DOC 2012.pdf

DEMONSTRATION OF CAPABILITY (DOC) GUIDELINES – BIOLOGICAL TESTING

Laboratories performing analysis of samples for projects in New York District and EPA Region 2 are required to perform a Demonstration of Capability (DOC), in order to minimize the potential for data unacceptability. The DOC for biological testing consists of two parts: Reference Toxicant Data and Control Performance Data. The acceptability and scope of data collected as part of the DOC are based on the performance criteria provided in the 1992 ACENYD/EPA Region 2 Regional Testing Manual on Dredged Material proposed for Ocean Disposal (RTM) and are summarized below.

1.0 Reference Toxicant Testing

1.1 A minimum of 5 valid reference toxicant tests for each species used in the dredging program must be provided. The tests must be conducted on a minimum of three different lots of each species tested.

1.2 Reference toxicant tests are water-only exposures for all species. Five test concentrations which bracket the LC50/EC50 value must be established for each test.

All concentrations are run in duplicate. The minimum control survival (90 percent) must be met for a test to be valid.

1.3 A control chart must be constructed which plots all of the data points for each species tested. The control chart must show the mean response and the +/- 2 SD (standard deviation) lines must also be included on each control chart.

1.4 Please refer to the species lists in the RTM for the appropriate species to conduct the DOC. It is recommended that data for potential alternate species be submitted as part of the DOC in case of the need for a substitute species arises during an actual dredging project.

2.0 Control Performance

2.1 A minimum of 5 valid control samples must be conducted for each species in the matrix used in the dredged material test. The control data from the reference toxicant portion of the DOC can be used for all water column dwelling organisms (silversides minnows, bivalve larvae).

2.2 Amphipods, mysids, and the bioaccumulation species (i.e. Neries virens and Macoma nasuta) control data using sediment as outlined in the RTM should be submitted as part of the DOC.

2.2.1 Control data from previous sediment testing projects may be submitted as part of the DOC.

2.2.2 It is recommended that the control sediment proposed for use in the dredged material program be used as part of the DOC.

2.2.3 Control Survival must be equal to or greater than 90 percent.

2.3 Please refer to the species lists in the RTM for the appropriate species to conduct the DOC. It is recommended that data for potential alternate species be submitted as part of the DOC in case of a need for a substitute species arises during the course of a dredged material testing project.

3.0 DOC Content

3.1 Data Reporting and Summary

All laboratories performing analysis should have and maintain a Quality System in place.

Laboratories are responsible for the biological data they generate/report. Biological data packages require a signature of the laboratory manager, Quality Assurance Officer and designated analyst verifying that the analytical data provided is valid.

The laboratory DOC biological data report must provide at a minimum:

3.1.1 All LC50/EC50 calculations and/or percent control survival must be provided.

3.1.2 A control chart for each test species with the LC50/EC50 endpoints plotted on the chart must be provided for all reference toxicant data.

3.1.3 Raw bench sheets with water quality and daily test observations must be provided for every reference toxicant and control test provided as part of the DOC.

3.1.4 All deviations from protocol must be provided in a narrative statement as part of the

DOC.

3.1.5 A checklist for the data reporting requirements is provided below. All the data requested in this checklist should be provided to complete the DOC.

3.1.6 The DOC Biological Data Checklist must be filled out and signed by the Laboratory

Director and Quality Assurance Officer.

4.0 DOC Reporting Checklist

Reference Toxicant and Control Data Checklist

RAW BIOLOGICAL AND WATER QUALITY DATA FROM TESTS (Reference Tox. & Control) Test Dates / Species Tested Name of Laboratory Performing the Test(s) Survival and/or Bivalve Development Data Water Quality Parameters Feeding Schedule and Amount (if applicable) Organism Observations Summary of Test Conditions Project Notebook/Log Entries and Deviations from Protocol Reference Toxicant Stock and Test Solution Preparation Data Validation (statement and signature indicating that the data was reviewed/validated) Problems/Corrective Actions (if any) TEST ORGANISM HOLDING, HANDLING AND ACCLIMATION (Reference Tox. & Control) Organism Shipping Data Sheet Provided by Supplier Copy of Overnight Shipping Air bill (if applicable) Internal Receiving and Distribution Data Holding/Acclimation Records (incl. water quality, renewals, and feeding) Mortality During Holding and Acclimation Taxonomic Identification for Each Species

REFERENCE TOXICANT DATA ONLY

Raw Bench Sheets For Reference Toxicant Tests Reference Toxicant Stock & Test Solution Preparation Sheet LC50/EC50 Statistical Calculations Reference Toxicant Control Charts w/ Acceptability Limits

CONTROL SAMPLE DATA ONLY

Control Sample Identification, Location, and Collection Date Table Summary of Results

DOC CERTIFICATIONS

Data Requirement Form, Signed and Dated (This Form) Biological Data Checklist, Signed and Dated

Please check All boxes to ensure All data reporting requirements were submitted.

Part 5.0 Biological Data Checklist

A. Reference Toxicant Test Data

____A minimum of 5 valid Reference Toxicant Tests were submitted for each species proposed for use in the USEPA Region 2 and USACE-NYD Dredged Material Testing Program.

Comments:

A Control Chart for each unique species was provided.

____Control survival in all tests submitted in all Reference Toxicant Tests meet the test acceptability criterion as outlined in this document and the RTM.

Please list any deviations from prescribe methods or other QC concerns which could impact the validity of the data.

B. CONTROL DATA

____A minimum of 5 valid Control Data Sets using the appropriate control matrix were submitted for each species proposed for use in the USEPA Region 2 and USACE-NYD Dredged Material Testing Program.

____Control survival in all tests submitted in all Reference Toxicant Tests meet the test acceptability criterion as outlined in this document and the RTM.

Please list any deviations from prescribed methods or other QC concerns which could impact the validity of the data.

DEMONSTRATION OF CAPABILITY (DOC) GUIDELINES – BIOLOGICAL TESTING