Packaging and Environmental Legislation in the United States: An Overview
By Keller and Heckman LLP’s Packaging Practice Group
In the absence of comprehensive federal legislation, some states and local jurisdictions in the United States have adopted laws and regulations affecting the production, use, and disposal of packaging. These provisions include standards for environmentally acceptable packaging, minimum requirements for recycled content, restrictions on the use of certain substances in packaging, and even outright bans on certain types of plastic packaging.
The pace of state and local enactments has slowed in recent years, however, as concern about solid waste disposal has receded behind other public policy issues such as terrorism, crime, and education. Three areas where the federal government has asserted its jurisdiction are:
- regulating packaging for food, drugs, and cosmetics (which is a very significant subject and beyond the scope of this article except in limited respects as discussed later);
- promoting government procurement of recycled products; and
- issuing guidelines intended to ensure that manufacturers do not make unfounded claims about the environmental benefits of their packaging in violation of federal truth-in-advertising laws.
U.S. Regulation of Solid Waste Disposal
One of the principal considerations during the 1980s and 1990s that led to the growth of packaging laws and regulations in the United States was concern about the effect on the environment of disposing of post- consumer packaging. Throughout most of the last century, more than 80 percent of America's solid waste, including packaging, was landfilled. While landfilling is likely to remain the major method for disposing of packaging and other materials found in municipal solid waste (MSW), greater reliance in recent years on recycling and composting has already had a noticeable effect on the solid waste stream entering landfills.1
Indeed, the amount of MSW being landfilled has declined to 57.4 percent,2 and the use of recycling and composting has grown from 16 percent of all MSW in 19903 to nearly 27.8 percent in 1999.4 Recovery of containers and packaging was 37 percent in 1999, the highest recycling recovery rate of the three product categories-nondurable goods, durable goods, and containers and packaging.5 While the overall tonnage of landfilled waste continues to grow along with the population and the economy,6 use of recycling and other options has slowed the rate of increase in landfilled waste and has helped reduce the public concern about exhausting the available landfill capacity.
Throughout the 1970s and 1980s, grass-roots resistance to the siting of new landfills, or incinerators that could reduce the strain on existing landfills, increased the costs of landfilling, as existing sites neared capacity and market forces increased prices at privately run facilities. Since air pollution and other concerns caused resistance to incineration, municipalities sought ways to reduce the volume of landfilled waste. In the absence of strong federal leadership, this search spawned a variety of state and local measures aimed at restricting or eliminating the use of certain packaging materials or products, on the theory that this would reduce the overall amount of solid waste sent to landfills. While the trend in the late 1980s and early 1990s to adopt measures compelling source reduction has slowed, the legacy of that period is a complex tapestry of state and local regulations covering labeling, recycled content, and other issues affecting the packaging industry.
The Federal Role—Environmental Protection Agency
The Environmental Protection Agency (EPA), the primary agency of the United States government responsible for regulating waste disposal, has broad authority over the management of solid waste under the Resource Conservation and Recovery Act (RCRA),7 as well as the Clean Air Act,8 the Clean Water Act,9 and the Comprehensive Environmental Response, Compensation and Liability Act10 (CERCLA, commonly referred to as "Superfund"). This authority includes power to set standards for the design and operation of MSW landfills and incinerators and other modes of waste disposal. In general, EPA's method for dealing with solid waste management issues, particularly issues concerning packaging, has been to make recommendations, such as "preferred options" for waste disposal,11 but to leave much of the actual regulation of waste to state and local officials.
Conflicts Over Interstate Shipment of Waste
During the 1970s and 1980s, some states and localities adopted laws and regulations designed to restrict the transport of solid waste. These laws had two primary purposes. First, states with limited capacity for solid waste disposal wanted to prevent out-of-state sources from using facilities within their jurisdiction, so they imposed higher fees or even outright bans to prevent the importation of MSW. The unconstitutionality of such barriers to interstate commerce was quickly settled,12 and these laws were reversed.
Second, and conversely, jurisdictions that had invested significant resources, often funded by municipal bonds, to build new solid waste disposal facilities during the 1970s and 1980s needed to ensure a certain volume of fee-paying waste haulers to meet their bond obligations. In order to prevent local haulers from bypassing their facilities for less-expensive facilities in other jurisdictions, localities imposed shipping fees or other restrictions designed to force local carriers to use local facilities. By the mid-1990s, such laws had been adopted in about 20 states. In 1994, however, the U.S. Supreme Court ruled that these "flow control" restrictions also unconstitutionally interfered with the free movement of commerce between the states.13
In the future, if Congress decides to allow states to impede the movement of waste, it could worsen the MSW disposal problem and lead to more attempts to ban materials usually disposed of by landfilling, including certain packaging materials. To date, courts have not been inclined to strike down more limited laws or regulations, such as restrictions on content, which also may have an indirect effect on MSW landfilling. These statutes, which arguably come under the state's traditional role of protecting public health, are discussed later.
Congress periodically has considered federal legislation addressing recycling, container deposits, the interstate transport of MSW, and other solid waste issues. No consensus has been reached, however, on significant amendments to RCRA or other solid waste legislation introduced in the 1990s. As a result, these issues continue to be handled primarily by state and local governments, industry groups, and environmental activists.
