Document M8vk4JDGLowxjdxoZeXb7a1j

BFGoodrich The BFGoodrich Company 3925 Embassy Parkway Akron. Ohio 44313-1799 September 7, 1990 Mr. Ron Hanson Hoffman Plastics 16616 Garfield Avenue Paramount, California 90723 RE: FDA STATUS OF POLYVINYL CHLORIDE (PVC) RESIN Dear Mr. Hanson: This is in response to our conversation regarding the prior sanctioned status of PVC. Polyvinyl chloride is prior sanctioned for use in general food contact applications, both flexible and rigid. The prior sanction is based on an article by A. J. Lehman, from the FDA, published in the Journal of the Association of Food and Drug Officials, July, 1951. The current Good Manufacturing Practice (GMP) specifications for prior sanctioned PVC are a maximum volatility of 3.0% (1 hour at 105C) and an inherent viscosity of not less than 0.35 by ASTM D-1243-79. PVC is also listed as an acceptable ingredient of food contact articles under 21CFR: 175.105 175.300 176.180 177.1010 177.1200 177.2250 179.45 As promised, I am enclosing a copy of the 1986 FDA PVC proposal which acknowledges the prior sanctioned status of PVC. To date, the FDA has not finalized the proposed regulation mostly due to preparation of an environmental impact analysis. Consequently, PVC retains its prior sanction status as explained above. T o o a z .80 i Mr. Ron Hanson September 7, 1990 Page 2 If you have any further questions, regarding the FDA status of PVC, please call me at 216/374-3422. Sincerely THE BFGOODRICH COMPANY Toxicologist Environmental Health and Safety Management Systems 0907-1/jp G. Schaaf - CL-OTM (w/o attachment) I 5 $3 Federal Register / Vol. 51, No. 22 / Monday, February 3. 1986 / Proposed Rules 4173 DEPARTMENT Of HEALTH ANO HUMAN SERVICES Food and Drug Administration 21 CFR Parts 172,175,176,177,179, and 161 (Docket No. 75N-01S0] Vinyl Chloride Polymers; Withdrawal of Proposal aqincy: 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 FDA has decided that the actions outlined in the proposal -no longer represent the appropriate course of regulatory action.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 FURTMDt INFORMATION CONTACT: Vir Anand. Center for Food end Safety end Applied Nutrition (HFF-335). Food end Drug Administration. 200 C St SW,, Washington. DC 20204.202-472-6680. SURMJMtMTARY MFORMATION: In the Federal Ragiatar of Septaober 3.1976 (40 FR 40529). FDA proposed to prohibit come usee 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 dsvaloped a policy concerning the regulation of food and color additives that may contain carcinogenic imparities: and (3) FDA now beliavaa that developments in scientific technology and its experience with risk assaesmsnt procedures make it possible for the agency to determine whether the use of additives that contain carcinogenic importbasis sals. As a consequence of these developments, many of the issues raised by the September 1976 proposal and by i the comments on that proposal an moot FDA now baUesire that the use of vinyl chlorida polymers can be regulated provided that such polymers mast certain limitations on the levels of residual vinyl chloride monomer. In the Federal Register of March IS. 1977 (42 FR 14302). FDX reorganized and repubiished regulations formerly codified in 21 CFR Part 121. In the present document. FDA will refer to the old Pari 121 section numbers and. if appropriate, to the recodified section numbers. Elsewhere is 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 far the use of certain previously unregulated vinyl chlorida polymers in manufacturing vinyl chloride bottles: and (4) to delate vinyl chloride-vinylidene chloride copolymers from the list of materials that may ba used as coatings on fresh dtrus fruit (21 CFR17T210). FDA received 190 comments on the September 1975 proposal. One hundred fifty-four of these commante did not include any data on the use of vinyl chloride polymers. Of these comments, 86 supported the proposal: 57 expressed concern about the risk associated with the use of vinyl chlorida polymers; and 11 opposed the proposed ban an 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 tha additional letters and memoranda contained data, but tha 15 supplements to comments contained scientific data that FDA reviewed and evaluated. All comments received in response to tha proposal are addressed in this document A Noaendatare 1. One comment stated that vinyl chlorida should ba referred to as "vinyl chlorida monomer" or as "VCM" in tha various proposed regulations to prevent any misunderstanding about what particular substance la being prohibited. The comment further stated that the . identification of vinyl chlorida monomer should include its chemical formula (CeftCl). its alternative name "cMoreetheua." and its Chemical Abstracts Registry Number (CAS Rag. No.). FDA apses that It should one the CAS Rag. No. and tha term "vinyl chlorida monomer" to identify the monomer. R has done so in the propoeal published elsewhere in this issue of the Federal Register. The term "chinroethere-' is not a commonly used term for vinyl chloride. FDA concludes that vinyl chloride is adequately defined by its chemical forinuia and its CAS Reg. No. 2. One comment stated that vinyl chloride-vrnytidene chloride copolymer should be renamed vinylidene chloride- 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 J component Although there may be some j advantage to naming copolymers by the predominance of monofhers. renaming the copolymers would only lead to confusion and unnecessary paperwork. / B. Administrative--Legal 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 Coametic Act (the act) defines 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, precasting preparing treating packaging transporting or holding food, and including any source of radiation intended for any such use) * " *"(2l U.S.G 321(s)). Section 408(d) of the act (21 U.S.C. 346(d)) authorizes FDA to estaQTsh regulations prescribing with respect to any particular use of a food additive, the conditions under which such additive may be safely used. Vinyl chloride polymer becomes s X* component of food (s food additive) when tha unacted vinyl chlorida ^; monomer trapped in tha polymer matrix . migrates from the polymer to food. Tha data, both experiments! and theoretical. ^ produced by industry and by FDA laboratories about vinyl chlorida polymers demonstrates that under 1 4174 Federal Register / Vol. 51, Na^ 22 f Monday, February 3, 1986 / Proposed Rules normal 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 1973 notice of proposed rulemaking, all types of vinyl chloride polymer food- FDA disagrets 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 vinyl chloride have led FDA to reconsider how it amount of vinyl chloride monomer that monomer will migrate in response to the regulates food and color additives when migrates to food will depend on the preceding comment In regard to a the additive as a whole contains initial residual monomer content, the request for a public hearing, section carcinogenic impurities but has not been time and temperature of exposure to 409(f)(1) of the act provides that within shown to be a carcinogen in appropristt 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 effected 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 asaesament shows One example of the work done on hearing on tha matter. Thera ere 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 tow that there ia a January 17.1973, 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 9. Two comments atated 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 haa been made of the 7. Four comments suggested that upon to predict the level of such potential migration from currently proposed f 121-2009 Vinyl chloride migration even when the monomer is produced vinyl chloride polymers that . polymer resine. which Ueted tits prior- not detectable by current analytical contain low levels of residual vinyl sanctioned usee of vinyl chlorida capabilities. chloride monomer. polymers, should be revised to permit On the basis of existing theories, FDA has reviewed the data on tha tha use of polymers listed ia 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 vinyl chloride monomer is capable of levels of residual monomer (Division of use of additional types of articles migrating into food from vinyl chloride Chemistry end Physics memorandum produced from vinyl chloride polymers. polymers in more than insignificant dated July 27.1979). The agency Tha agency finds that such 0 revision amounts. The use of models capable of concludes that migration of the * is inappropriate. Proposed ) 121.2009 predicting monomer migration has beat monomer into food will occur if there Is n was tntended to be a listing of those addressed in Monsanto v. Kennedy. 013 any residual monomer in tha polymer. I 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. La* those "Nor is it necessary that the level of elsewhere in this issue of the Federal r usee that were approved by FDA or the migration be significant with reference Register reflect this determination. US. Department of Agriculture (USDA) to the threshold of direct detectability, 0. Two comments objected to before September 0.193&. The list of so long as its presence in food can be permitting any use of vinyl chloride such uses esnnot be altered or predicted on the basis of a meaningful polymers in contact with food because expanded to Include additional uses protection 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 data. been shown to be a carcinogen, the permitting the use of these polymers. Therefore. the agency cannot expand projected vinyl chloride monomer FDA wee. in effect setting a tolerance the prior-sanctioned usaa of vinyl migration from vinyl chloride polymers ' for a carcinogen at the level of . chlorida polymers to com contact with under the conditions ofuse currently sensitivity of the analytical methoda to alltypaaof food as propoe**' { specified in its regulaians is not so small detect vinyl chloride monomer. Tha as to present no public health or safety comment stated that all asae of vinyl la the1878 propoaaLFDA.u*. concerns. The agency finds, however. chloride polymers should be banned prior sanctions tor 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, ss proposed chloride monomer; No evidaaca of othar prior sanctions elsewherein this issue of die Federal FDA agrees that vinyl chloride waa submitted to FDA. FDA. however, Register. The agency, therefore, is polymers with unsafe levels of vinyl located tat its own files evidence of four exercising its authority under section chloride monomer should not be additional prior sdnetiana. (1. Letter to 400 of the act to promulgate regulations permitted on the market However, FDA Flraetona Plastics Co. Pottstown. PA. that would pravant the marketing of does not believe that banning vinyl dated April 20,1901. permitting tha use polymers with unsafe levels of vtnyi ' chlorida polymers Is ntcaraaiy because of vinyl chloride resine as filrna for food e chloride monomer. these polymers now can bo packaging. 