Document XzMz7oOgjbbojGJ1eJ5bGv3LR

H. R. FlAMMER READER FILE MAY, 1988 b VPP 623256 PREMIERE POLYMERS )0W thniwwi Trail Jerr*naMMi, tUntndr 40299 KMOMOU TRANSMISSJ:OS FOR FACSIMILE MESSAGES: DATE: 5-lzzlxr /* FROM: LOCATION: SK. Sdx6orsAv/ PrO*vr-<_. f TO: M R Flavour*' LOCATION: ____ MospyV&^y. WO. OF FA0B8: __ INCLUDING THIS ONE. IW THE EVENT THAT ANX PAGES ARE MISSING OR UNREADABLE, PLEASE CONTACT US IMMEDIATELY. MESSAGEI Amo- o^teejle_iy M^iX- 7s- H7J Halt' VISTAPOLYMERS tkC. MAY 2 3 1988 PVC BUSlHlSS ARIA VFp 623257 =MT B'r iPFEMIEFE POL.MEP r: 0-^r IT ;5~j n t PREMIERE POLYMERS P30m01nWJkmuVmthxmTmrill tot Ofts* *c 57I ]<fftnMt0wm K*niuckr 402M 50MIM0II TRANSMISSION FOR FACSIMILE MESSAGES; CATE: 'f*3 lT% FROM: LOCATIONt TO, LOCATION: <T"r~^ Hfllj ^Ponra fCrt NO. Or PAOES: H. INCLUDINQ THIS ONE. cc : ffS'V F'AxJ hf-R. Ffa/vioil? Cus4~Oy\___ IN THE EVENT THAT Aft! PACES ARE MISSING OR UNREADABLE, PLEASE CONTACT US IMMEDIATELY. MESSAGE: IjtpUj JuStruAO J ITZV*^ 'tjb #-&<L c^jdtecA^/) (x\foA$Uj jxA*k)r^ -io- xkb ^ axvfi^Ldit/v^r /{Ark^cA^ 0 "AH. p-L<3jji-&L. , CaJ^lC^ -^Ccrt^ TXuaaTL. ai- ~&b> C(P*su2a^ JdUnA\oR, O'vvS Ju/m cJlAyw^, <x. oP bcry*Jru&Jhj^ /\r\^y^jLj ^tuaa^&_-. <j) psiS Jiv*\ CO <y>uD f/C,) 0 A^jiAva&tcivA crP<0~Q Qoa*s_ TK-tvCUv* ^ l/e^Jj^ci^. fCnj, WoajoAcJML. JU. AJiSTrvJ.1) go AiruA-' (pv-Q-- VPP 623258 "3 Ka C^OAX^^, jss-zruA^ JLAQA^O^ CL Ciy^VUdXx^A. *lf)jj yv^CJlA4-<XA^ ^ ^ jQX^t^CryZJ^r ^tAcC^~ Cj~U. CftJ^ ~xk%j l/_i_ ^*Jx T^fevn jax> , % <ruL^ jiAjsvvL6XLa____ /i^6\Av\^a^3Livi (2svwQ_, cTU^f. <^^-d, /O-ervvv^tfW^ MrJT^X rcsvCtetff' xSj3 \JT AV\o^ -oj uxL^ Co^x C@$- OA^t^P jh^JL cryi VPP 623259 EE' IT BV: PPEf-i [ gc VPP 623260 A :DrriON, 76 PAGES. *** OOPYtoGHTG1986, ThC COMER-JOUHMAL. LOUVIX. KY.. A GANNETT NEWSPAPER * Seat padding speeds bus fires.tests show By scom THURM Saff WrUer About the some time. NaakVUlewreo firefighters procticed rescuing passenger* trapped to Three weeks ago, Carlisle a tfh*1 has. But tbe results of Drtih-y conducted a frightening the fire made the rescue drill experiment. irrelevant. Beasley mid. \ The director of transportatloa for the metropolitan HaskvUte, TM-> school district staffed tenn or eight pieces of newspa per late a paper bag- Be placed the hag to the flnt row of a j7? school tow mx) xri u afire. -We concluded that the lire department wouldn't he oa the scene before the bus was lad" Beasley's expertmeat and others, are receiving scrutiny to light or a eolUstofl aad lire in Carrollton Satarday night that '-Lessthaa tour minutes later, r .VBeeatey Mid, the bos was ea ' gulfed to names. See SEAT PADDING Back page; cal 4, this sectiaa rn 1D1 r rTnt TODAY MAY 20. 1 3* CEN1 o n ] >ii (I j i'j a i. ;SNr E,- '7-Z.mt.-Z POL rrE= .1' Seat padding speeds bus fires "No materiel would stop a fire fed by an outiide fuel source, such as petroleum." said Morris Adams, Continued from Pete One Inches per minute, Ralph Hlichccck vice prasidenl for marketing at of (its National Highway Trarflc Thomas Built Buses to High Point, killed 27 people in a church group Safety Administration, which sets N. C. returning from Kinp bland In an the rules, said this week the stan One state -- New Mexico -- and older school bus. The state medical dard is `fairly stringent" and has several large school districts have examiner hu said all 27 survived not been a problem in other acci been using the materials. the crash but died of smoke Inhala dents. "We looked nt It as an Investment tion. Indeed, federal safety officials A growing number of scbool offi could cite only one other accident in In safety," said John LaRock. su perintendent of tbe Board nf Men cials and experts believe that the foam padding that cushions passen which school-bus passengers died of fire-retsted injuries. That was the tal Retardation to Greene County, Ohio, which baa n buses with tbe gers la collisions also bums repldly Jan. 21, !98s, collision between a highly fire-retardant seats. and greatly accelerates a fire's school bus and an empty gasoline Other scbool officials -- Includ Spread. Tbs padding also emits toxic tanker truck that killed aloe people In West Glacier, Mont ing Nashville's Beasley -- said they were considering using the new chemicals when burned, which But Stewart end others cited a materials but wera put off by re could make escape from a burning long aeries of close calls, In which ports that (bey are not durable. bus more difficult, they sty, children were evacuated from buses The accident has focused atten `There Isn't any question but that in any number of esses, the teats shortly before me vehicles were en gulfed in flames. And a federal re tion on a second factor relating to school-bus fires- the choice of fuel. helped spread the fire,'1 mid Paul search agency reported problems The bus that burned Saturday Stewart, a member of tbs National with similar seat cushions more night after being hit head-on by a Safety Council who recently retired than 10 years ago. pickup truck was powered by gaso as director of school transportation In a 1975 report, the Canter for line, which emits flammable vapors in West Virginia. Stewart reviewed Fire Research at iht National Bu at any temperature above <9 de more than a half-dozen Area In an reau of Standards la Gaithersburg, grees below zero. By contrast, va article for the American School Md., said seats on a city bus -- with pors from diesel fuel, used in an Board Journal last November. coverlnp that meet the federal increasing number of buses, do not Investigators are examining the standard -- are "the meet probable become flammable until they reach role of the seats in the fire that con cause of hazard" once a fire begins. more than 100 degrees. sumed the church but. Andrew Foweil, deputy director With temperature* to the 70s Sat "There's no doubt that they did of the center, said the report noted urday night, diesel fumes would lead to the extension of the fire, and that thick, heavy smoke can reduce have needed beat from another there's no doubt they did emit toxic visibility to nothtr.i in less than two source -- such as the exhaust eyefumes," Kentucky Fire Marshal Bill minutes and fire can spread from tern -- to become capable of Ignit Martin said. Bui he said he couldn't teat to seat -- as survivors snid Sat ing, said Martin, tbe fire marvhel. determine bow much the seats msy urday's fir# traveled. It recommend Officials of school systems and have contributed to the spread of ed reducing the risk by placing a bus manufacturer! sale more dl#: the fire or to the death*. fire-resistant barrier beatslh the sel'powertd busts are being bought Carroll County Coroner James seat covering. each year, and that diesel salea Dunn said be Is awaiting results of More then a decade later, several probably outnumber gasoline- blood tests to see whether toxic products claim to do just (bat. Using powered buses. The notion's largest fumes played a role in tne deaths. fire-resistant materials, manufactur school-bus-chassis