Proposed Enhancements to the Design for the Environment (DfE) Standard for Safer Products
Periodically, the U.S. EPA's DfE Program proposes and adopts enhancements to its "Standard for Safer Products (the "Standard"). The Standard establishes the minimum requirements for identifying products that satisfy DfE's safer product criteria and are eligible for partnership. Companies voluntarily submit themselves for evaluation under the Standard, which DfE implements through individual partnership agreements.
The enhancements serve multiple purposes, among them, they: keep the Standard current with the state of scientific and technological innovation; respond to stakeholder requests for clarity and added transparency; raise the bar of protectiveness to ensure leadership for DfE-labeled products; and, expand the scope of the program as demand, capacity, and opportunity warrant. While important, changes to the Standard can be disruptive for partners and make compliance—and its verification—more challenging; thus, DfE seeks to minimize their frequency and the difficulties associated with their implementation.
The proposed changes to the DfE Standard, presented below, would be the second set of enhancements since the Standard was posted on the DfE Web site in June 2009. The first set of enhancements were proposed in October 2009 and, following public notice and comments strongly supportive of the changes, adopted in March 2010. (The summary of comments and DfE responses is available on the DfE Web site at www.epa.gov/dfe.) DfE will follow a similar course for the current enhancements, notifying all stakeholders and interested parties by email and allowing a 60-day period for comment. The comment period, orignially scheduled to end on Dec. 31, 2010, will end on Jan. 14, 2011. Please note that DfE welcomes comments on its Standard and Safer Product Labeling Program ("Labeling Program") at any time.
To comment on the current enhancements, please email David DiFiore at firstname.lastname@example.org and write "Comments on the DfE Standard" in the subject line. Please click on this link to see a full version of the Standard PDF (39pp, 259K, About PDF) with the proposed changes in context and highlighted. (This version of the Standard also contains minor editorial and non-substantive technical corrections.)
Summary of Proposed Enhancements to the DfE Standard
DfE initiated a second round of enhancements in response to comments and suggestions from a broad spectrum of stakeholders, who support the new provisions. Importantly, the changes enhance the clarity and protectiveness of the DfE Standard and Labeling Program, which prevents pollution at its source by informing and ensuring the replacement of chemicals of concern with safer alternatives in a variety of chemical-based products.
When adopted, the changes to the Standard would be effective immediately. The new provisions would apply to candidate partners as a condition of partnership and for existing partners would be phased in over the course of a year, to coincide with the anniversary date of their partnership. The changes would address seven subject areas, two that would be new to the Standard and five current topics, and intended to accomplish the following:
The New Areas
- To enhance public awareness of the safer ingredients in DfE-labeled products, add a new provision on ingredient disclosure, which would require DfE partners to list all intentionally added, non-confidential ingredients on the label of recognized products or to indicate on the label an easily accessible public venue where such list can be found (please note: ingredients claimed as confidential must be revealed to DfE and must satisfy the safer ingredient criteria as a condition of partnership);
- To broaden the sectors open for partnership and increase the availability of labeled products, add a new provision for formulations designed for prolonged dermal contact, provided that such products satisfy, in addition to the current Standard, a number of supplemental criteria tailored to ensure a similarly high degree of protectiveness and to complement the activities of and be undertaken in cooperation with relevant agencies;
- To add clarity to the provisions on product performance, require that DfE-labeled products achieve a passing score in standardized performance tests and, alternatively, for products in categories that lack such tests, that consumer products demonstrate equivalence in performance to an industry-leading brand and that institutional products meet a DfE-agreed-to benchmark;
- To ensure that the provisions on packaging promote leadership, require that the packaging of labeled products meets threshold sustainability levels—as adopted by the Sustainable Packaging Coalition—and that those levels improve over the life of the partnership, as well as explicitly prohibiting the use of chemicals of concern;
- To ensure that allowable volatile organic compound (VOC) levels reflect the most stringent government criteria, require that labeled products limit VOCs to levels established by the California Air Resources Board and the Ozone Transportation Commission; include a heightened focus on ozone nonattainment areas;
- To clarify the flammability provision, reference only EPA's limits for potential ignitability and, to address a potential workplace hazard, require industrial laundry detergents to demonstrate they do not have the potential to combust spontaneously; and
- To allow for a broader range of enzymatic materials in labeled products, require that they be either in liquid or low-dust granulated form; have taxonomic data to help ensure non-contamination with residual microorganisms or enzymes of concern; and, if in a dry form, be made at a facility with a dust and allergy monitoring program and engineering controls to ensure particulates do not exceed a threshold limit value (TLV) ceiling of 60 nanograms/m3.