2. Latter to Firestone Plastics a' 4,One comment contended that that* manufactured with residual vinyl Co* Pottatown. PA. dated October & - was no reasonable expectation of, . chlorida monomer levels that are at. 1900, permitting the use of rigid migration and. also, that tha polymers least one milliea timet lower than the ware not food additives. The . residual monomer levels in polymer* . packeging poultry. 3. Letter to a requested a hearing if its point of view . that were marketed in the early lfiTffs. Fbaetaae Plastics Co^Pottetewn, PA. Federal Register / Vol. 51. No. 22 / Monday. February 3. 1986 / Proposed Rules 4175 dated February 2L1957. permitting the use of vinyl chloride and vinyl chlorideacetate resins for "food wrapping purposes." 4. Letter of Borden Co.. Santa Barbara. CA. dated August 15.1957. permitting the use of vinyl chloride soolymers as tubing for food-contact use.) ^ The agency has included these sanctions > in its proposal published elsewhere in M this issue of the Federal Register. The ^ 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 5 12L20O9(a)(3} should be revised to provide a proper description of the materials used far 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, aa described in the proposal. The original letters received by FDA on the conveyor belt coatings referred to the coatings as "resins." a term broadly applied to any thermoplastic material. Although the letters that FDA wrote in response refer to the conveyor belt l coatings as copolymers, the coatings were never identified as copolymers by the manufacturers. The agency, in reviewing these records, finds that the records contain no data that would limit the prior sanctions to copolymers rather than blends. Accordingly, in the propoael published elsewhere in this issue of the Federal Register, FDA has revised $ 181-37 (proposed as i 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 hat 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 limitationa on the amount of residual vinyl chloride monomer that may be present in various types qf vinyl chloride food contact surfaces. FDA also sets forth In that - proposal the bests on which it has tentatively concluded that vinyl chloride polymers that meet the proposed limitations are safe for food-contact net. Therefore, than is no need to label foods that have contacted vinyl chloride polymers. 10. One comment stated that the use of vinyl chloride polymers as coatings on fresh citrus fnrits. which is permitted under 21 CFR 121.1179 (now 21 CFR 172.210). has been discontinued. After publication of the 1975 proposal, the major producer of vinyl ehloridievmylidene chloride copolymers informed FDA that it wse unaware of any market for the coatings on hush citrus fruit (Telecommunication. M. Flood to }. 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 end semirigid polymers in f 121.108 Substances prohibited from use in human food (now 21 CFR Part 188). FDA has now completed its evaluation of all safety data pertinent to the use of rigid end semirigid vinyl . chloride polymers and has tentatively concluded that safe conditions of use can be prescribed for these polymers. Therefore, rather then banning the use of these polymers, elsewhere in this issue of the Federal Register. FDA is proposing to approve certain usee of these substances. C. Chemistry 12. Seven comments statsd that one or more of the proposed regulations should be revised to permit all ases of ymyt 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 dots not contain detectable level* of vinyl chloride monomer, the potential amount of migration of this monomsr so insignificant as to make it unreasonable to expect that vinyl chloride polymer will become component of food. One comment further stated that a regulation ' permitting the os* of ati vinyl chloride polymers when there was no detectable residual vinyl chloride monomer in the food-contact artidss or not detectable migration of vinyl chloride monomer to food would adequately protect the public health. A number of thaw comments discussed specific processes used to remove "atP residual vinyl chloride monomer from vinyl chloride polymers. According to the comments, these procawe* produced polymers in which there were either very low levels {i.e.. 2 to 50 parts per billion (ppbj) or no detectable amount of residual vinyl chloride monomer because the steps taken during these fabrication processes were adequate to remove ati of the residual vinyl chloride monomer. On the basis of all available evidence. FDA hss concluded that under normal use conditions, migration of vinyl chloride monomer wilt occur from all types of vinyl chloride polymer articles (see response to comment 3J. The amount of vinyl chloride monomer that will migrate n 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 e million. However, the data that FDA has received from industry dearly establish that vinyl chloride polymers still contain measurable levels of vinyl chloride monomer, and that available diffusion theory relates the level of monomer hi the polymer to the level of monomer m 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 te a corresponding reduction in the migration of the monomer. The comment theorized thst there are sites in a polymer to which some monomer can attach. Them sites are called "active binding sites." The comment asserted that these active binding sites prevent migration of tha monomer when there is less than o.l part per million of residual monomer. The comment argued that as a resell 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 r> Chemistry and Physics memorandum Q dated July 27.1979). { FDA's evaluation of tha data on vhr * >' chloride migration that were submitte as comments to the 1975 proposal by Ethyl Corp. revealed that under normc use condition, migration of vinyl chloride monomer wifi occur from all v`1 4178 Federal Register / Vol. 51. No. 22 / Monday, February 3, i960 A Proposed Rules types of vinyl chloride polymers, regardless of the monomer level in the polymers- Although the alternative active site'* theory, if correct would predict zero migration of vinyl chloride monomer to food at some minimum 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 levela 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 monomi-r in Us 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 it no monomer in the food container (Division of Chemistry and Physics memorandum dated July 27.1979). FDA is not aware at this time of any manufacturing process that can produce vinyl 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 end at length in the notice of proposed rulemaking published elsewhere in this issue of the Federal Register. 15. Three comments stated that the proposed regulations should be revised to exempt specific types of packaging such as laminates and packaging for dry solids. The comments stated that food packaged in such containers would not be expected t<>contain vinyl chloride monomer as a result of migration from the packaging materials. - As discussed in response to comment 12. the agency conclude* that us* of vinyl chloride polymer* as component* of the types of packaging materials described in these comments will result in low levela of migration of vinyl chloride monomer. However, the agency is proposing to permit such use of vinyl chloride polymers, with limitations on the level* of residual vinyl chloride monomer, as set forth in the proposed rule published elsewhere in this issue of the Federal Register. td. One comment stated that the restrictions on the us* of rigid and semirigid articles should be revised to permit their uso with ay food or that thepropoaad restrictionstn this - " regulations for adjuvants should be eliminated. As explained in the proposal published elsewhere in this issue of the Federal Register, based on the improvements in the manufacturing process for vinyl chloride poiymen and on other scientific and legal developments. FDA now believes that it can approve the use of vinyi chloride polymers in rigid and semirigid articles not only with dry food but also with aqueous, 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 end 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 bruit. The usF of this copolymer for coating fresh citrus fruit was discontinued several yean ago and there is no longer a need for the regulation. The deletion of this use af these adjuvants from FDA's regulations has no effect on their other regulated uses.. D. Toxicology 17. One comment stated that the use of vinyl chloride polymers in rigid and semirigid food-contact articles should be permitted on an interim basis pending the outcome of studies necessary to demonstrate the safety of such polymers. The comment stated that FDA had based the proposed regulations on preliminary reports, speculation, and rumors, and that animal feeding studies to demonstrate the toxicity of vinyl chloride monomer when ingested were now underway end were expected to be completed within 30 month* Since this comment wee submitted, FDA has received four reports of completed bioassay studies on the carcinogenicity of vinyl chloride monomer. These include: (l) Peron at *L chronic rat oral study performed at the QVO Institute TNO in the Netherlands {Food and Cosmetics Toxicology, 1*317-333.1931); (2) Maitoni et aL rat study on vinyl chloride monomer by both oral ingestion and inhalation routes of exposure [Annals of tin Now York Acadomy ofScience* 246:199-218.1973; Environmental Health Perspective*. 