3.1.5 The Department of Pesticide Regulation

Outline of the Department of Pesticide Regulation (DPR) Work Plan for the Implementation of the Recommendations of the Risk Assessment Advisory Committee (RAAC)

I. Harmonization and Consistency

A. Utilize the DPR-US EPA harmonization process to reduce duplication of effort.

1. Expand the harmonization process to include areas in addition to toxicology and exposure study review and human health risk assessment.

a. Coordinate regulatory actions. Initiate FY 1997/98 (Initiated Section 18 registration actions)

b. Integrate environmental fate reviews into the harmonization process. Implement FY 1998/99 (Future activity)

2. Increase the exchange of reviews and sharing of work products and workload to avoid duplication of effort.

a. Track the number of work sharing instances used for registration decisions. Initiate FY 1997/98 (Formal tracking not yet initiated)

b. Develop a quality assurance system to be implemented if the work sharing becomes a frequent procedure. Implement FY 1997/98 (Not yet applicable)

3. Work cooperatively with the US EPA in implementing the Food Quality Protection Act (FQPA).

a. DPR assistance to US EPA in meeting time frames. Ongoing

b. DPR representation on FQPA implementation panels. Ongoing

4. Continued DPR participation, with US EPA, on national and international harmonization work groups. Ongoing

a. Track the number of harmonization work groups in which DPR participates. Initiate FY 1997/98 (US EPA OPP resources have been primarily directed towards FQPA. DPR working with OPP on FQPA)

B. Continued participation within Cal/EPA to achieve consistency of risk assessment methods.

1. Continued participation in the Cal/EPA Risk Assessment Coordination Work Group (RACWG). Ongoing

2. Continued participation in the RACWG Environmental Fate and Transport Subcommittee. Ongoing

3. Develop an agreement between OEHHA and DPR defining organizational roles and responsibilities. Implement FY 1997/98 (Formal agreement will not be developed at this time)

II. Peer Review

A. Develop a consistent DPR institutional peer review process. (DPR worked with agency to develop Cal/EPA peer review guidance, in response to SB 1320)

1. Identify the types of DPR documents that are appropriate for internal or external peer review. Complete FY 1997/98 (Initiated)

2. Identify different levels and types of review that are currently used by DPR. Identify additional means of providing peer review (internal and external). Complete FY 1997/98 (Initiated)

3. Adopt a peer review policy. The policy and procedures should be consistent with the general peer review policy of Cal/EPA. The level of peer review should be commensurate with the document being reviewed. Implement FY 1998/99 (Development of the policy initiated)

III. Best Use of Scientific Information and Development of Guidelines

A. Implement a program to encourage and support staff training and professional development.

1. Develop a DPR policy that facilitates participation of staff in continuing education and scientific societies, based on institutional needs and Individual Development Plans. Implement FY 1997/98 (Under development)

2. Encourage and support staff participation in state and national scientific forums and publication of scientific papers on work related topics. Implement FY 1997/98 (Initiated, policy under development)

B. Document the procedures and assumptions used for scientific analyses.

1. Update scientific guidance documents. Include a documentation of the procedures as well as an identification of the default options and assumptions. Include a description of the criteria for using data obtained from various sources (e.g., open literature, manufacturer generated) for risk assessment. Include a documentation of characterization of uncertainty in the risk characterization process to ensure that the level of uncertainty is adequately and appropriately presented.

a. Medical Toxicology Branch guidance document on the conduct of risk assessments. Initiate FY 1997/98, Complete FY 1998/99 (Guidance document initiated)

b. Worker Health and Safety Branch guidance document on the conduct of exposure assessments. Initiate FY 1997/98, Complete FY 1998/99 (Initiated)

2. Develop a procedure to regularly examine and update the risk assessment process and guidance documents.

a. Medical Toxicology and Worker Health and Safety Branches will meet on a regular basis to specifically make recommendations for changes. Ongoing

C. Institute a process to ensure that the data collected and generated by DPR are in usable formats and are used in departmental analyses. (Internal work group has been formed to address the issues)

1. Catalog the data bases that are collected and maintained by DPR. Initiate FY 1997/98 (Initiated)

2. Implement a program to ensure that the data bases are in formats that are amenable to use in the appropriate programs. Implement FY 1998/99 (Under development)

