Information provided for informational purposes only

Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.

United States Environmental Protection Agency Office of Pesticide Programs

TRAC Science Policy

Staff Paper #41

October 8, 1999

Note To Reader:

The following three attachments provide a listing of and schedule for the TRAC science policy issues that EPA is committed to issuing in draft and revised so that these policies are publicly available for input, transparent and based on the best science possible. The attachments are as follows:

(1) "Revised Schedule for the FQPA Science Policy Papers"--A narrative summary of the progress made to date on issuing the science policy papers and of changes that have been made to the schedule.

(2) "FQPA TRAC Science Policy Issues and Related Papers"--A table listing all of the TRAC science policy papers and the dates on which they are planned or expected to be issued in draft and revised.

(3) "Overview of TRAC Science Policy Issues"--A table which groups all 26 of the science policy and related papers according to particular areas of human health exposure and risk assessment that they address.

REVISED SCHEDULE FOR THE FQPA SCIENCE POLICY PAPERS

The Office of Pesticide Programs (OPP) is providing the attached, updated schedule for issuance of its initial and revised science policy documents under the Food Quality Protection Act (FQPA).

Schedule for Initial Science Policy Documents. OPP has issued 14 of the originally planned 19 science policy papers. These papers address eight of the nine science policy areas identified by the Tolerance Reassessment Advisory Committee (TRAC) as critical to the implementation of FQPA. OPP has decided to merge two of the remaining papers ( #18, #19), concerning techniques for estimating drinking water exposure, into the paper already issued on that subject (#8), before that paper is issued in revised form this October. (See Drinking Water Exposure discussion below.) Of the 19 original papers, there are three remaining (#14, #15, and #17) to be issued for public comment. The Aggregate paper (#14, #15) is scheduled to be released by this October, while the Cumulative paper will be issued in January.

Additional Science Policy Documents Being Made Available For Public Comment. OPP has decided to expand the original scope of the public comment process to include seven additional science policy papers. Four papers (#20, #22, #25 and #26) have been issued for comment. Three additional policy documents to be issued include papers on (a) interim early assessments for organophosphates (#21), (b) quantitative assessment of uses of concern for drinking water (#23), and (c) factoring drinking water treatment into drinking water assessments (#24).

Schedules for Revised Science Policy Documents. Following public comment, EPA intends to revise the draft science policy papers to incorporate and address the comments received from the public. Revising the science policy papers is taking longer than OPP originally determined. Comments from the public have been extensive and the sheer volume and detail of those comments requires careful examination and consideration by OPP staff. The public input on these issues will be invaluable in assuring the ultimate development of sound and consistent science policies that will guide and inform pesticide regulation in the coming years.

OPP has also determined that several of the science policies would benefit significantly from review by the Scientific Advisory Panel (SAP), either for consultation or full review. Scientific peer review greatly contributes to assuring that OPP's science policies rest on a sound scientific foundation. In a number of instances, the SAP's early reviews have identified important issues or have indicated steps needed to strengthen a policy document.

Consequently, OPP is updating the schedule for issuing its revised science policy documents to reflect the additional time required to assure careful consideration of all public comments and to allow for SAP review of selected papers.

OPP has completed the notice and comment process for one paper--Common Mechanism (#1)--by issuing it in revised form in February 1999. The policy papers on Threshold of Regulation (#4) and Cholinesterase Inhibition (#2) are to be issued revised this October.

Science Policy Documents On Estimating Drinking Water Exposure. In addition to changing its schedules for revising the science policy papers, OPP has also decided to reconfigure the content of the group of science policy papers that address drinking water exposure. OPP originally planned to issue three documents (#8, #18, and #19) regarding its approach to addressing drinking water exposure in its aggregate human health risk assessment process. OPP issued the first paper (#8) - a general overview of its interim approach and a discussion of its plans to improve the initial screening process - for public comment in January 1999. Among other topics, this paper described two specific planned improvements: (1) substituting a small drinking water reservoir for a farm pond in the model currently used to estimate pesticide residues in water ; and (2) adjusting screening level estimates from the model to account for the percentage of cropped land surrounding the drinking water source. These two planned improvements were developed to provide more realistic screening level estimates of pesticide concentrations in surface water. In its January 1999 paper, OPP explained that it was planning to present to the SAP information useful to assess these two changes.

