Document 8VR583JjVZ7yLmxa7neOnb8gk

n 69-1 AMIRICAN INK MAKER MO. ZJOO ' PREPARATION The National Association of Print ing Ink Manufacturer* (N A PI M) has commissioned the National Printing Ink Research Institute (NPIRI) to prepare this brochure for the guid ance of its members and their cus tomers, the printers and converters, as well as other interested parties. PURPOSE The members of NAPIM are dedi cated to the betterment of their in dustry and the observance of the law. They intend lo deliver print ing inks that meet the requirements, not only of the application, but also of applicable government few* and regulations. In addition, they try through their association to ascer tain what these requirements may be in the future, so as to he prepared to meet them with minimum delay, cost, and inconvenience. The purpose of this brochure is to cite the government laws, rules, and regulations that cover printing inks with respect to consumer protection and to set forth the current Industry practices to comply with those laws. BACKGROUND The printing ink industry is a small but vital part of the graphic arts and communications industry, with annual sales of over MOO,000,COM MTM. *f. 000. Although small in site, this in dustry is complex and diversified, producing a large number of prod ucts with different formulations. II is estimated that one million new printing ink formulations are pro duced each year and another fourfive million older-hut still-useful for mulation* re kept un Ale. These dif ferent formulations use more than 2.000 different raw materials Such a wide variety of products, each tail ored to a specific application, can be produced only by a technicallysophisticated industry. Printing inks serve the consumer In all aspects of his daily life: in the THE RECORD The members of NAPIM haw an enviable record under normal nrcumstancr*. printed mb Dims do not cause harm or ni|iir. to ihr potv lie A discussion oi this statement follows: There are three wavs >n hit-h substances can enter the bods 1 Its ingestion; 2 bv inhalation. ) | contact. An* potential hazard from a printed ink Rim is almost certain to be by ingestion rather than Its in halation or contact Although inges tion of printed matter is not a like!* possibility, it should be pointed out PRINTING INKS morning they identity his brand of toothpaste; in midday they establish his financial credibility in the form of printed currency and checks, in the evening they provide his enter tainment In the form of reading mat ter. Because this important contri bution of printing Inks often goes unrecognised or may even be taken for granted, the members of NAPIM are concerned that the products they offer for tale do not cause harm to the consumer or expose him to un necessary risk. UM1I. 1SW FIGURE 1 that a small segment of ihr popula tion suffers from pica, an abnormal craving for non-food items. Early in 1973. a turves was con ducted among the members of NAPIM lo asc'rtam if am member company had knowledge of an in stance in which an individual or the public suffered harm or inisirv be cause of the ingestion of printed matter. A "yet" or no declaration was requested for each of the follow ing statements: "Regarding injurv harm or poi soning attributable to ingestion of pnnted matter. 1. I have personal knowledge a case. 2 I have read about a case 3. I have heard of a case Details were requested if am of the answers were ves The re sponse to these statements net "no, unanimous lor ihr first two and near-unanimous for ihe ihud (one rerpnndenl bed heard <it an alleged case of poisoning that oc curred thirty veers ago. another id alleged cases of allergy from han dling pnnted matter, details were unavailable) This result was suppuned h a literature search carried out hs the Toxicology Information Program ut the National Library of Medicine This search turned up several in vestigation! of the potential uixhiIs of printing inks and iheir ingredi ents, but no instance of harm, in- 16 AMERICAN INS MAKER JULY, irrs mcns 078071 jury, or poisoning attributable to in gestion of printed matter A subsequent survey of the volu minous literature on lead by NPIRI revealed only one case, reported in November 1973, in which ingestion of printed matter was suspected as contributing to an elevated blood level in a child afflicted with pica. Other non-food items implicated in the case were leaves, soil, and grass. The members of NAPIM are de termined to maintain this impressive record. They have expressed their determination by continued sup port of scientific research, by using good manufacturing and house- edge and even less control over the final composition and use of his products. For these reasons. NAPIM memben cannot give blanket warranties or guarantees as to the conformance of their products with various laws and regulations, now can they ac cept responsibility for the use or mis use of their products. NAPIM members are dedicated to observing the laws and regulations governing the use of their products and to cooperating with their cus tomers to ensure that these prod ucts conform to the applicable laws and regulations. stated in one of the letters < Figure 21, "The Food and Drug Administration has no authority to approve specific products. " its only means of expressing approval is by promulga tion of food additives regulations Printing inks used in food packag ing are nut considered food addi tives: therefore, no regulation on this subject