3. Implement procedures to ensure that the appropriate data bases are fully utilized in departmental scientific analyses. Implement FY 1998/99 (Under development)

D. Institute a process to facilitate the incorporation of new scientific knowledge and technology.

1. Institute a seminar series for external scientists to present advances in science and technology. Implement FY 1999/2000 (Future activity)

2. Establish an interdisciplinary technical team to develop recommendations for the incorporation of new technological developments into the appropriate DPR procedures. Implement FY 1997/98 (Future activity)

IV. Interface Between Risk Assessment and Risk Management

A. Institute a process to ensure that the risk assessments meet the needs of the DPR risk managers.

1. Implement meetings between the risk managers and risk assessors to document the risk management needs. Initiate FY 1997/98 (Initiated)

2. Develop a process to ensure early consultation with risk managers in a risk assessment. Initiate FY 1997/98 (Initiated)

3. Finalize the process for external stakeholder scientific input into a risk assessment. Complete FY 1997/98 (Completed)

4. Improve the Departments responsiveness to public concerns about pesticide application and potential impacts, through a public outreach program. Implement FY 1998/99 (Future activity)

V. Organization and Resources

A. Optimize the operational efficiency and consistency of the risk assessment process.

1. Evaluate the risk assessment process and identify appropriate methods of increasing the efficiency of the process, while still maintaining scientific quality.

a. Task each branch to address those portions of the risk assessment process in the branch’s area of responsibility. Initiate FY 1997/98 (Initiated)

b. Implement appropriate changes in procedures identified in (a). Implement FY 1998/99 (Future activity)

2. Evaluate the DPR resource requirements with regards to risk assessment. Initiate FY 1997/98 (Future activity)

VI. Continual Improvement

A. Consider additional RAAC recommendations.

1. Update the implementation work plan on a yearly basis to incorporate additional RAAC recommendations. Initiate FY 1997/98 9 (Ongoing)

Narrative Description of the Department of Pesticide Regulation Work Plan for the Implementation of the Recommendations of the Risk Assessment Advisory Committee (RAAC)

Harmonization and Consistency

Utilize the DPR-US EPA harmonization process to reduce duplication of effort.

The Department of Pesticide Regulation (DPR) has a memorandum of understanding (MOU) with the Office of Pesticide Programs (OPP) of the U.S. Environmental Protection Agency (US EPA). A major focus of the MOU is the harmonization of review and evaluation procedures. A major goal of the harmonization effort is to reach a level of consistency that will permit and promote sharing of resources and decrease duplication of effort. A primary focus of the harmonization effort has been on the review of toxicology and exposure studies as well as human health risk assessments. DPR will work with US EPA to expand the project to include environmental fate and effects.

DPR will work to develop a closer coordination of regulatory activities. If DPR evaluates a chemical that OPP does not plan to evaluate for several years, a joint review becomes difficult. However, if both agencies plan regulatory action on or evaluation of a specific chemical in the same time frame, the sharing of resources for addressing that chemical will be helped.

DPR and OPP have shared study evaluations both to compare the conclusions of each agency and to utilize each other’s evaluations. The comparison of conclusions leads to a harmonization of evaluation and assessment procedures. This, in turn, establishes a basis for using the evaluations of the other agency in place of a de novo evaluation. The initial exchanges have focused on acute toxicity studies; however, the exchange of reviews of chronic toxicity studies is increasing. It is important to remain focused on the fact that the goal is not the exchange of reviews for comparison alone, but the sharing of work to reduce duplication of effort. DPR will work to increase the number of instances in which work is shared in the process of reaching regulatory decisions. As the sharing of work products becomes more frequent, DPR will develop quality assurance procedures for the evaluations conducted by OPP and used by DPR in its regulatory decisions.

The federal Food Quality Protection Act (FQPA), passed in 1996, contains many new requirements for US EPA. DPR is currently working with OPP to identify various areas in which DPR can provide assistance in meeting the requirements and time frames. DPR is currently exploring the possibility of doing evaluations for Section 18 Emergency Exemptions from Registration and in setting time-limited tolerances for these exemptions. In addition, DPR personnel serve on advisory panels for the implementation of the FQPA, such as the Working Group on Common Mechanism of Toxicity and Organophosphate Pesticides, and participate in the meetings of other work groups, such as the Endocrine Disrupter Screening and Testing Advisory Committee. OPP and DPR are working to increase such DPR representation.

