Document NeL8vZMOg1qn0LLO76pqoBR6p

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 161 [Docket No. 75N-0190J Vinyl Chloride Polymers; Withdrawal of Proposal AGENCY: Food and Drug Administration. ACTION: Withdrawal of proposal. summary: The Food and Drug Administration (FDA) is withdrawing the notice of proposed rulemaking that would have restricted the uses of vinyl chloride polymers in contact with food. The agency is taking this action because, based upon new scientific and legal developments. FDA has decided that the actions outlined in the proposal -no longer represent the appropriate course of regulatory action. FOR FURTHER INFORMATION CONTACTS Vir Anand. Center for Food and Safety and Applied Nutrition (HFF-335), Food and Drug Administration. 200 C St. SWn Washington, DC 20204, 202-472-5690. SUPPLEMENTARY INFORMATION: In the Federal Register of September 3,197S (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 poBcy 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 moot FDA now believes that the use of vinyl chloride polymers can be regulated provided that such polymers meet certain limitations on the levels of residual vinyl chloride monomer. elsewhere in ibis issue of the Federal Register. The terra "cbloroethene" is not In the Federal Register of March 15, a commonly ased term for vinyl 1977 (42 FR 14302). FDfi 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 staled that vinyl old Part 121 section numbers and. if appropriate, to the recodified section chloride-vinylidene chloride copolymer should be renamed vinylidene chloride- numbers. Elsewhere in this issue of the Federal Register. FDA is proposing: (1) To provide for the safe use of vinyl chloride polymers; (2) to codify all known prior sanctions of vinyl chloride polymers: (3) to provide lor 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 Cresh citrus fruit (21 CFR 172.210). FELA received 190 comments on the September 1975 proposal. One hundred nifty-four of these comments did not include any data on the use of vinyl chloride polymers. Of these comments, vinyl chloride copolymer to reflect the relative dominance of the monomers. It noted that vinylidene chloride is the more dominant monomer in copolymers of vinyl chloride and vinylidene chloride. FDA concludes that vinyl chloride-' vinylidene chloride copolymers should . continue to be so named. Vinyl chloride \ has customarily been the first monomer \ cited in industry usage and In food additive regulations when referring to copolymers, regardless of the major component. Although there may be some advantage to naming copolymers by the predominance of monofriers, renaming the copolymers would only lead to . ( confusion and unnecessary paperwork. , 86 supported tire 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 la response to the proposal are addressed in this document. A. Nomenclature 3. Five comments stated that FDA did not have the statutory authority to issue food additive regulations prescribing conditions of use for a substance that may not reasonably be expected to become a component of food. The comments claimed that there was no expectation of migration of vinyl chloride monomer into food from the use of vinyl chloride polymer packaging. Section 201(s] of the Federal Food, Drug, and Cosmetic Act (the act) defines a food additives as "any substance tlse intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, 1. One comment stated that vinyl 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 409(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 (CtHsCl), its alternative name component of food (a food additive) "chloroethene." and its Chemical when the onreacted vinyl chloride Abstracts Registry Number (CAS Reg. monomer trapped in the polymer matrix No.). migrates from the polymer to food. The . FDA agrees that ft should tree 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, ft laboratories about vinyl chloride has done so hi the proposal published polymers demonstrate that, under 21155001 BFG10839 <174 Federal Register / Vol. 51, No._22 / Monday, February 3. 1980 / Proposed Rules nal conditions of use, migration of was not incorporated into the agency's Additionally, since the publication of vinyl chloride monomer will occur from final action on vinyl chloride polymers. the 1975 notice of proposed rulemaking, all types of vinyl chloride polymer food- FDA disagrees with this comment. scientific developments, such as contact articles, regardless of the levels FDA has explained why it has improved risk assessment procedures, of the monomer in the articles. The concluded that the viijyl chloride - have led FDA to reconsider how it amount of vinyl chloride monomer that monomer will migrate in response to the regulates food and color additives when migrates to food will, depend on the preceding comment. In regard to a the additive as a whole contains initial residual monomer content, the request for a public hearing, section carcinogenic impurities but has not been lime 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 hie 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 that the risk from the use of these vinyl chloride monomer is that of Ethyle provisions in section 409 of the act for 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. Cased on this model's success in predicting the . 