Document pm2RGmGJvDGbX0E1a5vn7oLzE

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because, based upon new scientific and legal developments, FDA has decided that the actions outlined in the proposal -no longer represent the appropriate v course of regulatory action.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 20204.202^72-6690. 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 > the comments on that proposal are mooL 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), FD^V 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 m industry usage and in food i additive regulations when referring to copolymers, regardless of the major component. Although there may be some advantage 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 of vinyl 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. 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 tlie 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, A. Nomenclature packaging, transporting, or holding food, 1. One comment stated that vinyl chloride should be referred to as "vinyl chloride monomer" or as "VCM" in the various proposed regulations to prevent any misunderstanding about what particular substance is being prohibited. The comment further stated that the . and including any source of radiation intended for any such.use) * * (21 U.S.C. 321 (s)). Section 40S(d] of the act (21 U.S.C. 348(d)) authorizes FDA to establish regulations prescribing, with respect to any particular use of a food additive, the conditions under which identification of vinyl chloride monomer such additive may be safely used. should include its chemical formula Vinyl chloride polymer becomes a ((^HaCl), its alternative name component of food (a food additive) "chloroethene." and its Chemical when the unreacted 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. R - laboratories about vinyl chloride has done so in the proposal published polymers demonstrate that, under 21155001 41*4 Federal Register / Vol. 51, No. 22 / Monday, February 3, 1986 / Proposed Rules nL. ,.al 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, ^11 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 fora 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 5. Two comments stated that no final proposed rulemaking appearing model's success in predicting the ! action to ban rigid and semirigid vinyl 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 5 121,2009 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 migration of vinyl chloride monomer in articles that will contact all types of - perimental data, FDA concludes that from polymers that contain varying food or should be revised to allow the iyl chloride monomer is capable of levels of residual monomer (Division of 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 9121.2009 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. ' 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 6.1958. 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 without proof that those additional uses . FDA has further concluded that, given chloride monomer) in these polymers. ' 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. the prior-sanctioned uses of vinyl, migration from vinyl chloride polymers ' for a carcinogen at the level of . chloride polymers to cover contact with under the conditions of use 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 FDA agrees that vinyl chloride was submitted to FDA. FDA, however, Register. The agency, therefore, is polymers with unsafe levels of vinyl 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 diloride monomer. these polymers now can be - packaging. 2. Letter to Firestone Plastics 4. One comment contended that there manufactured with residual vinyl 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 CoPottstown, PA, Federal Register / Vol. 51. No. 22 / Monday. February 3, 1986 / Proposed Rules 4175 iated. February 21.1957, permitting the use of vinyl chloride and vinyl chloride- acetate resins for "food wrapping purposes." 4. Letter of Borden Co.. Santa Barbara,,CA. dated August 15.1957, permitting the use of vinyl chloride .polymers as tubing for food-contact use.) The agency has included these sanctions in its proposal published elsewhere in this issue of the Federal Register. The agency believes that all valid prior sanctions of vinyl chloride polymers are set forth in the new proposaL 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/acrylonitrile 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 I 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 prior.sanctions to copolymers rather than blends. Accordingly, in the proposal published elsewhere in this issue of the 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 of 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 started that the use of vinyl chloride polymers as coatings on fresh citrus fruits, which is permitted under 21 CFR 12M179 (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 the 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 Substances prohibitedfrom 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 polymers 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 horn vinyl chloride polymers. According to the. commenls, 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 V* H* O 4176 Federal Register / Vol. 51, No. 22 / Monday, February 3, 1980 ^ Proposed Rules :s of vinyl chloride polymers, i-.gardless of the monomer level in the polymers. Although the alternative- "active site" theory, if correct, would predict zero migralion of vinyl chloride monomer to food at some minimum residual monomer level, 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 not aware at this time of any mufacturing 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 inthe 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 he Federal Register. 16. One comment stated that the . sirictions on the use of rigid arid ' semirigid articles should be revised to permit their use with dry food, or that theproposed restrictions in the-'- regulations for adjuvants should be 152 Weeks." dated 1980); (4) CIVO eliminated. 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 Oral 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 aaueous. alcoholic, and fatty foods. Because FDA is no longer proposing to- ban 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 us8 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 baaed 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 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. - completed within 30 months. 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, 19:317-333,1981); (2) Maltoni et al. rat polymers. FDA has prepared two 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 environihental 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' report'entitled "An Investigation Into ' Dockets Management Branch (HFA- theCarcinogenic-Potential 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; " - '. Federal Register / Vol. 51, No. 22 / Monday, February 3, 1986 f- 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 comment contained data concerning the polymers. This action is takenunder 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). Dated: January 27,1988. 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., Washington. DC 20204, 202-472-5690. 