Standardized environmental criteria technical details
(Sustainable procurement guide) Practice Greenhealth’s standardized environmental criteria are explained in detail below in order for suppliers and health care organizations to understand the intent, rationale, and applications to products.
Responses to the following criteria are for information and may or may not be required.
1. INGREDIENTS KNOWN - Does the manufacturer know all of the chemical and material ingredients in this product to 1000 ppm?
Scope: The intent of this criterion is to identify whether or not the product ingredients are known.
2. CHEMICAL ASSESSMENT: Has the manufacturer evaluated all of the ingredients to 1000 ppm for their hazard properties (meaning any health or environmental data)?
Scope: Knowing the chemical ingredients is a first step and evaluating the ingredients for any environmental or health data is the next step.
3.INGREDIENT DISCLOSURE: Upon request, will the manufacturer provide full ingredient information for this product?
Scope: The intent of this is to know if the product ingredients will be made available should the information be desired to confirm any health or environmental data.
4. NATURAL RUBBER LATEX: Is this product not made with natural latex rubber?
Scope: Knowing whether or not this ingredient is in the product to minimize allergic reactions in patients or staff with sensitivities
5. REUSE PRODUCT: Is this product designed for multi-use?
Scope: The intent is to know if the product was designed for more than one use on more than one patient and can be cleaned, disinfected, and reused.
Product must meet all of the chemical criteria contained herein.
1.EUROPEAN UNION RESTRICTION of HAZARDOUS SUBSTANCES (EU RoHS) DIRECTIVE (ELECTRONICS) – All homogeneous electronic parts are compliant with all EU RoHS Directive's restricted limits (excluding exemptions).
Scope: Chemicals include cadmium, mercury, lead, hexavalent chromium, and polybrominated biphenyls, polybrominated diphenyl ethers. RoHS Directive information, including exemptions and restricted limits, can be found on the U.K. government website.
Definition: RoHS originated in the European Union and restricts the use of specific hazardous materials found in electrical or electronic products.
Intent: This applies to electronic components of all products, even if not covered by RoHS. The intent is that electronic components meet the threshold limits specified for the restricted substances in RoHS criteria (excluding exemptions). For an electronic component that is exempted from RoHS, a supplier does not need to affirm “RoHS compliance.” However, the supplier does need to affirm the item meets the RoHS criteria in order to meet the standardized environmental criteria. The intent of this criterion is that electrical/electronic components are expected to meet the threshold limits specified for the restricted substances (excluding exemptions), but they are NOT expected to submit to an official RoHS Directive determination of compliance.
Rationale: Lead and mercury are potent neurotoxicants. Once released to the environment, they will persist. Depending on their form, lead and mercury can bioaccumulate. Hexavalent chromium is a known human carcinogen. Cadmium is an extremely toxic metal. Lead accounts for most of the cases of pediatric heavy metal poisoning (Roberts 1999). Landfill studies show electronics are the major source of heavy metals in leachate, which can contaminate ground and surface water. Mercury vaporizes at room temperature and can expose workers and travel miles from the source of its release. Metals may enter the human body through food, water, air, or absorption through the skin. They can build up in the food web and become a significant health hazard. See below for the rationale about Halogenated Organic Flame Retardants.
2. BISPHENOL A (BPA): All homogeneous materials contain less than 1000 ppm of Bisphenol A and related structural/functional analogues. Structural/functional analogues include: bisphenol AP, bisphenol AF, bisphenol B (BPB), bisphenol C, bisphenol C2, bisphenol E (BPE), bisphenol F (BPF), bisphenol G, bisphenol M, bisphenol S (BPS), bisphenol P, bisphenol PH, bisphenol TMC, bisphenol Z, and 4-cumylphenol (HPP) or Bisphenol A derived chemicals.
Definition: BPA is an organic compound used as a monomer or additive in the manufacturing of polycarbonate plastic, epoxy resins, and other applications. BPA and structural analogues are commonly used in products such as building materials, food containers, and thermal paper.
