The U.S. Environmental Protection Agency (EPA) announced proposed updates to the Safer Choice Standard on November 13, 2023. According to the November 14, 2023, notice, the proposed changes include a name change to the Safer Choice and Design for the Environment (DfE) Standard (Standard), an update to the packaging criteria, the addition of a Safer Choice certification for cleaning service providers, a provision allowing for preterm partnership termination under exceptional circumstances, and the addition of several product and functional use class requirements. 88 Fed. Reg. 78017. EPA notes that Safer Choice helps consumers, businesses, and purchasers find products that perform and contain ingredients that are safer for human health and the environment and states that DfE is a similar program currently used by EPA to help consumers and commercial buyers identify antimicrobial products that meet the health and safety standards of the typical pesticide registration process required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as well as other EPA DfE criteria. EPA will hold a webinar on December 19, 2023, on its proposed plans for updating the Standard. After EPA’s presentation, there will be time for a question and answer period. EPA asks that comments be submitted in writing after the webinar. Comments on the proposed changes are due January 16, 2024. EPA has posted on its website the proposed changes to the Standard, as well as a “preamble” explaining the proposed changes.
According to the preamble, when EPA adopts the revisions, it expects to make them effective “upon the finalization and public notification.” EPA states that candidate partners would need to comply with the updated Standard prior to becoming program partners and that existing program partners would be expected to comply with the revisions within the year following their next partnership renewal.
EPA notes that many of its proposed revisions are in the nature of technical amendments. EPA states that in some instances, it also deleted text from the Standard to avoid redundancy with program criteria expressed elsewhere. EPA proposes to introduce the following topics to highlight their importance and specifically requests comments on them:
Entering or Exiting a Product Class (Section 3.4)
EPA has added detail to the Standard on its process for entering and exiting product classes (i.e., a category of products that have similar functions). EPA states that it may solicit public input before entering or exiting a product class. According to EPA, for entering a new product class, it will consider various factors (e.g., product type, functionalities, and improvements to health and the environment) and determine whether entering the new product class will advance the goals of the Safer Choice and DfE programs.
EPA notes that on “rare occasions,” newly available information may indicate that a class of products poses unanticipated serious adverse health or environmental effects. In such circumstances, EPA may find it necessary to end any partnerships and discontinue certification of products in the class, at least until EPA can understand the cause of the adverse effects and, if possible, develop criteria to address them. EPA proposes to add provisions to address these situations in Section 3.4.2.1 Exceptional circumstances affecting health or the environment. The preamble states that “[i]n general, if EPA decides to exit a product class, EPA will allow a period of time for partners to cease use of the product label or logo.”
On-Site Audit (Section 3.6.2)
EPA currently requires audits on a yearly basis throughout the partnership, including one on-site audit in the first or second year of the partnership cycle. To ensure that partners are formulating certified products in compliance with Safer Choice criteria, EPA proposes, in Section 3.6.2 On-site audit, that the first audit for a new partner must be an on-site audit.
Information to Help Reduce Carbon-Based Energy Consumption (Section 4.2.3.1)
EPA proposes to update the Standard to encourage and recognize product manufacturers’ efforts to incorporate energy-saving technologies and approaches. This optional provision in Section 4.2.3.1 Information to help reduce carbon-based energy consumption lists actions manufacturers may implement. Partners may be recognized for demonstrating outstanding leadership and innovation in sustainable energy use.
Primary Packaging (Section 4.2.5)
To respond to increased demand for more sustainable practices, EPA proposes to update its packaging criteria to ensure that certified products also use safer, more sustainable packaging. According to the preamble, the revised requirements are informed by common themes across existing third-party packaging sustainability schemes. EPA notes that the proposed specific recycled content levels “do not necessarily come from existing schemes but, based on research, are understood to be leadership but achievable levels.”
EPA proposes to add requirements to Section 4.2.5 Primary packaging on recyclability and recycled content, label compatibility, and primary packaging ingredients. Specifically, EPA proposes to require that primary packaging either be recyclable and contain a minimum level of post-consumer recycled content or be designed to be reused. Additionally, EPA proposes to require that product labels associated with primary packaging not affect recyclability and that proper recycling method(s) be clearly indicated on the packaging.
