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QA Activities on Two Large RARE Projects at the US EPA, RTP, NC ─ from Fish to Humans
Citation:
HUGHES, T. J., J. J. DILIBERTO, AND L. S. BIRNBAUM. QA Activities on Two Large RARE Projects at the US EPA, RTP, NC ─ from Fish to Humans. Presented at EPA Quality Management Meeting, San Antonio, TX, May 12 - 14, 2009.
Impact/Purpose:
This abstract discusses two large Regional Applied Research Effort (RARE) projects outside the division. They are both considered to be QA 2 studies which required technical systems audits (TSAs) and other QA reviews (data audits, surveillances) during the course of these studies.
Description:
Two RARE (Regional Applied Research Effort) projects are being managed by Janet Diliberto, Linda Birnbaum, and Thomas Hughes. Janet is the Project Officer, Linda is the science advisor and Thomas is the QA and Records Manager for these two RARE projects. These are high visibility projects outside the division; therefore, they are both QA 2 studies which required technical systems audits (TSAs) and other QA reviews (data audits, surveillances) during the course of these studies. Initially, Quality Management Plans (QMPs), QA Project Plans (QAPPs), and Operating Procedures (OPs) were reviewed. One RARE is in West Virginia (Region 3) with Marshall University, the West Virginia Department of Environmental Protection and the CDC. It is investigating the relationship of endometrioses in women who live in areas with high concentrations of dioxin, dioxin-like compounds and PCBs. The endometrioses was surgically-identified at Marshall University Hospital and the analytical chemistry was conducted by CDC in Atlanta. TSAs were conducted in October 2005 in Huntington, West Virginia (lab visit, and review of OPs and record files), and in May 2008 (review of data and record files and complication of results). The other RARE is in Maine and it is with Region 1, the Penobscot Indian Nation (PIN), the PIN Department of Environmental Regulation, and eight other partners, including ATSDR, US Fish and Wildlife Service, USGS and other parts of the Agency. We have dubbed it “The 12 Lab Study.” The Maine study is identifying potential toxicants in the Penobscot River which the PIN uses for sustenance fishing, hunting, tribal foods, and recreation. Indian Island, home of the PIN, is on the banks of the Penobscot River. Two miles above their home island is an operating paper mill and municipal wastewater outflow. The State of Maine has issued a fish advisory not to consume the fish from the river for children and pregnant women. A site visit was conducted in October 2007 to observe the river, discuss the QAPP and meet the large study team (10 members were present). Two TSAs were conducted. One was conducted in July 2008 in Bangor, Maine (fish collection, processing, labeling and shipment) and the other was conducted in October 2008 in North Chelmsford, Massachusetts (inspection of the NELAC-certified chemistry lab in Region 1, review of control data from the four study chemistry laboratories and discussions with the regional scientists and the QA Manager). Results from this study will be available in the fall of 2009. A final TSA and data audit will be conducted at this time. These RARE projects are labor intensive but they assist the Regions and further the mission of the Agency to protect human health. This is an abstract for presentation which has been reviewed by the U.S. EPA; views expressed do not necessarily represent EPA policy.