On this page:

• Overview
• Considerations Given the Current OMB A-119 Revision Process
• Response to Overarching Themes Reflected in Public Comments
• Response to Comments on "Environmental Effectiveness" Guidelines
  • Functional Performance
  • Align with Relevant Standards
  • Measurability and Significant Measurable Difference
  • Performance-Based
  • Hotspots, Multiple Environmental Impacts, and Lifecycle Stages
  • Intrinsic Hazards
  • Chemical ingredient disclosure

Overview

On November 27, 2013, EPA issued for public comment Draft Guidelines for Product Environmental Performance Standards and Ecolabels for Voluntary Use in Federal Procurement. EPA received input from more than 75 individuals and organizations. As stated in the Federal Register notice, EPA's goal in developing these Guidelines is to create a "transparent, fair, and consistent approach to selecting environmental performance standards and ecolabels to support the Agency's mission and federal sustainable acquisition mandates." The fundamental aim of the Guidelines is to establish a cross-sector framework to be used in recognizing non-governmental environmental standards (and consequently, environmentally preferable products meeting these standards) for use in federal procurement. The Guidelines provide a foundation for making these determinations, while providing flexibility to accommodate the variety of approaches to and types of standards and ecolabels that exist in the marketplace today. Read the Federal Register notice.

EPA developed these Guidelines by integrating (1) accepted protocols for standards development, conformity assessment, and ecolabel program management consistent with U.S. Government policy, and (2) criteria that would support the claim of environmental preferability.

The draft Guidelines include four sections:

• Guidelines for the Process for Developing Standards refers to the procedures used to develop, maintain, and update an environmental standard.
• Guidelines for the Environmental Effectiveness of the Standards refers to the criteria in the environmental standard or ecolabel that support the claim of environmental preferability.
• Guidelines for Conformity Assessment refers to the procedures and practices by which products are assessed for conformity to the requirements specified by standards and ecolabeling programs.
• Guidelines for Management of Ecolabeling Programs refers to the organizational and management practices of an ecolabeling program.

Additional background and supplementary information available.

Considerations Given the Current OMB A-119 Revision Process

U.S. Federal agencies and departments must comply with several laws relating to the use of non-government (or private sector) standards. Two of these laws are the National Technology Transfer and Advancement Act (NTTAA - P.L 104-113) and the Trade Act. The NTTAA directs federal agencies to use private sector standards in procurement and regulatory activities, unless otherwise impracticable. Office of Management and Budget (OMB) Circular A-119 "Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities" implements the law and defines standards and voluntary consensus standards for the federal community. The full text of the revised OMB A-119 published on January 22,2016 can be found online (PDF). (43 pp, 505 K, About PDF)

In early 2014, the U.S. Office of Management and Budget proposed revisions to Circular A-119 for public comment. These materials are available online. Of particular interest to EPA, the proposed revisions include:

• Preference for voluntary consensus standards. The proposed revisions would state a clear preference among private sector standards for voluntary consensus standards. It would also acknowledge, however, that there may be some standards developed via non-consensus driven processes that are in use in the market and that may be relevant (and necessary) in meeting agency missions and priorities.
• Guidance on use of standards. The proposed revisions would also provide criteria for agencies to consider when examining whether a standard meets agency needs and should be adopted.
• Guidance on conformity assessment. The proposed revisions would encourage agencies to consider international conformity assessment schemes and private sector conformity assessment activities in lieu of conformity assessment activities or schemes developed or carried out by the government, and set out criteria for agencies to consider when they are selecting or designing an appropriate conformity assessment procedure.
• Federal coordination and consistency. The proposed revisions would encourage agencies to work together to reference the same version of a standard in regulation and procurements and coordinate on conformity assessment requirements, where feasible.