EPA also proposes to add per- and polyfluoroalkyl substances (PFAS) and all bisphenol-based chemicals to its list of ingredients that may not be intentionally introduced into primary packaging material. EPA states that it will explicitly list the four heavy metals (cadmium, lead, mercury, and hexavalent chromium) currently covered by the Standard as ingredients that may not be intentionally introduced into primary packaging material.
EPA seeks stakeholder comment on all aspects of the primary packaging requirements, including, but not limited to:
- Are the proposed minimum post-consumer recycled content levels feasible for primary packaging made of plastic, glass, metal, fiber (e.g., paper or cardboard), or other sustainable materials? If not, what levels would be feasible? How should EPA consider multi-material packaging?
- Is it reasonable for EPA to require that the entire product primary packaging be recyclable? If not, what is an appropriate minimum percent of recyclable material?
- Is it reasonable for EPA to require both a minimum recycled content and package recyclability? What are the challenges to achieving both simultaneously?
- In developing its final criteria, should EPA consider concerns for contaminants that may be intentionally added and/or unintentionally introduced into recycled materials? At what point should testing occur?
Yellow Triangle Content Limit (Section 4.2.8)
To enhance transparency, EPA is updating the Standard to reflect the ongoing practice of allowing the use of yellow-triangle designated chemicals from the Safer Chemical Ingredients List (SCIL) when they do not cumulatively exceed ten percent in the product as sold.
Ingredient Combinations Causing Adverse Effects (Section 4.5)
According to EPA, certain ingredients, while independently meeting Safer Choice ingredient criteria, may cause adverse effects when combined. EPA states that it does not allow ingredient combinations known to cause negative synergistic effects and is updating the Standard to reflect this ongoing practice in Section 4.5 Ingredient Combinations Causing Adverse Effects.
Products in Solid or Particulate-Generating Form (Section 4.6)
EPA proposes to add Section 4.6 Products in Solid or Particulate-Generating Form to require certain information from manufacturers. EPA proposes to require that, upon request, manufacturers of products in particulate-generating or solid form provide information to determine that the product does not contain or generate a substantial portion of particles that are respirable (ten microns or less).
Special Product Classes (Section 4.7)
EPA states that over the years, to extend the reach of the program into product categories where manufacturers sought to lead the market with safer ingredients, it has developed policy criteria and guidance as a supplement to the broader Standard. According to EPA, these policies have been distributed widely and posted on the Safer Choice website. EPA now proposes to add links to the Safer Choice website, where criteria can be found for the following product classes: Section 4.7.1 Ice-melt products, Section 4.7.2 Inorganic- and mineral-based products, Section 4.7.3 Microorganism-based products, and Section 4.7.6 Marine lubricants. EPA proposes to provide a brief description of each product class in the Standard and to refer readers to the Safer Choice website for the full criteria.
Products Intended for Use on Pets (Section 4.7.5)
EPA is adding a product class for non-pesticidal and non-drug pet care products in Section 4.7.5 Products intended for use on pets. EPA states that it will evaluate chemicals used in products intended for use on pets for human and pet health, in addition to environmental toxicity and fate. EPA will not allow ingredients in pet care products that are severely irritating or corrosive to skin or eyes unless whole product testing demonstrates low concern for irritation. EPA will also not allow Globally Harmonized System of Classification and Labeling of Chemicals (GHS) listed sensitizers in certified pet care products (unless the manufacturer provides whole product testing demonstrating low concern for sensitization or a rationale based on functional necessity that also addresses sensitization) and will require that ingredients meet direct release criteria, with the exception of fragrance materials.
EPA requests comment on the feasibility of the requirements for direct release, irritation, and sensitization for pet care products.
Direct Release Products (Section 4.8.1)
According to EPA, a number of stakeholders have approached Safer Choice to request the addition of a label that would distinguish products that meet Safer Choice direct release criteria. The preamble includes the following questions for comment:
- Would it be helpful to have a version of the Safer Choice label with text that distinguishes products that meet direct release criteria (similar to the Fragrance-Free Safer Choice label)?
- Would text such as “approved for outdoor use” better communicate the meaning of direct release to consumers and purchasers?
