External Peer Review of the FDA Office of Regulatory Affairs Pesticide Program FDA Science Board Advisory Committee Meeting March 31, 2006

ORA – CFSAN Pesticide Peer Review Implementation Team Representatives from ORA (DFS, OE, DIOP, DFI) have been meeting with CFSAN consumer safety officers and scientists to address the issues presented in the ORA Pesticide Peer Review. Representatives from ORA (DFS, OE, DIOP, DFI) have been meeting with CFSAN consumer safety officers and scientists to address the issues presented in the ORA Pesticide Peer Review.

Observation 1 FDA needs to clearly define goals, requirements, and desired outcomes for its pesticide program. FDA needs to clearly define goals, requirements, and desired outcomes for its pesticide program. Observation 2 Observation 3 Pesticide sampling should be risk-based. Pesticide sampling should be risk-based. Current pesticide sampling is not statistically based. Current pesticide sampling is not statistically based.

Observations 1,2 and 3 Status  ORA Senior management and CFSAN recognize the need to develop a risk- based approach to its regulatory decision-making, functions, and operations.

Observations 1,2 and 3 Status ORA is exploring information resources on pesticide usage and product pesticide analysis to better focus its program to meet public health and safety needs. Currently available information resources include FDA data on pesticide violations, eLEXNET data, USDA/AMS’s PDP program, and State data.

Observation 4 There is a general lack of coordination between sample collection and analysis. There is a general lack of coordination between sample collection and analysis.

ORA is developing a sampling scheduling application, the National Sample Distributor (NSD). The NSD allows laboratories to report their analytical capacity to investigators in the field. The NSD provides a real time determination of laboratory analytical capabilities and will be used field wide for all program areas. ORA is developing a sampling scheduling application, the National Sample Distributor (NSD). The NSD allows laboratories to report their analytical capacity to investigators in the field. The NSD provides a real time determination of laboratory analytical capabilities and will be used field wide for all program areas. Observation 4 STATUS

ORA is redrafting a Field Management Directive to reestablish Pesticide Coordination Teams (PCT) in each region. If authorized, these teams will be composed of laboratory personnel, investigators, compliance officers and CFSAN representatives. ORA is redrafting a Field Management Directive to reestablish Pesticide Coordination Teams (PCT) in each region. If authorized, these teams will be composed of laboratory personnel, investigators, compliance officers and CFSAN representatives.

Observation 5 The Pesticide Analytical Manual (PAM) is important, and should be updated in a timely manner. The Pesticide Analytical Manual (PAM) is important, and should be updated in a timely manner. Observation 6 There should be a defined process for method validation and acceptance. There should be a defined process for method validation and acceptance.

Observations 5 and 6 STATUS A Pesticide Steering Committee (PSC) has been formed. Members have been selected from representatives of CFSAN, DFS (Division of Field Science) and experts in the field laboratories. The PSC will function as the editorial board of the PAM

Observation 7 Most methods used to analyze samples are generally cost-effective and efficient, but not comprehensive. Most methods used to analyze samples are generally cost-effective and efficient, but not comprehensive.

Observation 7 STATUS ORA has established a Method Development and Validation Program (MDVP) that targets method development needs to service Center programs and provides resources and a review process for qualifying new methods for regulatory use.

Observation 8 Additional confirmation testing for “no-tolerance pesticides” increases time and resource requirements. Additional confirmation testing for “no-tolerance pesticides” increases time and resource requirements.

Observation 8 STATUS –The Pesticide Steering Committee will revise the "Criteria for Analytical Packages" to reduce redundant analyses and maintain regulatory standards and requirements. –A workgroup has been established at the direction of the Field Food Committee to better define and apply the import appearance standard in hopes of streamlining import testing and sample collection.

Observation 9 Uniform procedures for capturing, sharing, reporting, and auditing raw data are lacking. Uniform procedures for capturing, sharing, reporting, and auditing raw data are lacking.

Observation 9 STATUS –ORA contracted an application assessment of a Laboratory Information Management System (LIMS) for ORA field laboratories.. –MARCS, the emerging platform for ORA strategic systems and field applications, is currently under development and critical LIMS functions will be identified and considered for implementation. –MARCS, the emerging platform for ORA strategic systems and field applications, is currently under development and critical LIMS functions will be identified and considered for implementation.

Observation 10 Quality assurance programs are inconsistent across ORA laboratories. Quality assurance programs are inconsistent across ORA laboratories.

Observation 10 STATUS ORA pesticide field labs are undergoing accreditation. ORA pesticide field labs are undergoing accreditation. Status: Status: –ARL, PRL-NW, NRL – Accredited –PRL-SW – May 2006 –KAN-DO – May 2006 –SRL – June 2006