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Staff paper 37A

FOOD QUALITY PROTECTION ACT TRAC SCIENCE POLICY ISSUES

(http://www.epa.gov/oppfead1/trac/science/)



PRESENTED AT THE

TRAC MEETING


APRIL 27-28, 1999

EPA'S TRAC SCIENCE POLICY COMMITMENTS

#1: "Guidance for Identifying Pesticide Chemicals That Have a Common Mechanism of Toxicity for Use in Assessing the Cumulative Toxic Effects of Pesticides" (Area 8)

-Issued Draft: 8/6/98

-Comment Period Closed: 10/8/98

-Issued Revised: 2/5/99

-Draft Policy: EPA will identify pesticides and other substances that cause a common toxic effect by a common mechanism, when assessing cumulative toxic effects. This guidance document describes specific steps and criteria that EPA will follow.

-Public Comments: Exposure as a criterion; other substances; definitions; assessing cumulative toxicity.

-Revised Policy: Clarifications made; cumulative paper referenced.

#2: "Office of Pesticide Program's Science Policy on the Use of Cholinesterase Inhibition for Risk Assessments of Organophosphate and Carbamate Pesticides" (Area 9)

-Issued Draft: 11/5/98

-Comment Period Closed: 1/19/99

-Projected to Be Revised: 5/99

-Draft Policy: EPA will use a weight-of-evidence approach to setting reference doses in risk assessments of OP's and carbamates. That is, EPA will consider all data on ChE inhibition effects in plasma, red blood cells and/or the brain for defining critical effects.

-Public Comments: reliability of regional brain ChE measures; peripheral nervous system ChE measures; whether to use NOAELs or NOELs for ChE inhibition; relevance of IPCS/WHO draft policy paper; use of plasma and/or red blood cell ChE measures.

#3: "Guidance for Submission of Probabilistic Human Health Exposure Assessments to the Office of Pesticide Programs'" (Area 2)

-Issued Draft: 11/5/98

-Comment Period Closed: 1/19/99

-Projected to Be Revised: 8/99

-Draft Policy: Draft guidance is provided concerning the use of probabilistic, dietary exposure assessments (i.e., Monte-Carlo analysis) for one-day (acute) exposures.

-Public Comments: The Scientific Advisory Panel (SAP) generally supports this approach. Other issues include: whether to exclude "outlier" data points (consumption and residue data); the appropriateness of 99.9th percentile; whether to incorporate a range of typical application rates and PHI's.

#4: "Proposed Threshold of Regulation P olicy When a Food Use Does Not Require a Tolerance" (Area 3)

-Issued Draft: 12/4/98

-Comment Period Closed: 2/18/99

-Projected to Be Revised: 5/99

-Draft Policy: If a pesticide use has no detectable residues, and if "essentially zero" exposure or risk is shown, then a tolerance would not be required because the use would be under the "threshold of regulation."

-Public Comments: How to keep track of uses that qualified for TOR; availability of analytical method used to support a TOR decision; harmonization with Canada & Codex.

#5: "Assigning Values to Nondetected/Nonquantified Pesticide Residues in Human Health Dietary Exposure Assessments" (Area 3)

-Issued Draft: 12/4/98

-Comment Period Closed: 2/4/99

-Projected to Be Revised: 6/99

-Draft Policy: When performing probabilistic risk assessments, EPA will assign a value of zero to non-detects which comprise the "untreated" portion of a commodity, and will assign the limit of detection or quantitation to the "treated" portion of a commodity.

-Public Comments: Relation of this policy to TOR policy; how to determine LOD and LOQ; whether to use or full LOD or LOQ in acute risk assessments.

#6: "A Statistical Method for Incorporating Nondetected Pesticide Residues into Human Health Dietary Exposure Assessments." (to be merged with paper #5) (Area 3)

-Issued Draft: 12/4/98

-Comment Period Closed: 2/4/99

-Projected to Be Revised: 6/99

-Draft Policy: If non-detects for the treated portion of a commodity comprise less than half of the data set, a statistical method is available for estimating a value to assign non-detects other than LOD or LOQ.

-Public Comments: Methods other than "Cohen's Method" may be O.K.; whether methods should be limited to data sets that are < 50% non-detects; whether EPA should assume that data sets are lognormal.

#7: "A User's Guide to Available OPP Information on Assessing Dietary (Food) Exposure to Pesticides" (Area 4)

-Issued Draft: 1/4/99

-Comment Period Closes: 3/4/99

-Projected to Be Revised: 5/99

-Proposed Policy: EPA describes in "plain English" how it conducts acute and chronic dietary (food) exposure assessments and tells where more information on on these assessments appears in EPA documents.

#8: "Dietary (Drinking Water) Exposure Estimates" (Area 5)

-Issued Draft: 1/4/99

-Comment Period Closes: 3/4/99

-Projected to Be Revised: 7/99

-Proposed Policy: EPA describes its basic approach to screening methods that identify pesticides which may reach drinking water at levels of concern. Planned improvements include replacing "farm pond" with "drinking water reservoir," accounting for surrounding area that is cropped, and developing a tier 2 screening model for groundwater.

#9: "Framework for Assessing Non-Occupational, Non-Dietary (Residential) Exposure to Pesticides" (Area 6)

-Issued Draft: 1/4/99

-Comment Period Closes: 3/4/99

-Projected to Be Revised: 6/99

-Draft Policy: This document summarizes EPA's residential exposure assessment methods, the conservative nature of these methods, and how EPA is refining them.

