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December 1988 - Standard Operating Procedures for the HED FQPA SAfety Factor Committee

Background | Scope | Procedures | Attendees | Scheduling a Meeting
Standard Information to Be Provided by Reviewers
Special Procedures for Section 18 Emergency Exemptions

I. BACKGROUND

The Food Quality Protection Act of 1996 (FQPA) requires that in the case of threshold effects "an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure be applied to infants and children to take into account potential pre- and post-natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children......the Administrator may use a different margin of safety for the pesticide chemical residue only if, on the basis of reliable data, such margin will be safe for infants and children". The FQPA Safety Factor Committee will make FQPA safety factor recommendations on all chemical risk assessments generated by HED following the guidance in the policy paper, FQPA Safety Factor for Infants and Children: General Guidance for Use.

II. SCOPE

The HED Safety Factor Committee (FQPA SFC) will consider:

  1. the contribution of hazard and dose response evaluations in determining whether the FQPA safety factor should be retained, reduced, or removed;
  2. the contribution of exposure assessment(s) in evaluating whether retention, reduction, or removal of the safety factor is appropriate; and
  3. the characterization of the hazard (toxicology data base) and exposure (dietary food, dietary drinking water, and residential) data bases.

III. PROCEDURES

For special procedures for Section 18 Emergency Exemptions, see Section VII below.

In order to assess the completeness of the data used in risk assessments and any potential effects on infants and children, the Committee will have at its disposal the report of the Hazard Identification Assessment Review Committee (HIARC) and written responses to sets of standard questions regarding the hazard and exposure information (dietary food, dietary drinking water and residential exposure considerations) prepared by the reviewers. The final recommendation on the retention, reduction, or removal of the safety factor will be made by consensus of the committee members. If no consensus can be reached, the committee will seek guidance from the HED, RD, and SRRD Directors. The final committee decision, supported by the documentation presented at the meeting, will be summarized in a short report. The committee will maintain a compilation of its recommendations. The FQPA Safety Factor Committee expects to hold meetings approximately four weeks after the HIARC meetings. This committee schedule will be included in the master schedule on the LAN.

IV. ATTENDEES

All chemical reviewers, risk assessors, designated HED branch chiefs, and appropriate risk managers representing RD or SRRD, will attend the meeting to answer any additional questions that may arise during the deliberations of the committee. Each of the hazard and exposure assessment areas should be represented (toxicology, dietary food exposure, dietary drinking water exposure, and residential exposure). If a reviewer, assessor, or risk manager is unable to attend, that reviewer, assessor, or risk manager will designate an appropriate person to attend in their absence.

V. SCHEDULING A MEETING

For Section 18 Emergency Exemptions, see Section VII below.

The FQPA Safety Factor Committee (FQPA SFC) will work in conjunction with the Hazard Identification Assessment Review Committee (HIARC) in reviewing registration and reregistration chemicals (FQPA SFC meeting will be scheduled approximately four weeks after HIARC) and the schedule for the FQPA SFC meetings will be incorporated into the master SARC schedule on the LAN (T:\HED\SCHEDULE\HAZ_RISK).

For those chemicals not currently listed on the master SARC schedule, the lead reviewer for the chemical risk assessment will contact the Executive Secretary and/or Committee Chair to schedule a meeting date.

VI. STANDARD INFORMATION TO BE PROVIDED BY REVIEWERS

The decision to retain, reduce, or remove the FQPA safety factor will be based on the answers to the following questions. The committee seeks characterization of the uncertainties in the data used for the hazard and exposure assessment, as well as, of the susceptibilities of infants and children.

i. Toxicological Considerations for FQPA Safety Factor Selection

Your scientific judgment and qualitative description are just as important as quantitative data in characterizing the hazard in terms of the reliability of data, severity of the effects, populations exposed, and the likelihood of effects on infants and children. So please keep in mind the goal of these questions (i.e., characterization of hazard).

  1. Has the scientific quality of the toxicology data base and the confidence in the hazard endpoints and dose-response assessments been completely characterized?
  2. Do we have adequate hazard studies for evaluation of risk to infants and children? These include, but are not limited to, developmental studies in 2 species; multi generation reproduction studies; neurotoxicity and developmental neurotoxicity studies as required for chemicals which affect the nervous system. Are additional studies being required?
  3. Do these studies show enhanced susceptibility to infants and children? That is, do the effects in the young occur at doses not causing effects in the adults? Are the effects in the young at the same level but more severe? Completely describe the spectrum of effects in both adult and young animals (include the shape of the dose response curve, the reversibility of effects if known, etc.).
  4. Have other studies (e.g., from the published literature) been considered which might influence a FQPA safety factor finding? Are there mode of action studies which may provide information on precursor effects at lower doses? Are there comparative metabolism and pharmacokinetic studies evaluating the dose at the target site or the duration of effect?

ii. Dietary Food Exposure Considerations for FQPA Safety Factor Selection

Your scientific judgment and qualitative description are just as important as quantitative data in characterizing the exposure in terms of the reliability of data, magnitude (are we overestimating or underestimating the real exposure), and populations exposed. So please keep in mind the goal of these questions (i.e., characterization of exposure).

