T Hpfa V 4 LAW OFFICES JOSEPH E, KELLER Keller ajntd Heckman JEROME H HECKMAN CHARLES M.MEEHAN os^ 1130 17** STREET, N. W, WILLIAM H- BOHGHESANI, JK SUITE lOOO TELEPHONE WASHINGTON, D. C. 20036 803 300-3100 ROBERT R TIEHNAN WAYNE V, BLACK CABLE ADDRESS DAVID L. HILL ' *KEI.M\.S MARTIN W. BERCOVICI EDWIN B SPIEVACK PETER M. NEMKOV June 10, JOSEPH E, HADLEY CAROLE C 1974 HARRIS WILLIAM W PUGH Dr. Karl A. Hochschwender American Hoechst Corporation Post Office Box 2500 Somerville, New Jersey 08876 Re: a/ & w/j/ At * Proposed Regulation of Food-Cont. ot Articles in the Household; 39 Fed. Reg. 13285, et seq. Dear Karl: Firstly, once again I find it necessary to apologize to you and all of the members of the Food, Drug and Cosmetic Packaging Materials Committee for moving in a manner not comporting with previous in­ dications. You will recall that we wrote to everyone on April 16 shortly after the referenced Food and Drug Administration proposal was published and indicated in our letter that we would attempt to pre-circulate draft Society of the Plastics Industry, Inc. Comments, and a rulemaking Petition of our own looking once again towards trying to do something about the increas­ ingly intolerable lack of clarity relating to FDA's interpretations of when a substance may not reasonably be expected to become a component of foods. Due to the circumstances which I am counting on all of you to understand—the VCM and PVC crisis which has been commanding almost all of our time and attention and is being handled in a very compressed time frame because of the hearing schedules set by the Occupational Safety and Health Administration—we were simply unable to prepare Comments or a Petition in time to circulate the same in May. The fact is that we have drafted a Petition but do not feel it is ready for circulation yet so we will continue to refine it and attempt to send a draft to the Committee in due course. ASI-PR 0003223 Dr. Karl A. Hochschwender June 10, 1974 Page Two Obviously, there is no deadline for filing such a Petition so we will have an opportunity to get every­ one's views before such a document is filed. On the other hand, the deadline for the filing of Comments in the "housewares exemption" proceeding is today so we completed a set of Comments over the weekend and have now submitted them to the Food and Drug Admin­ istration. While we would certainly always prefer to pre-circulate any formal filing before it is made, in this instance we have taken the chance that our nearly eighteen years of working with the Food, Drug and Cos­ metic Packaging Mater.i als Committee has given us sufficient insight into the general wishes of the group to permit our submitting the statement with reasonable confidence that no one on the Committee will find the positions taken substantively objectionable. We believe that the Comments reflect the tenor of the Committee's members that has been expressed about the "housewares exemption" as an individual item, and FDA's "no-migration" posture as a prevailing and pervad­ ing problem in a general and continuing way. At this juncture, all that we can really do is hope that those receiving copies of this letter will agree although we invite any comments since we probably could advise Food and Drug in some way or another in an additional state­ ment if there is disagreement with the views we have enunciated. In any case, we are herewith sending a com­ plete set of what we have already filed to every member of the Committee. One final observation is probably in order here. We seriously doubt that the Comments we have filed will have great impact on the instant rulemaking proceeding. Instead, we would anticipate that Food and Drug might simply re-enunciate its willingness to accept some sort of Petition for more definitive treatment of the "no-migration" problem while moving forward with the elimination of the "housewares exemption." Nevertheless, ASI-PR 0003224 Dr. Karl A. Hochschwender June 10, 1974 Page Three the Comments might serve the useful purpose of again focusing attention on one of our major problems so that when we do finally present something in the form of a Petition, additional groundwork will have been laid. Our apologies once more to all of you for the unusual procedure we have employed in this instance. We will certainly try to avoid being placed in this position again and hope that everyone will be reasonably understanding taking into account all of the circumstances. Hally yours. Enclosure cc: SPI Food, Drug and Cosmetic Packaging Materials Committee ASI-PR 0003225 LAW OFFICES JOSEPH 15. KKLLFIi JEBOMK U Kelli5R and Heckman HECKMAN CHAlfLKS M.MKE1IAN UQO 17™ STREET, N. W. WILLIAM II. BOHOHKSANI. JR, TELE I’Hdn']’ JJOy ><>• >• SUITE lOOO ROBERT R TIEHNAN WASHINGTON, D. C- 20036 WAYNE V. BLACK CABLE ADDKl s1’ DAVID L. JT1TX MAHTIN AS' nKHCOVlCI June 10, EDWIN B SFIIIVACK J\ J 1974 PETER H. NEMJCOV JOSEPH E HADLEY CAllOLE C. HARRIS WILLIAM W PUOH Hearing Clerk Department of Health, Education and Welfare Food and Drug Administration Room 6-86 5600 Fishers