Document jm38p8E1nzdad7nxop6OVVey9

Federal Register / Vol. 51, No. 22 / Monday, February 3, 1986 / Proposed Rules 4173 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 172,175,176, 177, 179, and 181 [Docket No. 75N-0190] Vinyl Chloride Polymers; Withdrawal of Proposal agency: Food and Drug Administration. action: Withdrawal of proposal. summary: The Food and Drug Administration (FDA) is withdrawing the notice of proposed rulemaking that would have restricted the uses of vinyl chloride polymers in contact with food. The agency is taking this action because, based upon new scientific and legal developments. FDA has decided that the actions outlined in the proposal -no longer represent the appropriate course of regulatory action. FOR FURTHER INFORMATION CONTACT: Vir Anand. Center for Food and Safety and Applied Nutrition (HFF-335), Food and Drug Administration, 200 C St. SW,, Washington, DC 20204,202-472-5690. SUPPLEMENTARY INFORMATION: In the Federal Register of September 3,1975 (40 FR 40529), FDA proposed to prohibit some uses of vinyl chloride polymers (homo- and copolymers), including their use in semirigid and-rigid food-contact articles such as bottles and sheet, and to interim list the use of these polymers in water pipe. Since publication of the proposal, there have been a number of significant developments that bear on the agency's position concerning regulation of vinyl chloride polymers. The major developments include: (1) Vastly improved production technology has made it possible for manufacturers to succeed in reducing the level of residual vinyl chloride monomer in vinyl chloride polymer by a factor of nearly 1 million: (2) the agency has developed a policy concerning the regulation of food and color additives that may contain carcinogenic impurities; and (3) FDA now believes that developments in scientific technology and its experience with risk assessment procedures make it possible for the agency to determine whether the use of additives that contain carcinogenic impurities is safe. As a consequence of these ' developments, many of the issues raised by the September 1975 proposal and by 1 the comments on that proposal are moot FDA now believes that the use of vinyl chloride polymers can be regulated provided that such polymers meet certain limitations on the levels of elsewhere in this issue of the Federal residual vinyl chloride monomer. Register. The term "chloroethene" is not In the Federal Register of March 15, a commonly used term for vinyl 1977 (42 FR 14302). FDA reorganized and chloride. FDA concludes that vinyl republished regulations formerly chloride is adequately defined by its codified in 21 CER Part 121. In the chemical formula and its CAS Reg. No. present document. FDA will refer to the 2. One comment stated that vinyl old Part 121 section numbers and, if chloride-vinylidene chloride copolymer appropriate, to the recodified section should be renamed vinylidene chloride- numbers. vinyl chloride copolymer to reflect the Elsewhere in this issue of the Federal relative dominance of the monomers. It Register. FDA is proposing: (1) To noted that vinylidene chloride is the provide for the safe use of vinyl chloride more dominant monomer in copolymers polymers; (2) to codify all known prior sanctions of vinyl chloride polymers; (3) to provide for the use of certain previously unregulated vinyl chloride polymers in manufacturing vinyl chloride bottles: and (4) to delete vinyl chloride-vinylidene chloride copolymers from the list of materials that may be used as coatings on fresh citrus fruit (21 CFR 172.210). FDA received 190 comments on the September 1975 proposal. One hundred fifty-four of these comments did not include any data on the use of vinyl chloride polymers. Of these comments, of vinyl chloride and vinylidene chloride. FDA concludes that vinyl chloride-" vinylidene chloride copolymers should continue to be so named. Vinyl chloride \ has customarily been the first monomer \ cited in industry usage and in food \ additive regulations when referring to copolymers, regardless of the major j component. Although there may be some Jadvantage to naming copolymers by the predominance of monomers, renaming the copolymers would only lead to . / confusion and unnecessary paperwork. . 86 supported the proposal; 57 expressed B.Administrative--Legal concern about the risk associated with the use ofvinyl chloride polymers; and 11 opposed the proposed ban on rigid and semirigid vinyl chloride polymers. The remaining 36 comments did submit data or legal arguments for FDA's consideration. In addition, the docket contains 15 ' supplements to comments; 21 letters from industry, professional societies, public interest groups, and individuals; 11 memoranda of meetings; and 11 memoranda of telephone conversations. None of the additional letters and memoranda contained data, but the 15 supplements to comments contained scientific data that FDA reviewed and evaluated. All comments received in response to the proposal are addressed in this document. A. Nomenclature 3. Five comments stated that FDA did not have the statutory authority to issue food additive regulations prescribing conditions of use for a substance that may not reasonably be expected to become a component of food. The comments claimed that there was no expectation of migration of vinyl chloride monomer into food from the use of vinyl chloride polymer packaging. Section 201(s) of the Federal Food, Drug, and Cosmetic Act (the act) defines a food additives as "any substance Hie intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, 1. One comment stated that vinyl and including any source of radiation chloride should be referred to as "vinyl intended for any such.use) * " *" (21 chloride monomer" or as "VCM" in the U.S.C. 321 (s)). Section 409(d) of the act various proposed regulations to prevent (21 U.S.C. 348(d)) authorizes FDA to any misunderstanding about what estabfish regulations prescribing, with particular substance is being prohibited. respect to any particular use of a food The comment further stated that the . additive, the conditions under which identification of vinyl chloride monomer such additive may be safely used. should include its chemical fomula Vinyl chloride polymer becomes a (CjHaCl), its alternative name component of food (a food additive] "chloroethene." and its Chemical when the nnreacted vinyl chloride Abstracts Registry Number (CAS Reg. monomer trapped in the polymer matrix No.). migrates from the polymer to food. The FDA agrees that it should use the CAS data; both experimental and theoretical, Reg. No. and the term "vinyl chloride produced by industry and by FDA monomer" to identify the monomer. H laboratories about vinyl chloride has done so m the proposal published polymers demonstrate that, under 21155001 BFG10839 4174 Federal Register / Vol. 51, No^22 / Monday, February 3, 1980 / Proposed Rules ,rmal conditions of use, migration of was not incorporated into the agency's Additionally, since the publication of vinyl chloride monomer will occur from final action on vinyl chloride polymers. the 1975 notice of proposed rulemaking, all types of vinyl chloride polymer food- FDA disagrees with this comment. scientific developments, such as contact articles, regardless of the levels FDA has explained why it has improved risk assessment procedures, of the monomer in the articles. The concluded that the viijyl chloride have led FDA to reconsider how it amount of vinyl chloride monomer that monomer will migrate in response to the regulates food and color additives when migrates to food will depend on the preceding comment. In regard to a the additive as a whole contains initial residual monomer content, the request for a public hearing, section carcinogenic impurities but has not been time and temperature of exposure to 409(f)(1) of the act provides that, within shown to be a carcinogen in appropriate food, the thickness of the polymer, and 30 days after publication of a final order testing. As a result of its such other properties of the polymers as on a food additive, any person adversely reconsideration, the agency has decided their permeability and whether they affected by the order may file objections that it can approve or list the use of such have been plasticized. to the order and may request a public additives when an assessment shows One example of the work done on hearing on the matter. There are no vinyl chloride monomer is that of Ethyle provisions in section 409 of the act for that the risk from the use of these additives, with their carcinogenic Corp. In a series of reports dating from requesting a public hearing in response impurities, is so low that there is a January 17,1975, Ethyl proposed and to a notice of proposed rulemaking, reasonable certainty of no harm from utilized a diffusion model that although this request may be made in their use. The application of this accurately predicted levels of vinyl response to final regulations on this approach to vinyl chloride polymers is chloride monomer migration into food subject. described in detail in the notice of simulating solvents. Based on this model's success in predicting the ! 5. Two comments stated that no final action to ban rigid and semirigid vinyl, proposed rulemaking appearing, elsewhere in this issue of the Federal observed levels of monomer migration, chloride polymers should be taken until Register. Ethyle's diffusion model can be relied an examination has beep made of the 7. Four comments suggested that upon to predict the level of such - potential migration from currently* proposed 121,2009 Vinyl chloride migration even.when the monomer is produced vinyl chloride polymers that polymer resins, which listed the prior- not detectable by current analytical . contain low levels of residual vinyl : sanctioned uses of vinyl chloride capabilities. chloride monomer. - polymers, should be revised to permit On the basis of existing theories* FDA has reviewed the data on the the use of polymers listed.in that section diffusion models, and available experimental data, FDA concludes that vinyl chloride monomer is capable of migration of vinyl chloride monomer from polymers that contain varying levels of residual monomer (Division of in articles that will contact all types of ' food or should be revised to allow the use of additional types of articles migrating into food from vinyl chloride Chemistry and Physics memorandum produced from vinyl chloride polymers. polymers in more than insignificant , dated July 27,1979). The agency The agency finds that such a revision ' amounts. The use of models capable of concludes that migration of the ' \ is inappropriate. Proposed 121.2009 predicting monomer migration has been monomer into food will occur if there is /) was intended to be a listing of those- addressed in Monsanto v. Kennedy, 613 any residual monomer in the polymer. 1 uses of vinyl chloride polymers that are F.2d 947 (1979), where the court stated: The new proposed regulations published the subject of prior sanctions, i.e., those "Nor is it necessary that the level of elsewhere in this issue of the Federal - j k uses that were approved by FDA or the migration be significant with reference Register reflect this determination. U.S, Department of Agriculture (USDA) to the threshold of direct detectability, so long as its presence in food can be predicted'on the basis of a meaningful 6. Two comments objected to permitting any use of vinyl chloride . polymers in contact with food because before September 8,1958. The list of such uses cannot be altered or expanded to include additional uses projection from reliable data." . of the presence of a carcinogen (vinyl FDA has further concluded that, given chloride monomer) in these polymers. without proof that those additional uses were approved by FDA or USDA before the fact that vinyl chloride monomer has The comments claimed that, by that date. been shown to be a carcinogen, the permitting"the use of these polymers, Therefore, the agency cannot expand projected vinyl chloride monomer FDA was, in effect, setting a tolerance. migration from vinyl chloride polymers ' for a carcinogen at the level of . the prior-sanctioned uses of vinyl, chloride polymers to cover contact with under the conditions ofuse currently sensitivity of the analytical methods to - all .types of food as proposed in these specified in its regulaions is not so small detect vinyl chloride monomer. The - comments. as to present no public health or safety comment stated that all uses of vinyl . In the 1975 proposal, FDA listed those concerns. The agency finds, however, chloride polymers should be banned .. prior sanctions for which it could find that safety can be assured through the until manufacturers can produce vinyl- . evidence and explicitly solicited establishment of limits on residual chloride polymers that contain no vinyl - evidence of any additional sanctions. monomer concentrations, as proposed chloride monomer. No evidence of other prior sanctions elsewhere-in this issue of the Federal Register. The agency, therefore, is FDA agrees that vinyl chloride polymers with unsafe levels of vinyl was submitted to FDA. FDA, however, located in its own files evidence of four exercising its authority under section chloride monomer should not be additional prior sanctions. (1. Letter to 409 of the act to promulgate regulations permitted on the market. However, FDA Firestone Plastics Co., Pottstown, PA, that would prevent the marketing of does not believe that banning vinyl dated-April 20,1951, permitting the use polymers with unsafe levels of vinyl chloride polymers is necessary because of vinyl chloride resins as films for food chloride monomer, these polymers now can be - packaging. 