibi tion of the use of lead additives and phosphorus-containing additives and the reduction of gasoline lead content will not cause the use of any other fuel or fuel additive that w.;i produce emis sions which will endanger the public health or welfare to the same or greater degree. The bases for this finding are set forth m a paper entitled "Effects of Reduced Use of Lead in Gasoline on Ve hicle Emissions and Photochemical Re activity," copies of which are available from the Publications Section, Environ mental Protection Agency, 0600 Fishers Lane, Room 18B-08, Rockville, MD 20352. The Administrator is also considering the need for limiting the sulfur content of gasoline because sulfur may have an adverse effect on the performance of cat alytic emission control systems. Accord ingly, the Administrator invites com ments concerning the effect of various levels of sulfur concentrations in leadfree and phosp'norus-frco gasoline on such emission control systems: the max imum level of sulfur which can be toler ated if the catalyst is to function prop erly: the impact of a sulfur limitation on the petroleum industry; and the impact of a sulfur limitation on motor vehicle performance and the cost of gas oline to the consumer. The Administrator specifically invites all interested parlies to submit infor mation reflecting their interpretation of the significance of airborne lead as a health hazard. Additionally, com.'.'.:'.As are requested on the regulatory oppronh proposed herein and on possible alterna tives which would achieve the same re sult. Comments on any such alternative should be accompanied by infonr.at.cn on its cost-benefits and other effects. Among other things, these regulations set forth certain labeling requirements applicable to gasoline retailers. It is the Administrator's intent to coordinate such requirements with the Federal Trade ConunLcsi jn. Intel ested persons may submit writ ten comments on the proposed regula tions, in triplicate, to the Deputy Assist ant Administrator for Air Programs, En vironmental Protection Agency, 5GOO Fishers Lane. Room 17-59, Rockville, MD 20352. All releva" t comments post marked not later than 90 days after pub lication of this notice will be considered. Comments received will be available for public inspection during normal working hours (8 a.m. to 4:30 p.m.) at the Office of Public Affairs, Waterside Mall, 401 M Street 3W., Room 3241, Washington, DC 20450. The Act provides that if a manufac turer of motor vehicles, motor vehicle engines, fuels, or fuel additives submits a written request for a public hearing to the Administrator within 10 days of the publication of this notice, the Admin istrator will call a public hearing and subsequently will publish findings with respect to the matters he is required to consider under section 211(c)(2)(B) of the Act. However, because of the signifi cance of the proposed regulations, tie Administrator has decided to call the public hearings. Tire particulars concern ing the hearings will be annour -ed in the Federal Register at a later date. This notice of proposed rule making is issued under the authority of section 211 of the Clean Air Act as amended (42 U S.C. 1357f-6c, section 9, Public Law 91-504; 04 Stat. 1958). Dated: February 17, 1972. William D. Ruckelshavs, Administrator, Environmental Protection Agency. A now Part 80 would be added to Chapter I, Title 40 of the Code of Fed eral Regulations, as follows: PART 80--REGULATION OF FUELS AND FUEL ADDITIVES 5=-?. 80.1 80.2 80.3 80 4 80 5 Subpart A--G&n&ral Provision! Scope. Definitions. Ti'jt methods. Right or entry; touts and insmoctioi'-S. Penalties. Subpcrt B^Confrols and Prohibitions 80 20 80.21 30.22 CO 23 80 24 Controls applicable to gasoline refiners. Controls applicable to gacoline distributors. Controls applicable to gajolice retailers. Liability for violations. Controls applicable to motor vehicle manufactuters. FEDERAL REGISTiR, VOL 37, NO. 36--WEDNESDAY, fECRUARY 23, 1972 pR 0001492 A$l" APPENDIX D 4`7o NOTICES inetii.iiirt rates are foiecast to raise Air borne's icysnucs for that year by $1.2 m;'i on, o'" an average of 1.45 percent. 