manufacturer, Dr. Frank MlUer. s surgeon at Hu* er* say they can give paasefigers Navistar, stopped making gaioiloe* mans Hospital-University of Louis* vide who u treating some of those burned In the crash, said his pa tients' lung* and breathing cavities more Urn# to evacuate. But officials of several bus com panies that are offering the materi als say they have found few takers: powered vehicles fn 198*. But safety wee not a factor in (he shift. show evidence of being burned by all said fewer than 1 percent of "It made a tot of good economic chemicals. He could oot say wbtt their orders include requests for the sense and we did it," said John Mc chemicals. seats, which cost about 130 more Donald, spokesman for Navistar. Martin said he saw foam-rubber each, or about 8800 per bus. He said diesel engines last longer padding In the bus when he exam Even eo official of a firm that de and need fewer repair*. ined it Sunday. When burned, he veloped a fire-resistant seat doubts said, the foam emits hydrogen cya it would have beeo much help Satur 1rfermtlM (or this story was also nide gas, which is very toxic. In ad day night. gathered by tarry Heiberg. dition, he said, vinyl typically used for seats on scbool buses can emit another toxic gas, viftpTchtortde. fne bus that DurnW Saturday night was a 1977 Superior -- a dif ferent company from tha one that made the bus burned In Nashville. An official of Superior's parent com pany said yesterday he could not say whet toe cushions on hU com pany's 1977 models were made of. However, officials of three other bus maken said polyurethane, or rubber foam, has long been used al most exclusively on school buses. Federal rules spell out bow quick- A VPP 623261 H. R. FIAMMER READER F 1 LE MARCH 1 988 A A Division of The Society of The Plastics Industry, Inc. Roy T. Gottesman Executive Director March 24, 1988 TO: The Vinyl Institute Executive Board RE: FDA Evaluation of Market Potential For PVC Food Contact Applications Attached is self-explanatory and for your information and files. to' RTO/pmb cc: B. Luss Wayne Interchange Plaza II 155 Route 46 West Wayne, NJ 07470 (201) 890-9299 VPP 623263 A FED 2 13-9 Me, Richard E.' Sanderson, Director Office of Federal Activities, A-104 U. S. Environmental Protection Agency 401 M Street, S.W. Washington, D,C. 20460 Dear Mr. Sanderson: The purpose of this letter is to request EPA assistance In the environmental review of FDA's proposed rule on vinyl chloride polymers (PVC) (51 FR 4177; February 3, 1986). In support of the February 3, 1986, PVC proposal, FDA issued an Environ mental Assessment/Finding of No Significant Impact (EA/FONSI) to meet its obligations under the National Environmental Policy Act (NEPA). In addition, Che proposal requested data bearing on the Issues and conclusions contained in the EA/FONSI, including information on 1) the environmental fate and effects of plasticizers used with PVC, and 2) whether PVC con tributes to the emission of chlorinated dlbenzodioxins (CDD) and chlorinated dibenzofurans (CDF) from municipal solid waste incinerators* The proposal stated that the agency would reexamine its conclusions if new information suggested that the action would have a significant environmental impact. EPA has previously commented (see letter dated June 2, 1986, appendix A) that it had Identified no strong reasons for FDA not to proceed with the proposed action, but that it had concerns with the two areas of potential environmental problems identified by FDA (l.e., fate and effects of plasticizers and potential for CDD and CEF emissions). EPA also expressed concern that the EA did not thoroughly support the F0NS1, specifically with respect to 1) the quantity of plasticizers and plastic products affected by the proposal, 2) the extent of discussion of mitigating measures, snd 3) the need to clarify the decision against further studies to eliminate the uncertainties. In response to thi6 comment, the Environmental Impact Section, Center for. Food Safety and Applied Nutrition (CFSAN), contacted various scientists and State and municipal authorities to acquire data to further assess the environmental Impact of the PVC proposal and to address EPA's comments. As a result of these contacts, the agency has received about 1,400 comments and inquiries. Most of these comments and inquiries have expressed concern about FDA's action on PVC and have requested that FDA prepare an environ mental impact statement. These comments have also raised several additional issues Including 1) effect of PVC incineration on municipal incineration plant compliance with State emissions requirements for hydrogen chloride, 2) complications created in recycling programs as a result of the presence of PVC, and 3) the belief VPP 623267 * Page 2 -Mr. Richard E. Sanderson by some Stare and municipal officials that increasing use of PVC will exacerbate the solid waste management crisis resulting from diminishing landfil. capacity. A list of State and local governments and environmental organizations submitting comments is included in appendix B. We have also included in appendix B, a copy of several of these submissions as examples of the concerns raised by State and municipal officials and by environmental organiz iticrns. Copies of other submissions arc available upon request. The Society of the Plastics Industry (S?I) and other industry comments claia that FDA's action will not have a significant environmental impact and have urged FDA to promulgate a final rule as quickly as possible. It is our understanding that EPA has received from SPI a copy of SPI's Submissions to FDA dated January 13, 1987, April 20, 1987, and October 23, 1987. Copies of other industry comments are also available upon request. FDA's current understanding and analysis of the principal environmental issues, Including consideration of comments received from EPA and others, is described in appendix C. FDA has not yet decided whether an environmental impact statement is required. To make this decision, we must determine whether the action will cause significant environmental effects. The term "significantly" is defined by CEQ under 40 CFR 1508.27. This definition lists several criteria for judging whether an action is significant, including the degree to which environmental effects are likely to be highly controversial and highly uncertain, and whether an action will threaten a violation of Federal, State, or local laws for the protection of the environment. We are currently evaluating whether one or more of these criteria are met. Another factor to consider in determining the significance of the impact of this action is the magnitude of the projected increase in PVC market volume. EPA specifically requested in its June 2, 1986, comments that FDA present more clearly the effects of the proposed rule on present and future quantities of plasticizers and plastic products. The magnitude of the projected Increase in market volume of PVC remains an area