Document Ne41y0jKLzK3ypG0dJzkJb4pV

1 ii/ xcp ov 11 -oo 1JJ-V DM 1 t_ i loit MOV.10.1996 9:03PM BEHRING SALES & MKTG rnA iL\Ji.-oso~uiJOC NO.402 P.2/6 L. Mirubtk N. Schcd 5538 Monby&le Drive m JOX, CA 95138 November 17, 1996 DISTRIBUTION bv FAX; Frank Borreili, Vinyl Institute Robert Burnett, Vinyl Institute Connie DeFord, Dow Chemical Peter de la Cruz, Keller and Heckman Shari Jackson, SPI Jim Kachtick, OxyChem Robert Venezia, PhD.. Cma vinyl Chloride Panel REj Report of November 15 Public Workshop Sponsored by CalEPA's Office of Environmental Health Hazard Assessment At the request of the Vinyl Institute I attended the November 15, 1996 public workshop sponsored by the California Environmental Protection Agency's Office of Environmental Health Hazard Assessment (OEHHA) on the "Revised Draft Procedure for Prioritizing Candidate Chemicals for Consideration Under Proposition 65 by the State's Qualified Experts". This workshop also served as a public forum to receive any preliminary comments on the draft prioritized candidate chemicals under consideration for carcinogenicity and/or reproductive toxicity evaluation. The majority of time was devoted to a review of the document by staff and discussion with the audience participants (approximately 55) on recommended changes or problems, with a lesser amount of time and staff focue to specific chemicals, staff repeatedly stated that they would be relying heavily on the written comments (due November 20). In fact, most of those who did speak to specific chemical iasues (highlights of which are included below) noted that comments were preliminary and that written comments were being prepared for submission. Dr. Lauren Zeise (chief of the OEHHA's Reproductive and Cancer Hazard Assessment Section), gave a detailed review of the draft procedure document. I am assuming that the recipients of this report are familiar with tha contents of the October 1996 draft and have not, therefore, summarized its contents or repeated h r presentation. Dr. Zeise and Dr. Richard Becker, Dir etor of OEHHA, responded to most of the questions concerning the prioritization process and se m very pen to sp eific changes but ere not interested in SL 110288 11/13 30 11*00 in*viimu. iivioi iiyic NOV.18.1996 9:04AM BEHRING SALES & PKTG THIS *<;oi_030-0000 NO.402 CH<ao 0 P.3/6 *3 tfb making wholesale changes to the approach embodied in the October draft. It is OEHHA's stated intention to have refinements to the proposed prioritization document (based on discussions at this workshop meeting and the written comments received) ready for the December 4 meeting of the Science Advisory Board's Developmental and Reproductive Toxicant Identification Committee, with the procedure finalized and released in early 1997. The agency noted that at this time it does not anticipate changing the rankings for chemicals in tha medium area at the conclusion of the comment period December 4. As you know, vinyl chloride is in this medium category. Rather, the agency will focus its attention on those chemicals in tho high and medium-high level first. Ravlewof GeDR.ra_l_ issues Relative to the October 1996 Draft Procedure Document Discussed Purine Workshop --^Additional Writ-ton Input Being Sought by OEHKA; while tbe draft version of the VI comments does not specifically call for recommended changes in the procedure document, several of the points made about vinyl (such as ongoing epidemiological and toxicological studies, filling of data gaps, consideration of mechanistic data, etc.), might be expanded to some general suggestions. It is not critical that this be done, but If there is time, it might be useful to add some general discussion to tha VI comments. Given the shortness of time between the end of the comment period and the DART meeting, the structure of the process as spelled out In the draft will likely be finalized without much change unless the OEHHA receives targeted comments. Listed below are some of the topics discussed: 1. Review by "Won!d Claas'LScience croup*; There are some chemicals listed that are currently undergoing risk assessments by "world class" scientific groups (ex. TARC). Is there a way to procedurally include such types of review activity without the review being a delaying tactic. 2. Stigmatization of -Being a Listed Chemical: There was considerable discussion on the Issue of a chemical being stigmatized by its inclusion on a state list of carcinogens. The agency understands industry's sensitivity on this issue and is willing to examine some neutral nomenclature. 3. CojULroverer Regarding Use of Random Selection: There is not agreement that random selection is an appropriate component of this process; the Environmental Defense Fund believes that the use of random selection is nothing more than a way to defer/delay action and finds this approach unaccept ble. Tbe agency has taken th view that us of random selection will still all w tha chemicals with high and medium-high developmental/reproductive toxicity SL 110289 Ai' ia XX ILI. Vii'tlu l IVJO I i lUlt NOV.18.1996 9:04AM BO-RING SALES & WOTG THA *vi~OS>C"OOsX> NO.402 r riOu P.4^6 Ip concerns to proceed first to the outside science experts for review, while removing some of the political pressure that could result from the agency making selections among the 800 chemicals. The activist community will likely continue to focus its comments on removal of random selection. 