November 12, 2008

Toxics Use Reduction Institute Science Advisory Board Meeting Minutes
November 12, 2008

Members Present: Dave Williams, Chris Swartz, Hilary Eustace, Igor Linkov, Joann Lindenmayer, Lorraine Braunsdorf

Others Present: Heather Tenney (TURI), Mike Ellenbecker (TURI), John Raschko (OTA), Mary Butow (TURI), Liz Harriman (TURI), Carole Rowan-West (DEP), Tricia McCarthy (American Chemistry Council)

Welcome and Introductions

Program Updates

• TURI staff reported impact of 9C budget cuts on the TURA program including the significant cut in the budget for OTA. The effects of this severe budget cut are still forthcoming from OTA. DEP has been affected by special earmark elimination and a hiring freeze; specifically 2 TURA positions (which were about to be filled) have been eliminated.

• TURI staff reported the highlights of the Advisory Committee meeting including additional discussion and concern regarding the progress in the decision process. It was reiterated that under TURA, chemicals are either on or off of the list.

There was a suggestion for the SAB: Would SAB want to consider having a sufficient dataset on decisions for substances, to avoid decisions being made without data? There was noted concern that addressing these chemicals currently recommended by the SAB for no action, as de-listing petitions, could distract from the progress on higher hazard substances. The Administrative Council will be meeting 11/19/08 to review public comments on the current decisions.

Biographies are on the website under a newly established SAB Member List. They are currently being formatted to be hyperlinked from the current Member page.

Approve October Meeting Minutes

SAB members were given an opportunity to briefly review the minutes in the meeting in addition to having received them via email prior to the meeting. Suggestion was made to utilize the application tinyurl.com in order to consolidate web addresses being included in documents.
There was a motion to approve. All members were in favor of approving the minutes.

Lead and Mercury in Concrete Update
Several SAB members were present for the original lead and mercury in concrete recommendation; however, several members are new since then. That process was initiated when a petition was received to de-list lead and mercury in concrete for certain SIC codes. There are noted policy issues surrounding lead and mercury in concrete. The initial SAB recommendation was as follows: based upon the current information available to the SAB, it recommends that for the appropriate SIC codes (3271,3272, and 3273) planning should be exempted but reporting should still be continued. Since the SAB recommendation it has been determined that the law doesn't allow for the program to require reporting information without planning information. In addition, it may not be possible to delist a chemical for only certain SIC codes. Various counsels representing the program noted a problem with exempting a substance for certain SIC codes. There should be a decision soon as the new counsel is getting acquainted with the subject matter. One member indicated that there may be a precedent established based on a metal and coal mining exemption. TRI SIC code specific exemptions to be reviewed.

After a decision is made by counsel, the petition will be brought up again with the SAB, along with likely policy recommendations from TURI.

Diethyl phthalate

Extensive research/review of data was done by two members of the Board prior to the meeting. Information was distributed to the Board at the meeting summarizing the findings of several studies (recently released in the last 6-7 years and published in Environmental Health Perspectives) that related to diethyl phthalate.

The following studies were discussed at length:

• Swan_etal_EHP_2003; Geographic Differences in Semen Quality of Fertile U.S. Males

• Swan_etal_EHP_2005; Decrease in Anogenital Distance among Male Infants with Prenatal Phthalate Exposure

• Duty_etal_EHP_2003; The Relationship between Environmental Exposures to Phthalates and DNA Damage in Human Sperm Using the Neutral Comet Assay

• Colon_etal_EHP_2000; Identification of Phthalate Esters in the Serum of Young Puerto Rican Girls with Premature Breast Development

A fair amount of time was spent discussing the findings of each of the studies, with the overall conclusion that there were weak, though statistically significant, associations between the observances of DEP's main metabolic and a variety of biomarkers. It was noted that MEP (the metabolite of urine) was ubiquitous. In one study, the biological sample levels were 2 times as high as the blanks indicating mere association. Studies that measured bio-markers and serum urine levels are the strongest. Although there were issues with all of the studies, blanks, choices of statistical analysis; the consistency of associations was telling.

One member commented that DEP is used more in the cosmetic industry.

There was a question about the sample size for the studies. The SAB member noted that inDuty et al, n= 141. Even with small n the values are statistically significant.

A TURA program member inquired if MEP was only a metabolite from DEP or could it be from other phthalates? The SAB member confirmed that MEP was only a metabolite of DEP, it couldn't be a contaminant because it was a metabolite. Also, animal studies were used for corroborative evidence, particularly Swan et al. It was noted that animal studies usually have stronger statistical significance than the epidemiological studies. A member confirmed that all papers have statistical significance between 10-15%.

Motion was made to retain.

Based on the consistent pattern of results of the studies, particularly in regard to endocrine disruption, the Board decided to retain the chemical.
4 to retain, 1 opposed, 1 abstain

Discussion of Schedule and Process for the 14 No Action CERCLAs

There was continued discussion regarding the GRAS classifications for the 14 recently reported, currently recommended for No Action chemicals. Question regarding the food additive list was asked. One member noted that food has a positive list of ingredients that can be added vs. medicinal purposes which do not have an "acceptable" list. If something is listed as a food additive then it is acceptable for indirect contact. TURI will send information to respective teams pertaining to GRAS designations and the associated regulations. In addition, they will try to track down information pertaining to the date each chemical was added to the GRAS list.

A member noted that if there were a problem with a particular chemical it would have been removed from the GRAS list.

TURI will also provide follow-up information for the chemicals which had positive Mutagenicity data.

Current plan is to have one more meeting before scheduling 3 meetings that industry users will be invited to. Suggestion was made to postpone meetings until February as end of year would be short notice for industry. Heather will be scheduling the meetings and contacting companies in the near future.

Next Meeting

Tuesday, December 9, 2008, 1-4 PM, DEP

Adjourn