Extended Producer Responsibility (EPR) programs are intended to shift responsibility for the management and cost for the disposal (or other disposition) of products used by consumers to the producers and distributors of these products. The intent is to encourage material reduction, reuse, and recycling of products to stem the need for land disposal and incineration, as well as a sometimes unspoken objective: reduce the use of virgin plastics. Variations of the program have been in existence for many years in Western Europe, and now the programs seem to be making headway in several U.S. states.

As laudable as the goals of such programs may be, when it comes to food packaging, producers of these products must still take into account their role in assuring the integrity and safety of packaged food and the need to comply with applicable food packaging regulations.

At this time, four states—Maine, Oregon, Colorado, and California—have EPR laws that encompass food packaging. Several other states are following suit, with legislative bills having been introduced this year, including Tennessee (SB 573), Massachusetts (S 572), New York (S 1064), Rhode Island (HB 5091), Washington (HB 1131), Hawaii (HB 2399), and Maryland (SB 2022/HP 284). Although state legislation establishing these programs vary and such laws are still in the early implementation stage, the laws identify the producer of the food product, defined as the brand owner (with some exceptions), as the responsible party for post-consumer packaging waste.

There is no widely accepted model for EPR programs that include food packaging. General approaches to EPR programs include a reimbursement model and a stewardship/producer responsibility organization (PRO) model. Under the reimbursement model, producers of covered products pay into a fund based on the amount and recyclability of the packaging associated with their products. These funds are then used to reimburse municipalities for managing waste.

Under the PRO model, producers participate in an organization that establishes recycling rate goals, charges material-specific fees, and develops markets to encourage use of materials that are more easily recycled. Even within these models, however, there are hybrids. Let us examine the existing state packaging EPR laws.

Maine EPR Law

Maine (HP 1146/LD 15411) specifies that a Packaging Stewardship Organization will implement a program to assess and collect payments from producers and reimburse participating municipalities. Producers will pay fees that are intended to incentivize recyclability of packaging material, use of recycled content, reduction in amount of packaging material, and lower toxicity. The law defines the producer as the brand owner of the packaged product if located in the U.S., or the importer if the brand owner is not based in the U.S. Participating municipalities that voluntarily participate will be reimbursed based on average per-ton cost of managing packaging material.

Under Maine's law, exempt materials include beverage containers regulated under the state's bottle bill and packaging for long-term (more than five years) storage or protection of a durable product. Adoption of the technical rules is expected by summer 2023, with final adoption of the substantive rules expected by summer 2024. Once a Stewardship Organization is selected sometime in 2026, producers will have 80 days to make their initial payment. The first payment to municipalities is expected in 2027.

Colorado EPR Law

Colorado (HB 22-13552) establishes an advisory board for its producer responsibility program and specifies that a nonprofit producer responsibility organization (PRO) will implement and manage a statewide program that provides recycling services to covered entities in the state. The program will be funded by producers of products that use packaging materials and paper products.

The PRO's responsibilities include the creation of a statewide list of items that can be recycled and the establishment of targets for minimum collection rates, recycling rates, and post-consumer recycled content rates. Beverage containers subject to a returnable container deposit, packaging for long-term (more than five years) storage or protection of a durable product, packaging used exclusively in industrial or manufacturing processes, infant formula packaging, medical food packaging, and drug packaging are exempt from compliance with the law.

Under the timeline established by the Act, the Executive Director of the Colorado Department of Public Health and Environment was scheduled to designate a nonprofit PRO by June 1, 2023. The PRO will then hire an independent third party to conduct and assessment of the states’ existing recycling services and identify opportunities to increase recycling rates. The PRO needs assessment is due to the advisory board and the Executive Director by January 30, 2024. The PRO must then submit a proposed plan to the advisory board by February 1, 2025, which is then subject to approval or rejection by the Executive Director following an opportunity for public notice and comment. Effective July 1, 2025, a producer may not sell or distribute any products that use covered materials in the state unless the producer is participating in the program or an approved individual plan. Producers must pay the first annual dues to the PRO by January 1, 2026.

Oregon EPR Law

Oregon (SB 5823) specifies that producers of covered materials must join and pay a membership fee to a PRO. Covered products include packaging (made from but not limited to paper, plastic, glass, and metal), food service ware, and printing and writing paper. Packaging also includes single-use bags. The producer fees are based on material types and quantity and incentivize recyclability, recycled content, and reductions in the amount of packaging material. Additionally, producers must meet recycling goals for plastic packaging and food service ware. The PROs are responsible for collection and recycling of covered materials and for expanded access to recycling services. More than one PRO may operate in the state.

