# Presentation: 199115

## USEPA’s Proposed Competency Requirements for Performing Acid Rain & Mercury RATAs

- John Schakenbach, USEPA, CAMD
- SES Conference
- Hilton Head Island, SC
- March 18 - 23, 2007

## Background

- 1970’s stack test methods were developed
- 1990’s complaints on quality of stack testing
- Dan Bivins worked on accrediting individuals and companies; effort stalled
- 1999 Dan restarted accreditation effort; both SES and EPA wanted it; NELAC wanted to be in charge of it
- NELAC mainly involved in lab accreditation
- Proposed a fee-based State-by-State program; no individual qualification requirement

## Background

- 2001 Louisiana is only State with stack testing accreditation program
- Currently no other States have plans to adopt NELAC approach
- In 2001, to avoid State-by-State competency requirements and fees, ASTM got involved

## Background

- In 2004, ASTM D 7036-04 became final
- Consensus-based, representatives from large and small stack testing companies, State and federal govs, private industry
- Nationwide
- Based largely on ISO 17025

## Background

- August 22, 2006 EPA proposed Part 75 rule:
- Any AETB conducting RATAs of CEMS or sorbent trap monitoring systems, or Appendix E testing, or deriving default emission rates for LME units under this part must conform to the requirements of ASTM D 7036-04
- Not applicable to daily calibration error checks, daily flow interference checks, quarterly linearity checks or routine maintenance of CEMS
- Comment period closed Oct 23, 2006

## ASTM D 7036-04, “Standard Practice for Competence of Air Emission Testing Bodies”

- 	The following is a general summary of the Practice. Read the Practice for complete requirements.
- Scope
- Testing and calibration performed using standard methods, non-standard methods and methods developed by the AETB
- Applies to all bodies engaged in air emission testing
- Organization and Management
- Shall have a quality system to monitor and improve ability to deliver, measured by performance data

## ASTM D 7036-04, “Standard Practice for Competence of Air Emission Testing Bodies”

- Clear organizational structure
- Have a technical manager
- Have a quality manager
- Have a qualified individual on-site for each test project, who is qualified for each test method performed
- Upon request, provide documentation of compliance with Practice
- Document Control
- Sufficient to preclude use of invalid or obsolete documents
- Documents shall be uniquely identified
- Procedures for making document changes

## ASTM D 7036-04, “Standard Practice for Competence of Air Emission Testing Bodies”

- Quality System, Audit, and Review
- AETB shall have a quality policy commitment by top management to follow Practice
- Quality system to ensure consistent achievement of data, including quality objectives for AETB projects
- Quality manual (outline is provided at end of Practice) shall address all topics covered in the Practice
- Internal audits shall be conducted annually by AETB
- External audits (use of NACLA recognized bodies is encouraged) shall be performed if available and relevant
- AETB shall collect performance data and inform clients that it is available for review

## ASTM D 7036-04, “Standard Practice for Competence of Air Emission Testing Bodies”

- Personnel
- AETB management shall ensure competence of individuals performing testing or related activities, and formulate necessary training requirements
- Qualified individual shall meet experience requirements and pass qualification exam at least once every 5 years
- Accommodation and Environment
- To extent practical, ensure that environmental conditions do not invalidate measurement results
- Equipment and Reference Materials
- Proper equipment shall be available and calibrated with equip status labeled

## ASTM D 7036-04, “Standard Practice for Competence of Air Emission Testing Bodies”

- Measurement Traceability and Calibration
- All equipment shall be calibrated before use and be on a calibration schedule
- Reference materials shall be traceable to certified reference materials
- Test Methods
- AETB shall use latest edition of appropriate method
- Deviations shall be documented
- Site-specific test plan shall be used for each test project
- AETB shall have up to date instructions on use of all relevant equipment
- Uncertainty estimates for measurements shall be provided; following test protocol can meet this requirement

## ASTM D 7036-04, “Standard Practice for Competence of Air Emission Testing Bodies”

- Handling of Sampling and Calibration Material
- AETB shall use chain of custody and other necessary procedures to protect integrity of sample & calibration material
- Shall have a system for identifying samples
- Sample or calibration material abnormalities shall be recorded and client shall be consulted
- Records
- AETB shall establish and maintain procedures for storage, back-up, retrieval and protection of quality & technical records
- Data and calculations shall be recorded at the time they are made and in enough detail to establish an audit trail
- Mistakes shall be crossed out, dated, signed, and the correct value entered

## ASTM D 7036-04, “Standard Practice for Competence of Air Emission Testing Bodies”

- Reporting
- Test results shall be reported accurately, clearly, objectively and include specific information identified in the Practice
- Opinions and interpretations shall be clearly marked as such and the basis for them provided
- Signed statement by responsible official that the AETB conforms to the Practice during the test project
- Sub-contracting of Services
- AETB shall maintain a record of evidence that the subcontractor complies with Practice