EPA—as do all federal agencies—considers and applies the guidance in OMB A-119 in line with its mission and needs. Given that these pending revisions to OMB A-119 have the potential to further inform EPA on standards issues, EPA will wait for OMB's current revision process to conclude before making final decisions regarding Sections 1, 3, and 4 of the draft Guidelines. In the interim, consistent with EPA's mission and charge to provide guidance to federal agencies on environmentally preferable purchasing and sustainable acquisition mandates set forth in the Pollution Prevention Act, Executive Order 13423, Executive Order 13514, and FAR subpart 23.703, EPA plans to focus on the environmental and human health effectiveness of standards and ecolabels (Guidelines Section 2) and will consider the process by which standards and ecolabels are developed and managed (Guidelines Sections 1, 3, and 4) as OMB A-119 is finalized (which is expected in time for the pilot to incorporate).

EPA Response to Overarching Themes Reflected in Public Comments

EPA received comments on the Guidelines from close to 80 organizations and individuals; these comments provide valuable perspectives and positions that may be of value and interest to many stakeholders. As such, EPA is making the comments more accessible via links here.

The majority of comments expressed strong support for the Guidelines and the open process that EPA is undertaking. Commenters also agreed with EPA's overall goal of establishing a transparent, fair, and consistent approach to assessing environmental performance standards and ecolabels. Commenters stated that it is not appropriate to express a blanket preference for multi-attribute, multi-lifecycle stage (e.g., finished product) standards, because this approach is not applicable to process and production method (PPM) standards (e.g., those focused on sustainable forestry practices), and it may not be the most appropriate approach for specific product categories where a single environmental issue or lifecycle stage dominates environmental impacts; EPA agrees. Commenters also expressed support for EPA's proposal to pilot the Guidelines with a balanced, multi-stakeholder group. Finally, commenters encouraged alignment of this effort with related Federal Trade Commission (FTC) and National Institute of Standards and Technology (NIST) activities.

Commenters provided critical feedback in several areas. EPA provides responses to the common overarching themes below.

Comment: What is EPA's role in providing guidance and facilitating market clarity for sustainable purchasing? The following links exit the site Exit
The Pollution Prevention Act of 1990 (PDF)(10 pp, 38.7K, About PDF) (specifically 42 U.S.C.A. §13103(b)(11)) directed EPA to identify opportunities to use Federal procurement to encourage source reduction. E.O. 12873 Sec. 503 and E.O. 13101 Sec. 503 laid a foundation for federal "environmentally preferable purchasing" – taking into account multiple environmental impacts over the lifecycle of products and services and EPA's role in sustainable acquisition more broadly. (Note: E.O. 12873 and 13101 were revoked and replaced by 13423. "Environmentally preferable" is defined in Section 201 of both EO 13101 and EO 12873 to mean products or services that "have a lesser or reduced effect on human health and the environment when compared with competing products or services that serve the same purpose. This comparison may consider raw materials acquisition, production, manufacturing, packaging, distribution, reuse, operation, maintenance or disposal of the product or service.") Building on this foundation, EO 13423 mandated establishment of environmental management systems at all federal agencies to manage the agencies' environmental impacts. The "Instructions for Implementing E.O. 13423 (PDF)" (51 pp, 425K, About PDF) identifies EPA, the U.S. Department of Agriculture (USDA), and the U.S. Department of Energy (DOE) as the "Technical Leads for Product Designations and Guidance." Federal Acquisition Regulation (FAR) section 23.703 states that Agencies must "Maximize the utilization of environmentally preferable products and services (based on EPA-issued guidance)." And, most recently, EO 13514 (PDF) (15 pp, 87K, About PDF) and FAR section 23.103 strengthen these greening of government foundations by requiring 95% of applicable government contract actions to be sustainable. Section 2(h) of the Executive Order states that the head of each Agency shall:

"advance sustainable acquisition to ensure that 95 percent of new contract actions including task and delivery orders, for products and services with the exception of acquisition of weapon systems, are energy-efficient (Energy Star or Federal Energy Management Program (FEMP) designated), water-efficient, biobased, environmentally preferable (e.g., Electronic Product Environmental Assessment Tool (EPEAT) certified), non-ozone depleting, contain recycled content, or are non-toxic or less toxic alternatives, where such products and services meet agency performance requirements."

