1. Quality Requirements for Extramural Agreements: U.S. EPA Region 5 Perspectives Kevin Bolger Amberina Khan Office of the Regional Administrator U.S. EPA Region 5 San Antonio May 14, 2009

2. Quality Requirements for Extramural Agreements: Presentation Goals  Overview of the basis of EPA’s quality requirements for environmental data operations  Types of extramural agreements (EAs)  Assessing EAs for environmental data operations (EDOs)  Incorporating quality requirements during the EA lifecycle (Interagency Agreement example)  Recommendations for success with managing EAs (Interagency Agreement example)

3. Quality System (aka Quality Program)  Structured and documented management system describing controls, processes and documentation used to plan, implement and assess the application of quality within an organization  Provides the ability for organizations to utilize data and information of known and acceptable quality for decision-making

4. U.S. EPA Quality Systems for Environmental Programs  CIO 2105.0 Policy and Program Requirements for the Mandatory Agency-Wide Quality System (previously EPA Order 5360.1 A2 May 2000) – EPA Policy which applies directly to U.S. EPA and its environmental programs  ANSI/ASQ E4-2004 Quality Systems for Environmental Data and Technology Programs – Requirements with Guidance for Use February 2004 – Consensus standard which applies to both U.S. EPA and extramural organization environmental programs

5. Implementing U.S. EPA’s Quality System  CIO 2105 and ASNI/ASQ E4-2004 use a multi-tiered quality system to describe and document organization-level and project- level activities for environmental programs  Organization-level activities documented via a quality management plan (QMP)  Project-level activities documented via a quality assurance project plan (QAPP)

6. U.S. EPA Quality Systems for Environmental Programs: Keystone Definitions  Environmental Data  Environmental Technology  Environmental Data Operations

7. Environmental Data Measurements or information describing:  environmental processes, location, or conditions;  ecological or health effects and consequences; or  the performance of environmental technology

8. Environmental Data Environmental data includes the generation, assessment and/or use of:  Primary data includes new data from various sources including field, lab, computer models, and environmental technology, among others  Secondary data includes existing data from databases, data resulting from previous projects, and the scientific literature, among others

9. Environmental Technology All-inclusive term used to describe:  pollution monitoring, measurement and control devices and systems;  waste treatment processes and storage facilities;  site remediation technologies to remove or prevent pollutants from entering the environment

10. Environmental Data Operations (EDOs)  Work performed to obtain, use, or report information pertaining to environmental processes and conditions  Inclusive of environmental data and environmental technology

11. Applicability of U.S. EPA’s Quality System Quality systems must be documented and implemented when environmental data operations are conducted:  directly by U.S. EPA or  on behalf of U.S. EPA through various means including extramural agreements

12. Extramural Agreements  Documented legal agreements between EPA and an organization external to EPA for items and/or services by the organization  Acquisition agreements include all types of acquisitions from simple purchases to contracts (40 CFR 46)  Assistance agreements include grants, cooperative agreements and interagency agreements (40 CFR Parts 30, 31, 35 and 40 among others)

13. U.S. EPA Quality Requirements  Apply a Graded Approach to quality requirements commensurate with the proposed environmental data operations  EPA specifies quality requirements to be submitted and/or conducted during pre-award and post-award of EA lifecycle  Default quality requirements include organization-level documentation (i.e. QMP) during pre-award and project-level documentation (i.e. QAPPs, Standard Operating Procedures (SOPs)) during post-award  Other types of quality requirements may include non- traditional documents such as joint QMP/QAPP

14. Assessing EAs: General Issues  Identifying EDOs early and often in the scope of solicitations, proposals, work assignments and throughout the EA lifecycle (Can you find the EDOs?)  Recognition of models, secondary data, etc (“We’re not collecting any samples!”)  “Masking” of EDOs behind a non-EDO oriented proposal, work assignment, etc (“This is only an environmental education project”)  Dealing with existing quality documentation (“We already did a QAPP in 2002 !”)