has been issued, instead, the Food and Drug Administration has recommended that "printing inks (be used) on food packaging only under conditions where they are not food additives, that is, where no migration to food occurs (Figure 3). The Law and the Consumer Prepared by the National Printing Ink Research Institute for the National Association of Printing Ink Manufacturers. keeping practices, by establishing good communications with their customers and suppliers, and by try ing to gain a better understanding of the subtle effects of the environ ment on the human body. This bro chure is one result of NAPIM's con cern and determination. THE NAPIM POSITION The members of NAPIM are in business to manufacture and sell printing inks. Each member com pany is eager to supply inks for spe cific applications in its area of specialization. However, NAPIM members ere often asked to supply inks that meet the requirements, not only of the end use, but also of laws and regulations that do not apply to printing inks. In these cases, the printer or converter should not ex pect, nor should he be given the impression, that the inks supplied to him conform to these laws and regulations that do not apply to printing inks. Moreover, ink formulations are often altered (intentionally or inad vertently) in the converting plant or even on the press. In these cases, the NAPIM member has little knowl- THE LAWS THAT APPLY Currently, there are three Federal laws that apply to the manufacture and use of printing inks: 1. The Food Additives Amend ment (1958) of the Federal Food, Drug and Cosmetic Act (1938), as amended. 2. The U.S. Department of Agri culture Meat and Poultry Inspection Program Policy and Interpretation of Regulations. 3. The Federal Hazardous Sub stances Act (1969), as amended. The Federal Food Additives Amendment to the Food, Drug, and Cosmetic Act. The Food Additives Amendment is concerned with addi tives to food and their effect on the human body. Its applicability to printing inks for food packages is outlined in a series of letters to NAPIM from the Food and Drug Administration (FDA), which are summarized below and reproduced in this text as Figures 1, 2, 3 and re printed in the Appendix. The term "FDA-approved inks" is incorrect, and its use is totally without foundation. There are no FDA-approved inks. As clearly Printing Inks formulated entirely from components that are "prior sanctioned." "generally recognized as safe." "color additives regulated for direct addition to food" or" food additives resulting from contact with containers or equipment and food additives otherwise affecting food" are not considered food additives unless the migration of ink com ponents to the food is recognizable by observation or test. Moreover, printed films on coupon inserts in packages of ordinary dry granular foods are not considered food addi tives if there is no reasonable ex pectation of migration of ink com ponents to the food. The primary concern, however, is with food packaging inks other than those special cases described above. Due to certain performance re quirements, many food packaging inks cannot be formulated entirely with "prior sanctioned" ingredients. Even in these cases, "the ink manu facturer should be very selective in choosing materials of very low tox icity" (Figure 3). Moreover, the printed ink film must always be sep arated from the food by a functional barrier that prevents migration of ink components to the food (Figure 2). Therefore, ink films printed on the outside of a food package are not considered food additives provided the package serves as a functional HONS 076072 AMERICAN INK MAKER JULY. 1975 17 barrier between the ink and the food. If the printed ink film is ap plied to the inner food contact sur face, it mult be overcoated with a functional barrier film to prevent migration of ink components to the food. The important requirement is that, with the exception of the dry granular foods case, the printed ink must alway* be separated from the food by a functional barrier. This functional barrier must prevent con tact of the ink film with the food un der extra-ordinary as well as ordi nary conditions. Certain foods (e g., candy, cake) soften in hot weather and adhere to the inner surface of the wrapper Moreover, a person eating a candy bar or ice cream sucker may lick the food off the wrapper or even eat part of it. There fore, it is especially important to formulate printing inks for these ap plications from Ingredients of very low toxicity, even though there is a functional barrier between the ink film and the food that serves under ordinary conditions. POLYCHLORINATED ' BIPHENYLS The Food Additives Amendment of the Federal Food. Drug, and Cos metic Act has also been applied to limit the content of polychlorinated biphenyl's (PCB's) in milk, dairy products, pouitry. eggs, animal feed, fish and shellfish, infant and junior foods, and paper food pack aging materials (Appendix l). Polychlorinated biphenyls are sta ble, heat-resistant, nonflammable chemicals that have been used in dustrially as electrical transformer and capacitance fluids, heat transier fluids. hydrautlc fluids, and plasti cizers, as well as in the formulation of lubricants, coatings, and inks. Re cently these compounds have been found to be a persistent and ubiqui tous contaminant in the environ ment, causing contamination of certain foods. Also, they have been found In paper food-packaging ma terials made from