Document YaQ912NNg0vBwMw2DYRYEQ9y

DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE OFFICE OF THE SECRETARY rock VILLA. MO 20132 August 3, 1973 EXHIBIT A OFFICE OF THE GENERAL COUNSEL Jerane E. Hecknan, Esq. Keller and Heckman Suite 1000 1250 - 17th Street, N. W. Washington, D. C. 20036 Dear Jerry: In response to your letter of July 20, 1973, I am return ing the transcript with a minimum amount of editing. I have resisted the tarptation to perfect my grarrmar and lave limited the changes to substantive ones. I do believe it proper for this transcript to be made publicly available. I am therefore requesting that, when you send it to the Carmittee and others, you also send a copy to me and to the trade press so that any member of the public who is interested will have the benefit of these rsnarks. Sine ours Enclosure Peter Barton Hutt Assistant General Counsel Food and Drug Division BFG61599 ASI 00001134 Exhibit B SPI'S TROUBLE SHOOTER POOD, DRUG AND COSMETIC PACKAGING MATERIALS COMMITTEE Recognizing and Nipping Problems in the Bud la a Quiet. Full-Time Job That Serves All Members Because the function of SPI's Pood, Drag and Cosmetic Packaging Materials Ccenittee is to anticipate potential plastics Industry difficulties and resolve them before they become ma.lor and possibly Irreversible problems, the work of this group is perhaps less knovn than other SPI efforts marshalled to cope with three-alarm fires. In the packaging field, this committee is widely recognized as an extremely effective watchdog operation, keeping its members up to date on evolving technical and legal aspects of various types of legislation and policy that might affect them. The FDCH-5C sees its primary role to be the plastics industry's eyes, ears and voice, frequently bringing cogent persuasion to bear on the Food and Drug Administration, the Department of Agriculture, and other regulatory agencies. Its day to day activities are a vast and continuous preventive maintenance program, generally resulting in the avoidance of emergency crises that could have disastrous impact on the plastics industry. It has aptly been called the industry's "public health and environmental problems early warning system." FDCBC maintains a constant dialogue with the federal authorities. It acts as a primary source of Information--to the government regarding plastics; and to the plastics industry concerning the significance to plastics of planned government actions. It acts as a clearing house, and an information t-r. k; r. \ J BFG61600 J ASI 00001135 -2- EXHIF.TT B digesting and distributing organ, recognizing fully, for example, that the "FDA status" of a plastic resin or end product will invariably have a direct effect on the marketplace. Typical Cansnittee meetings receive reports and hold discussions on the technical and legal aspects of relevant pending and recently approved federal and state government regulations. Topics discussed include proposed govern mental rulings and shifts in policy, reports on liaison with other organizations whose activities bear on important Interests of the plastics industry, and reports of new and/or proposed legislation in the area of the Connittee's responsibilities. For example, when a revision of FDA concepts regarding a "generally p recognized as safe (GRAS)" list, as well as the "prior sanctioned" rule were pending, the Ccnaittee filed Consents documenting the desirability of avoiding adverse FDA action which could severely disrupt sales of long-used materials, not only in packaging, but also in appliances, dinnerware, etc. Another FDCIWC action filed formal Consents regarding a proposed rule that plastic food packaging materials would have to contain no more than 5 parts per million of polychlorinated biphenyls (PCB's) as an unavoidable contaminant. As a result, in part, the final proposal will not contain this limitation, since it was pointed out that no problem has been shown to exist with plastic packaging materials. Elimination of this requirement can save the plastics industry substantial costs which would otherwise be required in PCS testing and certification programs. Comments filed by the FDCH1C regarding colorants for plastics in food contact applications are expected to remove proposed new restrictions that might have seriously limited the use of several acceptable pigments now ASI OOOC1136 BFG61601 EXHIBIT B -3- widely employed, la addition, tbe Ccmnittee set up a task force to work with a group from tbe carbon black industry seeking an acceptable substitute for ebannel black, presently being phased out of commercial production. The TDCBtC was originally formed in 1957 to study a proposed Food Additives Amendment to the Food, Drug and Cosmetics Act which would have imposed onerous requirements for product pre-clearance. In good measure as a result of significant Committee contribution to the hearings on the amendment, most dishes, utensils, picnic ware and similar goods were exempted from the demanding specification. The Caasittee subsequently published a manual to acquaint the plastics industry with tbe basic requirements of the Food Additives Amendment of 1958, supplemented by a later manual--lauded by FDA--designed for chemists, food packers, raw materials suppliers and others involved in plastics packaging. During the 1960's FDCJMC was responsible for the publication of a manual on "Good Manufacturing Practices Criteria for Plastic Resins 'Prior Sanctioned' Under the Food Additives Amendment of 1958," which listed many of the basic resins that were "prior sanctioned"--something the FDA had not done. The FDA itself has referenced the manual on numerous occasions, which has consequently saved much valuable time and money which would have been required to clear these safe-for-food application plastics. The Ccoslttee has also published "Plastics Packaging for Drug Products--the Regulatory Story," which performs companion service for plastics in the drug and cosmetic fields. Clearly, the activities of the Committee have prevented the statutory elimination of many plastic resins from a variety of applications, not BFG61602 ASI 00001137 -4- EXHIRIT B only where food and drug packages are concerned, but also, by extension, to other areas where sensitivity to consumerist and