Lane Rockville, Maryland 20852 Re: Substances in Food Contact Articles in the Household, Food Service Establishments, and Food Dispensing Equip­ ment; Food Additive Status (39 Fed. Reg. No. 72, pps. 13285-13287) Dear Sir: Responsive to the above-referenced Food and Drug Administration Notice of Proposed Rulemaking pub­ lished on April 12, Industry, Inc. 1974, (SPI) , through its Food, The Society of the Plastics by its attorneys, and acting Drug and Cosmetic Packaging Materials 1/ Committee, hereby respectfully submits its views with 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 1400 member companies and individuals who supply raw mate­ rials; 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(cont’ ASI-PR 0003226 2 regard to the proposed amendment to Part 121 of the Feed and Drug Administration's Regulations which would add Section 121-14 thereto. I Statement of Position 1. Plastics It is Industry, the position of The Society of the Inc. that the instant proposal, the avowed purpose of which is to do away with what has be­ come known colloquially as the "housewares exemption" from the coverage of the Food Additives Amendment of 1958, is: (1) Ill-conceived and far too broadly framed to accomplish what might otherwise be a worthwhile objective; (2) Would, if adopted, violate basic precepts of statutory construction and defeat a clearly stated Congres­ sional intent; 1 (3) Broaden FDA regulatory authority so as to make the law, and particularly the Food Additive Regulations, even l7 (cont'd) of the plastics industry, 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 dirccLories, organization charts, and the like have been supplied to FDA in connection with some of these filings. Any further background information desired can be supplied immediately upon request. ASI-PR 0003227 / more unenforceable in any way that could remotely be considered clear and even-handed; (4) Bring within regulatory, and hence, questionable legal status a host of products never intended by Congress to be regulated by FDA; and (5) Leave wholly unanswered a fundamental question which urgently requires defi­ nition and yet has remained unanswered for at least the past thirteen or four­ teen years, while making it appear that this question is a simple one that will effectively delimit the application of the instantly proposed rule. [This question, of course, is the one of when FDA will move forthrightly, publicly and definitively to state the premises upon which a potentially affected party can confidently conclude in good faith that, under specified intended condi­ tions of use, a substance may not reasonably be expected to become a component of foods and, hence, is not a Food Additive so that it need not be dealt with through the cumbersome, expensive and inordinately time con­ suming Food Additive Petition-Regula­ tion Promulgation process.] 2. It should be clearly understood that the Society does not take issue with the Food and Drug Admin­ istration's desire to prevent food contamination by sub­ stances such as lead or similar known toxic materials. respectfully submit, however, We that this objective can be achieved by much more pin-pointed rulemaking or selective enforcement action than is being proposed here. FDA could easily and effectively accomplish its aims by use of its ASI-PR 0003228 4 considerable voluntary recall or involuntary seizure powers to bar such known toxic substances from use in dinnerware or cooking utensils when occasions so require, rather than cast doubt on the status of a host of mate­ rials and products which have never created a problem and are simply not worthy of the kind of government and industry cost and effort that always accompanies full- scale Food Additives Petition treatment. 3. Finally, great exception is yet perhaps most significantly, taken to a wholly misleading inference spread throughout the preamble to the Section 121.14 proposal, and included in the Section itself, ence being that it is this infer­ a simple matter to decide when a substance is not subject to FDA regulation because it may not reasonably be expected to become a component of foods. Were it in any realistic sense true that the Food and Drug Administration had some recognized and known criteria which would enable any interested party to de­ termine when a substance may be considered a non-migrant, ergo a non-additive, the instant proposal would still be in direct conflict with our view of Congressional intent but might not be considered of such great consequence, or so unreasonable. The fact is, however, that in actual practice the FDA Staff will seldom agree that ASI-PR 0003229 5 anything which might contact food in_ any way need not to considered a food additive because it may not reasonable- 2/ be expected to become a component of food. this situation remains fluid and undefined, So long as and the per­ sistent nemesis which it has been since at least 1960, it is our view that rulemakings like the instant one should be abandoned in favor of realistically narrow proposals, or enforcement action where a true health hazard is presented. 