Participating in the development of and encouraging the use of environmental performance standards and ecolabels is an important strategy used by EPA to assist the federal government in meeting environmentally preferable purchasing mandates and facilitating source reduction in the private sector. EPA developed the Guidelines to advance this strategy.

Comment: Is EPA intervention in the standards arena needed or appropriate?
Over the last decade, EPA has received numerous requests from federal and non-federal stakeholders to help identify appropriate private sector standards and ecolabels for environmentally preferable purchasing. Non-governmental environmental standards and ecolabels are already being used to promote sustainable purchasing throughout the federal government and the private sector. However, the growth of product environmental standards and ecolabels (more than 400 worldwide), and uncertainty among the purchasing workforce on how to determine which standards and ecolabels are effective and appropriate for a given procurement, have limited the implementation of sustainable acquisition. EPA's decision to develop the Guidelines is in large part a response to these challenges. Moreover, EPA considers the Guidelines and their implementation a cost-effective approach for federal sustainable acquisition. In addition, we expect that this effort can also provide some clarity and consistency, and thus cost-savings, for suppliers that wish to sell to the government.

There are other federal agency programs that assess private sector standards and list 'adopted' or 'recognized' standards to help meet their missions. For example, the Food and Drug Administration's Center for Devices and Radiological Health has a very robust standards engagement and recognition program. The Department of Homeland Security (DHS) has adopted standards for general preparedness, receiving input via public comment periods and an ANSI Homeland Security Standards Panel and works with the ANSI-maintained Homeland Security Standards Database to include the DHS Adopted Standards. DHS also has a new Resiliency STAR Program, based on private sector standards, in the pilot phase.

EPA is working with and learning from these and other federal agency efforts to guide this next phase of the Guidelines effort. Exit

Comment: What is the role of FTC and NIST in EPA's Guidelines effort?
The Federal Trade Commission (FTC) regulates advertising and marketing claims related to certain consumer products; it is charged with ensuring the veracity of product claims in the marketplace. The FTC Green Guides provide guidance to marketers to ensure that environmental claims are truthful, accurate, and substantiated (Section 5 of the FTC Act, 15 U.S.C. § 45).

EPA provided input to the FTC in the development of the original version of the Green Guides and shared its experience in environmentally preferable products and purchasing with the FTC during the latest revision of the Green Guides. The Green Guides discuss how seals and certifications are likely to be perceived by consumers and give guidance about the types of claims that could be supported. The Guides' primary focus is on providing guidance to marketers on how reasonable consumers are likely to interpret environmental marketing claims, and how marketers can substantiate them. They do not address the substance of standards or ecolabels, the process used to develop standards, or their use in the procurement process – all of which are important to federal purchasers. Moreover, under Section 5 of the FTC Act, marketers have flexibility in choosing how to substantiate their claims as long as they have competent and reliable scientific evidence to back up their claim.

The National Institute of Standards and Technology (NIST) is the federal entity charged with coordinating federal activities in standardization, and provides guidance to EPA and other federal agencies on the use of private sector standards and with respect to conformity assessment questions. NIST also has experience in the application of lifecycle assessment (LCA) and lifecycle costing (LCC).

EPA has worked with FTC and NIST on sustainable purchasing and conformity assessment matters, and will continue to consult with them, as well as the General Services Administration (GSA), Department of Defense, Defense Logistics Agency, and many other federal partners, during the pilot phase of the Guidelines.

Comment: How do the Guidelines apply to government-developed ecolabels? How did government mandated ecolabels influence the Guidelines?
The federal government is required by various statutes and Executive Orders and the Federal Acquisition Regulation to procure products and/or services meeting certain ecolabels, including those developed and/or managed by the government. These mandates include EPA's ENERGY STAR label, SNAP Program, and Comprehensive Procurement Guidelines Program; USDA's Bio-preferred label; DOE's Federal Energy Management Program; and the Green Electronic Council's EPEAT.