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 Commissioner ofFood and Drugs. (FR Doc. 86-2236 Filed 1-31-86; 8:45 am) BILLING CODE 4160-01-M I. Introduction The purpose of this proposal is to provide for the safe use of vinyl chloride published elsewhere in this issue of the polymers in contact with food. 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 FR14463). The use of this policy was upheld by the 21 CFR Parts 172,175,176,177,179, Vinyl chloride is a.chemical with the and 181 formulaCjHiCCused as a monomer in fa [Docket No. 84N-0334] the producticm 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 the same substance, the resulting summary; The Food and Drug molecule is called a "homopolymer." Administration (FDA) is proposing to The vinyl chloride hoihopolymer is amend its regulations to provide for the sometimes called "polyvinyl chloride" safe use of vinyl chloride polymers. The (CAS Reg. No. 9002-66-2). agency is proposing: (l) To provide for the safe use of certain vinyl chloride When molecules of different chemicals are polymerized together, the polymers by establishing limits on the resulting molecule is called a \f) amount of residual vinyl chloride "copolymer." Thus, when ethylene / monomer that they may contain; (2) to molecules are polymerized to vinyl codify all known prior sanctions for chloride molecules, the resulting_____ vinyl chloride polymers; (3) to provide copolymer is called "ethylene vinylidene, for the use of certain previously unregulated vinyl chloride polymers in chloride."' Elsewhere in this issue of the Federal manufacturing vinyl chloride bottles; 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 - IL 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 , C2H3CT, Molecular weight: 62.5 carcinogenic impurity, but when the additive as a whole was tested in laboratory animals it did not induce cancer. This policy is explained in detail in that document (47JFR14463). Accordingly, FDA is withdrawing the A wide variety of vinyl chloride proposal published in the Federal. polymers, including homopolymer and Register of September 3,1975 (40 FR various.copolymers, are available for 40529). Published elsewhere in this, issue ; use in the production of articles of the Federal Register is a notice of. j - : intended to contact food, including food- equipment, flexible tubing, and .. waterpipe. Under section 201(s) of the Federal Foo.d, Drug, and Cosmetic Apt (.the act).... (21.U.S.C. 321(b)). a substance is . .,,. proposed rulemaking (hat.would :, [j, ,packaging materials,.-postings,, plastisols, : excluded from.the definition of a "food authorize the safe use of regulated and .. gaskets,.parts for foqd^processing.. ... . additive? if Reuse was.sanctioned by . 4178 Federal Register / Vol. 51, No. 22 / Monday, February 3, 1986 / Proposed Rules FL \fore September 6,1958, the date vinyl chloride monomer as high as 20 have been permitted under the(an/ of i. enactment of the Food Additives parts per million (ppm). Other 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 ldri973, 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 enameis. 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 articles. The regulations codifying these approvals include: 172.210 Coatings on fresh citrus fruit (formerly 121.1179): 175.105 Adhesives (formerly 121.2520}; 175.300 Resinous andpolymeric coatings (formerly 5 121.2514); 5 175.320 Resinous andpolymeric coating for polyolefin films (formerly 1121.2569); 176.170 Component ofpaper and p board in contact with aqueous and By March 1974, the agency had received information from various sources Suggesting that the migration of vinyl chloride monomer from vinyl 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 requested data from industry about the Data Received in Response to Proposal As a result of the September .3,1975 proposal, FDA received numerous 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 response to the September 1975 proposal ft bods (formerly 121.2526); use of vinyl chloride polymers, the showed that manufacturers had a. j.180 Components ofpaper and paperboard in contact with dryfood residual concentration of vinyl chloride succeeded in reducing the vinyl chloride monomer in vinyl chloride polymers, monomer levels in vinyl chloride (formerly 121.2571); 5 177.1010 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 121.2591); 177.1200 Cellophane (formerly 5 121-2507); $ 177.1210 Closures with sealing gasketsforfood containers (formerly 5 121.2550); 177.1630 Polyethylene phthalate containers. 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 cosmetic products and that required that ppm were common. Since then, improved manufacturing procedures have lowered the residual vinyl chloride monomer levels by more than five orders of magnitude. Although methods for reducing vinyl polymers (formerly 121.2524); a manufacturer obtain an approved new chloride monomer levels have varied - 177.1850 Textryls (formerly S 121.2545); 177.1950 Vinyl chloride- drug application before using vinyl chloride as a propellant in aerosol drug from company to company, such methods generally have involved ethylene copolymers (formerly products. This action was based on application of heat and vacuum during 5121.2609); s 177.1960 Vinyl chloride- evidence that inhalation of high processing of the resin. Manufacturers hexene-1 copolymers (formerly concentrations of vinyl chloride resulted have also taken steps to produce small, S 121.2623); $ 177.1970 Vinyl chloride- in acute toxicity that was manifested by porous resin particles, which have lauryU vinyl either copolymers an array of symptoms, including facilitated diffusion of the monomer out (formerly 121.2608]; 177.1980 Vinyl unconsciousness, cardiac effects, bone of the resin. chloride-propylene copolymers changes, and degenerative changes in I Substantiation of the reduction in (formerly 5 121.2521); 5 177.2250 the brain, liver, and kidneys. I vinyl Chloride monomer has been Microporous polymericfilters (formerly As a result of the many comments that provided by reports of residual vinyl 121.2631); and $ 179.45 Packaging the agency received on the April 22,1974 chloride monomer levels of 10 ppb in materials used during the irradiation of packagedfoods (formerly 121.2543). The.renumbering of these sections occurred as part of a recodification that FDA announced in the Federal Register of March 15,1977 (42 FR14302). . proposal, in the Federal Register of September 3.1975 (40 FR 40529), FDA proposed further restrictions on the use of vinyl chloride polymers in contact with food. Underthe September 1975 proposal, vinyl chloride polymer bottles (The Society of the Plastics Industry, Inc., November 12,1982} and an estimated 100 parts per trillion in can coatings (Union Carbide Co., December 12,1980) The Society of the Plastics Industry, - On January 4,1973, representatives of- rigid and semirigid vinyl chloride Inc. (SPI), in a submission (November f -dey Distillers met with FDA to - polymers would have been banned from 12,1982) on behalf of the vinyl chloride r t the results of analyses that : . food-contact use because of possibly polymer manufacturers, informed the s*. - .