Workshop S. Clean Air Act Title V Assessing Reasonable Inquiry & Due Diligence. Tuesday, March 22, :30 p.m. to 4:45 p.m.

Transcription

1 Workshop S Clean Air Act Title V Assessing Reasonable Inquiry & Due Diligence Tuesday, March 22, :30 p.m. to 4:45 p.m.

2 Biographical Information Don Robin, P.E., HSE Consultant Eli Lilly and Company, Lilly Technology Center, Indianapolis, IN Fax: Don Robin has worked with state environmental agencies (Louisiana DEQ and Indiana DEM) as well as civil and environmental engineering consulting firms before joining Eli Lilly in He is a subject matter expert in air quality permitting and compliance for Eli Lilly s North American facilities with more than twenty years of professional environmental experience. Don supports and advises Eli Lilly and Company sites construction permitting, Title V reasonable inquiry and compliance certifications, and implementation of the Pharmaceutical MACT rule, RCRA BB/CC ( RCRA LDAR ), Boiler MACT/GACT, RICE MACT & NSPS IIII, and ozone depleting substance (40 CFR Part 82) regulations. We have most recently supported an assessment of the Indianapolis sites Title V reasonable inquiry process. Don is an alumna of Louisiana State University, with dual bachelors degrees in Environmental Science and Environmental Engineering. Don also holds an MBA from Indiana University s Kelley School of Business. He is a licensed engineer in Indiana for environmental engineering. Catherine Ehlhardt, HSE Consultant Eli Lilly and Company, Lilly Technology Center, Indianapolis, IN Fax: Ehlhardt_catherine_r@lilly.com Catherine Ehlhardt began her career with USEPA in Region 1, where she followed two years of observing stack tests with eight years as an enforcement engineer. In 1988, she moved to Indiana and joined the corporate Health, Safety and Environmental group at Eli Lilly and Company, supporting North American Clean Air Act programs. In the course of the past 28 years with Lilly, she participated in regulatory negotiations with USEPA on the Pharmaceutical MACT rule, the HON LDAR regulatory negotiation, and others. She supports and advises Eli Lilly and Company sites construction permitting, Title V reasonable inquiry and compliance certifications, and implementation of the Pharmaceutical MACT rule, RCRA BB/CC ( RCRA LDAR ), Boiler MACT/GACT, RICE MACT & NSPS IIII, and ozone depleting substance (40 CFR Part 82) regulations. She initiated a targeted assessment program with assessments of Lilly sites LDAR and refrigerant management programs, and most recently has supported an assessment of the Indianapolis sites Title V reasonable inquiry process. Catherine is an alumna of the University of Michigan, with dual bachelors degrees in Chemistry and Chemical Engineering. David R. Jordan, Partner ERM, 8425 Woodfield Crossing Blvd., Suite 560W, Indianapolis, IN Fax: dave.jordan@erm.com Dave Jordan is currently a partner in the Indianapolis office of ERM. Dave has more than 35 years of experience in the air pollution regulatory field. Dave served as a permit engineer, engineering manager, and administrator of the Indianapolis Air Pollution Control Division, where he worked for seventeen years. While employed by the City of Indianapolis, he was active in the Association of Local Air Pollution Control Officials (ALAPCO), including serving as president and serving as the national lead on the Title V Operating Permit Program for ALAPCO. Since joining ERM, he has participated in and managed construction permit and Title V permit applications for numerous sources throughout the Midwest. He has considerable experience with the Federal New Source Review and Title V permit programs, and has prepared expert testimony related to New Source Review issues. Dave has taught undergraduate and graduate courses in air pollution control at Indiana University - Purdue University at Indianapolis, and is a registered Professional Engineer in the State of Indiana. Dave is a graduate of Purdue University with a degree in Civil Engineering.

3 Clean Air Act Title V: Assessing Reasonable Inquiry Due Diligence Workshop S

4 Presenters Catherine Ehlhardt and Don Robin Eli Lilly and Company Consultants, North American Environmental Services Combined 50 years air program experience, now supporting 5 Title V permitted sources plus various FESOP and MSOP sources 3/7/2016 Company Confidential 2014 Eli Lilly and Company 2

5 Why is Title V Reasonable Inquiry Important? 3/7/2016 Company Confidential 2014 Eli Lilly and Company 3

6 The Compliance Certification Includes: the status of compliance with the permit including whether compliance during the period was continuous or intermittent. and the method and means by which this was determined. The methods and means include AT A MINIMUM the monitoring requirements established in the permit. I certify that, based on information and belief formed after reasonable inquiry, the statements and information in the document are true, accurate and complete. 3/7/2016 Company Confidential 2014 Eli Lilly and Company 4

