- Getting A Grasp on DfE
- By Megan Keenan, Callie McLellan, Ann Marie Gebhart, and Margaret H. Whittaker — posted 03/28/2011
For more than 15 years, the U.S. Environmental Protection Agency (EPA)’s Design for the Environment (DfE) program has evaluated human health and environmental concerns associated with traditional and alternative chemicals. DfE’s Safer Product Labeling program advances the EPA’s mission to protect the environment and human health. Only products that have met the program’s high protective standards can carry the DfE logo. This label allows consumers and commercial purchasers to select products that are safer for people and the environment, without sacrificing quality and performance. The Safer Product Labeling program recognizes a variety of cleaning products, including glass cleaners, general-purpose cleaners, carpet cleaners, odor removal products, and laundry detergents as well as paints, inks, pet care products, and industrial coatings.
To ensure products remain compliant, DfE has introduced an audit program, consisting of annual desk audits and triennial on-site audits. The audits are designed to ensure that all DfE-labeled products are in compliance with the requirements of DfE’s Safer Product Labeling Program, as delineated in the DfE Standard for Safer Products and Partnership Agreement Both the desk and on-site audits will focus primarily on verification of product ingredients and claims; the desk audit by scrutinizing a manufacturer’s paper trail and the on-site audits by examining manufacturing processes and procedures.
When a product is reviewed under the DfE program, each ingredient in the formulation is examined within its distinct functional class, comparing toxicity and environmental fate profiles to identify safer ingredients.
The DfE scientific review team has used the best available information, predictive models, and expert judgment to evaluate each ingredient in the product for potential environmental and human health effects and against the pass/fail criteria in the DfE Standard. This review process ensures that labeled products contain chemicals that pose the least concern in their respective functional classes. The DfE label is recognized as a mark of environmental preferability, allowing for the quick identification of products that are less harmful to people and more protective of the environment. The new audit program will reinforce DfE’s commitment to the safety of current and future products. But before DfE audits come partnering.
Partners for Health
To obtain DfE recognition, a product manufacturer must enter into a Partnership Agreement with DfE and must comply with various information requirements. The agreement contains provisions covering several areas such as: full ingredient disclosure; notification of changes in the product formula and the need for prior DfE approval; the partner’s commitment to continuous product improvement; limitations and responsibilities regarding use of the DfE recognition and logo; audits; and partnership sunset and opportunity for renewal.
A necessary component of the DfE partnership program involves third-party reviewers. Before a formulator may partner with DfE and gain permission to use the DfE logo, a qualified third-party must review all ingredients and their toxicological profiles. DfE believes that only a qualified third-party has the objectivity and proficiency needed to ensure a reliable and accurate quality review. In addition, third-party profiling has made it possible for DfE to expand its labeling activities while maintaining the program’s high standards and integrity.
DfE has labeled over 2000 products, the majority in the institutional and industrial cleaning sector, resulting in the use of hundreds of millions of pounds of safer chemicals.
DfE Audit Program
To ensure the contents of DfE-recognized products are formulated as represented to the EPA, each product manufacturer is required to participate in DfE’s surveillance and audit program, which, as mentioned earlier, consists of annual desk audits and on-site audits at least once every three years. Clients are required to make their manufacturing facilities and recognized-product-related records available to a DfE-approved third-party verifier.
If the audit reveals items of noncompliance, the DfE partner/client is required to promptly correct them. Within 30 days of receiving written notification of noncompliance, the following items shall be submitted in writing to the third-party verifier and DfE: A root-cause analysis; an explanation of the corrective action taken in regards to the area of noncompliance; and a preventive action plan. The third-party verifier, in collaboration with DfE, then must confirm that the client has taken the proper corrective action and is able to satisfy the terms of the Partnership Agreement. Unaddressed noncompliance areas may serve as grounds for termination of the partnership.
Drawn from elements of the Partnership Agreement and DfE criteria, annual desk audits will allow approved third parties to validate the following:
1 All ingredients for each recognized product
2 Statement provided from client that the ingredients are the same as they were when disclosed to DfE and referenced in both the Partnership Agreement or in a DfE-approved amendment to the agreement
3 Example of all product labels mentioning DfE recognition or bearing the DfE logo
4 Example any product or company literature that bears the DfE logo or mention of DfE recognition
5 Any private or licensed product labels and literature that use the DfE logo
6 Review of continuous improvement efforts as required by the Partnership agreement
7 Documentation of end-client education offered.
Based on the terms of the partnership agreement and DfE criteria, the third-party auditor will request the following information at the client’s facility during an on-site audit:
1 Verification that qualifying products are being manufactured using accepted suppliers and ingredients
2 Comparison of the authorized formula to the manufactured product through a review of production records, batch tickets, bills of lading, certificates of analysis, and any other necessary documentation
3 Verification that qualifying products are being manufactured with materials at proper use levels
4 Verification that any private label and licensed products that are being manufactured on-site are identical in formulation to the original, recognized product (i.e. no additional dyes or fragrances, dilution, or concentration changes)
5 Assessment of the customer complaint file
6 Confirmation of end-user education
7 Review of the documentation for end-user training offered
8 Confirmation of labeling requirements including DfE logo and product safety requirements
9 Verification that no logo or mention of the DfE program is located on non-qualifying products
10 Verification of appropriate packaging
11 Review of good manufacturing practices, including
• Production walk-through
• Review of efforts and practices for minimizing contamination of the certified product during the measuring, blending, packaging, and transport processes
• Verification that bulk product containers, transfer equipment, and holding vessels are maintained and in good repair for the recognized product
• Review of manufacturing equipment records including cleaning, maintenance, and calibration
• Evaluation of supplier qualification records, including test data, for raw materials, packaging, and product ingredients.
For more information, visit www.toxservices.com.