environmentalist pressures creates extreme caution. Because the consuaerist/environmentaLlis t temper of the times will undoubtedly intensify for the forseeable future, the work of the Food, Drug, and Cosmetic Packaging Materials Committee will undoubtedly be required to increase, and remain one of the first lines of interface between the plastics industry and the government in anticipating and helping solve the kinds of problem all industry will have to deal with. Serving as an early warning network for the entire plastics industry, the Cmanittee anticipated such problems as the plastic bag suffocation situation, the solid waste problem, PCB, mercury and other environmental contamination, and numerous other problems. In many instances overall industry response and action laid the problems to rest. The Ccemittee's thrust is based on the documented conviction that its numerous "quiet victories" have proven the most valuable and profitable for its industry. ASI 00001138 BFG61603 EXHIBIT E DSL - 72-900 Date: 2/6/73 Pro-scol Procedure for Moisture Permeability Prepare a saturated solution of sodium chlorate with excess undissolved (l50g for each 100 ml.) in the bottom of a desiccator and allow to equili brate for three days. This establishes a microenvironment of 75'?' relative humidity at 20P. Dry a suitable amount of 4 mesh anhydrous calcium chloride, taking care to exclude any fine powder, for 1 hour at 110. Cool in a desiccator to room temperature before use. Select a suitable number, not loos than three, of containers of the same size to be tested plus two controls. Fill the containers with the desiccant to within 13 am of the closure*. Fill the control vials with I'.lucs beads to the approximate weight of the other containers. Seal the containers immediately. Place the containers including the controls in the humid microenvironment and maintain at 200 2. Weirh each container within one our of the time of filling, returning it immediately to the desiccator, after 1, 7, 28 and 56 days. Subtract the average weight increase of the controls from the gross increase of each container to obtain the net increase in weight. Measure the whole volume of one of the containers by emptying an additional container, filled to the brim with water, into a suitable volu metric apparatus such as a graduated cylinder. Calculate the rate of passage of moisture into each test container in milligrams per day, per liter of container capacity. TORQUE TABLE** Suggested tightness in inch pounds Closure diameter in mm. torque as aoplied by hand 15 6 - 9 18 7 -11 20 8 -12 22 9 -13 24 10 -15 28 11 -17 33 13 -20 38 15 -23 43 17 -2b 48 19 -20 53 21 -32 58 23 -35 63 25 -38 '70 28 -42 83 34 -49 86 35 -51 8? 36 -53 100 4o -60 For 1 containers, fill 2/3 full. Owens-Illinois Torque Tester Manual. BFG61604 ASI 00001139 Fra;:.".'*': for Oxvgcr. Fcmeabilitv EXHIBIT E Rcarmc Solution. Prepare a suin'. ;on of 150 g. of .wjrtonium chloride in 500 ml. of nitrogen-purged distill-d water and make to one liter with concentrated anmoniian hydroxide. Procei--. Take a random of sampling of sixteen containers^. Fill there with 50 t.o 50 g. of copper turn!jigs for each lifer of capacity, taking care that the turnings are well distributed and extend into the headspace of the container, but not high enough to come into contact with the closure when scried. Purge each bottle with nitrogen. Fill each container with an accurately known volume of Rearont Solution to approximately 2/3 capacity, while ur.aer a nitrogen flow^, taking care to avoid vetting the surface near the closure. Immediately secure the closures, using the proper torque for screw cap containers. Allow the containers to stand 15 minutes. Shake one container, to uissolv any r'acted copper above the solution. Open it and immediately poui- the liquid through a funnel into an erlenmeyer flask, thereby separating the solution and undissolved copper turnings. Allow the filtrate to be exposed to oxygen for 15 to 20 minutes with periodic stirring or agitation. This is the v'-ocedurnl blank. Read the absorbance at (Ji 0 mu. At thr appo^ntm intervals, measure the absorbance of the solutions. If the observed absor! ance is greater than 1.00, make a dilution of 1 to IO ml. If it is still greater than 1.00, make a dilution of the original solution of 1 to 100 mis. Determine the amount of oxygen accumulated in the solution in ouch contain'by compering the observed absorbance to the Standard Calibration Graph makirg corrections for any dilutions ana subtracting the blank value. Intervals. An initial testing frequency of 1, 7, 1*+, 26 and 5n days is to be used}psrforming the test within one hour of the time of the day the teas containers were prepared. If the solutions in any of the sealed containers becomes an opaque blue or all of the copper in the headspace is dissolved, the experiment is terminated. To complete an experiment with at leas- four valid reading intervals, the time intervals and sample numbers are revised accordingly. Standard Calibration Graph. Weigh 1.135 g. of copper turnings ir. 10 mi. of HC1 (1:1 'with water) and dilute to 100.0 ml. with Reagent Solution. Transfer 1.00, ;.C0, 5.00 and 7.00 ml. aliquots to separate 100-ml. volumetric flasks, and si 1st-.* each to volume with Reagent Solution. Using distilled water as a reference, read the absorbance of the solutions. Plot the absoroancc vs. the corresponding oxygen concentration per liter of solution (10, 30, 50 and 70 ml. of oxygen). Subsequently read from the graph the value of the ml. of oxygon per liter of Reagent Solution (X) in each container. Calculate the ml. of oxygen per liter of container capacity by the following formula: (ml. of oxygen) (liter of container capacity) = X (volume 01' Reagent Solution ~ dispensed ir, liters (volume of containc1- capacity in liters) ---ovs triplicate container readings at each interval. Where suo- 2-^r- a~ variability is experienced, larger prexerred to charge the containers in test groups are needed, a nitrogen atmosphere to keep blank 3t a minimum. This is particularly important when low oxygen permea.ciaity is anticipated. 7'Solute, 0 or a c : may .aole be read on a Bausch 1 spectropnotomt'tti'i <_.u Lor.b 1 ur., Soectro THUS. r 20 in 13 mm (0D) cells ASI 00001140 BFG61605