both recycled and virgin pulp; in this case, their origin is not known. Because of the persistence of these polychlorinated biphenyls and the difficulty in tracking down their ori gin, the Food and Drug Administra tion has issued temporary tolerances effective September 4, 1973. The temporary tolerance is 10 parts per million or 0.001 percent for paper food packaging materials intended for human food, finished animal feed, and any components of animal In the past, these compounds have been used as an ingredient nf only a few specialty inks, and their prohibition presents few problems to the ink formulator More important, however, is the possible contamina tion of printing inks bv polychlori nated biphenyls of indeterminate origin, which can be resolved only by accurate chemical analysis. t/.S. Deportment of Agriculture Meat and Poultry inspection Pro gram and Interpretation of Regula tions; The United States Depart ment of Agriculture has jurisdiction over the packaging of meat and poultry in federally-inspected pack ing houses. The policy governing the use of various materials in these packaging applications is outlined in the "USDA APHIS Materials Evaluation and Acceptance" (A|> pendix 2). This policy states that any ma terial used in or on a container (for federally-inspected meat and poultry food products) must be considered a potential food sddltive. These ma terials must be examined for sub stances that are toxic or hazardous, or that could migrate to the food un der the conditions of use Materials found to be acceptable can be de scribed as "accepted by APHIS. FIGURE 3 5SE* 18 AMERICAN INK MASER JULY, MTS HONS 078073 1/5DA" in c*logs, brochure!, and letters, but not in advertising. Printing inks used in packaging of meat and poultry food products can be divided into three categories: 1. branding inks; 2. inks for insert labels; 3. inks for the outtkU of the immediate container. Printing or branding inks that are applied directly to food may contain only water, ethanol, acetone, sugar, and FDA-certified food colors. Printing inks for label inserts must conform to the Food Additives Amendment and may contain only FDA*certified food colors. Package and label inks (and over print varnishes) for the outside of the immediate container must be formulated from vehicles that con form to the Food Additives Amend ment and pigments from that Regu lation of FDA Provisional Lists of Food Colors, or from dyes and pig ments accepted by the Scientific Services (USDA). Acceptable color ants include: the provisionally-listed color additives; titanium dioxide; carbon black made by the impinge ment process; iron oxides; phthalocyanine blue, ultramarine blue; cal cium and magnesium lakes of FDAC dyes; and certain organic coloring materials. Specifically excluded are: lakes or pigments containing anti mony, arsenic, cadmium, chromium, lead, mercury, and other toxic met als; fluorescent brighteners; known DSTAanKHT or MU.T*. I carcinogens, mutagens and teratogen. It is agreed among NAPIM mem bers to identify inks that are accept able for the outside of the immediate container as 'meat and poultry" inksor'MAP" inks. The USDA evaluation of proposed materials takes into account the con ditions of use, i.e., the type of food (aqueous or fatty) and the tempera tures to which the material will be exposed. The temperature categories include: 1. "below 150*F"--frozen food storage, room temperature stor age, shrink tunnel treatments where the temperature of the food does not rise appreciably; 2. "below 250*F" --the foregoing plus boil-in-thebag, heat sterilization, retorting, etc.; 3. "oven temperatures"--the foregoing plus roasting or cooking above 250*F. The following information must be submitted for evaluation of a pro posed material: 1. the brand name or manufacturer's code; 2. a descrip tion of the conditions of use; 3. a list of components or ingredients. Trade secrets and proprietary infor mation are held in confidence and used only to evaluate the material. Federal Hazardous Substances Act (1969) as Amondad. The Hazardous Substances Act coven substances used in the household that are: toxic; corrosive, irritants, strong sen sitizers; flammable or combustible; FIGURE 4 generate pressure through decom position. heat, or other means, cause substantial personal injury or illness during or as a proximate result of any customary foreseeable handling or use, including reasonably fore seeable ingestion by children. It is applicable only to materials shipped in interstate commerce. Initially, the Act was administered by the Food and Drug Administra tion. As a result of the recent Con sumer Product Safety Act. which will be discussed later, jurisdiction is now under the newly created Consumer Product Safety Commission. A 1972 amendment (6) to the Federal Hazardous Substances Act specifically bans any paint or similar surface - coating material intended for use in or around the household that contains more than 0.5 percent lead. Also banned is any toy or other article intended for use by children that bean any paint or similar sur face-coating material containing more than 0.5 percent lead. The Act also provides that the al lowable lead content of household paints and paints for children's toys be lowered to 0.06 percent after De cember 31, 1973; however, at the time of writing, the Consumer Prod uct Safety Commission has deferred the implementation of this new limit. The applicability of the Federal Hazardous