Document X7nY0av9Xa4NdMNOvnnOJwN2g

THE REGULATORY CONTROL OF PLASTIC FOOD-PACKAGING ` ' MATERIALS IN THE UNITED STATES by William F. Randolph Petitions,Control Branch, Bureau of Science a, Food and Drug Administration Consumer ProtectiQn and Environmental Health Service 'Public Health Service U.S, Department of Health, Education, & Welfare Washington, D. C. The Food and Drug Administration has great respect for the excellent worR of the pan American Health Organization in combating * disease and promoting the health of the people of the Western Hemisphere. We are indeed honored to be invited to participate in this 5th Annual Seminar on Food and Drug Control and to discuss with you our regulatory control of plastic materials intended for use in contact with food. We currently exercise control over such plastics under the pro visions of the 1958 Food Additives Amendment to the U.S. Federal Food, Drug, and Cosmetic Act. This food protection amendment, together with the Pesticide: Chemicals Amendment of 1954 and the Color Additives Amendmoof ,1960, greatly strengthened our law to help us better protect the consumer against unsafe substances in his food supply. These three amendments have been well characterized as pretesting* preclearance amendments. In general, o they require proof of safdty and government clearance before any new chemicals can be added to food. For presentation at the World Health Qrganizatio'n/pan American Health Organization 5th Annual Seminar on Food and Drug Control for Central America and panama, May 26-31, 1969, Managua, Nicaragua. ASI 00000638 5 j. | Although the term "food additive" is of relatively recent orlg:` the addition of chemicals to food is a very old practice which probably i *'*' began when man first learned to preserve meat by putting salt on it. Since that time, the science of food chemistry has made tremendous progress, particularly since the turn of the century. Today, a great many chalice' substances are being safely employed to make food more attractive, better | tasting, and more economical. The gro'wing^processing, and packaging pZ i! ' 1 food so that it can be transported for thousands of miles and remain in | good condition for months or even years is truly one of the outstanding i achievements of our time. However, during Congressional hearings in the i middle and late 1950's, a consensus of expert opinion established that a number of these chemicals being used in foods had not been adequately tested for safety. Although most manufacturers made tests and consulted with FDA concerning the safety of their products, not all of them did nor Jere they required to do^ so. It became increasingly clear that our- lav; j had to be changed to prevent the addition to food of unsafe chemicals. ' Under the Federal Food, Drug, and cSsmetic Act of 1938, as it was i! prior to September 1958, FDA,-could not prevent the use of a chemical additive |I simply because it was questionable or had hot been adequately tested. It i was necessary to be able to prove the chemical additive was poisonous or deleterious. This was not difficult to prove in the case of chemicals that cause immediate or acute illness; however, scientists were concerned with the long-term effects of exposure to minute amounts of chemicals over a -2- ASI 00000639 period of years or even a life time, and proving a chemical to be poisonous or deleterious under these circumstances may be very difficult. Often several years of feeding tests on different kinds of animals may be required to determine the chronic effects resulting from Che addition of small amount? of chemicglp to the dietj i From 1950 to 1958 U. S. Congressional Committees intensively studied the problem of, how to protect the consumer from inadequately tc-si^d food additives. The culmination of these s|udies was the enactment of the i Food Additives Amendment in September 1958. | This Amendment was one of the pioneer statutes recognizing the need fir control of potential en vironmental hazards. It provides for the control of food additives, whether they are added directly and intentionally to food to accomplish a particular technical effect or whether they become a component of food indirec-tly through migration from food-packaging materials or other sources such as food-processing equipment and machinery. For purposes of the Food Additives Amendment, the term "food additive" means any substance the intended use of which results or may reasonably be expected to result^directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food subject to certain specified exemptions. The amendment specifically includes "any substance intended for use in producing, manufacturing, packing, pro cessing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use," Under 3- ASI 00000640 the amendment the term "food additive" does not include the following, i exempted substances: (1) substances recognized by appropriately qur,li-f->ed experts as being