OPP intended to describe specifically how these particular changes were being implemented in the two subsequent papers regarding drinking water (#18, #19) and to issue them for comment in late summer this year. In paper #18, OPP intended to present its decisions regarding the implementation of these two planned modifications, along with a revised policy statement and process description. Finally, in the last document on drinking water (#19), OPP intended to present its revised internal standard operating procedure for the implementation of these improvements.

Based on the public comments received on paper #8 and on the reactions to its May presentation to the SAP, OPP has decided to revise its approach to the drinking water papers. As planned, OPP presented to the SAP in May its approach for incorporating percent cropped area, coupled with a drinking water reservoir scenario, into its screening level drinking water assessments, where they were extensively discussed and commented upon. Since comments were supportive of the general direction of these two changes, OPP has decided to summarize these changes when it revises and reissues the January 1999 drinking water paper (#8), rather than delay or confuse the public regarding implementation of these improvements pending public comment on papers #18 and #19.

At the same time, OPP has identified two new science policy papers (#25 - #26) to be written regarding drinking water. EPA plans to issue the following: (1) a proposal (paper #25) for utilizing available data and models to develop quantitative estimates of pesticide concentrations in drinking water for certain pesticides and estimates of the potential size of the population exposed to these levels; and (2) a paper (# 26) on the effectiveness of water treatment in reducing pesticide levels in drinking water and a proposal for addressing treatment issues in the assessment process. OPP expects to propose that it begin to use the estimates developed in accordance with the methodologies described in these two papers in certain cases in quantitative, aggregate human health risk assessments.

FQPA TRAC SCIENCE POLICY ISSUES AND RELATED PAPERS

(10/4/99)

FQPA TRAC Science Policy Papers Status of Draft for Public Comment Status of Revision after Public Comment
1. Guidance for Identifying Pesticide Chemicals and Other Substances that Have a Common Mechanism of Toxicity Issued 8/6/98 Issued 2/5/99
2. Office of Pesticide Programs' Science Policy on the Use of Data on Cholinesterase Inhibition for Risk Assessments Issued 11/5/98

Went to SAP

several times.

Expected 10/99
3. Guidance for the Submission of Probabilistic Human Health Exposure Assessments to the Office of Pesticide Programs Issued 11/5/98

Went to SAP

3/98

Expected 6/00
4. Proposed Threshold of Regulation Policy When a Food Use Does Not Require a Tolerance Issued 12/4/98 Expected 10/99
5. Assigning Values to Nondetected/ Nonquantified Pesticide Residues in Human Health Dietary Exposure Assessments Issued 12/4/98 Expected 3/00
6. A Statistical Method for Incorporating Nondetected Pesticide Residues into Human Health Dietary Exposure Assessments Issued 12/4/98 Merged with #5
7. A User's Guide to Available OPP Information on Assessing Dietary (Food) Exposure to Pesticides Issued 1/4/99 Expected 3/00
8. Dietary (Drinking Water) Exposure Estimates Issued 1/4/99

Went to SAP 5/99

Expected 10/99
9. Framework for Assessing Non-Occupational/Non-Dietary (Residential) Exposure to Pesticides Issued 1/4/99 Expected 12/99
10. Standard Operating Procedures (SOPs) for Residential Exposure Assessment Issued 1/4/99

Went to SAP 9/99

Expected 12/99
11. Choosing a Percentile of Acute Dietary Exposure as a Threshold of Regulatory Concern (99.9th percentile) Issued 4/7/99

Went to SAP

as part of #3.