Text of Proposed Changes to the DfE Standard
In section 3, General requirements, DfE proposes to add a new section 3.8, to read as follows:
3.8 Ingredient Communication
To enhance public awareness of the safer ingredients in DfE-recognized cleaning products and in the spirit of more complete communications on chemicals in common use, formulator-partners must disclose the contents of their DfE-recognized products as described herein.
Except as provided below, manufacturers must disclose all intentionally added ingredients in their DfE-labeled products, except for "incidental ingredients," that is, ingredients present at insignificant levels that have no technical or functional effect (e.g., reagents, processing aids, and impurities, as defined in 21 CFR §701.3(l)).
3.8.2 Locus of disclosure
Ingredients must be disclosed in one of the following locations: on the product label; on the formulator's Web site; at a toll-free number; or, on another media approved by DfE. If disclosure does not occur on the product label, the formulator must provide the location of the ingredients on the label, e.g., the Web site address or toll-free number.
3.8.3 Ingredient descriptions
Formulators must use one or more of the following nomenclature systems to describe their ingredients: Chemical Abstract Service (CAS) number; CAS name; Consumer Specialty Products Association (CSPA) Dictionary name; International Nomenclature of Cosmetic Ingredients (INCI) name; or International Union of Pure and Applied Chemistry (IUPAC) name. Where needed to protect trade secret information (as defined in the Uniform Trade Secrets Act) a manufacturer may, at a minimum, use a functional descriptor in lieu of the specific chemical name; however, the name must be as specific as possible without revealing trade secret information.
Dyes and colorants. Dyes and colorants should be listed by a chemical-descriptive name.
Fragrances. Scent ingredients may be listed as "Fragrance" on the label, but the formulator must refer to availability of more detail elsewhere, such as the following: a Web site list of the actual ingredients in the fragrance; the list, or subset of the list, of fragrance materials authored by the International Fragrance Association (IFRA) and available on IFRA's Web site.
Preservatives. Preservatives in non-pesticidal products should be listed by a chemical-descriptive name. Pesticidal preservatives are subject to Office of Pesticide Program regulations and guidance.
3.8.4 Listing order
Formulators must use the following approach in listing ingredients: for those present at concentrations over 1.0 percent (measured on a weight-weight percentage basis), ingredients must be listed in descending order, with the ingredient at the highest percentage in formula listed first; for those present at not more than 1.0 percent, ingredients may be listed in any order.
In section 4, Product-level requirements, DfE proposes to add a new section 4.5, to read as follows:
4.5 Products Designed for Dermal ContactIn addition to the criteria in this standard, products whose use will involve prolonged dermal contact must comply with the supplemental requirements listed below (the DfE Ingredient Criteria at http://www.epa.gov/dfe/pubs/projects/gfcp/index.htm contain guidance on appropriate testing). To the extent these products fall under the jurisdiction of the Food and Drug Administration (FDA), DfE will consult with FDA prior to implementing this provision. (DfE will be guided by FDA judgments, as expressed, for example, in official monographs, on the safety of products and ingredients.)
Only ingredients that are non-irritating to skin and eyes, as demonstrated by testing, clinical studies or consumer experience, will be acceptable. At a minimum, a product or its ingredients must not be categorized as an irritant under EPA Office of Pesticide Program regulations (i.e., must not require a precautionary statement) or GHS criteria.
To further minimize the potential for dermal, eye or mucous membrane irritation, product pH must be greater than or equal to (>) 4 and less than or equal to (<) 9.5; products with a pH outside this range may be considered for recognition if in vivo testing demonstrates they are non-irritating, or if they are known to be non-irritating based on their physical-chemical properties (e.g., buffering capacity).
4.5.3 Potential allergens and sensitizers
No ingredients classified under GHS as skin or respiratory sensitizers are permitted in labeled products. The labeling of FDA food allergens (e.g., peanut, soy, dairy) must follow the requirements in the Food Allergen Labeling and Consumer Protection Act of 2004.
4.5.4 Dermal absorption
Where an ingredient may be dermally absorbed, the applicant must provide data, for example, repeated dose toxicity testing via the dermal route of exposure, on potential effects; these data must indicate that the ingredient presents a low hazard concern.
4.5.5 Potential endocrine effects
Chemicals that are candidates for endocrine screening will be part of the review. Chemicals found to interact with or perturb the endocrine system—potentially leading to reproductive, developmental, carcinogenic, systemic, hormonal or other effects—will not be allowed based on the toxicological hazards they pose.
4.5.6 Residuals of concern
Partnership candidates must submit to DfE data from raw material suppliers on the percentage of residuals in their products. Residuals of concern (see definition at 2.1.55 and provision at 5.13) that cannot be eliminated must be restricted to the lowest possible levels.