Federal Policy on Recycling
Federal Regulation—Environmental Protection Agency
Although RCRA provides EPA with a broad mandate to promote recycling, the agency has for the most part left the management of MSW in the hands of state and local jurisdictions-where such authority has traditionally rested.14 The major contribution of EPA has been in issuing recommendations on the siting of landfills or statistical reports on the management of MSW. One way EPA has attempted to increase recycling is through encouraging government procurement of recycled products. Section 6002 of RCRA requires EPA to develop guidelines for government agencies to use in procuring products containing recycled materials.15 EPA issued its first guidance in 1983, and updated it periodically. In April 1995, in response to a Presidential Executive Order,16 the agency issued a Comprehensive Procurement Guideline (CPG).17 The CPG included five items previously designated for preferential treatment (cement and concrete containing fly ash, paper and paper products containing recovered materials, reused lubricating oil, retread tires, and insulation products) plus 19 new ones. In November 1997, EPA added 12 more categories of products.18
A superceding Executive Order19 in September 1998 also directed EPA to develop a guidance document for procurement by government agencies of a wide range of "environmentally preferable" products and services. The Final Guidance on Environmentally Preferable Purchasing for Executive Agencies was published in 1999.20 A new Executive Order21 signed in April 2000 requires federal agencies to incorporate environmental management systems into agency day-to-day decision-making and long-term planning processes. Although the guidance documents do not specifically address packaging, they are intended to help stimulate the market for recycled packaging and other materials.
National Container Deposit Legislation
The issue of container deposits to increase recycling has resurfaced at the federal level. This month (July 2002), the Senate Environment and Public Works Committee is holding hearings on The National Beverage Producer Responsibility Act of 200222 introduced in April by Sen. James M. Jeffords (I-Vt.). The act mirrors state deposit laws by requiring a refundable deposit on beverage containers. It also would mandate an 80 percent national recycling rate and compel beverage companies to submit recycling plans to the EPA for approval.
Refundable deposits on beverage containers have been proposed from time to time in Congress, but the legislation has never progressed very far. Although Hawaii recently became the eleventh state to adopt such deposits (the first state to do so in 20 years), the prospects for Mr. Jeffords' latest proposal for nationwide deposits remain questionable in light of strong industry opposition based on issues such as cost and unequal treatment of beverage products.
Environmental Assessment of Food Packaging Materials and Regulation of Recycled Content—Food and Drug Administration
FDA and environmental assessments
The U.S. Food and Drug Administration (FDA) has responsibility under the Federal Food, Drug, and Cosmetic Act (FD Act) to (1) ensure that no packaging material adulterates food, and (2) conduct a premarket review of certain new food-contact materials and new uses of existing materials.23 Although FDA's primary concern in regulating food packaging is to ensure that the packaging is safe for its intended food-contact use, FDA also interprets the National Environmental Policy Act (NEPA) as requiring the agency to evaluate the impact that clearance of a packaging material may have on the environment. FDA has interpreted the vaguely worded NEPA statute as mandating a wide-ranging and highly speculative inquiry encompassing, in addition to recycling, such topics as impact on incinerator emissions and ash, landfill leachate, acid rain, and depletion of stratospheric ozone. NEPA does not require agencies to alter their actions based on the conclusions of environmental assessments. Where NEPA applies, however, agencies must make a "finding of no significant impact" (FONSI), or develop an environmental impact statement (EIS). The length of time required to conduct a full-blown EIS, when necessary, can stall agency action for years.
A case in point is FDA's 1986 proposed rule governing the safe use of polyvinyl chloride (PVC) food packaging. Questions about the post-consumer fate of PVC packaging prompted FDA to take the unusual step of preparing an EIS on the proposed rule (in nearly 100 percent of packaging clearances, FDA is able to issue a FONSI). FDA has indicated that the EIS will address every conceivable environmental issue relating to the proposed PVC rule, including such issues as the impact on emissions of dioxins, furans, and hydrogen chloride from incinerators; effects on recycling programs and solid waste management generally; and impact on the quantities of PVC plasticizers entering the environment. Thus far, the EIS has not been completed, and the regulation on PVC has not been finalized (although PVC and other vinyl chloride-based polymers remain in the packaging market due to prior FDA clearances).
We have learned recently that FDA has requested and obtained the withdrawal of the only remaining request by a company for clearance of a vinyl chloride-based polymer. This will eliminate the need for FDA to complete the EIS, at least for now. It is also an example of how the decision that an EIS is needed can derail the regulatory process.
Fortunately, food packaging clearances almost always require only an environmental assessment (EA), which leads to a FONSI and granting of the clearance by FDA without an EIS. Even an EA, however, can create a major problem in obtaining an FDA clearance.
FDA no longer requires information on environmental effects from manufacture of a food-contact material (because these effects are controlled by EPA or local or state authorities). Furthermore, FDA has exempted some food-contact clearances from the need for environmental assessments.24 In the absence of such an exemption, however, FDA still reviews potential environmental impacts from the use and disposal of the material.