Substances Act to print ing ink is outlined in a letter from HEW to NAPIM (Figure 4), which is summarized below Printing inks in general are not subject to regulation under the Act because they are not considered a paint or similar surface-coating ma terial nor are they intended for use in the household. Printed ink films applied to chil drens' toys, however, are subject to regulation by the Act, i.e . their lead content must be less than 05 per cent. The package in which the toy is sold is generally considered to be part of the toy unless it is obviously intended to be discarded le g., as is a cardboard header or display car ton). State and Local Regulations The foregoing Federal laws may not be applicable in all communities 20 AMERICA* 1NX MAKER JULY, 1975 HONS 078074 TW Subsidiaries of Contra) Solvonti ft Chomieala Company Atlanta (401) 449*710 Manta Sstoanta ft Charnica) Company Buffalo (714) 179*1171 vfMa Sahrama ft Chwnieal* Corporation CMeefe 1312) 594*7000 Control Salvama ft Chamicali Company Qnffnnaff m\ H2-7700 Amaco Solvanto ft Cttamicala Company Cleveland <2191212-ltOO Ohio Sahmnta ft Chomieala Company OaBaa 1214) U7-)*H Taiao Srivants ft Chamieala Company Doarali <313)041MU Waotam Katan Sahrorrta ft ChomicaiB Company Pt.Waynamn74ft.S1U Haaatar Sabines ft Chamieaio Corporofton Orand Waplia IftHI 240*0111 Wahwina Sebents ft ChamiealB Company Oraanabara Iftlff 4ft4*Iiftl SaMManO Srivama ft Chomieoi Company Mauataw 1713) 170*0241 Taaaa Ssbents ft Chamieala Company Mtoaapafta (31?) 139*1311 Haaaiar Sahranta ft Chomicaia Corporoban eCfcy (lift) 241*3223 urtSabanttft*" lee Angelas (2131773*3471 Cantral 3amenta ft Chamieala Ce. LeuMBelSUI 44MI11 OWa SebsrtaA Chanteala Company MMoauhaa |4i4|7>4*24ftft VWaeanoin lamamo ft ChamiealB CarporoPon NBnneapefte (112) U>*123ft Wiaaanoln ftaloanta ft Chamieaia Corporation New Ortaona (U4| 437W6 Souffam Samenta ft Chomieoi* Corporattan PWahui pfti (412) U287ft Mofthony 3abaMi ft Chomieala Company Portland, Ooa. ISM 2M*U21 Control Sabtma ft Chamieaia Co. BtUulal314)43t*3aH Mtaaaari Samanta ft Chamieala Company Baft LabeCity (Mil 232*0437 Central Samanta ft Chemioolo Co. Ban Antew)e{12) 533*0123 Toro* Samanta ft Chomieoi* Company Ban Pnnoloaa 1*15) 471-W20 Central Samamo ft Chamioalo Ca. Boattla (2U) 22H0M Control Somonto ft Chomieoto Co. Bpuhona IBM I34*ftft1ft Central Samonto ft Chamieoii Ca. Tataffa 1419) SU4771 Talaae Samamo ft Chomieoi* Company Terantn. Ontario<4lff74ft*l9ftl Wootom lomanto ft Chomieoi*(Can.) Uft. Von--near, B.C. (IP4) S2S-IK1 Wottom Solvents ft Chamiealt (Can.) US. WhMlaar. Ontario (lift) 252577ft Woetem Samonto ft Chamieoii (Con.) lift. Prove*Quim S.A. do C.V Menioe City. P. P. 517*01*55 Manterray, N.L. Man. 52*47-10 PunMa. Pimm Man. 2-ftft-tl Tairaan. Coeb., Man. 3*39*73 JTON W. Tlot Strati Chicipa. rilnora 40431 in the United States. For example, the USDA meat and poultry regula tions are applicable only in federallyinspected packing houses, and the Federal Hazardous Substances Act applies only to items shipped in in terstate commerce. To ensure the protection of their residents, many states and munici palities have passed ordinances sim ilar to the Federal laws. Others will pass such ordinances in the future. The provisions of many of these ordinances are identical to those of the Federal laws, but some differ significantly and thus should be checked locally. LAWS THAT DO NOT APPLY The following laws were enacted only recently and have not yet been fully implemented; however, at the time of writing, they are not con sidered to be applicable to printing inks. Consumer Product Safety Act The Consumer Product Safety Act of October 28, 1972, created an independent regulatory Consumer Product Safety Commission, effec tive December 19, 1972. The princi pal purpose of this Act is to protect the consumer from unreasonable risk of injury associated with consumer products. The Commission is empowered to develop and impose safety standards for consumer products under its jurisdiction. Products for which no feasible standard can be developed may be banned as hazardous. Also, the Act transfers to the Com mission a number of other functions heretofore administered by other Federal agencies, among them the Federal Hazardous Substances Act heretofore administered by the Food and Drug Administration. Aside from the provisions of the Federal Hazardous Substances Act, which are discussed in the foregoing section, this new Consumer Product Safety Act is not considered to be applicable to printing inks. Federal Flammable Fabrics Act At the time of writing, the Federal Flammable Fabrics Act is not con sidered to be applicable to printing inks; however, the inks used for printing vinyl upholslerv and textile* may possibly be construed as sub* ject to this Act. Federal Poison Prevention Act At the time of writing, the Federal Poison Prevention Act is not con sidered to be applicable to printing inks. GENERAL OBSERVATIONS ON PRINTING INKS Printed ink Aims comprise only a small part of the total weight and volume of a printed sheet. Just how small this part is can be shown by calculating typical ink film thick nesses. Let us assume that the cov erage of an ink is in the range 130 300,000 square inches per pound of ink and that the specific gravity of the ink is 1.2. Complete and uniform coverage of the substrate give an ink film thickness of only 2*4 microns (25.000 microns equal one inch). Just what proportion of the printed sheet this 