41:3-2* 1961b (3) The British Industrial Biological Research Association unpublished rat study on vinyl chloride monomer administered in the drinking water for up to 152 weeks (the final report entitled "An Investigation Into the Carcinogsnio>Potsntial of Vinyi . Chloride Monomer When Administered. to Rats tn the Drinking Water foe Up to. 152 Weeks." dated 1980): (4) CIVO Institute TNO second unpublished rat study on vinyl chloride monomer (the final report entitled "Lifespan Oral Carcinogenicity Study of Vinyl Chloride in Rats." dated September 1983). The agency has determined that vinyi 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, PDA ie proposing to establish safe condition* of use for vinyl chloride polymen. FDA believes that vinyi 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. The agency's proposed regulations published elsewhere in this issue of the Federal Rejectee deal with the use* of vinyl chloride polymers including rigid and semirigid article* and the specific limitations that are needed to ensure their safe us*. E. Environmental Impact 1& One comment stated that, under the proposed regulation* products expected to substitute for vinyl chloride polymer products would have far greater environmental impacts than vinyl chlonda polymer. In addition, the comment suggested that vinyi chloride polymer could be efficiently burned in properly designed and operated incinerator* The agency's proposaL set forth elsewhere in this issue of the Federal Register, provides conditions for the safe use of regulated and priorsanctioned vinyl chloride poiymen. This proposed action is in contrast to the 1073 proposaL which would have prohibited certain uses of vinyl chloride polymer* FDA has prepared two document* an environmental assessment and a finding of no significant impact that evaluate the potential Impact both advent and beneficUL expected from the increased uM of vinyl chloride polymer* These documents consider the environmental factor* addressed in the comment's subndssioin. lbs environmental assessment and tha finding of no significant impact may be seen in the Dockets Management Branch (HFA306). Food and Drug Administration. Rm. 4-32.3000 Ftobara Line. Rockville. MD 20667.  Federal Register / Vol. 51. No. 22 / Monday. February 3, 1986 I- Proposed Rules 4177 F. Economic Impact 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 prior-sanctioned vinyl chloride polymers. 11118 action is takeiwmder 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. 346. 371)) and under authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10). Aoomss: Written comments to the Dockets Management Branch (HFA305). Food and Drug Administration. Rm. 4-62,5600 Fishers Lane. Rockville. MD 20857. son furthir information contact: Vir Anand. Center for Food Safety and Applied Nutrition (HFF-335). Food and Drug Administration. 200 C St. SW.. comment contained data concerning the Dated: Jknuary 27.1980. Washington. DC 20204. 202-472-5690. economic impact the proposed Frank E. Young. SUFFLfMKMTARV INFORMATION: regulations would have upon the firm. FDA has considered these data and comments in preparing the economic assessment on the proposed regulations published elsewhere in this issue of the Federal Register. The economic assessment may be seen at the Dockets Management Branch (address above). G. Conclusions Since the publication of the September 1975 proposal, there have been significant scientific and legal developments that have caused FDA to reconsider its proposed regulations on the use of vinyl chloride polymers. Improvements in the manufacturing process have enabled vinyl chloride polymer manufacturers to lower greatly the levels of residual vinyl chloride monomer in the polymers. This development, along with procedures for risk assessment now make it possible for the agency to establish safe conditions of use for vinyl chloride polymers. Details of the scientific and legal developments as well as the risk assessment are set forth in the notice of proposed rulemaking published elsewhere in this issue of the Federal Register. The agencyahas 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 FR14465). The use of this policy was upheld by the Commissioner of Food and Drugs. (FR Doc. 86-223* Filed 1-31-6& 8:45 am) aOJJNQ COM <KM1 21 CFR Parts 172.17$, 178,177,176, and 161 (Docket No. MM-6334] Proposed Uena of Vinyl CMorMt Polymers aoincv: Food snd Drug Administration. action: Proposed rule. SUMSAitr The Food and Drug Administration (FDA) ia proposing to amend its regulations to provide for the safe use of vinyl chloride polymers. The agency is proposing: (1) To providt for the safe use of certain vinyl chloride polymers by establishing limits on the amount of residual vinyl chloride monomer that they may contain: (2) to codify ell known prior sanctions for 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 chloridevinylidene chloride copolymers from the list of materials that may be used as coatings on fresh citrus fruits. Elsewhere in this issue of the Federal Register. FDA is withdrawing the proposal on vinyl chloride polymers that it published in the Federal Register of September 3. 1975 (40 FR 40529). DATE Comments by April 4.1966. L Introduction The purpose of this proposal ia to provide for the safe use of vinyl chloride polymers in contact with food. Vinyl chloride is a chemical with the formula GtHtCTused at a monomer in t-r - the producudh of polymers. Other monomers are chemically bonded to this monomer by the process of polymerization to form larger, more complex molecules called "polymers" When ell of the monomers that are polymerized together ere molecules of the same substance, the resulting molecule is called a "homopolymer." The vinyl chloride homopolymer is sometimes called "polyvinyl chloride" (CAS Rag. No. 9002-66-2). When molecules of different chemicals are polymerized together, the resulting molecule is celled a f "copolymer." Thus when ethylene molecules art polymerized to vinyl chloride molecules the resultina_____ copolymer is called "ethylene vtnvliden# chlorids" Elsewhere in this issue of the Federal Register. FDA is withdrawing an earlier proposal on vinyl chloride polymers that it published on September 3.1975. Responses to comments received on the September 3,1975 proposal are set forth in the withdrawal document. IL Regulatory History Vinyl chloride (CAS Reg. N& 75-01-1) is a chemdal with the following structure: U.S. Court of Appeals in Scott v. FDA . 728 F^d 322 (6th Cir. 1984). a case involving FDA's decision to list - permanently the use of DSC Green No. 5.This color additive contains a , C2H3CI, 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 (47FR 14463). Accordingly, FDA is withdrawing the ' A wide variety of vinyl chloride proposal published in the Federal. polymers including homopolymer and Register of September 3.1978 (40 FR' various.copolymers era available far . 40529). Published elsewhere in thts isene ; use in the production of articles of the Federal Register Is a notice of t intended to contact food. Including food- proposed rulemaking that would;. packaging materials coatings plaetieols authorize the safe use of regulated and .. geekets parte for food:processing . _j. V equipment flexible tubing, and .. >^ waterptps s--' Under seedpa 301(e) of the Federal j- - Food, Drug, end Cosmetic Apt (the act) ' (21.UAC, 321(s)).a suhatenne is . . ^ exeluded from.the definition pf e"food O . additive" If ituse wMsancttaoed by 4178 Federal Register / Vol. 51. No. 22 / Monday, February 3, 1986 / Proposed Rules FDA before September G, 1958. the date vinyl chloride monomer as high as 20 have been permitted under the{*ry of the enectment of the Food Additive* 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 10.1973, 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, vinyi Regulations. FDA is aware of such published a notice of proposed chloride has been shown to be an sanctions for their use as components of rulemaking in the Federal Register of animal carcinogen both by inhalation film for food wraps, as components of May 17.1973 (38 FR 12931). to restrict and by oral administration and a human can enamels, arid 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 (IARC Monographs. 19:409-412. materials, excluding bottles. used with nonalcoholic foods. 1979). Since the enactment of the Food By March 1974. the agency had Additives Amendment in 1958. FDA has received information horn various Data Received in Response to Proposal approved a variety of uses of vinyl sources suggesting that the migration of As a result of the September 3,1975 chloride polymers in food-contact vinyl chloride monomer from vinyl proposal. FDA received numerous articles. The regulations codifying these chloride polymer resins was not limited comments, which an addressed approvals include: 1172-210 Coatings to situations in which the polymer was elsewhere in this issue of the Federal on fresh citrus fruit (formerly used in food-contact articles for Registar, and considerable analytical 1121.1179); 1175.105 Adhesives (formerly 1121.2520); 1175.300 Resinous andpolymeric coatings alcoholic beverages. By this time, vinyl chloride monomer had been linked to liver cancer in humans. Therefore, in the manufacturing and toxicological data bearing on th* reduction in th* level of vinyl chloride monomer in vinyl chloride (formerly 1121.2514); {175.320 Federal Registar of April 22.1974 (39 FR polyman. These data lad FDA to Resinous andpolymeric coating for 14215). FDA proposed to ban vinyl publish this new proposal on vinyl polyolefin films (formerly i 121.2580); chloride as an aerosol propellant in drug chlorida polyman. 