FDA's environmental review of packaging materials frequently focuses on the impact of the material on recycling. Unless the petitioner can provide a technical rationale as to why the material cannot be used in rigid single-use food containers, FDA requires data on the material's impact on recycling. In the case of a packaging material that might enter the recycling stream of a widely recycled material, such as PET (the plastic used in soda bottles), the party seeking the clearance has the burden of proving that the introduction of the new containers will have no significant effect on any of the end uses for the incumbent material. This can be a time-consuming and costly task, although it is ultimately accomplished in most cases.
FDA regulation of recycled content
Use of recycled materials in food packaging applications is governed by the same principles that apply to all food packaging. Typically, an FDA clearance for the use of a packaging material in food-contact applications sets no limits on the source of raw materials that go into making the food-contact substances. Instead, the regulations set specifications and, in some cases, end tests for the material, and authorize the use of any material that meets those standards. Consequently, if a "virgin" material is permitted for use in contact with food, the recycled version of the same material also is permitted as long as it will not render food unsafe or otherwise unsuitable for consumption.25
After several years of piecemeal regulation of food packaging containing recycled materials, FDA developed a guideline, "Points to Consider for the Use of Recycled Plastics in Food Packaging: Chemistry Considerations," to assist manufacturers of food packaging in evaluating processes for producing packaging from post-consumer recycled plastic.26 In general, FDA's policy is that recycled polymers, including any adjuvants, must be of a type permitted for food-contact and should be free from any contaminants that might make the food unsafe. Any other effects on the food (e.g., taste or odor) will be controlled by the steps to assure safety and by consumer acceptance. Concerns about contamination of the plastic can be addressed through a combination of the following factors:
- control of the source of the material for recycling to avoid using contaminated feedstock;
- decontamination features of the recycling process (sortation, washing, heat of processing, chemical treatment of feedstock);
- structure of the recycled material or package (presence of a functional barrier between the recycled material and food);
- limitation on the use of the material to certain conditions of use (dry foods, nuts in shells, frozen food); and
- testing of the recycled material to ensure that potential contaminants will not migrate to food from the package at levels of concern.27
FDA's guidelines generally follow the approach developed in guidelines drafted by industry under the sponsorship of The Society of the Plastics Industry, Inc. (SPI) and the National Food Processors Association (NFPA). The agency has been working for several years on a rule to formalize this guidance, but it is not clear when, if ever, this rule will be issued. However, determining the types of recycled plastic materials suitable for use in food packaging is listed as a priority research need in the May 2001 update of FDA's Center for Food Safety and Applied Nutrition Three Year Research Plan.28 Meanwhile, FDA's "Points to Consider" document continues to be the best written guidance on testing to establish that a plastics recycling process produces material of suitable purity for use in food packaging. Readers of "Points to Consider," however, should be aware that the details of the testing procedure have evolved, and the document does not fully reflect the currently accepted protocol.
FDA also is developing guidelines for testing paper products made from reclaimed pulp to ensure that the finished product will be suitably pure for use in food-contact applications. The guidelines are expected to recommend contaminant testing similar to that recommended for plastics, but addressing different potential contaminants that may be present in recycled paper as opposed to recycled plastics. The Three Year Plan also cites the need to determine the levels of the metals ubiquitous in paper/paperboard packaging from both virgin and recycled pulp.29
Although FDA permission is not required for the food-contact use of recycled material that meets the standards described above, many potential users of the recycled material want the assurance of official concurrence from FDA. The agency will provide "opinion letters" (formerly called "no objection letters") in response to letter requests supported by data establishing the safety and regulatory compliance of the recycled material.
State and Local Regulation on Packaging Disposal and Recycling
Packaging Bans and Recycling Considerations
States and local jurisdictions have invented a variety of regulatory programs designed to restrict or ban certain types of packaging or other products for environmental reasons. Two types of programs-restrictions on substances used in packaging and regulation of environmental labeling-are addressed later. This section focuses on the regulatory programs designed to reduce directly the amount of MSW entering landfills. These include packaging restrictions or bans, minimum recycled content requirements, the use of plastic resin identification codes, and tax credits or other incentives for recycling.
Restrictions or bans
One approach to waste reduction taken in the 1980s was outright bans on certain types of packaging. States banned such products because of perceptions that they occupy too much space in landfills, contribute to litter, or have some other undesirable environmental impact. Examples of outright bans include non-degradable plastic six-pack holders (based on concerns that animals were being trapped in them),30 removable tabs on soft drink cans,31 and glass bottles with attached ceramic caps (which complicate recycling).32 The most common bans were those targeting polystyrene containers and utensils commonly used by fast-food establishments. Another type of ban does not prohibit the sale of plastic containers, but instead bans the disposal of recyclable packaging in landfills.33
Polystyrene containers were a frequent target of bans during the 1980s. Iowa,34 North Carolina,35 and South Carolina36 adopted laws that would ban polystyrene containers if a specified recycling rate was not achieved by a certain date. These laws were subsequently repealed or are not being enforced. One jurisdiction, Suffolk County, N.Y., enacted a complete ban on polystyrene containers. That ordinance was challenged in the courts and subsequently repealed.37 At least 40 other local ordinances, however, still restrict the sale of polystyrene containers within the jurisdiction, ban the purchase of polystyrene containers by local government agencies, or outlaw the possession of polystyrene containers on government-owned land.