<red that alcoholic beverages stored unsafe levels of vinyl chloride monomer V agency "that with respect to vinyl ' in vinyl chloride polymer battles for migration, although continued use of \ chloride polymer bottles, the industry periods of up to 9 months-had levels of.. vinyixhloride polymer waterpipe would > Nmn provide products With residual - 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 veighl." The SP1 submission further differential equations expressing these levels in the extract from the 0.28 ppm stated "ihe quantity of vinly chloride laws contain a variable called sheet averaged 1.6 ppb (Diachenko, et available to migrate is so low, and the difrusivity. The form oUhe 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 contents even after an exaggerated / initiation of diffusion of vinyl chloride shelf-life exposure at moderately monomer, such as the intitial residual elevated temperatures will nof exceed monomer concentation. the safe {0.073 ppb) level." When applied to the particular To monitor the level of residual vinyl situation of monomer migration from a chloride monomer in vinyl chloride bottle, such as vinyl chloride monomer polymers, the agency has developed a from a vinyl chloride polymer bottle, the I sensitive gas chromatographic method diffusion equations derived from Fick's / titled "Head Space Sampling and Gas- Second Law always predict a finite Solid Chromatographic Determination migration of the monomer based on and Confirmation of >1 ppb Vinyl initial monomer concentration in the Chloride Residues in Polyvinyl Chloride bottle wall, provided diffusivity is not Food Packaging" (J.L Dennison, et al.. zero. Only if diffusivity is zero would no Journal of the Association of Official migration be likely. Analytical Chemists, 61:813-819.1978). Based on its review of published This analytical method has been tested experimental results and of theoretical by FDA and by at least one major calculations based on numberous manufacturer of vinyl chloride polymers systems, FDA believes that the___ and has been found to yield satisfactory diffusivity of vinyl chloride monomer in analytical results. However, the method vinyl chloride polymer will always be . has not been tested with all possible greater than zero, and that migration vinyl chloride-based food-contact will occur whenever residual vinyl ( articles. FDA invites comment* "" chloride monomer(^present in' the A? applicability of this analytical method polymer. and will consider, anyjcomments ; In a series of reports dating from received in developing a final rule. January 17.1975. Ethyl Corp, proposed 111. 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 Section 201(s) of the act defines a the initial residual vinyl chloride "food additive" as "any substance the intended use of which results or may monomer concentration in the bottle wall and the diffusivity are known. reasonably be expected to result, Ethyl Corp. originally applied this directly or indirectly, in its becoming a diffusion model to extraction data techniques, from vinyl chloride polymers that contain vinyl chloride monomer at the level of less than one ppm. According to the model, as migrant concentration in a polymer is reduced, the contribution to diffusion from the interaction among migrants also decreases. In the limiting case of a single migrant molecule, the only interaction that will occur is between the migrating monomer and the polymer. Even though diffusivity will be reduced to a finite constant in this case, it will not become zero. Thus, even when the 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). Therefore, based on the evidence . before it, FDA concludes that vinylchloride polymer will become a : component of food, and that the extent to which this will be the ease depends, 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 carcinogen. FDA has decided to regulate the use of vinyl chloride polymers under the act (21 U.S.C. 348) to ensure that the polymer that is marketed does not 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 IV. Carcinogenic Impurities Approach to vinyl chloride monomer at levels of from 80 to 330 parts per million (ppm). This 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 p 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. - contacbarticles. 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 Fick'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 ,180 Federal Register / Vol. 51, No. 22 / Monday, February 3, 1988 / Proposed Rules or tl ,se. The concept of safety The Delaney or anti-cancer clause is In the Maltoni study vinyl chloride mbodied in this requirement was not triggered unless the additive as a monomer was administered by various xplained in the legislative history of the whole is found to induce cancer. An routes (including oral gavage), doses, ood Additives Amendment of 1958. additive that has not beer^shown to . and schedules of treatment, to animals Safety requires proof of a reasonable induce cancer but that contains a of various species, strains, sex, and age. ertainty that no harm will result from a carcinogenic impurity is properly For the oral portion of the study, iroposed use of an additive. It does evaluated under the general safety Sprague-Dawley rats were administered iot--and cannot--require proof beyond clause of the statute, using risk vinyl chloride monomer in olive oil by ny possible doubt that no harm will assessment procedures to determine gavage for 52 weeks (5 times/week) and esult under any conceivable whether there is a reasonable certainty kept until spontaneous death (138 ircumstance." H. Rept. 2284, 85th Cong., that no harm will result from the weeks). The report contains few details d Sess. 1 (1958). This definition of proposed use of the additive. on the experimental design. However, afety is incorporated in FDA's food Therefore, because vinyl chloride the results of the oral portion of this ;dditive regulations (21 CFR 170.3(i)). polymers, manufactured from the study suggest that vinyl chloride 'he Delaney anticancer clause of the 'ood Additives Amendment of 1958 component vinyl chloride monomer, have not been shown to cause cancer, monomer is an animal carcinogen. The ' results have not been used for the section 409(c)(3)(A) of the act (21 U.S.C. 48(c)(3)(A)) provides further that no ood additive can be deemed to be safe f it is found to induce cancer when ngested by man or animal. In the past, FDA often refused to list a ood or color additive that contained or vas expected to contain minor amounts if a carcinogenic chemical, even if the 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. 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, idditive as a whole had not been shown B. Carcinogenicity Data on Vinyl o cause cancer. As explained below, Chloride Monomer lowever, scientific developments and xperience with risk assessment irocedures have made it possible for DA appropriate circumstances, to ippi the use of additives that :ont<. a carcinogenic chemical. In the preamble to the final rule lermanently listing D&C Green No. 0 mblished in the Federal Register of Vpril 2,1982 (47 FR 14138), FDA explained the basis for approving the 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 ise of a color additive that had not been hown to cause cancer, even though it ontains a carcinogenic constituent. Since that decision, FDA has listed, on he same basis, the uses of several color 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 idditives that contain carcinogenic mpurities, including the use of D8tC Investigation into the Carcinogenic Potential of Vinyl Chloride Monomer Jreen No. 6 for coloring contact lenses when Administered to Rats in the 48 FR 13020; March 29,1983) and the Drinking Water for up to 152 weeks," ise of DSC Green No. 5 (47 FR 24278: ' and (4) CIVO Institute's TNO une 4,1982) and of DSC Red No. 8 and unpublished study (1983) entitled