FDA Approval of Recycled-Content Packaging

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March/April 1993 

As more and more scrap is being recycled into food packaging, recyclers may wonder what federal guidelines and regulations apply. Here are some answers.

BY JOHN DOUGHERTY

John Dougherty is a Silver Spring, Md.-based freelance researcher and writer on environmental issues.


Scrap paper, glass, and metal have long been recycled into food-contact packaging products such as paperboard containers, beverage bottles, and food cans. More recently, some manufacturers have begun using recycled plastics in products such as soft drink bottles and egg cartons. This growing consumption of recycled material in food packaging—particularly postconsumer material recovered after use from industrial, commercial, and household generators—has created a need for new guidance from the federal government.

That's where the Food and Drug Administration (FDA) comes in. The FDA regulates both virgin and recycled food-packaging materials under its food-additive provisions, which govern not only the packaging material itself—glass, paper, and so on—but also the coatings, adhesives, compounds, and other aids used in the production of the package. Under the Food, Drug and Cosmetic Act, a food additive—which includes paper, glass, metal, and plastics—cannot be marketed without FDA approval, and it is the food packaging manufacturer's responsibility to ensure that the packaging—whether made of virgin or recycled material—complies with FDA regulations.

In this regard, the FDA is mainly concerned about the potential for contaminants to migrate from the food-contact packaging to the food it contains. In the recycling realm, the FDA has determined that the recovery of home scrap produced during the manufacture of food packaging—which the agency refers to as primary recycling—does not pose a health or safety concern and is acceptable, provided that "good manufacturing practices" outlined in existing FDA regulations are followed. The FDA is more concerned about food-contact packaging that contains postconsumer scrap because, the agency says, there's the heightened chance that chemical or microbiological contaminants could have been introduced by the consumer or generator—particularly in the recycling of paper and plastics. Recycled glass and metal are not as worrisome, the FDA believes, because they are generally impervious to contaminants and are automatically cleansed at the high temperatures used in their recycling.

Perusing Postconsumer Paper

FDA regulations permit the use of "reclaimed" fiber—including home and postconsumer scrap—in paper and paperboard packaging for food-contact use under certain conditions. At the moment, the FDA has not developed any guidelines or requirements against which recyclers and manufacturers of recycled paper and paperboard food packaging can test their products to ensure that they do not contain contaminants that could migrate to the food. In essence, therefore, recycled-content paper and paperboard food packaging must meet the FDA's specifications for virgin paper and paperboard products set forth in Title 21 of the Code of Federal Regulations, Part 176.

What little guidance the FDA has given notes that the recycled paper packaging product cannot contain any poisonous or deleterious substances that could be retained in the recycled pulp and migrate to the food. This includes inks, optical brighteners, and other contaminants that can be difficult to remove during processes such as deinking and repulping.

How can paper recyclers and packaging manufacturers ensure that their recycled products meet the FDA's virgin standard? Source control at all stages of the recycling and manufacturing processes is probably the best way to keep contaminants to a minimum, says Murrell E. Smith Jr., vice president of Chesapeake Paperboard Co. (Baltimore).

For packaging manufacturers, production control is also paramount. This issue is so important, in fact, that many large food companies fulfill all of their own packaging needs—producing paperboard, constructing the packaging, and packaging their food in-house. With this strategy, food companies maintain, contamination concerns are less prevalent and more easily monitored than when the company buys its recycled paperboard from an independent paperboard manufacturer. Those companies that do buy paperboard rather than producing it generally include FDA specifications in their contracts with paperboard suppliers, and test the packaging regularly to ensure that the products meet FDA guidelines.

Regardless of who manufactures the packaging, safety concerns are especially great if the recycled-paper packaging will be used to contain certain food products that are more susceptible to contamination from the packaging than others. Fatty foods such as bacon, for instance, are particularly prone to absorb contaminants in instances where there is direct contact between the food and the packaging, notes Rod Edwards, vice president of paperboard for the American Forest and Paper Association (New York City), formerly known as the American Paper Institute. Insertion of a barrier between the food and the food packaging—whether to keep the food fresh or separate it from the packaging—also reduces the prospect of contamination problems, according to FDA guidelines.

Plastic Packaging Cons

Because plastics are made of complex chemicals containing a number of additives, the FDA is concerned that they could be more likely than other recycled materials to retain contaminants through the recycling process. As such, in its informal guidance to manufacturers of food-contact packaging made from recycled resins, the agency makes a distinction not only between products made from home scrap and those manufactured from postconsumer materials, but also between what it calls secondary and tertiary recycling.

Secondary recycling refers to the process whereby postconsumer plastics are typically shredded, washed, and then ground, flaked, or pelletized. The basic polymer is not altered. Tertiary recycling involves chemically breaking down plastics to their monomers or oligomers, which can then be recombined—either alone or with virgin resin—to make food-grade recycled plastic. The most common types of tertiary recycling processes are methanolysis and glycolysis.

The FDA's main safety concerns on the use of postconsumer plastics in food-contact packaging are: 

  • Contaminants from the recovered plastics may find their way into the food packaging. Since secondary and tertiary plastic recycling processes effectively sterilize plastics through high temperatures and/or solvent baths, microbiological contamination is not a concern, the FDA says. Also, acute exposure to chemical contaminants from food containers produced through those processes is expected to be extremely low due to the small concentrations of contaminant residues in the recycled polymers.

The FDA is concerned, however, that traces of a carcinogenic substance, or other substances that could pose a chronic health hazard, could be carried through the secondary or tertiary recycling processes, become a part of the packaging, and pass into food.