Another way states have attempted to encourage recycling is by mandating minimum recycled content in certain products. California38 and Oregon39 have complex laws dealing with rigid plastic and glass containers. These statutes provide manufacturers with several options, including that the container be recyclable or reusable or that it contain a specified percentage of recycled content. Wisconsin's statute,40 like some others, simply requires plastic containers to consist of at least 10 percent recycled material, with an exception in the Wisconsin statute that FDA must approve of the amount of recycled content in plastic containers regulated by the FD Act.
SPI Resin Identification Code
In 1988, The Society of the Plastics Industry, Inc. (SPI), the major plastics trade association in the United States, developed a resin identification system to assist plastics recycling. Thirty-nine states have formally adopted laws requiring rigid plastic containers to include the SPI code or a similar code.
Tax credits, fees, and other incentives
Since MSW handling is usually a local matter, many states establish waste reduction or recycling goals for municipalities, although a few states have mandatory recycling programs. As a way to encourage local participation, states offer financial incentives to jurisdictions that adopt comprehensive programs or meet specified goals. Other financial mechanisms for reducing waste are a deposit or advance disposal fee (ADF) program. Eleven states have deposit laws, or so-called "bottle bills," for specific types of beverage containers.41 Typically, the consumer pays a deposit that can be collected by returning the container to the retailer. In contrast, ADFs are paid in advance by the manufacturer, distributor, or retailer, and are designed to pass the cost of disposal or recycling back to industry.
The adoption of new state and local packaging restrictions and recycling laws has declined in recent years, as concerns about landfill capacity and cost have diminished and other issues have drawn public attention. A patchwork of laws and regulations, however, remain in effect in various jurisdictions, and proposals to stimulate recycling or to restrict certain types of packaging continue to bubble to the surface haphazardly.
Environmental Advertising and Labeling
Federal Regulation—Federal Trade Commission
Federal regulation of environmental marketing claims, so-called "green claims," initially lagged behind state action, due in part to debate over whether the issue should be handled primarily by the U.S. Federal Trade Commission (FTC), which has long regulated all advertising and labeling of products sold in interstate commerce,42 or by the EPA as the leading environmental protection agency. This debate was largely ended in 1992 when the FTC issued its "Guides for the Use of Environmental Marketing Claims."43
The FTC guides represent the commission's administrative interpretation of what constitutes deceptive environmental advertising under the Federal Trade Commission Act.44 The guides cover claims that a product is recyclable, contains recycled content, or is degradable/biodegradable/photodegradable. The guides also address claims that a product is compostable, source reduced, or ozone safe, as well as general environmental benefit claims, such as "environmentally safe."
With regard to packaging, FTC enforcement of its guides has tended to focus on allegedly overstated claims regarding the recyclability of a particular packaging material.45 The position of the commission, as expressed in the guides, is that unqualified claims that a product or package is recyclable are appropriate only if it is being recycled in a substantial majority of the communities where it is sold or recycling programs are available to a substantial majority of consumers to whom it is marketed. If the limited availability of recycling programs is disclosed, recyclable claims may be made even if the product is recyclable in only a few communities. Similarly, if the amount of recycled material in the product is disclosed, a recycled content claim may be made for a product that contains only a small amount of recycled material (e.g., five percent).46 The FTC guides generally have been well-received by both industry and state regulators.
State Regulation of Environmental Advertising
Although the states-through the Attorneys General Task Force on Green Claims and the enactment of environmental advertising laws--arguably propelled the regulation of green claims in the late 1980s and early 1990s, state activity in this area has receded in recent years as states have deferred to the FTC's environmental advertising guides. The most prominent state foray into regulation of environmental claims was California's environmental advertising law, which, among other things, set limits on use of the terms "recyclable" and "recycled." In 1992, a federal district court ruled that the law's standard for "recyclable" claims violated the U.S. Constitution because it was too vague.47 In 1995, California repealed the environmental advertising law and adopted the FTC's guides as the state standard for environmental marketing claims. Other states that have adopted the FTC guides include Maine, Michigan, Wisconsin, New Mexico, and Rhode Island. Indiana continues to have its own environmental advertising law.48 Indiana's law has two distinctive features: it restricts use of the term "recycled" to products that contain a minimum of 10 percent post-consumer or post-manufacture material, and it requires companies to maintain specified records documenting claims. New York has minimum recycled content and recycling rate standards for use of the state's trademarked recyclable and recycled emblems. However, the emblem regulations were amended to provide that mere use of the terms "recyclable" and "recycled," as opposed to use of the state's emblems, is subject only to compliance with the FTC guides.49 Rhode Island has a similar recycling emblem law, but amended it to provide that compliance with the FTC guides is a defense to alleged violation of the emblem law.50
Although not preemptive, the FTC guides have become the de facto national standard for green claims, and a number of states that had their own divergent green claim rules have embraced the FTC guides. It appears that the states are content to let the FTC decide the nation's standards for green claims. The commission's own stance on green claims has remained fairly constant since the guides were issued. In 1998 revisions to the guides51 the commission modestly toughened its guidance on recycled content and recyclability claims but largely hewed to the positions it carved out in the first version of the guides in 1992.52
Control of Substances in Packaging
State Regulation—Restrictions on Heavy Metal Content of Packaging
Eighteen states53 have enacted statutes banning or restricting the intentional addition of lead, cadmium, mercury, or hexavalent chromium in inks, dyes, pigments, adhesives, stabilizers, and other components of packaging. Most of these laws, which are based on model legislation developed in 1989 by the Coalition of Northeastern Governors (CONEG) and updated in 1998, also limit the incidental presence of these metals.54 These laws have questionable scientific underpinnings, but they have become a de facto national (and even international) standard for packaging materials that are marketed widely.