with considerable uncertainty and disagreement. SPI, which in 1983 estimated that an annual increase in the PVC resin market of approximately 350 million pounds would result from FDA's proposed action, recently revised its estimate to reflect changes In market conditions, SPI now estimates that Che only increase in the PVC resin market that will result from FDA's proposed action will be the increase that results from the use of PVC in liquor bottles - which it estimates will be 12 million pounds per year* SPI estimates that current uses of PVC in non-liquor bottles will decline by 16 million pounds, resulting In a net decrease in the annual use of PVC bottles of 4 million pounds by 1991. However, CFSAN's Economics Section projects that FDA's action on PVC will result in an increase in the annual use of PVC of 180 million pounds (appendix D). VPP <=23266 A / t Pa*e 3 - Mr. Richard E. Sanderson At this cine, we are requesting EPA assistance as follows: 1. Please review and comment on our analysis of the environmental issues associated with FDA's proposed rule on PVC, :'*:e methods that we used in quantifying the relative magnitude of the action, and our preliminary findings (appendix C) 2. Please provide us with any new :.nformaCion that you have that bears 00 the Issues considered in appendix C, particularly information that would eliminate any of the uncertainties that we have identified. 3. We would appreciate it if you would suggest approaches to use to predict environmental exposures to, and environmental effects from, municipal solid waste incinerator emissions associated with the Increased use of PVC from FDA's action. We are particularly interested in HC1, CDD, CDF, chlorobenzenes, chlorophenols, organotlns, and metallic chlorides. 4. Please tell us whether you think that items 1 and 2 (paragraph 1) contained in EPA's undated letter to FDA are still accurate (appendix E). We are particularly Interested in whether these items would be affected by the July 28, 1987, U. S. Court of Appeals decision (NRDC v6. EPA) that directed EPA to revise its vinyl chloride NESHAP and to base the standard solely on risk to health. In addition, we understand that this NESHAP does not cover compounding and fabricating facilities. Please tell us whether you think FDA's actioncould result in increased vinyl chloride emissions from such facilities and what the potential is for adverse health or environmental effects. 5. Please comment on whether FDA's action will have any effect on industry compliance with the recently established effluent limitations and standards for vinyl chloride (52 FR 42522; November 5, 1987). 6. In light of EPA's intent to regulate incinerator emissions (52 FR 25399; July 7, 1987), please provide us with your view on whether FDA's action on PVC would a) run counter to any regulation promulgated by EPA, b) be mitigated by future EPA regulations, or c) affect (and if so, how) the ability of municipalities to comply with new Federal standards for solid waste incinerators. We would appreciate your response to this request within 80 days. If you have any questions, please contact Dr. Buzz L. Hoffmann at 485-0276. Sincerely yours, Acting Director Ceater for Food Safety and Applied Nutrition VPP 623269 APPENDIX A A VPP 623270 40A UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, O.C. 20460 ^ OFFICE OF EXTERNAL AFFAIRS Buzz L. Hoffman, Ph.D. Chief, Environmental Impact Section Center for Food Safety and Applied Nutrition Food and Drug Administration Washington, OC 20240 Dear Dr. Hoffman: In accordance with our responsibilities under the National Environ* mental Policy Act (NEPA), and Section 309 of the Clean Air Act, and at . the direct request of the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA) has reviewed the proposed rule on vinyl chloride polymers (51 FR 4177, 2/3/86) and the associated environ mental assessment (EA). Included In our comnents are the comments of the five EPA staff members that you specifically suggested review these docunents In your letter of February 19, 1986. In general, EPA feels that the proposed changes are consistent with protecting human health and the environment. The new, proposed restric tions on any residual moncmer contents of the products to very low ppm levels should provide adequate protection while also representing economically feasible operational limits to the manufacturing Industry. Therefore, based on current evidence, we have Identified no strong reasons for not proceeding with the proposed action. Nevertheless, EPA has concerns with the two areas of potential environmental problems Identified by FDA. They stem from uncertainty In 1) the environmental fate and effects of dl(2-ethylhexyl) phthalate (DEHP), d1(2-ethylhexyl) adipate (DEHA) and epoxidlzed soybean oil, plasticizers used In conjunction with vinyl chloride polymers; and,.2) the extent to which vinyl chloride polymers contribute to the mission of polychlorinated dlbenzo-p-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) from municipal solid waste Incinerators. Because of these uncertainties, we must point out that our present lack of objections does not preclude future EPA action to address the Issue If additional Information becanes available to warrant such action. EPA Is also concerned that the envlrormental assessment (EA) for the FDA-proposed action does not thoroughly support the finding of no significant impact (FONSI). We feel that (1) the potential effects of the proposed rule on present and future quantities of plasticizers VPF 623271 A and plastic products to be used and disposed of needs to be more clearly presented; (2) the discussion on mitigation measures needs to be expanded; and, (3) clarifications need to be made for the decision against further studies on eliminating the uncertainties. Given the carcinogenic potential of the plasticizers, and their uncertain behavior In the environment, and with the uncertainties surrounding the correlatlon of PCDO and PCOF emissions with plastics incineration, the EA needs to analyze the potential changes In the amounts produced and disposed. This means demonstrating the quantita tive Impact of the proposed rule on existing use patterns. If it can be shown that the proposed action will riot lead to a significant increase In the production, use, and destruction of these materials, relative to present quantities. It might be seen that the Impact of the proposed rule will be environmentally Insignificant. Therefore, we encourage FDA to make clear the quantities presently being produced, used and incinerated and to compare this to the possible effects associated with the increased use of vinyl chloride polymers permitted under the proposed rule. With respect to mitigation measures, FDA states only that It "has not Identified any measures It could take to avoid or mitigate potential adverse environmental effects associated with the proposed action (p. 36, EA)." All mitigation measures considered should