Under Oregon's laws, exempt materials include beverage containers as defined by the Oregon bottle bill; packaging for long-term (more than five years) storage or protection of a durable product; packaging used exclusively in industrial or manufacturing processes; infant formula, medical food, and drug packaging; wine and spirit containers with refund value under Oregon law; napkins and paper towels; and cores and wraps for rolls of packaging. The program became effective on January 1, 2022, and the first PRO program plans are due by March 31, 2024. Producers must join a PRO, and the approved PROs must begin implementation by July 1, 2025. The recycling rate goals for plastic products are at least 25 percent by calendar year 2028, 50 percent by calendar year 2040, and 70 percent by calendar year 2050.

California EPR Law

California (SB544) establishes an EPR program under which producers of covered material must join a PRO or comply with an approved individual plan. Covered material is defined as single-use packaging and single-use food service ware, which includes plastic, plastic-coated paper, paper with intentionally added plastic, and multi-layered flexible materials. Beverage containers subject to the California Beverage Container Recycling and Litter Reduction Act; packaging for long-term storage or protection of a product that has a lifespan greater than five years; and infant formula, medical food, and drug packaging are exempted. The PROs are required to pay $500 million annually to the California Plastic Pollution Mitigation Fund.

The law directs EPR program regulations to be adopted by January 1, 2025. Producers must join a PRO (or have an approved individual plan) by January 1, 2024, and they are prohibited from selling, importing, or distributing covered materials effective January 1, 2027, unless they participate in PRO (or an approved individual plan).

SB 54 also includes packaging source reduction and recycling rate goals, including a 2032 deadline that 100 percent of packaging in the state be recyclable or compostable, plastic packing be reduced in weight by 25 percent, and 65 percent of all single-use plastic packaging be recycled.5

Preparing for Source Reduction and Recycling Goals

As described above, the existing state EPR laws either include specific packaging source and recycling reduction goals, or establish incentives to increase recycling rates and use of recycled content and reduce the amount of packaging material used. As companies prepare to meet these goals, it will be necessary to consider how any changes to food packaging materials or formats could impact food safety.

Historically, the main function of food packaging has been to hold and deliver food for consumption while providing a physical barrier to help maintain food and beverages in a sanitary condition. Food packaging regulations were established to enhance and assure the safety of packaging materials by prohibiting the use of materials or manufacturing/use patterns that would result in the adulteration of food by making the product deleterious or injurious to human health, or imparting off-odors or tastes from the packaging to the food. Thus, requiring (or incentivizing) modifications to packaging materials or uses to achieve the laudable goals of sustainable practices should avoid compromising the primary objectives of providing a package that is technically suitable for use with specific food types, while being safe for use with food. In a word, meeting these latter objectives means that sustainable food packaging must be as safe for use as is the packaging it is replacing, while also being technically suitable for use.

In this respect, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Section 301, et seq., provides that any substance, the intended use of which is reasonably expected to become a component of food (e.g., migrates from packaging into food) must be authorized for such use by the U.S Food and Drug Administration (FDA) through a food additive regulation. In the case of packaging and other food contact materials, a Food Contact Notification (FCN) may be issued, or the substance must be "generally recognized as safe" (GRAS) or used in accordance with a sanction or approval issued prior to 1958, among other potentially available exemptions and exclusions. 

Today, FCNs are the primary pathway for clearing new food contact materials with FDA. The Food and Drug Administration Modernization Act of 1997 (FDAMA) allows a manufacturer or supplier of a food contact material to submit a notice to FDA that includes the identity and intended use of the new food contact substance, along with information supporting the conclusion that the substance is safe for its intended use. If FDA does not object to an FCN submission within 120 days, then the new food contact substance (FCS), or materials made with it, may be marketed. It is important to note that FCNs are proprietary; i.e., they can be relied upon only by the manufacturer of the FCS identified in the FCN and by its customers.

In addition, any food packaging material intended to come into contact with food must comply with FDA's Good Manufacturing Practices (GMP) regulation. GMP requirements for indirect food additives apply to both the use level of the additive and its purity. This means that additives may be used only in an amount necessary to achieve their function or purpose, may not contain impurities at levels sufficiently high as to result in the adulteration of food, and must be suitably pure for their intended use. To meet the suitable purity requirement, the manufacturer must consider the safety of foreseeable impurities in the FCS, including residual monomers, other starting reactants, degradation products, and reaction byproducts.