2. Letter to Firestone Plastics 4, One comment contended that there manufactured with residual \rinyl Co., Pottstown, PA, dated October 5, was no reasonable expectation of, - chloride monomer levels that are at. - 1956, permitting the use of rigid migration and, also, that the polymers least one million times lower than the: . polyvinyl chloride (homopolymer) sheet were not food additives. The comment residual monomer levels in polymers for packaging poultry. 3. Letter to requested a hearing if its point of view. .. that were marketed-in the early 1970's. - Firestone Plastics Co. Pottstown, PA, BFG10840 Federal Register / Vol. 51. No. 22 / Monday. February 3, 1986 / Proposed Rules 4175 dated February 21. 1957, permitting the use of vinyl chloride and vinyl chlorideacetate resins for "food wrapping purposes." 4. Letter of Borden Co., Santa Barbara. CA. dated August 15.1957. permitting the use of vinyl chloride fjjolymers as tubing for food-contact use.) ^ The agency has included these sanctions ^ in its proposal published elsewhere in m this issue of the Federal Register. The Aq agency believes that all valid prior sanctions of vinyl chloride polymers are set forth in the new proposaL ' v 8. Two comments stated that the wording of proposed 121.2009(a)(3) should be revised to provide a proper description of the materials used for coating conveyor belts. The comments asserted that these materials are blends of vinyl chloride homopolymer and butadiene or butadiene/acrylonitriie copolymer rather than "vinyl chloride/ butadiene" or "vinyl chloride/ butadiene/acrylonitrile" copolymer, as described in the proposal. The original letters received by FDA on the conveyor belt coatings referred to the coatings as "resins." a term broadly applied to any thermoplastic material. Although the letters that FDA wrote in response refer to the conveyor belt l coatings as copolymers, the coatings were never identified as copolymers by the manufacturers. The agency, in reviewing these records, finds that the records contain no data that would limit the priorsanctions to copolymers rather than blends. Accordingly, in the proposal published elsewhere in this issue of die Federal Register, FDA has revised 181.37 (proposed as 5 121.2009(a)(3)) to use the term "resin," rather than "copolymer," to refer to both the resin blend and the copolymer. 9. One comment stated that all food packaged in vinyl chloride polymers or prepared with equipment in which the food will come into contact with vinyl chloride polymers should be so labeled. FDA has considered this comment and has concluded that the requested labeling is not necessary to ensure the safety of foods that contact vinyl. chloride polymers. In a notice of proposed rulemaking published elsewhere in this issue of the Federal Register, FDA sets forth proposed regulations that contain limitations on the amount of residual vinyl chloride monomer that may be present in various types qf vinyl, chloride food contact surfaces. FDA also sets forth in that ' proposal the basis on which it has tentatively concluded that vinyl chloride polymers that meet the proposed limitations are safe for food-contact use. Therefore, there is no need to label foods that have contacted' vinyl chloride polymers. 10. One comment stated that the use of vinyl chloride polymers as coatings on fresh citrus fruits, which is permitted under 21 CFR 12T:1179 (now 21 CFR 172.210), has been discontinued. After publication of the 1975 proposal, the major producer of vinyl chloride- vinylidene chloride copolymers informed FDA that it was unaware of any market for the coatings on fresh citrus fruit (Telecommunication, M. Flood to J. Cobler, September 30 and October 3,1983, Dow Chemical Co.). On the basis of this information, the agency is proposing elsewhere in this issue of the Federal Register to revoke the regulation for die use of vinyl chloride polymers as coatings on fresh citrus fruit. . 11. Four comments were received objecting to the inclusion of rigid and semirigid polymers in 121.106 Substancesprohibitedfrom use in human food (now 21 CFR Part 189). FDA has now completed its evaluation of all safety data pertinent to the use of rigid and semirigid vinyl . chloride polymers and has tentatively concluded that safe conditions of use can be prescribed for these polymers. Therefore, rather than banning the use of these polymers, elsewhere in this issue of the Federal Register, FDA is proposing to approve certain uses of these substances. C. Chemistry 12. Seven comments stated that one or more of the proposed regulations should be revised to permit all uses of vinyl chloride polymars for which there is no reasonable expectation of. migration of vinyl chloride monomer to food. Five of these comments contained data for calculations to support the contention that when a food-contact article does not contain detectable levels of vinyl chloride monomer, the potential amount of migration of this monomer is so insignificant as to make it unreasonable to expect that vinyl chloride polymer will become a component of food. One comment further stated that a regulation ' permitting the use of all vinyl chloride polymers when there was no detectable residual vinyl chloride monomer in the food-contact articles or not detectable migration of vinyl chloride monomer to food would adequately protect the public health. A number, of these comments discussed specific processes used to remove "all" residual vinyl chloride monomer from vinyl chloride polymers. According to the. comments, these processes produced polymers in which there were either very low levels (i.e.. 2 to 50 parts per billion (ppb)) or no detectable amount of residual vinyl chloride monomer because the steps taken during these fabrication processes were adequate to remove aH of the residual vinyl chloride monomer. On the basis of all available evidence! FDA has concluded that under normal use conditions, migration of vinyl chloride monomer will occur from all types of vinyl chloride polymer articles (see response to comment 3). The amount of vinyl chloride monomer that will migrate is determined by the nature of the articles (e.g.. film, bottle, or coating); the residual vinyl chloride monomer content; and the conditions of use (time'and temperature of exposure to food). The agency is aware that over the past 10 years, the manufacturers of vinyl chloride polymer products have succeeded in reducing the levels of residual vinyl chloride monomer by a factor of nearly a million. However, the data that FDA has received from industry clearly establish that vinyl chloride polymers still contain measurable levels of vinyl chloride monomer, and that available diffusion theory relates the level of monomer in the polymer to the level of monomer in the food, even though the level may be below current analytical detection limits. Therefore, FDA concludes that regulation should be based on safe upper limits of migration rather than the level of detectability. 13. One comment state'd that as the level of residual vinyl chloride monomer in a vinyl chloride polymer is reduced, there is a corresponding reduction in the migration of the monomer. The comment theorized that there are sites in a polymer to which some monomer can attach. These sites are called "active binding sites." The comment asserted that these active binding sites prevent migration of the monomer when there is less than 0.1 part per million of residual monomer. The comment argued that as a result. FDA had no authority to regulate the polymer when it contained such low levels of the monomer. FDA finds that the available experimental data on the process of migration of vinyl chloride monomer from vinyl chloride polymers do not support this theory (Division of Chemistry and Physics memorandum dated July 27.1979). FDA's evaluation of the data on vinyl chloride migration that were submitted as comments to the 1975 proposal by Ethyl Corp. revealed that under normal use condition, migration of vinyl chloride monomer will occur from all 21155003 BFG10841 4176 Federal Register / Vol. 51, No. 22 / Monday, February 3, 1988 / Proposed Rules pcs of vinyl chloride polymers, regardless of the monomer level in the polymers. Although the alternative "active site" theory, if correct, would predict zero migration of vinyl chloride monomer to food at some minimum residualmonomerlevel.no experimental data have been submitted . to FDA that would confirm the theory. A more detailed discussion of the migration issue is contained in the notice of proposed rulemaking published elsewhere in this issue of the Federal Register. 14. One comment outlined a mathematical model that reportedly predicted the extractable levels of vinyl chloride monomer from any level of residual vinyl chloride monomer in vinyl chloride polymers. The comment stated that, based on the model and the low concentration of residual vinyl chloride monomer in its product, there is not a reasonable possibility of migration of vinyl chloride monomer. FDA disagrees and finds, upon evaluation of the model, that the model . predicts zero migration only if there is no-monomer in the food container (Division of Chemistry and Physics memorandum dated July 27,1979). FDA is not aware at this time of any manufacturing process that can producevinyl chloride polymers without some level of residual vinyl chloride monomer being present. The diffusivity of the vinyl chloride monomer is discussed ,, briefly in comment 12 and at length in the notice of proposed rulemaking published elsewhere in this issue of the Federal Register. 15. Three comments stated that the proposed regulations should be revised to exempt specific types of packaging such as laminates and packaging for dry solids. The comments stated that food packaged in such containers would not be expected to. contain vinyl chloride monomer as a result of migration from the packaging materials. - As discussed in response to comment 12, the agency concludes that use of vinyl chloride polymers as components of the types of packaging materials described in these comments will result in low levels of migration of vinyl - chloride monomer. However, the agency is proposing to permit such use of vinyl chloride polymers, with limitations on the levels of residual vinyl chloride monomer, as set forth in the proposed rule published elsewhere in this issue of the Federal Register. 18. One comment stated that the . restrictions on the use of rigid and ' semirigid articles should be revised to permit their use with dry food, or that the-proposed restrictlorts ih the- regulations for adjuvants should be eliminated. 152 Weeks." dated 1980); (4) CIVO Institute TNO second unpublished rat As explained in the proposal study on vinyl chloride monomer (the published elsewhere in this issue of the final report.entitled "Lifespan Ora) Federal Register, based^on the Carcinogenicity Study of Vinyl Chloride improvements in the manufacturing in Rats," dated September 1983). process for vinyl chloride polymers and on other scientific and legal developments, FDA now believes that it can approve the use of vinyl chloride polymers in rigid and semirigid articles not only with dry food but also with aqueous. alcoholic, and fatty foods. Because FDA is no longer proposing toban these uses of rigid and semirigid vinyl chloride polymers, the question of restriction of adjuvants for use in rigid and semirigid vinyl chloride polymers is moot. However, FDA is proposing to . delete certain adjuvants currently regulated for use in vinyl chloride/ vinylidene chloride copolymer coatings for fresh citrus fruit. The us of this copolymer for coating fresh citrus fruit was discontinued several years ago and The agency has determined that vinyl chloride monomer is a carcinogen via oral route of exposure on the basis of the results from these studies. Elsewhere in this issue of the Federal Register, FDA is proposing to establish safe conditions of use for vinyl chloride polymers. FDA believes that vinyl chloride polymers can be regulated under the agency's carcinogenic impurities policy, which is described elsewhere in this document and in the accompanying notice of proposed rulemaking. FDA has used this policy to regulate food and color additives that contain carcinogenic impurities but which themselves have not been found to be carcinogenic. there is no longer a need for the The agency's proposed regulations regulation. The deletion of this use of published elsewhere in this issue Of the these adjuvants from FDA's regulations Federal Register deal with the uses of has no effect on their other regulated vinyl chloride polymers including rigid uses. and semirigid articles.and the specific D. Toxicology' 17. One commenj stated that the use of vinyl chloride polymers in rigid and limitations that are heeded to ensure.. ' their safe use. . E. Environmental Impact semirigid food-contact articles should be permitted on an interim basis pending the outcome of studies necessary to demonstrate the safety of such polymers. The comment stated that FDA had based the proposed regulations on preliminary reports, speculation, and rumors, and that animal feeding studies to demonstrate the toxicity of vinyl chloride monomer when ingested were now underway and were expected to be completed within 30 months. 