2-4-micron-thick film would comprise depends upon (he thickness of the sheet end the extent of ink coverage. For example, if (hr paper thickness were 5 mils and its porosity 50 percent, the ink film of 2*4 microns thickness completely covering its surface would amount to only 1.5-3.0 percent of its total vol ume and 0.75-1.5 percent of its total weight. In many cases, however, the print ed ink film covers only a small part of the surface, often 5 percent or less. A 2-4-micron-thick ink film cover ing 5 percent of the surface of (he same paper sheet would amount to only 0.08-0.16 percent of the total volume and 0.04-0.08 percent of the total weight of the printed sheet. These very small proportions would be correspondingly smaller for thicker paper or paperboard sub strates and correspondingly greater for greater coverages. These very thin printed ink films usually are not subject to peeling or Baking (as are paint films which be come embrittled with age). There fore, it is unlikely that fragments of free ink films would be ingested by an individual. Instead, the Ingestion of printed ink films usually requires the ingestion of the entire printed substrate. Such ingestion by adults MGNS O70C75 AMERICAN INK MAKER JULY. 1975 23 It unlikely, but muit be considered ui possibility with children. The more-than-2.000 different in* gradients used in the formulation of printing inks include a wide variety of pigments, dyes, polymers, resitu. solvents, catalysts, driers, antioxi dants, and surfactants. Some of the pigments used are lead compounds. Although the effects of excess lead in the body are known to be harmful, these lead pigments can be used in printing inks, subject to the laws described in the foregoing section and employing good formulation practioes, with negligible risk of harm to the public. Some printers and converters have asked their ink suppliers for "leadfree'* inks, and some ink makers have used this term in promoting their products. This usually means that the inks have been formulated with non*lead*based pigments. However, the term "lead-free'* is a misnomer and a myth--"land /ret" tab de nos exist Lead Is all around us---in the food we eat, the air we breathe, the clothing we wear, as well as the newspaper or magazine we reed. In moat cases, the lead con centration is too small to bo of con cern. The important point to consider with printing inks is the load con centration in relation to the possi bility of Ingestion. For example, food containing 1.000 parts per million or 0.1 percent of a soluble lead com pound would cartainly came lead poisoning if Ingested in tufldent quantities over a prolonged period of time. In comparison, a magazine color page containing 1,000 ports per million of a sparinglysoluble lead pigmant ancapaulatod in a polymer matrix would poao no hazard to tha consumer, provided it were not In gested. Even If such a page were in gested, it would bo unlikely to cause any harm, because there is consid erable doubt whether spariogly-soluble leed compounds cen be digested completely and absorbed by the body through the digestive tract. Even if the digestion were complete, the Ingestion of a single sheet would be unlikely to introduce enough lead to cause harm. Lead poisoning re sults from the continue! intake of lead at a rate greater than that of elimination. It is extremely unlikely that such a buildup could arise from the ingestion of printed matter. Well-worked-out analytical pro cedures are available for the de termination of lead and other heavy metals in printing inks. The meth ods and instrumentation used de pend upon the metal to be deter mined. the solubility of the metal compound, its concentration, and the accuracy and precision required. The application of these analytical methods to printing inks is unneces sary in most cases and can be justi fied only in special cases. Because of the very large number of ink formulations produced each year, the cost of analyzing each batch would amount to a prohibitive to tal, which must be passed on to the user. Therefore, such analyses should be carried out only when necessary. NFIRI ANALYTICAL FACILITY NAPIM has established at the Na tional Printing Ink Research Insti tute (NPIBI) an analytical facility for the determination of lead, other heavy metals, and PCB's in printed matter and its constituents. This facility will carry out analyses on a service basis not only for NAPIM members, but also for their custom ers and suppliers. In addition, it will be used in the NPIRI research program to survey the content of lead In various forms of printed mat ter. For more information, please Reprints of this irtiefo may bg obtained from tha National Association of Printing Ink Manufacture era, 101 ExacutWo Mvd.f Elmtford, N. Y. 10021 Tha talaphOM numbtr Is 014*002*4090. Prices are SO# for members, $1.00 for non-members. Prices In bulk on request contact the National Printing In Research Institute. Lehigh L'nivet sity, Bethlehem, Pennsylvania INI (telephone (215) 691-7000, ext. 2201 REFERENCES AND APPENDIX Figure l. Letter to NAPIV from Wulfsbergof FDA. 3-11-63. Figure 2. Letter to NAPIM from Strand of FDA, 9-26-66. Figure 3. Letter to NAPIM from Strand of FDA, 5-26*71. Figure 4. Letter to NAPIM from Hallman of FDA. 12-19-71 Appendix l. Excerpt from Fed eral Register 38 (129) 16006-18100, July 6, 1973. Appendix 2. USDA APHIS Malm rials Evaluation and Acceptance, 1973. Appendix 3. Excerpt from Food Drug Cosmetic Law Reports. GUIDELINES FOE THE INK MAXES 1. Know the laws and regulation* that apply to printing inks and fol low them. 2. Find out as much as possible about the ultimate use of the ink and be prepared to advise your custom ers accordingly. 