15. EA Example: Interagency Agreements (IAs)  IAs are different and can be more complex compared with other types of EAs  IAs use an assistance agreement vehicle supported by other extramural agreements such as contracts or cooperative agreements  EPA role as either a receiving vs servicing agency  EPA staff with assistance and acquisition experience increase the odds for the IA’s potential success

16. Types of IAs EAs which provide goods and/or services as follows:  Federal – between Federal agencies  Intergovernmental – between Federal agency and state, local, tribal government  International – between Federal agency and foreign government, entity,etc

17. IA Funds Flow  Funds Out – EPA provides funds and receives products/services  Funds In – EPA receives funds and provides products/services  No Funds Exchanged – No transfer of funds; each organization bears own expenses  Allocation transfers – funds transferred between agencies by special authorization in conjunction with OMB

18. IA-Specific Quality Issues  Identify quality issues pertinent to each IA and the structure of the IA-supporting contracts, cooperative agreements, etc  U.S. EPA’s role/perspective as either the servicing or receiving organization  Negotiation of quality requirements between U.S. EPA and the extramural organization  Negotiation of quality assurance roles and responsibilities for each organization

19. IA Lifecycle: Development  IA Project Officer (IA PO) initiates discussion of potential IA with the designated U.S. EPA QA representative  IA PO and designated QA representative jointly determine whether the scope of the IA will or may include environmental data operations  Include U.S. EPA and extramural organization QA managers in joint meetings for IAs with environmental data operations

20. IA Lifecycle: Development For IAs which include environmental data operations, identify the following:  Applicable extramural agreements, international consensus standards (ISO 9000), Federal and/or state laws (i.e. Information Quality Act), multi-agency policies (Uniform Federal Policy between EPA & DOD) or other overarching quality-related documents which must be considered in conjunction with the new IA  Existing quality system documents (i.e. QMPs) for the requesting and servicing organizations and other supporting organizations (i.e. contractors)

21. IA Lifecycle: Development  Identify new or existing quality documentation and/or other quality requirements to be submitted, reviewed and approved/completed during pre-award and post-award of the IA  Identify respective QA roles and responsibilities of U.S. EPA and other organization throughout the IA cycle  Document the quality requirements and QA roles and responsibilities as IA terms and conditions

22. IA Lifecycle: Pre-Award IA PO and U.S. EPA QA Manager jointly:  Review, reconcile issues and approve all submitted pre-award quality requirements and coordinate closely with their counterparts at the other agency and/or and/or  Provide same with other agency when EPA provides environmental data operations

23. IA Lifecycle: Post-Award IA PO and U.S. EPA QA Manager jointly:  Review, reconcile issues and approve all submitted post-award quality requirements and coordinate closely with their counterparts at the other agency and/or and/or  Provide same with other agency when EPA provides environmental data operations

24. IA Lifecycle: Implementation, Oversight and Closeout IA PO and U.S. EPA QA Manager jointly:  Assess/report implementation of quality requirements (i.e. project-level QA activities, periodic audits) in conjunction with their counterparts in the other agency  Confirm that all IA QA requirements and environmental data operations were completed and met quality objectives

25. Recommendations for Success with IAs 1. IA PO and QA Manager jointly assess the scope of the proposed IA for environmental data operations 2. Document/summarize the relationship under the IA between EPA and the other agency 3. Define EPA’s and other agency’s roles and responsibilities (including QA) for the EDOs 4. Identify existing EAs which will support the IA

26. Recommendations for Success with IAs 5.Assess the applicability of existing quality documentation, audits and consensus standards to the IA 6.Negotiate IA quality requirements between EPA and the other agency 7.Document quality requirements as terms and conditions for all stages (i.e. pre- and post-award) of the IA lifecycle 8.IA PO and QA Manager maintain active involvement through review, approval and assessment of all quality requirements

27. More Questions? Kevin Bolger Kevin Bolger Regional QA Manager Regional QA Manager U.S.EPA Region 5 U.S.EPA Region 5 312-886-6762 312-886-6762 bolger.kevin@epa.gov bolger.kevin@epa.govbolger.kevin@epa.gov