18; One comment stated that, under the proposed regulations, products . expected to substitute for vinyl chloride polymer products would have far greater environmental impacts than vinyl chloride polymer. In addition, the comment suggested that vinyl chloride polymer could be efficiently burned in properly designed and operated incinerators. The agency's proposal, set forth Since this comment was submitted, elsewhere in this issue of the Federal FDA has received four reports of Register, provides conditions for the completed bioassay studies on the safe use of regulated and prior- carcinogenicity of vinyl chloride sanctioned vinyl chloride polymers. This monomer. These include: (1) Feron et al.. . proposed action is in contrast to the chronic rat oral study performed at the 1975 proposal; which would have CIVO Institute TNO in the Netherlands prohibited certain uses of vinyl chloride [Food and Cosmetics Toxicology, polymers. FDA has prepared two 19:317-333.1981): (2) Maltoni et al. rat documents, an environmental study on vinyl chloride monomer by assessment and a finding of no both oral ingestion and inhalation routes significant impact, that evaluate the of exposure [Atmals of the New York potential impact, both adverse and Academy of Sciences, 246:195-218,1975: beneficial, expected from the increased Environmental Health Perspectives, use. of vinyl chloride polymers. These 41:3-29:1981); (3) The British Industrial documents consider the environmental Biological Research Association factors addressed in the comment's unpublished rat study on vinyl chloride submission. The environmental monomer administered in the drinking assessment and the finding'of no . water for up to 152 weeks (the final ; significant impact may be seen in the reportentitied "An Investigation Into " Dockets Management Branch (HFA- the Carcinogenio-Potentlal of Vinyl 305), Food and Drug Administration, Rm Chloride Monomer When Administered. " 4-62,5600 Fishers Lane, Rockville, MD to Rats in the Drinking Water'for Up to 20857; ' `. ' BFG10842  Federal Register / Vol. 51. No. 22 / Monday, February 3, 1988 / Proposed Rules 4177 F. Economic Impact ,, prior-sanctioned vinyl chloride ADDRESS: Written comments to the 19. One comment stated that the proposed regulations appeared to be more restrictive than necessary to assure protection of the public health from ingestion of vinyl chloride and discussed shortcomings and omissions in FDA's analysis of potential economic impact of the regulations. Another polymers. This action is takerrander the Federal Food. Drug, and Cosmetic Act (secs. 201 (s). 402. 409. 701, 52 Stat. 1042, 10461047 as amended,*1049,1055 (21 U.S.C. 321 (s), 342. 348. 371)) and under authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10). Dockets Management Branch (HFA- 305). Food and Drug Administration, Rm. 4-62. 5600 Fishers Lane. Rockville. MD 20857. - FOR FURTHER INFORMATION CONTACT: Vir Anand, Center for Food Safety and Applied Nutrition (HFF-335), Food and Drug Administration, 200 C St. SW., comment contained data concerning the Dated: January 27,1988. Washington. DC 20204. 202^172-5690. economic impact the proposed Frank E. Young. SUPPLEMENTARY INFORMATION: regulations would have upon the firm. FDA has considered these data and comments in preparing the economic assessment on the proposed regulations published elsewhere in this issue of the Federal Register. The economic assessment may be seen at the Dockets Management Branch (address above). G. Conclusions Since the publication of the ' September 1975 proposal, there have been significant scientific and legal developments that have caused FDA to reconsider its proposed regulations on the use of vinyl chloride polymers. Improvements in the manufacturing process have enabled vinyl chloride ; polymer manufacturers to lower greatly the levels of residual vinyl chloride.- - monomer in the polymers. This . development, along with procedures for risk assessment, now make it possible . for the agency to establish safe conditions of use for vinyl chloride polymers. Details of the scientific and legal developments as well as the risk assessment are set forth in the notice of proposed rulemaking published elsewhere in this issue of the Federal Register. The agency has also developed a policy for providing for the safe use of food additives and color additives containing low levels of carcinogenic impurities. This policy was set forth in an advance notice of proposed rulemaking published in the Federal. Register of April 2,1982 (47 FR 14463). The use of this policy was upheld by the Commissioner ofFood and Drugs. [FR Doc. 86-2236 Filed 1-31-86: 8:45 am] I. Introduction BIUJNG CODE 4160-01-61 The purpose of this proposal is to provide for the safe use of vinyl chloride polymers m contact with food. 21 CFR Parts 172,175,176,177, 179, Vinyl chloride is a chemical with the and 181 formulacCiH^CFused as a monomer in ? [Docket No. 84N-0334] the production of polymers. Other monomers-are chemically bonded to this Proposed Uses of Vinyl Chloride Polymers monomer by the process of polymerization to form larger, more complex molecules called "polymers." agency; Food and Drug Administration. When all of the monomers that are action: Proposed rule, polymerized together are molecules of summary; The Food and Drug the same substance, the resulting molecule is called a "homopolymer." Administration (FDA) is proposing to amend its regulations to provide for the safe use of vinyl chloride polymers. The agency.is proposing: (1) To provide for the safe use of certain vinyl chloride polymers by establishing limits on the The vinyl chloride homopolymer is sometimes called "polyvinyl chloride" (CAS Reg. No. 9002-86-2). When molecules of different . chemicals are polymerized together, the resulting molecule is called a f] ' amount of residual vinyl chloride monomer that they may contain; (2) to codify all known prior sanctions for "copolymer." Thus, when ethylene l molecules are polymerized to vinyl chloride molecules, the resulting^_____ vinyl chloride polymers; (3) to provide for the use of certain previously unregulated vinyl chloride polymers in manufacturing vinyl chloride bottles; copolymer is called "ethylene vmylidene. chloride."' Elsewhere in this issue of the Federal Register, FDA is withdrawing an earlier .and (4} to delete vinyl chloride- proposal on vinyl chloride polymers that vinylidene chloride copolymers from the it published on September 3,1975. list of materials that may be used as Responses to comments received on the coatings on fresh citrus fruits. Elsewhere September 3,1975 proposal are set forth in this issue of the Federal Register, FDA in the withdrawal document. is withdrawing the proposal on vinyl chloride polymers that it published in - 1L Regulatory History the Federal Register of September 3, Vinyl chloride [CAS Reg. No. 75-01-4) 1975 (40 FR 40529). is a chemcial with the following date: Comments by April 4,1986. structure: U.S. Court of Appeals in Scott v. FDA... 728 F.2d 322 (6th Cir. 1984), a case . involving FDA's decision to list permanently the use of D&C Green No. 5. This color additive contains a , carcinogenic impurity, but when the additive as a whole was tested in Cl / \ H C2H3CI, Molecular weight: 62.5 laboratory animals it did not induce cancer. This policy is explained in detail in that document (47PR 14463). Accordingly, FDA is withdrawing the ' A wide variety of vinyl chloride equipment, flexible tubing, and ., proposal published in the Federal - polymers, including homopolymer and waterpipe. , Register of September 3,1975 (40 FR' various .copolymers, are available for . Under section 201(a) of the Federal 40529). Published elsewhere in this, issue . use in the production of articles Footd, Drug, and Cosmetic Apt tthe act) . of the Federal Register is a notice of j intended to contact food, including food- (21.U.S.C. 321(b)), a substance is ... f proposed rulemaking (hat would ; .packaging materiala.coatings, plastisols. . excluded from.the definition pf a "food i authorize the safe use of regulated and .. gaskets, parts for food-processing.. ... . additive" If itsuse waa.sanctipned by - i i ! I I BFG10843 4178 Federal Register / Vol. 51. No. 22 / Monday, February 3, 1986 / Proposed Rules r ' before September 6,1958. the date e enactment of the Food Additives vinyl chloride monomer as high as 20 parts per million (ppm). Other have been permitted under the(an/ interim regulation. Amendment. FDA issued several components of the bottles that gave gin The September 1975 proposal cited sanctions for uses of vinyl chloride and vodka an off-flavor were also inhalation studies by Dr. Cesare polymers before that date. Those extracted, but these components were Maltoni, who reported the development sanctions were in the form of letters, not identified. By May 1CT1973, FDA of angiosarcomas of the liver along with advisory opinions, and articles by FDA chemists had confirmed that vinyl other types of tumors at levels of scientists that appeared in scientific chloride monomer was present in vinyl atmospheric exposure as low as 250 journals. Although currently there is no chloride polymer liquor bottles, and that ppm ("Carcinogenicity Biossay of Vinyl list of the prior-sanctioned uses of vinyl it migrated into the liquor. Chloride,'" Environmental Research, chloride polymers in the Code of Federal As a result of these findings, FDA 7:387-045,1974). Since then, vinyl Regulations, FDA is aware of such published a notice of proposed chloride has been shown to be an sanctions for their use as components of rulemaking in the Federal Register of animal carcinogen both by inhalation Film for food wraps, as components of May 17,1973 (38 FR 12931), to restrict and by oral administration and a human can enamels, and as components of the use of vinyl chloride polymer resins carcinogen by inhalation, as discussed certain types of rigid food-packaging to food-packaging materials that were below (1ARC Monographs, 19:409-412, materials, excluding bottles. used with nonalcoholic foods. 1979). Since the enactment of the Food Additives Amendment in 1958. FDA has approved a variety of uses of vinyl chloride polymers in food-contact By March 1974, the agency had received information from various sources suggesting that the migration of vinyl chloride monomer from vinyl Data Received in Response to Proposal As a result of the September .3,1975 proposal, FDA received numerous articles. The regulations codifying these approvals include: 172.210 Coatings on fresh citrus fruit (formerly 121.1179); 175.105 Adhesives (formerly 5 121.2520); 9 175.300 Resinous andpolymeric coatings (formerly 121.2514); 9 175.320 Resinous and polymeric coating for polyolefin films (formerly 9 121.2569); 9 178.170 Component ofpaper and chloride polymer resins was not limited to situations in which the polymer was used in food-contact articles for alcoholic beverages. By this time, vinyl chloride monomer had been linked to liver cancer in humans. Therefore, in the Federal Register of April 22,1974 (39 FR 14215), FDA proposed to ban vinyl chloride as ah aerosol propellant in drug and cosmetic preparations and also comments, which are addressed elsewhere in this issue of the Federal Register, and considerable analytical manufacturing and toxicological data bearing on the reduction in the level of , vinyl chloride monomer in vinyl chloride polymers. These data led FDA to publish this new proposal on vinyl chloride polymers. Data submitted by industry in paperboard in contact with aqueous and 'tyfoods (formerly 9 121.2526); .76.180 Components ofpaper and paperboard in contact with dryfood requested data Grom industry about the use of vinyl chloride polymers, the residual concentration of vinyl chloride monomer in vinyl chloride polymers, response to the September 1975 proposal showed that manufacturers had succeeded in reducing the vinyl chloride monomer levels in vinyl chloride (formerly 9 121.2571); 9177.1010 and the migration of vinyl chloride polymer resin. Before 1975, residual Acrylic and modified acrylicplastics, monomer from vinyl chloride'polymer vinyl chloride monomer levels of 1,000 semirigid and rigid (formerly containers. ppm were common. Since then, 9 1212591); 9 177.1200 Cellophane (formerly 9 1212507); 9 177.1210 Closures with sealing gaskets forfood containers (formerly 9 121.2550); In the Federal Register of August 26, 1974 (39 FR 30830), the agency issued a final rule that prohibited the use of vinyl chloride as a propellant in aerosol improved manufacturing procedures have lowered the residual vinyl chloride monomer levels by more than five orders of magnitude. 9 177.1630 Polyethylene phthalate cosmetic products and that required that Although methods for reducing vinyl polymers (formerly 9 121.2524); a manufacturer obtain an approved new chloride monomer levels have varied 9 177.1850 Textryls (formerly drug application before using vinyl from company to company, such 9 1212545); 9 177.1950 Vinyl chloride- chloride as a propellant in aerosol drug methods generally have involved ethylene copolymers (formerly products. This action was based on. application of heat and vacuum during 9 1212609); 9 177.1960 Vinyl chloridehexene-1 copolymers (formerly 9 1212623); 9 177.1970 Vinyl chloride- evidence that inhalation of high concentrations of vinyl chloride resulted in acute toxicity that was manifested by processing of the resin. Manufacturers have also taken steps to produce small, porous resin particles, which have lauryU vinyl either copolymers an array of symptoms, including facilitated diffusion of the monomer out (formerly 9 1212608); 9 177.1980 Vinyl chloride-propylene copolymers unconsciousness, cardiac effects, bone changes, and degenerative changes in of the resin. / Substantiation of the reduction in v \ (formerly 9 121.2521); 9 1772250 the brain, liver, and kidneys. / vinyl chloride monomer has been \ Microporous polymericfilters (formerly As a result of the many comments that provided by reports of residual vinyl 9 1212631); and 9 179.45 Packaging the agency received on the April 22,1974 chloride monomer levels of 10 ppb in j materials used during the irradiation of proposal, in the Federal Register of vinyl chloride polymer bottles (The packagedfoods (formerly 9 1212543). September 3,1975 (40 FR 40529), FDA Society^of the Plastics Industry, Inc., The .renumbering of these sections occurred as part of a recodification that FDA announced in the Federal Register proposed further restrictions on the use of vinyl chloride polymers in contact with food. November 12,1982) and an estimated 100 parts per trillion in can coatings > (Union Carbide Co., December 12,1980). of March 15,1977 (42 FR14302). Underthe September 1975 proposal, The Society of the Plastics Industry, - N On January 4.1973, representatives of: rigid and semirigid vinyl chloride Inc. (SPI), in a submission (November Schenley Distillers met with FDA to - polymers would have been banned from 12,1982) on behalf of the vinyl chloride sport the results of analyses that food-contact use because of possibly polymer manufacturers, informed the .towed that alcoholic beverages stored unsafe levels of vinyl chloride monomer in vinyl chloride polymer bottles for migration, although continued use of periods of up to 9 months-had levels of.. -s. vinylxhloride polymer waterpipe would agency "that with respect to vinyl chloride polymer bottles, the industry 'can provide products with residual - BFG10844 Federal Register / Vol. 51. No. 22 / Monday, February 3, 1986 / Proposed Rules 4179 monomer levels not exceeding 10 ppb by 4, Oxford Press, London. 