Expected 12/99
12. 10X Task Force and OPP Guidance Documents (three draft documents; one final) Issued 7/8/99

Went to SAP 5/99

Expected 4/00
13. Standard Operating Procedures (SOPs) for Use of the FQPA Factor Issued 7/8/99

Went to SAP 5/99

Expected 4/00
14. Guidance for Performing Aggregate Exposure and Risk Assessment Expected 10/99 Expected 5/00
15. SOP: Interim Guidance for Conducting Aggregate Exposure and Risk Assessment Merge with #14 Merge with #14
16. Use of the Pesticide Data Program (PDP) in Acute Dietary Assessment Issued 5/26/99

Went to SAP 5/99

Expected 1/00
17. Cumulative Risk Assessment Guidance Expected 1/00.

Hazard part went

to SAP 9/99; Exposure part to

SAP 12/99

Expected 8/00
18. Drinking Water Screening Level Assessment (Merge with

paper #8)

N/A
19. SOP for Drinking Water Assessments, including Reservoir Model (Merge with

paper #8)

N/A
Additional Related Papers
20. Data for Refining Anticipated Residue Estimates Used in Dietary Risk Assessments for Organophosphate Pesticides Issued 4/7/99 Expected 3/00
21. Interim Early Assessment Policy for Organosphosphate Pesticides To Be Determined To Be Determined
22. The Role of Use-Related Data in Pesticide Risk Assessment and Risk Management Issued 7/14/99 Expected 2/00
23. Guidelines for the Conduct of Bridging Studies for Use in Probabilistic Risk Assessment Issued 8/4/99 Merge with #20
24. Guidelines for the Conduct of Residue Decline Studies for Use in Prob. Risk Assess. Issued 8/4/99 Merge with #20
25. Quantitative Assessment of Uses of Concern for Drinking Water Expected 12/99

To SAP 5/00

Expected 7/00
26. Factoring Drinking Water Treatment into Drinking Water Assessments for Pesticides Expected 2/00

To SAP 5/00

Expected 9/00


OVERVIEW OF TRAC SCIENCE POLICY PAPERS

(10/6/99)


CHARACTERIZING HAZARD OF INDIVIDUAL PESTICIDES

Use of Data on Cholinesterase Inhibition for Risk Assessments (#2)

ASSESSING EXPOSURE OF AN INDIVIDUAL PESTICIDE

FOOD

DRINKING WATER

RESIDENTIAL

USE INFO

A User's Guide to Dietary (Food) Exposure (#7) Non-Detected Dietary Pesticide (Food) Residues (#5 & 6) Use of PDP Data in Acute Dietary Assess-ment (#16) Dietary (Drinking Water) Exposure Estimates (#8, 18, 19) Framework for Assessing Non-Occupational/ Non-Dietary (Residential) Exposure to Pesticides (#9) The Role of Use-Related Data in Pesticide Risk Assessment and Risk Management (#22)
Data for Refining Antici-pated Residue Estimates for OPs (#20) Guidelines for Conduct of Bridging Studies (#23) Guidelines for Conduct of Residue Decline Studies (#24) Quantitative Assessment of Uses of Concern for Drinking Water (#25) Factoring Drinking Water Treatment into Drinking Water Assessments (#26) Standard Operating Procedures (SOPs) for Residential Exposure Assessment (#10)

CHARACTERIZING RISK

Guidance for the Submission of Probabilistic Human Health Exposure Assessments (#3) OPP 10X Guidance Document

(#12, 13)

AGGREGATING RISK

Guidance for Performing Aggregate Exposure and Risk Assessment (#14 & 15)

CUMULATING RISK

Common Mechanism (#1) Cumulative Risk Assessment Guidance (#17)

RISK MANAGEMENT

Threshold of Regulation Policy (#4) Interim Early Assessment Policy for Organophosphate Pesticides (#21) Choosing a Percentile of Acute Dietary Exposure (99.9) as a Threshold of Regulatory Concern (#11)


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