3 Ti1? increaied rates are forecast to reoilt in a profit margin before taxes of 2 f.S prieent of revenues, as cornp'.red with 5 `.Ci percent for tiro first 11 me: liis of 1971," 4. The record provides sufficient evi- tlea.ce to cor.clavie that: a. The increase proposed is cojt-based rnd does not reflect future mffitionary expectations; b. The increase is ths minimum re quired to assure continued, adequate, and safe service and to provide for necessary expansion to meet future requirements'; c. Tht increase v:ll achieve the mini mum pro.it margin to atti\ / capital at reasonable co^ts and not m.p.dr Air borne's credit ** In View of the foregoing considerate as. the Board linos that there is no b.^,s to continue the investigation previo.dd7 initiated in this docket and accord:: jiy it will be disrni:- ed and the suspension vacated. * . Accordingly, if is ordered. That: 1. The suspension of increased rates, charges, and provision-, in Order 72-1-25, dated Jan* --7 ll, It- in Docket 24110 is vacated and the 1 .stigalion insti tuted in that docket dismissed; 7 2, A copy of tills ore: r shall be filed v/tth the taritfs and served upon Airborne Freight Coip. Tills order will be published m the Federal Kcgistsh. By the Civil Aeronautics Board. [seal] Hahry J. Zinn, Secretary. [TH Doc.72-3493 Filed 3-7-72,8:59 am] 4 These are the figures in the pet1 Mon for reconsideration. In a letter ampluym.g it3 original justification, Airborne forecast that the profit margin for 1972 before taxes would otnount to 2 72 percent of revenues after the rate Increa>-_, while the figure without the rate incre^w would be 1 40 percent. 4 The Board has not heretofore established a rate or return for airfreight forwarders and has not deemed It appropriate to do so, in. view of the Board's long-standing policy of free entry Into the air freight forwarding field and the resultant forces of competition which operate on the many entrants In this field. Accordingly, we are not In a position to apply a rate of return analyst: :o this seg ment of the air transportation industry. * On the basis of information before us. It appears that if the increases here sought were not permitted the profit margins which would result would be substantially below tnat other freight forwarders will achieve, and this fact would be relevant to potential lenders of capital, Accordingly, we conclude that the profit margin here sought is not excessive. `Tiie Increases rate?, charges, and provitlfii-. permitted by this order will be cttecUve vip'm che filing of appropriate tariff revisions as required by Part 221 of the Roaids econo-iuc regulations but on. not less than 10 d.i^ >' notice, and in no case be effective prior to M.irch 10, 1072 unlevs otherwise peunitted by ttv? Uor.rJ. FEDERAL COM?i!CATiO?l$ COMMISSION (Docket No. 102f>0, FCC 72-207] FAIRNESS DOCTRINE AND PU3LIC INTEREST STANDARDS Order Regarding Oral Argurvvnf "En 3tmc" and Handling of Public Issues In the matter of the handling of public issues under the fain;' . docti ine and the public interest standards of the Com munications Act, Docket No. 15260. 