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Proposed Enhancements to the Criteria for Safer Cleaning Products

The following are DfE’s draft changes to “EPA’s DfE Criteria for Safer Cleaning Products (CSCP) in the Form of a Standard” (“DfE Criteria”).  DfE has initiated the changes in response to comments and suggestions from a broad spectrum of stakeholders who support these new  provisions.  Importantly, the changes enhance the DfE Criteria and DfE Safer Product Labeling Program, which prevents pollution at its source by guiding and encouraging the replacement of chemicals of concern with safer alternatives in a variety of chemical-based products.

If implemented, the changes would increase:

A full criteria document appears at the end of this proposal with the changes in context and highlighted.

Please submit your written comments to the EPA docket (detailed instructions for accessing the docket are at the end of this document). Also, please email a copy to David DiFiore at difiore.david@epa.gov.

Proposed Changes to the DfE Criteria

I.  Definitions.  Certain terms are used to describe DfE-recognized products that are not directly manufactured by a DfE partner or that are manufactured by a DfE partner for a non-partner.  DfE has adopted the following definitions for these terms as they are commonly understood by DfE and its partners.  Originally, DfE defined the terms “licensee” and “private label,” rather than “licensee product” and “private label product”; these changes make appropriate adjustments to those definitions.  Also, DfE is defining “toll manufacture product” for the first time.

In section 2, “References,” the definitions of “Licensee” and “Private label” will be deleted and replaced by definitions for “Licensee product” and “Private label product.” Also, a definition for “Toll manufacture product” will be added. These definitions will read as follows:

Licensee product.  A product whose contents are identical to those in a DfE-recognized product that is manufactured by a third-party, non-DfE partner under a contract between the DfE-partner/manufacturer and the third party/licensee.

Private label product. A product whose contents are identical to those in a DfE-recognized product, or vary only as to minor components (reviewed by DfE and specified in the partnership agreement), that is manufactured by a DfE partner for a third-party/private-label company or distributor.

Toll manufacture product.  A product whose contents are identical to those in a DfE-recognized product that is manufactured by a third-party, non-DfE partner under an agreement between the DfE partner and the third-party/toll manufacturer.

II. General Provisions.  DfE is proposing to add new general provisions for verification of partnership compliance (specifically, desk and on-site audits) that would serve as assurance that the contents and quality of DfE-labeled products and manufacturing processes align with the program’s criteria and requirements. DfE is also proposing to add several terms that will delineate and prescribe a DfE partner’s relationship to third parties who manufacture DfE-labeled products on the partner’s or their own behalf or for whom the partner manufacture DfE-labeled products. DfE has undertaken to add these provisions in response to stakeholder interest in greater clarity and oversight regarding the sourcing and characteristics of DfE-labeled products.

In section 3, “General requirements,” a new section 3.6 would be added to read as follows:

A. Verification of Partnership Compliance: Audits

The DfE Program will use an audit process to ensure that recognized products satisfy the DfE criteria and the terms of the Partnership Agreement, with appropriate auditing of manufacturing processes to ensure product integrity (as outlined in Annex B, “Elements of Desk Audits and On-site Audits”).  DfE will use a combination of two audit types:  On-site audits, conducted once per three-year partnership period, and annual desk audits.  These audit requirements apply to all DfE Partners, their licensees and toll manufacturers and will be added to individual partnership agreements, as well as the DfE Criteria.  The provisions will be effective as soon as these enhancements are posted on the DfE Web site as final.  For existing partnerships, the audit provisions will be added to the partnership agreement at the time of renewal (within 3 years). 

Audits will be sufficient in scope to accomplish the purpose of this section.

Annual desk audit.  DfE partners will submit to the third-party verifier specified materials (elements of the desk audit are listed in Annex B.1).  These materials will include a list of ingredients for each recognized product and a statement that the ingredients and all claims made regarding the Agency’s recognition (e.g. use of the DfE logo) comport with the Partnership Agreement.

On-site audit.  DfE partners will allow the third-party verifier to visit their manufacturing facilities and conduct audits (elements of the on-site audit are listed in Annex B.2).  The audit will focus on the manufacturing process and the procedures in place to ensure that recognized products comport with the Partnership Agreement.

If a single facility produces a recognized product, that facility will be subject to a site audit once per three-year partnership period.  If multiple facilities produce a recognized product, two sites will be selected for an audit once per three-year partnership period.  Licensees and toll manufacturers are subject to the same rules as primary partners and their facilities will be considered separately from the facilities of the primary partner.

External verifier.  An external verifier—a person or body carrying out the verification—will conduct the site visits or paper audits.  The external verifier must meet the criteria for qualified third parties in section 7 of this document, as well as the competencies for external verifiers for products in ISO/IEC Guide 65: General criteria for bodies operating product certification systems. Competence criteria are specified in sections 5.1.1, 5.1.2 and 5.2.1. An external verifier must be free of any potential conflicts of interest.