Like that for paper, the potential for migration of packaging components to food is determined by the conditions under which the recycled plastics are used, such as the type of food involved (dry, aqueous, fatty), the temperature during time of contact, and the duration of contact, notes Jerome Heckman, a partner with Keller and Heckman (Washington, D.C.) and legal representative for food packaging manufacturers.

  • Plastics not approved for food-contact use could be incorporated into recycled food-contact packaging. When recyclers maintain tight source control, the problem of commingling postconsumer food-contact plastics with other postconsumer plastics can be minimized or eliminated. Nevertheless, even if all the recovered postconsumer plastics are food-contact products, there is still the risk that a plastic regulated for use with aqueous food, such as soft drinks, or for refrigerated use could be incorporated in packaging intended for high-temperature use with fatty foods. The result could be a food-contact plastic that may not comply with FDA regulations. This problem can be avoided by sorting procedures that focus on separation by type of plastic product, the FDA says.
  • Substances used in recycling plastics, such as wash solutions and detergents, which are not approved for food-contact use, could find their way into the recycled product.
  • Quantities of certain additives could exceed levels approved for food-contact use. Recycled resins that require new additives or greater quantities of additives in excess of what is currently permitted would require an FDA food-additive petition for food-contact use. Another concern is that different resins may undergo different reforming conditions, such as processing temperatures or vacuum stripping, which the FDA believes could influence contaminant levels.
  • Package integrity could be compromised by using postconsumer plastics.

Offering Guidance

Despite these many concerns, the FDA has not implemented any regulations that deal specifically with the use of postconsumer plastic in food-contact packaging. In fact, the FDA typically does not regulate the process a manufacturer uses to make a packaging component, such as a finished polymer, and it does not dictate the source—that is, virgin or secondary—of the component. Thus, makers of recycled plastic packaging for food-contact use must comply with the same requirements that pertain to virgin plastic packaging, as outlined in the Food, Drug and Cosmetic Act and the FDA's food-additive regulations in Title 21 of the Code of Federal Regulations, Part 177, Heckman says.

Nevertheless, the agency has specifically noted in congressional testimony that it sees no objection to the use of postconsumer plastics in three food-contact uses: polystyrene in cartons for eggs in shells; polyethylene or polypropylene crates for transporting fruits and vegetables for short periods; and baskets and trays made from polyethylene terephthalate (PET) soft drink bottles for packaging fresh fruits and vegetables. In addition, the FDA has determined that plastic grocery bags containing postconsumer plastics do not come into significant contact with food and, therefore, are not to be regulated as food additives.

Furthermore, the FDA has supplied "no objection" letters to three companies that use tertiary recycling processes to produce soft drink bottles from postconsumer PET—Eastman Chemical Co. (Kingsport, Tenn.), which sells its recycled pellets to Johnson Controls Inc. (Rancho Cucamonga, Calif.) for use in 7-up containers; Hoechst Celanese Corp. (Bridgewater, N.J.), which works with Coca-Cola Co. (Atlanta); and Goodyear Tire and Rubber Co. (Akron, Ohio), which produces its "Repete" recycled resin for use by Pepsi-Cola Co. (Somers, N.Y.). All three produce a resin that contains 25-percent recycled postconsumer PET, with Eastman Chemical and Hoechst Celanese using methanolysis to make their resin, and Goodyear using glycolysis.

According to Heckman, plastic recyclers are not required by law to receive the FDA's "no objection" letter. To be on the safe side, however, any company that plans to produce a postconsumer-plastic-content package for food-contact use would be wise to get the FDA's blessing prior to marketing the product to avoid health and safety problems later on, says Richard Oblath, manager of the polyester technical center of Shell Chemical Co. (Houston), the parent company of Goodyear's polyester division. The FDA recommends that secondary recyclers seeking "approval" of recycled plastic for food-contact use should submit information on—among others topics—source control, use limitations on the recycled plastics (such as "use at room temperature or below"), and food-type restrictions (such as "dry or aqueous foods only").

In a set of informal guidelines titled "Points to Consider for the Use of Recycled Plastics in Food Packaging: Chemistry Considerations" published in May 1992, the also FDA offers a testing protocol for recyclers to use to show that their recycling processes can remove contaminants from plastic containers that may have been misused by the consumer—for example, by storing pesticides or used oil. (Containers intended to hold such non-food products would never be approved for recycling into food-use packaging, of course.)

Following the FDA's protocol, consumer misuse can be simulated by exposing postconsumer plastics, either in container form or as flaked or ground resin, to surrogate contaminants. The plastics are then run through the recycling process and subsequently analyzed for the contaminants. If the process fails to remove contaminants to the limit of dietary exposure—currently recommended at 1 part per billion—additional steps may be required by the FDA, such as using recycled/virgin blend, improving source control, using a functional barrier between the food and the packaging, or restricting the container's uses.

Beyond the FDA's health and safety concerns, plastic food packaging manufacturers have a couple of concerns of their own. First, even if a recycled postconsumer plastic passes the FDA's tests for food-contact uses, the question remains whether the finished product is marketable. Second, manufacturers are concerned about whether there is an adequate supply of clean postconsumer plastics to enable them to produce a reasonably priced product at a reasonable cost.

In the next few years, recyclers and manufacturers of postconsumer-content food packaging should keep their eyes on the FDA, for that agency could either bolster or discourage the recycled-packaging business through its guidelines and regulations, both existing and emerging. Now, though the FDA's guidance has been slight, the message is clear: Food-contact packaging made with postconsumer material must meet the same standards as its virgin counterparts. If that high standard can be met—and some recyclers and manufacturers are showing that it can—then the postconsumer food-contact packaging market could have a bright future indeed.

As more and more scrap is being recycled into food packaging, recyclers may wonder what federal guidelines and regulations apply. Here are some answers.
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