3. Recognise the limits of control you have over the ink you deliver and the extent to which you can a* sutne responsibility for its use oe misuse. 4. Maintain good housekeeping practices to rigorously segregate the various ink ingredients. GUIDELINES FOR THE INK USER 1. Know the laws and regulation* that apply to printing inks and fok low them (NAPIM is one of the best sources for such information). 2. Inform the ink maker of the application and its special require ments. 3. Recognise that ink making is a highly-specialized activity and rh each different application requires an ink formulated especially for it 4. Maintain good housekeeping practices to avoid the inadvertent mixing of inks. 24 AMERICAN INK MAKER JULY, l7S HONS 078076 Appendix 1 EXCERPT FROM FEDERAL REGISTER Volume 38, Number 129, Friday, July 6, 1973 pages 18096-18013 Title 21--Food end Drug* packaging manufacturing establish- (e) The provisions of this section do CHAPTER I--FOOD AMO DRUG AOMINI* TRATION, DEPARTMENT OF HEALTH EDUCATION, AMO WELFARE menu. Since PCB's are toxic chemicela. the PCB contamination of food-packaglng materials as a result of Industrial accident*, which can cause the PCB con- not epply to electrical transformer* end condensers containing PCB's in issued containers, -- SUPCMAPTCR A--OCNCNAk tamlnatlon of food, represents e hasard FART 121--FDOO AOOfTIVCS U0CM*rr* 0--FOOD AND FOOD PNOOMCTt t public health. It is therefore necessary , ^ ... .... ____ ... POLYCHLORINATED DIPHENYLS (PCD*> to pl.es ctrtsln restriction, on tit. In- h 2 Contemkietion oI Anknol Food*. Foods, end Food-Peckegtng Materials duntrt.1 urn* or PCB's In ntsbltihmsnu manufacturing food-packaging materials. b* ,r*^*lnt wbp.reir.ph. ill and >*i. M loiiowe. I 111.2544 Pulp from rerUimrd Him* <b> The following special provisions PART STATEMENTS OF GENERAL POLICY OR INTERPRETATION are necessary to preclude the accidental PCB contamination of food-peckaxing materials: ##m ** ,, ,l> Industrial waste from the msnu* j. The following new section U Added (1) New equipment or machinery for **ture of paper and paperboard product* to Pert S: manufacturing food-packaging materials Mdudlng that which bears or contain* | J.9S l)w of polyeMerloeted biphenyl* (PCD'*) hi e*iebU*hment* menofoe* shall not contain or use PCB's. w Poisonous or deleterious substance (2) On or before August 4. 1973. the wh`c* u retained tn the recovered r lrl*| f--dpechsplwp msieriel*i management of establishments menu- In* migrates to the feed, cxcet * (a) Polychlorinated biphenyls <PCB's> lecturing shell: food-packaging materials Provided in regulations promulga -4 under sections 404 end 409 of the Federal represent a class of toxic industrial chemicals manufactured and sold under <li Have the heat exchange fluid used ^bod. Drug, and Cosmetic Act. In existing equipment for manufacturing f2 Balvage from used paper and a variety of trade name*, Arodor < United Statesi; including: Phenoclor food-packaging materials sampled and poporboard excluding that which 't> tested to determine whether it contains ^ contains any psissneus er <Pr*nee>; Colphen (Oermany); and PCB's or verify the absence of PCB's in dtlHertoua substance which is retains* Kanaelor (Japan). PCB't are highly such formulations by other appropriate in the recovered pubs and that ndgroMo stable, heat resistant, and non-flamma means. On or before Sept. 4. 1973. any 10 food, except ae provided in non ble chemicals. Industrial usee of PCB's such fluid formulated with PCB's must lotions promulgated under seettene sit include, or did include In the poet, their to the fullest extent poseUde commen- and 409 of the act or <H> has been used use as electrical transformer and capaci surate with currant good manufacturing for shipping or handling any such tor fluids, heat transfer fluids, hydraulic practices be replaced with a heat ex- etane*. fluids, and plasticisers, and In formula tions of lubricants, coatings, and Inks. chance fluid that does not contain FCB'a < tl) Bimlnate to the fullest extent pee- . __ Their unique physical and chemical ilbie commensurate with currant good ,M--- ----------------- -- ------------- properties and widespread, uncontrolled Industrial Applications here censed FOB'S to be a persistent and ubiquitous mmaanmuiffaawcttuurHinng. nprra^cttilc*e*s. tfrmomm tthhe. Mesta.bhlishment any other PCB-containing equipment, machinery and materials _ CONTAM* NANTS IN F000 AND FDOO-PAOIA* IND MATERIAL contaminant in the environment, caus wherever there is a reasonable expecta 3. A new Fart 122 it added ea follow: ing the contamination of certain foods. tion that such articles could cause food- Xn addition. Incidents have occurred In paebagtng materials to become contam Subpart leduetrial Cewtemlweets in which FOB'S have directly contaminated inated with PCB's either ae a result of animal foods as a mult of industrial accidents (leakage or spillage of FOB fluids from plant equipment). These ac normal use or ae a result of accident, breakage, or other mishap. (Ill) The toxicity and other charac | 122.14 T^manrevy tsltrenr#* fee pntyfhUrifteirs biphenyls (Nl'i). cidents tn turn caused the contamina teristics of fluids selected as PCB replace tion of food products