Besides the above work groups, DPR is also working to increase its participation in international technical groups. DPR will continue to provide comments, through US EPA, on relevant draft Organization for Economic Cooperation and Development (OECD) guidelines. DPR representatives are participating in the North America Free Trade Agreement (NAFTA) Technical Working Group including participation on the subcommittee on Pesticides: Occupational/ Bystander/Residential Exposure. The goal of this working group is to harmonize the default assumptions and data analyses for worker and residential exposure assessments. Draft position papers have been prepared on several topics including protection factors for personal protective equipment and standard reference values.

DPR, US EPA, and Health Canada are participating in a work share project for the review of data for a new active ingredient. In the current work share project, Canada will provide reviews of data related to exposure, reentry, and residue chemistry; US EPA will provide reviews related to product and residue chemistry; and DPR will provide toxicology reviews. The three agencies will determine the adequacy of the shared data and will arrange a joint peer review process. Depending on the results of the current work share project, this cooperative process could be a model for future efforts.

Continued participation within Cal/EPA to achieve consistency of risk assessment methods.

The RAAC recommended that Cal/EPA form an internal technical advisory group to ensure agency-wide consistency. The Standards and Criteria Work Group served this purpose on a more informal basis. In response to the RAAC recommendation, the Cal/EPA Risk Assessment Coordination Work Group (RACWG) was formally established under the lead of the Office of Environmental Health Hazard Assessment (OEHHA). DPR is committed to participate in the efforts of the RACWG and has assigned resources, in the form of personnel, to the efforts. Also, in response to a recommendation of the RAAC, the RACWG formed the Environmental Fate and Transport Subcommittee. DPR is participating in this work group and in the initial efforts to catalog the various fate and transport models in use within Cal/EPA.

DPR and OEHHA are currently working to develop an agreement defining roles and responsibilities. The purpose of this agreement will be to eliminate duplication of effort, streamline the interagency review process, and share technical expertise.

Peer Review

Develop a consistent DPR institutional peer review process.

DPR recognizes the importance of peer review (internal and external) to ensure the high quality of its scientific documents. At the same time, DPR also recognizes the importance of ensuring that the level of review is commensurate with the importance of the document being reviewed and that the peer review process does not prevent the fulfillment of statutory mandates. While DPR currently uses peer review, it does not have a consistent approach. DPR will develop a consistent institutional peer review process that is in concert with Cal/EPA peer review policies. The first step will be to identify the various types of documents produced by DPR for which technical review is appropriate. DPR will then identify the types and levels of review that are currently being used and will identify additional peer review procedures (internal and external) that could be used. DPR will adopt a formal policy for a consistent and systematic approach to the peer review of DPR scientific documents.

Best Use of Scientific Information and Development of Guidelines

Implement a program to encourage and support staff training and professional development.

DPR recognizes the need to employ high quality science in its risk assessment activities. A highly trained technical staff, conversant with the latest scientific information, is critical to meeting this need. At the same time, DPR recognizes the need to remain focused on its mission and to work within budgetary constraints. DPR will evaluate its existing procedures and develop or modify a professional development policy that will facilitate the participation of staff in continuing education. The continuing education may be sponsored by DPR or Cal/EPA or may occur through scientific societies. The continuing education will be based on the Individual Development Plans of staff as well as on DPR’s institutional needs. Participation in scientific societies and state and national forums also play important roles in professional development. The publication of scientific papers in peer reviewed journals is a means of receiving external input, remaining current on scientific issues, and promoting the activities of DPR. Therefore, the professional development policy will also specifically address participation in scientific forums and publication of scientific papers on work related topics and will address the pursuit of additional financial support.

Document the procedures and assumptions used for scientific analyses.