JSC Red No. 7 (47 FR 57881; December "Lifespan Oral Carcinogenicity Study of 8,1982) for coloring drugs and Vinyl Chloride in Rats." osmetics. (See also the advance notice In the Feron et al. study, Wistar rats if proposed rulemaking published in the were fed a diet containing vinyl chloride :ederal Register of April 2,1982 (47 FR monomer in vinyl chloride homopolymer 4462).) powder or were administered vinyl The appropriateness of FDA's chloride monomer in soybean oil by lecision to list the uses of these color gavage. The results of this study show idditives is supported by Scott vrFDA, that vinyl chloride monomer is a 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 28 F.2d 322 (6th Cir. 1984). That case carcinogen in Wistar rats, inducing exposure/ nvolved a challenge to FDA's decision neoplastic liver cell nodules, An extensive review of the . o approve the use of DSC Green No. 5, hepatocellular carcinomas, and toxicological effects of vinyl chloride vhich contains a carcinogenic chemical angiosarcomas of the liver and the lung. monomer has also been presented in tut h iot itself been shown to cause The agency chose this study for International Agency for Research on :anc elying heavily on the reasoning computation of the risk for human n th>. 0ency's decision, the U.S. Court exposure to vinyl chloride monomer Cancer (IARC) monograph No. 19 (published February 1979), which was if Appeals for the Sixth Circuit rejected because it was a lifetime (135 to 144 prepared by an IARC evaluation group he challenge to FDA's action and weeks) feeding study, and because the that met in February 1978. The iffirmed the listing regulation. individual animal data were available. evaluation group concluded that vinyl 2A155008 Federal Register / Vol. 51. No. 22 / Monday. February 3, 1986 / Proposed Rules 4181 chloride monomer is a carcinogen in inimals (both via inhalation and oral f far been demonstrated only in workers ' liters (letter dated August 17,1983, from who were.involved in the production, The Society of the Plastics Industry, outes) and in humans (inhalation), it polymerization, and processing Inc.). If the vinyl chloride monomer found that vinyl chloride monomer is industries and who wp exposed to residual level is 10 ppb. the proposed carcinogenic by the inhalation route to high environmental concentrations of limitation in 177.1975, and if 100 mice. rats, rabbits, hamsters, and vinyl chloride monomer vapor. Based on percent migration occurs, the predicted humans. The evaluation group also its own review of*the data, FDA concurs vinyl chloride monomer level m the found that the monomeT produces with this conclusion. beverage would be 0.65 ppb. The 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 (IARC Monographs. Supplement 1, p. 45.1979); A. Evidence for Carcinogenicity to Homans (Sufficient) Vinyl chloride causes angiosarcomas of the liver; H 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 Carcmogenicity to Aainsb (Sufficient} Vinyl chloride is carcinogenic to mice, rats, and hamsters after its administration orally ' 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 methods. vinyl chloride polymers, the agency has The actual migration expected over used risk assessment procedures that the shelf life of liquor is likely to be are similar to those that it used in lower based on experimental migration evaluating the risk from the minor levels from containers having higher carcinogenic impurities that may be residual monomer levels. For example, present in the color additives that FDA when bottles containing 0.9 ppm discussed, above. residual vinyl chloride monomeT were The risk evaluation of the extracted with 50 percent ethanol for 9 carcinogenic constituent has two months at 72* F, no vinyl chloride 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. monomer could be detected in the solvent at a level of detection of 10 ppb (Ethyl Corp., report dated September 27, 1976). Therefore, if it is assumed that , migration occurs at the level of detection, 5.5 percent of the residual vinyl chloride monomer migrated. Because diffusivity has been shown by or by inhalation, producing tumors at several sites, including.angiosarcomas of the liver. C. Evidence far Activity m Short Term Tests (Sufficient) Vinyl chloride induces DNA damage in prokaryotes and.in mammalian cells in vitro. It was mutagenic to Salmonella typin'murium in the absence of an exogenous metabolic activation system and to Escherichia colL Schizosaccharomyces pombe and Sacchammyces cerevlsiae but not to Neurvspora crassa. ft was mutagenic to Drosophila mekmogaster, inducting sex- linked recessive lethal mutations and to hamster cells in vitro. It induced chromosomal aberrations and sister chromatid exchanges in Chinese hamsters exposed in vivo. 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 aormaLJ The 19^9 monograph concluded that, 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 vinyLchloridepolymers as potential well aradditional uses taking intcTaccbunt \ the fraction of the daily diet that might be packagedin materials made of vinyl chloride polymers. Vinyl chloride monomer exposure may be estimated using known vinyl chloride monomer residuals in the vinyl chloride homopolymer or copolymer and vinyl chloride monomer is reduced, the percent migration must also decrease. Therefore, 5.5 percentmigration of residuaTvinyThHibride mcmomerfrom-^ bottles containing 10 ppb vinyl chloride ) nomer is an upper limit, if 5.5 percent ofTHe available vinyl chloridelndnomer migrates from a 175-liter bottle having 10 ppb residual vinyl chloride monomer, the predicted level of vinyl chloride y monomer in the packaged food would be V(M)36 ppb. 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 forvinyl chloride polymers and Statistics Division, Distilled Spirits are as follows: Council of the United States, Inc.), per 1. Liquor bottles. Because this nse of capita liquor consumption in 1980 was vinyl-chloride polymers is not permitted 1.98 gallons or about 19 grams per day. by current regulations or by a prior sanction, there are no available The average vinyl chloride monomer 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 Survey, 1977-1978. Of the 37,874 conservative assumption that all liquor 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 40 grams per day. The 90th polyethylene terephthalate and glass, percentile intake for users was 98 grams which are currently used for packaging per day. If this latter value is usei vinyl while vinyl chloride monomer is an liquor,. chloride monomer exposure becomes 3.5 established animal carcinogen, via both - A typical vinyl chloride ploymer \ nanograms per day. This number is inhalation and oral ingestion, its liquor bottle will weigh approximately carcinogenic activity in humans hag so - 105-grains and ha ve a capacity of 1.75 conservative because users who consume liquor less frequently than 4102 Federal Register / Vol. 51, No. 22 / Monday, February 3, 1986 / Proposed Rules i in 3 days were not included in the by The Society of the Plastics Industry', of the total daily diet is packaged in s, y. 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 homopolymerfilm. 