EPA Screening for endocrine modulators
Concerns about the effects of so-called "endocrine disruptors" are affecting many industries around the world, including the packaging industry. Endocrine disruptors are chemicals that cause effects on the endocrine systems of humans or wildlife and are hypothesized to cause cancer or harm to the reproductive system or thyroid function. Public concern about endocrine disruptors was fanned in 1996 with the publication of several magazine articles and a book on the subject. These publications identified a great many "estrogen mimics" and in at least one instance expressed concern about the presence of p- nonylphenol and bisphenol A (BPA) in polymer-coated food cans and bottles for drinking water, respectively. The issue resurfaced in 1999 when the Consumers Union advised parents to dispose of polycarbonate baby bottles because of BPA, and with the coinciding airing of a report on ABC's news program, 20/20, on the safety of polycarbonate and certain plasticizers in food contact materials. The National Environmental Trust requested that FDA assess potential harm from DEHA (di-2-ethylhexyl- adipate) and BPA.
For several years, the plastics industry has evaluated exposure and toxicology data on endocrine disruptors that may be found in food-contact materials, including BPA and alkyl phenols. The work has focused on the documentation of the amount of human exposure to endocrine disruptors from consumer use of plastics articles. The technical work, which has been shared with FDA, supports the conclusion that plastics are safe regardless of questions concerning endocrine effects of some chemicals used to produce plastics.
The National Toxicology Program (NTP) completed a study in August 2001 that looked at the low-dose effects and dose-response relationships of endocrine disruptors to determine what changes were needed in EPA's toxicity testing guidelines.55 The study found insufficient data to determine the endocrine effects of BPA, found low-dose effects of nonylphenol, and found no low-dose effect of octylphenol. The report indicated that, at this point, there is no scientific basis for EPA or FDA to make endocrine testing a general requirement for food-contact materials. FDA's current position is that neither BPA nor DEHA presents a safety concern for adults or children. On the basis of this NTP study, EPA also has decided not to require the testing described below to account for alleged "low-dose" endocrine effects of certain chemicals.
Adopted in 1996, the Food Quality Protection Act56 and the Safe Drinking Water Amendments57 require EPA to develop a screening program to evaluate estrogenic effects of pesticidal and some nonpesticidal substances. For substances found to have an endocrine effect on humans, EPA is required to take appropriate action to protect public health. An advisory committee has developed screening and testing recommendations to test chemicals for estrogenic, androgenic and thyroid receptor effects. Pursuant to the recommendations made in the committee's final report,58 the EPA established the Endocrine Disruptor Screening Program (EDSP). The EPA has set priorities for screening compounds and is performing prevalidation and validation studies that will be used in the testing. A continuing validation subcommittee also has been established.
The final report suggests that about 86,000 chemicals should be considered for screening. Under the proposed prioritization scheme, polymers having molecular weights above 1000 Daltons would not be screened unless tests on their monomeric or oligomeric components indicate an effect. The monomers and oligomers used to manufacture these polymers would be given priority for testing, as would chemicals produced in excess of 10,000 pounds per year. The priority group consists of about 15,000 chemicals. Screening of this first set of chemicals is scheduled for completion in 2005.
California's Proposition 65
Perhaps the most far-reaching state environmental law directed at the content of packaging and other consumer products is California's Safe Drinking Water and Toxic Enforcement Act,59 popularly known as "Proposition 65." Proposition 65, approved by a sizeable majority (63 percent) of California voters as an initiative in 1986, is a right-to-know law that requires companies to either establish that their products are not likely to expose any individual to a "significant" amount of any of over 500 chemicals, or to provide a "clear and reasonable" warning that the product contains a known carcinogen or reproductive toxin.60
The law has several unusual enforcement features. Private citizens are authorized to bring enforcement actions if the state declines to do so, and are entitled to 25 percent of any penalty assessed.61 With penalties for violations of the law set at $2500 per violation per day, the incentive for such "bounty hunters" is great. In an enforcement action, if it can be shown that the product at issue contains a chemical on the state's list of known carcinogens or reproductive toxins subject to the law, the defendant has the heavy burden of proving that the level of exposure poses "no significant risk."62
Several groups and some lawyers have become systematic in bringing bounty-hunter enforcement actions targeting entire industries that use a particular chemical in their products for failure to warn regarding allegedly significant chemical exposures. For example, one group filed notices of intent to sue most, if not all, of the major companies making nail polish remover containing toluene. On another occasion, most of the manufacturers of paint remover products were challenged over exposure to methylene chloride from their products.