5. Two comments stated that no final action to ban rigid and semirigid vinyl proposed rulemaking appearing, elsewhere in this issue of the Federal observed levels of monomer migration, chloride polymers should be taken until Register. Ethyle's diffusion model can be relied an examination has been made of the 7. Four comments suggested that. upon to predict the level of such . potential migration from currently' proposed $ 121.2009 Vinyl chloride migration even when the monomer is produced vinyl chloride polymers.that . polymerresins, 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 deta on the the use of polymers listed.ln that section diffusion models, and available migration of vinyl chloride monomer in articles that will contact all-types of * experimental data. FDA concludes that from polymers that contain varying food or Should be revised to allow the tyl 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 9 121.2009 ' predicting monomer migration has been monomer into food will occur if there is /i 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 * ; 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, 6. Two comments objected to before September ft. 1958. The list of so long as its presence in food can be permitting any use of vinyl chloride such uses cannot be altered or predicted'on the basis of a meaningful polymers in contact with food because expanded to include additional uses projection from reliable data." . of die 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 theses 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 bdnned . prior sanctions for which it could find that safety cap be assured through the until manufacturers can produce vinyl . evidence and explicitly solicited establishment of limits on residua] chloride polymers that contain no vuiyl . 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 sdnetiona. (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 polymerawith unsafe levels of vinyl' chloride polymers is necessary because of vinyl chloride resins as films for food chloride monomer. these polymers now can be packaging. 2. Letter to Firestone Plastics 4, One comment contended that there manufactured with residua! vinyl Com 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 millien times lower than the * . polyvinyl chloride (homopolymer) sheet were not food additives. The comment residual monomer levels in polymers for packaging poultry. 3. Letter to requested a hearing if its point of view. ... that were marketed-in the early 1970's, Firestone Plastics Co.* Pottstown. PA. BFG10840 Federal Register / Vol, 51. No. 22 / Monday, February 3. 1986 / Proposed Rules 4175 daled February 21.1957. permitting the use of vmyl chloride and vinyl chlorideacetate resins for "food wrapping purposes." 4. Letter of Borden Co., Santa Barbara. CA. dated August 15.19S7. 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 staled that the wording of proposed $ 121.2009(a}(3} should be revised to provide a proper description of the materials used for coa ting 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 Ielters 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 f coatings as copolymers, the coatings were never identified as copolymers by the manufacturers. Hie 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 S 181.37 (proposed as 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 conclude.d that the requested labeling is not necessary to ensure the safety of foods that contact vinyl chloride polymers. In a nolice 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 m various types qf vinyl, chloride food contact surfaces. FDA also sets forth in that proposal the basis on which it has tentatively concluded that vinyl chloride polymers that meet the proposed limitations are safe for food-contact uee. Therefore, there is no need to label foods that have contacted vinyl chloride polymers. 10. One comment stated that tbe ase of vinyl chloride polymers as coatings on fresh citrus fruits, which is permitted under 21 CFR 12T.1179 (now 21 CFR 172.210). has been discontinued. After publication of the 1975 proposal, the major producer of vinyl chloride- vinylidene chloride copolymers informed FDA that it was unaware of any market For the costings 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 costings on fresh citrus fruit. . - 11. Four comments were received objecting to th*e 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 oTall 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. G. 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 from vinyl chloride polymers. According to the. comments, these processes produced polymers in which there were either very low levels (i.e., 2 to 50 parts per billion (ppb)) or no detectable amount of residual vinyl chloride monomer because the steps taken during these fabrication processes were adequate to remove aH of the residual vinyl chloride monomer. On the basis of all available evidence. FDA has concluded that under normal use conditions, migration of vinyl chloride monomer will occur from all types of vinyl chloride polymer articles (see response to comment 3). The amount of vinyl chloride monomer that will migrate is determined by the nature of the articles (e.g.. film, bottle, or coating); (he residual vmyl 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 ht 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 stated 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 commeiTt 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 th8t the available experimental data on the process of migration of vinyl chloride monomer from vinyl chloride polymers do not support this theory (Division of Chemistry and Physics memorandum dated July 27,1979). FDA's evaluation of the data on vinyl chloride migration that were submitted as comments to the 1975 proposal by Ethyl Corp. revealed that under normal use condition, migration of vinyl, chloride monomer will occur from all 21155003 BFG10841