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 film can be obtained by telephone conversation, M. Flood, FDA, Consumption Survey; 1977-1978). If all assuming that all of the vinyl chloride and ]. Cobler. Dow Chemical Co- this wine contained vinyl chloride monomer in the film migrates into food. N 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 t has determined that this copolymer is no on the Ethyl Corp. 50 percent ethanol / mil (0.0025 centimeter), a density of 1.28 '/'longer used as a coating on fresh citrus extraction experiments referred to grams per cubic centimeter, and a vinyl i*i fruit. Therefore, the agency is proposing above), ingestion of vinyl chloride chloride monomer residual of 5 ppb to revoke the regulation permitting this monomer would be 8.4 nanograms per-^ day. This number is even more would yield 0.010 ppb, if a 1 maximum level in food square inch of film ofj/ucsoentarinbduitsionnoot finvcinluydlicnhgloarnidye 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 al.. Journal of the chloride monomer. It has not included beverages containing 50 percent alcohoL- Association of Official Analytical other food-contact uses of vinyl chloride Furthennore, as with liquor, the Chemists, 61:4:813-319.1978). The homopolymers and copolymers because assumption that all wine will be assumption of 100 percent migration is they contribute such a small amount of p lged in vinyl chloride polymer likely to be an exaggeration even for use vinyl chloride monomer to the diet that, b s is highly conservative. (The with fatty foods such as meat and in view of the conservatisms used in Cc -sponding MRCA 14-day survey, poultry, which would extract vinyl estimating exposure from the primary gives a level of 78 grams per day for the 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 3. 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 224} 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 56 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 per day.) chloride monomer levels are higher than upper limit exposures from each of the those encountered in vinyl chloride J\ primary contributors to the exposure. Experimental results demonstrate that homopolymer films. If the vinyl chloride 1l!* FrmDAac__o__n_s_JidJ_e_r__sisit__u__nUlitk__e1l_y. itLh_ait _a Lhiig.Lh the migration rate of vinyl chloride monomer residual is 50 ppb, a level thpi- user of vinyl chloride polymer food- monomer, from a rigid vinyl chloride . FDA believes is the lowest level y contact products would be exposed at polymer bottle into, a vegetable oil achievable with current technology, a maximum levels of vinyl chloride - ar ximates the migration rate into 50 ' calculation similar to that for / .; ; monomer from each use. Because it is - pi it alcohol. (See, e.g.. extraction : homopolymer film yields a level of 0.14 - most unlikely that a 90th percentile wine re. .a reported by Ethyl Corp. in the.. . ppb in food from 100*percent migration. consumer is also a 90th percentile liquor April 1975 Issue of "Modem Information submittedby 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 '&><> f*'- ^ r>opP 6 ., Federal Register / Vol. 51, No. 22 / Monday, February 3, 1986 f Proposed Rules 4183 4 added together. Instead. FDAis ing the higher value for wine in the . tnyl chloride monomer Camillafive calculation. FDA conservatively estimates that the lifetime-averaged individual exposure to vinyl chloride monomer from the probable foodcontact use of vinyl chloride polymer* will not exceed ^ponograms per day. sanctions discovered since publication of that proposal. As discussed above, the use of a substance is excluded from the definition of "food additive" m section 201{s) of the act if that use is in accordance with a "sanction or approval granted prior to the enactment of the Food Additives Amendment. Section 2. Extrapolation of Risk 181.5 of FDA's regulations (21 CFR 181.5) The agency used a quantitative risk provides that a prior sanction exists only for specific uses al a substance; Te assessment procedure (linear proportional model) to extrapolate from the dose in the animal experiment to the very low doses of possible human exposure. This procedure is not likely to underestimate the actual risk from rery low doses. In fact, the estimate of the risk is most likely exaggerated because the extrapolation models used are designed to estimate thp 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. FT)A has used data from a carcinogenicity bioassay in which vinyl chloride monomer was administered in the diet of Tats to estimate the upper level of human risk from exposure to this impurity from the proposed use of vinyl.chloride polymers (Feron et al. study and memorandum dated May 27, 1984, from Cancer Assessment ^Committee to V. Anand, FDA). at the levels required for the technical effects and in the food categories for which there is explicit approval. As a 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 linns that were known to be manufacturing vinyl chloride polymers for use in food-contact articles before the effective date of the Food Additives Amendment.to the act. This review revealed the following additional prior sanctions: FDA has calculated that the 1. Letter to Firestone Plastics Co., I individual lifetime risk of cancer from / Pottstown. PA. dated April 20.1951, exposure to vinyi chloride monomer at ^ permitting the use of vinyl chloride 25 nanoyrams per day is less than-1 in it)) 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, die 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 2JL. 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 are necessary to polymers as tubing for food-contact use. ensure that the present and future FDA is proposing to establish 18137 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 The agency is proposing to establish a sanction for a rigid or semirigid vinyl listing of ail known prior sanctions for the use of vinyl chloride polymers in chloride polymer bottle. The only documented prior sanctions for rigid packaging materials. These prior vinyl chloride polymer that the agency sanctions include those listed in the 1975 found were for waterpipe and poultry ' proposal, as well as additional prior packaging traya. V. Proposed Regulations A. Currently Regulated Polymers In order to provide for the safe use of vinyl chloride polymers currently regulated under Title 21 of the Code of Federal Regulations, FDA is proposing the following: 1. In ? 172.210 Coatings cm fresh citrus 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 fruiL 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 plans 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-pyrrolldone, potassium persulfate, propylene glycol alginate, and sodium decylbenzene sulfonate from $ 172310. because the only use of these adjuvants permitted by this regulation is in vinyl chloride-vinylidene chloride coplymers. 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, lor 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. i 175.320 Resinous andpolymeric coatings forpolyolefin films. FDA is proposing to establish a limit on residual vinyl chloride monomer of 5 ppb by weight of the vinyl chloride copolymer component of the olefin polymer coating. 5. 176.170 Components ofpaper and paperboard in contact with aqueous and fatty foods. FDA is proposing to establish a limit on residual vinyl chloride monomer of 5 ppb by weight of the listed vinyl chloride copolymer components of the paper and paperboard. 6. In 176.180 Components ofpaper andpaperboard in contact with dry foods, 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. 