1178.170 Component ofpaper and and cosmetic preparations and also Data submitted by industry in paperboardin contact with aqueous and requested data from industry about the response to the September 1975 proposal fattyfoods (formerly 1121.2528); use of vinyl chloride polymers, the showed that manufacturers had 1178.180 Components ofpaper and residual concentration of vinyl chloride succeeded in reducing the vinyl chloride paperboardin contact with dry food monomer in vinyl chloride polymers, monomer levels in vinyl chloride (formerly 1121.2571); 1177.1010 and the migration of vinyl chloride polymer resin. Before 1975, residual Acrylic andmodified acrylicplastics, monomer from vinyl chloride' polymer vinyl chlorida monomer levels of 1.000 semirigid and rigid (formerly containers. ppm wan common. Since than, S 121.2591); i 177.1200 Cellophane In the Federal Registar of August 28, improved manufacturing procedure* (formerly 1121.2507); 1177.1210 1974 (39 FR 30830), the agency issued a have lowered the residuiu vinyl chloride Closures with seeling gaskets forfood final rule that prohibited the use of vinyl monomer levels by more than fiva containers (formerly i 121.2550); chloride as a propellant in aerosol orders of magnitude. 1177.1830 Polyethylene phthalate cosmetic products and that required that Although methods for reducing vinyl polymers (formerly 1121.2524); a manufacturer obtain an approved new chloride monomer levels have varied S 177.1850 Textryls (formerly drug application before using vinyl from company to company, such 11212545); 1177.1950 Vinyl chloride- chloride as a propellant in aerosol drug methods gtnarally have involved ethylene copolymers (formerly products. This action was based on spplicatiaa of hast and vacuum during - 11212809); 1177.1900 Vinyl chloride- evidence that Inhalation of high processing of the resin. Manufacturers hexene-l copolymers (formerly concentration* of vinyl chloride resulted nave also taken steps to produce small. 1121.2823); i 177.1970 Vinyl chloride- in acuta toxicity that was manifested by ^CTOwaffrato^rtMaa ^Icbhava lauryb vinyl either copolymers an array of symptoms, including (formerly 11212808); 1177.1980 Vinyl unconsciousness, cardiac effects, bone of tha resin. chloride-propylene copolymers rtfwg-- and degenerative changes in / Substantiation of dm reduction in (formerly 11212521); 11772280 the brain, liver, and kidneys. / vinyl chlorida monomar has bean Microporous polymericfilters (formerly As a result of the many comments that provided by raporta of residual vinyl 11212831); and 1179.45 Packaging the agency received on the April 22.1974 chlorida monomer levels of 10 ppb in material* used during the irradiation of proposal, in the Federal Registar of vinyl chlorida polymer bottles (Tha packaged foods (formerly 1121.2543). September 3.1975 (40 FR 40529). FDA Society of tba Plastics industry, Inc, The .renumbering of these sections proposed further restrictions on the use November 121982) and an estimated occurred as part of a recodification that of vinyl chloride polymers in contact 100 parts per trillion In can coatings FDA announced in the Federal Reflates of March 15.1977 (42 FR14302), with food. Under the September 1975 proposal, (Union Carbide Co^ December 121980). The Society of tha Plastics Industry, On January 4.1973. representatives of rigid and semirigid vinyl chloride Inc (SPQ. in a submission (November Schuisy Distillers met with FDA to . polymers would have been banned from 121962) on behalf of tb* vinyl chlorida rspart the results of enelyses that food-contact use because of possibly polymer manufacturers, informed tha showed that alcoholic beverages stated unsafe levels of vinyl chloride monomer i agency "that with respect to vinyl in vinyl chloride polymer battles for migration, although caatteued use of \ chloride polymer bottles, the Industry periods of up to 9 moathe-hed levels of .-< vinylchloride polymer waterpipe would *Nqan provide products with raaidual Federal Register / Vol. 51, No. 22 / Monday. February 3. 1986 / Proposed Rules 4179 monomer levels not exceeding 10 ppb by 4. Oxford Press. London. 1976). The 2.4 ppb. while vinyl chloride monomer weight." The SP1 submission further differential equations expressing these levels in the extract from the 0.28 ppm stated "the quantity of viniy chloride laws contain a variable called sheet averaged 1.6 ppb' (Diachenko, et available to migrate is so low, and the diffusivity. The form oQhe differential al.. Journal of the Association of Official rate of migration of vinyl chloride from equations derived from Fick's laws Analytical Chemists. 80:570-575.1977). vinyl chloride polymer containers made with a residual [vinyl chloride monomer] content of 10 ppb or less is so slow that the concentration of vinyl chloride in the contents even after an exaggerated / shelf-life exposure at moderately elevated temperatures will not exceed l the safe (0.073 ppb) level." To monitor the level of residual vinyl chloride monomer in vinyl chloride polymers, the agency has developed a sensitive gas chromatographic method titled "Head Space Sampling and GasSolid Chromatographic Determination and Confirmation of >1 ppb Vinyl Chloride Residues in Polyvinyl Chloride Food Packaging" (J.L. Dennison, et aL. Journal of the Association of Official Analytical Chemists. 81:813-819.1978). This analytical method has been tested by FDA and by at least one major manufacturer of vinyl chloride polymers and has been found to yield satisfactory analytical results. However, the method has not been tested with all possible vinyl chloride-based food-contact articles.FDA invity? mnwnuts --tth* applicability of this analytical method an/^WUI rsminw "y receiveSTn developing a final rule. IIL The Use of Vinyl Chloride Polymers in Food-Contact Articles WID Result in Their Becoming Components of Food Section 201(s) of the act defines a "food additive" as "any substance the intended use of which results or may reasonably be expected to result directly or indirectly, in its becoming a depends on the boundary conditions, i.e.. monomer concentration inside and outside the bottle wall, and on the conditions existing at the time of initiation of diffusion of vinyl chloride monomer, such as the intitial residual monomer concentation. When applied to the particular situation of monomer migration from a bottle, such as vinyl chloride monomer from a vinyl chloride polymer bottle, the diffusion equations derived from Fick's Second Law always predict a finite migration of the monomer based on initial monomer concentration in the bottle walL provided diffusivity is not zero. Only if diffusivity is zero would no migration be likely. Based on its review of published experimental results and of theoretical calculations based on numberous systems. FDA believes that the diffusivity of vinyl chloride monomer in vinyl chloride polymer will always be greater than zero, and that migration will occur whenever residual vinyl , chloride monomer ^present in the A* polymer. In a series of reports dating from January 17.1975. Ethyl Corp. proposed 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 the initial residual vinyl chloride monomer concentration in the bottle wall and the diffusivity are known. Ethyl Corp. originally applied this diffusion model to extraction data The Ethyl predicts that there will be migration, albeit below the limits of detection by current analytical 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. 813 F.2d 947. 955 (D.C Cir. 1979). Therefore, besed on the evidence before it. FDA concludes that vinyl chloride polymer will become e component of food, and that the extent to which this will be the case 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 tha 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(a)). 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 V extracts from vinyl chloride polymers, those methods have shown that, consistent with Ethyl's model the levels of monomer in tha 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 (c.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. contact-articles. contained 0.44 ppm residual vinyl Under section 409(c)(3)(A) of die act The migration of vinyl chloride chloride monomer and the other (US ; (21 U.S.C. 346(c)(3)(A)). the so-celled monomer from vinyl chloride polymers ppm. Samples from each lot ware "general safety clause" of the Food can be described by Fick's First and. extracted with SO 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 1858 (Crank. 4- "The monomer levels in the extract from the unless the data presented to FDA Mathematics of Diffusion." 2d Ed. pp. 2- , polymer containing 044 ppm averaged establish that the food additive is safe \ -.30 4180 Federal Register f Vol. 51. No. 22 / Monday. February 3. 1988 / Proposed Rules for that um. the concept of safety embodied in this requirement was explained in the legislative history of the Food Additives Amendment of 1958. "Safety requires proof of a reasonable certainty that no barm will result from a proposed use of an additive. It does not--and cannot--require proof beyond any possible doubt that no harm will result under any conceivable circumstance." H. Rept. 2284. 85th Cong., 2d Sess. 1 (1958). This definition of safety is incorporated in FDA's food additive regulations (21 CFR 170.3(i)). The Delaney anticancer clause of the Food Additives Amendment of 1958 (section 409(c)(3)(A) of the act (21 U.S.C. 348(c)(3)(A)) provides further that no food additive can be deemed to be safe if it is found to induce cancer when ingested by man or animal. In the past FDA often refused to list a food or color additive that contained or was expected to contain minor amounts of a carcinogenic chemical, even if the additive as a whole had not been shown to cause cancer. As explained below, however, scientific developments and experience with risk assessment procedures have made it possible for FDA. in appropriate circumstances, to approve the use of additives that contain a carcinogenic chemical. In the preamble to the final rule permanently listing D&C Green No. 8 published in the Federal Register of April 2.1982 (47 FR14138). FDA explained the basis for approving the use of a color additive that had not been shown to cause cancer, even though it contains a carcinogenic constituent Since that decision. FDA has listed, on the $c-= basis, the uses of several color addu fei that contain carcinogenic impurities, including the use of D&C Green No. 8 for coloring contact lenses (48 FR 13020; March 29.1983) and the use of D&C Green No. 5 (47 FR 24Z78; June 4.1982) and of D&C Red No. 8 and D&C Red No. 7 (47 FR 57881: December 28.1982) for coloring drugs and cosmetics. (See also tha advenes notice of proposed rulemaking publiahed in the Federal Register of April 2.1982 (47 FR 14482).) The appropriateness of FDA's decision to list the uses of these color additives is supported by Scott v.