As noted above, OMB Circular A-119 directs government agencies to use private-sector standards except where "inconsistent with law or otherwise impractical." It defines "impractical" as including "circumstances in which such use would fail to serve the agency's program needs; would be infeasible; would be inadequate, ineffectual, inefficient; or would impose more burdens, or would be less useful, than use of another standard." As a result, government-managed standards and ecolabels, including the EPA's WaterSense Program and the EPA's Design for the Environment (DfE) Safer Product Labeling Program, are required or encouraged to be used in federal procurement. In cases where such standards and ecolabels have a long history of effectively supporting federal sustainable acquisition, there would not be significant value to the government in assessing them against the Guidelines. That said, the existing mandates and government ecolabels were very influential in framing the draft Guidelines, especially Guidelines regarding environmental effectiveness. These standards and ecolabels align in principle (e.g., participatory process, transparency), considering the differences in administrative procedures of the government and of private sector standards development and conformity assessment organizations. (See the findings of these initial assessments here).

Comment: Should EPA express a blanket preference for voluntary consensus standards? 
The current version of OMB A-119, which has been in place since 1998, does not provide a preference for consensus standards. Specifically, the Circular says:

This policy does not establish a preference among standards developed in the private sector. Specifically, agencies that promulgate regulations referencing non-consensus standards developed in the private sector are not required to report on these actions, and agencies that procure products or services based on non-consensus standards are not required to report on such procurements. For example, this policy allows agencies to select a non-consensus standard developed in the private sector as a means of establishing testing methods in a regulation and to choose among commercial-off-the-shelf products, regardless of whether the underlying standards are developed by voluntary consensus standards bodies or not.

EPA appreciates OMB's current approach, which provides agencies much-needed flexibility to utilize a wide range of private sector standards and focus on the criteria of those standards in determining whether they meet their needs. However, as stated above, OMB is currently in the process of revising Circular A-119. Until those revisions are complete, EPA will not make final decisions regarding Sections 1, 3, and 4 of the Guidelines, which address standards development, conformity assessment, and ecolabel program management, respectively.

Comment: How should EPA define consensus and balance of interests? 
EPA recognizes the critical importance of having a balance of experts and stakeholders participate in the standards development process to ensure that environmental and public health impacts are adequately addressed and that products are available in the marketplace to meet federal needs. However, EPA also recognizes the wide array of credible approaches currently utilized to develop standards, and does not want to preclude the use of certain standards based solely on their development process. Other agencies have similar interests and goals. Again, EPA will learn from the OMB A-119 revision process before making changes to the Guidelines to address these issues.

Comment: Do the Guidelines affect federal mandatory-source programs?
No. The federal government has identified mandatory sources of supply, including for certain items from the Ability One Program (NIB/NISH), the UNICOR (Federal Prison Industries) programs, and other sources. These are statutory mandates, and as stated in OMB Circular A-119, government agencies must use private-sector standards except where "inconsistent with law or otherwise impractical." In the event of any conflicts, such statutory mandates would clearly take precedence over the Guidelines. Ability One and UNICOR, among other programs, are making great strides in 'greening' their offerings, and EPA and GSA will continue to work with these programs to further these efforts.

Comment: What are Baseline and Leadership Guidelines and why are they needed?
Based on EPA's initial analysis of the draft Guidelines, "Baseline" Guidelines align with federal goals and requirements, are relatively straightforward to evaluate, and are applicable across industry sectors. "Leadership" Guidelines represent best practices and are currently achievable by some standards and ecolabels or for some product sectors, but not for others. Multi-stakeholder panel(s), as described below, will determine the applicability of the Leadership Guidelines Exit to standards and ecolabels on a product-category-by-product-category basis. For certain product categories, specific Leadership Guidelines may be considered essential along with the Baseline Guidelines. The multi-stakeholder panel(s) will also decide if and how to weight the Leadership Guidelines.