1. On June 11, 1071, the Commission released its Notice of Inquiry in this pro ceeding in; . mtirsg a broad-ranging study of ths Fairness Doctrine and related pub lic interest policies (36 F_R. 11825). We divided the Inquiry into four parts; H. The- Fairness Doctrine Generally. tit. Access to the Broadcast Media as a F-esult. of Carriage of Product Com mercials- IV. Access Generally to the Broadcast Media for the Discussion of Pu. .be Issue . V. Application of the Fairness Doc trine to Political Broadcasts. Ey March 15, 1972, we expect that all comment.; and reply comments will have been submitted in response both to the June 11, 1971 notice of inquiry (36 F.B. 11325) and our further notice of inquiry, released March 2, 1972, requesting com ments on the isjue (under Part IV of the June-11 notice of inquiry) of access under the public interest standard of the Communications Act.1 -' 2. We indicated in the June 9, 1971, notice of inquiry that, in view of the importance of the subject matter, we intend to employ special procedures to assist us in resolving the difficult issues involved. We have decided to utilize both the custom:.:y oral presentations to the Commission "en banc" by interested parties or their representatives and, in addition, a series of panel discussions by knowledgeable persons directed to some of the important questions presented by our two- notices and the responses to these notices winch we have received-We are following this course because we found it to be of substantial benefit when we utilized it for the first time in con nection.,-with the proceedings on cable television. (See orders released Febru ary 4, 1971, and March 8, 1971. in "Com munity Antenna Television Systems," Docket No. 18397--A et 27 FCC 2d 303, 27 FCC 2d 932). In that proceeding we embarked upon the novel ^course of using panel discussions as a mechanEm for sharpening the issues in the give and take of a form of discus.,ion which is not available in the normal oral argument form of presentation. Since the panels fulfilled our expectations in the cable television proceeding, they should also 1 The further nohee of inquiry stated that cqm.men.LS o:i Part IV should be directed to thd statutory public interest expect of acce.s rather than constitutional .arguments. be of benefit m the complex faum"ss area, 3. Rne issues for panel discussion will be as follows: P*ET II 1. Is the Fairness Doctrlre serving ius basic purpose of promoting robust, wide open, acd reasonably balanced debate on impor. i public ksues9 Does ic. in practice, encou--* *? or inhibit the presentation of contro--'-v j prograr.'' Does it. in. practice, cor.SN/i/.e undue Government Intrusion In hcec-ee discretion or, on the contrary, Lnadenune Government assurance that controversial Issues are co'ered and covered falrlv? Wnat changei.. If any, should he made by the Com mission or by way of recommendation.* ;o Congress (i c . what snecLfic statutory amend ment-? are required) 7 2. If the Fairneaa Doctrine la funda mentally iiouncl, v/hat policies and procedures could be institu* <-* to improve it* efilcacr? (a) What poU:' and procedure should b* employed by the Commission, in determin.-osy whether a complaint warrants referral co the licensee? Y/hat burden should be placed on the comp' 'innt to. make a. showing ot unfairness b tf^"rrr the licensee 's ohiiffamj zo demonstrate compiniEU with tha Fairness Doctrine (io, "hct` . to Mr.- Allen- Phelps,** 21 F.C.C. 2d 12 (19 .'})? (b) What policy and procedure-should be- employed by the Coinnviidon in determining whether the licensee* h horded "reasonable opportunity for the tU ^;oo of conflicting views on i:suas of pubLc importance" (5*c* tion 315(a)) 7 Should the license* be required to fum . h recordings or iraoscrlpts of all program matter (Including all pertinent news icema)- dealtng with the Uaue in on nioa over 3^ considerable period of time?" Should the Commission estab. * some minimum ratio of viewpoint to \ iwpom- which is necessary to achieve fairness (e,, 2 to 1, 3 to 1,, 5 to 1, etc.)'' Is any such "stop-watch" technique app`^ -jrtate? Can the Commission accurately review a licence's judgment as to how programing segments should be categorized. (eg., pro, anti, neutral) ? Should factors other than quantity of time - be considered (eg., frequency of