California Prop 65
Manufacturers and distributors of all sizes increasingly face challenges that result from the globalization of the marketplace and constantly changing international regulatory initiatives. For companies with intermediary and end markets that include the United States and specifically the State of California, Proposition 65 (Prop 65) significantly increases the complexity of maintaining compliance.
The Safe Drinking Water and Toxic Enforcement Act of 1986 (CA Prop 65) was enacted in California as a ballot initiative in November 1986. It states: “No person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual.”
Define Your Prop 65 Role in the Supply Chain
All manufacturers and distributors should understand the obligations of California’s requirement to give clear and reasonable warning for any exposure above safe harbor levels for a growing list of over 890 chemicals. Suppliers and distributors play a large role in providing information to their downstream customers and stakeholders to assist with compliance. Updated United States GHS MSDS / SDSs with an optional Prop 65 statement in the Section 15 Regulatory section is just a first step. Additional information and warnings may be requested of upstream partners, including regular ingredient disclosures for, at a minimum, all current or proposed Prop 65 chemicals.
Manufacturers/Importers/Distributors causing exposure to a listed substance in California should determine which substance-level information is needed and how frequently it must be updated. Compliance is required within 12 months of any new substance being added to the Prop 65 list. Both government requirements and a company’s internal policy requirements are factors in evaluating a supplier’s compliance.
How 3E Company Can Help
Prop 65 compliance is no simple task. Companies are likely to seek assistance from a number of consultants and/or legal service providers to support various improvements in their compliance programs. Companies that are impacted by Prop 65 should seek assistance from providers who thoroughly and holistically understand the Prop 65 regulatory environment and are well-versed in data and information as it relates to global EH&S and supply chain compliance.
3E Company has spent more than two decades helping customers understand chemical, regulatory and compliance management. Data, information and professional expertise are at the very core of all the products and services we deliver, and Prop 65 is no exception. 3E Company offers a unique combination of tools and services that can help companies fill their compliance gaps and help with on-going compliance. As the execution of Prop 65 is revised by the California Office of Environmental Health Hazard Assessment (OEHHA), 3E Company’s products and services evolve to meet the demands of the market.
Substance Information Management
Ariel® chemical and regulatory content fuels the Prop 65 support that 3E Company offers. Ariel Content consists of a massive, aggregated collection of lists, legislation, and compliance guides for regulated chemicals throughout the world at multiple levels of jurisdiction, including CA Prop 65. Lists of chemicals and substances will continue to be included as they are published by OEHHA as well as, chemical, toxicological and eco-toxicological data as it is submitted and accumulated. The text of the regulation, as well as Prop 65 lists of chemical substances and safe harbor levels are available in Ariel WebInsight, our online chemical regulatory compliance reference tool. Ariel WebInsight's Prop 65 content can be used to categorize and identify substances, exemptions and as lists are published, search if a chemical is on the list or not.
Ariel data also includes multilingual phrases, which can be integrated into corporate systems, such as SAP® EHS Management. In-house authors can use the Ariel Multilingual ES (Exposure Scenario) Phrase Library to create SDSs to meet Prop 65 requirements where language translation may be required in unique cases.
Supply Chain Compliance
The collection, validation, enrichment and contextualization of supplier data are required for continuous Prop 65 compliance. 3E Company Supply Chain Solution (3ESC®) offers a comprehensive solution set to help your organization with Prop 65 compliance. 3E leverages its global supplier network to quickly identify critical Prop 65 contacts within your supply chain. 3E's own experienced North American-based obtainment team reaches deep into your supplier base for supplier and product level data with the intent that executable intelligence can result. The data is securely stored in 3ESC’s industry leading web-based software platform, which feeds into your ERP system. 3ESC’s Prop 65 compliance program enables your organization to quickly respond to and fulfill Prop 65 requests from your downstream customers. 3ESC also supplements the existing list of Prop 65 chemicals, as provided by Ariel WebInsight, by integrating proposed and pending Prop 65 chemicals into the 3ESC notification system. At a fraction of the cost to manage the program in-house, your organization can partner with 3E to launch your Prop 65 compliance program today.
Prop 65 changes as additional substances are proposed for the list in an irregular manner. 3E Regulatory Monitoring ensures you stay current. A twelve month requirement for warning from the date of a Prop 65 listing is a short amount of time for some products and companies to adapt. Having as much notice as possible of executable intelligence may be of value to allow for either reformulation or relabeling of your product in under a year.
Prop 65 Impact Analysis Using 3E Online®
Establishing which category individual substances in your chemical inventory fall into is a feature of the 3E Online. Evaluating the disclosed composition of mixtures from the SDS enables an evaluation of regulatory impact at the substance level. For manufacturers who need to create a list of substances in their product inventory, the RegImpact module within 3E Online is a great place to start. It accesses the Prop 65 lists maintained by Ariel WebInsight to enable users to compare the lists against their product inventory and to identify which substances are likely impacted. However, companies should be aware that not all Prop 65 substances are necessarily disclosed on an SDS. Also the presence of a Prop 65 substance does not necessarily mean exposure and thus a required warning in California. For these reasons, it should be noted that 3E Online is a starting point to be used in conjunction with a campaign to suppliers using 3ESC.
Supply Chain Communication Using 3E Online
If you are a downstream user, another important aspect of Proposition 65 is ensuring that the product/substance that is used within your facility will be properly labeled by the manufacturer. Downstream Users Reports in 3E Online provide a list of substances by product and manufacturer, which can then be used to communicate with your suppliers.
Outsourced Prop 65 Services
3E Company employs industry professionals well versed in many areas of EH&S compliance, including Prop 65. The 3E Regulatory Consulting team can work collaboratively with a company, 3ESC services and the analysis of data. Toxicological determination from 3E Regulatory Consulting may be needed to determine if a product has the potential for exposure over safe harbor levels.
Authoring, Producing and Distributing MSDS / SDSs
As companies consider the impact of Prop 65 on their MSDS / SDSs for Section 15 updates and/or new MSDS / SDSs, 3E Authoring Services can alleviate some of the burden so that internal EH&S and Product Stewardship resources are able to focus on other aspects of Prop 65. The multi-lingual staff can create, analyze and manage globally compliant MSDS / SDSs, product label content and hazardous materials transportation documents covering regulatory and language requirements for dozens of countries and states, including California.
For companies with in-house EH&S staff that need to effectively manage the complexities of issuing Prop 65-compliant MSDS / SDSs, our MSDgen® enterprise authoring software system can help. MSDgen stores substance details and automatically recognizes regulatory statuses based on the data retrieved from the regulatory data content source (Ariel WebInsight). It should be noted that presence does not necessarily mean exposure so additional review will be necessary to determine if a Prop 65 warning is required. MSDgen has powerful features that leverage data for multiple uses, enabling significantly increased efficiency and productivity of authoring staff.
Downstream Supply Chain Communication: 3E SDS Distribution Services
3E Company offers a variety of products and services to ensure that Prop 65-compliant MSDS / SDSs are published, distributed, and retrieved by downstream users, resulting in cost savings, increased efficiency and improved compliance.