Some commenters assumed that with Baseline and Leadership Guidelines, EPA was also proposing that standards and ecolabels themselves would be rated as "Baseline" or "Leadership." That was not intended. Rather, the Baseline and Leadership designations are necessary to provide flexibility in how the Guidelines are tailored into product category-specific assessment tools (or "checklists" or "rating systems," depending on the findings in the pilot). While EPA wants to ensure that the assessments of standards and ecolabels are made available to federal procurers (and some may draw conclusions along these lines), the overall goal is clarity and, specifically, a list of recognized standards for federal environmentally preferable purchasing. However, some commenters felt strongly that greater differentiation amongst conforming standards and ecolabels would be desirable. As such, the pilot phase will also explore if/how to distinguish higher-performing standards and ecolabels (e.g., those that satisfy a number of optional "Leadership" Guidelines) from those that do not go beyond Baseline criteria.

It is important to note that language throughout Section II of the Guidelines has been changed to include mandatory language (e.g., "The standard requires…") for both Baseline and Leadership standards. However, the applicability of Leadership Guidelines, and the precise methods of conformance, will vary by product category.

Response to Comments on the "Environmental Effectiveness" Guidelines

Functional Performance: Several commenters indicated that the functional performance Guideline should be removed, because functional performance is outside the scope of many environmental performance standards, and because functional performance is already routinely considered as part of agencies' acquisition processes. EPA concurs with these commenters and has eliminated this Guideline. However, EPA will develop language to accompany the Guidelines noting that functional performance should continue to be addressed via agencies' established processes for setting and evaluating technical requirements.

Align with Relevant Standards. Most commenters were supportive of the inclusion of a Guideline addressing alignment with relevant existing standards, but felt that the proposed language should be clarified. Commenters indicated that the term "alignment" should be clarified in general, and reworded to ensure that the Guideline would not inadvertently stifle innovation or continuous improvement, or encourage duplication of existing standards.

One commenter indicated that a major challenge faced by environmental standards striving to recognize only "top performers" is "partial alignment," in which multiple standards are aligned thematically (i.e., addressing the same environmental issues) but not with respect to performance (i.e., rigor). For example, a new standard may create confusion in the marketplace by partially aligning with an existing standard by addressing the same environmental impact(s), but requiring a significantly lower level of environmental performance.

EPA agreed with these commenters; the revised Guideline reads as follows:

Align with Relevant Standards: To avoid duplication or confusion in the marketplace, environmental standards align performance requirements with relevant existing standards, including building upon existing, federal, regional, national, and international standards where relevant to the scope and goals of the standard. Aligning performance requirements refers to performance that is equivalent to or better than performance requirements in relevant existing standards.

Measurability and Significant Measurable Difference: EPA agreed with the many commenters who suggested combining these two Guidelines into one, given how closely they are related. EPA also clarified the definition of "measurable difference" to specify that sustainable products should exceed legal minimum requirements and exceed the industry average for claimed environmental attributes. Finally, in response to comments, EPA has added a provision to allow for qualitative methods of measurement where quantitative approaches are not available.

The revised Guideline reads as follows:

Measurability and Significant Measurable Difference: The product environmental performance criteria are, to the greatest extent practicable, measurable and convey improved environmental outcomes for the environmental attribute(s) addressed. Criteria should ensure that environmental performance of conforming products exceeds legal minimum requirements (where applicable), and exceeds the industry average for the environmental impact(s) addressed. Quantitative measures are strongly preferred, but qualitative measures may be used where quantitative approaches are infeasible.

Other commenters questioned whether the Guidelines should set a minimum floor for performance, and/or identify products that score above a certain threshold compared to competitors. Government standards have used a variety of approaches to assess and recognize a "significant measurable difference" in the marketplace. For example, to qualify as an ENERGY STAR Building, a commercial building must score in the top quartile in energy use compared to similar building types. To qualify for the WaterSense label, products need to be at least 20 percent more efficient than the industry average. In contrast, EPA's Design for the Environment Program (now the Safer Choice program) uses a different approach. The Program's scientific review team screens each ingredient in a product for potential human health and environmental effects and assesses, based on currently available information, EPA predictive models, and expert judgment, whether the product contains only those ingredients that pose the least concern among chemicals in their class. Based on these varying methods, EPA believes that the determination of approaches for assessing significant measurable differences must be conducted at the product-category level.

