Francisca Liem, Chief of the Laboratory Data Integrity Branch of EPA gave a synopsis of the 1997 fiscal year inspection results and compared the numbers to the 1996 results. In 1997, a total of 127 labs were inspected in 1997 compared with 95 in 1996 (84 new labs in 97 compared with 56 in 96). The percentage of labs "in compliance" increased for field sites, stayed the same for Eco-tox and Microbiology labs and decreased for analytical and toxicology facilities. She went on to say that after receiving a notice of inspection, there were 7-10 products immediately withdrawn from the market, with 7 companies indicating they would no longer do GLP work. Over 50% of the companies contacted requested that the inspection be rescheduled. It appears that the findings are typical of what we have seen in the past, with the majority of findings being in subparts B, D, E, F, and G.
Some of the findings she noted included:
Perhaps the most interesting statistic was that out of 84 "first time" labs inspected, 32 were referred for enforcement, while only 6 out of the 43 "old labs" inspected were referred. It appears that EPA is finding most of their compliance issues with Sponsor labs that have never been inspected. Out of the 44 Sponsor labs inspected, 38 had never been inspected before and 24 of these had significant problems.
The compliance statement is being used to target studies and labs for inspection, especially those statements that indicate major deviations from GLP or state the study was not conducted according to GLP. OPP is finding that lack of GLP compliance generally indicates problems with the data and science of a study.
There was one enforcement initiative in 1997, against 6 registrants and 7 laboratories. Most of the labs were product chemistry type laboratories. More enforcement initiatives are in the pipe-line. In the future, a false compliance statement will be fined at a maximum of $5,000.00, regardless of how many "false" items are listed on the compliance statement. However, enforcement will also be pursued under the record keeping section (12a2bi) of FIFRA. If there are conflicting compliance statements in a final report (PI's vs. the Study Directors), it is EPA's opinion that one of them is false.
The merged FIFRA/TSCA GLPs have been completed and are currently under review. It is anticipated that the will be published in March of 1998.
| Summary of 1996/1997 EPA Inspection Statistics | ||
| ----- | 1997 | 1996 |
| Total Labs Inspected | 127 | 95 |
| Data Audits | 480 | 320 |
| New Labs | 84 (66%) | 56 (59%) |
| Closures | 97 | 141 |
| Toxicology Labs | 16.5% | 16.8% |
| Field Sites | 17.3% | 25.3% |
| Chemistry Labs | 52% | 35.8% |
| Ecotox facilities | 3.9% | 7.4% |
| Antimicrobial | 7.1% | 9.5% |
| Other | 3.1% | 5.3% |
| Number referred for enforcement | 38 | 43 |
- Debi Garvin