Document VJvdnj80eM7Jg9qXr7evjo31N

TALK BY RICHAFD J. WIECHMANN for the UAL TAPPI MEETING Chicago . Monday, March 5, 1973 "A LETHE IEAEN3NG..." Many of you will ranadber from your college freshman English course a quotation by Alexander Pqpe: "A little learning is a dangerous thing. Drink deep or taste not the Pierian spring." This thought is particularly applicable to environmental matters these days. Time and again, we see that the more we learn about a particular subject -- the less it develops we really know. This has frequently applied to various environmental "solutions" which, later on, turned out to have unforeseen and dire environmental affects. As cne might say, the cure kills deader than the disease To look at cne specific environmental problem, it may very well be that a proposed rule-making by the Food and Drug Administration, establishing a temporary tolerance for polychlorinated biphenyls - PCB*s - in paperboard food packaging, falls into this category. 2 So let me briefly give you some background on PCB's, describe sons of the factors which led up to the FDA issuing the proposed rule-making almost cue year agor and bring you up to date onwhat has transpired between the FDA and the paper industry since then. Although the FCB family of chemicals was known before the turn of the century, and ocitmercial production in this country and in the industrial nations of the world began sometime in the late 1920's, it has only been inthe last few years that PCB's have became a subject for headlines or have been referred to in speeches on the flora: of Congress. Along with the matters of the press and the poli ticians, the scientific catimmity has also moved PCB's into the spotlight. A good deal of research has recently been done to determine their affects on fish, birds and other wildlife. And, as a result, numerous scientific reports an PCB's axe now available. NEV 036463 3 lb mention just two examples of this recent interest in PCB's, in September 1970, the National Swedish Givironment Protection Board sponsored a conference on FCB's investigating all aspects of this chemical carpound from its history as acontaminant of the environment to the possible ways of destroying it. Moreover, at the last meeting of the American Chemical Society in New York City, sane 30 papers were presented an the subject of FCB's. FCB's have been manufactured in most of the world's industrial countries. In the United States, Monsanto has been the sole producer. although FCB's have been marketed under private labels by a ranker of firms In this country, lhe remarkable properties of the PCB family have made them most versatile as far as their usage is concerned; laat, on the other hand, their resistance to chemical, thermal and biological degradation have made them most troublesome when released into the environment. 036^ 4 The discovery of FCB's as an environmental contaminant was made in Sweden in 1966 by Dr. Soren Jensen. Actually they were found by accident while he was analyzing certain bio logical materials for EXT. This discovery led to investigations which revealed that industrial uses of FCB's vrcre contaminating estuarial waters and, since FCB's are persistent, they were being aocunilatad`in the tissues of marine life and aquatic birds as a result of the food chain syndrane. Four years after his original discovery of PCB as an anvircnnaital contaminant, Dr. Jensen stated that FCB's were almost as widespread in nature as DCT and could be found all over the world. The one major instance involving acute hunan exposure to FCB's occurred in Japan in 1968. Kanechlor 400, a PCB containing 48% chlorine manufactured in Japan, leaked from a heat exbhanger into rice oil that was censured by many Japanese families. The rice oil became heavily contaminated in the range of 2,000 to 2,500 parts per million of PCB. About 1,000 people were affected. And NEV 036465 I 5. although there were no deaths, sane birth abnormalities were recorded. However, it is reported that after three years the children new appear norral in every respect. In that particular case the purity of the PCB was unknown, and there is sane question as to whether its toxicity might have been due to the presence of highly tcocicpoly chlorinated dibenzofuran or chloro-dibenzodioKin .v iirpurities. In the Uhited States, the Food and Drug Adninistration has endeavored to investigate all reported examples of PCB contamination. These have included instances involving milk, eggs and poultry which were contaminated from the use of PCB's in silo paints, or fran the use of. PCB18 for a herbicide, or fran PCB fluid leaking fraila heat exchanger. Environmental contamination in the United States has been largely associated with surface waters, lakes and estuaries. Municipal and Industrial waste water discharges have been primary .