Performance-Based: OMB A-119 defines "performance standard" as a standard that states requirements in terms of required results with criteria for verifying compliance, but without stating the methods for achieving required results. A performance standard differs from a prescriptive standard, which typically specifies design requirements such as materials to be used, how a requirement is to be achieved, or how an item is to be fabricated or constructed.

This Guideline states that criteria should be performance-based "when such criteria may reasonably be used in lieu of prescriptive criteria." This is designated as a Leadership Guideline. Some commenters felt that the Guideline did not express a sufficient preference for performance-based criteria. Others believed that the Guideline went too far in promoting a performance-based approach, pointing out that certain product categories face "significant limitations to measurement for some environmental impact areas," meaning that prescriptive criteria are the only practical means for ensuring the desired environmental outcomes.

EPA believes that the Guideline strikes an appropriate balance between these two competing viewpoints. It clearly signals a general preference for a performance-based approach. However, EPA recognizes that a performance-based approach may not be desirable or achievable for all product categories or all environmental attributes. The fact that this is a Leadership Guideline rather than a Baseline Guideline reflects that understanding; the applicability of this Guideline, as with all Leadership Guidelines, will be determined on a product category-specific basis. Thus, there may be select product categories or environmental criteria within a standard for which a prescriptive approach would not be considered acceptable under the Guidelines, while for others it would be acceptable. The revised Guideline reads as follows:

Performance-based: The criteria are performance-based when such criteria may reasonably be used in lieu of prescriptive criteria. Prescriptive criteria are used when there is empirical-based evidence to support that the action will achieve the desired outcome. Criteria must be sufficiently specific with respect to a desired performance outcome or prescriptive outcome.1

The accompanying footnote includes the OMB definition above and adds:

1 …. Unacceptably vague criteria would include those stating that an entity should "be involved in" or "promote" an activity, approach, or philosophy without specifying resulting performance or prescriptive outcomes.

Hotspots, Multiple Environmental Impacts, and Lifecycle Stages: Several commenters expressed confusion about the applicability of the Guidelines for Hotspots, Multiple Environmental Impacts, and Lifecycle Stages, and EPA's intent regarding the implementation of these particular Guidelines. To clarify, EPA's position is that lifecycle thinking and information must be considered, at the product-category level, to inform whether a standard (or standards) used in procurement for that category should address multiple environmental impacts and/or lifecycle stages. EPA uses the term 'hotspot' to refer to either a particular environmental impact (e.g., energy use) or a particular lifecycle stage (e.g., end-of-life) that has significant impact. For example, high levels of water consumption in the manufacturing lifecycle stage might represent one hotspot for a particular product category, and a significant indoor air quality issue caused by the outgassing of products may represent a second hotspot for that same product category. If a hotspot analysis identifies multiple significant environmental impacts for a product category, standards in that category should address all significant impacts unless extenuating circumstances are identified and explained.

Similarly, EPA's position is that if a hotspot analysis identifies multiple lifecycle stages with significant environmental impacts for a product category, standards in that category should address all significant lifecycle stages, unless extenuating circumstances are identified and explained. As such, the Hotspots Guideline is a Baseline Guideline, whereas the Multiple Environmental Impacts and Lifecycle Stages Guidelines are Leadership Guidelines, as the latter may not apply to all product categories. As with all Leadership Guidelines, the Multiple Environmental Impacts Guidelines and Lifecycle Stages Guidelines may be required for specific product categories.

In addition, some commenters indicated that EPA should include language that specifies both human health and environmental impacts as part of the Hotspots and Multiple Environmental Impacts Guidelines; the revised Guidelines reflect this addition.