7. In 177.1010.Acrylic and modified acrylic plastics, semirigid and rigid, FDA is proposing to establish a limit on residue! vinyl chloride monomer of 5 tsi 4181 Federal Register / Vol. 51, No. 22 / Monday. February 3, 1986 / Proposed Rules p y weight of the vinyl chloride provides for the use of those vinyl ' copolymers as a component of coatings c ymer component. chloride polymers that are not covered of fresh citrus fruit. o. m 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 177.1210 Closures with sealing weight of the vinyl chloride polymer. with FDA (see 44 FR 42775; July 20, gaskets forfood 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 5 177.1850 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 chloride-. ethylene 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 c de monomer of 10 ppb by weight 0 vinyl chloride copolymer cc...ponent '- . 14. In 5 177.1970 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 chloride- propylene copolymers, FDA is proposing to establish a limit on residual vinyl chloride monomer of 10 ppb by weight of the vinyl chloride copolymer component ' 18. In S 177.2250 Filters, microporous polymeric, FDA is proposing to establish a Limit on residual vinyl chloride monomer of 50 ppb by weight of the 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 weight of the vinyl chloride polymer component. VI. Conclusions . 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 . . Register of April 26,1985 (50 FR 16636, . effective July 25,1985). , FDA welcomes the submission of any data bearing on the issues and vinyl chloride homo- or copolymer Based on available toxicity data, the component - r agency's exposure calcuations, and its 17. In 179.45 Packaging materials for estimates of the risk from the conclusions contained in the finding of no significant impact and 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 -- ('e.g.7per8istence)"orar(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 as food-contact materials, as described and benthic environments, and any 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 Vinyl chloride ' proposing to amend the food-additive chemicals-on representative organisms polymer resins, rigid and semirigid, to. regulations and to adopt new from those environments. FDA would . pr `de for the safe use of rigid and regulations to provide for the safe use of also like additional information on 1 si igid vinyl chloride polymers that vinyl chloride polymers. The agency is whether vinyl chloride polymers < h, jeen marketed 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 regulations the use of ' polychlorinated dibenzo^pj-dioxins and valid prior sanction; This: regulation . . vinyl chloride-vinylidene chloride >; poivchlorinated dTbenzofurang from Federal Register / Vol. 51, No. 22 / Monday, February 3, 1986 / Proposed Rules 4185 municipal solid waste incinerators. FDA 21 CFR Part 176 Substances limitations will reexamine its~conclusions,iLnew informatidfTbecomes available suggesting that this action will.have significant environmental impact. The agency has prepared an Food additives, Food packaging. 21 CFR Part 177 -- Food additives. Food packaging. Polymers. Homopolymers and copolymers of the following 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 monomer to acceptable levels in foodcontact articles containing vinyl 21 CFR Part 179 Food additives, Food packaging, Radiation protection. 21 CFR Part 161 Vinyl chloride____Residual vinyl chloride monomer content determined in the finished adhesives. using the method described in 5 177.1975(c) of this chapter, shaft not exceed S ports per brilion by weight ot the vinyl chloride homo-_or_ cppbjycner component -fnpipb flL.A'U _____________ chloride. FDA has found that since 1975,. 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 .Food ingredients, Food packaging. ; Therefore, under the Federal Food. Drug, and Cosmetic Act and under authority delegated to the Commissioner1 of Food arid Drugs, it is proposed that . Parts 172,175,176,177,179, and 181 be amended as fQllows: 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. (i) Residual vinyl chloride monomer content determined in the finished coatings, using the method described in 177.1975(c) of this chapter, shall not exceed 5 parts per billion by 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. FDA, in accordance with the 1 Regulatory Flexibility Act, has considered the effect that this proposal would have on small entities including ' Authority: Secs. 201(s). 409, 72 stat. 17841788 as amended (21-U.S.C. 321(s), 348); 21 CFR 5.10. . 2. lii 172,210 by removing and reserving paragraph (b)(3) and by revising the introductory text of paragraph (b)(4) to read as follows:1 6. In 175.320 by redesignating paragraph (c) as paragraph (c)(1) and by adding new paragraph (c)(2) to read as 175.320 Resinous and polymeric : coastings for polyolefin films small businesses and certifies in (c)*** accordance with section 605(b) of the Regulatory Flexibility Act that no 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). Interested persons may. on or before April 4,1986, submit to the Dockets 172J10 Coatings on fresh citrus fruit . * *'* * (bp * * . (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: (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 177.1975(c) of this chapter, shall not exceed 5 parts per billion by weight ofthe vinyl chloride copolymer component. 4 A. Management Branch (address above) written comments regarding this proposal. Two copies of any comments 1 . are to be submitted, except that t PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS PART 176--INDIRECT FOOD ADDITIVES: PAPER ANO PAPERBOARD COMPONENTS individuals may submit one copy. : j . 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: heading of this document. Received Authority: Secs. 201(s), 409, 72 Stat. 1784- comments may be seen in the office 1788 as amended (21 U.S.C. 321(s), 348); 21 above between 9 a.m. and 4 p.m.,' CFR 5.10. ' . Monday through Friday. . 4. In 175.105 (c) (5) by revising the List of Subjects item "Vinyl chloride" to read as follows: - 7. The-authority -citation for 21 CFR - Part 176 continues to read as follows: ' Authority: Secs. 201(s), 409.72 Stat. 1784- 1788 as amended (21 U.S.C 321(a). 348): 21 CFR 5.10. 1 - ' 1 11 8. In 176.170(b)(2) in the table by adding limitations to the items "vinyl \ 21 CFR Part 172 Food additives. .. 21 CFR Part 175 \" 175.105 ? ' Ad>h.e: sives.1" . 1 chloride copolymers," "Vinyl chloride- ' vinyl acetate hydroxyl-modified copolymers," "Vinyl chloride-vinyl '' : acetate hydroxyl-modified copolymers. reacted with trimellitic anhydride'" and Adhesives. Food additives.-Food... . packaging. - .. "Vinylidene chloride copolymers" to . / - read a$ follows: ~n ... f .w: U 4186 Federal Register / Vol. 51, No. 22 / Monday, February 3, 1986 / Proposed Rules t, 170 Components of paper and p board in contact with aqueous and fatty foods. * ** * * ((b2)) * * * Ltst of substances limitations Vinyl Florida copolymers Vinyl cNoridevinyf acetate hydroxylmodified copolymers. Vinyl chloridevtnyl acetate hydroxylmodffied copolymers racted with trimeffitic anhydride. VmvWene . chloride copolymers For paper or paperboardJg_the finishedform in which to contact food. residual vinyl chloride monomer, de termined by the method described in 9 177.1975(c) of this chapter, shall not exceed 5 pans per triton by weight of the vinyl chloride copolymer compo-ee O-stUvj Do. Da * * * * . % In 176.180(b)(2) by revising the a "Vinyl chloride" to read as follows: . ./6.180 Components of paper and paperboard In contact wtth dry foods. * .