} offenders, together with ordinary incinerators which volatilize PCB's and add them to the atmosphere. In many of the instances where traces of PCB's hove been found inpaper-and paperboard made fran virgin pulp, it is presumed that these 036^66 6. / / PCB's originated in the process water. In this regard, last May, the Environmental Pro tection Agency declared PCB's to be a toxic substance and announced that the agency will restrict the discharge of industrial effluents of PCB's, so that the levels in waterways do not exceed one hundredeth of a part per billion. levels of PCB's ere discovered in recycled paperboard in October of 1970. However* it was not until a meeting in early January 1971 of the Biological and Chemical Research Ccmnittee of the American Paper Institute that one of mr+1 j - the matters of this ccmnittee reported analytical determinations of PCB's in recycled or com bination paperboard and identified the source of this contamination as NCR carbonless copy paper. This NCR copy paper was included in the bales of waste paper used as furnish inmanufacturing ccnbination paperboard, it was recommended that the industry adopt defensive measures in the selection of its paper stock for food grades, and, on January 12, 1971, the American Paper Institute advised its maibership of the FGB NfeV 036^^7 7 contamination from NCR carbonless copy paper and urged extreme caution in the selection of waste paper for food grade paperboard. This major problem for the paper industry resulted from the use of Aroclor 1242, a liquid PCB of 42% average chlorine aontent, as a vehicle for the dye in NCR carbonless oopy paper. Aroclor, incidentally, is a Monsanto brand name. Minute encapsulations containing this PCB with colorless dye were coated on a business form stock. With the pressure of a pen, pencil or typewriter, the encapsulations were crushed exposing the dye to an activator -- which developed the clue color on the receptor sheet, lhis carbonless oopy paper contained 30,000 parts per million, or 3% of PCB by weight, f&en you realize that one pound of such paper hidden in a bale of paper stock for recycling could theoretically contaminate one and a half tons of paperboard to the extent of 10 parts per million, you will get an idea of the potential probl^n. * \ 03646B 8 After the discovery of PCB's as an environ mental ccntaninant, interest in and awareness of the ecological Incidences of PCB's accelerated in this country. The accidental food contaminations investigated by the FDA received wide publicity and headlines. In May of 1971, the late Congressman WilliamA. Ryan of New York introduced legislation to make illegal the shipment of PCB's in inter state ocxmerce -- except as uses far a dielectric In electrical capacitors and as a fire-resistant ingredient In heat transformer media. In September of that year, Ryan introduced another bill which would have totally banned the distribution of PCB's in interstate ccnneroe. Monsanto, the sole producer in this countxy of PCB's, had already taken action to restrict their production. As of the first of September of 1970, Monsanto withdrew PCB's from the market far any use other than inclosed systems such as electrical transformers and closedsystem heat exchangers. By the first of Jtine 1971, NCR stepped^psing Pdfe's as encapsulating agents in their carbonless copy paper. NtV 036469 9 During the sumner of 1971, the Food and Drug Adninistration was able to document the finding of PCB's in recycled paperboard used as packaging far breakfast cereal,and also to show that there was a migration of the PCB's rqn the paperboard to the food. This stimulated FDA's field investigations, but at no time did the government instigate a seizure or recall action as a result of food contamination from PCB's in the packaging material* There were, however, several discussions between the FDA and matters of the paper industry with regard to the potential threat of migration of PCB's between the packaging material and the food. Therefore, in December 1971, API's Biological and Chemical Research Oanmittee contracted with the Hazelton Laboratories of Vienna, Virginia, to survey papers and paperboards used in packaging for PCB's* At the same time the B&CR Gcnmittee sponsored another study by Hazelton to determine the nature of the migration phenomenon and the *% a barrier effect^over extended periods of time. 036*70 10 of certain films and glassine papers such as are used as inner linings in cereal packaging. This latter study was