7 What is Reasonable Inquiry? Reasonable inquiry is the set of actions that is undertaken to measure whether each requirement of the Title V permit is met. 3/7/2016 Company Confidential 2014 Eli Lilly and Company 5

8 Why Look at Reasonable Inquiry? The reasonable inquiry process provides the basis for your Responsible Official to certify reports it must be properly planned and organized To make the process work, everyone beneath the R.O. must execute within their own areas to evaluate and report deviations. The inquiry process deserves the same periodic scrutiny as the compliance process 3/7/2016 Company Confidential 2014 Eli Lilly and Company 6

9 How to Measure Reasonable Inquiry Two models for measurement of programs Corporate Audit Targeted Assessment 3/7/2016 Company Confidential 2014 Eli Lilly and Company 7

10 Corporate Audit Corporate Audit Program: 2 people x 4 days x air AND water AND waste AND transportation AND sustainability AND management systems = everything is seen but there is not time for deep analysis 3/7/2016 Company Confidential 2014 Eli Lilly and Company 8

11 Targeted Assessment Targeted Assessment: a deep dive into a fairly narrow set of topics, looks at systems and execution in detail 3/7/2016 Company Confidential 2014 Eli Lilly and Company 9

12 What Do You Look At? Compliance Audit: are you conforming to requirements show me the original data Reasonable Inquiry Assessment: how do you go from the data to the statement of compliance or list of deviations in the report how do you know your report is accurate? 3/7/2016 Company Confidential 2014 Eli Lilly and Company 10

13 Reasonable Inquiry vs Compliance Requirement Type Compliance Reasonable Inquiry Emission Limit Meet Emission Limit How do you identify deviations and credible evidence? Have all changes been addressed appropriately? What is measured to confirm conformance to limit (items not specified by permit)? Operating Limits Meet Operating Limit See above 3/7/2016 Company Confidential 2014 Eli Lilly and Company 11

14 Reasonable Inquiry vs Compliance Requirement Type Compliance Reasonable Inquiry Monitor emissions/parameters Collect specified monitoring data and quality assurance How do we check we are executing required monitoring correctly? Identification of and response to missing data, measurements outside expectation. Traceability of measurements. Change management for data acquisition systems. Maintenance of updated SOP. Process changes is the measurement requirement, location, etc. still appropriate. Are people properly trained? 3/7/2016 Company Confidential 2014 Eli Lilly and Company 12

15 Reasonable Inquiry vs Compliance Requirement Type Compliance Reasonable Inquiry Work Practices Execute specified practices What is the basis for concluding you are in or out of compliance? How do you know the practices were completed timely and correctly? What is quality assurance for work practice? Are people properly trained? 3/7/2016 Company Confidential 2014 Eli Lilly and Company 13

16 Reasonable Inquiry vs Compliance Requirement Type Compliance Reasonable Inquiry Recordkeeping Keep required records How do we know all required records were created timely? How do we know they are retained appropriately? How do we know they are correct? Are people properly trained? Reporting Report deviations and specified data and Annual Compliance Certifications, Pay fees What is process for advising management chain regarding responsible inquiry activities and results? Are people properly trained? 3/7/2016 Company Confidential 2014 Eli Lilly and Company 14

17 Reasonable Inquiry vs Compliance Requirement Type Compliance Reasonable Inquiry Keep Permit Up to Date Non Applicability (e.g. Permit Shield) Obtain required amendments timely. What is process for identifying changes requiring permit amendments? Is there appropriate documentation explaining why requirements do not apply 3/7/2016 Company Confidential 2014 Eli Lilly and Company 15

18 Example: Reasonable Inquiry in a Solids Handling Process Particulate Limit: lbs/hr if process handles 100 lbs/hr No data on emissions available from AP-42 or from measurements BUT: FDA GMP process accountability must be able to account for, say, 99% of material on a mass balance basis Conclusion based on cycle time: if meet GMP criterion, emissions process weight limit Compliance process: every batch lot is measured against GMP criterion; all failures are entered to event management system Reasonable inquiry: environmental reviewer looks at event management system if no lots failed the GMP criterion, no Title V deviations Each failure must then be investigated individually to determine whether Title V deviations would have been possible 3/7/2016 Company Confidential 2014 Eli Lilly and Company 16

19 Example: Assessment of the Reasonable Inquiry Has the analysis/calculation leading to the compliance conclusion been validated? When changes affect lot size, cycle time, or GMP criteria occur, does change management address recalculation? When events are further analyzed for deviation reporting, is the analysis verified and documented? Are events reviewed timely for inclusion in the quarterly report for the quarter in which they occur? 3/7/2016 Company Confidential 2014 Eli Lilly and Company 17