-FDA. 728 F.2d 322 (8th Cir. 1964). That ease involved a challenge to FDA's decision to approve the use of D&C Green No. 5. which contains a carcinogenic chemical but has not itself been shown to cause cancer. Relying heavily on the reasoning in the agency's decision, the U.S. Coart of Appeals for the Sixth Circuit refected the challenge to FDA's action and affirmed tha Hating regulation. The Delaney or anti-cancer clause is not triggered unless the additive as a whole is found to induce cancer. An additive that has not been shown to . induce cancer but that contains a carcinogenic impurity is propeny evaluated under the general safety clause of the statute, using risk assessment procedures to determine whether there is a reasonable certainty that no harm will result from the proposed use of the additive. Therefore, because vinyl chloride polymers, manufactured from tha component vinyl ehlonde monomer, have not been shown to causa canear, 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 presenttd by the carcinogenic chemical that may be present as an impurity in tha additive. Thia discussion is presented below. B. Carcinogenicity Data an Vinyl Chloride Monomer FDA. since tbs early 1970's, has bean monitoring ongoing animal studies that hava investigated the toxicity of vinyl chloride monomer. The agency has reviewed four available oral cardnoganidty 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) tha chronic oral study performed by Feron at al. (Food and Cosmetic Toxicology, 19^17-333.1981), (3) Tha British industrial Biological Research Association (BZB unpublished study (1980) enutled "An Investigation into the Carcinogenic Potential of Vinyl Chloride Monomer when Administered to Rate in the Drinking Water for up 52 weeks." and (4) CIVO Institute 9 unpublished study (19&>j entitled "Lifespan Oral Carcinogenicity Study of Vinyl Chloride in Rata." In tha Feron et aL study, Wistar rats were fed a diet containing vinyl chloride monomer in vinyl chloride homopolymer powder or were administered vinyl chloride monomer in soybean oil by gavage. The results of this study show that vinyl chloride me earner ia a carcinogen in Wistar rata, inducing neoplastic livtr call nodules, hepatocellular carcinomas, and angiosarcomas of tha liver and the lung. Tha agency chose this study for computation of tha risk for human axpoaura to vinyl chlnaida mooomar because it wee a lifetime (133 to 144 weeks) feeding study, and because tha individual misl data wart available. In the Maltoni study vinyl eh;c*lde monomer was administered by v us routes (including oral gavage). dost, and schedules of treatment, to animals of various species, strains, sex. and age. For the oral portion of the study. Sprague-Dawley rats were administered vinyl chloride monomer in olive oil by gavage for 52 weeks (5 times/week) and kept until spontaneous death (136 weeks). The report contains few details on the experimental design. Howsver. the results of the oral portion of this study suggest that vinyl chloride monomer ia an animal carcinogen. Tha results have not been used for the agency's risk assessment because the treatment issue only 52 weeks. The data from this experiment were also presented by Maltoni at "Tha Conference to Re-evaluate the Toxicology of Vinyl Chloride Monomer. Polyvinyl Chloride and Structural Analogues" held at the National Institute! of Health, Bethesda. MD. March 20 and 21.1980, and ware publiahed in Environmental Health Perspectives, 41:3-29.1981. In the BORA study. Wistar rats war* administered vinyl chloride monomer as solutions in tha drinking water for up to 152 weeks. The wsuts show that vinyl chloride monomer ia carcinogenic to Wistar rats, inducing predominantly hepatic hemangioaarcomaa. The leteat CIVO Institutes TNO study (1983) is actually a repeated study of Feron et at. (1981). but at lower test levels of vinyl chloride monomer. The earlier study (Feron et si. 1981) had shown that liver neoplasia were found to occur at all doaa 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 tha same laboratory. Tha results of this study essentially confirmed tha 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 la an animal liver carcinogen via tha oral route of exposure.' An extensive review of the . toxicological affects of vinyl chloride monomer has also bean presented in International Agency for Research on Cancer (1ARC) monograph No. 19 (published February 1979). which was prepared by an 1ARC evaluation group that mat in February 1973. Tha evaluation group concluded that vinyl Federal Register / Vol. 51. No. 22 / Monday. February 3. 1966 / Proposed Rules 4181 chloride monomer ia a carcmogen in animals (both via inhalation and oral routes) and in humane (inhalation). It found that vinyl chloride monomer ia carcinogenic by the inhalation route to mica. rats, rabbits, hamsters, and humans. The evaluation group also found that the monomer produces tumors at multiple aites but ia most active in induction of the otherwise rare hepatic angiosarcomas. IARC summarized the data on vinyl chloride monomer as follows (1ARC Monographs. Supplement 1. p. 4S. 1978); A. Evidence for Cartteogenidty to Haitians (Sufficiaiit) Vinyl chloride causes angiosarcomas of the liver h has also been associated with tumors of the braia and lung and ef the haematopoietic and lymphatic systems In humans. Reports of inaeaaad fnddram of tumors of the digestive system wwery tract, and breast (in women) are inadequate to evaluate the carcinogenicity ai vinyl chloride for these sites. (Sufficient) ilJ Vinyl chloride is catcioogeaic is nice. rats, sad haautars after its edmioistratiea welly or by inhalation producing tumors at eaveiai sites, including anginaawnmaa ofihe lives Cl r Activity to Short Tent Teals (Suffci--I) Vinyl chloride induces DNA damage in prokaryotaa and. in maannalian cads w rJtn It was amtagensr to SaianneUa typhimuritm in the ebaence of aa exogenous metehoiic actlvatina system and to Escherichia ceU. Schizosaccharamycet pcmbe and Socchammyces cenvisiae but not to Neumpoie erasso. h wss mutagenic to Drosophila mefawogoafer. inducting sex* linked mceasivu lethal anitattaaa sad to homateroeiissn wan. It i chrootaeomel ebenutu chromatid exchanges ia Cbsaasa haamtaea . exposed is viva it did not indues dominant lethal or sostatic mutations in mica. Vinyl chloride alkylated the liver DNA of rats treated in rfvo. Chromosomal aberrations and sister chromatid exchangee were induced in worker* expooed to vtayt chloride. Moat such data mart obtained whaoexpomeu was tu levels of 23 ppm. in fallow m studies, ia which workers wee exposed to Wvuis that had bean reduced tn 13 ppm or lower, ap aberrations or sister chromatid evrhsngss were reported. Sister duomaOd exdtange inbdant* dropped to s noraud level shortly after termination of exposure to levels. Howuver. the tnridenee of chromoeomel berratiooe retiaued to mnoai only after two year*. (Thus, although i evrhiagee ware oot oboereod to i studies, sampling may have i the lsvsl ratumad to aomalj ThelflbPi wiriia vinyl chloride monomar is am astahdshsd animal carcmoyearia both inhaladonaad oral ingasdon. its carciaoganlc activity iabrnnama has so 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. polymerization, and processing Inc.). If the vinyl chloride monomer industries and who wgjp exposed to residual level is 10 ppb. the proposed * high environmental concentrations of limitation in 1177.1975. and if 100 vinyl chloride monomer vapor. Based on percent migration occurs, the predicted its own review of the data. FDA concurs vinyl chloride monomer level in the with this conclusion. beverage would be 0.65 ppb. The C. Risk Assessment in assessing the risk presented by vinyl chloride monomer from the ose of vinyl chloride polymers, the agency has used risk assessment procedures that are similar to those that it used in evaluating the risk from the minor carcinogenic impurities that may be present in the color edditivee that FDA discussed above. The risk evaluation of the raranogenir. constituent has two aspects: (lj Assessment of the probable exposure to the constituent (vinyl chloride monomer) from all the regulated and prior-eanctinnad usee of vinyl chloride polymers, and (2) extrapolation of the risk obseived la the animal bioasaays to the conditions of probable exposure to humans. resulting vinyl chloride monomer levels in the liquor would be below the detection limits of current analytical methods. The actual migration expected over the shelf life of liquor is likely to be lower based on experimental migration levels from containers having higher residual monomer levels. For example, when bottles containing 0.9 ppm residua! vinyl chloride monomer were extracted with 90 percent ethanol for 9 months at 72* F. no vinyl chlorids monomar could be detected in the solvent at a level of detection of 10 ppb (Ethyl Carp., report dated September 27. 1976). Therefore, if it is assumed that migration nocure at die level of detection. 5J percent of the raeidual vinyl chloride monomer migrated. Because dlffushrity has bean shown by 1. Exposure \ ^ Ethyl's work to decrease as die residual The agency has calculated an estimated daily intake for vinyl chloride monomar from known current uses of vinyl chloridepolymers as potential wall atadditional uses taking into account the fraction of the daily diet that might be packaged In materials made of vinyl chloride polymers. Vinyl chloride monomer exposure may be estimated using known vinyl chloride monomer residuals tn the vinyl chloride homopolymer or copolymer and survey data for current production levels for these polymers. The estimated daily intake calculations for-vtnyi chloride polymers vinyl chloride monomer ia redaesd. dm percent migration must also decreets. Therefore. 