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

1
External Peer Review of the FDA Office of
Regulatory Affairs Pesticide Program

• FDA Science Board Advisory Committee Meeting
• March 31, 2006

2
ORA CFSANPesticide 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.

3
Observation 1

• FDA needs to clearly define goals, requirements,
  and desired outcomes for its pesticide program.

Observation 2

• Pesticide sampling should be risk-based.

Observation 3

• Current pesticide sampling is not statistically
  based.

4
Observations 1,2 and 3Status

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

5
Observations 1,2 and 3Status

• 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/AMSs PDP program, and State data.

6
Observation 4

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

7
Observation 4 STATUS

• 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.

8
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.

9
Observation 5

• 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.

10
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

11
Observation 7

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

12
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.

13
Observation 8

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

14
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.

15
Observation 9

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

16
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.  

17
Observation 10

• Quality assurance programs are inconsistent
  across ORA laboratories.

18
Observation 10 STATUS

• ORA pesticide field labs are undergoing
  accreditation.
• Status
• ARL, PRL-NW, NRL Accredited
• PRL-SW May 2006
• KAN-DO May 2006
• SRL June 2006