External Peer Review of External Peer Review of the FDA Office of the FDA Office of Regulatory Affairs Regulatory Affairs Pesticide ProgramPesticide Program

FDA Science Board FDA Science Board Advisory Committee Advisory Committee

MeetingMeetingMarch 31, 2006March 31, 2006

ORA – CFSANORA – CFSANPesticide Peer Review Pesticide Peer Review Implementation TeamImplementation Team

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

Observation 1Observation 1 FDA needs to clearly define goals, FDA needs to clearly define goals,

requirements, and desired outcomes requirements, and desired outcomes for its pesticide program.for its pesticide program.

Observation 2Observation 2

Observation 3Observation 3 Pesticide sampling should be risk-based.Pesticide sampling should be risk-based.

Current pesticide sampling is not Current pesticide sampling is not statistically based.statistically based.

Observations 1,2 and 3Observations 1,2 and 3StatusStatus

ORA Senior management and ORA Senior management and CFSAN recognize the need to CFSAN recognize the need to develop a risk-based approach to develop a risk-based approach to its regulatory decision-making, its regulatory decision-making, functions, and operations.functions, and operations.

Observations 1,2 and 3Observations 1,2 and 3StatusStatus• 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 4Observation 4

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

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

Observation 4Observation 4 STATUSSTATUS

Observation 4Observation 4 STATUSSTATUS

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

Observation 5Observation 5 The Pesticide Analytical Manual The Pesticide Analytical Manual

(PAM) is important, and should be (PAM) is important, and should be updated in a timely manner.updated in a timely manner.

Observation 6Observation 6 There should be a defined process for There should be a defined process for

method validation and acceptance. method validation and acceptance.

Observations 5 and 6Observations 5 and 6STATUSSTATUS

• 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 7Observation 7

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

Observation 7Observation 7 STATUSSTATUS

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

Observation 8Observation 8

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

Observation 8Observation 8 STATUSSTATUS

– The Pesticide Steering Committee will The Pesticide Steering Committee will revise the "Criteria for Analytical revise the "Criteria for Analytical Packages" to reduce redundant analyses Packages" to reduce redundant analyses and maintain regulatory standards and and maintain regulatory standards and requirements.requirements.

– A workgroup has been established at the A workgroup has been established at the direction of the Field Food Committee to direction of the Field Food Committee to better define and apply the import better define and apply the import appearance standard in hopes of appearance standard in hopes of streamlining import testing and sample streamlining import testing and sample collection.collection.

Observation 9Observation 9 Uniform procedures for capturing, Uniform procedures for capturing,

sharing, reporting, and auditing sharing, reporting, and auditing raw data are lacking. raw data are lacking.

Observation 9Observation 9 STATUSSTATUS

– ORA contracted an application assessment ORA contracted an application assessment of a Laboratory Information Management of a Laboratory Information Management System (LIMS) for ORA field laboratories..System (LIMS) for ORA field laboratories..

– MARCS, the emerging platform for ORA MARCS, the emerging platform for ORA strategic systems and field applications, is strategic systems and field applications, is currently under development and critical currently under development and critical LIMS functions will be identified and LIMS functions will be identified and considered for implementation.considered for implementation.    

Observation 10Observation 10 Quality assurance programs are Quality assurance programs are

inconsistent across ORA laboratories.inconsistent across ORA laboratories.

Observation 10Observation 10 STATUSSTATUS

ORA pesticide field labs are ORA pesticide field labs are undergoing accreditation.undergoing accreditation.

Status:Status:– ARL, PRL-NW, NRL – AccreditedARL, PRL-NW, NRL – Accredited– PRL-SW – May 2006PRL-SW – May 2006– KAN-DO – May 2006KAN-DO – May 2006– SRL – June 2006SRL – June 2006