2/ Indeed,at one time, the then Deputy Commissioner of FDA, John L. Harvey, candidly stated in an address given at Rutgers University on January 18, 1962 that: "...if there [is] enough reason to run extraction studies on packaging or equipment materials, why shouldn't it be concluded that it would be reasonable to expect that the substances involved would, in fact, become a part of the' food? Since the law refers to 'reasonably to be expected' we then began to advise those who asked that we were not in a position to give them a letter which would absolve their product from any responsibility from under the Food Additives Amendment but instead suggested that they file petitions. That is the present status of this item." (Emphasis supplied.) Harvey, Food Additives and Regulations, 17 Food, Drug Cosmetic Law Journal 275 (Apri.t , 1962.) In theory this almost unbelievable legal conceptualization has been abrogated by subsequent informal communications such as the so-called "Tom Brown Letter" of August 21, 1970, a copy of which is attached hereto as Appendix A. Despite the existence of this letter and other pronouncements by the Assistant General Counsel, Food, Drugs and Environmental Health Division, of the Department of Health, Education and Welfare, Mr. Peter Barton Hutt, in specific cases, the fact is that there is no clear Food and Drug Administration policy or quantitative guideline to steer those who must make decisions on when a food additive problem is at hand or not. ASI-PR 0003230 6 II The Food and Drug Administration's Contention That the Legislative History of the Food Additives Amendment of 1958 Does not Support the So-called "Housewares Exemption" is Erroneously Premised, Requires Specious and Circuitous Argumentation, and Ignores Well Accepted Principles of Legislative Interpretation 4. As is conceded in the April 12 notice pub­ lished in the Federal Register, during the floor debate on the Food Additives Amendment of 1958, the Congressman who chaired essentially all of the hearings leading to the enactment of the lav/, and the Floor Manager for the Food Additives Bill, 13254, H.R. Mr. John Bell Williams, stated without equivocation that the bill was tended, for example, "not in­ to give the Food and Drug Administra­ tion authority to regulate the use of components ware or ordinary eating utensils." that it is Williams' ology entirely specious statement, "for example" in dinner- We respectfully submit to argue away from Mr. ignore the emphasis on the termin­ and some 16 years legislative interpretation so as Drug Administration's later revise a to expand the Food and powers over articles of commerce, many of which might present only the remotest possibility of adding any component to foods. 5. FDA has In the April 12 notice of proposed rulemaking set forth various rationales to justify expansion ASI-PR 0003231 7 of its statutory authority; is nevertheless its conclusion in direct contradiction to the legislative intent under­ lying passage of that part of the 1958 Food Additives Amendment relevant to indirect additives. The fact is that Congressman Williams clearly sought to explain in part what was meant by the implied exclusion in the law as to food contact articles not reasonably expected to become components of food when he said, and we repeat for emphasis: "This bill .'s not intended, for example, to give the Food and Drug Administration authority to regulate the use of components in dinnerware or ordinary eating utensils." [Congressional Record, 104:17418.] 6. In statutory interpretation, it is a well- recognized principle that legislative intent must be recognized. The Supreme Court in U.S. Industrial Organizations, 68 S. that the purpose of Congress is Ct. 1349 142 F. 2d 363 (4th Cir. Congress of (1948), held the dominant factor in determining the meaning of a statute, federal court in Gruver v. v. while another Commissioner of Internal Revenue, 1944) held that statutory terms of variable meaning must be construed in harmony with tive purpose. In another case, legisla­ it was held that in de­ termining whether a situation is within the purview of a ASI-RR 0003232 8 statute, the court is to put itself, the position of the Congress so far as it can, li­ that enacted it and decide whether or not the Congress would have declared the situa­ tion was covered by the statute, 443 (2d. Cir. 7. Calley v. U.S., 1960) . Further, it is clear that the scope of a statute is not to be expanded by an overly broad pretation. McGuire, 272 F.2nd inter­ Thus, in Commissioner of Internal Revenue v. 3/ 111 F.2d 843, 845 (7th Cir. 1940), the Court stated: "...where language is used [in the statute] which admits of more than one meaning, it is to be taken in such sense as will conform to the scope of the act and carry out the purpose of the statute, being mindful, however, that it is not permissible under the pretense fo~r interpretation to make a law, either by ex­ tension or restriction, which shall depart from legislative intent. In such a situa­ tion , resort to aids outside the language itself is necessary." [Emphasis supplied.] 