presenta*- tion, probable audience for the time periods employed, timing of the broadcast in rela tion to the crucial event involved, ie,. elec tion, decision, %'ote, etc.) ? Should the Commission instead adopt a test of whether or not the broadcasting audi ence of a particular station has been afforded the opportunity of being reasonably in formed. on an overall basis, on issues- of public importance (e.g., "Green v. F.C.C.,'* 447 F. 2d 323 (D.C. Clr. 1971))? If So, how should such a standard be determined and. applied? (c) \Vhafc policy and procedure should the- Commission employ In ruling on Fairness Doctrine complaints? How should the Commission determine whether a controversial Issue of public im portance is Involved? Should there be a time limitation of filing falrnes.? complaints against a licensee and, if so. how long? How v/ould such a proce dure worl: with continuing issues? Should the Commission defer action on fairness complaints until renewal, at which time the Commlsslo would consider the licensee's overall pe'aormance? Can revised renewal policies and procedures (eg, such as those proposed in Dochet No, 19153) con tribute in any va7 to insuring compliance with the Fairnors Doctrine* V/ould periodic reviews p.t intervals shorter than 3 yj.-'rs be preferable and. If so, how long? FSD-2U a = Ci;T:7, VOL. 37, NO. <6--WEDNESDAY, MATCH 1 77 2 ASI-PR 0001493 NOTICE 4979 If ,ny ourti "ciofCTTcd lulls"" pro'-.dcro ho v `O'dd LdrnO'>i be Li^iu - on. indr. iCmM 1-oU': 1 ij^O'dri a:i e^oepiioa be m.run- for nj\"-s,r> (i>^.. e>w;l-r.5l referea^i, efc.),J (cl) Dw'-js `he cLctru-.c dfiril effectltcly \vUh b*i f, p"rlr'r!r`'cr subjidi'iry reieroncr* 'O z. cv'Uu.y'-j-'O jo.vter rt g., "In Re m;u-.n. bv NUU L r r ^cons'cV *on of p.ulmj i ..- g'.-Ciiv; Aircrift 0./0"f.. ?,ad R 'ot* A*,ocla- tiou." n, C 2.1 733 (i970/) 9 (o) f)o t3 yy'oorv.l att*.c% u.:d editor.`ilLi- lng rii'.ej serve tb.ff'P intended purpose O" (J > tir:y inhibit fr'i* and op?n riisca^stoa? Vn:,' t h..:,"^ 11 m.y, should he mede witii rev:,-.!, to tbJ licensee's aL'irmati'.'e ob- I.j'tlcu to e:.cr:v"e and irnpw.-ier.t the pieSRW.W.on of contrr.-^ing v-.*'.points0 (g) a -.on.ld th? "Cui'nii.n doctrine (C'.Ll- mii.i 3ron.de;.iatiiig Co.." `0 jP.C.C. 573 (1U" 3>) be exploded or restricted in any way? (h) Should, the Commission. Impose ferr- feUuros for rairno'-i Doctrine violations? 3. Docs the Fairness Doctrine seme the public interest in if* application to news? 4. Is tns Fcumsso Doctrine neceso\ry tot nil categories of nioadcavw licensees? 5. What is the relatoj^-hlp of this part or the inquiry to the o:her parts? Specld- coAly. what policies, if any, corcermqrj access to the brcadc.i^t media cuqhr. properly and feasibly be evolved uodvr the public interest ssjuid ird of the Commanic&siozis Act, aud what v.ould he r.heir relationship to, r-nd effect upon, present or proposed Fairness Poctrb - poUc.es"3 * Past nr SKSCC OtTZSTTO.VS 1. Under the Fairness Doctrine, or p.lfer- nc.tlvely a public interest standard, sh i'.d time--either on a free or paid basu e afforde- by the broadcaster for the earn. ir;e Of so-called comitercommercials or other countcrcomm^cial programing? 2. Would ' purposes of the Fairness Doc trine, day. ns it is to Illumine sigri-}- ennt coatro. j'S'.al Issues, be served. by re quiring countjrcommerciais? 1$ the public interest so served (? 5., do spot announce- meats add sufcjtantlcUy to pubbe knowledge; is repetition z sign Scant factor to be con sidered) ? srrccic qijrs-nois's 3. If the broadcaster sells time for the promotion of products and services, must hs a'^o *v\\ time to tho^e who wish to nt-gue aictirxst pu'obc use cf the^e s?.tne products or serncee (cl., "P.et'ul S;cce Etniployee^ Un ion, `Local GSO v F.C.C 436 F. 2d 248 (D-C. Clr. 1970)) ? I' so, wrvat v/ould be the pre dictable effect on the continued carriage o! piocluct commercials and thus on the continued econcmx health and growth of the commercial broadcastmg system? If nott vubat v/oaid be the predictable effect oa the public Interest? 