be presented and dis missed with a discussion as to why they are not viable; If, for example, source-separation of plastics, vtnyl chloride polymer re-use, or a deposit on PCY products are Infeasible or unrealistic, this should be lb/ explained. We believe that the rationale presented to support FDA's decision not to wait for or initiate further study on PCDDs and PCDFs before proceeding with the proposed action are misleading, if not Inaccurate. FDA bases Its decision on 1) the suggestion that "vinyl chloride polymers are not important in the formation of polychlorinated dibenzo-p-dloxins In municipal incinerator emissions (pp. 36-37 EA)," and 2) the expecta tion that the U. S. Environmental Protection Agency will "Issue guide lines to help limit PCDDs from solid waste Incinerators (pp. 36-37, EA)." Apparently, FDA relies solely on the work of Karasek et al., (1963) to support the first point/ In our view, this Is not enough to discount the "hypothesis that vinyl chloride polymer Is a primary source of chlorobenzenes, and that consequently, PCDDs are end-products of vinyl chloride polymer waste Incineration (p. 14, EA)." In our judgment, current test data are at best. Inconclusive (see discussion). On the second point, EPA currently plans to Issue an Information document on emissions from municipal waste combustion early In 1987. While this report will discuss measures that may reduce the expected level of dioxin emissions, the current state of knowledge does not allow us to presume that those measures are sufficient to render inconsequential the effect of an Increase of vinyl chloride In the waste feed. In our view, neither the Information currently available, nor the prospect of EPA guidance, supports the decision that no further testing Is necessary prior to Implementation of the proposed action. gpp 62327 A In what follows Is a discussion, with references, to assist the FDA In the ongoing effort to assess the potential Impacts associated with the proposed rule. If you have any questions on our comments or the enclosed documents, please contact Paul Kaldjlan of my staff at 475-8797. Sincerely Enclosures Allan Hirsch Director Office of Federal Activities VPP 623273 A Discussion Plasticizers DEHP, because of Its high production volume and Its presence throughout the environment, is currently the most studied plasticizer; at high concentrations. It Is a recognized carcinogen, with some evidence of mutagenicity and teratogenicity. In the "Finding of No Significant Impact (F0NSI)," FDA states that they can expect "adverse chronic effects to some aquatic organisms to occur from exposure to DEHP before Introduction levels from land disposal site leachate are reduced by fate processes." Though FDA expects introduction levels of DEHP to be ultimately reduced through biodegradation, the extent to which this process actually occurs remains unclear. For example, phthalates are readily broken down to CO2 and H^O In the aqueous phase, and when they partition from the water column to sediment they concentrate and remain persistent. Concentrations of DEHP measured in parts per billion are found throughout the environment. But where there is sorption and accumulation onto sediment, concentrations may Increase to parts per million, a concentration sufficient to cause noticeable adverse effects on the benthic community. Enclosed is a paper addressing this issue, "Environmental Assessment of a Phthalate Ester, D1(2-ethylhexy Phthalate (DEHP), Derived from a Marine Microcosm, (Perez, et al., 1984)." It should be of some assistance. In addition to the Pere2, et al. paper, we have Included excerpts from one by the National Research Council of Canada, a list of tests received by EPA from the Chemical Manufacturers Association testing program for phthalate esters. Federal Register notices describing the testing program, a draft summary of "EPA and other Agency Activities on DEHP," and a chemical hazard Information profile (CHIP) on d1(2-ethy1ehexyl) adipate. We hope they will be of assistance in developing guide lines for the use of plasticizers. PCDDs and PCDFs The current EPA view Is that emissions of PCDDs and PCDFs from properly designed and operated municipal waste combustors (MWCs) Is not a cause for concern given present, available.technologies. However, the Increased use of vinyl chloride products will result In an Increase In vinyl chloride waste streams and, as the number and capacities of Incinerators increase, greater amounts of plastics will be burned. The extent to which these might cause or contribute to PCDD/PCDF emis sions from MWCs Is not clear. Investigators such as Christopher Rappe and Otto Hutzinger have published results and theoretical arguments that suggest that chlorinated plastics, including PVC, can contribute to the emission of PCDDs and PCDFs from the combustion of municipal wastes. (Perhaps FDA can begin by following up a paper by Rappe, "PCDDs and PCDFs from Various Incinerators," presented at the Dioxin 85 conference held In Bayreuth, West Germany, and soon to be pUETTsFed TfT Chemosphere.) Further, there are, undoubtedly, MWCs that do not operate up to state-of-the-art Incineration levels. EPA Is aware of control technologies which apparetly reduce emissions of PCDDs/PCDFs significantly, based on the limited testing that has been done to date. VPP 623274 Karasek et al ., (1983), speculate that synthesis of the adsorbed PCODs on fly ash may be more dependent on Incinerator conditions than the presence of vinyl chloride polymers and suggest a detailed, sys tematic study of Incinerator conditions. A study similar to the one proposed Is currently being carried out in Pittsfield, Massachusetts by the New York State Energy Research and Development Authority. Enclosed Is a page from Public Works describing the study; with It Is the name and address of a contact person. ERA encourages FDA to follow the study and to use the results In their decision-making. For your information, we have also enclosed EPA's "National Dioxin Study Tier 4-Combustion Sources" project plan. VPP 623275 APPENDIX B * Ls VPP 623276 * APPENDIX B. COMMENTS RECEIVED IN RESPONSE TO FDA'S PROPOSED RULE ON PVC Among the 1,400 comments and inquiries received by FDA in response to its environmental assessment (EA) and finding of no significant impact (FONS1) prepared in support o'f the proposed rule on PVC, a number of environmental organizations and State and local governments submitted comments. These groups are Identified below. Comments marked with an asterisk have been attached. Also attached is a comment from the Coalition on Resource Recovery and the Environment. Environmental Organizations A1abama Alabama Conservancy Shoals Chapter Birmingham Audubon Society Fowl River Protective Association, Inc. California Californians Against Waste Ecology Center of Southern California Sierra Club Southern Calif. Regional Conservation Committee The Planning and Conservation League Connecticut Connecticut Fund