In 2001, the California legislature made significant amendments to Proposition 65 in an attempt to put an end to frivolous lawsuits.63 The 60-day notice letters filed by plaintiffs must now be accompanied by a Certificate of Merit that shows the case is reasonable and meritorious. However, since this certificate is reviewed only after completion of the action, there is no real detriment to initiating suit. The second change in the law requires the settlement of any Proposition 65 action to be approved by a court based on its compliance with Proposition 65 and the reasonableness of attorneys' fees and penalty amount. The law, however, does not preclude subsequent suits by other parties for the same violation.
In addition to these amendments, in February 2002, California State Senator Byron D. Sher (D) introduced a bill that would close a loophole that allows enforcers who settle Proposition 65 claims without filing a lawsuit to avoid reporting such settlements to the Attorney General's office.64 Preliminary talks have begun between legislative staff, the Attorney General's office, industry, and the environmental community regarding continued reform in 2002.
Impact on packaging
Numerous substances potentially present in glass, metal, or plastic food packaging materials are subject to Proposition 65, including lead, cadmium, hexavalent chromium, dioxin (2,3,7 ,8-tetrachlorodibenzo-para-dioxin), acrylonitrile, vinyl chloride, and benzene. With the exception of litigation in the early 1990s concerning lead in crystalware, ceramicware, and lead capsules on wine bottles,65 there have been no Proposition 65 enforcement actions regarding food packaging of any sort, despite the elimination, in 1994, of the so-called food and drug "safe harbor," which is discussed below. Even in the absence of enforcement actions, companies marketing packaging materials are under pressure from their customers to provide broad guarantees that their products comply with the law.
Interaction with federal law
Proposition 65 was intended to remedy perceived flaws in federal health and safety regulation and thus encroaches on the domain of a variety of federal regulatory agencies. This encroachment raises the issue of whether Proposition 65 is preempted by these federal laws. With regard to its impact on packaging, the issue is whether Proposition 65 is preempted by the laws and regulations administered by FDA. Until 1992, California had a food and drug "safe harbor" regulation that provided a limited exception for most FDA regulated products, including food-packaging materials. However, this exemption was challenged in court and the state settled the case by agreeing to revoke the regulation, which it did in 1993.66
A federal bill, which attempts to address case law construing Proposition 65 preemption,67 was introduced in the House in July 2001 and would preempt any nonidentical state laws requiring food warnings.68 The bill has been referred to the House Committee on Energy and Commerce, Subcommittee on Health. The recent amendments to Proposition 65 are an attempt to appease Congress, which, while considering legislation, has so far been unwilling to preempt state laws like Proposition 65.
At the beginning of the 1990s the environmental regulation of packaging in the United States was marked by increased-and increasingly divergent-state and local packaging legislation prompted by a combination of federal deregulation policies in the 1980s and the rise of public concern about environmental issues. Since 1991, some of the more divergent state or local laws have fallen by the wayside in such areas as environmental marketing claims and solid waste-related packaging bans. Other state measures, such as Proposition 65 and state heavy metal restrictions, remain but have not been expanded. State and federal laws and regulations continue to exist in areas such as minimum recycled content requirements (in certain states) and EPA procurement guidelines. There is, however, no significant movement to expand these mandates.
It seems clear that the momentum of solid-waste-related environmental regulation of packaging has slowed somewhat since the early 1990s. It is less clear whether this slowdown is attributable to increased understanding of the value of food packaging materials and the arguably excessive blame they have taken as the cause of waste management problems, or to a possibly temporary shift in regulatory priorities to competing "hot" environmental topics, such as bioterrorism, global warming, endocrine disruptors, and control of food-borne pathogens.
Reprinted with permission from Packaging and Environmental Legislation - The United States, in Packaging, Policy and the Environment, G. Levy, ed., pp. 115-130, copyright 2000, Aspen Publishers, Inc.
1U.S. Environmental Protection Agency, Municipal Solid Waste in the United States: 1999 Facts and Figures, Final Report, 1 (1999).
2Id. at 15.
3Id. at 5.
4Id. at 14.
5Id. at 8.
6Id. at 1-3.
742 U.S.C. ßß 6901 et seq. Under the complex RCRA statute, Congress has divided waste management into two discrete universes: hazardous waste, which is regulated under subtitle C of the statute, and all other waste, which is regulated under subtitle D. Most packaging waste is subject to subtitle D, which governs MSW. During the past 20 years, most of EPA's resources have been directed toward toughening standards for land disposal of Subtitle C hazardous waste to make them commensurate with pollution controls already in place for air emissions and water discharges under the Clean Air Act and Clean Water Act.
842 U.S.C. ßß 7401 et seq.
933 U.S.C. ßß 1251 et seq.
1042 U.S.C. ßß 9601 et seq.
11EPA advocates an integrated waste management approach based, in order of preference, on (1) source reduction, including reuse and on-site composting, (2) recycling and off-site composting, and (3) disposal, including combustion and landfilling. U.S. Environmental Protection Agency, Municipal Solid Waste in the United States: 1999 Facts and Figures, Final Report, 12 (1999).
12The leading case in the area is City of Philadelphia v. New Jersey, 437 U.S. 617 (1978), in which the U.S. Supreme Court struck down a New Jersey restriction on imported waste. Such laws are an unconstitutional burden on interstate commerce, the regulation of which, under the commerce clause of the U.S. Constitution, is the domain of Congress. U.S. Const, art. I, ß 8; cl. 3.