Written guidelines can be used to promote consistency, transparency, and quality in the scientific analyses conducted by DPR. DPR has used guidance documents for specific phases of the risk assessment process. These guidance documents will be expanded, updated, and completed. Special attention will be paid to both documenting procedures as well as identifying default assumptions and options. The guidance documents will address uncertainty to ensure that uncertainty is adequately and appropriately presented in each risk assessment. In addition, the documents will include descriptions of the criteria for using data obtained from various sources (e.g., open literature, manufacturer generated). The first efforts will be focused on completing a Medical Toxicology Branch guidance document on the conduct of risk assessments, and updating the Worker Health and Safety guidance document on the conduct of exposure assessments. A process will be instituted to regularly examine and update the risk assessment process and the guidance documents. The Medical Toxicology and Worker Health and Safety Branches will meet on a regular basis specifically to make recommendations for such changes.

Institute a process to ensure that the data collected and generated by DPR are in usable formats and are used in departmental analyses.

A large amount of data are collected and generated by DPR. In many cases, these data are assembled into data bases. However, there is no procedure to ensure that these data bases are meeting the needs for which they were initially intended, are in useable formats for both internal and external use, and are utilized to their fullest extent in departmental analyses. DPR will initiate a process to catalog all the data bases developed and maintained by DPR. DPR will then implement a program to transform the data bases, as needed, into consistent formats that are amenable to use in the appropriate program applications. DPR will also implement procedures to ensure that scientific analyses, including risk assessments, fully use these data bases. This will be an ongoing and iterative process.

Institute a process to incorporate new scientific knowledge and technology.

There is sometimes a tendency for government agencies to become insular in their scientific activities, which can impede the incorporation of new scientific knowledge and technology. To help combat this tendency, DPR will institute a seminar series in which external scientists will present advances in science and technology. DPR will also establish an interdisciplinary technical team that will develop recommendations for the incorporation of new technological developments into the appropriate DPR procedures.

Interface Between Risk Assessment and Risk Management

Institute a process to ensure that the risk assessments meet the needs of DPR risk managers.

The RAAC concentrated on risk assessment issues; however, the review also addressed risk management. The value of a risk assessment will be judged based on its utility in enabling and supporting a sound risk management decision. While it is important to maintain a distinction between risk assessment and risk management, it is equally important to foster close communication and cooperation between the risk assessor and risk manager. The RAAC recognized this need and made recommendations addressing communication and cooperation.

DPR will initiate a series of meetings between its risk assessors and risk managers. These meetings will not address specific chemicals, risk assessments, or risk management decisions, but will concentrate on the overall structure of the risk assessment process within DPR. The purpose of this interchange will be to document the needs of the risk managers and to decide if the risk assessments meet these needs. Potential changes to the risk assessment and risk management processes may be identified. A process will be developed to ensure early consultation with risk managers on a risk assessment. The purpose of this consultation will be to give the risk assessor as much relevant information as possible (e.g., actual use practices for the application of the pesticide in question, probable exposure durations, identification of exposed populations, etc.).

A process is under development to facilitate early external shareholder scientific input into a risk assessment. A notice will be prepared that announces the initiation of a risk assessment, identifies the toxicology studies that are expected to be of primary importance in the risk assessment, identifies the toxicological values and endpoints (e.g., No Observed Affect Levels) that are expected to drive the risk assessment, and identifies some of the initial exposure values (e.g., dermal exposure) that may be used. The notices will also invite any additional relevant scientific data. DPR is currently evaluating procedures with which to release drafts of the risk characterization documents for comment. Some procedures may be initiated on a trial basis.

Like risk management, risk communication can also not be divorced from risk assessment. Public outreach is an important component of any risk assessment process. DPR will initiate a public outreach program to improve its responsiveness to public concerns about pesticide application and potential impacts.

Organization and Resources

Optimize the operational efficiency and consistency of the risk assessment process.

Increasing pressures on available resources and expanding departmental risk assessment needs demand that the risk assessment process be as efficient as possible, while not sacrificing scientific quality. The most appropriate means for increasing the efficiency can best be identified by the people performing the risk assessments, based on appropriate information from the risk managers regarding their needs. Each DPR branch that contributes to the risk assessment process will address those portions of the risk assessment process in the branch’s areas of responsibility and will identify various ways to increase efficiency, while still maintaining the appropriate level of scientific quality. This process will also identify the resource needs regarding risk assessment. This will be an iterative process.

Continual Improvement

DPR recognizes that this initial work plan primarily addresses the major areas of RAAC recommendations. DPR will revisit and update this work plan on a yearly basis. Such modifications may also identify the need for changes to the Department’s strategic plan.