#10: "Standard Operating Procedures (SOPs) for Residential Exposure Assessment" (Area 6)

-Issued Draft: 1/4/99

-Comment Period Closes: 3/4/99

-Projected to Be Revised: 6/99

-Draft Policy: Standard methods for conducting residential exposure assessments are described for handler and post-application scenarios when actual data are not available. This draft has been updated from the 1997 draft. The SAP reviewed the first draft in 9/97; EPA has responded to these comments, but plans to go back to the SAP in 7/99.

#11: "Choosing a Percentile of Acute Dietary Exposure as a Threshold of Regulatory Concern" (Area 2)

-Issued: 4/7/99

-Comment Period to Close: 6/99

-Projected to Be Revised: 9/99

-Draft Policy: EPA has chosen to regulate at the 99.9th percentile of acute dietary (food) exposure when using a probabilistic risk assessment method. EPA will conduct sensitivity analyses, as needed, to pinpoint any problems with the assessment.

#12: "10X Task Force and OPP Guidance Documents" (3 documents; Area 1)

-Drafts to be Issued: 4/99

-Comment Period to Close: 6/99

-Projected to Be Revised: 9/99

-Draft Policy: When assessing dietary (food) risk from pesticides, EPA will use a 10-fold factor unless, based on a weight-of-the-evidence evaluation of available and reliable data, it concludes that this factor should be modified or not used. These documents will contain criteria and procedures for making this determination.

#13: "Standard Operating Procedure for the Use of the FQPA Factor" (Area 1)

-Draft to be Issued: 4/99

-Comment Period to Close: 6/99

-Projected to Be Revised: 9/99

-Draft Policy: EPA will develop detailed, working level guidance for applying the policy established in the 10X Task Force guidance documents. This document was presented to the SAP in December 1998; EPA will address these comments in the draft document.

#14: "Guidance for Performing Aggregate Exposure and Risk Assessments" (Area 7)

-Draft to be Issued: 5/99

-Comment Period to Close: 7/99

-Projected to Be Revised: 10/99

-Draft Policy: Guidance will be provided concerning methods of aggregating dietary (food/water) and non-occupational (residential) exposure, ranging from simple addition of point estimates (deterministic) to distributions of risks for the general population and subpopulations (probabilistic).

#15: "Standard Operating Procedures for Performing Aggregate Exposure and Risk Assessments" (Area 7)

-Draft to be Issued: 5/99

-Comment Period to Close: 7/99

-Projected to Be Revised: 10/99

-Draft Policy: EPA will develop detailed, working level guidance for applying the policy established in the Aggregate Exposure Assessment Policy guidance document.

#16: "Use of the Pesticide Data Program in Acute Dietary Exposure Assessment" (Area 2)

-Draft to be Issued: 5/99

-Comment Period to Close: 7/99

-Projected to Be Revised: 10/99

-Draft Policy: EPA will describe statistical methods for using composite data to estimate exposure from single serving food items.

#17: " Cumulative Risk Guidance" (Area 9)

-Draft to be Issued: 8/99

-Comment Period to Close: 11/99

-Projected to Be Revised: 2/00

-Draft Policy: The Agency will describe its approach to conducting cumulative risk assessment for pesticide chemicals that have a common toxic effect by a common mechanism. The International Life Sciences Institute (ILSI) is developing recommendations for EPA's consideration.

#18: "Drinking Water Screening Level Assessments" (Area 5)

-Draft to be Issued: 8/99

-Comment Period to Close: 10/99

-Projected to Be Revised: 1/00

-Draft Policy: EPA will consider the percentage of the area around a reservoir that is cropped (i.e.,potentially treated) when it uses its model to predict pesticide levels in a drinking water reservoir. Currently, EPA assumes that 100% of the surrounding area is cropped.

#19: " Revised SOP for Drinking Water Assessments" (Area 5)

-Draft to be Issued: 8/99

-Comment Period to Close: 10/99

-Projected to Be Revised: 1/00

-Draft Policy: EPA will update its current SOP to include the percent cropped area treated around a drinking water reservoir.

"Interim Early Assessment Policy for

Organophosphate Pesticides"

--Make some early tolerance reassessment decisions, thereby reducing the number of tolerances remaining to be reassessed.

--Focus EPA resources on higher risk uses.

-Provide certainty to users about regulatory status of certain uses.

-Dietary risk is an insignificant percentage of projected cumulative risk value.

-All other risks are acceptable.

-No water-related concerns exist.

-No more than 5% of "risk cup" allotted to eligible uses.

-"No reported" and "trace" consumption foods

-"Low consumption" foods

-Feed commodities that produce "No reasonable expectation of finite residues" in livestock and poultry

"The Role of Use-Related Information in Pesticide Risk Assessment and Risk Management"

"Data for Refining Anticipated Residue Estimates Used in Dietary Risk Assessments for

Organophosphate Pesticides"

(Issued 4/7/99)

--how residue data and usage data are linked

--types of residue studies that are used to evaluate impact on residues of different application parameters

--how EPA will use such data in dietary exposure assessments

1. Reduced rate studies which measure changes in residues resulting from decreasing rate of frequency of application

2. Residue decline studies, which can be used to quantify the differences in residues resulting from various pre-harvest intervals (PHIs)

3. Residue degradation studies, which characterize the decreasing amounts of residues over time

4. Cooking and processing data

5. Market basket data

6. Residues in meat and milk


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updated April 26, 1998