4. Should the "Cigarette' Advertising'' rul ing: (q F.C.C. 2d 921 (1367). aff'd, "Banzhaf v, F,C.C./` 405 F. 2d 1082 (D.C. Clr. 1963) c*rt den, sub nom. "Tobacco Intsttute v. F.CC; 3D6 U.S 812 (1963)), Idvolvihg free tima, b-" expanded to cover additional prod uct commercials or should It be abandoned? If ti e former, what would be the predictable on the continued broadcast carriage of rrndvet comnerciiiij ancl thus on. the eco nomic heal til mid growth of the commercial br^ rn'cauting stern? V/lrit v/ouui be the ef- /tct :i codiih-wcial time were reduced, for i, by 20 t, ;(.--nt to accommodate co'.me-romm r'ol *.s"> If the latter, v/hit v-wnhl ne the prrcuctab'o cheat on t'o.e nv.b- Lc :,,*rcst? 3o. niLI ` Ch^rette A Iv^rtising'' ho rephicod by 1 ne atterhatt^c policy iiucl, \i :o, -perlfically r/h.tt poUcy0 5 To tiiere s-v:vv W'-./V a j'e otandaid for d`3- tl ishln:; v.i.vii Cat";:or*.^i of product c JMrv'ro! tn "Ctjar ,fb Adv^'d'.s- lfu;" v/01:1 t or would no*, apply'1 (a) For examp'e, shs.;M it zp?\j only to cohmiercicU. ^ luch e-.p'Ul:y p: arr,u- iren^vt on controvcr-hd of public importance? (b) to all other C1T.re.Tl.1i5, should tn.i're be a presimiptibh t':;..: product adver- do nut rcioe cc-rrroverM.u ux>u^-i of pubhc importance, a preiumption which would be rebuts i he only by compelling evi dence to the contrary? 6 A'^stUiiing the applititic-h of the Fair- iicjs Doctrine to product cominercsal^, s'.iO'dci it apply only to the text of the advertisement or al:o to any coutrvv^my surrounding the Uj& c! the prexiixt aclve:- ..vd"3 7. /-rc new cr didc-ent FCC standards re quired in c&tuuctioa v't' ' ...l^e or Lug adverfr'.i.ng'1 What rr.o ..ab the ec'ect of consumer complaints, cr the ft Lug of a FTC cora-plalnt, that a partlcsl.-r advertlsemc*ac is In scans way frds^ or misleading? 8. Are there any methods of providing "nccsis" for the dlscus^on of countercom- merclai content other than requiring accest ance by licensees of mdiriduai countercom- tncrciais (e g,, requiring blocks of time fordid* cussion-format programs on commercials)? 9. Should the "Cullman" doctrine be ap plicable to countered mm e mi als th?mseiv or other councercommercial progrrimihg'' 10 What specific ConstlvUt'.oaal comc?r- atlons, L? any, ore relevi-at to this part of the inquiry? Fa-ht IV Our pcalUcn ha:n has been, tst lorth In an. order and further notice, itsuetl March.3, 1972 (FCC 72-154), C ^deration Of the CorutN tuttonal issues a* mg from the Court'.*, de cision in "Buciness Executives* Move for Vietnam Penca v, FC.C.,"___ ___ U.S. Aon. D.C. ............ . 450 F. 2d 42 (1371) (see para graph 4 o? the further Notice of February 3, 1972) must await the Supreme Court'.! de cision. indeed, we have made clear that the entire Part IV access area may he resolved In Light of the Supreme Coitcts action. V/e have, however, afforded interested parties the op portunity to ?dwx?e cons'd-r v.ons germane to access under the public merest standard p.r.d their relation to present cr proposed Fairness Doctrine polio.es. (See order and further notice, paragraph 2, ICC 72-194: paragraph ID, *-otlce of inquiry. FCC 71-623). We believe that the oral procaedmg* should also afford an opportun.tv to address this issue. We therefore have included it in the general fairness panels (see Question 5, Part II), PfRT V 1. Should the Commission revise or clarify its interpretation of the Fairness Doctrine with respect to Presidential appearances (see "Democratic National Cor mit'ee. et al./' 31 FCC 2d 708 (1071), aff'd, "Democratic Na tional Committee v. F.C GV'_______UJS. App. D.C._____ ___________ F. 2d ............ . Case No. 71-1637, decided February 2, 1972)? Should any such revision or clarizcation ba extended to other important public officials (e.g.. Gov ernors, mayors, etc)? 2. Should the quasi-equal opportunities approach (e 5.. "Letter to Mr. Nicholas Zapple," 23 F.CC. 2d 707 (1970)) be re stricted or expanded, and what is the feasi bility ar.d effect o' any proposed revision on the underlying policies of the stature (see section 3 13(a) ) ? Should the Commlrsion. adopt a pOoitlon. that ' Zapple" applies only to political cam paigns and not to other Should *,Z?ppU" be disasbOC'.ated iron\ the Fairnes? Doctrine and incorporated laco r*ctio'A 3La7 Should "Zipplc" be by applying a 7-clay deadline for requestirg "quasi-equai opportuniclc-i"? Should "Zapple" continue to apply only to major parties (sea "Letter to Lav.Tence M. C. Smith." 25 T; F 291 (p-^.l)), or should it h_' c.'.:uv.l'd to "'ll p^.r' -n or to some ir"i`lea!Iy dt-^ra^d ofvqo-y o' "partis v.rh sub'-i int'z.'. cupp"'.-"/' (eg., por*;^.at-vy: of prjpu!-r ot_*) i Ifo.v rhouid it ?pply to "new" p arci-. Should `Zapple" b>* c-tend^d lo Include spo-esmen to: bailee L-uies such as bond issues, arucadrae.vs of state e'ju.'h'LUtloos, etc ? 3. What us tim effect c: the he*v Federal Carr.p \ign Spending Abt (Faibi'c Law 92-225) on political broadLV (aMd part*-u.arly ^ectlou 1031a) (`2) (A) of the Acs which require* broadcast hcen.aees to aUo-.v rea^onabla acc-^o to the',- facilitiej by c\r.didat'-s for federal clect1.'*^ office)? 4, V/hat snould the ConuTUsslca do to en courage the u.desc, possible coverage of polit ical ciu:pi\i;,T.j' a. What should the Commisoion do to Tester free time for political oroadcoaU? What Commission rule revisions, if any, would be helpful'5 What statutory amend ments, If any. would oe n-ece-i^ary? b. A-re therf conjstructlo::.' of the news exempcioua in section 315(a) that are avail able to the Cammdaslau az,d would further the jjoal of enhancing appearances by politi cal candidates? 4. In order to avail mirselv^-s of a wide ran^eof views by kno'.v^ge^L'e person^ from both within and tvitK^ut the in dustry. *va will select panelists by invita tion. To a considerable extent, ve shall talie into account the filings of inter ested persons or m*oups in making our selection. 5. As stated, above, we also expect to hold an "en banc*' oral argument in which all interested persons T7ho have hied comments or reply comments may participate. Persons wis: ny to be heard should su` mis notices of appearance vnthm 5 days of the release of th.s ordc^, sfatmy whether they wnh to address all of the fo'ir mam subjects referred to m paraiyraph l above or, if not, which of the four areas they intend to address. Parties vnch a common viewport aie tirged to select a single spokesman in order to avoid unnecessary duplication of arguments. The Commission, by further order, will specify the order of appearance of the participating parties with appropriate grouping by subject matter; it will also announce the amount of time allocated t-o each participant.. 6. Accordingly, it is ordered. That panel discussions will be held at Wash ington. . D.C,,. during a 3-day period commencing March 27,1972. at a location and cimes to be announced by subsequent order, and that oral argument vnll be held before the Commission "en banc" at its offices in Washington, D.C*. begin ning on March 30 at 9:30 a,m. and con tinuing on the following day. Persons desiring to participate in the oral argu ment shall file a notice of appearance m accordance with the terms of this order within 5 days of the date of release of this order. Adopted: March 2.1972, ReUoaed: March 3,1972. fSCAL] Federal Communication's Commission/ Dzs F. Wapls, Secretary, |FR Doc.72-3 199 Filed 3-7-72;S:5l zrz] 3 Commissioners Bartley p.nd H. Rex Lee ftbient. i\o, 45----5 :C'sT:?, vat. 37. NO. 46__ V;jDn=S0AV, WAUCH 8, 1972 ASI-PR 0001494