for the Environment, Inc. Don't Dump On Us District of Audubon Naturalist Society Columbia Environmental Task Force Fund for Renewable Energy and the Environment L Greenpeace Institute for Local Self Reliance Florida Environ. Information Serv. of Friends of the Everglades Illinois Center for Neighborhood Technology Coalition for Appropriate Waste Disposal McHenry County Defenders People for Community Recovery Indiana Northwest Indiana Coalition for the Environment Massachusetts Coalition for Household Hazardous Waste Conservation Law Foundation of New England, Inc. Quabog Bird Sanctuary Maryland Audubon Naturalist Society of the Central Atlantic States Michigan Michigan United Conservation Clubs Western Michigan Environmental Action Council Minnesota Earth Protection, Inc. Minnesota Herbicide Coalition St. Cloud Area Environmental Council New Jersey Colts Neck Environmental Commission New York Council on the Environment of New York City Environmental Action Coalition Environmental Defense Fund Environmental Planning Lobby Hudson River Sloop Clearwater, Inc. Hudson Valley Green Malverne Environmental Council, Inc. Udalls Cove Preservation Committee, Inc. Pennsylvania Clean Air Council Governor Pinchot Chapter, Sierra Club Green Valleys Association VPP 623277 - Environmental Organizations (Cont.) Texas Vermont Washington Wisconsin Ecology Action Outdoor Nature Club of Houston Conservation Society of Southern Vermont Otter Creek Audubon Society Sierra Club Hazardous Materials Committee Washington Citizens for Recycling Citizens Natural Resources Association of Wisconsin State Governments Illinois Department of Energy and Natural Resources Illinois General Assembly ^Massachusetts Bureau of Solid Waste *Minnesota Pollution Control Agency New Hampshire House of Representatives New Jersey Department of Environmental Protection *New York State Department of Environmental Conservation New York State Legislative Commission on Solid Waste Management *Pennsylvania Department of Environmental Resources Vermont Governor's Office Local Governments California Connecticut Illinois Maine New Jersey New York Wisconsin San Diego Santa Cruz County New Haven Champaign County (Regional Planning Commission) Champaign Urbana Buckf teld *Essex County Evesham Township Hardwick Township Hunterdon County Mullica Township Newark Rahway Somerset County West Windsor Township New York City (Department of Sanitation) New York City (City Council) New York City (Comptroller's Office) Eau Claire County (Landfill) Waukesha County (Solid Wa9te Management Board) / APPENDIX D / A VPP 623279 DEPARTMENT OF HEALTH * HUMAN SERVICES Public Service o-. June 1, 1987 Memorandum From Patricia M. Lasonde, Ph.D. Economics Section (HFF-303) Subiet Market Potent 1 al for PVC for Food-Contact Uses Buzz Hoffmann, Ph.D. to Chief, Environmental Impact Section (HFF-304) Through: Chief, Economics Section (HFF-303) This memo provides comments regarding the validity of the market volume estimates for food-contact uses of vinyl chloride polymers submitted by Keller and Heckman (for the Society of the Plastics Industry, Inc. (SPI)). This analysis 1s.necess1tated by the uncertainty surrounding the market volume forecasts for PVC provided by SPI In four separate submissions: August 17, 1983, November 7, 1986, January 13, 1987, and April 20, 1987. The most significant difference between the estimates contained in these submissions Is the reduction In the expected use of PVC resin In rigid and semi-rigid container applications resulting from the promulgation of a final rule regarding the use of PVC In food-contact applications. SPI, which originally forecast an Increase in the use of PVC resin In rigid and semi-rigid containers from 31 to 291 million pounds (1983 1988) now predicts a net decrease In the use of PVC resin for such applications from 66 to 62 million pounds (1986 - 1991). SPI has Indicated that their current estimates of the potential growth of PVC containers (and other PVC food packaging In general) are substantially lower than their original estimates because: (a) the PVC resin forecasts for 1988 provided In the 1983 submission were overly optimistic based on market conditions existing at that time; and, (b) certain market conditions have changed which would reduce the penetration rate of PVC Into certain food-contact applications. At a February 27, 1987 meeting, FDA explained to Industry representatives and members of the Keller and Heckman law firm that Information supporting the lower market projections were needed In order to evaluate the revised estimates. (See attached memorandum for details of that meeting). Consequently, Keller and Heckman submitted additional market projections for PVC for FDA review (April 20, 1987). My comments, which will address the four Keller and Heckman submissions, are presented in three sec-tlons. The first section addresses the market potential for vinyl chloride polymers (PVC) In alcoholic beverage containers resulting from a final regulation for PVC. Keller and Heckman argue that PVC Is currently approved for use In all food-contact applications for which It Is currently technically and economically feasible (1/13/87 and 4/20/87 submissions). Consequently, they contend that the only major new use resulting from FDA's promulgitlon of a PVC regulation In 1987 Page 2-3uzz Hoffmann, Ph.D. would be the use of PVC In rigid liquor containers. Based on supporting Informati.on {discussed below), a reduction In SPI's previous estimate of 43.3 million pounds to 12 million pounds of PVC resin associated with liquor containers Is reasonable. The second section discusses the effect of a PVC regulation on food-contact uses other than liquor containers (e.g., juices, bottled water, beer and wine). SPI estimates now Indicate that the use of PVC containers will be limited to the liquor and, presumably, edible oils markets. Although Keller and Heckman show that there Is some shifting from PVC to polyethylene terephthalate (PET) In the edible oil market which would explain the lower estimate for this application, they do not explain what will prevent PVC containers from competing In other food-contact applications. As FDA Indicated In the February meeting with Industry representatives, FDA cannot evaluate the validity of the new estimates without supporting evidence. Consequently, this section reviews SPI's original 1983 estimates for PVC use In rigid* and semi-rigid containers In light of the existing trade literature concerning the potentlal. uses of PVC In food-contact applIcatlons The third section provides FDA projections of the usage of PVC In food-contact applications based on the estimates provided by SPI and other PVC market Information available in trade journals. 