Staying on top of the ever-changing regulatory environment can be hard, requiring both a vigilant eye on policy makers and a deep understanding of the science. Know which changes may affect your business – and plan appropriately.
Perhaps you’ve heard that DINP (a commonly used plasticizer found in many PVC compounds) is now a Prop 65 listed chemical and you’re wondering if there is any impact to your business. Teknor Apex, in an effort to help our customers navigate the constantly changing regulatory environment, has assembled what we think are the relevant facts and updates to the DINP-Prop 65 story.
What is Prop 65?
It is the Safe Drinking Water and Toxic Enforcement Act of 1986, also known as Proposition 65. Prop 65 requires anyone doing business in California to label a product if human exposure to a listed substance in the product is expected to be at a level above the established “safe harbor” level for that substance.
Since when is DINP on the Prop 65 list of substances?
Effective December 20, 2013, the State of California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) added diisononyl phthalate (DINP) to its Prop 65 list of chemicals. On June 10, 2014, the American Chemistry Council (ACC) filed a lawsuit challenging the state’s listing as unwarranted and defies the state of the science which demonstrates that DINP does not cause cancer in humans. In its filing in Sacramento County Superior Court, the ACC asked that the Court order the OEHHA to remove DINP from the Prop 65 list.
So how do I know if my product exceeds the threshold for needing a label?
Prop 65 places the responsibility for demonstrating the safe use of a listed chemical with businesses, not OEHHA. (It might surprise you to know that safe harbor levels have been published for only about one third of listed chemicals.)
What is the “safe harbor” level of exposure for DINP?
The safe harbor level has not been published by OEHHA, which is the body responsible for administering the law. In light of the legal action noted above, OEHHA has dropped the plan to develop a safe harbor level for DINP, at least for now. In light of this, it is unknown what the exact threshold is for the labeling requirement relative to DINP as mandated by Prop 65.
Does the law require my product to be labeled?
To determine whether a Prop 65 warning is required on consumer products in California, the business needs two main pieces of information: 1) how much a consumer would be exposed to a listed chemical, and 2) what is the safe level of exposure for the listed chemical? A warning is only needed if exposure is greater than the safe level. In other words, a business has a “safe harbor” from Prop 65 warning requirements if exposure to a substance occurs at or below the safe harbor level.
How do I know what the DINP level is in my product?
The ACC High Phthalates Panel has come to the aid of business by developing a DINP exposure estimation tool. The tool is free and available upon request by sending an email to Eileen_Conneely@americanchemistry.com with the subject line “DINP Exposure Workbook”.
When is a warning needed?
A Prop 65 warning label is not required for all DINP containing products. Product warning only applies if the following three criteria are met:
- The product containing DINP is sold in California, and
- The product is sold after December 20, 2014, and
- DINP exposure is above the safe harbor level
What is next for my business?
Teknor Apex is ready to help you understand the impact of this Prop 65 regulation on your business. The ACC has published an excellent presentation on the topic and of course you can always contact us via email at vinyl@teknorapex.com if you think we can help.