* * * (b) * * * (2) * * * list o* subslancn ' Umrtafiona Polymers: Hompoiymere and copolymers ol the folowing monomers. Vinyl chloride--------. For paper or paperboard in fee finished term in which H as to contact lood, repduai vinyl chloride monomer, de termined by tea method described in f Y77.1075(e) of fete chapter, shaft not exceed 6 parte per triton by weight ol tee vinyl chloride^bomo- or copolymer 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 the 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 5 177.1975(c), shall not exceed 5 parts per billion by weight-ofthe-YUiyFchloriderCopolyirter=componei>b- '. (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 ere 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 fooH-r^ntarl article, using the method described in 177.1975(c), shall not exceed 5 parts par billion by weight of the vinyl chloride homo- or copolymer component' ft ft ft ft' 12. In S 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 chloridemethacryiic decyloctyl copolymer," and by adding new item "Vinyl chloride homopolymer" to read as follows: 9177.1200 Cellophane*. ft ft ft. (c)* Usi of substances Limitations Vinylidene chlorine copolymerged with one or more of the following: Acrylic acid, acryKyvirite, t>ut^ so rytata. butyl meinaerylata, ethyl acrylate. 2-ethyfhexyl acrylate. 2-ethyfheryf rneifv acrylate, ethyl methacrylata, itaconic acid. methacrylic sod. methyl acrylate, methyl methacrylate, propyl acrylate, propyl methacry late. vinyl chloride. Do. Vinyl chloride homopolyme*___As the base polymer. For thefinished cellophane baa* sheet intended to contact lood, residual vinyl Chloride monomer, deter mined in the Iniehod sheet using the meftiod -described in t77.1975|c), shaft not exceed 5 parts per bilion by weigh! & vinyl chloride homo- or co polymer component Vinylidene chloride- methe- Aa (he basic polymer, crytic decyloctyl copolymer. 13. In 5177.1210(b)(5) by revising the item "Vinyl chloride-vinyl stearate copolymer" to read as follows: 9177.1210 Closures with sealing gaskets for food containers. ft ft ft ft ft (b) * * * (5) * * * List oTautetancss Lindaboro laxpresaed as pansft el waitfa ol cloaufa-aaaiing gaakat composition) - Vinyl cotordavinyl stawale copotymar. Residual nny< tidoade monow. delermined in 9 Sniahad cloauma nim seeing gasket*. using the mePicd dascribed ie |177.17S<0, she! not eacsed S pens per baton by adjSd ol *w yiwyl aWeride copolymer coinpo- 14. In 9 177T630(e)(4)(iii) by revising the item "Vinyl chloride" to read as follows: 9177.1630 Pofyethytens phthafate polymers. ft 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(4. 409.72 Slat. 178488 as amended (23 U.S.C. 3ZMsl. 348): zi K 5I .i a . ' ' .. , ' * . li r- .8 ' ` IT. In 5 177.1010 by revising the introductory testa of paragraph (a) (2) and (4) to read as-follows: . Polyvinyl ------- As the basic polymer. (e) * * * (4)*** (iii).e. Vinyl acetate-vinyl chloride copolymer reaint. Wiyl acetate-vinyl chloride matojc add copolymer mint. > A fee. basic polymer. For fee finished filllfiBtMPt- ' baas sheet totended tc "contact tood. residual vinyl chloride fflonomar, deter mined by me mediod dfe 'scribed' in V77.197S<C>. shaft not exceed 5 pmte pertriton by weight of the vinyl chloride copolymer .component Do. l*t (! t* .t f Vinylidene chloride copolymenzed with one o.r more. of the following: . Vinyl chloride. Residual vinyl chloride monomer, determined in thqJLnished cppolymer coating, using the method described in J 177.1975(c), shall not exceed 5 parts per billion by weight of-the-vinyl chloride copolymer-component.' ' *3 U1 tn 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, .)(2) to read as follows: rigid and semirigid. 177.1850 Textryls. (c)` ' Vinyl chloride polynjers may be safely used as articles or components of articles intended for use in contact with food subject to thirprovisions of this section. (a) Identity. Vinyl chloride polymer resins consist of (1) homopolymer resins |2>Fxy(s As tt>e basic copolymer. For textryls produced by polymerization of vinyl prepared from virryt chlonctevmyt acetate containing vinyl chloride-vinyl acetate chloride, which has the molecular copolymer, residual vinyl chloride monomer, determined in the finished formula CjH,Cl [CAS Reg. No. 75-01^1). copolymer. lood-contact article, by the method Oescnbed'TrP? 177.1975(c). shall not exceed 5 parts per billion by weight oF the-wiyt^cbionde-cepoiycier compo- Vinyl chloride polymer resins (molecular formula {C*HjCl)n: Cas Reg. No. 900286-2) have a maximum volatility of not over 3 percent when heated for 1 hour at 105 C (221*F) and an inherent viscosity of at least 0.35 when determined by ASTM method D1243-79, ``Standard 16. In 177.1950 by adding new Method of Test for Dilute Solution paragraph (c)(l)(iii] to read as follows: - Viscosity of Vinyl Chloride Polymers" 177.1950 Vinyl chloride-ethylene copolymers. ** * * (c) * ` * (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 U)*** Federal Register, 1100 L St, NW, (iii) Residual vinyl chloride monomer, Washington. DC 20408; and (2) determined in the finished food-contact copolymer resins produced by the article, using the method described in copolymerization of vinyl chloride with 1177.1975(c). shall not exceed 10 parts . other monomeric polymeric substances. per billion by weight of the-vinyi chloride=Gopslymer-eompenent ; '` * (b) Conditions of use. Vinyl chloride . polymers identified in this section may be used alone or admixed with polymer 17. In 177.1960 by adding new modifiers identified in accordance with paragraph (b)(l)(iii) to read as follows: the following prescribed conditions: 177.1960 Vinyl chloride-hexene-1 copolymers. * (b) * * * (I)*** (iii) Residual vinyl chloride monomer, determined in the finished food-contact article, using the method described in S 177.1975(c). shall not exceed 10 parts per billion by weight of-the-vinyl .chloride-copolymer component. ' ' (1) No chemical reactions, other than addition reactions, occur among the vinyl chloride polymers and the modifying polymers present in the manufacture of the finished food-contact article. - (c) Limitations. The finished food- 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 18. In 177.1970 by adding new method of analysis^titled, "Headspace \ paragraph (c)(l)(iii) to read as follows: Sampling and Gas-Solid ' /Chromatographic Determination arid 177.1970 Vinyl chloride-lauryl vinyl ether I Confirmation of > 1 ppb Vinyl Chloride copolymers. * * / Residues in Polyvinyl Chloride Food ' Packaging," which is incorporated by (c)~* * * reference. Copies are available from the W * * ' (iii) Residual vinyl chloride monomer, determined in the finished food-contact Division of Food and Color Additives, ' Center for Food Safety and Applied Nutrition (HFF-330), Food and Drug article, using the method described in Administration. 200 C St. SW, . S 177.1975, shall not exceed 10 parts per Washington. DC 20204. or available for billion by weight of-the-vinyl-chloride copolymercomponent. . inspectioii at the Office of the Federal Register, 1100 L St. NW; Washington. * -* 3C 20408. --------- -- 19. By adding a new 177.1975 to read 20. In 1177.1980 by adding new as follows: paragraph (c)(l)(iii) to read as follows: 177.1980 Vinyl chloride-propylene copolymers. ***** (c) * * * (1) * * * (iii) Residual vinyl chloride monomer, determined in the finishedJpod-con.ta.ct article, using the method described in 177.1975(c), shall not exceed 10 parts per billion by weight ef-tfwvtnyl chloride-copolymercomponent. * *' * 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, mlcroporous polymeric. **** (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 vinyi-ehloride-home^-or-copoiymer component. 