published in June of 1972. It indicated that PCS migration from packaging materials to feed is essentially a vapor-phase adsorption phenoneccn. In the absenoe of an effective barrier, Aroclor 1242 was shown to migrate fran paperboard to food in measurable amounts when the paperboard contained a significant mount of the Arcelor. However, by interposing barrier materials, migration to food was significantly reduced. Hie degree of reduction appeared to be inversely correlated with the known gas permeabilities for the classes of barrier material studied. Of these PVDC coated paper and waxed glassine paper were found to be effective barriers over a 90-day test period. Polyethylene, on the other hand, was relatively ineffective. The survey of paper food packaging materials showed that onrhinatien paperboard samples contained PCB's in amounts ranging fran less than 10 parts per million to over^200 parts per millira. It also shewed that certain products NEV 036471 11 made from virgin pulp had definite detectable mounts of PCB's* Meanwhile, there had been other important .developments on the FOB front* At the beginning of September 1971,.an inter-departmental task force on PCB's was established, made up of the representatives of several agencies of the federal government* The task force Included operating units of five Executive Branch departments 1* Department of Agriculture 2. Department of Canterce (The Assistant Secretary for Science & Technology and the National Oceanic and Atmosphere Administration) 3, Envinonnental Protection Agency 4* Department of Health, Education fi Welfare (The Food and Drug Adninistratlon and the National Institute of Environmental Health Sciences of the National Institute of Health) 5* Department of the Interior (Bureau of Sport Fisheries and Wildlife) This task force was established in order to coordinate the scientific efforts of the goverxvnexxt, MirrmA at understanding the entire family of PCB's 12. so as to strengthen the government's ability to protect the public fran the actual and potential hazards of PCB's. As the first order of business the task force indicated that it would "coordinate a govexnnent-wide Investigation into FCB contamination of food and other products." This study was conducted over the fall and winter and the results were published in * Hay 1972. The full results of this 181-page study would be too much to go into at this time. However, they made two points of specific interest. First, they recognized the source of contamination in recycled paperboard as having been carbonless copy paper and noted that the use of PCB's in this had been discontinued. Second, while they recognized PCB's as a potential food contaminant, they found that the "dietary intake of PCB's is of low order and does not present an Imminent health hazard." They further noted that "to date all of the high levels of PCB's encountered in foods have been associated with accidents." NEV 036473 13 By the end of September 1971, public Interest and political clamor cn FCB's had reached sufficient Intensity to cause Carmissioner Edwards of the FDA. to call a press conference* He advised that there was no immediate hazard to public health, but stated that EDA would take aiy necessary steps txsact In tillsmatter. He also announced that EDA planned on conducting a nation wide survey of packaged foods in order to determine the amount of FCB's in packaging materials and in the foods within the contaminated packages. This packaged food survey, which was conducted during the fall and early winter months, yielded additional findings of FCB's In paper and paperiboard packaging, and also examples of FCB's in the food * which were presumed to have migrated from the packaging. Qa March 18, 1972, EDA published its proposed rule making on polychlorinated biphenyls. In the prologue of this regulation they reported on the results of the packaged food survey and noted again that the toxicological affects of FCB's were limited and that there was no iirmediate hazard to the public health, nevertheless, they felt that the levels of FCB's in food for hunan and. animal use should be significantly reduced and proposed temporary tolerances on certain specific types of foods, ranging fran 1/10 of a"part per million 0364 74 14 to 5 parts per million. .Uley also established a tanporary tolerance of 5 parts per million on food packaging materials. Sixty days were allowed far contents on this proposed rule making, which was later extended to 120 days. In meetings with FDA.officials following the publication of this proposed rule making, it developed that in referring to a "tenporary" tolerance, they meant that -- vhereas