safe for their intended use, (2) substances used in ac cordance with a sanction or approval granted prior to September 6, lfk i' under the Federal Food, Drug, and Cosmetic Act, the Meat Inspection Act, or the Poultry Products Inspection Act; however, such exemptions ore limited to the specific uses for which th'c sanctions were given, (3) !j pesticide i chemicals used under the provisions of the pesticide * Chemicals Amendment to the Act, and (4) color additives used under the provisions i of the Color Additives Amendment to the Act, The law specifies that a t food additive is deemed to be unsafe unless its use is subject to an exemption or unless it is used in accordance with a food additive regu lation prescribing safe conditions of use. It establishes a procedure whereby a person v?ishing to use a food additive may petition for a regu lation for such use by demonstrating that it is, in fact, safe for its j: intended use. . : When the Food Additives Amendment was passed in 1958, plastics ti and other materials intended for use in contact with food became a matter <j>f increased interest to the Food and Drug Administration. Basic materials I. ' ` required study to determine whether they would migrate to food in sufficient quantity to be hazardous to the consumer. Similar studies were also necessary on the adjuvants, such as stabilizers, plasticizers, etc.., needed to make the basic materials functional. All had to be considered under the Act and their use as food additives required regulation prescribing b safe conditions of use, - 4- ) ASI 00000641 ; The following discus'sion will beiimited to plastics and their I adjuvants that have been regulated or otherwise permitted for use in i contact with food under the provisions of our Food Additives Amendment, It provides a summary of materials under regulation; Complete details i can be obtained by consulting the cited references which include inf on r.tion ? 3 on any usage restrictions or other limitations considered necessary t-o assure safe use'of the additives. These references refer to the appropriate ^ijetion of the U. S, food additive regulations which are found under ^ JTitle 21 of our Code of Federal Regulations. In the ten years we have been regulating food additives, we have issued a number of regulations to provide for the use of many synthetic polymers and their adjuvants in contact with food. These regulations may be divided into thr.ee groups: those dealing with the basic synthetic polymer (Table 1); compositions containing synthetic polymers (Table 2), 1nd adjuvant materials used with synthetic polymers (Table 3). } 5- ASI 00000642 TABLE 1--SYNTHETIC POLYMERS REGULATED AS INDIRECT FOOD ADDITIVES Acrylamide-acrylic acid resins Acrylate ester copolymer coatings i Acrylic and modified acrylic plastics, | semirigid and rigid. Chlorinated polycthcr resins 1,4-Cyclohexylene dimcthylene terephthald'te*and '4-cyclohoxylene dimethylane dsophthnlate copolymer Ethylene-ocrylic. acid Ethylene-ethyl acrylate copolymers Ethylene-methacrylic acid copolymers, ethylenemethacrylic acid-viny(l acetate copolymers, and their partial salts Ethylene-methyl acrylate copolymers i Ethylean-vinyl acetate copolymers l! F luoroesrbon resins J . Hydro.eyethy1 cellulose, water insoluble film Isobutylene polymers 4,4'-Isopropylidcnedj phenol-opichlorohydrin | resins, minimum molecular weight 10,000 4,41-Isopropylidenediphenol-epichlorbhydrin, i thermosetting 'epoxy resins ;7 Melamine-formaldehyde resins in molded articles Nylon resins ' / Olefin polymers j Partial phosphoric acid esters of polyester resins Ferfluorocarbon resins Phenolic resins in molded articles (Reference) 121.2512 121.2525 121.2591 121.2581 121.2533 121.2564 121.2554 121.2582 121.2528 121.2570 121.2523 121.2567 121.2590 121.2579 121,2585 121.2569 121.2502 121.2501 121.2601 121.2555 ' 121.2587 6 ASX 00000643 Table 1 (cont'd) Ij ' Polycarbonate resins i' Poly (2,6-dimethyl** 1,4-phenylene) oxide resins Polyester resins, cross-linked ! Polyethylene '* Polyethylene, chlorinated j polyethylene, oxidized j\ ... Polyethylene resins, carboxy modified Polymer modifiers in semirigid and rigid polyvinyl chloride poly(methylpentene) | Polypropylene ! I I Polystyrene and rubber-modified polystyrene * Polysulfide polymer-polyepoxy resins * Polyurethane f Polyvinyl alcohol film i_ jolyvinylidene fluoride resins - [ I Styrene-divinylbenzene copolymers jJrea-formaldehyde resins in molded articles Vinyl acetate-crotonic acid copolymers Vinyl chloride-ethylene copolymers 1t Vinyl chloride-propylene copolymers Vinylidene chloride copolymer coatings for nylon film Vinylidene chloride copolymer coatings for polycarbonate film Vinyl chloride-lauryl vinyl ether copolymers \yle:.e-iormaiaunyac resms ccnc.enscd uitn 4,41-isopropylidencdiphenol-epichlorohydrin epoxy resins -7- (Reference) 121.2574 121.2603 121.2576 121.2501 121.2532 121.2517 121.2530 121.2597 121.2501 121.2501. 