8. The language of these cases is wholly apt here where a very specific statement made at the time of the law's enactment leaves no real doubt of the intent to exclude housewares and similar articles provisions of the Williams Amendment. 3/ Affirmed 61 S.Ct. 789, from the general In the face of the rehearing denied 61 S.Ct. 936. ASI-pr 0003233 patently stated exclusionary intent of Congress, contrary argument can only be characterized as FDA's tortured and specious. 9. It is strangely based in part upon use of the "incidental additives" definition, which includes coverage of the Act those substances in the "which may reasonably be expected to become a component of any food." FDA argues that housewares may be sources of substances become components of additive" food. It is true that the that "incidental definition is directed towards the destination of the additives, of food or not, i.e. whether they might become a componen rather than the source of additives. also true that the statute is silent as regards It is the source question generally but it is submitted that the silence in the case of housewares was very effectively and in­ tentionally broken on the Floor of the House. situations of statutory silence or ambiguity, In such resort must be made to clear evidence of legislative intent. Here Congressman Williams1 statement in the Congressional Record, which certainly constitutes intent, specifically exempts housewares 10. Congress FDA also argues a firm statement of from coverage. that were it the intention of to exempt housewares, it would have done so by ASI~pR 0003234 10 specifically enumerating housewares emptions in Section 201 (s) wares as an "item" in the list of ex­ of the Act. However, are not in the same vein as items excluded under Section 201 (s) All of the exemptions the Food, federal listed in that Section are either list housewares or covered statute or by different sections of Drug and Cosmetic Act. list in 201 (s) the other of the FDA statute. enumerated by allusion to scientific precepts, by another house- Thus, the exemption would have been an inappropriate place to (unless the Consumer Product Safety Act had been law at the time) and FDA's attenuated reliance on the absence of housewares in the 201 (s) exemption list is inapt. Ill There is no Need for the Food and Drug Administration to Adopt the Instant Rulemaking Since its Other Considerable Powers Can be Used to Deal With any Public Health Hazard Presented Without Forcing a Preclearance Procedure on Innocuous Substances or Products 11. As is indicated in the preamble to the pro­ posed new Section 121.14, "FDA has for several years conducted a widely publicized regulatory program against., products" ware, like migratory substances enamel ware or pewter. in pottery, dinner- To the best of our knowledge a$i-pr 0003235 11 this program has been or could have been conducted under the virtually plenary powers given FDA under the provis­ ions of Section 402 of the Federal Food, Cosmetic Act, hazards makes as amended, Drug and to proceed in situations where to public health are concerned. it quite clear that FDA has This section the power to seize foods which are adulterated and industry has conceded, practical matter, as a that this power may reasonably be exercised so that FDA can order recalls or seize any food contact materials where there is a valid reason to believe that the same will add a poisonous or deleterious sub­ stance to foods. In light of the general effectiveness of this approach, it is difficult to understand why further authority is now needed. authority is At the very least, truly required, if such taking into account the broad poweis given the Consumer Product Safety Commission relative to all types of articles use, intended for household the Food and Drug Administration should seek the authority it believes it requires from Congress instead of arrogating such power in a rulemaking proceeding which is so obviously extra-statutory. ASI-PR 0003236 / - 12. 12 - On this ground also, it is submitted that the instant proposal is unnecessary, conception, illegal in and should be abandoned forthwith. XV The Adoption of the Proposal Will Further Complicate and Confuse Statutory Interpretation, Disrupt Important Commercial Relationships, and Perpetuate a Basic Regulatory Dilemma Which has Been Widely Discussed While Remaining Unresolved Since Shortly After the Enactment of the Food Additives Amendment of 1958 13. Once again, a seemingly straightforward Food and Drug Administration rulemaking proposal has brought into focus -the increasingly intolerable burden which industry has been forced to officials began in 19^0 face since Food and Drug to cast a cloud over that very important part of the Food Additives Amendment and the Food and Drug Administration's Regulations which state, effect, that a substance is not a food additive unless "may reasonably be expected to result, ly, undersigned, it directly or indirect­ in its becoming a component...of any food." least 1966, in representatives of industry, Since at including the have decried the Food and Drug Administra­ tion's unreasonable interpretations of Section 201 (s) of ASI-PR 0003237 13 the Act and Section 121.1(e) of the Food Additive 4/ Regulations. 