it was 5 parts per million now -- in a year or so it might be reduced to 2 parts per million and eventually to 0. Cn March 29, at a meeting of API's B&CR Ocmnittee, under the Chairmanship of Paul Cundy of the American Can Gcnpany, it was determined that the paper industry shcwld file ocranents on this FDA proposal. A suggestion was made that special legal counsel be retained to assist in the prepara* tion of the industry's brief. Cn April 20, representatives from the legal sub* ocmnittee of the B&CR Ccnmittae met in Washington 036475 ir *1 <3 15. -- along with API's regular counsel -- to interview four candidate law finis. Their reodrnendation -- *which was approved by API's Executive Cernnittee -- was that Hiss Selma Levine * of Wald, Harkrader Ross be retained. Miss Levine has extensive experience in cases involving the Food and Drug Administration. The FCB task force, an ad hoc subcommittee of the B&CR Cerrmittee, which under the Chairmanship of Paul Trout of Container Corporation had been i working cm the FCB problsn with FDA, met with Selma Levine on April 24 to determine the paper Industry's strategy in preparing contents on the proposed regulation. It was decided that it vrculd be most helpful to . have an independent and credible assessment of the eocnoidc inpact of this proposed FDA regulation on the recycled paperboard segment of the paper industry. The firm of Arthur D. Little in Ganfaridge, Massachusetts, was retained Nl to do the study. ADL was fanri1iar with the paper industry and had just completed a study fdr the federal government ga the eccncrdc inpact of pollution control for various segments of the industry. * NEV 036476 * ii 16. The PCB task force spent a busy spring: meeting regularly with our special Washington counsel -- and fran time to time with Arthur D. Little, and on the 7th of July, the full B&CR Camdttee met in Washington to review a draft of the hrief which our ffeshingbdn counsel had prepared, re sponding to ITA's proposed regulation. Following this, on July 17, the Garments of.the American Paper Institute in the matter of polychlorinated biphenyls were filed with the Hearing deck at HEW. What did we say? Our Garments covered sane 54 pages -- not including 5 lengthy exhibits. So, I will not try to do anything more than hit the high spots. Our position was basically that, while we were in full accord with reducing the levels of PCB in the food supply, we did not believe that establishing a tolerance on FCB's in food packaging materials would acoarplish ] this. We felt, in short, that tolerances should ]j be imposed on the foods. We pointed out that the rule making would require testing of all ` packaging materials even though present test procedures axe too inaccurate to insure carpilance NEV 036477 17. at a 5 parts per million level. Hie added costs resulting from this testing 'would be disposed at both virgin and recycling mills, however we showed that the major cost inpactwould fall on combination paperboard mills, vhich are economically one of the weaker sectors of the paper industry. He cited the Arthur D. Little study which projected that, at a minium, this regulation would cause by the end of 1974 the closing of 5 to 9 recycling mills. This, we indicated, was not in the public interest inasnudi as . such shutdowns would entail adverse environ mentaleconomic and social consequences. Ha ocrmented cn the unreliability of the test procedure and the variations intest results on the same sanples between different labs. Quoting the Hazelton study on effective barriers, as well as other authorities, we pointed out that the proposed rule failed to take into aeoount the protection against FCB migration afforded by such factors as barrier naterials, the nature of the food being packaged,and the package-weight to food-weight ratio. ~ NEV 036478 le Na further pointed cut that Aroclor 1242 -- the FCB found in recycled paperboard -- is the least chlorinated form of FCB found in the environment, and there is no evidence to indicate that Aroclor 1242 either persists,or accurulates In the environment .,. and so becomes a toxicological hazard to man. Moreover, Aroclor 1242 has over the years oonprised the largest share of denestic FCB production, so it should be the most widely fouqd FCB in the environment. This, however, is not the case. API was not the only ona to content on this rule making. Many companies and other associa tions within the pager and paper-packaging industries filed consents. One of the officials at FDA told us they were overwhelmed at the degree of response. For the of the summer and the fall, aside from a few informal conversations between FDA. personnel and our