Data Usability in Brazil
Assessment of environmental laboratory results via data verification and validation is often a routine activity for projects where risks and liabilities are compelling. However, the process of assessing laboratory data is not as common outside of the U.S. Recent work by Environmental Standards, Inc. (Environmental Standards) has highlighted the infrequent thorough review and assessment of environmental data collected in Brazil. Companies conducting monitoring and remediation within Brazil should take pause before reporting data without inspection and assessment.
In Brazil, the Brazilian Institute for Environmental and Natural Renewable Resources (IBAMA) is the federal agency with environmental jurisdiction, but municipal and state environmental agencies have jurisdiction for local activities. While some states have procedures in place for investigating contaminated areas, the process rarely includes steps to evaluate the analytical data with respect to data completeness, correctness, and usability. As an example, Annex 2, Procedures for the Management of Contaminated Sites (DD38) adopted by Environmental Company of the State of São Paulo (CETESB) includes a process to investigate potential contamination including human health risk assessment. Though the Procedure is only applicable within the state of São Paulo, it influences several state environmental agencies in Brazil, which set additional parameters, compliance requirements and thresholds on the management of impacted areas. Yet, this procedure does not mention assessment of environmental data quality and a usability evaluation.
Hampering an assessment of data usability is the limited level of detail included in reports produced by Brazilian laboratories. In addition, based upon Environmental Standards support to multinational industrial clients, we have noted the following issues:
- Few laboratories routinely report results with method and batch quality control (QC) results including method blanks, laboratory control samples, and matrix spike samples (if requested), nor are QC failures routinely discussed in a report narrative.
- Contamination in laboratory blanks is not considered an issue, but is often present up to the reporting limit (RL) level. As such, the data associated with blank contamination are not qualified or identified by the laboratory.
- Anomalous quantitation limits are reported, in some cases, which do not match the associated data.
- Matrix spike sample analyses are very rarely requested by sampling personnel; thus, the laboratories are unaccustomed to being asked to infer accuracy associated with project-specific matrices.
- Transcription errors are not uncommon.
- Qualitative interpretation is often incorrect. One example would be chromatography-impacted results, which result in false positive data being reported.
With this background, we believe it is prudent to include the following three assessment components with the level of verification and validation tailored to the laboratory program or project risk and regulatory oversight.
- Confirm all samples collected/requested were analyzed and reported.
- Check that all analytes analyzed/requested were reported.
- Verify correct methods, method detection limits (MDLs)/RLs, and units are provided.
- Confirm Qualitative identification of target compounds is correct.
- Ensure Quantitative values are correct and verified via recalculation of results.
- Confirm compliance with the published/cited analytical method.
- Verify compliance with project control documents:
– Quality Assurance Project Plan (QAPP)
– Sampling and Analysis Plan (SAP)
– Work Plan
– Project Specifications
- Assess compliance with regulatory requirements.
- Review QC samples, calibrations, holding times, and sample receipt. Qualify results to note usability:
– Blank Qualification – U or B
– Rejection of Data – R
– Estimating Data – J
- Provide critical information to the data user on the appropriate use and potential limitations of the analytical data.
If you are engaged in monitoring and remediation outside of the U.S., Environmental Standards can support those efforts via data verification, validation, laboratory auditing, and other quality assurance oversight services.