Intent: To eliminate residual BPA. Not intended to eliminate polycarbonate or epoxy.
Scope: Structural analogs to be avoided include bisphenol AP, bisphenol AF, bisphenol B, bisphenol C, bisphenol Cl2, bisphenol E, bisphenol F, bisphenol G, bisphenol M, bisphenol S, bisphenol P, bisphenol PH, bisphenol TMC, bisphenol Z, and 4‑cumylphenol (HPP). A more extensive list of structural analogs to be avoided includes any compound with the following characteristics:
1. All compounds with a Tanimoto Coefficient of 0.9-1.0 (compared to Bisphenol-A CASRN 80-05-7) are restricted. See Tanimoto Coefficient at EPA’s CompTox Dashboard
2. Any compound with a TC of 0.8-0.9 is restricted until there are publicly-available, valid in vitro or in vivo hazard data that enable evaluation of estrogen and androgen receptor agonism and antagonism. If a compound does not have significant endocrine-disrupting potential, it would not be included.
3. Chemicals with a Tanimoto Coefficient <0.8 may would be considered restricted if:
a. The compound has demonstrated endocrine-disrupting potential (estrogen and/or androgen receptor agonism and/or antagonism) and is used as a functional substitute for BPA OR
b. The compound is detected in environmental media or human biomonitoring studies and it is used as a functional substitute for BPA and publicly available hazard data to evaluate endocrine-disrupting potential (estrogen and/or androgen receptor agonism and/or antagonism) are lacking.
Note: If the compound is detected in environmental media or human bio-monitoring studies and it is used as a functional substitute for BPA but has sufficient publicly available hazard data to demonstrate that it does not have endocrine-disrupting potential (estrogen and/or androgen receptor agonism and/or antagonism), it is not restricted.
Rationale: Bisphenol A (BPA) is a reproductive and developmental toxicant and endocrine disruptor. Emerging evidence finds an association between prenatal or postnatal exposure to BPA and a variety of adverse health outcomes. Listed BPA structural analogs are also prohibited because virtually all currently studied have some evidence of toxic profiles similar to BPA.
3. POLYVINYL CHLORIDE (PVC) - The product does not contain polyvinyl chloride (PVC) or other chlorinated polymers.
Exemption: Products made up of less than 1% (one percent) of PVC by weight are exempt.
Definition: PVC, or vinyl, is a synthetic thermoplastic material made by polymerizing vinyl chloride. The properties of the material depend on the additives, including plasticizers.
Rationale: This plastic (PVC) is particularly problematic because of the toxicity of the monomers required to make the polymer and the generation and release of hazardous compounds during manufacture and disposal. PVC also generally requires more additives, many with their own toxic properties, when compared to other polymers. The diverse additives can also make PVC difficult to recycle.
4. FLAME RETARDANTS (ELECTRONICS) - Electronic product is free of halogenated organic flame retardants by weight of homogeneous material (less than 1000 ppm).
Scope: Electronic Products means computer monitors, televisions, computers (mainframe, desktop and laptop computers); and cell phones, or anything that plugs in or has a battery.
Definition: Halogenated flame retardants are flame retardants that contain halogen chemistry, and are designed to inhibit, suppress, or delay the production of flames to prevent the spread of fire. To meet certain flammability standards, flame retardant chemicals may be added to a range of products, including electronics, upholstered furniture, and hospital privacy curtains. For example, see the list of Halogenated Flame Retardants in the Pharos database, an online tool provided by Healthy Building Network. (Note: To access the information in Pharos, please first create a free account on the website, and the link will then direct to the halogenated flame retardants group. This serves as a point of reference but is not an exhaustive list of all flame retardants in this class of chemicals).
Homogeneous material means a material that cannot be mechanically disjointed into different materials; it is of uniform composition throughout.