13Carbone v. Town of Clarkstown, 114 S. Ct. 1677 (1994).
14Historically, solid waste management in the United States has been a local affair. In fact, until the passage of the Solid Waste Disposal Act of 1965, the predecessor to the current Resource Conservation and Recovery Act of 1976, the federal government had essentially no role in regulating solid waste.
1542 U.S.C. ß 6962.
16Executive Order 12873 (Oct. 20, 1993).
1760 Fed. Reg. 21370 (May 1, 1995).
1862 Fed. Reg. 60962 (Nov. 13, 1997).
19Executive Order 13101 (Sept. 14, 1998).
20Final Guidance on Environmentally Preferable Purchasing for Executive Agencies, 64 Fed. Reg. 45810 (Aug. 20, 1999).
21Executive Order 13148 (Apr. 21, 2000).
22S. 2220, 107th Cong. (2002).
23An "uncleared" food additive is any substance that meets the statutory definition of a food additive in the Food, Drug, and Cosmetic Act (FD Act), 21 U.S.C. ßß 301 et seq., but that does not comply with a food additive regulation issued by FDA. Under the act, any substance that is "reasonably expected to become a component of food under the intended conditions of use" and is not otherwise exempt, must be cleared by a food additive regulation prescribing the conditions under which the material may be used. 21 U.S.C. ß 321(s). There are several exemptions from the food additive definition, some expressly stated in the FD Act, others arising from FDA policy and practice over the past 30 years. See Jerome H. Heckman and Deborah W. Ziffer, Fathoming Food Packaging Regulation Revisited, 56 Food Drug Cosm. L.J., 179-196 (2001) (reprinted elsewhere on PackagingLaw.com).
2465 Fed. Reg. 30355 (May 11, 2000), codified at 21 C.F.R. ß 25.32.
25This interpretation of the law governing recycled food packaging was confirmed by Dr. Fred Shank, director of FDA's Center for Food Safety and Applied Nutrition, in a presentation to The Society of the Plastics Industry, Inc. in June 1990. According to Dr. Shank, "(a)ssuming that a container (made from recycled materials) meets the specifications, and uses materials that meet the specifications, is not contaminated in any way, and contains no uncleared additives of any type, I don't know of any reason why it can't be used." FDAers Voice Concerns About Recycling for Food-Contact Use, 32 Food Chemical News at 59 (June 11, 1990).
26U.S. Food and Drug Administration, Points to Consider for the Use of Recycled Plastics in Food Packaging: Chemistry Considerations (Dec. 1992).
28U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Three Year Research Plan, 2000-2002 Update, Appendix E (May 2001).
30Cal. Pub. Res. Code ß 42350.
31Del. Code Ann. tit 7, ß 6059.
32Cal. Pub. Res. Code ß 70020.
33Massachusetts bans single polymer plastics. Mass. Regs. Code tit. 310, ß 19.017(3)(b).
34Iowa Code ß 455D.16, repealed by 1995 IA ALS 44.
35N.C. Gen. Stat ß 130A-309.10(d) as amended by 1995 NC ALS 321. The previous law banned polystyrene containers unless they contained 25 percent recycled content. The current law bans polystyrene containers unless they are recyclable.
36S.C. Code Ann. ß 44-96-1 50(E). This law bans polystyrene containers unless they are recyclable and labeled with the appropriate code.
37The plastics industry challenged a 1988 ordinance enacted by Suffolk County, N.Y., banning plastic carry-out containers, foam cups, utensils, and grocery bags. Industry argued that the county had failed to consider the environmental impact of the ban, including the impact of increased use of paper and other materials that would replace the banned plastic products. The industry prevailed in two courts, but in May of 1991 lost on appeal on purely procedural grounds. 77 N.Y.2d 761 (1991). The New York Court of Appeals did not address the lower courts' conclusions on the need for a careful environmental evaluation to avoid ill-considered local government action. Instead, in a 4-3 decision the court ruled that trade groups and companies lack standing to challenge this sort of legislation and dismissed the case on that basis alone.
38Cal. Pub. Res. Code ßß 42300-42340.
39Ore. Rev. Stat. ßß 459A.650-459A.665.
40Wisc. Stat. Ann. ß 100.297.
41These states are California, Connecticut, Delaware, Iowa, Hawaii, Maine, Massachusetts, Michigan, New York, Oregon, and Vermont.
42The FTC regulates false, deceptive or misleading advertising pursuant to authority granted the agency under Section 5 of the Federal Trade Commission Act (15 U.S.C. ß 45(a)(1)), which prohibits unfair or deceptive acts and practices affecting interstate commerce. The commission has interpreted the act as essentially requiring companies to be able to substantiate the truthfulness of both express claims and any inferences a reasonable consumer is likely to draw from the express claim.
43The guides are published at 16 C.F.R. Part 260. They were revised in 1996 and again in 1998.
44Claims inconsistent with the guides may lead to an FTC investigation and corrective action, if the commission concludes that Section 5 of the FTC Act has been violated. The FTC has authority to seek damages and an injunction, although most actions result in consent agreements under which the party making the claim agrees to stop doing so.