8J percent migration of n l residual vinyl chloride monamerfroa^ }v bottles containing 10 ppb vtnyl chloride \ npnomer is an upper limit W 5.5 percent if the available vinyl chloride monomer migrates from a 1-75-Hter bottle having 10 ppb raeidual vinyl chloride monomer. / the predicted level of vinyl chloride j monomer in the packaged food would be/ sQ.036 ppb. According to available statistics ("Public Revenues from Alcoholic Beverages." p. 26,1980/1981. Economics and Statistics Division. Distilled Spirits are ae foOowr t. Liquor bottfes. Because this ose of Council of dm United States, lac.), par capita liquor consumption in 1980 was vinyl chloride polymers is not permitted 198 gallons or about 19 grams per day. by current regulations or by a prior The avenge vinyl chloride monomer sanction, than are no available ingested par person par day from this marketing data from which die agency use would be about 0.88 nanogrmm per might estimate potential vinyl chloride day if vlnyi chloride monomer migration monomer expose! a from vinyl chloride is 0988 ppb. polymer Hquor bottles. There are severe! Exposure may also be estimated using waye 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 37974 conservative assumption that all Hquor individuals surveyed, those who will be packaged in these bottiae. In consumed liquor at least once during the reality, vinyl dhtorids polymer* wf8 3-day study period consumed an compete with other materials guch as polyethylene tarsphthalataand flash which are Uqoor.. average of 48 mams par day. Tht 90th parcantSa farina for tiaara was 98 grams par day. V this Uttar vahm is used, vinyl chloride monomer txpoanra becomes 39 nc c A typical vinyl chloride ploymar - \- nanugrams per day. This number is liquor bottle will weigh approximately conservative because users who 109 peats and have a capacity dug consuom liquor lass fraquandy than i 4182 Federal Register / Voi. 51. No. 22 / Monday, February 3. 1986 / Proposed Rules once in 3 days were not included in the survey. The 1977-1978 Market Research Corp. of America (MRCA) survey of food consumed over a 14-day period reports an upper 90th percentile level of only 28 grams per day for brandy, whiskey, rum. and vodka. 2. Wine bottles. According to the Distilled Spirits Council of the United States. Inc-1980 consumption of wine was approximately the same as that of liquor. However, the 90th percentile users' intake reported by USDA is 232 grams per day (USDA Nationwide Food Consumption Survey. 1977-1978). If all this wine contained vinyl chloride monomer at a level of 0.036 ppb (baaed on the Ethyl Corp. 50 percent ethainol extraction experiments referred to above), ingestion of vinyl chloride monomer would be 8.4 nanograms per*'' day. This number is even more conservative than that calculated for liquor because water does not extract vinyl chloride monomer as well as alcohol and migration into a beverage containing 14 percent or less alcohol should be lower than migration into beverages containing 50 percent alcohol Furthermore, as with liquor, the assumption that all wine will be packaged in vinyl chloride polymer bottles is highly conservative. (The corresponding MRCA 14-day survey, gives a level of 78 grams per day for the 90th percentile user.) 3. Oil bottles. There are vinyl chloride' polymer vegetable oil bottles on the market and, although the number of these bottles is small there are indications that the number will increase. In contrast to the consumption pattern for liquor and wine, fats and oils are consumed by almost the entire population. In 1978. salad and cooking oil consumption (including oils used in commercial salad dressings) averaged 2Z4 pounds per person per year ("Fatr and Oils Situation." USDA. May 1980) or 28 grams per day per capita. For food. items with broad consumption patterns, the 90th percentile users' intaka la generally about two times the per capita intake and yields an estimated 58 grama per day for 90th percentile users ofsalad and cooking oil (The MRCA 90th percentile level for retail salad and - cooking oils is a much lower 5.2 grama P day.) ............. Experimental results demonstrate that the migration rate of vinyl chloride monomer, from a rigid vinyl chloride . polymer bottle into a vegetable oil approximates the miration rate into 90 ' percent sicohoL (See. e.g-extraction - results reported by Ethyl Corp. in the. April 1973 issue of "Modsm Packaging.") From Information supplied by The Society of the Plastics Industry, of the total daily diet is packaged in Inc., a typical oil bottle contains 38 vinylidene chloride-vinyl chloride ounces of oil and weighs 70 grams. copolymers. Using the maximum value Assuming a migration rate for oil that is of 24 percent, the migration level of 0.14 identical to that for 50 percent alcohol ppb. and a total dietary intake of 3.000 the estimated 90th percentile user intake grams per day. FDA calculates exposure is 24 nanograms per day. to vinyl chloride monomer from this use 4. Vinyl chloride homopolymer film. to be 12 nanograms per-day. Vinyl chloride monomer levels in (ii) Vinyl chloride-vinylidene plasticized vinyl chloride homopolymer copolymer coatings on fresh citrus fruit. film are lower than those found in rigid Based on information from a major vinyl chloride polymer. An upper limit of producer of vinyl chloride-vinylidene exposure to vinyl chloride monomer chloride copolymer (memorandum of from the film can be obtained by telephone conversation. M. Flood. FDA assuming that all of the vinyl chloride and). Cobier. Dow Chemical Co- monomer in th film migrates into food. N September 30 and October 3.1983). FDA For example, a film with a thickness of 1 has determined that this copolymer is no mil (0.0025 centimeter), a density of 1.28 /'longer used as a coating on fresh citrus grams per cubic centimeter, and a vinyl, fruit Therefore, the agency is proposing chloride monomer residual of 5 ppb < to revoke the regulation permitting this would yield a maximum level in food o'f use and is not including any 0.010 ppb. if 1 square inch of film contribution of vinyl chloride monomer ^contacts 10 grama of food--FDA's usual from this use in its calculation of the assumption. Analyses of plasticized film estimated daily intake. for vinyl chloride monomer have * 6. Other uses. FDA has only included generally shown residual vinyl chloride the primary probable contributors in monomer levels of less than 5 ppb estimating the daily intake of vinyl (Dennison, et aL. Journal of the chloride monomer. It has not included ' Association of Official Analytical other food-contact uses of vinyl chloride Chemists. 61:4413-619.1978). The homopolymers and copolymers because assumption of 100 percent migration is they contribute such a small amount of likely to be an exaggeration even for use vinyl chloride monomer to the diet that, with fatty foods such as meat and in view of the conservatisms used in poultry, which would extract vinyl estimating exposure from the primary chloride monomer to a greater extent contributors, they can be disregarded. than other nonalcoholic foods. An example of these uses includes vinyl Currently, food packaged in chloride copolymers used as coatings, plasticized film is estimated to be about where heat treatment of the coating 5 percent of the diet. Industry after application would reduce vinyl projections indicate that this percentage choride monomer in the coating to levels may rise to about 74 percent in 5 years. not measurable by current analytical FDA used the latter value in computing technology. Additionally, uses of vinyl its estimates. chloride in articles such as water pipe or Considering migration, fraction of the filters can be disregarded. These articles diet packaged in film (74 percent), and a have a long service life, come into total dietary intake of 3.000 grams per contact with extremely large amounts of day. FDA estimates exposure to vinyl water and other food, and will contain chloride monomer from the use of vinyl small amounts of vinyl chloride chloride homopolymer film to be 12 monomer. Therefore. FDA believes that nanograms per day ("Guidelines tot these uses will not contribute any Estimating Exposure to Indirect Food measurable amounts of vinyl chloride Additives." FDA. June 1961). monomer when used in accordance with 9. Vinyl chJoride-rinylidene chloride the proposed regulations. - copolymers (i) Films. Although the use To obtain an estimate of the upper of this type of film with food is mote limit vinyl chloride monomer exposure limited than the use of vinyl chloride from all food-contact uses of vinyl homopolymer films, residual vinyl ^ chloride polymers. FDA has summed the chloride monomer levels are higher than upper limit exposures from each of the those encountered in vinyl chloride ,A primary contributors to the exposure, homopolymer films. If the vinyl chloride v FDA considers it unlikely that a high monomer residual is 30 ppb. a level thaf user of vinyl chloride polymer food- FDA believes la the lowest level contact products would be exposed at achieveble with current technology, a1 maximum levels of vinyl chloride ' calculation similar to that for. monomer from each use. Because it la- * homopolymer film yields a level of (LI* most unlikely that a 90th percentile wine ppb-in food from lWkporcant migration. consumer is also e 90th percentile liquor Information submitted by indnstiy consumer, particularly on a lifetime indicates that 14 percent to 24 percent. basis, these two `exposure eetimetes are , rynffb*4, JUA^* Federal Register / Vol. 51, No. 22 / Monday, February 3. 1986 / Proposed Rules 4183 not added together, kntead. FLAts using the higher value for wine ta the vinyl chloride monomer cmdetivv calculation. FLA conservatively estimates that the ii/uiiiee net aged individual exposure to vmyi chloride monomer from the probable food* contact use of vinyl chloride polymers will not excee^^^onograma per day. 2. Extrapolation of Risk The agency used a quantitative risk 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 net likely to underestimate the actual risk from very low doses. In fact the of the risk is most likely exaggerated hecenae (he extrapolation models used ate designed to estimate the maximum possible risk consistent with the date. For this reason, the estimate can be used with confidence to determine to a reasonable certainty whether any barm will result from the use of vinyl chloride polymem. FLA has used date from e carcinogenicity hioassay in which vinyl chloride monomer was administered in the diet of nts to estimate the upper level of human risk from axposnre to . this impurity from the proposed use of vinyl chloride polymers (Faron et al. study and memorandum dated May 27. 