4. No Time Frames Specified for Actions: Specific time frames for eaeh step of the process were reportedly part of the initial OEHHA document, specific time slots are not included In this draft; the EDF spokesperson is unhappy with this change. 5. Exiting Listing; There was discussion on whethei there should/can be a mechanism by which a chemical can "exit" the process following its random selection and review. This topic was raised by Paul Kronenberg of the California CIC and others. As the process now exists, a chemical would remain assigned to category II if it received anything other than a "high ranking (i.e., medium-high, medium, low, and postponed). Items receiving a "high ranking would be listed on the Candidate list and a Hazard Identification Document would be prepared. The Agency agreed that they have not clearly spelled out exactly what would happen to those chemicals in category II and they understand the need for the process to be more specific as to the path forward. 6. Consideration of Other Data Input.; The document does not specifically include consideration of mechanistic data (John O'Donohue representing a CMA panel on hydroquinone noted that his panel is submitting such date but it is not dear how this data will be considered or reviewed). 7. Filling of Data Gaos; The agency, in responding to questions by the audience, said it is relying on outside interests to Identify potential gaps. Several participants Stated that they believed the Agency ehould identify places where they believe data is needed to make a determination regarding the proper priority. The staff will be discussing this issue. I don't anticipate changes in this area. Hixhlights_of Chemical Specific Comments by Part ialPAnt-ft.; (Please forgive misspellings of names -- there were no name tags and individuals were not asked to spell their names) 1. Grocery Manufacturer's Association: While a good portion of James Coughlin's (sp?) comments focused on issues uch as random selection, consideration of mechanistic data, he also specifically discussed the issue of essential trace elements such as chromium and copper sulfate. He talked ab ut activities underway within respected scientific bodies (the Institute of Medicine's Pood and Nutrition Board and SL 110290 Ov 1 j. O'* i u * i 1*1 L, 1IW1 ( tylt NOV.18.1996 9:04AM BEHRING SALES & MKTG r CIA C.U1 rcnjc. NO.402 P.5/6 * H fr the World Health Organization) that will be discussed in detail in GMA'a comments. 2. Environmental Defense Fund (BiLl Pease 1: While a majority of his comments dealt with the procedural issues (and he spoke at quite some length), he expressed outrage that stvreqp was dropped off the list with no explanation other than what he believes must be a purely political decision. No one on the staff responded on this item. 3. Murray Associates (Jav Murray): He is a former member of the SAD and spoke on behalf of several different groups on general topics as well as chemical specific items. He suggested that in additional to considering mechanistic data that the agency might also consider pharmakokinctic data. He noted that relative to carbaryl (for which he was representing Rhone Poulenc) a lower ranking should be received. He stated that it was reviewed by EPA in 1994 and it received a Group C designation. 4. Halogenatad Solvents Industry Al1iance (Hichael Neale) . He spoke to tr i chi ore thy lene and methylene chloride and noted that some of the flawed studies included in the chemical drafts have already been reviewed by the U.S. Agency for Toxic Substances and Disease Registry. 5. Lonza Chemicals (Bill Thomas); He spoke about formaldehyde and challenged its ranking. Jay Murray also addressed formaldehyde on bebalf of an independent resin producers group and noted that CARB, OSHA, and the CPSC have ail considered pieces of the issue being considered- 6. CMA Hydroquinone Panel (John O'Donohue): Ho was the individual who first raised the data gap issue. He noted that CMA members are willing to collect data to fill identified gaps, but noted that there doesn't seam to be a way to find out what the agency believes they are. 7. Baker Performance Products (Arthur Lawyer); He spoke to acrolein and stated that Baker wants the status lowered as there are new events sinee the original comments to the State were submitted. 8. Monsanto (Ron Hogue): Spoke about butyl benzyl phthalate, for which they are the only u.S. producer and noted that in 199S the USEPa deleted BBT from Its SARA 313 listing. He further noted that four studies by NTP have all indicated that BBT should be listed ae of "no immediate concern." He also referenced biodegradation studies and stated that in only one of 54 samples taken was there a measurement and it was lass than 1 ppb per liter of California water. He noted that it is used aa a plasticizer in PVC as part of a flooring matrix. SL 110291 / / Z> 3V 11 *0*4 - V IN i L. 1IM0 I i 1 U iL NOV. 18.1996 9`-05ftN BEHRING SALES & W<TG TrA -Cwi"OCQ_UO^^ NO.402 r no;. P.6/6 (e v t. If you havs any questions on the above please lei me know. I can be reached at 403/531-0356 PST. Meredith N. Scheck SL 110292