Quality Requirements for Extramural Agreements: U.S. EPA Region 5 Perspectives

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 2105.0Policy 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 E4-2004Quality 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 • 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 • 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 • IA PO and QA Manager jointly assess the scope of the proposed IA for environmental data operations • Document/summarize the relationship under the IA between EPA and the other agency • Define EPA’s and other agency’s roles and responsibilities (including QA) for the EDOs • Identify existing EAs which will support the IA

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

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