1984. from Cancer Assessment Committee to V. Anand, FDA). f FDA has calculated that the "\ ) individual lifetime risk of cencer from /- *{ exposure to vinyl chloride monomer et S [^23 naimgmms p-- Amj is 1-- i te in) million. Because of numerous conservatisms in the axpoeere estimate, lifetime-averaged individual exposure is expected to be substantially ices then 29 nanograms per day. Thus, die agency concludes that there is e reasonable certainty of no harm from the exposure to vinyl chloride monomer diet may result from die oee of vinyl chloride polymers hi food perlreging compiytng with the vinyl chloride monomer limitations set forth in tide ducemaut These limitations oa resides! vinyl chloride monomer era necessary to ensure that the preeent and fttore exposure to vinyl chloride monomer to the daily diet remains within dm Units used to conclude that vinyl chloride polymers may be used safely. V. Mar sanctions The neeney <e propaefog to estohfish a listing of all known prior aanctioaa for the use of vinyl chloride polymers in packaging materials. These prior sanctions include thoee hated in the 2B7& propaaeL so well as additional prior sanctions discovered since publication V. Proposed Regulations of that proposal. As discussed above, die ese of a substance is excluded from the A. Curmndy Regulated Polymers In order to provide for the safe use of definition of "food additive" ht section vinyl chloride polymer* currently 2<Jt(3) of the ect if that use ie in regulated under Title 21 of the Code of accordance with a sanction or approval Federal Regulations, FDA is proposing granted prior to the enactment of the the following: Food Additives Amendment Section 1. In 1172210 Coatings on fresh citrus 181.5 of FDA's regulations (21 CFR 1815) froit. FDA is proposing to delete the use provides that a prior sanction exists of vinyl chloride-vinylidena chloride only for specific uses oi a substance; ie.. copolymer, und the adjuvant* used in its at the levels required for the technical production, as components of coatings effects and in the food categories lor on fresh citrus fruit The only known which there is explicit approval. As a manufacturer of this copolymer reported result same uses of e substance may be to FDA that the materiel has not been food additive uses while other uses may used to coat fresh citrus fruit for many - be prior sanctioned. Indeed. FLA years, and that there an no plana to regulations list uses of a number of market the product for this use in the substances, including vinyl chloride future. Deletion of the additive vinyl polymers, in each category. chloride-vinylldene chloride copolymer Lie 1975 proposal listed several prior- in this regulatoin will also result in the sanctioned uses of vinyl chloride deletion of polyethylene glycol, polymers and requested that firms poiyvinyl-pytrolidana. potassium holding other valid prior sanctions for persulfate, propylene glycol alginate, these polymers forward them to FLA for end sodium iscylbenxene sulfonate inclusion in the final regulation. Theca from 117? nn because din only use of were no suhmieainns in response to that these adjuvants permitted by this request. regulation is in vinyl cbiorids-vinylidane Subsequently. FDA reviewed its files on ell firms that wars known to be manufacturing vinyl chloride polymers chloride coplymeta. The deletion of these adjuvants has no effect an their statue in other food additive regulations. for sm m food-contact articles before 2 In | 172305AeUasfim FDA is the effective date of the Food Additives proposing to establish a limit on residual Amendment-to the act. This review vinyl chloride eumoeier of 3 ppb by revealed the following additional prior weight of tbs vinyl chloride homo- or sanctions: L Letter to Flnsstana Mastics Co* copolymer component of tha adhesive. 2 In f 175300 Resinous andpolymeric Pottstown. PA. dated April 20. US1. coatings, tot the vinyl chloride homo- or permitting the use of vinyl chloride ramus as films for food packaging. copolymer component of the coatings. FDA is proposing to establish a halt on 2. Letter toFirestone Plastics Co. reeiriutl vinyl chtorida nsaonmer of 9 Pottstown. PA. dated October A IMA Permitting the use of rigid polyvinyl ppb by weight 4. i 175.330 Bmiootm andpolymeric chloride (bornopoijruwr) sheet for coatings fotpoiyoiefia pirns. FDA is packaging poultry. proposing to establish a limit on raaidiial 3. Loiter to Firestone Plastics Co. vinyl chloride maocener of 5 ppb by Pottstown. PA. dated February 221087. weight of the vinyl chloride oopotymer permitting the use of vinyl chloride and vinyl chloride-acetate resins for "food wrapping purposes-*' component of the olefin polymer coating. 2 1XTltfQQsmporwats ofpaper<md 4. Letter to Borden Co. Sente paperboard in contact with aqmaeeond Barabara. CA. dated Angus! IS. M87. fattyfoods. FDA ie proposing to Permitting the ese of vinyl diteride establish a limit an residual vtoyi polymers as tubing for food-contact eae. chloride monomer of 8 ppb by weight of FLA is proposing to establish f 111.37 the listed vinyl chloride copolymer to cover those uses of these vinyl chloride potynan for which documentation of the prior aaactloue Ie 2 In 1172180 Cooipaoenta ofpaper avaiiabia. FDA's review of its files far and paperboard in contact with dry all known pre-19BB manafactarvrs failed foods. FDA la proposing to establish a to locate any docaaentatioa of a prior eanction for a rigid or semirigid vinyl chloride polymer bottle. The only liarit on reelduel vinyl chloride monowen? of 3 ppb by wright of the vtejd chloride O homo- or copolymer component (. V 7. In 1177.1010Acrylic and modified * i vfaxyi chloride polymer that the apeacy acrylicplastics, semirigidend rigid. found were for wuterptpeend poulhy FDA Is propeeutg to establish a Until anr^ packaging tray* residual vinyl chtoride 1 rof 5 u 4181 Federal Register / Vol. 51, No. 22 / Monday, February 3, 1986 / Proposed Rules ppb by weight of the vinyl chloride copolymer component. a. In f 177.1200 Cellophane. FDA ia proposing to establish a limit on residual vinyl chloride monomer of S ppb by weight of the vinyl chloride homo- or copolymer components. 9. In { 177.1210 Closures with sealing gaskets forfood containers. FDA is proposing to establish a limit on residual vinyl chloride monomer of 5 ppb by weight of the yinyl chloride copolymer component. 10. In 177.1830 Polyethylene phthalate polymers. FDA is proposing to establish a limit on residual vinyl chloride monomer of S ppb by weight of the vinyl chloride copolymer component. 11. In 1177.1850 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 1177.1950 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 1177.1960 Vinyl chloride- hexene-1 copolymers, FDA is proposing to establish a limit on residual vinyl chloride monomer of 10 ppb by weight of the vinyl chloride copolymer component 14. In 1177.1970 Vinyl chloride-louryi 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 i 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 1177.2250 Filters, microporous polymeric. FDA is proposing to establish a limit on residual vinyl chloride . monomer of 50 ppb by weight of the vinyl chloride homo- or copolymer component - t 17. In 1179.45 Packagingmaterials for use during the irradiation of prepackagedfoods, FDA is proposing to establish a limit on residual vinyl chloride monomer of 5 ppb by weight of the vinyl chloride copolymer component B. Polymers Not Previously Regulated In Part 177. FDA is also proposing to establish new.|177.1975 Vinyl ihloride polymer resins, rigid and semirigid, to. provide for the safe use of rigid end semirigid vinyl chloride polymers that have beenmarketed beaed on the belief that they are covered for food use by a vaUd-prior sanction.-TUa regulation. provides for the use of those vinyl ' chloride polymers that are not covered by a valid prior sanction or by existing regulations. This regulation proposes various specifications, including a residual vinyl chloride monomer limit of 10 ppb by weight of the vinyl chloride polymer. C. Prior-sanctioned Polymers FDA is proposing new i 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 hat determined the manufactuera 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 es noted below, FDA proposes to limit residue! vinyl chloride monomer to 5 ppb by weight of the vinyl chloride homo- or copolymer component 2. In vinyl chloride-vinyUdene chloride film*. FDA propose* to limit residual vinyl chloride monomer to 50 ppb by weight of the vinyl chloride copolymer . component 3. In vinyl chloride polymer waterpip*. FDA proposes to limit residual vinyl chloride monomer to SO ppb by weight of the vinyl chloride homopolymer component 4. In plasticized vinyl chloride for use as flexible tubing and es gaskets and bottle or far linen. FDA proposes to . limit residual vinyl chloride monomer to 5 ppb by weight of the vinyl chloride polymer components. 5. For rigid vinyl chloridt polymer sheet FDA proposes to limit residual vinyl chloride monomer to 10 ppb by weight of the vinyl chloride polymer component Based on available toxicity data, the agency's sxposun cslcustions. and its ssdmites of the risk from tha cartinogtnic constituent vinyl chloride monomer, in tbs polymer when the . polymer complies with the specifications that the agency isproposing. FDA tentatively concludes that the use of vinyl chloride polymers as food-contact materials, as described above is safe. The agency Is. therefore, proposing to emend the food additive regulations and to adopt new regulations to provide for the sale use of vinyl chloride polymers. Tha agsncy is also proposing to delete from the current food additive regulations the use ai vinyl chloride-vinyhdane chloride copolymers as s component of coatings of fresh citrus fruit. Following publication of the 1975 ------- proposal, the Environmental Protection Agency (EPA). under authority of the 1974 Safe Drinking Water Act executed a memorandum of understanding (MOl') with FDA (see 44 FR 42775: July 20. 