20 Elements of Reasonable Inquiry to be Assessed Documented understanding of permit requirements How is conformance to permit requirements measured? Are potential deviations managed appropriately? Review and approval of the results of the reasonable inquiry Engagement of the Responsible Official/Authorized Individual 3/7/2016 Company Confidential 2014 Eli Lilly and Company 18

21 Documented Understanding of Permit Requirements What the permit language says; what it means in the business applicability, deliverables Change management for emission limits, work practices, measurement, monitoring, recordkeeping, and reporting; Relevant non-applicability analyses 3/7/2016 Company Confidential 2014 Eli Lilly and Company 19

22 How is Conformance to Requirements Measured? What is examined or measured Traceability of measurements and calculations to raw data Scope; confirmation that scope remains current Frequency of measurement Interpretation of results Events Credible evidence Timing of gap filling (e.g. missing data caught on QA/QC) Documented in such a way that the interpretation can be reconstructed 3/7/2016 Company Confidential 2014 Eli Lilly and Company 20

23 Are Potential Deviations Managed Appropriately? Are events investigated with a depth commensurate with their possible importance? Is there communication to ensure events are communicated to a management level sufficient to ensure they are corrected? Is credible evidence analyzed and reported? Are reportable data supported by documentation? Is each event documented such that it can be reconstructed? 3/7/2016 Company Confidential 2014 Eli Lilly and Company 21

24 Review and Approval of the Results of Reasonable Inquiry Is the business unit management (not just HSE): Familiar with the reasonable inquiry process? Routinely advised of reasonable inquiry results? Internally reviewing and approving the reasonable inquiry results? Are reasonable inquiry results from the business unit then reviewed by Environmental and, when appropriate, by Legal, before the Responsible Official is advised of the results? 3/7/2016 Company Confidential 2014 Eli Lilly and Company 22

25 Engagement of the Responsible Official/ Authorized Individual Considering the business structure, which is the most appropriate RO? Which positions are appropriate alternate or delegated RO? (backup signers) Should others concur in writing internally, or sign the reports as well? Is the RO, and are the alternate/delegated backups, appropriately knowledgeable and trained regarding their responsibility? Is the RO advised of all that is necessary/appropriate? Are business units appropriately involved in advising the RO? Should there be a direct roll-up with management signature at every level? 3/7/2016 Company Confidential 2014 Eli Lilly and Company 23

26 Assessor s Process Review/analysis of the Title V permit Requirements Expectations Review of reasonable inquiry actions as documented Including the Environmental Information Management System (EIMS) activities but what is done on the ground that supports the EIMS assignments Documentation of reasonable inquiry results review records & record retention Interviews Documentation of findings List of observations, categorized & rated as to criticality Recommended improvements Opening and closing meetings Daily update meetings 3/7/2016 Company Confidential 2014 Eli Lilly and Company 24

27 Things We Learned Keep your operating procedures and tracking tools up to date as permit conditions & individual responsibilities change over time Annual review? Full update at renewal? Keep non-applicability documentation up to date periodic reviews help Train/provide procedures for all accountable individuals. Use the training as an opportunity to receive feedback and improve the process/procedures 3/7/2016 Company Confidential 2014 Eli Lilly and Company 25

28 Things We Learned: the RO Educate the RO on the due diligence process Provide the RO with a summary against the requirements what is required; what had NO deviations; as well as the deviations The RO should ask questions EVERY TIME 3/7/2016 Company Confidential 2014 Eli Lilly and Company 26

29 Sample RO Summary Type of Requirement Status Details Emission Limits No deviations Opacity limits were met Operational Limits No deviations Control devices operated as required Monitoring Deviations Requirements Baghouse pressure monitor hit by wrench & disconnected 6/1/2020; returned to operation 6/2/2020; 16 hours of data missed. Work Practice Requirements No deviations Any out of range compliance monitoring measurements were properly responded to. Emergency generators have been maintained as required. Misc. Items No deviations All records have been maintained as required. Permit Changes No deviations No site activities requiring permit changes occurred. Application for permit renewal submitted timely. Non Applicability No deviations 3/7/2016 Company Confidential 2014 Eli Lilly and Company No halogenated solvents are used in parts washers 27

30 Things We Learned: Information Management Integrate your permit compliance systems with the ordinary business data collection and processes as much as possible Down side: you may end up pulling information from a multitude of information systems; it won t all be neatly presented Up side: you minimize duplicative recordkeeping (which minimizes the problems of non-matching information) 3/7/2016 Company Confidential 2014 Eli Lilly and Company 28