Rationale: Flame retardants can be persistent and have a variety of toxic properties depending on the specific flame retardant. Non-polymeric flame retardants can migrate out of products into the environment, resulting in human exposure.
5. FLAME RETARDANTS (NON-ELECTRONICS) - Non-electronic product is free of all flame retardants by weight of homogeneous material (less than 1000 ppm).
Exemption: Where flammability standards require the use of flame retardants in resilient flooring or carpet, inorganic flame retardants approved under the Blue Angel Low-Emission Textile Floor Coverings, DE-UZ 128, criteria are allowed. In particular, the following compounds may be used: inorganic ammonium phosphates (for example, diammonium phosphate or ammonium polyphosphate), other dehydrating minerals (for example, aluminium hydroxide), or expandable graphite. Antimony oxides may not be used.
Definition: Flame retardants are designed to inhibit, suppress, or delay the production of flames to prevent the spread of fire. For example, see the list of Flame Retardants in the Pharos Database (see description about Pharos in Section 4, above).
Rationale: Flame retardants can be persistent and have a variety of toxic properties depending on the specific flame retardant. Flame retardants can migrate out of products into the environment, resulting in human exposure.
6. ORTHO-PHTHALATES, INCLUDING di(2-ethylhexyl) phthalate (DEHP) – All homogeneous
materials contain less than 1000 ppm of ortho-phthalates.
Scope: Ortho-phthalates include Di-2-ethyl hexyl phthalate (DEHP) CAS 117-81-7, Benzylbutylphthalate (BBP) CAS 85-68-7, Di-n-hexyl phthalate (DnHP) CAS 84-75-3, Di-isodecyl phthalate (DIDP) CAS 68515-49-1 or 26761-40-0, Dibutyl phthalate (DBP) CAS 84-74-2, Diisononyl phthalate (DINP) CAS 28553-12-0 and 68515-48-0, Diisobutyl phthalate (DIBP) CAS 84-69-5, as well as Di n-pentyl phthalate (DPENP) CAS 131-18-0, Dicyclohexyl (DCHP) CAS 84-61-7 and Di-n-hexyl phthalate (DHEXP) CAS 84-75-3.
For more details on the compounds considered ortho-phthalates, please see the list of Ortho-Phthalates in the Pharos Database (see description about Pharos in Section 4, above).
Definition: Ortho-phthalates have the general chemical structure shown below:
Rationale: The hazard profile of ortho-phthalates varies with side-chain lengths. Adverse effects include hormone disruption, reproductive and developmental impacts, and kidney toxicity. Exposure to some ortho-phthalates is associated with an increased risk of asthma. The National Research Council reports the importance of looking at cumulative exposure from multiple phthalates; exposure routes include ingestion, inhalation, intravenous injection, and skin absorption.
7. PROP 65 CHEMICALS - The product does not contain intentionally added chemicals listed under the California Safe Drinking Water and Toxic Enforcement Act of 1986, Proposition 65, at levels that require warning or are prohibited from release to the environment.
Scope: The Prop 65 list can be found at http://oehha.ca.gov/proposition-65/proposition-65-list
If answered “No” to Prop 65 criteria, list Chemical Abstracts Service (CAS) #'s.
Restrictions established by other criteria in this document supersede this criterion to the extent they conflict.
Definition: Proposition 65 requires California to publish a list of chemicals known to cause cancer, birth defects, or other reproductive harm. It requires businesses to provide warnings to Californians about significant exposures to these chemicals. The Proposition 65 list, which must be updated at least once a year, has grown to include approximately 900 chemicals since it was first published in 1987.
Rationale: Proposition 65 chemicals are chemicals known to the State of California to cause cancer or adverse impacts on reproduction or development.
8. ANTIMICROBIAL / ANTIBACTERIAL AGENTS - Does not contain intentionally added antimicrobial/antibacterial agents to reduce surface pathogens.