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 aa 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 Sefe Drinking Water Act the Toxic Substances Contr *, and the Federal Insecticide. Fung., and Rodenticide Act Therefore. FDA hea 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 envoronmentel effects of this action and hea concluded that the action will not have a significant impact on tha human environment and that an environmantal impact statement ia not required. The agency's finding of no significant impact end the evidence supporting that finding, contained in an environmantal 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 (21CFR Part 25) that was published in the Federal Register of April 28.1985 (50 FR 10638. effective July 23,1985). FDA welcomes the submission of any data bearing on tha issues and conclusions contained in tha finding of no significant impact and the environmental sssessment FDA would particularly Uka any additional information on tha environmental fate (e.g.. persistence; of dl(i-sthyinaxyl) IflJ ijgpats. and sxpoxtdtzedToybean ou in terrvsT ana Dentrue environments, and any additional information on the effects (acute, subacute, and chronie) of these chemicali on representative organisms from those environments. FDA would also likeadditional Information an whether vinyl chloride polymers . contribute >" l-- polychlorinated dibenzn-p-diiwii.. MtiYchUiwnstoo dTihhoennszaoffuurrasnna* from 1 Federal Register / Vol. 51. No. 22 / Monday. February 3. 1966 / Proposed Rules 4185 municipal solid waste incinerators. FDA will reexamine its conclusions if new information became* av.uahU suMesting that this action will have significant environmental Impact The agency has prepared an 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 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 before 1975. The egency estimates that , these new methods cost about S2J million more annually than their predecessors. FDA. in accordance with the Regulatory Flexibility Act. has considered the effect that this proposal would have on small entities including small businesses and certifies in accordance with section 005(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 Management Branch (address above) . written comments regarding this proposal. Two copies of any comments ' are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document Received comments may be seen in the office above between 9 a.m. and 4 pm.' Monday through Friday. List of Subjects 21 CFR Part 176 Food additives. Food packaging. 21 CFR Part 177 ~ Food additives. Food packaging. 21 CFR Part 179 Food additives. Food packaging. Radiation protection. 21 CFR Part 161 Food ingredients. Food packaging. Therefore, under the Federal Food. Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that Parts 172,175.176.177,179. and 181 be amended as follows: PART 172--FOOO ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION 1. The authority citation for 21 CFR Part 172 continues to read as follows: Authority: Sms. 201(a). 409.72 stat 17841788 as amended (21 U.S.C. 321(a). 348k a CFRS.10. 2. In 117210 by removing and reserving paragraph (b)(3) and by revising the introductory text of paragraph (b)(4) to read as follows: 1172210 Coatings on fresh citrus frutt. (b) * (3) [Reserved] (4) In lieu of the components listed in paragraph (b)(2) of this section, the following rosin derivatives and either or both of foe listed adjuvants: PART 175--INDIRECT FOOO ADOITIVES: ADHESIVES AND COMPONENTS OF COATINGS 3. The authority citation for a CFR Part 175 continues to read as follows: Authority: Secs. 201(s). 409.72 StaL 17841788 as amended (a U&C 32Us). 348): 21 CFRS.10. 4. In 1175.105 (c) (5) by revising foe item "Vinyl chloride" to read as follows: 21CFR Part 172 ' 1171.tOi Food additives. .. 21 CFR Part 175 ` Adhesives. Food additives. Food .. packaging. . --. ................ -F'vfb SeMHK mV cmenM menu* cctimm I <77 iTj<ei rm cnaour. m* net iMMlwniwmeiti yi ot VS M^fl cMpnflg Qf MBC^MT Lj . .1/ 5. In 1175-300 by adding new paragraph (i) to read as follows: 1175J00 Resinous and polymeric coatings. (i) Residual vinyl chloride monomer content determined in the finished coatings, using the method described in 1177.1975(c) of this chapter, shall not exceed 5 parts par billion hy weight of the vinyl chloride homo- orcopolymer 6. In i 175.320 by redesignating paragraph (e) as paragraph (cHl) and by adding new paragraph (c)(2) to read as follows: . 1178220 Raalnoua and polymeric coastings lor polyolefin fMma (c) 84 (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 thejuihad miHnw using foe methoJ described in 1177.1975(c) of this chapter, shall not exceed 5 parts per billion by weight ofthe vinyl idycopoij VfliGn-' PART m INDIRECT FOOO ADOITIVES: PAPER ANO -7. Theauthority citation for 21 CFR....... Part 176 continues to read as follows: Authority: Sacs. 201(1). 409.72 Stat 17041788 as amendad (21 U.S.C. 321(a). 348): 21 CFRS.10. 8. In | 176.170(b)(2) in foe table by f V adding limitations to the items "vinyl 'qJ chloride copolymers," "Vinyl chloride- FZ vinyl acetate hydroxyl-modified . copolymers." "Vinyl chlbride-vinyl aoetate hydroxyl-modified copolymecs ^ reacted with trimellitic anhydride." and --; "Vlnyiidena chloride copolymers" to - p*. < reads* follows: - *188 Federal Reliefer / Vol. 51. No. 22 / Monday, February 3. 1986 / Proposed Rules 17g.l70 Components of paper and paperboard In contact wittt aqueous and fatty' foods. (b) * ' * (2) * * * a*onat cepohnriara Far papar or nuaiiiiiaiil (| iru Mini Mwi i a eonaa ao* 1177 1973(C) a* M neii 5 aora aor a ft* ot 9. In 1175.180(b)(2) by revising the item "Vinyl chloride" to reed as follows: 178.180 Components of paper and ffl MRIIKI WVUV W J IwUli 177.1010 Acrylic and modffled acrylic plastic*. *mirlgid and rigid, * * * i (a) * * * (2) Copolymer* produced by copolymerization of one or more of the monomers listed in paragraph (a](l) 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. fee be determined in the finished form in which the articles are to contact food using the method described in 1177.1975(c). shall not exceed 5 parts per billion by weight-ofths vinyl chloride oapalystsrcggpoasw*. (4) Polymers identified in paragraph (a) (1). (2). and (3) of this section are mixed together and/or with the following polymers, provided that no chemical reactions, other than addition reactions, occur when they are mixed: provided further that for any polymers that include a vinyl chloride homo* or copolymer, residual vinyl chloride monomer, to be determined in the finished foyj-^nff**'-* using the method described in 1177.1975(c). shall not axcaad 5 parts par billion by weight of the vinyl chloride homo* or copolymer im ot i VriyldPtf CfiOM 0 ATM 0I V 9 Do. fyw*. duty rrmriaytiim. m* tavw. erytMa. 2-*9*r999* iWk cryfw. Myl iwdwgy 1818. 'tacone 804. RlfPlfr crytC 804 fWW|8 80y8R8. f7i#i^o MfigcryiM, pnpfl 8ery8i8. propyl motapy 18(8. wnyi cfRond* Vinyl emend* herwopnrywr___A8 pip Mhc porymer For pom i dame 9 0 13. In f 177.1210(b)(5) by revising tbs item "Vinyl chloride-vinyl stearate copolymer" to read at follows: (b) * (*]* PART 177--fMOmiCT TOOO . AODITIVESt POLYMERS 10.The authority citation far a CFR Part 177 continues to mad as foilowc Authority: See* 201(a). 40* 73 Stat 1784- 17M as amended (21 U.&C.3a(s). 344k & Gntua; ^ n. fat 11771010 by revising the introductory tests of paragraph (a) (2) end (4) to read asfollows: 12. In 1177.1200(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 chioride-malaie add copolymer resins," "Vinylidana chloride copolymerizad with * * V and "VInylidena chloride* math*crylie decyloctyl copolymer," and by adding naw item "Vinyl chloride homopolymar" to read as follows: 177.1200 CaOophawoa (c) * ' * 14. In 1177.16ao(eM4Xili) by revising the item "Vinyl chloride" to read as follows: 177.1030 PstyeOiytows 8 W# (4) * * * (Ui) * * * Vinylidana chloride oopolymerised with oneor mere of the following: Vinyl chloride. Residual vinyl chloride monomer, determined in thifiaiahtd gmobmaunating. using the method described in I l77.l*7S(c|. shell ao< exceed 5 parts per billion by weight at Ihs vtayl ahieride-eepeiyweaeempoaHt' Federal Repair / Vol. 51. No. 22 / Monday. February 3. 1986 / Proposed Rules 4187 IS. In ) 177.1850 by revising paragraph (c)(2) to read as follows: {177.1850 Tsrtryte. see* (c) * ' * SuMtVCM UMMM (2) Ffen* pror0 wn* Crtona *nyt KMH COQOhF^Ff * m ease cBBaamo mryw ntonetw. outmma tw Swwd moMS * |!m*7J<ci. 1W not I S pars nr MMn W i 16. In 177.1950 by adding new paragraph (c)(l)(iii) to read as follows: { 177.1950 Vinyl cMorida ethylene 1177.1975 Vinyl cMoride polyar realm, rigid and semirigid. Vinyl chloride polynjgrs may be safely used as articles or components of articles intended for use in contact with food subject to the provisions of this, section. (a) Identity. Vinyl chloride polymer resins consist of (1) homopolymer resins produced by polymerization of vinyl chloride, which has the molecular formula C.H.Q (CAS Reg. No. 75-01-5). Vinyl chlonde polymer resins (molecular formula (CiHiCl).; Cas Reg. No. 900286-2) have s 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 Method of Test for Dilute Solution Viscosity of Vinyl Chloride Polymers" (Method A), which is incorporated by reference. Cooies are available front the copolymers. ee e (c)* * * (D* * * (iii) Residual vinyl chloride monomer, determined in the finished food-contact article, using the method described in { 177.1975(c). shall not exceed 10 parts per billion by weight of the vinyl rhlnridt nspilymrr rnmpnnrnt tea 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: 1177.2250 ntora, mlcroporoua polymeric. 90S (e) Residual vinyl chloride monomer, determined in the finiihed microporous .polymeric filters, using the method dasaeikad tea ft tATKfal akell ears*