14. Rather than burden this set of Comments with another recital of industry's continuing quandary in this respect, the Food and Drug Administration is asked to consider incorporated by reference herein the voluminous Comments submitted to FDA on November 6, 1967 in response to the then proposed and never subse­ quently acted upon Food Additive: (32 Fed. Reg. 152 p. Procedural Regulations 11443 et seq.). In this document, the checkered history of the varying interpretations afforded the phrase "reasonably... expected to result, directly or indirectly, any in its becoming a component...of food" was discussed at great length, and an urgent plea for definitive action was made. 15. Subsequently, Congressional inquiries, and partly as a result of the Food and Drug Administration called the National Conference on Indirect Food Additives where the entire problem of defining what is an indirect 47 See American Chemical Society Division of Organic Coatings and Plastics Chemistry Papers Presented at the New York Meeting, September, 1966, Vol. 26, No. 2. ASI-PR 0003238 14 food additive was discussed and recorded in a two-volume 5/ transcript presumably resting in the FDA files. 16. During and after this Conference, the Com­ missioner of the Food and Drug Administration and the members of its Staff committed FDA to take action which would clarify the question of when a non-food article is or is not to be considered a food additive. 17. Still later, in May of 1969, industry was informally presented with a proposal commonly referred to as the "Ramsey proposal," it being stated in the cov­ ering letter executed by the then Assistant Director for Regulatory Programs of the Bureau of Science, that the informal proposal was L. L. Ramsey, intended to be responsive to the importunings of industry prior to and during the Nationa 6/ Conference on Indirect Food Additives. for reasons which have never been coherently disclosed, has and fully explained or even no version of the ever been published as Nonetheless, "Ramsey proposal" a proposed or final rule. 5/ Copies of this transcript, ai" well as the aforementioned Comments of The Society of the Plastics Industry, Inc. in the Food Additives Procedural Regulations rulemaking are available to FDA immediately upon request should the Agency be unable to locate its own copies conveniently. 6/ In an excellent paper entitled The Food Additive Problem of Plastics Used in Food Packaging, Mr. Ramsey (cont'd) ASI-PR 0003239 / - 15 - 18. istration's remains As a result of the Food and Drug Admin­ failure to deal with this issue, industry in a constant state of uncertainty as to when a food additive problem is presented where food contact surfaces or packages are involved. situation persists, and so long as So long as this food processors understandably demand assurance that a product meets Food and Drug Administration requirements, it is totally inequitable and misleading for FDA to take the position that a rulemaking of the type at hand here will not create virtual havoc in the marketplace because: course, "Of if there is no migration of a substance to food...the substance is not a food additive and no Petition is required." 19. The fact is that the Food and Drug Administration will rarely concur in a no-migration conclusion and, instead, will almost invariably insist on a Food Additive Petition to establish the status of a food contact article or component thereof. This, in 67 (Con'td.) explained much of the background which led to his proposal and reported on its status in 1969. A complete copy of this paper, delivered at the National Technical Conference of The Society of Plastics Engineers meeting in Dallas, Texas on November 4-6, is attached to this set of Comments as Appendix B. ASI-PR 0003240 16 turn, can impose upon a party manufacturing something as innocuous as doilies, general purpose pails or jars, or ordinary dishes the necessity for spending very sub­ stantial amounts of time and money on acquiring and pre­ senting the data for a Food Additive Petition, after which the expectation must be that a Regulation will not 7/ be promulgated in less than 184 days even if the peti­ tion is "perfect," which is seldom the case in light of FDA's constantly changing demands for supporting data. 77 See Transcript of Proceedings, Seminar—Food and Drug Administration/Society of the Plastics Industry, Inc., June 18, 1971. On page 128 of that transcript, Mr. Nathaniel Geary of the Food and Drug Administration Staff candidly reported on an internal FDA study of petition processing and noted, in part, as follows: "Our sample looked at the petitions that were good and sailed through. "We found the average time of the sample was 184 days to get the thing through the Agency. This is four days over the upper extension