EPA REGULATORY UPDATE

Transcription

1 SOCIETY OF QUALITY ASSURANCE REGULATORY FORUM EPA REGULATORY UPDATE Linthicum Heights, Maryland January 24, 2008 Robert Cypher United States Environmental Protection Agency 2/13/2008 SQA Baltimore 1

2 ANY UNITED STATES GLP FIELD TRIAL MAY BE SUBMITTED TO OTHER COUNTRIES IN THE WORLD 2/13/2008 SQA Baltimore 2

3 FY INSPECTIONS BY DISCIPLINE Field Sites 36.5% 35 7 Toxicology 7.3% Chemistry 12.5% Others 4.2% 22 4 Product Chemistry 22.9% Antimicrobial 4.2% Insecticide 12.5% Total Inspections 96 Total data audits 304 Human studies 11 2/13/2008 SQA Baltimore 3

4 FIELD SITES INSPECTED - FY2007 Total field sites inspected 35 IR-4 field sites 13 (37%) Non IR-4 field sites 22 (63%) 2/13/2008 SQA Baltimore 4

5 FY2007 FIELD SITES INSPECTIONS Total Inspections Field Sites Gov/Public/Academia No. Inspections In Compliance (Inspector's Findings) % Non-Gov/Private Sector No. Inspections In Compliance (Inspector's Findings) % /13/2008 SQA Baltimore 5

6 COMPLIANCE PROFILE FY 2007 High Level Violations FIELD SITES Total GLP Inspections 96 Inspections 35 In Compliance 34 (97%) 2/13/2008 SQA Baltimore 6

7 GLP COMPLIANCE RATE - FY2007 Inspections Compliance Rate (No findings) Compliance Rate (High Level Violations) % 30 80% % % 100% 25% 50% 83% 100% 58% 75% 50% 68% 100% 100% 0 Field Toxicology Antimicrobial Analy Chemistry Insecticide Eff Prod Chemistry Others 2/13/2008 SQA Baltimore 7

8 FIELD SITES FY2004-FY2007 COMPLIANCE STATISTICS 120 Fy2004 FY2005 FY2006 FY % 77% 74% 80% 94% 97% 89% 97% Total Inspections Field Sites In Compliance In Compliance (No findings) (High level violations) 2/13/2008 SQA Baltimore 8

9 Subpart A Subpart B Subpart C Subpart D Subpart E Subpart F Subpart G Subpart J Science Issues FY 2007 GLP VIOLATIONS FIELD SITES /13/2008 SQA Baltimore 9

10 GLP FIELD SITE VIOLATIONS BY CITATION FY2007 Subpart B Training records, experience and job descriptions not available Final report does not reflect raw data 2/13/2008 SQA Baltimore 10

11 GLP FIELD SITE VIOLATIONS BY CITATION FY2007 Subpart E SOP deviations Reagents were not labeled according to GLP Experimental dates were determined arbitrarily 2/13/2008 SQA Baltimore 11

12 GLP FIELD SITE VIOLATIONS BY CITATION FY2007 Subpart G Changes to protocol were not signed by the Study Director PI do not have a complete protocol Activity and observations were not recorded 2/13/2008 SQA Baltimore 12

13 GLP FIELD SITE VIOLATIONS BY CITATION FY2007 Subpart J Test facility (Study Director) did not have a copy of the final report Final report does not reflect raw data 2/13/2008 SQA Baltimore 13

14 FY2007 STUDY REJECTIONS Product chemistry Five (5) studies One (1) laboratory 2/13/2008 SQA Baltimore 14

15 EPA INTERNATIONAL ACTIVITIES OECD MUTUAL ACCEPTANCE OF DATA (MAD) Chair of OECD GLP Working Group EPA Full members of OECD MAD 27 Members of MAD (non OECD members) Provisional members of MAD (non OECD members) 3 (South Africa, Slovenia, Israel) 4 (India, Singapore, Brazil, Argentina) Guidance document Archives Establishment and Control of Archives that Operate in Compliance with Principles of Good Laboratory Practice 2/13/2008 SQA Baltimore 15

16 GUIDANCE DOCUMENTS RELEVANT TO FIELD RESEARCHERS No. 1 The OECD Principles of GLP No. 4 Quality Assurance and GLP No. 5 Compliance of Laboratory Suppliers with GLP Principles No. 6 The Application of the GLP Principles to Field Studies No. 8 The Role and Responsibility of the Study Director in GLP Studies No. 10 The Application of the Principles of GLP to Computerized Systems No. 11 The Role and Responsibilities of the Sponsor in the Application of the Principles of GLP No. 13 The Application of the Principles of GLP to the Organization and Management of Multisite Studies No. 15 Establishment and Control of Archives that Operate in Compliance with Principles of Good Laboratory Practice. 2/13/2008 SQA Baltimore 16

17 OECD MUTUAL ACCEPTANCE OF DATA WHAT IS NEW? 2/13/2008 SQA Baltimore 17

18 THE WORLD ACCORDING TO GLP THE WORLD ACCORDING TO GLP THE WORLD ACCORDING TO GLP THE WORLD ACCORDING TO GLP THE WORLD ACCORDING TO GLP THE WORLD ACCORDING TO GLP THE WORLD ACCORDING TO GLP THE WORLD ACCORDING TO GLP THE WORLD ACCORDING TO GLP THE WORLD ACCORDING TO GLP 2/13/2008 SQA Baltimore 18

19 Brazil India China Argentina Singapore Taiwan Turkey Malaysia 2/13/2008 SQA Baltimore 19

20 OECD ACTIVITIES No revisions of OECD Principles of GLP No changes of GLP affecting field research in the US Field studies conducted according to EPA GLP in the US will be accepted for review in other OECD Member countries China* Turkey* Malaysia* Taiwan* Brazil* Argentina Other countries * Have visited EPA 2/13/2008 SQA Baltimore 20

21 OECD FUTURE ACTIVITIES 1) OECD event with industry in April 2008 in Rome, NAICC participates 2) GLP inspectors training Israel, September ) Evaluation of GLP compliance monitoring programs of Members of MAD 4) Evaluation of US EPA GLP program in 2010, FDA in ) Evaluation of India s GLP program in February /13/2008 SQA Baltimore 21

22 Foreign countries inquiring about GLP compliance status of US Field Sites and laboratories If your facility has not been inspected for the discipline they are interested in, your study will not be accepted by foreign countries 2/13/2008 SQA Baltimore 22

23 FUTURE ACTIVITIES Biotechnology studies Nanotechnology Human testing 2/13/2008 SQA Baltimore 23

24 Robert Cypher U.S. Environmental Protection Agency 1200 Pennsylvania Ave., NW (2225A) Washington, DC Tel Fax /13/2008 SQA Baltimore 24