Results.  If the audit reveals items of noncompliance, the partner shall promptly correct the noncompliance.  The noncompliant company shall submit to the external verifier and to DfE, in writing and within 30 days of receiving written notice of noncompliance, the following: a root-cause analysis, an explanation of corrective action, and a preventive action plan. In collaboration with DfE, the external verifier shall confirm that the partner has taken the remedial action necessary to assure DfE of the partner’s ability to satisfy the terms of the partnership agreement.  Unaddressed or egregious noncompliance may serve as grounds for terminating the partnership. In any case of serious noncompliance, the DfE partner may be asked to immediately cease use of the DfE logo; procedures for handling existing stocks of products and labels will be determined on a case-by-case basis. The noncompliant partner must provide written confirmation that they have ceased using the DfE logo and an estimate of the quantities of currently labeled product.

B. Third-party Manufacture of DfE-labeled Products.

To ensure that DfE partners understand the appropriate roles and responsibilities when third parties are involved in the manufacture of DfE-recognized products, DfE is proposing to add, also in section 3, new provisions for “Private label products,” “Licensee products,” and “Toll manufacture products,” to read as follows:

Private label products

A private label product may carry the DfE logo provided that its contents are either identical to those in a specified DfE-recognized product, or very similar, and the ingredients that are different have been approved in the partnership agreement.  Before manufacture of the private label product that will carry DfE recognition, the DfE partner must inform and receive permission from DfE, indicating the name of the private label product, the label owner, and the specific DfE-recognized product to which it is identical or on which it is based.  Private label products are subject to the audit provisions contained in section 3.6.

Licensee products

A licensee product may carry the DfE logo provided that its contents are identical to those in a specified DfE-recognized product.  Before manufacture of the licensee product, the DfE partner must inform and receive permission from DfE, indicating the name of the licensee manufacturer and of the specific DfE-recognized product to which the licensee product is identical.  To assure quality, the licensee product must be manufactured under an agreement between the DfE partner and the licensee and the agreement must be available to DfE on request.  DfE partners must ensure that their licensees submit to the audit provisions contained in section 3.6.

Toll manufacture products

A toll manufacture product may carry the DfE logo provided that its contents are identical to those in a specified DfE-recognized product.  Before toll manufacture of the DfE-recognized product, the DfE partner must inform and receive permission from DfE, indicating the name of the toll manufacturer and of the specific DfE-recognized product to which the toll manufacture product is identical.  To assure quality and compliance with the partnership agreement, the toll manufacture product must be manufactured under an agreement between the DfE partner and the toll manufacturer and the agreement must be available to DfE on request.  DfE partners must ensure that their toll manufacturers submit to the audit provisions contained in section 3.6.

III. Product-level requirements.  DfE is proposing to add a provision on continuous delivery systems for consumer products to the product-level requirements.  This provision will open for potential DfE recognition consumer products that otherwise meet the DfE Criteria but are packaged in certain continuous delivery systems, currently not eligible for DfE labeling.  Innovative continuous delivery systems are a relatively new but growing market segment.  Systems that meet the provision’s requirements will increase the availability of DfE-recognized products—which reduce the source of pollution by replacing chemicals of concern with safer alternatives—in a dispensing format that improves consumer ease-of-use.

In section 4, “Product-level requirements,” a new provision on “Continuous delivery systems for consumer products” would be added to read as follows:

Continuous delivery systems for consumer products

DfE will consider for recognition consumer products in innovative continuous delivery systems (as distinct from products poured from a bottle or manual spray pumps) that reduce the potential for inhalation exposure and meet other environmental goals.  Recognition candidates must demonstrate significant innovation and environmental leadership.  Product ingredients must satisfy the DfE criteria set forth in this document.

If their ingredients satisfy DfE criteria, products in continuous delivery systems may be recognized if they meet the following conditions:

1) Propellant. The system propellant does not pose concerns for the environment and human health (e.g., compressed air; inert gas, like nitrogen; or CO2, if captured from combustion processes, with zero net increase in atmospheric CO2).

2) Particle size distribution. Either a) the product contents from nozzle to the point of delivery are in a form that does not contain inhalable or respirable particles (e.g., foam); or, b) if the product contents are delivered in particle form, the distribution of particles below 10 microns (the inhalation threshold) must be less than 1% and below 3.5 microns (the deep-lung respirability threshold) must be at 0%, as demonstrated by the Malvern Mastersizers or other generally accepted method for measuring particle size of liquid sprays.

3) Packaging. a) Internal packaging.  Any internal product packaging must not contain chemicals of concern per the DfE criteria; b) External packaging. The product container and other external packaging is made, to the extent feasible, of recycled materials and is itself recyclable.

In the Annexes to the Criteria for Safer Cleaning Products, a new Annex B on “Elements of Desk Audits and On-site Audits” will be added to read as follows:

Annex B

Elements of Desk Audits and On-Site Audits

B.1 Desk audits

DfE partners will submit to the third-party verifier the following items, which are drawn from elements of the partnership agreement and DfE Criteria:

B.2 On-site audits

The third-party verifier will seek the following information, based on the terms of the partnership agreement and DfE Criteria, at subject facilities:

Submit your comments, identified by docket identification (ID) number EPA–HQ–OPPT–2009-0829, by one of the following methods:

      Instructions:  Direct your comments to docket ID number EPA–HQ–OPPT–2009-0829.  EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail.  The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment.  If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet.  If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit.  If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.  Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

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