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 Slat 17841788 as amended (21 U.S.C. 321(s). 348): 21 CFR 5.10. 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: 179.45 Packaging materials for use during the Irradiation ot prepackaged foods. **' (b) * * * (9) * * * For vihylidene chloridevinyl copolymer films identified in this paragraph residual vinyl chloride monomer in the finished foothcontact 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 copolymer component. ** ** (c) * * * (2) * * * (iv) * * * For vinyl chloride-vinyl acetate copolymer Rim identified in this paragraph residuai 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 viny! chloride copolymer component. 21155015 4: Federal Register / Vol. 51, No. 22 / Monday, February 3, 1986 / Proposed Rules PART 181--PRIOR-SANCTIONED (3) Waterpipe. Vinyl chloride polymer ppb Vinyl Chloride Residues in FOOD INGREDIENTS waterpipe used for carrying water inside Polyvinyl Chloride Food Packaging" 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 which is incorporated by reference. Copies are available from the Division of Food and Color Additives (HFF-330), Authority: Secs. 201(s), 402, 409. 701. 52 ranging in internal diameter fro Center for Food Safety and Applied StaL 1046-1047 as amended. 1055-1056 as inches for transporting food. Nutrition. Food and Drug amended, 72 Slat. 1784-1788 as amended (21 (5) Caskets and bottle orjar liners. Administration. 200 C St. SW,, U.S.C. 321 (s), 342. 348, 371); 21 CFR 5.10. Vinyl chloride popoTymej^resin ' Washington, DC 20204, or may be 25. By adding new 181.37 to read as compositions colrtainingup to 80 percent examined at the Office of the Federal follows: basic resin for use in contact with food. Register, 1100 L St. NW., Washington, 181.37 Vinyl chloride homo- and copolymer resins. (a) Identity. Vinyl chloride homopolymers consist of basic resins (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 DC 20408. Dated: January 27,1986. Frank E. Young. Commissioner ofFood and Drugs. produced by the polymerization of vinyl chloride monomer, determined in the [FR Doc. 88-2235 Filed 1-31-88; 8:45 ami chloride monomer (molecular formula finished food-contact article described BILLING COOE 4140-0t-M CsHsCl; CAS Reg. No. 75-Ol^i). Vinyl in paragraph (a) (1) (i), (ii), (iv) and (2) of chloride homopolymer resins (molecular this section, using the method described formula (CjHsCl) CAS Reg. No. 9002- in paragraph (c) of this section, shall not 21 CFR Part 880 86-2) have maximum volatility of not exceed 5 parts per billionjjy weight of over 3 percent when heated for 1 hour at. the vinyl chloride homof'copdymer [Docket No. 85N-0285] 105* C (221 *F) and an inherent viscosity of not less than 0.35 when determined by ASTM Method D1243-79, "Standard Method of Test for Dilute Solution component. ~ --(2) For vinyl chloride-vinylidene------- chloride copolymer film described in paragraph (a)(l)(iii) of this section, General Hospital and Personal Use Devices; Premarket Approval of the Infant Radiant Warmer Viscosity of Vinyl Chloride Polymers"' (Method A), which is incorporated by ref"-ence. Copies are available from the I ican Society for Testing Materials, 1 lace St- Philadelphia, PA 19103, or oe examined at the Office of the -Federal Register, 1100 L St. NW., Washington. DC 20408. Vinyl chloride residual vinyl chloride monomer, determined in the finished food-contact article using the method described in paragraph (c) of this section, shall not exceed 50 parts per billion by weight of the vinyl copolymer component. (3) For vinyl chloride polymer waterpipe described in paragraph (a)(3) 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 copolymer resins are the polymers produced by the copolymerization of of this section, residual vinyl chloride monomer, determined in the finished U.S.C 351(f)". 2. On page 1911, third column, last line vinyl chloride monomer with other waterpipe using the method described in "Wu" should have read "Wu". monomeric or polymeric substances. paragraph (c) of this section, shall not BILLING CODE 1505-01-M Vinyl chloride homopolymers and exceed 50 parts per billion by weight of copolymers may be safely used as vinyl chloride homoploymer component. follows: (-1) Films, (i) Vinyl chloride polymers (4) For plasticized vinyl chloride polymer for use as flexible tubing and as DEPARTMENT OF THE INTERIOR 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- ( described in paragraph (a) (4) and (5) of Office, of Surface Mining Reclamation and Enforcement acrylonitrile copolymer for use in this section, respectively, residual vinyl 30 CFR Part 935 plasticized film in contact with f" chloride monomer determined in the oleomargarine. finished food-contact article, using the Reopening and Extension of Public (iii) Vinyl chloride-vinylidene chloride method described in paragraph (c) of Comment Period on a Proposed copolymer for use in plasticized film in this section, shall not exceed 5 parts per Amendment to the Ohio Permanent contact with food. (iv) Vinyl chloride-vinyl acetate billion by weight of the vinyl chloride polymer component. Regulatory Program copolymer for use m plasticized Rim in contact with food. (5) For rigid vinyl chloride-vinyl acetate resin sheet described in AGENCY: Office of Surface Mining Reclamation and Enforcement (OSMRE), (2) Coatings. (i)Vinyl chloride^for use paragraph (a)(6) of this section,.residual Interior. as a can enamel. vinyl chloride monomer, determined in action: Reopening and extension of (ii) Vinyl chloride-vinyl acetate the finished food-contact article using public comment period. copolymer for use as a can enamel. the method described in paragraph (c) of f (iii) Vinyl chloride-butadiene- this section, shall not exceed 10 parts summary: By letter dated November 8. Ir'acrylonitrile resin for use as a per billion by weight of the vinyl 1984, Ohio submitted a program L component of conveyor belts intended fchloride copolymer component amendment consisting of a revision to nIi1-f1' se with fresh fruits, vegetables, and ' (c) Analytical method. The residual rule 1501:13-14-03 concerning civil >nd as a component of coatings for . concentration of vinyl chloride monomer penalties. OSMRE published a notice in t : and paperboard in contact with ... in food-contact articles shall be the Federal Register on December 12, meat and lard. . determined by using-the method of 1984, announcing receipt of the (iv) Vinyl chloride-vinylidene chloride, analysis titled. "Headspace Sampling amendment and inviting public comment copolymer for use as a liner, i^.. coating and Gas-Solid Chromatographic . on the adequacy of the proposed for steel pipe. ; Determination and Confirmation of >1 ' amendment (49 FR 48324). 21155016 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 paper board 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) Section 181.37 RVCM 5 ppb ------------------------- 50 ppb 5 ppb ----------- -- 10 ppb 2 Subiect Vinyl chloride homo- and copolymer resins films and coatings (but 50 ppb for vinyl chloride-vinylidene chloride) Waterpipe inside food-processing plant Plasticized applications (flexible tubing, gaskets, bottle or jar liners) Rigid vinyl chloride-vinyl acetate sheet *3 H- W Vx QO