45The guides state that a product or package should only be advertised as recyclable if it "can be collected, separated, or otherwise recovered from the solid waste stream for reuse, or in the manufacture or assembly of another package or product, through an established recycling program." 16 C.F.R. ß 260.7(d). FTC enforcement actions concerning recyclability claims for packaging include In re Mr. Coffee, Inc., FTC Docket No. C-3486, 59 Fed. Reg. 19019 (Apr. 21, 1994), and In re White Castle System, Inc., FTC Docket No. C-3477, 59 Fed. Reg. 8648 (Feb. 23, 1994).
46The guides provide that a recycled content claim may be made for "materials that have been recovered or otherwise diverted from the solid waste stream, either during the manufacturing process (pre- consumer), or after consumer use (post-consumer)." 16 C.F.R. ß 260.7(e)(1). If a product is only partially made of recycled material, the amount of recycled material, by weight, in the product must be disclosed. However, companies are not required to indicate how much of the recycled content in a product is pre- consumer material or post-consumer material.
47The statute provided that a product could be advertised as "recyclable" only if it could be "conveniently recycled" in counties within the state with populations exceeding 300,000. In December 1992, the U.S. District Court for the Northern District of California held that this provision was invalid because, contrary to the Constitution, it was so vague as not to give parties subject to the law, who could face criminal penalties for violating the law, sufficiently clear guidance of the conduct that was necessary to comply with the law.
48Ind. Code ß 24-5-17.
49N.Y. Comp. Codes R. & Regs. tit 6, ß 368.1(b).
50R.I. Gen. Laws ß 6-13.3. New Hampshire also enacted a recycling emblem law, but has never adopted regulations implementing it.
5163 Fed. Reg. 24240 (May 1, 1998).
52In addition to tweaking its guidance on recycling, the commission for the first time addressed the phrase "Please Recycle," taking the position, based on consumer survey data, that the phrase is an unqualified claim that the labeled product or package is recyclable. The commission, however, rejected recommendations that recycled content claims disclose the specific pre-consumer and post-consumer content of the product. It also maintained its prior guidance recognizing the distinction between The Society of the Plastics Industry, Inc.'s resin identification code, use of which is mandatory for certain products in 39 states, and the three-chasing arrows recycling symbol. According to the commission, while placement of the code in a conspicuous location may constitute a claim of recyclability, the code, without more, is not a recyclability claim when placed in an inconspicuous location on a container. 16 C.F.R. ß 260.7(d) (example 1).
53The states with heavy metal reduction laws are Connecticut, Florida, Georgia, Illinois Iowa, Maine, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, Washington and Wisconsin.
54The typical restriction on incidental presence of the metals is 600 parts per million (ppm) within two years of enactment, 250 ppm in three years, and 100 ppm in four years. All of the states that have adopted similar legislation did so more than four years ago and therefore should be at the 100 ppm limit.
55National Toxicology Program, Report of the Endocrine Disruptors Low-Dose Peer Review (Aug. 2001).
56Pub. L. 104-170.
57Pub. L. 104-182.
58U.S. Environmental Protection Agency, Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) Final Report (Aug. 1998).
59Cal. Health & Safety Code ß 25249.5-.13.
60For exposures to a designated carcinogen, the product must be accompanied by or carry on its label the following statement: "WARNING: This product contains a chemical known to the state of California to cause cancer." The law also applies to environmental emissions and exposures in the workplace; for these exposure situations, similar warnings are required.
61Cal. Health & Safety Code ß 25192(a)(2).
62The procedure for determining whether a given exposure triggers the warning requirement is complex and poorly understood by many parties subject to the law.
63S.B. 471, 2001 Legis. (Cal. 2001).
64S.B. 1752, 2002 Legis. (Cal. 2002).
65Magnini v. Waterford Wedgewood et al., No. 931884 (Super. Ct. San Francisco) (crystalware); California v. Baccarat, Inc. et al., No. 932292 (Super. Ct. San Francisco) (crystalware); California v. Josiah Wedgewood & Sons et al., No. 938439 (Super. Ct. San Francisco) (ceramicware); Lockhon v. Mondavi et al., No. 640698 (Super. Ct. San Diego) (lead capsules).
66A lawsuit seeking judgment that application of Proposition 65 to food and food packaging is impliedly preempted by the FD Act was never adjudicated; and, after years in a "hold" posture, in March 1994 the parties stipulated to a dismissal, without prejudice, of the entire case. A federal district court held that the express preemption provisions of the medical device amendments of the FD Act did preempt application of Proposition 65 to dental mercury, but that ruling was reversed on appeal. Lawsuits claiming that Proposition 65 is preempted by the Federal Insecticide, Fungicide and Rodenticide Act, and the workplace warning requirements of the Federal Hazard Communication Standard have been unsuccessful.
67The statute defines the term "notification requirement" to include any mandatory disclosure requirement relating to the dissemination of information about a food by a manufacturer or distributor of a food in any manner, such as through a label, labeling, poster, public notice, advertising, or any other means of communication.
68National Uniformity for Food Act of 2001, H.R. 2649, 107th Cong. (2001). The bill was introduced by Representative Richard Burr (R-N.C.).