EDSTAC Review

Davis Baltz / Commonweal 6may00

Davis Baltz, M.S. is a Senior Associate with Commonweal, Bolinas CA. These are notes from his presentation at the Symposium on Endocrine Disruptors held at the Women's Building in San Francisco on 6may00

* EDSTAC (Endocrine Disruptor Screening and Testing and Advisory Committee)

Recommendations Made by EDSTAC

• 87,000 chemicals in commercial use can be considered.

• Estrogen, Androgen, and Thyroid effects on humans will be included

• Citizens should be able to nominate a chemical not included by other means.

• 6 mixtures were recommended for inclusion.

  • Contaminants of human breast milk

  • Phytoestrogens in soy-based infant formulas

  • Common chemicals found together in 'Superfund' sites

  • Pesticide/fertilizer mixes

  • Disinfection byproducts

  • Gasoline

  • Fish tissue was suggested by EDSTAC but ultimately not included as a recommendation.

Some of the Negative Aspects

• No developmental assay in Tier-1 screening - This is a serious flaw

• Functionally Equivalent Information (FEI) - would allow chemicals be evaluated with less than complete testing if industry can demonstrate that existing information is functionally equivalent. There is no definition of FEI.

• There was no consensus recommendation on dealing with low doses. Industry's greatest fear is that, if there is a nonmonotonic dose response curve, or no identifiable threshold, the adage that "The dose makes the poison" is no longer valid. The implication is that there may be NO threshold at which adverse effects appear. If there is no threshold, then risk assessment is not an appropriate tool for regulation. Rather, if there is no safe dose, a precautionary approach would require that chemical must be sunsetted -- taken out of production.

The EDSTAC made its final recommendations to EPA in Sep98. EPA proposed the program at the end of 1998 and it was opened for public comments. It has gone through scientific pier-review. This is where it all sits, mostly from lack of funding for EPA to complete some key tasks before the program can begin. These tasks are to standardize and validate all proposed assays in order to assure reliable results from the many laboratories that will be required. 

Industry has been unwilling to assume any financial responsibility for the funding of this preliminary process.

Since May 2000, EPA has slowly moved ahead with these tasks. Additional expert committees are being formed, and increasing levels of funding has been allocated. However, an operational screening and testing system is still years in the future, if then.

The cost for the standardization and validation processes alone come to about $40 million. Congress appropriated only $3.2 million in FY 99 to fund all of EPA's endocrine disruptor activities. The appropriation in FY 2000 went up to $12.7 million, with congress adding more than what Clinton requested. 

Delays are to industry's benefit, as their profits from unsafe chemicals continues without necessary information that this program would afford. History has proven delay to be a prime method for industry. In California, Nancy Pelosi has been a leader in the fight against EDs.

One of the benefits to activists of getting the information that this program would generate would be to inform communities. Everyone has hundreds of chemicals in their body that are new within the last 50 years or so. Because everyone's body has been contaminated with these chemicals, everyone is a constituent to be activated. When issues effect us personally, we have more incentive to act. There are 1,000 to 1,500 new chemicals introduced into commerce each year with little to no information on their potential health effects

If a manufacturer wants to introduce a new industrial chemical, it must notify EPA of its intentions. The EPA then has 90 days to respond. If, for some reason EPA does not respond to this premanufacturing notice within 90 days, the chemical is automatically approved. Generally, if EPA does not suspect a problem or does not have sufficient funding to investigate, it will not make a challenge to the premanufacturing notice. Around 1,000 chemicals are "approved" by this method each year.

Other speakers at symposium:
Gina Solomon, M.D., M.P.H.,
senior scientist at the Natural Resources Defense Council,  Assistant Clinical Professor of Medicine at UCSF; and author of Generations at Risk: Reproductive Health and the Environment
Marc Lappé, Ph.D.
director and founder of The Center for Ethics and Toxics (CETOS), and author of Against the Grain: Biotechnology and the Corporate Takeover of Your Food
Jacquee Castain, Sierra Club and Environmental Advocate

Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) Final Report
http://www.epa.gov/scipoly/oscpendo/history/finalrpt.htm