## ASTM D 7036-04, “Standard Practice for Competence of Air Emission Testing Bodies”

- Outside Support and Supplies
- AETB shall ensure that purchased supplies or services comply with specified requirements prior to use; records of such compliance checks shall be maintained
- Identification and Control of Non-conforming Work
- AETB shall have defined procedures to handle nonconforming work, including corrective actions
- Corrective Action
- Determine root cause of problem
- Document and implement any required changes resulting from corrective actions and monitor results to ensure effectiveness; audits should be implemented

## Summary of Draft Response to Comments on Proposed Part 75 AETB Provision

- Because we are between proposed and final rules, the following responses do not necessarily represent EPA’s position
- All discussions related to the proposed Part 75 AETB provision will be documented and placed in the rulemaking docket

## Summary of Draft Response to Comments on Proposed Part 75 AETB Provision

- _Comment_: Will increase cost and difficulty
- 	_Response_: EPA estimates an average per company cost of approximately $4,000 one time cost to create a QA manual, and $500 every 5 years for QSTI exam
- _Comment_: QSTI exams and accreditation are unavailable
- 	_Response_: Accreditation is not required.  STAC is providing accreditation if a company chooses to be accredited.  SES is improving and expanding the QSTI examination process. If an external exam is not available, a company may provide internal exams.

## Summary of Draft Response to Comments on Proposed Part 75 AETB Provision

- _Comment_: Quality of data will not improve
- 	_Response_: The experience of the ASTM work group made up of stack test companies, regulators and others indicates otherwise.  EPA has several documented cases of poor test team performance.
- _Comment_: Should exclude testing done by plant employees
- 	_Response_: EPA sees no reason why the requirements for plant test teams should be any different.  Even a small utility should be able to easily absorb related costs.

## Summary of Draft Response to Comments on Proposed Part 75 AETB Provision

- _Comment_: How will compliance be determined?
- 	_Response_:
- §6.1.2, Appendix A of the proposed Part 75 rule has two ways an AETB can certify compliance:
- A certificate of accreditation, or
- A letter of certification signed by senior management
- Every State has a field test observer program
- A standardized State observer checklist is being developed
- EPA will use enforcement discretion to treat non-compliance
- Minor infractions, e.g., failure to initial or date amendments to documents, are noted and possibly reported to source
- If severe infractions, e.g., not having a Qualified Individual on-site, stack test may be rejected

## Summary of Draft Response to Comments on Proposed Part 75 AETB Provision

- _Comment_: What happens when test methods are created or revised?
- 	_Response_:
- All Qualified Individuals must re-test every 5 years
- If an external exam is unavailable, internal testing may be used to meet the requirements of D7036 until an external test is available
- §§8.1, 8.2, 8.4, 12.6 and 12.9 of D7036 require an AETB to provide training to keep personnel up-to-date for any new or revised methods, and to evaluate the effectiveness of such training

## Summary of Draft Response to Comments on Proposed Part 75 AETB Provision

- _Comment_: Several commenters suggested that a transition period should be provided before D7036 is required
- 	_Response_:
- As of Dec 2006, 95 people have taken QSTI exam; 60 have passed
- SES is taking steps to improve and expand testing
- Many AETBs are going through STAC accreditation; others will choose senior management certification
- If external exam not available, internal testing may be done until external exam is available
- A transition period longer than 6 months would eliminate most of the CAMR Hg certification testing from being covered by D7036 (not desirable)

## Summary of Draft Response to Comments on Proposed Part 75 AETB Provision

- _Comment_: One commenter suggested that the term “documented quality system” was unclear
- 	_Response_:
- The term is generally described in D7036, Sections 7.2.1, 7.2.2, and Note 7
- ANSI/ASQ E4-1994 defines a quality system as:
- 	“a structured and documented system describing the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring the quality in its work processes, products, items, and services.  The quality system provides the framework for planning, implementing, and assessing work performed by the organization and for carrying out required QA and QC.”

## Summary of Draft Response to Comments on Proposed Part 75 AETB Provision

- _Comment_: Do internal test teams need to incorporate or get a business license to conform to D7036?
- 	_Response_:
- No

## Summary of Draft Response to Comments on Proposed Part 75 AETB Provision

- _Comment_: EPA should allow certification to other programs, e.g., Louisiana
- 	_Response_:
- LELAP was created before D7036 and was designed for Louisiana; it is not a consensus standard
- Some stack test companies intend to comply with both D7036 and LELAP
- If EPA allowed certification to a State program, many States may ultimately adopt their own program, and companies would need to maintain and pay for the program in every State they plan to test in

## Next Steps

- The proposed Part 75 rule is expected to become final this summer

## How to Get ASTM D 7036-04

- To get a copy of ASTM D 7036-04, “Standard Practice for Competence of Air Emission Testing Bodies”:
- 	e-mail:  _[service@astm.org](mailto:service@astm.org)_
- 	web:  _[www.astm.org](http://www.astm.org/)_
- 	phone: 610-832-9585
- 	fax:  610-832-9555
- 	cost: $35

## For a Copy of Presentation

- www.epa.gov/airmarkets, click on Recent Additions, scroll to the presentation
- or
- John Schakenbach
- Phone:  202-343-9158
- schakenbach.john@epa.gov