New California Regulations
Research and developed by Sarah (Steve) Mosko, Ph.D.
Updated Nov. 2004. For references click here.
In Oct. 2003, California added DEHP to list of known reproductive toxicants regulated under Proposition 65 (Safe Drinking Water and Toxic Enforcement Act of 1986)). Manufacturers have 1 yr to label affected products to be sold in CA as containing a reproductive poison. As of June 2004, the level of DEHP that is deemed toxic is still being worked out per OEHHA (Office of Environmental Health Hazard Assessment). Neither the federal government nor any other state has acted against DEHP. Specifically, it is now listed under Prop 65 as causing "developmental and male reproductive toxicity." Four other phthalates that are also under consideration for listing are: BBP, BDP, DnHP and DIDP (for causing combinations of developmental toxicity, male reproductive toxicity, & female reproductive toxicity). Note that DEHP was previously listed as a carcinogen under Prop 65 but was removed from list of human carcinogens in 2000 as a consequence of the decision in Baxter Healthcare Corp. vs. Denton that DEHP poses no risk of cancer to humans. (OEHHA had argued unsuccessfully that Baxter Healthcare, a supplier of DEHP-containing medical devices, had not shown any human risk).
- In a 1998 US EPA technical fact sheet on DEHP (part of a document on National Primary Drinking Water Regulations) it was concluded that "DEHP has the potential to cause the following health effects from long-term exposures at levels above the MCL (maximum contaminant level allowed): damage to liver and testes; reproductive effects." Regarding risk for cancer, it was concluded "there is some evidence that DEHP may have the potential to cause cancer from a lifetime exposure at levels above MCL."
Drinking Water Standards
- MCLG (maximum contaminant level goal): zero
- MCL (maximum contaminant level allowed): 0.006 mg/L
- This means public drinking water must be tested regularly for DEHP.
- "Human exposure will occur in occupational settings and from air, from consumption of drinking water, food (especially fish etc., where bio-concentration can occur) and food wrapped in PVC, as well as during blood transfusions from PVC blood bags."
- In 2002, FDA released a Public Health Notice on safety assessment of DEHP released from PVC medical devices.62 Animal studies were cited showing effects on the development of the male reproductive system and production of normal sperm. FDA labeled human males at fetal, neonatal and peripubertal ages as high-risk groups and identified various medical procedures where exposure levels could be high. FDA also recommended using alternative products when available in high-risk situations. However, FDA has rejected petitions (e.g. from Healthcare Without Harm) seeking warning labels on all medical devices containing DEHP because of low risk level for most patients. (www.fda.gov/cdrh/safety/dehp.pdf). U.S. government has declined to regulate phthalates, so CA has the only regulation in place.
Nontoxic plasticizers are available
Korean engineers have developed a new class of "nontoxic" plasticizers, known as epsilon-caprolactone molecules. They claim that, in PVC products, the new plasticizer is every bit as flexible as DEHP but does not migrate/leach out at all. This new PVC formulation is being tested in blood bags and food wrap.(55)
Can we use the PCBs story as an analogous model for regulating plastics or plastics additives?
- PCBs banned because they built up in the environment and caused ill health.
- Most studies on health in lab animals.
- Do not readily breakdown in the environment.
- Taken up by small organisms & fish, accumulate in larger fish/animals/mammals.
- Deposited in areas far from original site of introduction.