121.2510 121.2572 121.2522 121.2593 121.2593 121.2584 121.2595 121.2540 121.2609 121.2521 121.2599 121.2600 121.2608 1-21.2559 ASI 00000644 A. * ,I TABLE 2--MATERIALS CONTAINING SYNTHETIC POLYMERS REGULATED AS 1 INDIRECT FOOD ADDITIVES Adhesives c*. (Reference) 121.2520 Cellophane 121.2507 Closures with sealing, gaskets for food containers 121.2550 Components of pap'er and paperboard in contact , with aqueous ' and fatty foods 121.2526 Components of paper and paperboard in contact with dry food ' filters, resin-bonded 121*2571 121.2536 d Hot-melt strippable food coatings 121.2578 Lubricants with incidental food contact i Packaging materials for use during the irradiation of prepackaged foods 121.2553 121.2543 Polyethylene terephthalate film 1 Pres sure -sens! tivc ridheflivcs ii Reinforced wax f 121.2524 121.2577 121.2530 Resinous and polymeric.coatings Resinous and polymeric coatings for polyolefin films ' 1 <i Rubber articles intended for repeated use 1 121.2514 121.2569 121.25C2 Surface lubricants used in the manufacture of metal articles . 121.2531 Textiles and textile fibers 121.2535 Textryls 121.2545 - 8- ASI O0O0O0C00645 TABLE 3--ADJUVANTS FOR' SYNTHETIC POLYMERS. REGULATED AS ` , INDIRECT FOOD ADDITIVES Adjuvant substances used in the manufacture of foamed polystyrene Antioxidants at d/or stabilizers for polymers Antistatic and/or antifogging agent in food packaging materials Emulsifiers and/or surface-active agents .Emulsifiers used in the manufacture of coatings for paper and paperboard 4-Kydroxymethyl-2,6-dj-tert-butylbhenol Octyltin stabilizers in polyvinyl chloride p1astics II plasticizers for polymeric materials polyhydric. alcohol diesters of oxidatively refined (Gersthoffen' process) montan wax acids Release agents Ultramarine blue . ^ I I ,! (Reference) 121.2583 121,2560 121.2527 121.2541 121.2521 121.2508 121.2602 121.2511 121.2605 121.2509 121.2563 -9 ASI 00000646 h In addition to these regulated additives, there are a number of synthetic polymers and their adjuvant^ that may be used in contact with food in accordance with sanctions or approvals granted prior to passage of the Food Additives Amendment. Section 121.2001 of the food additive regulations contains a partial listing of substances, including i, a number of synthetic polyme-/adjuvants,, that are prior sanctioned for ', / use in the manufacture of food-packaging materials. In addition to `substances listed in section 121.2001, FDA recognizes a prior sanction for all food-packaging applications for polyvinyl chloride basic resins that have a maximal volatility of not over, 3.0- percent when heated for one hour at 105 C. and that have an inherent viscosity of not less than 0.35, as determined by ASDM D 1243-60, Method A. In addition Table 4 I contains a list of other synthetic polymers for which prior sanctions have been granted for use as films for food-contact use. 1 - 10- ASI 00000647 TABLE 4--SYNTHElxC POLYMERS FOR WHICH PRIOR SANCTIONS HAVE BE.: I I* GRAFTED FOR USE AS FILMS Acrylonitrile-butadiene-styrene copolymers i' Butadiene-acrylonitrile copolymers ] Cellulose acetate ' i l Ethyl cellulose. j Polyester-ethylene terephthalate and ethylene isophthalate Pplyethyl acrylate Polytaethyl acrylate pblyvinyl chloride-acetate 'T \ hes e-\\ (-.eh-imi crvh C-I* by ? ) 1 - 11 - / ASI 0000064S There are elso a few synthetic,polymers that are generally I '1 i j jrecogniaed as safe for their intended use as listed in Section 121,103 :of the food additiveregulations. Table 5 contains the synthetic poly, ;rs j' in that list. The methyl cellulose and sodium carboxymethyl cellulose j ml' Trust be the grades specified for direct food use. l / / / / \ ASI 00000649 / TABLE 5--SYNTHETIC POLYMERS GENERALLY.RECOGNIZED AS SAFE FOR THE INTENDED PURPOSE / Direct Food Additives: Methyl cellulose / Sodium carboxymethyl cellulose l Substances Migrating from Paper and paperboard:. Cellulose acetate Ethyl acrylate Ethyl cellulose Methyl acrylate i " 1-S - / ASI 00000650 Section 121.2500 of the food additive, regulations defines good manufacturing practice for additives regulated for food packaging use. the This regulation includea^provision that substances used as components of ** , food-contact articles shall be of a purity suitable for their intended use and further stipulates t^hat. regulated) packaging-materials shall not impart odor or taste to any food product such as to render it unfit for use within the meaning'of the Act. Basic polymers that are permitted f^>r use in contact with food under the provisions of the food Additives iimendment, may be mixed with I each other provided there is no chemical reaction between the component of the mix. In such cases, the most restrictive use limitation applies p r. a. V, to the mixture. For example, polyurethane resins are limited to use with dry bulk foods only, so mixtures containing these resins would be subject to the same limitation. The adjuvants, limited according to their regu lations, may also be used