of the statutory limit." rt o It is possible that some improvements may have been made in the Food and Drug Administration's processing of "perfect" incidental food additive petitions since the time of Mr. Geary's statement but, if so, this has net been noticeable. On an average, it has been our experi­ ence that almost no petitions are processed within 180 days. We would estimate that since the enactment of th Food Additives Amendment some type of averaging of peti processing time for incidental food additives petitions would probably show a mean of from one to two years, or more. ASI-PR 0003241 17 * * * The foregoing premises considered, and unless and until such time as definitive action along the lines of that suggested by Mr. Ramsey in his May 6, 1969 letter is taken, we respectfully submit that rulemakings of the type here contemplated should be abandoned or indefinitely delayed. Of Counsel: Keller and Heckman 1150 Seventeenth Street, Washington, D. C. 20036 N. W. A$I~Pr 0003242 / .nix a department or HEALTH, education, and welfare pum.ic hi:altii r,i..r rmuo AnrwiNir.TUA'riON waoiiii/c.roN, n.c. :u?ot •August 21, 1970 Mr. Jerome H. Heckman Law Offices Keller and Heckman 1712 JI Street, H. U. Washington, D. C. 20036 * Dear Mr. Heckman:. * % This is in response to your letter of July 23, 1970 in vjhic.h you ask for our views concerning section 121.1(e) of the food additive regulations. This is the section which states in the next-tc-last sentence: "If there is no migration of a packaging cornpone:W from the package to the food, it dees not become a component of the feed and thus is not a food additive." Your question 'concerns subsecticn(s) (21 U.S.C. 321), particu larly as it relates to migration of substances from food packaging materials. It is our position, as regards such substances, L if a food manufacturer, or his food packaging supplicr(s) has ■migration data 'which establishes that there is no reasonable likeli hood of migration to food, he need not seek confirmation of h decision from the Food and Drug Administration that the pecka material is net a food additive. However, if he desires such, c ou­ -firmation he should furnish the details of his scientific (ox tre ction) studies. Where the reviev; of the extraction studies co nfirw: a lack of potential for migration, no regulation is necessary. lie trust this statement of our position is responsive to your letter. ■ ’ Sinfcerely yours, /•;f (1 n 11ones VI. Drown, Director' Office of Compliance Bureau of Foods, Pesticides and Product Safety ASI-PR 0003243 - PP^NDIX’ff'.'"- • • *’ ! * * * • 1 . ■ TOE FOOD ADDITIVE PROBLEM Ov MASTICS USED IN FOOD PACKAGING* • . • . '. / 4 , • V ’ .*• C‘« • ‘ . 4. ' » l •> _* . *, k . ■■ ... ■ ' , • . . * * * • .■ by L, L. Ramsey Assistant Director for Regulatory Programs . ' Bureau of Science • * Food and Drug Administration • Consumer Protection and Environmental Health Service ' MIS, DHEW . y ’* . ' * . , , ' * 7:, * - _ * « • ■ • : • ' . * ‘i • ■ . « . - 7: ‘ *' ■ * ’ ‘ * * ■ * ; " : .1 welcome the opportunity, here fhia afternoon to review with ; you soma of the regulatory developments in the area of indirect feed additives, which, of course, include the taigrat 'ry substances from : plaoticn used in food packaging. 1 : t ' / In response to indu3try,a need we developed and issued a document ■., - “I-VV: • '.'I ■'* .in August 1966 entitled "FDA Guidelines for Chemistry and Technology .•■; Requircmento of Food Additive/PetitionsYou ore undoubtedly fsmilinr with it. The purpose of this document wao to elaborate and clarify the regulations with vespeetj to the chemistry and technology data required for the^/clearance jot not only direct food additives but also indirect food additives. £he document, itself, made it clear that it wao not to be construed oj a regulation, that it oet forth guidelines; l . not inflexlble^requireinento, In the Federal Register of August S, 1967, FDA published a proposal to revise its procedureJ. regulations for food additive petitions. Quoting from thio publication: ■*For presentation at the National Technical Conference of the Society of Plastics Engineers, November 4-6, 1969, Dallas, Texan, ASI-PR 0003244 V • \ *t . 1 * . . > V / f ■-.'V,. %• ■ _ - V 2 f* ”Tho Comiaisaioner df Food and Drugs propooeo that the proc.::,l food additivo regulations bo revised as set forth below to obtain improvement in the quality and organization of food additive petition. kh^rriit {*'1 to tialfiiitifi.n t(rv}tv by tbo I'ood r-h4 ])rur. 4 Administration. ' A. The/need for ouch revision is breed on the follcring: 'Almost hair of the food additivo petitions as originally / . 7 ‘ • submitted to the Food and Drug Administration have been incomplete or have not adequately supported the regulation requested end, therefore* have required subsequent supplementation, amendment, withdrawal, or B. Scientific review of deficient and poorly organized petition: is an unnecessary burden that wastes the time and efforts of both I Administration and industry scientists."