1976). The 2.4 ppb. while vinyl chloride monomer weight." The SPI submission further differential equations expressing these levels in the extract from the 0.28 ppm stated "the quantity of vinly chloride laws contain a variable called sheet averaged 1.6 ppb (Diachenko, et available to migrate is so low, and the diffusivity. The form ofjhe differential al.. Journal of the Association of Official rate of migration of vinyl chloride from equations derived from Fick's laws Analytical Chemists. 60:570-575.1977). vinyl chloride polymer containers made depends on the boundary conditions, The Ethyl predicts that there will be with a residual [vinyl chloride monomer] i.e.. monomer concentration inside and migration, albeit below the limits of content of 10 ppb or less is so slow that outside the bottle wall, and on the detection by current analytical the concentration of vinyl chloride in the/ conditions existing at the time of techniques, from vinyl chloride polymers contents even after an exaggerated / initiation of diffusion of vinyl chloride that contain vinyl chloride monomer at \ shelf-life exposure at moderately elevated temperatures will not exceed monomer, such as the intitial residual monomer concentation. the level of less than one ppm. According to the model, as migrant the safe (0.073 ppb) level." When applied to the particular concentration in a polymer is reduced, To monitor the level of residual vinyl situation of monomer migration from a the contribution to diffusion from the chloride monomer in vinyl chloride bottle, such as vinyl chloride monomer interaction among migrants also polymers, the agency has developed a from a vinyl chloride polymer bottle, the decreases. In the limiting case of a sensitive gas chromatographic method diffusion equations derived from Fick's single migrant molecule, the only titled "Head Space Sampling and Gas- Second Law always predict a finite interaction that will occur is between Solid Chromatographic Determination migration of the monomer based on the migrating monomer and the polymer. and Confirmation of >1 ppb Vinyl Chloride Residues in Polyvinyl Chloride Food Packaging" (J.L. Dennison, et al.. initial monomer concentration in the bottle wall, provided diffusivity is not zero. Only if diffusivity is zero would no Even thou'gh diffusivity will be reduced to a finite constant in this case, it will not become zero. Thus, even when the Journal of the Association of Official Analytical Chemists. 61:813-819.1978). This analytical method has been tested by FDA and by at least one major manufacturer of vinyl chloride polymers and has been found to yield satisfactory analytical results. However, the method has not been tested with all possible migration be likely. Based on its review of published experimental results and of theoretical calculations based on numberous systems. FDA believes that the diffusivity of vinyl chloride monomer in vinyl chloride polymer will always be greater than zero, and that migration polymer contains the monomer at very low levels, the presence of the vinyl chloride monomer in food "* * * can be predicted on the basis of a meaningful projection from reliable data." See Monsanto Co. v. Kennedy. 613 F.2d 947. 955 (D.C. Cir. 1979). vinyl chloride-based food-contact will occur whenever residual vinyl t Therefore, based on the evidence . articles. FDA invites comments on-the chloride monomer ({^present in the before it, FDA concludes that vinyl applicability of this analytical method polymer. chloride polymer will become a : and wili'CgnsiderJmy-jcojnments ; In a series of reports dating from component of food, and that the extent ' . 'received in developing a final rule. January 17,1975. Ethyl Coil), proposed to which this will be the case depends, I1L The Use of Vinyl Chloride Polymers in Food-Contact Articles Will Result in Their Becoming Components of Food and utilized a diffusion model that it has derived from Fick's Second Law. This model can be used to predict monomer levels in various food simulants when at least in part, on the amount of monomer in the polymer. Given these facts and the fact that vinyl chloride monomer has been shown to be a Section 201(s) of the act defines a the initial residual vinyl chloride carcinogen. FDA has decided to regulate "food additive" as "any substance the monomer concentration in the bottle the use of vinyl chloride polymers under intended use of which results or may wall and the diffusivity are known. the act (21 U.S.C. 348) to ensure that the reasonably be expected to result, Ethyl Corp. originally applied this polymer that is marketed does not directly or indirectly, in its becoming a diffusion model to extraction data contain unsafe levels of the monomer. component or otherwise affecting the characteristics of any food (including any substance intended for use in derived from bottles containing residual vinyl chloride monomer at levels of from 80 to 330 parts per million (ppm). This IV. Carcinogenic Impurities Approach to Safety Evaluation producing, manufacturing, packing, model accurately predicted the level of A. Applicable Legal Standards processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use) * *" (21 U.S.C. 321(s)). FDA finds that vinyl chloride polymers used in food-contact articles meet this definition. Existing theory, supported with data produced by industy and by FDA laboratories., demonstrates that, under normal conditions of use. vinyl chloride monomer will migrate to food from all types of vinyl chloride polymer food- monomer that migrated into food simulating solvents. FDA also has used sensitive ' analytical methods to measure the , X' levels of vinyl chloride monomer in Y extracts from vinyl chloride polymers, those methods have shown that, consistent with Ethyl's model, the levels of monomer in the extract could be related to the intitial residual concentration of the monomer in the polymer. For example, FDA conducted a migration study on two lots of unplasticized polymer sheet One lot FDA. in its evaluation of the safety of vinyl chloride polymers, reviewed, as it does with all indirect food additives, the safety of both the polymer and its possible impurities (e.g., starting . materials used to manufacture the. . additive). As stated above, the polymer is likely to contain residual amounts of a carcinogenic compound, vinyl chloride monomer, that is used in the manufacture of the polymer. The level of residual monomer in polymers is an important factor in assessing safety. contacterticles. contained 0.44 ppm residual vinyl Under section 409(c)(3)(A) of the act The migration of vinyl chloride chloride monomer and the other 0.28 (21 U.S.C. 348(c)(3)(A)). the so-called monomer from vinyl chloride polymers ppm. Samples from each lot were "general safety clause" of the Food can be described by pick's First and. extracted with 50 percent ethanol for 19 . Additives Amendment, a food additive Second Laws of Diffusion, first days at 49 `C (120 'F). Vinyl chloride cannot be approved for a particular use enunciated in 1855 (Crank, J-"The monomer levels in the extract from the unless the data presented to FDA - Mathematics of Diffusion," 2d Ed., pp.,2- ^polymer containing 0.44 ppm averaged establish that the food additive is safe 21155007 BFG10845 4180 Federal Register / Vol. 51, No. 22 / Monday, February 3, 1988 / Proposed Rules fv. at use. The concept of safety embodied in this requirement was explained in the legislative history of the Food Additives Amendment of 1958. "Safely requires proof of a reasonable certainty that no harm will result from a proposed use of an additive. It does not--and cannot--require proof beyond any possible doubt that no harm will result under any conceivable circumstance." H. Rept. 2284, 85th Cong., 2d Sess. 1 (1958). This definition of safety is incorporated in FDA's food additive regulations [21 CFR 170.3(i)). The Delaney anticancer clause of the Food Additives Amendment of 1958 (section 409(c)(3)(A) of the act (21 U.S.C. 348(c)(3)(A)) provides further that no food additive can be deemed to be safe if it is found to induce cancer when ingested by man or animal. In the past. FDA often refused to list a food or color additive that contained or was expected to contain minor amounts of a carcinogenic chemical, even if the additive as a whole had not been shown to cause cancer. As explained below, however, scientific developments and experience with risk assessment procedures have made it possible for FDA, in appropriate circumstances, to ove the use of additives that v. ain a carcinogenic chemical. In the preamble to the final rule permanently listing D&C Green No. 8 published in the Federal Register of April 2,1982 (47 FR 14138), FDA explained the basis for approving the use of a color additive that had not been shown to cause cancer, even though it contains a carcinogenic constituent. Since that decision, FDA has listed, on the same basis, the uses of several color additives that contain carcinogenic impurities, including the use of D&C Green No. 6 for coloring contact lenses (48 FR 13020; March 29,1983) and the use of D&C Green No. 5 (47 FR 24278; June 4,1982) and of D&C Red No. 6 and D&C Red No. 7 (47 FR 57881; December 28,1982) for coloring drugs and cosmetics. (See also the advance notice of proposed rulemaking published in the Federal Register of April 2,1982 (47 FR 14462).) The appropriateness of FDA's decision to list the uses of these color additives is supported by Scott vrFDA, 728 F.2d 322 (6th Cir. 1984). That case involved a challenge to FDA's decision to approve the use of D&C Green No. 5, which contains a carcinogenic chemical but has not itself been shown to cause ;er. Relying heavily on the reasoning .ie agency's decision, the U.S. Court of Appeals for the Sixth Circuit rejected the challenge to FDA's action and affirmed the listing regulation. The Delaney or anti-cancer clause is not triggered unless the additive as a whole is found to induce cancer. An additive that has not beeij_shown to . induce cancer but that contains a carcinogenic impurity is properly evaluated under the general safety clause of the statute, using risk assessment procedures to determine whether there is a reasonable certainty that no harm will result from the proposed use of the additive. Therefore, because vinyl chloride polymers, manufactured from the component vinyl chloride monomer, have not been shown to cause cancer, the anticancer clause does not apply. FDA has evaluated the safety of this additive under the general safety clause, using risk assessment procedures to estimate the upper bound limit of risk presented by the carcinogenic chemical that may be present as an impurity in the additive. This discussion is presented below. B. Carcinogenicity Data on Vinyl Chloride Monomer FDA, since the early 1970's, has been monitoring ongoing animal studies that have investigated the toxicity of vinyl chloride monomer. The agency has reviewed four available oral carcinogenicity studies'on vinyl chloride monomer. These four studies are: (1) Cesare Maltoni's vinyl chloride monomer carcinogenicity study (Environmental Health Perspectives, 41:3-29,1981), (2) the chronic oral study performed by Feron et al. {Food and Cosmetic Toxicology, 19:317-333,1981), (3) The British Industrial Biological Research Association (BIBRA), unpublished study (1980) entitled "An Investigation into the Carcinogenic Potential of Vinyl Chloride Monomer when Administered to Rats in the Drinking Water for up to 152 weeks," and (4) CIVO Institute's TNO unpublished study (1983) entitled "Lifespan Oral Carcinogenicity Study of Vinyl Chloride in Rats." In the Feron et al. study, Wistar rats were fed a diet containing vinyl chloride monomer in vinyl chloride homopolymer powder or were administered vinyl chloride monomer in soybean oil by gavage. The results of this study show that vinyl chloride monomer is a carcinogen in Wistar rats, inducing neoplastic liver cell nodules, hepatocellular carcinomas, and angiosarcomas of the liver and the lung. The agency chose this study for computation of the risk for human exposure to vinyl chloride monomer because it was a lifetime (135 to 144 weeks) feeding study, and because the individual animal data were available.. In the Maltoni study vinyl chloride monomer was administered by various routes (including oral gavage), doses, and schedules of treatment, to animals of various species, strains, sex, and age. For the oral portion of the study, Sprague-Dawley rats were administered vinyl chloride monomer in olive oil by gavage for 52 weeks (5 times/week) and kept until spontaneous death (138 weeks). The report contains few details on the experimental design. However, the results of the oral portion of this study suggest that vinyl chloride monomer is an animal carcinogen. The results have not been used for the agency's risk assessment because the treatment lasted only 52 weeks. The data from this experiment were also presented by Maltoni at `The Conference to.Re-evaluate the Toxicology of Vinyl Chloride Monomer, Polyvinyl Chloride and Structural Analogues" held at the National Institutes of Health, Bethesda, MD, March 20 and 21,1980, and