in mixture with other basic polymers. Other adjuvants listed in the prior sanction list may also be mixed x^ith regulated synthetic polymers. Certain of the regulations -- most of those in Table 2 -- cover a wide variety of synthetic polymers. The appearance of the material in these regulations does not indicate safety for all uses, but only for those specified. For example, Section 121.2520 of .the food additive regu lations (Adhesives) is written to.minimize the contact between food and adhesives. With such use restrictions, m^ny components are listed in this - 34- i \ / ,* 'A ASI 00000651 regulation as safe only because migration to food will be toxicologically I insignificant. Similarly, some of the substances listed in certain othei regulations have been established as safe only under the specified conditions i .; As part of a continuing effort to improve administration of the i' provisions of the Food Additives Amendment, the Food and Drug Administration ii conducted a National Conference on Indirect Food Additives on February j; /k ' 13-14, 1968,in Washington, D. C. One of the objectives of the confe^enc, was to seek the advice of the scientific community on the adequacy and appropriateness of the Food and Drug Administration's scientific policies i' concerning control and regulation of the so-called "incidental additives" i that become a component of food indirectly through migration from food packaging materials or other sources such as food processing equipment and nachindry, A major controversial issue discussed at that conference is whether all of the requirements of food additive petitions for indirect rood additives are actually necessary. Many of the industries represented 1 a|t that conference endorsed' the opinion of Dr. John p. Frawley of Hercules, j1 Inc., first expressed in a paper delivered before the American'Chemical sjociety in New York on December 14, 1966, and reiterated on a number of I; occasions subsequently. Dr. Frawley holds that any substance (axcept pesticides, heavy metals, and carcinogens) which is suitable for use as J'functional component in a food package or container, at a level of 0,2 percent of less, cannot become a component of food at an unsafe level and i hence toxicology studies or Migration studies need not be required. -15 - ASI 00000652 Dr. Frawley cqnten^s'that it is a waste of our scientific ^sources to utilize them on' packaging problems in such cases because they can be of no possible health significance. Although we have b$en unable to accept Dr. Frawley's proposal completely, wo arc presently considering proposing amendment of our food additive regulations to establish additional broad categories of substances that under conditions of good manufacturing practice may be i j safely used as components of articles that contact food. Under the contemplated conditions of use, we would not expect these additional substances to become components of food in any toxicologically significant k1 amounts. In this connection we are considering proposing amendment of our food additive regulations to permit substances (except carcinogens, heavy metals, and any other substances that have been demonstrated -to produce toxic reactions when present at levels at 40 parts per million or less in the diet of men or animals) to be used under any one of the following conditions; (1) as components of food-contact articles, provided any substance so used contributes no more than 0.05 part per million of I l additives to the contacted food as determined by analysis of the food, or by appropriate extraction studies, or by calculations assuming 100 percent migration; (2) as components of articles intended for use in contact with 9i dry foods with surfaces containing no free jfat or oil, provided the finished 1 food-contact surface contains no free oils kot otherwise permitted for such use; (3) as components of articles intended for repeated use in contact with bulk quantities of food, provided the' finished food-contact article is thoroughly cleansed prior to first use in contact - 16 - ASI 00000653 with food; (4) as components of defoaming agents employe prior to .[ * or during the sheet-forming operation in the manufacture of paper and . paperboard intended for use in contact with food; and (5) as component: of ,food-,packaging adhesives used under conditions precluding any significant ;* migration of adhesive to food, A preliminary draft of our proposal was sent early this month r.o representatives of the various industry trade associations which took part in our 1968 FDA-Industry Conference on Indirect Additives. We*have ,,I | asked these affected industries to express their views on our proposal Which we believe would simplify and improve our indirect food additive ii Regulatory process Without' in any way jeopardizing public safety. There 'are, of course, still a number of synthetic polymers and Synthetic polymer adjuvants that could be used in food-packaging