Definition: Antimicrobials are substances or mixtures of substances designed to destroy or suppress the growth of harmful microorganisms whether bacteria, viruses, or fungi on inanimate objects or surfaces. These products are typically used for two purposes: 1) Disinfect, sanitize, reduce, or mitigate growth of microbiological organisms; 2) Protect inanimate objects (floors, walls, and/or furniture), industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime.
Rationale: Human toxicity and ecotoxicity profiles differ among antimicrobial agents, but none are entirely benign. The addition of antimicrobials can also contribute to more widespread antibiotic resistance. There is often little evidence that the addition of antimicrobials in non-medical products reduces HAI’s.
9. PERSISTENT, BIOACCUMULATIVE AND TOXIC CHEMICALS (PBTs) - All homogeneous materials contain less than 1000 ppm of persistent, bioaccumulative toxins (PBTs)*.
Definition: PBTs are a class of compounds that have high resistance to degradation from abiotic and biotic factors, high mobility in the environment, and high toxicity. Because of these factors, PBTs have been observed to have a high order of bioaccumulation and biomagnification, very long retention times in various media, and widespread distribution across the globe.
*PBTs include chemicals on any of the following lists:
Rationale: These four lists represent authoritative government lists of chemicals known to be persistent, bioaccumulative, and toxic. This combination of properties makes PBTs particularly hazardous. PBTs are long-lasting substances that can build up in the food chain to levels that are harmful to human and ecosystem health. Because of their persistence and bioaccumulative properties, they do not break down easily and are particularly difficult to clean up.
10. METALS - Product does not contain mercury, lead, cadmium, or organotin compounds.
Scope: Lead and lead-containing compounds in concentrations exceeding 40 ppm, mercury and mercury- containing compounds exceeding 100 ppm, cadmium and cadmium-containing compounds exceeding 100 ppm, organotin compounds [e.g. tributyltin (TBT), dibutyltin (DBT)] exceeding 100 ppm. However, in the case of the electronic components of products, the metals limits described here are superseded by the RoHS requirements (see Section 1, above).
Definition: Metals represent a broad category, which can include certain elements, compounds, and alloys. Of particular concern are lead, mercury, cadmium, and organotins and compounds that contain these metals. For example, see the list of Toxic Heavy Metals and list of Organotin Compounds in the Pharos Database (see description about Pharos in Section 4, above).
Rationale: A wide variety of health and ecosystem concerns are associated with the toxic metals prioritized in this criterion, including neurotoxicity, cancer, reproductive and developmental effects, and aquatic toxicity.
Notes: Hexavalent chromium and nickel and other metals were considered for inclusion here. Instead they are recommended for category specific consideration when relevant- not on all products.
11. PER AND POLY-FLUORINATED ALKYL SUBSTANCES (PFAS) - Product does not contain stain- or water-repellent treatments or other surface protection that contain a per- or poly-fluorinated alkyl substance.
Scope: No intentionally added fluorine compounds are allowed, and total fluorine must be less than 100 ppm.
Definition: PFAS are a large group of compounds that contain a carbon-fluorine bond. PFAS include long- and short-chain per- and poly-fluorinated alkyl substances and fluorinated polymers. This includes any substance that meets any one of the definitions:
-Perfluoroalkyl substances: Substances for which all hydrogen atoms on all carbon atoms (except for carbons associated with functional groups) have been replaced by fluorine atoms.
-Polyfluoroalkyl substances: Substances for which all hydrogen atoms on at least one (but not all) carbon atom have been replaced by fluorine atoms.
-Fluoropolymers: Carbon-only polymer backbone with fluorine atoms directly bound.
-Perfluoropolyethers: Carbon and oxygen polymer backbone with fluorine atoms directly bound to carbon atoms.
-Side-chain fluorinated polymers: Variable composition non-fluorinated polymer backbone with fluorinated side chains.
For a list of some of the specific chemicals included in these categories, see Per- and Polyfluorinated Alkyl Substances (PFAS) / Perfluorinated Compounds (PFCs) in the Pharos Database (see description about Pharos in Section 4, above).