1, PVC Liquor Containers The following table provides a summary of the estimates of the current and potential use of PVC In all alcoholic beverage bottles submitted by Keller and Heckman on August 17, 1983. TABLE 1: PVC Resin use In Alcoholic Beverage Containers (ml 11 ions of pounds) Beverage 1983 1988 LIquor rlgid/semi-rlgld containers VI ne rlgld/semi-rlgld containers plastlsols and organosols Beer r1g1d/s*mi-Mgid containers coatings piastlsols and organosols 1.0 2.0 0.0 3.5 12.0 o o 43.3 22.0 3.0 10.0 3.5 15.0 TOTAL 18.5 96.8 A Page 3-Buzz Hoffmann, Ph.D. These estimates Indicate that the amount of PVC resin expected to enter the market from rigid containers for all alcoholic beverage containers (liquor, wine and beer) to be approximately 75,3 \ million pounds in 1988. The remaining PVC resin, 21,5 million pounds, would be consumed In plastlsols and coatings. Keller and Heckman's most recent submission (April 20, 1987) provides the following estimates from industry representatives as well as PVC penetration estimates from various journals. TABLE 2: PVC Resin use In PVC Alcoholic Beverage Containers (miVjlorTs of pounds) Beverage 1985 1995 LIquor SPI estimate 0 12.0 Market Search Wine .0 8.2 SPI estimate 0 0 Market Search 0 11.8 r Beer SPI estimate 0 0 Market Search NA NA It Is Important to note that Keller and Heckman's submission provides PVC resin estimates for liquor only. They state that some Industry analysts have expressed doubt that PVC will have a significant Impact on the wine packaging market. There Is no mention of any Impact on the beer packaging market. It Is assumed that SP1 currently believes that PVC rigid containers will not capture any of the beer packaging market. The Market Search, Inc. estimate of 8.2 million pounds of PVC resin for liquor bottles in 1995 Is consistent with SPI`s reduced estimate. The estimated figures provided by SPI and Market Research are also consistent with the liquor bottle data provided by DISCUS (Distilled Spirits Council of America). DISCUS estimates the number of 1.75-11ter liquor bottles as approximately 231.5 million In 1984.[1] A trend estimate based On 1980-1984 DISCUS figures indicates the expected 1991 production of l.?5-11ttr liquor bottles to be approximately 277 million. ypp 6232B2 Page 4-Buzz Hoffmann, Ph.D. Because the apparent consumptlon of liquor Is presently decreasing (a trend expected to.continue because of higher liquor taxes, an Increase In the legal drinking age,changes In consumer preferences[2]), this 1991 figure for the 1.75-11ter liquor bottle market is considered an upper-bound estimate. Assuming: 1. approximately 277 million 1,75-liter liquor bottles in 1995; 2* a 1.75-llter PVC bottle weight of 110 grams (.243 Ibs)[3]; 3. that PVC resin constitutes approximately 831 of PVC bottle compound[4]; 4. that approximately 65% of 1.75-liter liquor bottles have handles[5]; and 5. a PVC market penetration Into the 1.75-11ter handled bottle market of 25% [6]; Implies that approximately 9.3 million pounds of PVC resin will be used In liquor applications In 1991% Consequently, SPI's estimate of 12 million pounds of PVC resin for liquor applications seems reasonable based on existing market conditions. 2. Other Food Contact Applications The 1983 projection of the 1988 usage of PVC resin In rigid and semi-rigid containers for food classes other than alcoholic beverages was estimated to be 215 million pounds. Although Industry representatives emphasized at the February 27th meeting that the original estimates for PVC penetration into these, food-contact applications are also overstated (and for some food product categories, unrealistic), the most recent Industry submission does not explicitly discuss the reduction in the SPI forecast for most of these applications. The 1987 projection of the 1991 usage of PVC resin in rigid pnd semi-rigid containers for food classes other than alcoholic beverages Is 50 million pounds. (It Is Interesting to note that the SPI's 1983 projection of 1988 PVC usage In rigid containers for edible oils Is 69 million pounds. SPI's April 20, 1987 estimate for current PVC usage in bottle applications (presumably all edible oil containers) Is 66.4 million pounds. The proximity of these two estimates Indicates that the original estimates may not have been unreasonable for some food products). There are two explanations for the reduction In SPI's estimate for PVC usage In other food-contact applications. One, SPI now predicts that PVC will not be used in any future food-contact application other than In liquor bottles and edible oils. Two, * Page 5-Buzz Hoffmann, Ph.D. Keller and Heckman are arguing that PVC usage for all other current or future food-contact applications {other than for liquor containers) Is already approved by FDA and should not be considered In the environmental Impact estimates. In response to the first explanation, Keller and Heckman have not provided any direct evidence that PVC cannot effectively compete with PET, polyethylene or polypropylene In other food-contact applications. Keller and Heckman do Indicate that "the markets once anticipated for PVC because of distinct advantages over other packaging materials are not now available because of strong competition from these other plastics, principally PET* (Keller and Heckman, 4/20/87, p. 6). However, It Is expected that PVC's potential share of these markets will be reduced to some positive number greater than zero as Is the case for liquor bottles and edible oils.[7] In addition, there Is no Indication In any trade Journal that rigid bottle PVC applications will be limited to the 1.75 liter, liquor bottle market. On the contrary, various trade journals Indicate that the potential market for PVC bottle applications Is strong for bottling water, juices, and wine.[8] Research Is currently underway for PVC and other plastics which may Increase the applicability of these substances In other food product markets^ For example. It 1$ noted that market penetration by PVC bottles will be accelerated once the resin's heet-dlstortlon temperature Is raised above the temperature required for hot-filling. This would allow jams, jellies, and puddings to be packaged In rigid PVC contalners .