- Are there alternative phrases to “approved for outdoor use” that EPA should consider?
General Requirements (Section 5.2): Use of New Approach Methodologies (NAM)
EPA states that it continues to advance the use of NAMs to replace laboratory animal studies, and the program will continue to adopt NAMs as they are developed. The proposed revisions to the Standard include changes in the following sections to formalize the ongoing Safer Choice use of NAMs: Section 5.2 General Requirements and Section 4.2.2 pH.
Component-Specific Requirements (Sections 5.3, 5.11, and 5.17)
EPA states that it proposes several revisions and additions to Section 5 Component-Specific Requirements.
Surfactants (Section 5.3)
Under Section 5.3 Surfactants, EPA is proposing to require aquatic toxicity data for at least one trophic level for surfactants (or a close analog). EPA notes its ongoing practice that where data for human health are available, EPA will evaluate chemicals based on the thresholds in the Master Criteria.
Disposable Wipes (Section 5.11)
EPA notes that the Standard currently limits the composition of wipe materials to those that are readily compostable and cites cotton and bamboo as examples. To reinforce current industry practice, EPA proposes to require that all wipe-based products indicate they are not flushable to carry the Safer Choice label or DfE logo. EPA proposes to modify Section 5.11 Disposable Wipes to indicate that wipes made from both natural fibers and synthetic fibers from renewable sources are acceptable, provided they have similar biodegradability profiles (as demonstrated by one of the following or similar methods: EN13432, ASTM 6400, ASTM 5338, or ISO 14855). Wipes-based products must also include a “do not flush” logo and language on product labels to qualify for certification. Since fibers are often treated with processing chemicals to create the nonwoven substrates, EPA states that it is also adding clarifying language on additive components (such as binders or coatings) in nonwoven substrates and how they must also meet program criteria.
EPA requests comment on the functionality and consumer acceptance of wipes that are composed of natural fibers and synthetic fibers from renewable sources, and the preamble includes the following question:
- Should EPA only allow natural fibers in disposable wipes or also allow compostable synthetic fibers from renewable sources?
Odor Elimination Chemicals (Section 5.17)
EPA proposes to add Section 5.17 Odor Elimination Chemicals to formalize the evaluation criteria already used for odor elimination chemicals, which function to reduce or eliminate odorous chemicals. According to EPA, it would continue to evaluate odor elimination chemicals based on general requirements in Section 5.2 and based on requirements provided on the Safer Choice website.
SCIL (Section 5.18)
EPA states that it believes that additional language further describing the relationship between the SCIL, the Standard, and Safer Choice- and DfE-certified products would provide additional transparency. Specifically, EPA proposes to describe the evaluation process for single Chemical Abstracts Service Registry Numbers® (CAS RN®) that cover broad ranges of chemical structures.
Use of the Safer Choice Label by Raw Material Suppliers (Section 6.3)
EPA states that it is aware that raw material suppliers may wish to communicate that they supply ingredients that meet Safer Choice criteria and proposes to add language to the Standard that explains how the Safer Choice label should be used by material suppliers. EPA proposes to add Section 6.3 Use of the Safer Choice Label by Raw Material Suppliers to document the ongoing practice under which raw material suppliers may use the Safer Choice label to indicate that certain raw materials meet Safer Choice criteria or that a specific supplier can formulate to meet Safer Choice criteria. EPA notes that it currently allows this practice for raw material suppliers with chemical ingredients listed on CleanGredients (https://cleangredients.org/). EPA proposes to continue to work with interested raw material suppliers on a case-by-case basis.
Safer Choice Cleaning Service Certification (Section 7)
EPA requests comment on whether it should establish a Safer Choice Cleaning Service Certification for cleaning service providers that use Safer Choice-certified products for cleaning and DfE-certified products for disinfecting. EPA states that residential and commercial cleaning service providers, as well as facility owners, managers, and government entities that provide in-house cleaning would be eligible for this certification. Entities that could be certified must be organizations and businesses that use cleaners, detergents, disinfectants, and related products as part of their primary operations. According to EPA, program certification would require organizations and businesses to use exclusively Safer Choice-certified products for cleaning and DfE-certified products for disinfecting, in product categories with Safer Choice- and DfE-certified products, to the maximum extent practicable. EPA may grant exceptions at its discretion on a case-by-case basis. Certified cleaning service providers would be permitted to display the Safer Choice Service Certification logo (outlined in Section 7.6), and their name and contact information would be listed on the Safer Choice website.