intended for human ments must be adequately determined so <) 10 parts per million in paper food* consumption (meat, milk and eggs). In vestigations by the ftod and Drug Ad that the least potentially hesardous replacement is used. In making this deter- ^ - ~ - eriai intendM for orwith human food, finished animal feed ministration have revealed that a signifi mination with respect to a clven fluid. *d components intended for enlmn! cant percentage of paper food-packaging consideration should be given to (a) its The tolerance shall net apply Is material contain* PCS'* which can mi toxicity: <b> the maximum quantity that paper food-packaging material sepofafem grate to the packaged fooU. The origin could be spilled onto a given quantity of from the food therein by a funrt--P of KB's In such material Is not fully food before it would be noticed, taking barrier which la impermeable to m*gr understood. Reclaimed fibers containing Into account Its color and odor: (c> poa- t,on of PCB's. carbonless copy paper contains 3 to 5 tible signaling devices In the equipment <b> A compilation entitled "Analyttcn percent PCB's* have been identified as to indicate a loss of fluid, etc.: and id) Mothodolecy for Polychlorinated II a primary source of PCB's In paper prod Its environmental stability and tendency phenyls. February 1973" for deteramun ucts. Some virgin paper products have to survive and be concentrated through compliance with the tolerances eMab also been found to contain PCB's, the the food chain. The judgment as to Ushed In this ssctlon la evailaMe (Ns source of which I* generally attributed whether a replacement fluid is cuffl- the Hearing Cterk. Department o to direct contamination from industrial clentiy non-hetsrdous Is to be made on Health. Education, and Welfare. Hasp accidents from the use of FCB-contaln- an Individual installation and operation 4-44. 5400 Fishers Lane. Reckvtue. IS lng equipment and machinery In food basis. 20452. 26 AMERICAN INK MAKER JULY. 1975 WCNS 076077 Appendix 2 MATERIALS EVALUATION 8 ACCEPTANCE United States Department of Apiculture Animal and Plant Health Inspection Service Meet and Poultry inspection Program Scientific Services Washington. 0, C. 20250 Introduction. The safety of materials for packaging and handing of meat and poultry food products la pert of the responsibility assigned to the Meat and Poultry Inspection Program by tha Federal Meat Inspection Act aa amended by the Whoieeome Meat Act of 1967 and by the Poultry Product! Inspection Act aa amended by the WhofoMtnt Poultry Products Act of life. Materials containing, contacting, or even rfoeafy approaching food products may be composed of ubotancea some of which could migrate to the food by dif fusion, dissolution, absorption, accidental abrasion, or other moans of transfer. Therefore, the materials must be examined for substances which are toxic or hexarebus or which could migrate in undesirable amounts under the actual conditions of uaa. When a material or container is found acceptable for the proposed use, a latter of acceptance la issued referring to It by brand name or code. The supplier or manufacturer should make this latter available to buyer* and inspectors aa needed. Reqtemmtat. Throe pieces of Information must be supplied for our evaluation of an item or group of items: 1. Brand name or manufacturer's identifying math. 2. Description of the conditions of ueo. 3. List of substances composing the material. The list must identify all major and minor constituents by proper chsmical name aa It appears in the appropriate Pood Additives Regulation, or by reference to previous acceptance. Trade secrets and proprietary Information are hrid in con fidence and used only to evaluate the material. Sand the in formation to: Mr. John W. Sloan Chemistry Staff Sdeatifle Sendees, APHIS U.S. Department of Agriculture Washington, D.C. 20190 Telephone: (2H) 447-79M must comply with the appropriate Pood Addtttvoe B^ulatisn extractabUlty requirements. Aritealvw for lamtamMg mi fabricating must comply with 21 CTR 12M9M sad pwara sonsitive adhaaivos for band labels, etc., must comply wtth 21 CFR 121.2977. lak and colmeats am evaluatad eccordtag to thrir uaa. Bramttng Ink, for direct and prnlnngwl contact wtth moat or poultry, la described in tha Manual of Moat taspaattei Procedures, Sections 310.10 and 3li.lL R may ceteris anly wotmr, ethanol, acetone, sugar and PDA certtflod food cetera. Inks for insert labels must comply with 21 CFR 12UU4 phi PDA certified food colors. Package and label late (ate overprint lacquer) for the outride of tmmodlate eaataiasre must have a vehicle in compliance wtth 21 CFR isuuo and pigments chosen from that RemUatka or tram FDA Provisional Lists of Food Colors or Deal dyes and pIpMate accepted by Sdmttfk Sendee*. The followtaig era spsdfleaMy excluded: Lakes or pigments containing Anttmany, Arootec, Cathnlum, Chromium, Lead, Msrcwyaad otter tedcawltet, fluorescent brigbtoners; known rsrrtnsgriii, nratagma sad tmalogena. Coleranta for plastic films, tuba, coteatoon, ste, am subject to the same restrictions. Dyoe and pipnenta tested always be identified by their frdlgtt Colour laden ranter or structural formula. Equipment Materiaia am svaluatsd on tha bask of ttelr chemical composition. Small equipment such as aprons, bag* cutting boards, gloves, pins, stewora, Umars, took, twtna, ole., is handled the same as immediate cental--a. Larpr equipment such as conveyor betting, bean, metato, matte