Rationale: PFAS compounds are generally highly persistent chemicals or break down into highly persistent chemicals. They have been nicknamed “forever chemicals” because of their extreme persistence. Some but not all bioaccumulate. They are regularly found in people and animals in all areas of the planet. Because of their persistence, continued use will inevitably lead to increasing environmental concentrations of PFAS compounds. The health effects of the most well studied include high cholesterol, thyroid disorders, pregnancy-induced hypertension and preeclampsia, cancer (testicular and kidney), and altered metabolism, among others. Many of these compounds have not been adequately evaluated.
Product must meet two (2) of the waste criteria contained herein.
1. DOES NOT CREATE A HAZARDOUS WASTE (PRODUCT) - Product does not become or generate a hazardous waste according to state or federal hazardous waste rules (e.g. EPA’s RCRA).
Definition: The product does not create or become a hazardous waste on its own or when aggregated. Hazardous waste, or listed wastes, are those the EPA has determined are hazardous- including F-list (wastes from common manufacturing and industrial processes), K-list (wastes from specific industries), and P- and U-lists (wastes from commercial chemical products); wastes that do not meet any of the listings above but exhibit ignitability, corrosivity, reactivity, or toxicity; universal wastes include batteries, pesticides, mercury-containing equipment and lamps; and mixed waste containing both radioactive and hazardous waste components.
2. 10% OR MORE POST CONSUMER RECYCLED CONTENT (PRODUCT)
Product contains more than 10% post-consumer recycled content.
Definition: Post-consumer recycled content is a material or finished product that has served its intended use and has been diverted or recovered from waste destined for disposal, having completed its life as a consumer item. Post-consumer recycled content is the material
collected from recycling programs. Post-consumer content is calculated as a percentage of the total weight of the product. Postconsumer content excludes all metals; metals are commonly recycled. Devices with patient contact (such as surface contacting, external communicating or implantable devices) shall be defined by ISO 10993-1-2009. This does does not apply to patient contact devices.
Rationale: Purchasers should prefer products with the highest post-consumer recycled content that also meet other considerations. Use of post-consumer recycled content is fundamental to closing the loop in the recycling process, using fewer natural resources, and reducing greenhouse gas emissions (based on EPA’s ReCon Tool).
Note: This criterion is not intended to support using more plastic
3. RECYCLABILITY (PRODUCT) - Product is recyclable.
Scope: A product is recyclable if it can be collected, separated, or otherwise recovered from the waste stream through an established recycling program for reuse or use in manufacturing or assembling another item, with recycling facilities for the item available to at least 60 percent of communities where the item is sold.
Definition: Recyclable, according to the FTC Green Guides, means the product can be collected, separated, or otherwise recovered from the waste stream through an established recycling program for reuse or use in manufacturing or assembling another item. Any unqualified claims of recyclability indicates the supplier can demonstrate that at least 60% (substantial majority) of consumers or communities where the item is sold have recycling facilities. If recycling facilities are available to less than a substantial majority of consumers and
communities, then marketers should qualify all recyclable claims by stating the percentage of consumers or communities that have access to facilities that recycle the item.
Recyclable does not describe FDA-regulated single-use device reprocessing. This question refers to the product only, not packaging. Products that become regulated medical waste after use cannot claim to be recyclable. Primary packaging is not considered part of the product for the purpose of this question.
Rationale: Recyclable products in communities in the U.S. reduce materials going to the waste stream and their associated costs.
4. RECYCLED CONTENT (PRIMARY PACKAGING) - Primary packaging - Contains more than 10% post-consumer recycled content.
Definition: The primary packaging surrounds the product. For example the paper wrap surrounding a roll of toilet paper is primary packaging. (Secondary packaging surrounds a group of products, such as the box containing rolls of toilet paper.) Post-consumer recycled content material is a material or finished product that has served its intended use and has been diverted or recovered from waste destined for disposal, having completed its life as a consumer item. Post-consumer recycled content is the material collected from recycling programs and is calculated as a percentage of the total weight of the product.