applications which j ^arc not yet covered by our regulations. In addition, interest has bjeen expressed in obtaining clearance for additional food-packaging uses j1 for a number of the presently regulated synthetic polymers and their adjuvants. Last year we received an average of six new food additivp petitions each month requesting regulations for food-packaging applications, i Juaxnly involving synthetic polymers and their adjuvants. Section 121.51 I' ** bf the food additive regulations details the procedures to be followed in preparing such petitions. In this connect:!ion, I have available for dis- N . tribution copies of our "FDA Guideline for Chemistry and Technology Requirements of Food Additive Petitions.'1 'These guidelines reflect our views with respect to the type of data and other information needed for -1,7- ASI 00000654 making an intelligent and*informed evaluation of a food additive petition in thq area pfrchemistry technology. These guidelines suggest ' 1 v ` ways to conduct:'', extraction studies to determine what and how much of any indirect food additives can be expected to migrate from food-packaging materials and food-processing equipment to individual foods or classes i >" of foods under the proposed conditions of "use. We find' that extraction or migration sLudies for plastics and other food-packaging materials are ` , v usually required to provide a sound basis for assessing the safety of their use. Before the toxicologist can give purposeful attention, to tf-je appraisal of the safety of any substance in food, it is essential that be know the nature and the amount of the substance expected to migrate to the food as a result of the proposed use. Without this information we are unable to comment regarding what additional toxicity studies, 'if any, may be necessary for the purpose of a petition. It is also necessary to consider the extent to which a new food-packaging material is likely to be used. As Indicated in Table 6, polyethylene and cellophane presently account for approximately 80% of all food-fackaging films used in the United States. - 18 - `r . j As ASI 00000655 TABLE 6 -- H1LLI0NS OF POUNDS OF FOOD-PACKAGING FILM USED IN VUE U.S.A, I 1966_____________ 1967 1968 !i Polyethylene (%) 360 (47.3) (%) 365 (46.9) 395 1 i. Cellophane 296 (39.0) 285 ` (36.6) 280 (/ (47.6) (33,8) p olyvinyl chloride 2 28 ,2 Polypropylene , ji j Polyvinylidene chloride 31.5 14 1- 9 Polystyrene .i 17 Polyester io Rubber hydrochloride 7.7 5.is ` 10.5 ( 3,7) 49 ( 6.3) 63 ( 7.6) ( 4.1) 35 < 4.5) 45.5 ^ 5.5) ( 1.8) 14 < 1.8) . 15.4 ( 1.9) ( i.o) ( 0.7) ' 8.4 < 1.1) 5.6 ( 0.7) 9.1 '( 1.1) ' 5.6 ( t-.7, C 1.4) , . 7 ( 0.9) 4.9 ( 0.6) Cellulose acetate^ 2 A 11 others (including nylon, fluorocarbon, polyvinyl alcohol, polycarbonate, etc.) 3.5 ( 0.5) 3.5 ( 0.5) / 3.5 (0.5) f ,.s ( 0.7) 3.5 ( 0.4) 7 ( 0.8) '! T OTAL 760.3 (100) 778.1 (100) 829 (100) Industry estimates as reported in Modern packaging Encyclopedia (1968 Edition) Estimated maximum calculated at 70% total production for this type of film as reported.in Modern packaging Encyclopedia (1968 Edition) - 19 i ASI 00000656 In conclu ng my remarks, I would like to ,oint out to mu that there is no authority under the .Food Additives Amendment for our | individual* 'Japproval" of A proprietary products. We have no control over the day- I' ' .' to-day formulation of proprietary products and the responsibility for compliance with the requirements of the Food Additives Amendment to our j Act must in all cases fall upon the manufacturer. We do, however, routinely offer informal comment regarding the food additive status of i constituents in formulations when we are furnished quantitative formulas. |' * Anyone desiring advisory assistance or information concerning the status ! i i of his products under the Federal Food, Drug, and Cosmetic Act is invited to contact the Bureau ofi I Compliance, Division of Case Guidance, Food and Drug Administration, Consumer protection add Environmental Health Service, Public Health Service, U. S. Departnent of Health, Education, and Welfare, Washington, D, C. 20204. Requests for such advisory opinions should give the essential facts and details of the inquiry, including, when applicable, a complete description of the pfoduct and its intended use. If desired, interested parties may also obtain through our Bureau of Compliance reprints of the food additive and other FDA regulations that are published in the FEDERAL REGISTER, If desired, we will also add tjheir names to our mailing list so that they receive future reprints of changes to these regulations. There is no charge for this service. In this brief and general discussion of our regulatory program, I have passed quickly over many important parts and will be glad to attempt to answer any questions you may have. In closing, I want to thank you again for your invitation to participate in the Seminar and for your i attention. - 20 - '"'Y i ASI 00000657