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Panel: Eileen Conneely
Media: Brian Grossman

In December 2013, the California Office of Environmental Health Hazard Assessment (OEHHA) added diisononyl phthalate (DINP) to California's Proposition 65 list as “known to the State to cause cancer” despite the weight of scientific evidence indicating that DINP should not be listed on Prop 65.

Currently, there are more than 800 substances on the Prop 65 list, including food ingredients and common household products, naturally occurring substances, ethyl alcohol in alcoholic beverages, aspirin and many prescription drugs. Prop 65 requires anyone doing business in California to label a product unless the anticipated human exposure to a listed substance in the product will not pose a significant risk of cancer or reproductive harm. Labeling requirements for DINP went into effect on December 20, 2014.

Under Prop 65, it is the responsibility of California businesses to determine whether a product warning is required. OEHHA has the authority, but is not required, to establish “safe harbor levels” for Prop 65 substances. For carcinogens, the safe harbor level is referred to as a “no significant risk level” (NSRL). Safe harbor levels have been established by OEHHA for only about 1/3 of the listed chemicals.

OEHHA has not established an NSRL for DINP. Therefore, to support the value chain, ACC’s High Phthalates Panel and DINP manufacturers have calculated a level of exposure to DINP that is not expected to result in more than one excess case of cancer in 100,000 individuals exposed to the chemical over a 70-year lifetime, which is how an NSRL is defined in the OEHHA regulations. The Panel has also developed a workbook to assist companies in estimating potential exposures to DINP from consumer products.

The Panel has also presented three webinars to help companies understand how DINP is used in vinyl products and how to use the tools the Panel has developed.


Prop 65 and High Phthalate DINP: Estimating Exposure from Consumer Products
May 8, 2014
This webinar provided an overview of Prop 65, gave a brief background on how DINP was added to the Prop 65 list, discussed the development of an NSRL for DINP and explained how to estimate potential exposures from consumer products using the DINP-specific workbook.

» View the webinar and download the slides
» View questions and answers about DINP and Prop 65


Prop 65 and High Phthalates
March 6, 2014
This webinar provided an overview of Prop 65, discussed how an ACC member company complies with Prop 65 and explained how to estimate potential exposures to DIDP from consumer products using an existing tool developed by ACC’s High Phthalates Panel.

» View the webinar and download the slides


Phthalates: Softening Plastics and Making Vinyl Soft and Pliant
October 30, 2013
During this webinar, Raymond David, PhD, Manager of Toxicology for Industrial Chemicals at BASF Corporation, provided background and safety information on phthalates and outlined recent regulatory reviews of the family of compounds. 

» View the webinar and download the slides


American Chemistry Council Files Lawsuit to Remove DINP from Prop 65 List—DINP Is Not a Human Carcinogen

On June 9, 2014, the American Chemistry Council (ACC) filed a lawsuit challenging the state of California’s listing of diisononyl phthalate (DINP) under the Safe Drinking Water and Toxic Enforcement Act of 1986, also known as Proposition 65. The state’s listing of DINP as “known to cause cancer” is unwarranted and defies the state of the science, which demonstrates that DINP does not cause cancer in humans. DINP is one of the most thoroughly studied compounds in the world. DINP has been reviewed by numerous international scientific panels over decades, and the conclusions are essentially the same each time: DINP as currently used in commercial and consumer products does not pose a risk to human health at typical exposure levels. The conclusion was confirmed most recently by the European Commission (January 2014) following a four-year in-depth evaluation by the European Chemical Agency (ECHA), which did not conclude that DINP is a human carcinogen.

In its filing in Sacramento County Superior Court, ACC asks that the Court order California Environmental Protection Agency’s (Cal/EPA) Office of Environmental Health Hazard Assessment (OEHHA) to remove DINP from the Proposition 65 list.

» View ACC’s statement on the litigation

» View ACC's statement that followed the listing of DINP on Prop 65 in December of 2013

» View a full list of comments submitted to OEHHA outlining the scientific evidence against the listing of DINP on Prop 65



ACC High Phthalates Panel Develops Tool to Estimate Exposures to DINP from Consumer Products

To support the DINP value chain, the ACC High Phthalates Panel has developed two Prop 65 specific tools:

  1. A level of exposure to DINP that is not expected to result in more than one excess case of cancer in 100,000 individuals exposed to the chemical over a 70-year lifetime, which is how a No Significant Risk Level (NSRL) is defined in OEHHA regulations, and

  2. A DINP exposure-estimation workbook. The workbook contains technical guidance on how to estimate potential product exposures to DINP and compare it with the calculated exposure level and includes examples. As a manufacturer and/or seller of consumer products in California, you can use these tools to determine whether or not a warning may be required for DINP-containing products. For more information, or to receive a copy of the workbook, which is now available at no cost, please contact ACC at eileen_conneely@americanchemistry.com and include “DINP Exposure Workbook” in the subject line.


Questions and Answers: DINP and Prop 65

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