were published in Environmental Health Perspectives, 41:3-29,1981. In the BIBRA study, Wistar rats were administered vinyl chloride monomer as solutions in the drinking water for up to 152 weeks. The results show that vinyl chloride monomer is carcinogenic to Wistar rats, inducing predominantly hepatic hemangiosarcomas. The latest CIVO Institutes TNO study (1983) is actually a repeated study of Feron et al. (1981), but at lower test levels of vinyl chloride monomer. The earlier study (Feron et al., 1981) had shown that liver neoplasia were found to occur at all dose levels. Therefore, in order to provide ideal experimental data for risk extrapolation, a similar life-span oral carcinogenicity study with vinyl chloride monomer in Wistar rats was carried out at lower dose levels at the same laboratory. The results of this study essentially confirmed the results observed in the earlier study in that vinyl chloride monomer, at the lower doses, induced only hepatocellular tumors (neoplastic nodules and hepatocellular carcinomas). Upon reviewing the results of these studies, the agency concluded that vinyl chloride monomer is an animal liver carcinogen via the oral route of exposure.' An extensive review of the . toxicological effects of vinyl chloride monomer has also been presented in International Agency for Research on Cancer (IARC) monograph No. 19 (published February 1979), which was prepared by an IARC evaluation group that met in February 1978. The evaluation group concluded that vinyl BFG10846 Federal Register / Vol. 51, No. 22 / Monday, February 3, 1986 / Proposed Rules 4181 chloride monomer is a carcinogen in animals (both via inhalation and oral routes) and in humans (inhalation), it found that vinyl chloride monomer is carcinogenic by the inhalation route to mice, rats, rabbits, hamsters, and humans. The evaluation group also found that the monomer produces tumors at multiple sites but is most active in induction of the otherwise rare hepatic angiosarcomas. IARC summarized the data on vinyl chloride monomer as follows (1ARC Monographs, Supplement 1, p. 45,1979); A. Evidence for Carrirrogenirity to Humans (Sufficient) Vinyl chloride causes angiosarcomas of the lirer it has also been associated with tumors of the brain and lung and of the haematopoietic and lymphatic systems in humans. Reports of increased incidence of tumors of the digestive system, urinary tract, and breast (in women) are inadequate to evaluate the carcinogenicity of vinyl chloride for these sites. B. Evidence of Carcmogenhaty to Aanaab (Sufficient) Vinyl chloride is carcinogenic to mice, rats, and hamsters after its administration orally or by inhalation, producing tumors at several sites, including angiosarcomas of the liver. C. Evidence for Activity in Short Term Tests (Sufficient) Vinyl chloride induces DNA damage in prokaryotes and.in mammalian cells ia vitro. It was mutagenic to Salmonella typhimuriam in the absence of an exogenous metabolic activation system and to Escherichia coil Schizosaccharamyces pombe and Saccharomyces cerevisiae but not to Nevrospora crassa. !t was mutagenic to Drosophila mekmogaster. inducting sexlinked recessive lethal mutations and to hamster cells in vitro. It induced chromosomal aberrations and sister chromatid exchanges in Chinese hamsters exposed ia viva. It did not induce dominant lethal or somatic mutations in mice. Vinyl chloride alkylated the liver DNA of rats treated in vivo. Chromosomal aberrations and sister chromatid exchanges were induced in workers exposed to vinyl chloride. Most such data were obtained when exposure was to levels of 25 ppm. in follow-up studies, in which workers were exposed to levels that had been reduced to 15 ppm or lower, no aberrations or sister chromatid exchanges were reported. Sister chromatid exchange incidence dropped to a normal level shortly after termination of exposure to higher levels. However, the incidence of chromosomal aberrations returned to normal only after two years. (Thus, although sister chromatid exchanges were not observed in some studies, sampling may have occurred after the level returned to nomaLj Hie 1979 monograph concluded that, while vinyl chloride monomer is an established animal carcinogen via both inhalation and oral ingestion, its carcinogenic activity in hnmans has so far been demonstrated only in workers liters (letter dated August 17.19B3, from who were.involved in the production, The Society of the Plastics Industry, polymerization, and processing Inc.). If the vinyl chloride monomer industries and who wgjp exposed to residual level is 10 ppb, the proposed high environmental concentrations of limitation in 177.1975, and if 100 vinyl chloride monomer vapor. Based on percent migration occurs, the predicted its own review of*the data, FDA concurs vinyl chloride monomer level m the with this conclusion. beverage would be 0.65 ppb. The C. Risk Assessment resulting vinyl chloride monomer levels in the liquor would be below the In assessing the risk presented by detection limits of current analytical vinyl chloride monomer from the use of vinyl chloride polymers, the agency has used risk assessment procedures that are similar to those that it used in evaluating the risk from the minor carcinogenic impurities that may be present in thecolor additives that FDA discussed above. The risk evaluation of the carcinogenic constituent has two aspects: (1) Assessment of the probable exposure to the constituent (vinyl chloride monomer) from all the regulated and prior-sanctioned uses of vinyl chloride polymers, and (2) extrapolation of the risk observed in the animal bioassays to the conditions of probable exposure to humans. methods. The actual migration expected over the shelf life of liquor is likely to be lower based on experimental migration levels from containers having higher residual monomer levels. For example, when bottles containing 0.9 ppm residual vinyl chloride monomeT were extracted with 50 percent ethanol for 9 months at 72* F, no vinyl chloride monomer could be detected in the solvent at a level of detection of 10 ppb (Ethyl Coip., report dated September 27, 1976). Therefore, if it is bssumed that migration occurs at the level of detection, 5.5 percent of the residual vinyl chloride monomer migrated. Because diffusivity has been shown by 1. Exposure \ Ethyl's work to decrease as the residual The agency has calculated an estimated daily intake for vinyl chloride monomer from known current uses of vinyl chloride polymers as potential well aradditionaluses takingmtoaccbiiml the fraction of the daily diet that might be packaged'in materials made of vinyl vinyl chloride monomer is reduced, the percent migration must also decrease. Therefore, 5.5 percent migration of re'siduaTvmyl chloride manomerfrom bottles containing 10 ppb vinyl chloride ) monomer is an upper limit. If 5.5 percent of tfie available vinyl chloride monomer chloride polymers. Vinyl chloride monomer exposure may be estimated migrates from a 1.75-liter bottle having 10 ppb residual vinyl chloride monomer, using known vinyl chloride monomer the predicted level of vinyl chloride residuals in the vinyl chloride homopolymer ot copolymer and y monomer in the packaged food would be \ft036ppb. survey data for current production levels According to available statistics for these polymers. ("Public Revenues from Alcoholic The estimated daily intake Beverages," p. 26,1980/1981, Economics calculations for vinyl chloride polymers and Statistics Division, Distilled Spirits are as follows; Council of the United States, Inc.), per t. Liquor bottles. Because this use of capita liquor consumption in 1980 was vinyl-chloride polymers is not permitted 1.98 gallons or about 19 grams peT day. by current regulations or by a prior The average vinyl chloride monomer sanction, there are no available ingested per person per day from this marketing data from which die agency use would be about 0.68 nanogram per might estimate potential vinyl chloride day if vinyl chloride monomer migration monomer exposure from vinyl chloride is 0.036 ppb. polymer liquor bottles. There are several Exposure may also be estimated using ways of estimating exposure to vinyl the U.S. Department of Agriculture chloride monomer from use of these (USDA) Nationwide Food Consumption liquor bottles, each using the conservative assumption that all liquor Survey, 1977-1978. Of the 37,874 individuals surveyed, those who will be packaged in these bottles. In consumed liquor at least once during the reality, vinyl chloride polymers will 3-day study period consumed an compete with other materials such as average of 48 grams per day. The 90th polyethylene terephthalate end glass, which are currently used for packaging liquor.. percentile intake for users was 98 grams per day. If this latter value is used, vinyl chloride monomer exposure becomes 3.5 A typical vinyl chloride ploymer \ nanograms per day. This number is liquor bottle will weigh approximately conservative because users who 105 grams and have a capacity of 1.75 consume liquor less frequently than BFG10847 41G2 Federal Register / Vol. 51, No. 22 / Monday, February 3, 1986 / Proposed Rules e in 3 days were not included in the by The Society of the Plastics Industry, of the total daily diet is packaged in ley. The 1977-1978 Market Research Inc., a typical oil bottle contains 38 vinvlidene chloride-vinyl chloride Corp. of America (MRCA) survey of ounces of oil and weighs 70 grams. copolymers. Using the maximum value food consumed over a 14-day period Assuming a migration rate for oil that is of 2.8 percent, the migration level of 0.14 reports an upper 90th percentile level of identical to that for 50 percent alcohol, ppb, and a total dietary intake of 3,000 only 28 grams per day for brandy, the estimated 90th percentile user intake grams per day, FDA calculates exposure whiskey, rum, and vodka. . is 2.5 nanograms per day. to vinyl chloride monomer from this use 2. Wine bottles. According to the 4. Vinyl chloride homopolymer film. to be 12 nanograms per-day. Distilled Spirits Council of the United Vinyl chloride monomer levels in (ii) Vinyl chloride-vinylidene States. Inc.. 1980 consumption of wine plasticized vinyl chloride homopolymer copolymer coatings on fresh citrus fruit. was approximately the same as that of film are lower than those found in rigid Based on information from a major liquor. However, the 90th percentile vinyl chloride polymer. An upper limit of producer of vinyl chloride-vinylidene users' intake reported by USDA is 232 exposure to vinyl chloride monomer chloride copolymer (memorandum of grams per day (USDA Nationwide Food from the Him can be obtained by telephone conversation, M. Flood, FDA, Consumption Survey. 1977-1978). If aU assuming that all of the vinyl chloride and J. Cobler. Dow Chemical Co., this wine contained vinyl chloride monomer in the film migrates into food. September 30 and October 3,1983), FDA monomer at a level of 0.036 ppb (based /For example, a film with a thickness of 1 has determined that this copolymer is no on the Ethyl Corp. 50 percent ethanol / mil (0.0025 centimeter), a density of 1.20 ^Monger used as a coating on fresh citrus extraction experiments referred to grams per cubic centimeter, and a vinyl ^ fruit. Therefore, the agency is proposing above), ingestion of vinyl chloride chloride monomer residual of5 ppb r to revoke the regulation permitting this monomer would be 8.4 nanograms per-^ would yield a maximum level in food of / use and is not including any day. This number is even more \ 0.010 ppb, if 1 square inch of film J contribution of vinyl chloride monomer conservative than that calculated for Contacts 10 grams of food--FDA's usual from this use in its calculation of the liquor because water does not extract assumption; Analyses of plasticized film estimated daily intake. vinyl chloride monomer as well as for vinyl chloride monomer have<- 6. Other uses. FDA has only included alcohol and migration into a beverage generally shown residual vinyl chloride the primary probable contributors in containing 14 percent or less alcohol monomer levels of less than 5 ppb estimating the daily intake of vinyl should be lower than migration into (Dennison, et e\,, Journal of the chloride monomer. It has not included beverages containing 50 percent alcohoL- Association of OfficialAnalytical other food-contact uses of vinyl chloride Furthermore, as with liquor, the Chemists. 61:4:813-819.1978). The homopolymers and copolymers because assumption that all wine will be assumption of 100 percent migration is they contribute such a small amount of packaged in vinyl chloride polymer likely to be an exaggeration even for use vinyl chloride monomer to the diet that, 'ties is highly conservative. (The with fatty foods such as meat and in view of the conservatisms used in responding MRCA 14-day survey, poultry, which would extract vinyl estimating exposure from the primary gives a level of 78 grams per day for the 1 chloride monomer to a greater extent contributors, they can be disregarded. 