Environmental Protection Agency

Scientific Integrity in Regulatory Agencies

Scientific Integrity includes, but is not limited to, people engaged in the combination of transparency in the preparation, identification, use of scientific information in policymaking, and strict adherence to: policies; peer-review guidelines; procedures; ethics; and the concept of continuous improvement resulting from scientific assessments; audits; and evaluations.

 

Since 2004, the US EPA has been using contractors to perform independent external assessments to demonstrate and document that EPA operated laboratories, including government-owned contractor laboratories, are adhering to the procedures and policies described in the documented, mandated EPA Quality System. The term for these external assessments is “Laboratory Competency Audits” (LCA).

 

EPAs’ use of contractors to perform LCAs may be perceived as a conflict with Inherently Governmental Functions per FAR 17.5; and/or OMB Circular A-76, Appendix 5, OFPP Letter 92-1 (09/23/1992).

 

This idea is put forth to facilitate saving, increase inter-agency communication and result in improved cross-organizational, multi-disciplined scientific interactions in research and development.

 

The EPA and the Food and Drug Administration (FDA) are mirrored-Agencies and have numerous commonalities: The EPA and FDA are:

• Regulatory agencies;

• Perform R&D of the same scientific issues, but from different perspectives; and

• Working to improve the quality and longevity of life to leave the world a better place for those who follow.

 

I believe the EPA and the Food and Drug Administration (FDA) should create an MOU to perform periodic LCAs of each other’s laboratories.

 

Benefits to the Government include:

• Reduction of financial cost of LCAs;

• Reduce or eliminate any perception that a contractor has an advantage;

• Increases and improves Inter-Agency communication and understanding;

• Reduces duplication of effort; and

• Sparks new ideas resulting from fresh perspectives as scientists communicate during LCAs.

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Idea No. 16830