[9j Reason two can perhaps be explained by the January 13, 1987 submission. Keller and Heckman argue that FDA's promulgation of a final rule on PVC will have little impact on overall PVC production because PVC Is prlor-sanctjoned for use In. all food contact applications. They further argue that any barriers to PVC's entry into food-contact markets are technical or economic rather than legal (p. 63). However, It is FDA's determination that PVC Is not prior-sanctioned for al1 food contact applIcatlons. In fact, there Is no regulation or prior sanction for PVC's use In rigid and semirigid containers. Consequently, since there is no substantive evidence to the. contrary. It Is assumed that there will be an increase In the use of PVC In food-contact applications other than In the liquor container market and that this increase should be evaluated In the envlronmental Impact estimates. Although Keller and Heckman contend that SPI's August 17, 1983 estimates are overstated, these data.represent the most detailed VPP 623284 -j * Page 6-Buzz Hoffmann, Ph.D. forecasts currently available to the FOA. The survey results for food-contact uses other than for liquor bottles are presented below* Table 3: Estimates of PVC Usage In Rigid Containers " fnn H Tons oT pounds) Food Class 1983 1988 Fluid MiTk o ~vr Processed Milk Products 0 20 Cream 05 Ice Cream 0 10 Meat, Fresh 0.8 1 Canned Meats and Fish 37 Oil 17 69 Butter 14 Shortening 02 Non-Alcoholic Beverages 0.2 2.6 Fruits and Vegetables (In cans or jars) 5 8.6 Nuts, Shelled 0 2.6 Powdered Dry Food 0.5 7 .Jr Tea, Coffee, Cocoa 0 4.6 Desserts 02 Preserves 0.2 23 All Other Frozen Meals 1 10 Spices, Seasonings, Condiments 1 21 Water 0.25 6.5 TOTAL 29.95 216.0 Although FOA has no other direct Information from SPI to assess the accuracy of these estimates, the following market projections for plastic rigid packaging provides Indirect evidence regarding the potential use of PVC In food-contact applications. The table presented below, provides projections for 1991 of the consumption of plastics for rigid packaging that Incorporate extrudable high barrier resins for various food product categories. The first column contains projections of plastic rigid container usage In various food-contact applications for the year 1991 (Plastics Engineering, 1986). The second column contains s{lmates~b'Tthe consumption of PVC compound based on hypothetical' PVC penetration rates of It, 2.5t, and 51. Since PVC compound typically consists of 831 resin, total PVC resin consumption for'each penetration rate is calculated by multiplying total PVC compound consumption by ,83 (SPI estimate, 4/20/87). vpp 6232SS i Page 7-0UZ2 Hoffmann, Ph.O. Total PVC resin consumption is also computed net baby food and Infant formula. Tab!e 4: Estimate of PVC Usage by Food Category fml 1!1ons o f p o u n d s) " Food Typ_e Consumption of PVC Consumption of Compound Assuming Various All Plastics PVC Penetration Rates Low Acid Vegetables Puddings Baby Food Infant Formula Soup Other High Acid Baby Food Jams. Jellies, Desserts Vegetables Peanut Butter Dressings Juice, Juice Drinks Sauces Fruits and Vegetables 336 379 622 746 1,185 2,000 383 439 547 588 1,280 2,247 3,116 4.910 (It) (2.5X) (**) 3 8 17 4 9 19 6 16 31 7 19 37 12 30 59 20 50 100 4 10 4 11 5 14 6 15 13 32 22 56 31 78 49 123 19 22 27 29 64 112 156 246 TOTAL: 18,770 188 469 939 ALL FOOD TYPES AFFECTED: PVC Compound Consumption: PVC Resin Consumption: (83X of PVC compound) ALL FOOD TYPES EXCLUDING BABY FOOD AND INFANT FORMULA AFFECTED: PVC Compound Consumption: PVC Rtsln Consumption: (83X of PVC compound) 188 469 166 389 939 779 170 426 141 353 851 706 Source: "Barrier Resins Hold Key to Plastics Food Packaging", Plastics Engineering. 1986. Page 8-Buzz Hoffmann, Ph.D. Based on these forecasts for all plastics. If PVC were to capture between 1% to 5% of the rigid plastic market (excluding baby food and Infant formula), PVC resin consumption would total 141 to 706 million pounds In 1991 for rigid container applications. FOA realizes that these estimates are rough and that the penetration rates will vary widely across food-contact applications. However, these estimates do demonstrate that If PVC Is able to compete with other plastics and capture even a small portion of the rigid container market, the future usage of PVC will be significant. In addition, these estimates provide Indirect evidence supporting the plausibility of SPl's original estimates for rigid and semi-rigid PVC packaging. 3. FDA Estimates of PVC Resin Use In Food-Contact Applications FDA projections of PVC resin usage In food-contact application for 1991 are contained In the following table. Table 5; FDA Estimates of Current and Future PVC Resin Use in Food Contact Applications (mYlTTons of pounds) 1986 1991- 1991- FDA PROMULGATION OF NO FDA ACTION PVC RULE IN 1987 Bottles, Nonalcohol 1c edible oil other Bottles, Alcoholic 11quor wl ne 66 0 0 0 37 50 0 147 (a) 0 12 0 7 (b) Film PIastlsols Sheet 105 106 106 50 55 55 15 25 25 TOTAL (bottles and other packaging): 236 223 402 Compounded Growth Rate (1986-1991): -1% 11% TV) S>r*s 1983 projection for 1988 for other foods excluding edible Oils (216 million pounds - 69 million pounds). (b) Based on Market Search Inc. estimates for PVC usage In wine* A Page 9-Buzz Hoffmann, Ph.D. Tne most striking difference between PDA's estimates and the estimates provided by SPI In the April 20, 1987 submission Is^the market projection for nonalcoholc bottles other than edible oil and high-alcohol liquor bottles. (SPI's 4/20/87 estimates are' provided In the Appendix.) PDA has received no direct Information to Indicate that PVC rigid container bottles will be limited to either edible oil or high alcohol liquor containers If the agency promulgates a final PVC regulation. Consequently, SPI's 1983 projection of PVC resin consumption In other nonalcoholic bottles for 1988 Is substituted for SPI's current estimate of zero. Based on SPI's 1983 projections along with SPI's revised estimates for liquor bottles and presumably edible oil, FDA estimates that the effect of this regulation Is an Increase In the use of PVC of 179 (or approximately 180) million pounds. As can be seen In Table 6 below, this Increase arises from an Increase In the projected use of PVC bottles. SPI estimates that with no PVC regulation, the use of PVC bottles will drop to 37 million pounds In 1991. However, If FDA prmulgates a PVC regulation, FDA estimates an Increase In the use of'PVC in bottle applications to 216 million pounds. The difference between these two estimates represents the effect of the regulation. Since Pyc applications for film, plastlsols and sheet are currently approved for al 1 food-contact applications, a PVC regulation is not expected to dramatically affect these uses. Although, this regulation may have an indirect effect for some products (e.g., any Increase In the use of PVC film, plastlsol, or sheet associated with the expansion of PVC bottles Into new markets), this Indirect affect Is expected to be small.CIO] SPI current estimates project an annual growth rate for these applications of approximately 2%. Table 6: FDA Estimates - Bottles *and FIIm/Sheet/Plastlsol 1986 1991- 1991- FDA PROMULGATION OF NO FDA ACTION PVC RULE IN 1987 Bottles 66 37 216 FI 1m/Sheet/PIast1 sol s 170 186 186 TOTAL 236 223 402 VPP 623288 A Page 10-Buzz Hoffmann, Ph.D. FDA1 s estimates Imply a 27% compounded growth rate for PVC use In rigid and semi-rigid bottles for 1966-1991, about half of the 54% compounded growth rate Implied by SPl*s 1983 projection for 1983-1988, although substantially higher than the -1% compounded growth rate implied by SPI's 1987 projection for 1986-1991. SPI PVC bottle estimates for 1975-1986 for food and non-food applications Indicate a 12.6% compounded rate of growth. Keller and Heckman have Indicated that a 10-15 year trend of PVC food packaging could not be assembled. Consequently a more sophisticated trend analysis could