31 More Learning: Data Management But try to persuade your business partners to use the same tools where it makes sense sometimes there really is a best practice. 3/7/2016 Company Confidential 2014 Eli Lilly and Company 29

32 Clean Air Act Title V Assessing Reasonable Inquiry & Due Diligence Sustainability and Environmental, Health & Safety Symposium Workshop S Tuesday March 22, 2016 The world s leading sustainability consultancy

33 Reasonable Inquiry Reasonable Inquiry This language is similar to that in Rule 11 of the Federal Rules of Civil Procedure, upon which it was modeled. The provision makes clear that the signer must make a reasonable (under the circumstances) inquiry before attesting to the truth, accuracy, and completeness of the information and statements Fed. Reg. 21,712 (May 10, 1991) Under the Circumstances Reliability of monitoring and recordkeeping Past compliance or concerns Experience and competence of employees in the data gathering process 31 The world s leading sustainability consultancy

34 Title V Permit Structure and Reasonable Inquiry 32 Standards of Performance (emission limits and work practice requirement) Must have monitoring, recordkeeping and reporting (MRR) Reasonable Inquiry involves looking at the required MRR Having a logical, systematic review of MRR information what did they review Having systems in place that assure the completeness and accuracy of that information how reliable was it Looking for credible evidence that a deviation has occurred what questions where asked to assure compliance The world s leading sustainability consultancy

35 Title V Permit Structure and Reasonable Inquiry Audit Approach: Review the systems that assure the completeness and accuracy of the information and supporting processes available to the RO Interview individuals involved in the Title V Reasonable Inquiry process Review records pertaining to the manner in which Reasonable Inquiry documents are circulated Evaluate the engagement of the Responsible Official in the Reasonable Inquiry process 33 The world s leading sustainability consultancy

36 ERM Reasonable Inquiry Systems Review Procedures, including any data capture plans Other documents such as forms and information requests Recordkeeping General awareness Roles & responsibilities, accountability Assurance processes Management of change 34 The world s leading sustainability consultancy

37 Procedures Exist Adequate Understandable Available Properly used/referenced Integrated into training/awareness material Up to date Includes appropriate translation of permit/rule mandated requirements Addresses procedures as well as provisions, roles and responsibilities, authorities, and nonconformance 35 The world s leading sustainability consultancy

38 Recordkeeping Dedicated location secure but accessible Mechanisms designed/aligned to assure complete and accurate (compliant) records Periodic audits Consistency 36 The world s leading sustainability consultancy

39 Awareness Responsible parties (e.g., data owners as well as EHS professionals) knowledgeable of: What is required of them Why, when, and how Aware of available references, tools, support 37 The world s leading sustainability consultancy

40 Roles & Responsibilities/Accountability Accountabilities defined, documented, communicated, and implemented including back-ups Appropriate decision-makers engaged and aware of issues and performance Communication channels and mechanisms capable of addressing issues and concerns 38 The world s leading sustainability consultancy

41 Assurance Compliance is reviewed/assured by identified and competent professionals with the appropriate level of authority data reviewers, reporting reviews, and approvals or sign-offs Adequacy of other compliance-critical professionals appropriately identified, educated, and engaged 39 The world s leading sustainability consultancy

42 Management of Change Process by which changes are identified Who involved in the review process Documented and implemented Consistent throughout organization 40 The world s leading sustainability consultancy

43 Contractor Management Where are contractors involved in the Title V process? Are contractors aware of their role in the Title V compliance process? Do contractors follow same procedures as company staff; including recordkeeping and reporting? Is there an established oversight/review process of contractors? Are there training programs in place regarding Title V roles and responsibilities for contractors? 41 The world s leading sustainability consultancy

44 Responsible Official Example questions Can you describe key operations and key air emission sources or categories of air emission sources? In general, can you describe the permit and how those sources are regulated (high level)? What are the most significant challenges associated with the permit either with the permit itself, or in achieving compliance? Can you identify any recent compliance deviations and how and when those were brought to your attention? Please describe roles and responsibilities as it relates to compliance with the permit 42 The world s leading sustainability consultancy

45 Example Observations Consistency from location to location Different departments at the same site; between sites How data is managed and evaluated Consistency of training from location to location Availability of trained back-ups Regular updates to procedures to incorporate changes 43 The world s leading sustainability consultancy

46 Example Observations (cont) Clear lines of data ownership Discuss what is meant by training/roles and responsibilities Other credible evidence Is there a recognition that other evidence can lead to the potential for a deviation? Do systems exist to allow such other evidence to be considered in making compliance certification statements? Will the Responsible Official be informed of the existence and nature of other credible evidence when it is identified? 44 The world s leading sustainability consultancy

47 Subheading Questions 45 The world s leading sustainability consultancy