Approval of PVC for Packaging Distilled Liquors: Still Waiting After All These Years
On your last trip to the local liquor store, you may have noticed the expanding variety of materials in which liquor, wine, and beer is sold. While glass remains the most widely used material, and most beer is still sold in aluminum cans, plastics are becoming increasingly popular. Many brands of liquor are now sold in polyethylene terephthalate (PET) bottles, as are several brands of beer. Inexpensive wines packaged in polyethylene bags and held in a box are in favor for marketing larger quantities of the beverage, and several frozen specialty drinks, such as daiquiris and margaritas, are packaged in multi-layered laminate structures.
Where are the bottles made out of polyvinyl chloride (PVC) resins? Known for its good barrier qualities, it would seem a great choice for packaging distilled liquors–and, in fact, at one time it was.
But that was before three different federal agencies got into the act.
For over 40 years, PVC has been used to package food. Throughout the years, however, PVC has never been the subject of a food additive regulation. Instead, its use has been based upon several sanctions or approvals issued by the U.S. Food and Drug Administration (FDA) prior to 1958, including those clearing its use as a component of food wraps, can enamels, and specific types of rigid food packaging materials.1 PVC has always been, and continues to be, permitted by FDA for use in these food-contact applications.
With regard to the use of PVC to package liquor, however, approval by the U.S. Bureau of Alcohol, Tobacco, and Firearms (BATF) is necessary. In issuing such approvals, BATF usually relies heavily on FDA's approval of such materials for use in food-contact applications. In the case of PVC, BATF's reliance on FDA clearance for food packaging materials–in the form of a final rule–has led to a 15-year (and running) delay in the use of PVC with distilled liquors.
The history of PVC and alcohol began on Nov. 21, 1968, when BATF first authorized the use of PVC liquor bottles in selected sizes on an experimental basis. This temporary authorization was renewable on an annual basis. Although it continued to annually issue temporary authorizations, BATF indicated in 1971 that an environmental impact statement (EIS) would be required in conjunction with its review of PVC liquor bottles. This EIS was later issued in March of 1975.
Two months later, however, FDA published a proposed rule restricting the use of PVC resins in food packaging to nonalcoholic foods, based on data indicating that alcoholic beverages stored in PVC bottles for periods of up to nine months had elevated levels of vinyl chloride monomer (VCM), a known human carcinogen. As a result of this proposed rule, BATF announced that it would no longer renew the experimental use authorization.
Later that year, based on toxicological data presented during Occupational Safety and Health Administration (OSHA) proceedings, FDA broadened its proposal to ban the use of all rigid and semi-rigid PVC in contact with food. Over the next few years, however, advances in technology permitted vast reductions in the residual level of VCM in rigid PVC containers. This data was submitted to FDA, and provided, in part, the basis for a petition filed with BATF in 1980 by The Society for the Plastics Industry (SPI) for generic approval of PVC for packaging distilled spirits.
In response to the petition, BATF solicited FDA's position on the status of PVC, and was told that FDA had no documentation of a prior sanction for the use of PVC liquor bottles. While FDA indicated that it would take no action against the use of rigid and semi-rigid PVC, it stated that BATF would be taking a chance if it permitted the use of PVC to package distilled spirits.
In late 1982, Keller and Heckman, on behalf of several members of the industry, wrote to FDA seeking reaffirmation of the propriety of using PVC for liquor bottles. The letter noted that a number of producers represented their ability to fabricate PVC liquor bottles with residual VCM levels of 10 parts per billion (ppb) or less. Calculations included with the letter demonstrated that any potential migration of monomer into the liquor would be below the acceptable daily intake (ADI) level for VCM calculated by FDA. Thus, FDA was asked to advise BATF that PVC is suitable for use in making liquor bottles.
In response, FDA agreed that PVC liquor bottles do not present a health or safety concern, but indicated that the agency wished to develop a proposed regulation to cover all food-contact uses of PVC. For that purpose, FDA requested the submission of marketing data and environmental information. Such data was forwarded to FDA and, in 1983, FDA prepared a draft proposal to regulate the use of PVC in food as a replacement for the limited existing prior sanctions.
EPA Enters the Fray
On Feb. 3, 1986, FDA withdrew its proposed ban on rigid and semi-rigid PVC food-contact articles, and simultaneously issued a new proposal providing for the safe use of PVC in contact with food, which included limits on the level of residual VCM permitted in the finished article. FDA also announced its tentative finding that the proposed rule would have no significant environmental impact, but requested additional data on several specific environmental issues.
In response to this proposal, the U.S. Environmental Protection Agency (EPA) filed comments, in which it raised questions regarding the impact of the rulemaking on dioxin and furan levels generated by incineration of PVC, as well as the increased use of plasticizers.
Later that year, BATF was requested to approve the use of PVC containers for packaging liquor based on FDA's withdrawal of the 1975 PVC proposal, as well as statements in its preamble to the 1986 proposal indicating that rigid PVC containers are safe for use in contact with food if residual VCM levels are within specified limits. In November of 1986, BATF rejected this request, stating that it would not approve PVC liquor packaging until FDA issued its final rule for PVC.
Throughout 1987, industry submitted data to FDA in support of its finding of no significant environmental impact. Nonetheless, by the end of 1987, FDA had decided to seek EPA's views on the principal environmental issues involved in the rulemaking. In mid-1988, EPA responded, recommending that FDA perform a comprehensive environmental impact statement for the proposed expanded use of PVC.
An EIS, of course, is a document of no small magnitude. National Environmental Policy Act regulations require the review and analysis of relevant data related to every conceivable (and some not-so-conceivable) effect that a proposed action may have on the environment. They are punishing in their detail, and easily subject to legal challenge once issued.
Having never before completed an EIS, FDA undertook the work with some trepidation. In fact, the agency's work on the document continues today. Of course, until the EIS is completed, FDA cannot issue a final rule to permit the use of PVC in food packaging applications, including alcoholic beverages. And, with no final rule ever having been issued, BATF continues to withhold its approval of PVC for use in packaging distilled liquors.
1A substance is considered "prior sanctioned" if it was permitted or approved for use in food applications by FDA or USDA, usually in response to an informal inquiry, prior to 1958. These informal approvals attained official status with the enactment of the Food Additives Amendment in 1958, which explicitly excludes such substances from the definition of a food additive and therefore from the food additive clearance requirements of Section 409 of the Federal Food, Drug, and Cosmetic Act.