Rationale: Buying recycled-content products ensures that the materials collected in recycling programs will be used again in the manufacture of new products. According to the EPA, recommending post-consumer recycled content levels for items will have the most positive impact on reducing the amount of solid waste requiring disposal. Purchasers should prefer products with the highest post-consumer recycled content that also meet other considerations. Use of post-consumer recycled content is fundamental to closing the loop in the recycling process, using fewer natural resources, and based on EPA’s ReCon Tool, can reduce greenhouse gas emissions. There are exceptions to the use of postconsumer recycled content in sterile barrier packaging (ISO 11607-1).
5. RECYCLED CONTENT (SECONDARY PACKAGING) - Secondary Packaging - Contains more than 30% post consumer recycled content.
Definition: See above
Rationale: See above
6. FOREST STEWARDSHIP COUNCIL Ⓡ - Packaging has received Forest Stewardship Council certification
Scope: Packaging has one of the following certifications: 100% - From well-managed forests; Mix From responsible sources; Recycled - Made from recycled material.
Definition: The Forest Stewardship Council ® is a nonprofit organization that certifies wood that is harvested from sustainably managed forests based on strict guidelines.
Rationale: Deforestation and forest destruction is the second leading cause of carbon pollution, causing 20% of total greenhouse gas emissions. Certain parts of the U.S. are seeing declining forest coverage lost to suburban real estate development. By creating demand for products from responsibly managed forests, this helps protect forests for future generations. FSCⓇ certification ensures that products come from responsibly managed forests that provide environmental, social, and economic benefits.
7. RECYCLING INFORMATION - Packaging is labeled with recycling information.
Scope: Labels meet US Federal Trade Commission Green Guides.
Definition: Labels on the product package identify the packaging as recyclable. All recyclable claims meet the Federal Trade Commission Green Guides. The recyclable labels used are from a standardized labeling system that clearly communicates recycling instructions, such as the How2Recycle label.
Rationale: Labels provide consumers and businesses with clear instructions on the recyclability of the material in order to properly recycle the item at the end of use. Recycling products and packaging reduces waste, waste cost, negative environmental impacts associated with waste, and supports a circular economy.
8. RECYCLABILITY (PACKAGING) - Primary packaging is recyclable.
Definition: A package is recyclable if it can be collected, separated, or otherwise recovered from the waste stream through an established recycling program for reuse or use in manufacturing or assembling another item, with recycling facilities for the item available to at least 60 percent of communities where the item is sold. Primary packaging is the layer of packaging in immediate contact with the product.
Rationale: The volume of packaging used in healthcare is large, and is a leading source of waste. Recycling packaging reduces waste and the costs of waste handling for health care. Recycling reduces the negative environmental impacts associated with both production and waste disposal. Recycling also enables raw material reuse and supports a circular economy. See above.
9. PVC, POLYSTYRENE (PACKAGING) - Product is packaged without both polyvinyl chloride (PVC) and polystyrene.
Definition: PVC, or vinyl, is a synthetic thermoplastic material made by polymerizing vinyl chloride. The properties of the material depend on the additives, including plasticizers. Polystyrene is a plastic polymer from the monomer styrene. It comes in many forms: sheet, expanded or extruded foam, or as oriented polystyrene. What is commonly known as Styrofoam™ refers only to the extruded form of polystyrene.
Rationale: PVC is a particularly problematic plastic because of the toxicity of the monomers required to make the polymer and the generation and release of hazardous compounds during manufacture and disposal. PVC also generally requires more additives, many with their own toxic properties, when compared to other polymers. The diverse additives can also make PVC difficult to recycle. Styrene is considered a probable carcinogen and also has life cycle concerns. Foam blowing agents used to make polystyrene may have ozone depletion potential or contribute to global warming, and polystyrene is difficult to recycle.