90th percentile user.) than other nonalcoholic foods. An example of these uses includes vinyl X Oil bottles. There are vinyl chloride' Currently, food packaged in chloride copolymers used as coatings, polymer vegetable oil bottles on the plasticized film is estimated to be about where heat treatment of the coating market and. although the number of 5 percent of the diet. Industry after application would reduce vinyl these bottles is small, there are projections indicate that this percentage choride monomer in the coating to levels indications that the number will may rise to about 7.5 percent in 5 years. not measurable by current analytical increase. In contrast to the consumption FDA used the latter value in computing technology. Additionally, uses of vinyl pattern for liquor and wine, fats and oils its estimates. chloride in articles such as water pipe or are consumed by almost the entire Considering migration, fraction of the filters can be disregarded. These articles population. In 1978, salad and cooking diet-packaged in film (7.5 percent), and a have a long service life, come into oil consumption (including oils used in total dietary intake of 3,000 grams per .. contact with extremely large amounts of commercial salad dressings) averaged day, FDA estimates exposure to vinyl water and other food, and will contain 22M pounds per person per year ("Fats- : chloride monomer from the use of vinyl- small amounts of vinyl chloride and.Oils Situation," USDA. May 1980) or chloride homopolymer film to be 2.2 monomer. Therefore, FDA believes that 28 grams per day per capita. For food. nanograms per day ("Guidelines for these uses will not contribute any items with broad consumption patterns, Estimating Exposure to Indirect Food measurable amounts of vinyl chloride the 90th percentile users' intake is Additives," FDA, June 1981). monomer when used in accordance with generally about two times the per capita 5. Vinyl chloride-vinylidene chloride the proposed regulations. - intake and yields an estimated 58 grams . copolymers--(i) Films. Although the use To obtain an estimate of the upper per .day for 90th percentile users of salad of this type of film with food is more limit vinyl chloride monomer exposure and cooking oil. (The MRCA 90th limited than the use of vinyl chloride from all food-contact uses of vinyl percentile level for retail salad and homopolymer films, residual vinyl x chloride polymers, FDA has summed the cooking oils is a much lower 5.2 grams chloride monomer jevels are higher than upper limit exposures from each of the per day.) those encountered in vinyl chloride primary contributors to the exposure. Experimental results demonstrate that homopolymer films. If the vinyl chloride \ FDA considers it unlikely that a high the migration rate of vinyl chloride monomer residual is 50 ppb, a level th?f- user of vinyl chloride polymer food- monomer,from a rigid vinyl chloride . FDA believes is the lowest level ^ ` contact products would be exposed at : polymer bottle into, a vegetable oil achievable with current technology, a' maximum levels of vinyl chloride approximates the migration rate into 50 ' calculation similar to that for, - monomer from each use. Because it is -- -cent alcohol. (See, e.g., extraction homopolymer film yields a level of 0.14 most unlikely that a 90th percentile wine ults reported by Ethyl Corp. in the. '. ppb-in food from 10O^ercent migration. consumer is also a 90th percentile liquor April 1975 issue of "Modern Information submitted-by industry: consumer, particularly on a lifetime - Packaging.") From Information supplied indicates that 1.5 percent to 2.8 percent ; basis, these two exposure estimates are BFG10848 Federal Register / Vol. 51, No. 22 / Monday, February 3, 1986 / Proposed Rules 4183 not added together, instead, FDA is sanctions discovered since publication V. Proposed Regulations using the higher value for wine in the vinyl chloride monomer cumulative calculation. FDA conservatively of that proposal. As discussed above, the use of a substance is excluded from the A. Currently Regulated Polymers In order to provide for the safe use of estimates that the lifetime-averaged individual exposure to vinyl chloride monomer from the probable food- definition of "food additive" m section 201{s) of the act if that use is in accordance with a "sanction or approval vinyl chloride polymers currently regulated under Title 21 of the Code of Federal Regulations, FDA is proposing contacl use of vinyl chloride polymer* will not exceedj^jonograms per day. granted prior to the enactment of the Food Additives Amendment Section the following: 1. In 5 172.210 Coatings cm fresh citrus 2. Extrapolation of Risk 181.5 of FDA's regulations (21 CFR 181-5) provides that a prior sanction exists The agency used a quantitative risk only for specific uses of a substance; be assessment procedure (linear at the levels required for the technical proportional model) to extrapolate from effects and in the food categories for the dose in the animal experiment to the which there is explicit approval As a very low doses of possible human exposure. This procedure is not likely to underestimate the actual risk from very low doses. In fact, the estimate of the risk is most likely exaggerated because the extrapolation models used are designed to estimate the maximum possible risk consistent with the data. For this reason, the estimate can be used with confidence to determine to a reasonable certainty whether any harm will result from the use of vinyl chloride polymers, FDA has used data from a carcinogenicity bioassay in which vinyl chloride monomer was administered in the diet of rats to estimate the upper result, some uses of a substance may be food additive uses while other uses may be prior sanctioned. Indeed. FDA regulations list uses of a number of substances, including vinyl chloride polymers, in each category. The 1975 proposal listed several priorsanctioned uses of vinyl chloride polymers and requested that firms holding other valid prior sanctions for these polymers forward them to FDA for inclusion in the final regulation. There were no submissions in response to that - request Subsequently. FDA reviewed its files on all firms that were known to be level of human risk from exposure to manufacturing vinyl chloride polymers this impurity from the proposed use of for use in food-contact articles before vinyl chloride polymers (Feron et al. the effective date of the Food Additives study and memorandum dated May 27, Amendment.to the acL This review 1984, from Cancer Assessment revealed the following additional prior Committee to V. Anand. FDA). sanctions: f FDA has calculated that the "\ 1. Letter to Firestone Plastics Co., 1 individual lifetime risk of cancer from / Poitstown. PA, dated April 20,1951, exposure to vinyl chloride monomer at S permitting the use of vinyl chloride [^25 nanograms per day fa 1pm than.1 in If)] resins as films for food packaging. million. Because of numerous 2. Letter to Firestone Plastics Co- conservatisms in the exposure estimate, Pottstown, PA, dated October 5.1956. lifetime-averaged individual exposure is Permitting the use of rigid polyvinyl expected to be substantially less than 25 chloride (homopolymer) sheet for nanograms per day. Thus, the agency packaging poultry. concludes that there is a reasonable 3. Letter to Firestone Plastics Co- certainty of no harm from the exposure Pottstown, PA dated February ZL. 1957. to vinyl chloride monomer that may permitting the use of vinyl chloride and result from the use of vinyl chloride vinyl chloride-acetate resins for "food polymers in food packaging complying wrapping purposes.*' with the vinyl chloride monomer 4. Letter to Borden Co- Santa limitations set forth in this document. Barabara. CA dated August 15,1957. These limitations on residual vinyl Permitting the use of vinyl chloride chloride monomer ate necessary to polymers as tubing for food-contact use. ensure that the present and future FDA is proposing to establish $ 181.37 exposure to vinyl chloride monomer In to cover those uses of these vinyl the daily diet remains within the limits chloride polymers for which used to conclude that vinyl chloride documentation of the prior sanctions is polymers may be used safely. available. FDA's review of its files for V. Prior sanctions all known pre-1958 manufacturers failed to locate any documentation of a prior fruit, FDA is proposing to delete the use of vinyl chloride-vinylidene chloride copolymer, and the adjuvants used in its production, as components of coatings on fresh citrus fruit The only known manufacturer of this copolymer reported to FDA that the material has not been used to coat fresh citrus fruit For many years, and that there are no plan* to market the product for this use in the future. Deletion of the additive vinyl chloride-vinylidene chloride copolymer in this regulatoin will also result in the deletion of polyethylene glycol, polyvinyl-pyrrolidone. potassium persulfate, propylene glycol alginate, and sodium decylbenzene sulfonate from S 172.210. because Che only use of these adjuvants permitted by this regulation is in vinyl chloride-vinylidene chloride coplymere. The deletion of these adjuvants has no effect on their status in other food additive regulations. 2. In 175.105 Adhesives, FDA is proposing to establish a limit on residual vinyl chloride monomer of 5 ppb by weight of the vinyl chloride homo- or copolymer component of the adhesive. 3. In 175300 Resinous andpolymeric coatings, for the vinyl chloride homo- or copolymer component of the coatings. FDA is proposing to establish a limit on residual vinyl chloride monomer of 5 ppb by weight. 4.1175,320 Resinous andpolymeric coatings forpolyolefin films. FDA is proposing to establish a limit on residual vinyl chloride monomer of S ppb by weight of the vinyl chloride copolymer component of the olefin polymer coating. 5. 178.170 Components ofpaper and paperboard in contact with aqueous and fattyfoods. FDA is proposing to establish a limit on residual vinyl chloride monomer of5 ppb by weight of the listed vinyl chloride copolymer components of the paper and paperboard. 8. In 5 176.180 Components ofpaper and paperboard in contact with dry foods, FDA Is proposing to establish a limit on residual vinyl chloride monomer The agency is proposing to establish a sanction for a rigid or semirigid vinyl of 5 ppb by weight of the vinyl chloride listing of all known prior sanctions for chloride polymer bottle. The only homo- of copolymer component the use of vinyl chloride polymers in documented prior sanctions for rigid )C 7. In 5 177.1010.Acrylic and modified packaging materials. These prior vinyl chloride polymer that the agency acrylic plastics, semirigid and rigid, sanctions include those listed in the 1975 found were for waterpipe and poultry FDA i< proposing to establish a limit on proposal, as well as additional prior packaging trays. residue! vinyl chloride monomer of 5 BFG10849 4184 Federal Register / Vol. 51, No. 22 / Monday, February 3, 1986 / Proposed Rules b by weight of the vinyl chloride provides for the use of those vinyl copolymers as a component of coatings jolymer component. chloride polymers that are not covered of fresh citrus fruit. 8. In 5 177.1200 Cellophane, FDA is by a valid prior sanction or by existing Following publication of the 1975 ~ proposing to establish a limit on residual regulations. proposal, the Environmental Protection vinyl chloride monomer of 5 ppb by This regulation proposes various Agency (EPA), under authority of the weight of the vinyl chloride homo- or ' specifications, including^ residual vinyl 1974 Safe Drinking Water Act. executed copolymer components. chloride monomer limit of 10 ppb by a memorandum of understanding (MOU) 9. In 1177.1210Closures with sealing weight of the vinyl chloride polymer. with FDA (see 44 FR 42775; July 20, gaskets for food containers, FDA is proposing to establish a limit on residual vinyl chloride monomer of 5 ppb by weight of the vinyl chloride copolymer component. 10. In 177.1630 Polyethylene phthalate polymers, FDA is proposing to establish a limit on residual vinyl chloride monomer of 5 ppb by weight of the vinyl chloride copolymer component 11. In 177.1850 Textryls, FDA is proposing to establish a limit on residual vinyl chloride monomer of 5 ppb by weight of the vinyl chloride copolymer component 12. In 177.1950 Vinyl chlorideethylene copolymers, FDA is proposing to establish a limit on residual vinyl chloride monomer of 10 ppb by weight of the vinyl chloride copolymer component. 13. In 177.1960 Vinyl chloride- . hexene-1 copolymers, FDA is proposing to establish a limit on residual vinyl chloride monomer of 10 ppb by weight the vinyl chloride copolymer . .omponent 14. In 177.1970 Vinyl chloride-lauryl vinyl ether copolymers, FDA is proposing to establish a limit on residual vinyl chloride monomer of 10 ppb by weight of the vinyl chloride copolymer component 15. In 177.1980 Vinyl chloridepropylene copolymers, FDA is proposing to establish a limit on residual vinyl chloride monomer of 10 ppb by weight of the vinyl chloride copolymer component C. Prior-sanctioned Polymers FDA is proposing new 181.37 Vinyl chloride homo- and copolymer resins, which sets forth all known prior sanctions for vinyl chloride homo- and copolymers and sets forth limits on residual vinyl chloride monomer in these polymers based on what FDA has determined the manufactuers are capable of achieving. The specific ; proposed limits, expressed by weight of the vinyl chloride homo- or copolymer component, are as follows: 1. In vinyl chloride homo- or copolymer films and coatings, except as noted below, FDA proposes to limit residual vinyl chloride monomer to 5 ppb by weight of the vinyl chloride homo- or copolymer component. 2. In vinyl chloride-vmylidene chloride films, FDA proposes to limit residual vinyl chloride monomer to 50 ppb by weight of the vinyl chloride copolymer ; component. 3. In vinyl chloride polymer waterpipe, FDA proposes to limit residual vinyl chloride' monomer to 50 ppb by weight of the vinyl chloride homopolymer component. 4. In plasticized vinyl chloride for use as flexible tubing and as gaskets and bottle or jar liners, FDA proposes to . limit residual vinyl chloride monomer to 5 ppb by weight of the vinyl chloride polymer components. 