Commenters raised a couple of different concerns regarding the specific language of the Hotspots Guideline. A few commenters indicated that the Guideline's language about "opportunity for environmental improvement" could be misinterpreted by standards development organizations as providing "permission" to focus primarily on those environmental attributes that are the most cost-effective to address. EPA revised the language to eliminate this misconception. In addition, a few commenters inquired about methods of identifying hotspots for product categories without conducting a new lifecycle assessment. EPA amended the footnote for this Guideline to state that "Hotspots can be identified via conducting a lifecycle assessment, or by consulting existing, credible literature and analyses of significant impacts available at the product category level."

The revised Hotspots Guideline reads as follows:

Where there are certain lifecycle stages or impacts that dominate the overall environmental and/or health impact of the product category, those significant impacts (or "hotspots") are clearly defined and given greater emphasis in differentiating environmental performance. If additional impacts are addressed, the standard clearly identifies any known trade-offs between impacts.²

The associated footnote reads:

² Depending on the product and application, it may be appropriate to develop standards that address those significant impacts, and do not include other, less relevant, impacts or lifecycle stages. See definition of lifecycle stages in footnote 4. However, if reliable evidence is available to meaningfully differentiate the performance of that product based on additional environmental impacts of concern or lifecycle stages (e.g., packaging, energy use in manufacturing, etc.), standards for green products should consider addressing those impacts, as well. Hotspots can be identified via conducting a lifecycle assessment, or by consulting existing, credible literature and analyses of significant impacts available at the product category level. Claims about products meeting environmental standards should be consistent with the standard's scope and avoid broad claims of environmental performance if other factors were not considered when the standard was developed (e.g. WaterSense is clearly about water, ENERGY STAR about energy, etc.).

The revised Multiple Environmental Impacts Guideline reads as follows:

Standards developers considered the full range of environmental and human health impacts applicable to the relevant product or product sector. Exclusion of a significant impact is explained in the standard or other appropriate, publicly available documentation. The explanation includes scientific and/or empiric reasoning of the exclusions and addresses the measurability of the excluded impact, and/or reasoning pertaining to the standard development organization's targeted focus on a particular environmental medium (or media).³

The associated footnote reads:

³When a standard does not address a significant or major environmental impact (aka "hotspot"), standards developers are encouraged to explain its exclusion. The intent is to ensure clarity about the relevance of environmental impacts that may be included (or excluded) from the standard. Environmental impacts include, but are not limited to, human and environmental toxicity, acidification, smog, climate change, stratospheric ozone depletion, natural resource depletion, and water quality. For simplification, environmental impacts also include environmental aspects such as energy use, water use, material use, and waste generation.

Finally, several commenters expressed concern about the applicability of the Lifecycle Stages Guideline to process and production method (PPM) standards or other standards that do not address a finished product's environmental performance. EPA revised the Guideline to clearly state that it is not applicable to these standards; however, a role of the pilot will be to determine if the Guidelines, when applied on a whole, appropriately differentiate among single lifecycle stage and multiple lifecycle stage standards and ecolabels in product categories in which both types exist.

The revised Lifecycle Stages Guideline reads as follows:

Standards developers considered all product lifecycle stages. Exclusion of a lifecycle stage with clear impacts is explained in the standard or other appropriate, publicly available documentation.⁴ This guideline is not applicable to standards that only address process and production methods (PPM), or other standards that do not address the environmental performance of a finished product.

The associated footnote reads:

⁴ Lifecycle stages of a product include sourcing and processing of raw materials to manufacturing, packaging, transportation, distribution, retailing, use of the product, and end-of-life management (through reuse, repair, upgrading, recycling, or safe disposal). The Federal government recognizes that lifecycle assessment is a complex and evolving field and performing full lifecycle assessments (LCA) is challenging at this time due to cost, access to data, and uncertainties associated with the methodologies and tools. Also, the Federal government recognizes that there are environmental issues for which LCA cannot adequately address impacts such as biodiversity loss, land use changes, impacts to ecosystem services, and biogenic carbon impacts. Therefore, this guideline intends to encourage standards developers to use lifecycle thinking as they develop criteria for products.