coatings, pipe, plastics, rubbers, seldom, sic., must have its chemical ccmporition ckamd and than be referred to Equipment Staff. Plant Padlitiss and Pqulpmmt Staff, Technical Services Staffs, APHIS. Paints sod coatings appltati to equipment, machinery or panels before inatallatkn are evaluated similarly to inks by this ofllet. Immediate Containers for meat or poultry food product murt bo fabricated of only thoee materials in compliance with the Food AddlUves Regulations, particularly 21CTR121 Subperta B (Exemptions), E (Prior Sanctions) and P (ContaiMrs). It is important to noto.the type of food in direct contact (aqueous and fatty) aa well aa the temperatures to which the packager! food will boexposed. "Below ISO degrees Fahrenheit'' indudas fromn Horace, room tempurature storage and shrink tuimsl treatment, where the temperature of the food product dom not rise appreciably. "Below 290 dogrsos FahrenMt" includes These plus boil-in-the-bag, hast sterilisation, retorting, etc. Oven temperatures" includes all those phis meeting or cooking above 290 dogmas Fahrmbeit Plastic rmla films Palais and eeatinp to be appllod on site am evaluafod by the Compounds Evahiatfcm Laboratory, aa sm caao> pounds such aa deansn, aaottiaara, bolkr water treatment, pesticides, lubricants, etc. Send this information, wtth auR sample, to: Mr. Donald D. Dorr Chemistry Staff Scientific Service*. APHB U.S. Department of Agriculture Building 30t, ARC Boltsvilla, Maryland 2*701 Telephone: (301) M4-2M 28 AMERICAN INK MAKER JULY, 197S M0Ns 0 7601a Y Giiral CMMmUm. This Agvncy (APHIS) has no authority to ovoluatt matorisla (or um with foods othsr than fadvally inspsctad moat and poultry. Material! which moot our criteria aro tarmad "accaptabla" bacauso tba term "approved" might orronoowaly indicate a prBarones (Or ono brand over another 1710 phrasa "scented by APHIS, USDA" may bo usod in brochures, catalogs and tetters to customers where valid but is Inappropriate far use in advertising. Although basic materials are often evaluated, it is more useful to the moat or poultry inspector to have an acceptance on the finished item as it appears in the processing or packaging area. Thus a corrugated carton might bo found acceptable provided all its componente-llner board, corrugating medium, adheeivee, wax coating, printing inks, etc.,--comply with the requireiMnts. This may be simplified to an acceptable corrugated stock plus an acceptable ink system. Similarly, s transparent package may consist of acceptable polyvinylchloride film (PVC, stabilisers, plasticisers, etc.) phis an acceptable ink system. Manufacturers requesting acceptance of many similar items such as a system of inks or paiats differing only tn pigment, gloves of the same material but different style, cartons of the same compotetten but venom slaoe, film of the same resin bland but different gauge, should group them in e convenient way to facilitate the acceptance. Materials net specifically described hwe or in tba Feed i*lfMHheo Regulations must be considered individually and repainted Us a way most likely to guarantee tha consumer complete protection against toxic or hasardnus eubetenroe. g a motertel is found to contain an unacceptable lubsfaaco, tha correspondent will be so advised end allowed to make su^ stitution or withdraw the requt. Once so evaluation has beat made and materials found acceptable, ono final criterten mmt be met. Tho material, whon placed in actual uee, must perform in a safe and satisfactory manner. Appendix 3 EXCERPT FROM FOOD DRUG COSMETIC LAW REPORTS 8-7-72, pages 494-5 j\l 9309 J Banned hazardous substances >)... -> Caution: Reg. 5 191.9(a) reads as amended and (a)(7) reads as added, effective September 24, 1972. --CCH. 5 191.9 (a) Under the authority of section 2(q)(l)(B) of the act. the Commissioner declares as banned hazardous substances the following articles because they possess such a degree or nature of hazard that adequate cautionary labeling cannot be written and the public health and safety can be served only by keeping such articles out of interstate commerce. (6)(1) Any paint or other similar surface-coating material Intended, or packaged in a form suitable, for use in or around the household that: (a) Is shipped in Interstate commerce after December 31, 1973, and contains lead compounds of which the lead content (calculated as the metal) is in excess of 0.06 percent of the total weight of the contained solids or dried paint film; or (b) Is shipped In interstate commerce between December 31, 1972, and December 31, 1973, and contains lead compounds of which the lead content (calculated as the metal) is in excess of 0.5 percent of the total weight of the contained solids or dried paint film. (11) Any toy or other article intended for use by children that: (a) Is shipped in interstate commerce after December 31, 1973, and bears any paint or other similar surface-coating material containing lead compounds of which the lead content (calculated as the metal) is In excess of 0.06 percent of the total weight of the contained solids or dried paint film: or (b) Is shipped In interstate commerce between December 31, 1972, and December 31, 1973, and bears any paint or other similar surface-coating material containing lead compounds of which the lead content (calculated as the metal) is in excess of 0.5 percent of the total weight of the contained solids or dried paint film. 30 AMERICAN INK MAKER JULY, 1975 MGNS 078079