5. For rigid vinyl chloride polymer sheet, FDA proposes to limit residual vinyl chloride monomer to 10 ppb by 1979). That MOU established an agreement between EPA and FDA with regard to the control of direct and indirect additives in drinking water. According to that MOU, FDA has the regulatory responsibility with respect to water, and substances in water, used in food and food processing, as well as regulatory responsibility for bottled drinking water under the act. The MOU also gives primary regulatory responsibility to EPA for direct and indirect additives in municipal drinking water under the Safe Drinking Water Act. the Toxic Substances Control Act* and the Federal. Insecticide. Fungicide and Rodenticide Act. Therefore. FDA has deferred to EPA to prescribe conditions for the safe use of vinyl chloride polymer pipe in municipal . water systems. ~ The agency has carefully considered the potential envoronmental effects of. this action and has concluded that the . action will not have a significant impact on the human environment and that an environmental impact statement is not required. The agency's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday. This action was considered under FDA's final rule implementing the National Environmental Policy Act (21 CFR Part 25) that was published in the Federal 16. In 177.2250 Filters, microporous weight of the vinyl chloride polymer Register of April 26.1985 (50 FR 16636, . polymeric, FDA is proposing to establish component. effective July 25,1985). . a limit on residual vinyl chloride monomer of 50 ppb by weight of the VI. Conclusions FDA welcomes the submission of any data bearing on the issues and vinyl chloride homo- or copolymer Based on available toxicity data, the conclusions contained in the finding of component - i agency's exposure calculations, and its no significant impact and the 17. In 179.45 Packaging materials for estimates of the risk from the environmental assessment. FDA would use during the irradiation of carcinogenic constituent, vinyl chloride particularly like any additional prepackagedfoods, FDA is proposing to monomer, in the polymer when the . information on the environmental fate establish a limit on residual vinyl polymer complies with the (eg~per5isTencg)"oF3I(2-ethylhexyl) . chloride monomer of 5 ppb by weight of specifications that the agency is- phthalate, di(2-ethylhexyl) adipate, and the vinyl chloride copolymer component. proposing, FDA tentatively concludes expoxidized soybean oil in terrestrial ... B. Polymers Not Previously Regulated that the use of vinyl chloride polymers . arid benthic environments, and any as food-contact materials, as described additional information on the effects . In Part 177, FDA is also proposing to above Is safe. The agency is, therefore, (acute, subacute, and chronic) of these establish new. 177.1975 Vinylchloride proposing to amend the food additive chemicals on representative organisms polymer resins, rigid and semirigid, to. regulations and to adopt new from those environriients. FDA would . / provide for the safe use of rigid and regulations to provide for the safe use of also like.additional information on "' / emirigid vinyl chloride.polymers that vinyl chloride polymers. The agency is whether vinyl chloride polymers >j ave beenmarketed based on the belief . also proposing to delete from the current contribute to the emission of . / that they are covered for food use by a food additive regula lions the use of ' polychlorinated dibenzo^j-dioxins and valid prior sanction: This regulation.' vinyl chloride-vinylidene chloride ; polychlorinated dibenzoftwans from BFG10850 Federal Register / Vol. 51, No. 22 / Monday, February 3, . 1906 / Proposed Rules 4185 municipal solid waste incinerators. FDA 21 CFR Part 176 Substances Limitations wi! 1 reexamine its conclusionsJLnew informatfonFiecomes available suggesting that this action will have significant environmental impact. Food additives, Food packaging. 21 CFR Part 177 -- Polymers. Homopoiymera tod copolymers The agency has prepared an Food additives. Food packaging. Of the tollowing monomers: assessment concerning the economic impact of the proposed rule. The cost expected to arise from any final rule based on this proposed rule is the cost of reducing residual vinyl chloride 21 CFR Part 179 Food additives. Food packaging. Radiation protection. Vinyl chloride___ Residual vinyl chloride monomer content determined in the finished adhesives. using the method tfescnbed in 9 177.1975(c) of this chapter, shafl not exceed S parts per brition by weight of the vmyj chloride homo-^jy .CPtfQfrgtflr monomer to acceptable levels in foodcontact articles containing vinyl 21 CFR Partial component ~ r't /. ?-_______ ___ chloride. FDA has found that since 1975- . Food ingredients. Food packaging. e ':* * * * most vinyl chloride polymer resin manufacturers and manufacturers of food-contact articles containing vinyl chloride have made the changes in their manfuacturing processes that are necessary to produce vinyl chloride polymers that comply with this regulation. Therefore, this regulation should not produce any new................ developmental costs for manufacturers. The agency notes, however, that the improved methods of manufacturing vinyl chloride polymers are more expensive than those that were in use Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner' of Food arid Drugs, it is proposed that . Parts 172,175,176,177,179, and 181 be amended as follows: . PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION 1. The authority citation for 21 CFR Part 172 continues to read as follows: 5. In 175.300 by adding new paragraph (i) to read as follows: 175.300 Resinous and polymeric coatings. a* . (i) Residual vinyl chloride monomer content determined in the finished coatings, using the method described in 8 177.1975(c) of this chapter, shall not exceed 5 parts per billion bv weight of the vinyl chloride home- or copolymer component! before 1975. The agency estimates that , these new methods cost about $2.9 million more annually than their predecessors. Authority: Secs. 201(s). 409, 72 stat. 17841788 as amended (21 U.S.C. 321(a). 348); 21 CFR 5.10. FDA, in accordance with the ' . 2. In $ 172.210 by removing and ; Regulatory Flexibility Act. has ; reserving paragraph (b)(3) and by considered the effect that this proposal revising the introductory text of - would have on small entities including paragraph (b)(4) to read as follows:' 6. In 175.320 by redesignating paragraph (c) as paragraph (c)(1) and by adding new paragraph (c)(2) to read as follows: - 175.320 Resinous and polymeric ; coastings for polyolefin films . * * * small businesses and certifies in accordance with section 605(b) of the Regulatory Flexibility Act that no - $ 17Z210 Coatings on fresh citrus fruit **.* *'** * significant economic impact on a substantial number of small entities will result from this action. A copy of the assessment supporting these determinations may be seen in the Dockets Management Branch (address above). (b)* *"* , (3) [Reserved] (4) In lieu of the components listed in paragraph (b)(2) of this section, the . following rosin derivatives and either or both of the listed adjuvants: Interested persons may. on or before April 4,1986, submit to the Dockets (2) For coatings formulated with a vinyl chloride homo- or copolymer listed in paragraph (b)(3) of this section, residual vinyl chloride monomer content, determined in the finished matings, using the method described in 8 177.1975(c) of this chapter, shall not exceed 5 parts per billion by weight of the vinyl chlpride.copolymer cempgaent. J A. f Management Branch (address above) written comments regarding this proposal. Two copies of any comments ' are to be submitted, except that t PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS PART 176--INDIRECT FOOD : ADDITIVES: PAPER AND PAPERBOARD COMPONENTS individuals may submit one copy. : . 3. The authority citation for 21 CFR Comments are to be identified with the docket number found in brackets in the - Part 175 continues to read as follows: -7.The-authority-citation for 21 GFR......... - Part 176 continues to read as follows: heading of this document. Received comments may be seen in the office above between 9 a.m. and 4 p.m.,' Monday through Friday.' . List of Subjects Authority: Secs. 201(s), 409,72 Stat 1784- 1788 as amended (21 U.S.C. 321(s), 348): 21 CFR 5.10. '. 4. In 8 175.105 (c) (5) by revising the item "Vinyl chloride" to read as follows: Authority: Secs. 201(s), 409. 72 Stat. 1784- 1788 as amended (21 U.S.C. 321(s), 348); 21 ' CFR 5,10. '- - 1 ; " " \2 >V . 8. In 8 176.170(b)(2) in the table by adding limitations to the items "vinyl \ p/0 21 CFR Part 172 Food additive.s. .. 21 CFR Part 175 ; ; 5 175.105 Adhesives.''' - chloride copolymers,'' "Vinyl chloride- '/ vinyl acetate hydroxyl-modified ' copolymers," "Vinyl chlbride-vinylfw ,; acetate hydroxyl-modified copolymers. }=* reacted with trimellitic anhydride." and Adhesives, Food additives, Food .. packaging. . . v :. ... "Vinylidene chloride copolymers" to r >read a#follows:- .... BFG10851 <u 4186 Federal Register / Vol. 51, No. 22 / Monday, February 3, 1986 / Proposed Rules 76.170 Components of paper and ^perboard In contact with aqueous and fatty foods. ***** (b) * * ` (2) * * * , Usi ol substances Limitations Vinyl chloride copolymers Vinyl chloridevmyl acetate hydroxylmodified copolymers. Vmyl chloridevinyl acetate hydroxyimodffied copolymers racted with trimeftitic anhydride. Vnybdene . chloride copolymers For paper or paperboard in. the finishedform in which it is to contact food, residual vinyl chloride monomer, de termined by the method described in 177.1975(c) ol this chapter, shall not exceed S parts per Mbon by weight ol the vinyl chloride copolymer compo-am Do. Do. ft . 9. In 9 176.180(b)(2) by revising the item "Vinyl chloride" to read as follows: 9 176.180 Components of paper and paperboard In contact with dry foods. ' ft ft _ ft (b) * * * (2) * * a - List o< substances Urntebom Polymers:' Hompoiymert and copolymers of the tolowing monomers. Vmyl chloride.____ . For paper or paperboard in the finished term in which it is to contact food, residual vinyl chloride monomer, de termined by the method described in 1177.1975(c) of this chapter, shel no! exceed 5 parts per Mtion by weight of the vinyl chtorittohomo- or copolymer * $ - * * ft ft ` * PART 177--INDIRECT FOOD , ADDITIVES: POLYMERS 10. -The authority citation for 21 CFR Part 177 continues to read as follows: Authority: Secs. 201(s). 409. 72 Slat. 1784- ' 1788 as amended (21 U.S.G. 321(a), 348): 21, GFR5.10. _. 11. In 9 177.1010 by revising the introductory tests of paragraph (a) (2). and (4) to read as-follows: - 177.1010 Acrylic and modified acrylic plastics, semirigid and rigid. **** (a)* * * (2) Copolymers produced by copolymerization of one or more of the monomers listed in paragraph (a)(1) of this section with one or more of ihe following monomers, provided that for any articles that contain a vinyl chloride polymer, residual vinyl chloride monomer, tbe be determined in the finished form in which the articles are to contact food, using the method described in 177.1975(c), shall not exceed 5 parts per billion by weight-ofthe-vinyVehloride-copolymer^omponenU. ft* ' ft ' ft ft (4) Polymers identified in paragraph (a) (1), (2), and (3] of this section are mixed together and/or with the following polymers, provided that no chemical reactions, other than addition reactions, occur when they are mixed: provided further that for any polymers that include a vinyl chloride homo* or copolymer, residual vinyl chloride monomer, to be determined in the finished food-contact artirln using the method described in 177.1975(c), shall not exceed 5 parts per billion by weight of the vinyl chloride homo- or copolymer component' * '* * * * 12. In 9 177.1200(c) in the table by removing the item "Polyvinyl chloride," by revising the items "Polyvinyl stearate," "Vinyl acetate-vinyl chloride copolymer resins," "Vinyl acetate-vinyl chloride-maleic acid copolymer resins," "Vinylidene chloride copolymerized with * * *," and "Vinylidene chloridemethacrylic decyloctyl copolymer," and by adding new item "Vinyl chloride homopolymer" to read as follows: 9177.1200 Cellophane*. * * * ft (c) * * * Usl of substances limitations Vinylidene chloride copoly- merized with one or more ol the following: Acrylic acid, acrykyviriie, butyl ac rylate. butyl methacrylate, ethyl acrylate. 2-eihyfhe*yt acrylate. 2-ethyfriexyt meth acrylate. etbyt methacry late, itaconic acid, methacryfic sod. methyl acrylate, methyl methacrylate, propyl acrylate, propyl methacry late. v*nyl chloride. Do. Vinyl chloride homopolymer___As the basic polymer. For the finished cellophane base sheet intended to contact lood. residual vinyl chloride monomer, deter mined in the fcnahed sheet using the'medwd -besS&d in } 177.1975(c). shad not exceed 5 parts per brifion by weight ol vinyl chloride homo- or co polymer Component Vinylidene chloride- metha- As the basic polymer, cryfic decyiodyl copofymer. .see* 13. In 9 177.1210(b)(5) by revising the item "Vinyl chloride-vinyl stearate copolymer" to read as follows: 9177.1210 Closures with sealing gaskets for food containers. (b) * * * (5) * * * lilt of aubstenoea Limitations (expressed as percent of wsighf of cteaure-sealing gasfcef composition) Vinyl colond*- vinyl stearate copolymer. Heaidud vinyl chloride monomer, deter- mined In fte finished closures with seaRng gaiAett, using the method de scribed m f 177.1975(c). she! not exceed S pens par Mho* by weight of the viwyt chloride copotymor-compo- 14. In 9 177.1630(e)(4)(iii) by revising the item "Vinyl chloride" to read as follows: 9 177.1630 Polyethylene phthatate polymers. * * * ** LM ct substance* Limiuaon* Polyvinyl alaaralaA* tha baaic potymar. ae e a Vinyl eoetste-wnyt chtoridr copobpnaf ravin*. Vinyl acetate-vinyl chloride maleic add copotynw resins. As fee-basic pofymec. For tie finished ceHoohene_ b--e sheet tmended to ' confect food, residual vinyl chloride monomer, deter mined by the milhorf de scribed in f F77,197S<C). sheN not exceed 5 parts per bitton by weight of the vinyl chloride copolymer component Do. ) (e) * * * (4)*** (iii) * * * Vinylidene chloride copolymerized with one or more of the following: ... * ftft. . ft ' ; ft Vinyl chloride. Residual vinyl chloride monomer, determined in the finished ' copolymercoating, using the method described in 9 177.1975(c), shall not exceed 5 parts per billion by weight of-the-vinyl chloride copolymer-component.: Federal Register / Vol. 51, No. 22 / Monday. February 3, 1986 / Proposed Rules 4187 15. In 177.1850 by revising paragraph 177.1975 . Vinyl chloride polyer resins, (c)(2) to read as follows: rigid and semirigid. 