Technical Workshop to Peer Review Toxicology Testing Initiative on Styrene-Acrylonitrile Trimer

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of meeting.

SUMMARY:

EPA is announcing a workshop to be conducted by the Eastern Research Group, Inc. (ERG), an EPA contractor, for the external scientific peer review of the proposed toxicology testing initiative and associated experimental protocols for styrene-acrylonitrile (SAN₂) trimer, a contaminant at the Reich Farm Superfund site in Ocean County, New Jersey, which has migrated into the ground water. The peer review workshop is being organized to assist in conducting the most scientifically credible and relevant testing for carcinogenicity of the trimer, particularly during the perinatal period, and for chronic non-cancer health effects. The one-day workshop will be held in Toms River, New Jersey, on March 7, 2000, and will be open to members of the public as observers. It will be conducted in accordance with EPA's 1998 Peer Review Handbook. Stakeholders in the issue who have additional information which is relevant to the testing initiative are invited to submit written comments and/or make brief oral comments at the peer review workshop.

DATES:

The workshop will be held on Tuesday, March 7, 2000, from 8:00 a.m. to 5:00 p.m. Members of the public may attend as observers. There will be a 30-minute session at the commencement of the workshop in which observers will have the opportunity to make brief comments relevant to the proposed testing initiative. Observers who wish to make such comments should register to do so with ERG by March 1, 2000. The time allotted for each comment will be limited based upon the number of persons requesting to make comments, but will be no more than five (5) minutes. Interested parties who wish to submit written comments for consideration by the peer reviewers should submit them so that ERG receives them on or before February 25, 2000.

ADDRESSES:

The meeting will be held in the L. Manuel Hirshblond Meeting Room, at the Township of Dover Municipal Building, 33 Washington Street, Toms River, New Jersey 08753. Since seating capacity is limited, please contact Ms. Meg Vrablik of ERG, by telephone, at 781-674-7374; by facsimile, at 781-674-2906; or by E-mail, at mvrablik@erg.com, by March 1, 2000, to register to attend the workshop as an observer. Also please register with Ms. Vrablik to make brief comments at the workshop. Kindly send written comments to Ms. Vrablik at Eastern Research Group, Inc., 110 Hartwell Avenue, Lexington, MA 02421-3136, by February 25, 2000.

FOR FURTHER INFORMATION CONTACT:

To register and for logistical inquires, contact Ms. Vrablik or Ms. Kate Schalk at Eastern Research Group at the above numbers. For information on documents cited in this notice, contact Dr. Dorothy Canter, US EPA, at 202-260-2230.

SUPPLEMENTARY INFORMATION:

Background

Spent process streams from the manufacture of styrene acrylonitrile polymer by Union Carbide Corporation (UCC) were disposed of at the Reich Farm property in Ocean County, New Jersey. The waste contains SAN₂ trimer, a chemical mixture which has migrated from the Reich Farm property into groundwater. Levels of SAN₂ trimer measured in water drawn from groundwater wells have been in the parts per billion and lower. The site is on the National Priorities List (NPL) of hazardous waste sites, and remedial activities are currently underway.

Increased incidences of certain forms of cancer in children, specifically certain types of leukemia, neuroblastoma, and brain and central nervous system cancers, have been observed in Ocean County, Dover Township and Toms River. To develop scientific data on the toxicologic and carcinogenic potential of the SAN2 trimer and to address concerns of citizens in the area about the toxicity of this previously untested mixture, UCC undertook an initial round of toxicology experiments, which consisted of genotoxicity studies, an acute toxicity study in rats and a 14-day repeated dose study in rats. The results from these studies are now available.

The Interagency Workgroup for the Toxicity Testing of the SAN2 Trimer was formed to provide guidance to UCC on the testing of the SAN2 trimer. In late 1998, the National Toxicology Program (NTP) of the National Institute of Environmental Health Sciences joined the Workgroup based upon its commitment to perform rodent carcinogenicity studies which include perinatal exposures. The current governmental agencies represented on the Workgroup are the US Environmental Protection Agency, the Agency for Toxic Substances and Disease Registry, NTP, the New Jersey Department of Environmental Protection, and the New Jersey Department of Health and Senior Services. Representatives of UCC and the consultant representing the Ocean County Department of Health also participate in the Workgroup.

The Workgroup has met four times since November 1998, evaluating the results of the studies previously performed by UCC, and reviewing additional studies proposed to be performed by the NTP and UCC. The Workgroup has developed a consensus testing strategy with associated experimental protocols. A key step in the finalization of this testing strategy will be the external peer review workshop on March 7, 2000. The Workgroup also formed a subgroup which developed a group of pharmacokinetics studies that will be conducted concurrently with the range finding studies of the NTP toxicity testing initiative.

Twelve independent scientists with expertise in general toxicology, carcinogenesis, developmental toxicology, neurotoxicology, pharmacokinetics, genetic toxicology, biostatistics, veterinary pathology, and analytical chemistry were selected by ERG from among the experts nominated by stakeholders for possible service on the peer review panel. In making the selections, ERG determined that the panel members had no real or perceived conflicts of interest. The panel will evaluate only those issues which are relevant to the toxicologic potential of the SAN₂ trimer.

Following the peer review workshop, ERG will prepare a summary report on the workshop which will present the panel's recommendations. This report will be available to dinterested parties and will be posted on EPA's website. The Interagency Workgroup will address the panel recommendations in finalizing the toxicology testing initiative for the SAN₂ trimer.