not be performed. It should be noted that the growth rates for PVC usage In food-contact applications Implied by FDA estimates (27% for bottle applications and 11% for all PVC food-contact uses) are expected to eventually decline as the market for new PVC applications matures. As Indicated above, the growth rate implied by SPl's current estimates of the use of PVC In film, sheet and plastlsols between 1986 and 1991 Is 2%. This rate Is lower than the 7% compounded growth rate for film, sheet, film, coatings, plastlsols, and organosols reported by Keller and 'Heckman In the 1983 submission for 1983-1988. Keller and Heckman do not provide an explanation for the decrease in the growth rate estimate although they do provide estimates of the use of PVC in film (1975, 1981, and 1986) and plastlsols (1975 and 1986) for food use only which support the lower growth rate projections. Of course, It would be useful to obtain estimates for the Intervening years (l.e., 1976-1980 and 1982-1985) In order to evaluate the stability of this trend estimate. In considering these estimates for PVC, It Is important to note that SPI figures represent PYC resin used In domestically produced containers. These figures do not take Into consideration the finished products which may be Imported In PVC containers and will eventually be disposed of In the U.S. (e.g., bottled water) nor do they account for finished products which may be exported. Unfortunately, any estimate of the net effect of International trade on the amount of PVC entering the U.S. disposal stream would be purely a conjecture. o Patricia M. Lasonde, Ph.D. VPP 623289 Page 11-Buzz Hoffmann, Ph.D APPENDIX Estimated of Current and Future PVC Resin Use In Food-Contact AppiicatTons Bottles , Nona!cohol1c Bottles, Alcoholic (11quor) Film Plastlsols Sheet TOTAL SPI ESTIMATES (mil lions of pounds) 1986 1991- 1991- FDA PROMULGATION OF NO FDA ACTION PVC RULE IN 1987 66 37 50 0 0 12 105 106 50 55 15 25 106 55 25 236 223 248 Food Packaging Liquor Packaging Wine Packaging MARKET SEARCH ESTIMATES (ml 11 Ions of pounds) 1985 1995 161.45 0 0 283.24 8.2 * 11.8 VPP 623290 A Page 12-Buzz Hoffmann, Ph.D FOOTNOTES [1] PVC bottles, unlike PET bottles, can be manufactured with hollow handles. Most sources agree that this may Important In the 1.75 liter bottle market. 1984 1.75 liter bottle estimate: Annual Statistical Review 1984/85 . Table 23, DISCUS, Economics and statistics Division, 1985. [2] Between 1983 and 1984, U.S. bottling of distilled spirits decreased 2.7%. Jobson's liquor Handbook, 1986, p.ll. [3] Correspondence between Ron McHugh and Ethyl Corporation, July 6, 1983. Submission, Keller and Heckman, Attachment 5: "Pet to Dominate Plastics for liquor Packaging", Plastics World. October 1985. # [4] Submission, Keller and Heckman, April 20, 1987, Attachment 2. [5] "The Plastic Invasion Continues: PET for Liquor", Food Engineering. August 1983. [6] Submission, Keller and Heckman, Attachment 5. [7] In''fact, Keller and Heckman do not explain the decrease in the use of PVC in food classes other than edible oils which reportedly used PVC In rigid containers In 1983 (e.g., fruits and vegetables in cans or jars used 5 million pounds of PVC * in rigid containers in 1983). [83 "PVC Bottles Coming On Strong", Plastics Engineering, August 1986, "Polyvinyl Chloride" , Modern"Piastlcs, January 1987. [93 Ibid [103 The compounded growth rates provided by SPI (4/30/87 submission, attachment 3) for film and plastlsols for food-contact use only for 1975-1986 are 1.4% and 2.0%, respectively. However, the data Indicates that the growth of film has declined to less than 1% between 1981 and 1986. Keller and Heckman do not provide data for past PVC sheet use. VPP 623291 i APPENDIX E A VPP 623292 A BuZ2 L* Hoffman, Ph.D Chief, Environmental Impact Section, Bureau of Foods Food and Drug Administration Washington, D.C. 20240 OFFICE Of EXTERNAL AFFAIRS * Dear Dr. Hoffman: This letter responds to your November 18, 1983 request for information concerning the environmental effects associated Kith the use of polyvinyl chloride (PVC) as a food container. My office sought comments from a variety of sources within EPA In an effort to provide specific answers to your questions. 1. The proposed action should not Impact the vinyl chloride NESHAP. Producers of ethylene dichloride, vinyl chloride, and polyvinyl chloride resins are already subject to provisions of the vinyl chloride NESHAP'. Should this action result in new plant construction, those plants would be regulated as well. 2. The Society of the Plastics Industry (SPI) has estimated that there would be an approximate Increase of 350 million pounds per year of PVC In food contact applications if present restrictions were removed. The capacity of U.S. PVC producers is estimated to be 8.2 to 8.3 billion pounds per year with a demand of 6.6 to 6.9 billion pounds per year (1984 projections). An Increase of 350 million pounds would represent about 4S of the current Industry capacity. Since the industry Is operating at about 80S of capacity. Increased demand for PVC would probably be accomodated by existing PVC capacity. Further, reviewers were concerned that PVC Incineration may result In the formation of toxic chlorinated aromatic pollutants, e.g., chlorinated dlbenzofurans and chlorinated dibenzodloxins (CDF's and CDD's). Recent monitoring of municipal Incinerators has shown that CDD's are produced at low levels. Although chlorinated aromatics (PCB's, chlorobenzyenes, and chlorophenols) are considered the most VPP 623293 likely precursors, some reports have suggested the possibility that PVC's could also contribute to the formation of COO's and CDF*s. More Information on this point should be sought from the appropriate experts In Incineration at EPA, other agencies, and the scientific community. Also, FDA should review the potential litter problem resulting from a manifold increase In the use of disposable containers (like soda bottles). \ 3. EPA does not anticipate any actions that would cause hydrogen chlorides to be regulated by NESHAP, NAAQS, or NSPS and feels It unlikely that the proposed action would precipitate consequent regulation. 4, Regarding possible groundwater contamination, our reviewers feel that problems arising from land disposal of PVC might be significant, noting that vinyl chloride had been found In groundwater near landfills (e.g., lee Lanes landfill In West Virginia). I have enclosed copies of five documents that our reviewers believed would assist you in preparing the environmental assessment. In addition, they recommended the following studies: 1. "Chlorine and Hydrogen Chloride," National Research Council, National Academy of Sciences, NAS Press (1976) and; 2. Environmental Health Criteria - 21, Hydrogen Chloride - ICPS International Programme on Chemical Safety, World Health Organization, Geneva 1982. If we can be of further assistance, please contact David Parker (382-5046). Sincerely Enclosure VPP 623294