Light-weighting is being used to reduce the amount of plastic in some food packages. For example, light-weighting technology for polyethylene terephthalate (PET) bottles can reduce the amount of PET in bottles for alcoholic beverages, food products, and other products. However, since light-weighting food packaging can affect barrier properties, shelf life, package integrity, and possibly seal strength, testing of the redesigned package, including end testing, may be necessary to ensure that the product is technically suitable for its use.

Moreover, if an additive, including the addition of another polymer, is used to make up for lost oxygen barrier properties, it must comply with food additive regulations, be the subject of an effective food contact notification, be GRAS, or otherwise be cleared under the Act or the regulations for its intended use.

Recycled materials do not need to undergo an independent review by FDA or pre-clearance because the agency regulates food contact materials (FCMs) based on their composition, rather than a specific manufacturing process or the source of their raw materials. This means, however, that recycled materials intended for use with food must meet the same compositional and end-test requirements that virgin material is required to meet. Therefore, companies may independently evaluate the status and safety of FCMs produced through a recycling process to determine if they compositionally comply with the regulations and meet FDA GMP requirements for packaging materials. To assist companies in undertaking these assessments, FDA has issued guidance on recycled plastics for use in food packaging.6

For paper products, FDA issued a draft guidance document many years ago, which is sorely out of date in many respects, while still capturing the agency's fundamental views on the issue. In addition, paper made from reclaimed fiber is the subject of a regulation requiring that the pulp made from reclaimed fiber not contain any "poisonous or deleterious substances" that may migrate to food, and the source of the paper may not have been used to hold or ship poisonous or deleterious substances.7

Whether paper or plastic, FDA will accept for review a company's determination of the suitability of its product for use with food, and if the agency agrees with the conclusion reached, it will issue a letter (sometimes referred to as a No Objection Letter, or NOL) on the suitability of the process for producing an article for food contact use.

Bio-based plastics—or plastics manufactured from renewable biomass, such as vegetable oil, cornstarch, pea starch, and microbiota—are required to comply with the same regulations with respect to food safety as fossil-based plastics. However, there are several regulatory issues, such as determining the appropriate food simulants to be used to estimate the potential for migration, that must be considered for new bio-based material or new applications for existing materials.

For companies desiring to submit an FCN for a degradable polymer, FDA recommends thoroughly describing the degradation or reaction mechanism and conducting stability and migration testing.8 In addition, it may be necessary to consider the suitable purity of the finished product with respect to the potential presence of organic matter, such as cellular debris, and naturally occurring contaminants (e.g., mycotoxins and algal biotoxins).

Takeaway

State-level activity with respect to EPR requirements for food packaging is increasing. These programs will take several years to plan and implement. While the specific requirements are generally not yet known, ambitious recycling rates and requirements are likely to be included.

In preparation, food companies should participate in state rulemakings and advisory boards and engage with PROs once they are formed. Also, if they have not already done so, food companies must start considering the types of packaging changes that may be needed and begin work with suppliers to ensure that their needs are met. After all, food companies will be on the line for compliance with EPR requirements and held accountable by consumers for achieving sustainability goals—not their suppliers.

References

  1. Maine Legislature. "Title 38: Waters and Navigation, Chapter 24: Solid Waste Management and Recycling, Subchapter 3: Waste Reduction and Recycling." https://legislature.maine.gov/statutes/38/title38sec2146.html.
  2. Colorado General Assembly. "HB 22-1355: Producer Responsibility Program for Recycling." https://leg.colorado.gov/bills/hb22-1355.
  3. Oregon Legislative Assembly. "SB 582: Modernizing Oregon's Recycling System." https://olis.oregonlegislature.gov/liz/2021R1/Downloads/MeasureDocument/SB582/Enrolled.
  4. California Legislative Counsel. "SB 54: Solid Waste: Reporting, Packaging, and Plastic Food Service Ware." July 1, 2022. https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=202120220SB54.
  5. CalRecycle. "SB 54: Plastic Pollution Prevention and Packaging Producer Responsibility Act." 2023. https://calrecycle.ca.gov/packaging/packaging-epr/.
  6. FDA. "Guidance Document: Use of Recycled Plastics in Food Packaging (Chemistry Considerations)." July 16, 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-use-recycled-plastics-food-packaging-chemistry-considerations.
  7. FDA. "21 C.F.R. § 176.260: Pulp from reclaimed fiber." https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=176.260#:~:text=176.260%20Pulp%20from%20reclaimed%20fiber,(b)%20of%20this%20section.
  8. FDA. "Guidance for Industry: Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations." December 2007. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-preparation-premarket-submissions-food-contact-substances-chemistry.

George G. Misko, Esq., is a partner in the Washington, D.C., office of Keller and Heckman LLP.