Color additives, in any product type, must meet both FDA requirements and DfE criteria for health and environmental safety. Any candidate colorant must appear on the FDA list for use in the United States and comply with FDA regulations on appropriate conditions for use (as per 21 CFR Parts 70-82).
Fragrances must comply with the DfE Criteria for Fragrances (at http://www.epa.gov/dfe/pubs/projects/gfcp/index.htm#Fragrances ); the criteria will apply to all fragrance components regardless of percentage in the fragrance.
4.5.9 Ingredients on prohibited lists
Ingredients on authoritative lists of chemicals prohibited or restricted for use in cosmetics—notably, the FDA Costmetics list (see 21 CFR 700.11 et seq.), the European Union Cosmetic Directive (Annex II), the Health Canada "Hotlist," and the Cosmetic Ingredient Review "Unsafe for Use" list (at http://www.cir-safety.org)—will not be acceptable in labeled products, as confirmed by their toxicological hazard.
In section 4.2.1, Performance, DfE proposes to delete the current provisions and replace them with the following:
To ensure a baseline measure of performance, the applicant must make a good faith demonstration that their products perform effectively. Applicants must submit appropriate test results as specified below or provide equivalent performance tests agreed upon by DfE.
Performance testing requirements are product-category specific. Partners and candidate partners must consult DfE or an authorized third-party profiler concerning product categories not specifically addressed below. Each product shall effectively clean common soils and surfaces in its category at the most diluted/least concentrated manufacturer-recommended dilution level for routine cleaning, as measured by the following applicable standard test methods.
Manufacturers may use an alternative method approved by DfE to test performance. The alternative method must be objective and scientifically validated, conducted under controlled and reproducible laboratory conditions. For consumer products, the product must perform as well as or better than a conventional, nationally recognized product in its category and at equivalent product-specific use directions. For non-consumer products, DfE must approve the acceptable performance level. Test methodology and results must be documented in sufficient detail for this determination to be made.
Examples of performance requirements that are acceptable to DfE include but are not limited to:
22.214.171.124 Glass cleaners
The product must achieve at least a rating of three for cleaning, streaking and smearing when tested according to CSPA method DCC-09 and DCC-09A or equivalent method agreed upon by DfE.
126.96.36.199 All-purpose cleaners
The product must remove at least 80% of the particulate or greasy soils, as appropriate, when tested according to ASTM G122, DCC-17, CAN/CGSB 2-GP-11 Method 20.3 or an equivalent method agreed upon by DfE.
188.8.131.52 Carpet cleaners/spot cleaners
The product must meet user requirements when tested according to CSPA DCC-03 and AATCC Test Method 171-1995. Alternatively, the product may be tested for cleaning efficacy and resoiling resistance using another equivalent method agreed upon by DfE as described in Section 4.2.1. Products that have WoolSafe certification or a Carpet and Rug Institute Cleaning Solutions Seal of Approval, or the equivalent, will be deemed to satisfy this provision.
184.108.40.206 Washroom cleaners
The product must remove at least 75% of soil using ASTM D5343-06, CSPA DCC-16 or equivalent method agreed upon by DfE. If the product is used for toilet bowl or urinal cleaning,it must also demonstrate efficacy under diverse water hardness conditions using an appropriate method agreed upon by DfE, as described in Section 4.2.1.
The product must meet user requirements for soil removal on relevant substrates when tested according to ASTM method G122, CAN/CGSB 2-GP-11, Method 20.3, CSPA DCC-17 or an equivalent method agreed upon by DfE.
220.127.116.11 Laundry and related products
A consumer pre-wash spotter stain remover must meet user requirements in CSPA DCC-11 or an equivalent method agreed upon by DfE.
A fabric softener must meet user requirements in CSPA DCC-13 or an equivalent method agreed upon by DfE.
A laundry detergent must meet user requirements in CSPA DCC-14 or an equivalent method agreed upon by DfE.
18.104.22.168 Oven cleaners
An over cleaner must meet user requirements in CSPA DCC-12 or an equivalent method agreed upon by DfE.
22.214.171.124 Hand dish soaps
A hand dish soap must meet user requirements in CSPA DCC-10 or an equivalent method agreed upon by DfE.
In section 4.2.5, Packaging, DfE proposes to delete the current provision and replace it with the following:
DfE requires partners to implement sustainable packaging measures and to improve the packaging profile for their recognized products during the partnership. To qualify as a partner, a company must be at least at a 25 percent level with regard to its labeled products in one of the six sustainability criteria listed below, developed by the Sustainable Packaging Coalition (http://www.sustainablepackaging.org). For example, to meet the minimum initial DfE packaging requirement, a qualifying partner must be using 25 percent renewable or recycled source materials in its primary packaging. (This provision pertains to the primary packaging or inner container, in other words, the material that comes in contact with the cleaning product ingredients.)