Intrinsic Hazards: An intrinsic hazard is the potential for harm based on the chemical structure and properties that define its ability to interact with biological molecules. Some commenters suggested that the Guidelines should take a risk-based approach instead of focusing this Guideline on intrinsic hazards. Risk assessment and hazard assessment are both useful tools that help EPA fulfill its human and environmental health protection mission. EPA uses risk assessment under the Toxic Substances Control Act (TSCA) in a regulatory setting to manage chemical risks by setting levels at which exposure to a given chemical poses an acceptable risk. Risk assessment is, in effect, a regulatory floor. For the DfE Program, a voluntary program for environmental leadership, the Agency uses hazard assessment to identify the safest chemicals that can satisfy a functional need. EPA believes this higher bar (e.g., it does not allow carcinogens, developmental and reproductive toxicants, or persistent and bioaccumulative chemicals) is appropriate for recognizing top performers in chemical safety. This approach allows the Agency to distinguish the safest products available, promotes innovation, and helps consumers and institutional purchasers quickly identify safer products.

EPA made minor revisions to this Guideline in response to comments, to clarify that intrinsic hazards should be assessed across the full lifecycle, and that functional alternatives may include non-chemical approaches. The revised Guideline reads as follows:

Intrinsic Hazards: Product environmental criteria focus on the intrinsic hazards of chemicals across the full lifecycle of the product, and require safer substitutes where possible, considering existing data and availability of functional alternatives (including non-chemical approaches as applicable).5

The associated footnote reads:

⁵ An intrinsic hazard is the potential for harm based on the chemical structure and properties that define its ability to interact with biological molecules. A hazard-based approach, grounded in Green Chemistry principles, can reduce the use of hazardous substances, and lower overall risk to people and the environment. Key to this approach is an understanding of the potential hazards of chemicals in products and availability of safer alternatives. Generally speaking, "hazardous chemicals" are those which have a human or environmental toxicity profile such that exposure to people or flora/fauna in the environment could lead to adverse health impacts. Consistent with Green Chemistry principles and established methods for risk assessment and management, standards and ecolabel programs can help lower overall risk to people and flora/fauna present in the environment. Key to this approach is to understand how the reduction of human and ecological health hazards can contribute to overall risk reduction. Steps can then be taken to decrease the hazards of products through: ingredient substitution; alternative design approaches; and/or reducing hazardous chemicals. Standards and ecolabel programs should also assess the potential trade-offs associated with alternatives/substitutes elsewhere in a product's lifecycle and impacts on the functional ("fitness for use") performance of the product.

Chemical ingredient disclosure: Some commenters expressed intellectual property concerns over this Guideline. While EPA is sensitive to issues of intellectual property, the Agency strongly feels that transparency and disclosure are critical for understanding the environmental impacts of a given product or service, providing information to purchasers, and moving the market toward safer chemicals. Many sustainability standards in the marketplace have criteria for manufacturers to submit a chemical inventory to a third party as part of the conformance assessment process. However, EPA will defer to product-category level analyses to determine the appropriate mechanisms for requiring disclosure while protecting intellectual property. In response to comments, EPA also clarified that this Guideline is not applicable to PPM standards, or other standards that do not address the environmental performance of a finished product.

The revised Guideline reads as follows:

The standard requires manufacturers to disclose ingredients in products (to other businesses in the supply chain and/or consumers).6 The method of disclosure may vary depending on the product category. This Guideline is not applicable to process and production method (PPM) standards, or other standards that do not address the environmental performance of a finished product.

The associated footnote reads:

⁶ The intent of this guideline is to encourage greater disclosure, while recognizing a number of challenges in doing so for manufacturers, including supply chain complexity and intellectual property confidentiality. This guideline is not relevant to products that do not include chemicals with known intrinsic hazards.

The Data Quality and Reliability (II.3) guideline, formerly referred to as "Credible Scientific Reasoning," was augmented for additional clarity, drawing from EPA's Scientific Integrity Policy and EPA's Information Quality Guidelines. The Weighting Methodologies (II.8), and Impact Assessment Disclosure (II.11) Guidelines did not change in this new version.