counsel In Washington, nothing of any great significance happened until, on Deoenfcer 21, 1972, FDA published their Final Brvirormental impact Statement, under the National EnvironnentaT'Folicy Act, all governmental NV 036*79 19. .agencies are required to file an envirorrental inpact statement whenever any of their adminis trative actions could have inpact on the environment. The M S (Final Environmental Itrpact Statsnent) indicated that FDA plans to make three major changes in its rule making. First* that now the tolerance would not be on all food packaging materials as in the original proposed regulation; but rauld be limited to paper food packaging material. y/ Second; that the temporary tolerance of 5 parts per million on food packaging materials is to be raised,to a taiporary tolerance of 10 parts per million and. / Third; that they recognize functional barriers. / Hawever, this latter change was qualified by saying that such barriers must be "inpermeable to PCB's." Further discussions with FDA indicated that the only items they would now consider "impermeable" ware glass, meted and foil* 036^8 20 It was the opinion of our counsel that the FEUS was -- and I quote -- "grossly deficient." It was inadequate because there was no evaluation of the environmental results of adopting a 10 ppn tolerance. Moreover, alternatives to the proposed regulation were not mentioned and accordingly their enviroimental ixrpectwas never weighed. Also, the FEIS did not discuss the environmental impact of the possible removal ty other Washington agencies of carbonless copy paper from inventories. API's comments on the FEUS were filed on January 22. What is the situation now and what are our plans? Currently we understand that FDA is preparing a supplement to its Final Environmental tttpact Statement, and is also working on the final rule making. There seems to be some question as to whether they plan to publish these together or will first issue the supplement to the FEIS and follow up at a later date with the proposed rule treking. In either case, once the rule making .is published, we have the option of requesting a hearing -- which wuldthen give us an automatic * stay of the rule making. If FDA should turn us down on such a request -- which our Washington counsel feels is likely -- the industry will then NEV 036481 21 have to decide whether it'wishes to go to the Appellate Court and request then to direct FDA to hold a hearing an the PCB rule making. ttiilewe axe waiting for FDA to act, we are presently preparing a letter suggesting that FDA update sate of the information on which the original proposed rule making was based. The packaged food survey, which FDA conducted in the fall of 1971, was based on sanples collected during the suimer of that year. At that time the waste stream was heavily contaminated with NCR papers and the paper industry had not instituted the strong quality control measures with regard to paper stock, which now exist at canfcination paperboard mills. Ha have taken one other step. Ha hate contracted with Arthur D. Little again to survey the recycled paperboard industry to determine what the actual eoonanic impact will be with the 10 part per million tolerance. This study, which is currently underway, should be conpleted around the first of April. NEV 036462 i i 22. Up to now, tills has all been sometfut theoretical. Wfehave been dealing with a proposed regulation. Moreover, no testing or sanpling procedure, as yet, has been even suggested by FDA. Ait, hen you consider that the price of paperboard is around $150 per ton and the cost of each test for PCB is about $30, you can see the potential economic inpact to recycled paperboard mills. Also, keep in mind that the food packager has only one thought, he does not want to see headlines about PCB's and his product. Therefore, be will insist on a guarantee that the packaging material he buys is under the tolerance. So, we begin to see that, although FDA has stated again and again that PCB's represent no iranediate hazard to the public health, and although there is no evidence that Arcelor 1242 -- the PCB under question -- accunulates in human tissue, FDA proposes to "solve" a problem that they, in effect, admit may not exist,by placing a further economic burden on a seepent of our industry which.already suffers from marginal profitability. NEV 036483 I I 23 Hill the envirormental, the economic and the social losses resulting fran tills proposed action be outweighed by a questionable protection of the public health? Ctithe contrary, th paper industry believes that this is but another exanple of, "a little learning is a dangerous thing. #t * NV 036484