At each renewal of DfE partnership agreements, partners must report on the status of their packaging practices in relation to each listed criterion and show progress in meeting their sustainability goals.
- Is sourced, manufactured, transported, and recycled using renewable energy;
- Optimizes the use of renewable or recycled source materials;
- Is manufactured using clean production technologies and best practices;
- Is made from materials healthful in all probable end-of-life scenarios;
- Is physically designed to optimize materials and energy; and
- Is effectively recovered and used in biological and/or industrial closed-loop cycles.
Packaging materials may not contain heavy metals in accordance with Toxics and Packaging Clearinghouse (TPCH) model legislation. These criteria may be found at http://www.toxicsinpackaging.org/model_legislation.html. Additionally, packaging materials may not contain other ingredients of concern, including Bisphenol A (BPA) or the following phthalates: dibutyl phthalate (DBP), diisobutyl phthalate (DIBP), butyl benzyl phthalate (BBP), di-n-pentyl phthalate (DnPP), di (2-ethylhexyl) phthalate (DEHP), di-n-octyl phthalate (DnOP), diisononyl phthalate (DINP), and diisodecyl phthalate (DIDP).
In section 4.2.6, Volatile organic compounds (VOCs), Hazardous air pollutants (HAPs), and EPA's Toxics Release Inventory (TRI), DfE proposes to delete the current provisions and replace them with the following (DfE has only changed the organization of the provisions for HAPs and TRI chemicals, and left the substance unchanged):
4.2.6 Volatile organic compounds (VOCs), Hazardous air pollutants (HAPs), and Toxics Release Inventory (TRI) toxic chemicals
In view of the contribution VOCs make to indoor air pollution and associated respiratory concerns, DfE restricts product VOC-content based on the most stringent government criteria. Thus, pending revision to the EPA Office of Air and Radiation (OAR) regulations on product VOC content (at 40 CFR 59, Subpart C), DfE will adhere to VOC restrictions as prescribed by the Ozone Transport Commission (OTC) (see federal Clean Air Act, sections 176A and 184) and the California Air Resource Board (CARB). When these criteria are not in agreement and a product may be used in an ozone-nonattainment area (as per OAR regulations at 40 CFR 50, 51 and 81), the more stringent standard will apply. (VOC criteria from OTC can be found under "Model Rule 2006 Consumer Products" at http://www.otcair.org/interest.asp?Fview=stationary#. VOC criteria from CARB can be found under "Regulation for Reducing VOC Emissions from Consumer Products" at http://www.arb.ca.gov/consprod/regs/gencpregs.htm.)
DfE does not allow products containing chemicals that are included on EPA's list of pollutants designated as hazardous air pollutants (HAPs) or air toxics. The list of HAPs can be found at http://www.epa.gov/ttn/atw/188polls.html.
DfE does not allow products containing chemicals included on EPA's Toxics Release Inventory chemical list. The TRI list of chemicals can be found at http://www.epa.gov/tri/trichemicals/index.htm.
In section 4.2.7, Flammability, DfE proposes to delete the current provision and replace it with the following:
Labeled products must not exhibit the characteristic of ignitability, as defined at 40 CFR 261.21 (a)(1)). For example, a liquid containing greater than 24 percent alcohol by volume must have a flash point at or above 60°C (140°F). The flash point shall be determined by a closed-cup method, specifically, ASTM E502, or an equivalent method agreed to by EPA/DfE.
126.96.36.199 Industrial laundry detergents
Manufacturers of laundry detergents formulated for industrial applications must have information on the product's potential to combust spontaneously, i.e., the temperature at which they would catch fire without an outside source of ignition.
In section 5.11, Enzyme stabilizers, DfE proposes to delete the title and contents and replace them with the following:
5.11 Enzymes and enzyme stabilizers
Enzymes and enzyme stabilizers shall meet the general requirements in Section 5.2, except as defined herein. (Products that contain live microbial cultures or viable spores are addressed in separate DfE guidance.)
To help prevent inhalation of aerosolized enzymes, only liquid enzyme formulations or low-dust granulated enzyme formulations (i.e., encapsulated products with a minimum diameter of 0.15 mm) will be acceptable in labeled products. If in a dry form, in addition to using only low-dust granulated enzymes, manufacturers must exercise and be able to demonstrate best efforts to ensure a safe workplace (for example, through dust control and allergy surveillance programs and the use of appropriate personal protective equipment, as needed).
The enzymes used in cleaning products must be well characterized, and their technical names and catalytic activities must be provided to DfE. Candidate partners must also submit the genus and species of the production organisms, including appropriate taxonomic data, as needed, and documentation of appropriate quality control measures.
If present at appropriate levels, boric acid may be used as a stabilizer in products containing acceptable protease enzymes.