177.1980 Vinyl chloride-propylene copolymers. 177.1850 Textryls. * (c) * * * Substances Limitations (2) Ftoryts prepared from vinyl cMonde* vmyt acetate copolymer. As the basic copolymer. For texlryts containing vinyl chloride-vinyl acetate copolymer, residual vinyl chloride monomer, determined in the finished food-contact article^ by trie method described~ih jTTV. 1975(c). shall not exceed 5 parts per WMon by weight oF tbe-vinyt^cbtonde copolymer-compo- -went--* * * * * * * * * 16. In 177.1950 by adding new paragraph (c](l)(iii) to read as follows: - 177.1950 Vinyl chloride-ethylene copolymers. * ft (c) ' * * (1) * * * (iii) Residual vinyl chloride monomer, determined in the finishedLfgod-contact article, using the method described in : ~ 177.1975(c), shall not exceed 10 parts per billion by weight of the-vmyl cUoride^polymer-component ; ' . .* ' * * * 17. In 177.1960 by adding new paragraph (b)(l)(iii) to read as follows: Vinyl chloride polynjers may be safely used as articles or components of articles intended for use in contact with food subject to the"provisions of this section. (a) Identity. Vinyl chloride polymer resins consist of (1) homopolymer resins produced by polymerization of vinyl chloride, which has the molecular formula G,H>C1 (CAS Reg. No. 75-01-4). Vinyl chloride polymer resins (molecular formula (G-HjCl),,: Cas Reg. No. 900286-2) have a maximum volatility of not over 3 percent when heated for 1 hour at 105 C (22l*F) and an inherent viscosity of at least 0.35 When determined by ASTM method D1243-79, "Standard Method of Test for Dilute Solution Viscosity of Vinyl Chloride Polymers" (Method A), which is incorporated by reference. Copies are available from the American Society for Testing Materials, 1916 Race St, Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 1100 L St,, NW.. Washington. DC 20408; and (2) copolymer resins produced by the copolymerization of vinyl chloride with other monomeric polymeric substances. (b) Conditions of use. Vinyl chloride polymers identified in this section may be used alone or admixed with polymer modifiers identified in accordance with the following prescribed conditions: (iii) Residual vinyl chloride monomer, determined in the finished Jpod-cgn.ta.ct article, using the method described in 177.1975(c). shall not exceed 10 parts per billion by weight eHhe~vtnyl chlnride-eepdymer-component. 21. In 177.2250 by redesignating existing paragraphs {e). (f). and (g). as paragraphs (f), (g) and (h). respectively, and by adding new paragraph (e) to read as follows: 177.2250 Filters, microporous polymeric. ft ft ft (e) Residual vinyl chloride monomer, determined in the finished microporous . .polymeric filters, using the method described in 177.1975(c). shall not exceed 50 parts per billion by weight of-- the vinyl chloride-honTe--orcopdymer component. ft ft ft ft ft PART 179--IRRADIATION IN THE PRODUCTION PROCESSING, AND HANDLING OF FOOD 22. The authority citation for 21 CFR Part 179 continues to read as follows: Authority: Secs. 201(s). 409,72 Stat 17841788 as amended (21 U.S.C. 321 (s). 348); 21 CFR 5.10. 177.1960 Vinyl chloride-hexene-1 copolymers. ft ft ft (1) No chemical reactions, other than addition reactions, occur among the vinyl chloride polymers and the 23. In 179.45 (b)(9) and (c)(2)(iv) by adding a new sentence at the end of each paragraph to read as follows: (b) * * modifying polymers present in the manufacture of the finished food-contact article. - 179.45 Packaging materials tor use during the Irradiation of prepackaged foods. (iii) Residual vinyl chloride monomer, (c) Limitations. The finished food- ft ft ft 'ft ' determined in the finished food-contact article, using the method described in 177.1975(c), shall not exceed 10 parts per billion by weight of-the-vinyl .chloride-copolymer component. * ft* ft ' ft contact articles, semirigid and rigid, for single or repeated use, shall not contain residual vinyl chloride monomer levels in excess of 10 parts per billion by weight of-the-vinyl chloride polymer (b) * * * . (9) * * * For vinylidene chloridevinyl copolymer films identified in this paragraph residual vinyl chloride monomer in the finished food-contact ' 18. In 177.1970 by adding new paragraph (c)(l)(iii) to read as follows: article, determined using the method method of analysis titled7"Headspace \ described in 177.1975(c) of this Sampling and Gas-Solid . \ chapter, shall not exceed 5 parts per 177.1970 Vinyl chloride-lauryl vinyl ether copolymers. * ft ft /fchromatographic Determination and \ \/ Confirmation of > 1 ppb Vinyl Chloride I Residues in Polyvinyl Chloride Food Packaging," which is incorporated by billion by weight of the vinyl chloride copolymer component. ft ft ft ft * (c)- * reference. Copies are available from the (c) * * * (IP Division of Food and Color Additives, (iii) Residual vinyl chloride monomer, ' Center for Food Safety and Applied determined in the finished food-contact Nutrition (HFF-330), Food and Drug article, using the method descrlbecTliP Administration, 200 C St. SW., . 177.1975, shall not exceed 10 parts per Washington, DC 20204, or available for billion by weight of-the-vinyl-chloride copolymer-component. . inspection at the Office of the Federal \ Register, 1100 L St. NW,, Washington. / * . ft MJC20408. ' ; --------- -- (2J*** (iv) * * * For vinyl chloride-vinyl acetate copolymer film identified in this paragraph residual vinyl chloride . monomer in the finished food-contact article, determined using the method described in 177.1975(c) of this chapter, shall not exceed 5 parts per billion by weight of the vinyl chloride 19. By adding a new 177.1975 to read 20. In 1177.1960 by adding new copolymer component. as follows: paragraph (c)(l)(iii) to read as follows: 21155015 BFG10853 4188 Federal Register / Vol. 51. No. 22 / Monday, February 3, 1986 / Proposed Rules . .,,RT 181--PRIOR-SANCTIONED (3) Waterpipe. Vinyl chloride polymer FOOD INGREDIENTS waterpipe used for carrying water inside 24. The authority citation for 21 CFR Part 181 is revised to read as follows: a food-processing plant. (4) Flexible tubing. Plasticized vinyl chloride homopolymer flexible tubing 1 Authority: Secs. 201(s), 402. 409. 701. 52 ranging in internal diameter front's to 4 / StaL 1046-1047 as amended, 1055-1056 as amended, 72 Stat. 1784-1788 as amended (21 U.S.C. 321 (s), 342. 348. 371); 21 CFR 5.10. inches for transporting food. ^ (5) Gaskets and bottle orjar liners. Vinyl chloride MjToTymeriresin 7 25. By adding new 5 181.37 to read as compositions colrtaTmng up to 80 percent follows: basic resin for use in contact with food. 181.37 Vinyl chloride homo- and copolymer resins. (a) Identity. Vinyl chloride homopolymers consist of basic resins produced by the polymerization of vinyl chloride monomer (molecular formula CiHaCl; CAS Reg. No. 75-01--4). Vinyl chloride homopolymer resins (molecular formula (CjHaCl) CAS Reg. No. 9002- 88-2) have maximum volatility of not over 3 percent when heated for 1 hour at 105* C (221 *F) and an inherent viscosity of not less than 0.35 when determined by ASTM Method D1243-79, "Standard (6) Rigid sheet. Vinyl chloride-vinyl acetate copolymers as basic resin in containers made from polymeric rigid sheet for packaging poultry only. (b) Limitations. (1) Residual vinyl chloride monomer, determined in the finished food-contact article described in paragraph (a) (1) (i). (ii), (iv) and (2) of this section, using the method described in paragraph (c) of this section, shall not exceed 5 parts per billionjjy weight of the vinyl chloride homoi'copoiymer component. (2) For vinyl chloride-vinylidene chloride copolymer film described in Method of Test for Dilute Solution Viscosity of Vinyl Chloride Polymers"' (Method A), which is incorporated by reference. Copies are available from the American Society for Testing Materials, paragraph (a)(l)(iii) of this section, residual vinyl chloride monomer, determined in the finished food-contact article using the method described in paragraph (c) of this section, shall not "'16 Race St,, Philadelphia, PA 19103, or exceed 50 parts per billion by weight of ;y be examined at the Office of the the vinyl copolymer component. rederal Register, 1100 L St. NW., (3) For vinyl chloride polymer Washington. DC 20408. Vinyl chloride waterpipe described in paragraph (a)(3) copolymer resins are the polymers of this section, residual vinyl chloride produced by the copolymerization of monomer, determined in the finished vinyl chloride monomer with other waterpipe using the method described in monomeric or polymeric substances. paragraph (c) of this section, shall not Vinyl chloride homopolymers and exceed 50 parts per billion by weight of copolymers may be safely used as vinyl chloride homoploymer component. follows: (4) For plasticized vinyl chloride (-1) Films, (i) Vinyl chloride polymers polymer for use as flexible tubing and as for use in plasticized film in contact with gaskets and bottle or jar liners made food. from vinyl chloride resin compositions (ii) Vinyl chloride-butadiene- (i described in paragraph (a) (4) and (5) of acrylonitrile copolymer for use in ,i this section, respectively, residual vinyl plasticized film in contact with f chloride monomer determined in the oleomargarine. finished food-contact article, using the (iii) Vinyl chloride-vinylidene chloride method described in paragraph (c) of copolymer for use in plasticized film in this section, shall not exceed 5 parts per contact with food. billion by weight of the vinyl chloride ' (iv) Vinyl chloride-vinyl acetate polymer component copolymer for use in plasticized film in (5) For rigid vinyl chloride-vinyl contact with food. ^*1^" acetate resin sheet described in (2) Coatings. (i)Vinyl chloridejfor use paragraph (a)(6) of this section. residual as a can enamel. vinyl chloride monomer, determined in (ii) Vinyl chloride-vinyl acetate the finished food-contact article using copolymer for use as a can enamel. (iii) Vinyl chloride-butadiene- the method described in paragraph (c) of this section, shall not exceed 10 parts acrylonitrile resin for use as a per billion by weight of the vinyl component of conveyor belts intended ,chloride copolymer component for use with freshJjuits, vegetables, and ' (c) Analytical method. The residual fish and as a component of coatings for - . concentration of vinyl chloride monomer per and paperboard in contact with in food-contact articles shall be V .eat and lari . (iv) Vinyl chloride-vinylidene chloride. determined by using.the method of analysis titled, "Headspace Sampling copolymer for use as a liner, i^., coating. and Gas-Solid Chromatographic for steel pipe. . , Determination and Confirmation of ' ppb Vinyl Chloride Residues in Polyvinyl Chloride Food Packaging," which is incorporated by reference. Copies are available from the Division of Food and Color Additives (HFF-330), Center for Food Safety and Applied Nutrition. Food and Drug Administration. 200 C St. SW., Washington, DC 20204, or may be examined at the Office of the Federal Register, 1100 L St. NW., Washington, DC 20408. Dated: January 27,1986. Frank E. Young, Commissioner ofFood and Drugs. (FR Doc. 88-2235 Filed 1-31-88; 8:45 amj BILLING COOE 4100-01-M 21 CFR Part 880 [Docket No. 85N-0285] General Hospital and Personal Use Devices; Premarket Approval of the Infant Radiant Warmer Correction In FR Doc. 86-832, beginning on page 1910 in the issue of Wednesday, January 15,1988, make the following corrections: 1. On page 1910, second column, first complete paragraph, second line, "21 U.S.C. 231(f)" should have read "21 U.S.C 351(f)". 2. On page 1911, third column, last line "Wn" should have read "Wu". BILLING COOE 15OS-01-N DEPARTMENT OF THE INTERIOR % Office, of Surface Mining Reclamation and Enforcement 30 CFR Part 93S Reopening and Extension of Public Comment Period on a Proposed Amendment to the Ohio Permanent Regulatory Program agency: Office of Surface Mining Reclamation and Enforcement (OSMRE), Interior. action: Reopening and extension of public comment period. summary: By letter dated November 6. 1984, Ohio submitted a program amendment consisting of a revision to rule 1501:13-14-03 concerning civil penalties. OSMRE published a notice in the Federal Register on December 12, 1984, announcing receipt of the amendment and inviting public comment on the adequacy of the proposed amendment (49 FR 48324). 21155016 BFG10854 Section 175.105 175.300 175.320 176.170 176.180 177.1010 177.1200 177.1210 177.1630 177.1850 177.1950 177.1960 177.1970 -177.1975 177.1980 177.2250 179.45 RVCM 5 ppb 5 ppb 5 ppb 5 ppb 5 ppb 5 ppb 5 ppb 5 ppb 5 ppb 5 ppb 10 ppb 10 ppb 10 ppb 10 ppb 10 ppb 10 ppb 5 ppb Subject Adhesive Resinous and polymeric coatings (can) Resinous and polymeric coatings for polyolefin films Components of paper and paperboard in contact with aqueous and fatty foods Components of paper and paperboard in contact with dry food Acrylic and modified acrylic plastics Cellophane Closures with sealing gaskets Polyethylene phthalate polymers Textryls (Fibryls) Vinyl chloride-ethylene copolymers Vinyl chloride-hexene-1 copolymers Vinyl chloride-lauryl vinyl-ether copolymers Vinyl chloride/polymer resins, rigid and semi-rigid ' Vinyl chloride-propylene copolymers Microporous polymeric filters Packaging materials for use during the irradiation of prepackaged foods (films) BFG10855 Ol Section 181.37 RVCM 5 ppb 50 ppb 5 ppb 10 ppb 2 Subject Vinyl chloride homo- and copolymer resins films and coatings (but 50 ppb for vinyl chlor ide-vinyl.idene chloride) Waterpipe inside food-processing plant Plasticized applications (flexible tubing, gaskets, bottle or jar liners) Rigid vinyl chloride-vinyl acetate sheet BFG10856 *3 $ O QD