EPA states that candidates for Safer Choice Cleaning Service Certification must use a Safer Choice-qualified third-party profiler to prepare and submit applications, document exceptions, and conduct annual virtual audits. There is a cost associated with obtaining these services. The proposal for the Safer Choice Cleaning Service Certification is in Section 7 of the Standard, with a template partnership agreement in Annex D. EPA requests comment on the following questions:
- Other than the exceptions outlined in Section 7.3.1.1, should other exceptions be included? Are these exceptions overly broad? Is granting the exceptions under this certification appropriate?
- Do you have a preference between the Safer Choice Service Certification logos in Section 7.6? Comments on the logo elements (e.g., tagline, color, and shape) would be especially valuable. Which do you think would best communicate the meaning of the certification?
- Should any of the locations for use of the Safer Choice Service Certification logo listed in Section 7.6.2 be removed or should additional locations be added?
Private Label, Licensee, and Toll Manufacture Products (Sections A.13 and B.13): Private Label Company Dilution
To document the ongoing practice under which EPA explicitly allows for dilution of a concentrated form of a product by a private label company at its facility, EPA proposes to add language to the Safer Choice Partnership Agreement template in Section A.13 Private Label, Licensee, and Toll Manufacture Products and in the equivalent section (B.13) in the DfE Partnership Agreement template to allow dilution of a certified concentrate conducted by a private label company. EPA states that it allows such “Ready To Use” private label products to be certified on a case-by-case basis. The partner must communicate that the concentrate is being diluted and the corresponding dilution rates to EPA.
Commentary
We commend EPA for seeking to expand the utility of its Safer Choice/DfE recognition. Such recognition provides consumers and end users a robust system from which to select “greener” products. Many have argued that the Safer Choice/DfE program should be managed by a non-governmental organization (like other green standards), but our view is that Safer Choice provides benefits to the marketplace because it carries EPA’s imprimatur and it provides EPA greater visibility in an area EPA is committed to promote.
The packaging criteria are important but present many challenges to Safer Choice partners. Most packaging is considered an article under TSCA, and there is limited supply chain visibility into the content of packaging. Participants in Safer Choice and their suppliers need to provide EPA with a practicable standard. Supply chain agreements can provide insight into what is intentionally added and may include limits on impurities, but will have to avoid “free of” standards because suppliers may be reluctant to provide certification that any particular contaminant is not present at all at any level. The spate of PFAS consumer product litigation has made that reality abundantly clear. This is especially true for recycled content, such as recycled plastic. If the Safer Choice standard is such that it can only be met by virgin plastic resin, the standard that is meant to drive circularity will instead effectively force products out of Safer Choice when participants cannot meet an impossibly difficult packaging standard.
EPA’s proposed consideration of synergistic effects could benefit from clarity on how EPA will consider and evaluate synergistic effects. Will EPA require testing for synergistic effects, or will EPA consider such effects only in cases in which EPA has had some indication of synergistic effects? In those cases, will the standard prohibit one or both of the ingredients, or only prohibit the combination?
EPA’s proposed category for non-pesticidal and non-drug pet care products is a sensible expansion for Safer Choice. It may be surprising to readers that while a shampoo intended for humans is regulated as a cosmetic in the United States by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA), an identical formulation for a shampoo intended for pets is regulated by EPA under TSCA. EPA’s criteria for household care products should provide a foundation upon which EPA can develop criteria for pet care.
A key expansion that EPA proposes is recognition for service providers. The idea is that a cleaning service provider that uses Safer Choice/DfE products to the extent practicable can receive recognition and advertise that recognition to potential customers. This expansion of Safer Choice has the potential to increase substantially the quantity of Safer Choice-recognized products by encouraging service providers to maximize their use of such products.
There are great opportunities for the expansion of Safer Choice. It is important for suppliers and formulators to engage with EPA to ensure that the criteria are robust and practicable.