• This proposal prescribes the format and content of the petition / and its organization In greater detail than previously, requires < * adequate indexing, and requires a summary of the petition. Vc received 53 communications, including one from the Society of Plastics Industry, commenting upon this propoonl. l . Some of these communications were rather . voluminousJ the opposing point of view being argued in detail and at some lengtn. Three major issues were ovident from the3e comments; J 1. Whether the analytical method and a summary of the toxi­ cological information upon which a regulation has issued con properly be considered public information, 2. -S ‘ • Whether it is proper to require that 10 year old data <5r • * * • older must be resubmitted. o ASI-PR 0003245 ^. ■ ' — ^ : *4 •’*• * * . '' .* . ’ / /■/ to listen, to ob .n your views “find recommends^ .,ns (I) with regr * , t f, to ----- poooible changco that coa.be made in FDA petition requirements find in • • criteria for evaluating the safety of the indirect additives from- food • packaging materials and food processing equipment, and (2) with regard to any possible changes in the scientific or administrative handling of this whole area of indirect food additives. * . »**••* accept any recommendations which sacrifice the consumer protection afforded by the Food Additives Amendment against unsafe amounts of * ■. -• : We cannot, of course, ■ foroign substances in the country’s food supply. - And perhaps this is . the crux of the whole problem, hew much of a health risk should the *.“1 ’ \ * consumer bo subjected to, for the risk from indirect food additives, .however slight, cannot be summarily dismissed; it ia merely a matter of degreo. . Absolute safety, like the absolute zero, can never bo ,r. Unequivocally demonstrated although in many instances it can be approached % ever so closely. . We are indeed hopeful that we shall receive.some proctical and specific suggestions during this conference, suggestions that arc both scientifically and administratively sound.n „ - ■ ■\ At this conference. Dr. Frawley reiterated his proposal 03 follows: « •'Thus, we propose three categories of food packaging components: * <’ r * j ‘1) those used at 0,2% or less which cannot 'reasonably be expected' to become componcnto of food, and these should be exempt, 2) those used above 0.27. which my 'reasonably be expected' to become a component of food, 'but in fact do not,' and these should be considered nonminrntory„ i and 3) those used above 0.27. which are indeed food additives ancj should 1 * * be subject to appropriate examination for safety and regulation under the law." ' i* / , ' •» * •* ' *** ' ■ • V- / . j / • • . * ; ,. ' r ASI-PR 0003246 . . , r j ~ / t. 3. Vnc thet^^ Whether^!. a proper ra~rcquiro"details / • proccso for every additive. -the minufoct^ ’•*■■■■ .. "• ■ ‘ * ■ : • In.addition ond aside from the procedural regulations the Society of Pieties Induotry seized upon this opportunity to recommend a major change In the handling of indirect food additive petitions In­ volving trace amounto of food additives. Pointing to a paper presented by Dr, Join P. Frawley at the national meeting of tha American Chemical Society in New York, September 1966, the SPI objected strongly to the need for migration' and toxicology studies vheto the usage level of a eubstanco in the packaging material was less than 0,27., with certain 'exceptions. About this time, tho diosatiafaction of a part of tha food packaging industry with FDA's requirements for clearance of in­ direct food additives also came to the attention of a congressional committee. In order to provide an opportunity for the industry and other interested groups to review and discuss with FDA the scientific basis for its policy with respect to indirect food additives, the FDA scheduled a National Conference on Indirect Food Additives. This conference was held in Washington, D. C., on February 13-14, 1968. « It was well attended % » and while representatives of your organization did not appear on the program, I believe your Induotry was well represented by speakers for ■ The Society of the Plastics Industry, Inc. The representatives from FDA explained our present policy and reviewed the scientific basis for it. They made it clear, however, that FDA come primarily flecking information and advice. Quoting from the paper I presented: "I U t. conclusion. I would only remind you that we in the FDA are hero primarily O-' i ................ .1 . . •! ** ■ • * »■ , . “■* . . * „ , * . • ■ • , -------- t—'*’- ASI-PR 0003247 " T * I. t f - 5 Ho explainer ^urthcr that a~Tcvol of 0.27. ur less of o comp;."erit la the packaging material'or in the food contact curfaco V;ould not be expected to contribute more than 0.1 ppm of on individual substance f to the total diet of man and ho regarded thla aa ineignifleant toxicologically, He would exclude heavy metals and pesticides, how­ ever, from this concept of safety at 0.1 ppm. The industry speakers at the conference generally endorsed the essence of Dr. Frawley’s proposal. / . i ‘. v. . . . *' • ■ * Following this national conference we iu FDA undertook a reappraisal \ • of our requirements and procedures for the indirect food additives in light o.f the recommendations and suggestions of industry and in light of our own experience during a decade of administration of the Food Additives Amendment. Xhi3 reappraisal was initiated to determine whether any changes should be made. ■While our own study was underway we were informed that a tr.3k force on Toxicologic Insignificance had been established by tha Food Protection Committee of the Food and Nutrition Board-,. NAS-NhC, to study the broad problem of the safety.of minute amounts of substances in man’s diet. The NAS-KRC report entitled "Guidelines for Estimating Toxicologically /^ * Insignificant Levels of Chemicals In Food" is the result of this.ctudy and has just been published. Wc Relayed the development of any proposal until wo could have the benefit .faf thia report. / / However, we were fur- niched a pre-publication copy by the Academy on a confidential basis • several months ago and used ij in the development of an in-liouse (Bureau of Science) proposal. A draft of this proposal was oent to the Industrie V ' ( * . -.-ASI-PR 0003248 'f* . represented at the National Conference for comment and. for disci', as Jons with us. We concluded those discussions on the proposal with the industry this pest September. This in-house proposal would amend tho regulations to permit the use of substances (except heavy metals* carcinogens, and other substances thnt havo been demonstrated to produce toxic reactions when present at levels of 40 ppm or less in the diet of man or animals) in food pack-aging materials and other food contact aurfaces aa followsj (1> ■ • As components of food-contact articles provided any substance Bo used contributes no moro than 0.05 ppm to tha contacted food; * (2) As components of articles for use in contact with dry, nen- fotty food; (") Ao components of articles/ intended for repeated use in contact with bulk quantities of food. (4) Aa components of dcfosrflng agents employed in tha manufacture of paper and paperboard intended for U3C in contact with food, t (5) f As components of food-packaging adhesives. / / , We have not yet reached h decision on whether or not to publish the proposal formally in the/Fcderal Register; and, of course, I ca unable to make any reliable/prediction in this regard. We do intend to finalize a revision of the food additive procedural regulations mentioned earlier, and we expect to adopt some of the I ‘ suggestions received which we havo evaluated and found to bo sound. * ■ r / ASI-PR 0003249 * r \\ • Lct'o turi^r petitions. -attention nny_to the'proccr of-food .■■■' / ■ In opite of the Guidelines and the proposed revision of the procedural regulations, we continue to receive a high percentage of deficient petitions./ The moot/common deficiency io a leek of’ / adequate extraction-data from wh/ch to estimate the likely migration of packaging components to food| Anothor common deficiency io e failure to identifyfully the proposed packaging component by its Chemical Abstracts name and bV physical and chemical specifications, Identity is, as you undoubtedly appreciate, basic to our consideration. Vq oIbo urge you Lo provide/n general summary of any petition you submit . which will includo among otp;cr thing3 the following: tho' expected quantity of the^food additive in individual foods or classes of food3 , under tho proposed conditions of use, the maximum as well as the average quantity to be expected.in the total daily diet of the con­ sumer, and the/ margin of/ safety provided by the animal feeding studio; / The submission of an inadequate petition imposes an unnecessary burden upon our scientific staff ond more importantly from your view­ point results in costly delays in time for you, I would urge you to mako every effort to /assure yourself that the petition you submit Lb ■indeed fully supported by the necessary data and information when it Lb submitted, t / About one half of all food additive petitions received are in the indirect area, /During the period July 1, 1963, to June 30, 1969, ve received a total of 121 food additive petitiona; Cl of those wefe for indirect additives. The receipts of petitions since last June /jro continuing at /about the name rate. \ i- •* *: • «■ , • - v: ^ • r-r ■‘>ri • -J • .. •' *'r. •' ; > f . “ ■/ •w. ASI~pr °0032S0 7 V r* 4**«44«* 4 ' . > V I - o Currently, witH only nn occasional exception, food.addit:;. p:titIons’ ore being handled within the statutory time liralto. This worh ir. accorded high priority arid we expect to maintain this level oJ; performance in the future. Vour cooperation in observing the Guidelines and the regulations * / • in preparing sound, well organized food ndditlvo petitions will help assure fcho realization of an important mutual goal of industry and FDA, the prompt processing of the petitions,- . ‘ ' ■ V' ‘ /, .. . v *. .* - iricMctrfe - . I; f ' £ ■ ASI-PR 0003251 l* T * . ^• "'.■***. V*. .•*; . V ' I rt y . - * ■-i ■