  1. Describe (semi-quantitatively) the typical use rates and frequency of application. [There is no need to reproduce the labels. We are trying to determine whether there is a likelihood of quantifiable residues in the food.] Are there Codex MRL's for the compound?
  2. What metabolites require regulation? Are the residues systemic? That is, are they distributed throughout the plant or likely to be removed during preparation (washing, peeling, etc.)? Is information available about the dissipation or half-life of the pesticide?
  3. State and characterize the available residue databases for each crop (i.e field study data, sources of available monitoring data such as PDP, FDA, etc.). What are the limits of quantitation used ? Describe semi-quantitatively the results of residue testing (ranges, frequency of positive findings, etc.).
  4. Is there information available on % crop treated? If so, what is the source of the information and the uncertainties around the number? What is the likely maximum % crop treated for each crop (based on potential market)?
  5. Based on the consumption data base used by DRES or DEEM, which crops contribute significantly to the human diet for adults? Which contribute significantly to the diet of infants and children? Is there likelihood of transfer of residues to meat and/or milk? Describe the degree of refinement of the DRES or DEEM analyses for acute and chronic exposure.

iii. Dietary Drinking Water Exposure Considerations for FQPA Safety Factor Selection

Your scientific judgment and qualitative description are just as important as quantitative data in characterizing the exposure in terms of the reliability of data, magnitude (are we overestimating or underestimating the real exposure), and populations exposed. So please keep in mind the goal of these questions (i.e., characterization of exposure).

  1. Is the environmental fate database complete enough to characterize drinking water exposure?
    • a) Provide a brief summary of the environmental fate assessment for this compound and any metabolite that may potentially get into drinking water based on metabolite fate characteristics.
      b) Is the compound or any of its metabolites mobile and persistent? (A bottom line summary statement on drinking water exposure potential should be included.)
  2. Discuss method for drinking water exposure assessment (ex. monitoring data, modeling, combination).
    • a) If models are used, discuss which models, describe the resulting estimated environmental concentrations (EECs), and the scenarios used in the model.
      b) If monitoring data are used (ground water or surface water), describe the monitoring data and conditions under which they were collected (e.g., from vulnerable areas at maximum label rates).
  3. Please discuss the magnitude of the population potentially exposed to the pesticide via drinking water based on the extent of usage and whether the chemical characteristics indicate a likelihood of drinking water contamination.

iv. Residential Exposure Considerations for FQPA Safety Factor Selection

Your scientific judgment and qualitative description are just as important as quantitative data in characterizing the exposure in terms of the reliability of data, magnitude (are we overestimating or underestimating the real exposure), and populations exposed. So please keep in mind the goal of these questions (i.e., characterization of exposure).

  1. Is the compound used around the home in such a way that children and infants may be exposed? What is the frequency and rate of application?
  2. Have Pesticide Handler Exposure Database (PHED) data been used in estimating the exposure? How well does the PHED scenario reflect the actual use pattern? Rate the data used based on the PHED grading criteria (high quality, medium quality, or low quality). If chemical- specific or other non-PHED data have been used, describe the scope of the study, resulting exposure values, and general quality of the study.
  3. For residential post application exposure scenarios, have the Draft Standard Operating Procedures for Residential Exposure Assessments been used as the basis for all calculations? Describe any deviations from DRAFT SOP calculations and the impact on the assessment results (e.g., assessment reflects a less conservative approach by altering transfer coefficient value for dermal exposure).
  4. Is chemical-specific product use information available through BEAD or some other source? Has the assessment been developed to reflect this information? Has this information been used as a basis for characterizing the populations considered in the assessment?
  5. Are reliable biologically-based exposure data or epidemiology data available to support the results of the assessment (e.g., incident report, CDC biomonitoring data, etc.)?
  6. Have models other than PHED or those presented in the DRAFT Residential SOPs been used to calculate dose in any aspect of the assessment (e.g., CONSEXPO, TherDbase, etc)? Summarize how these are integrated into the assessment.
  7. Is 100% dermal absorption assumed (when dermal endpoints are derived from oral studies)? Or, are there chemical-specific data available that indicate a different dermal absorption rate?

v. Other Factors for FQPA Safety Factor Selection

VII. SPECIAL PROCEDURE FOR SECTION 18 EMERGENCY EXEMPTIONS

  1. A "Tier I" risk assessment for the Section 18 action is performed, assuming that the 10x factor for enhanced sensitivity to infants and children (as required by FQPA) is retained. If risk estimates do not exceed HED's level of concern under these circumstances, the Section 18 goes forward noting that the safety factor determination applies only to the Section 18 and is subject to change when the chemical undergoes full review by the FQPA Safety Factor Committee.
  2. If risk estimates exceed HED's level of concern when the 10x is assumed to be retained, the Section 18 team will contact designated "adhoc" representatives to make the safety factor determination for the Section 18. This will be a conservative decision since all the data and information needed may not be available. The Section 18 review team will document the recommendation by completing the Section 18 FQPA Safety Factor Determination form (found on the LAN). Reviewers will note in the risk assessment document that the safety factor determination applies only to the Section 18 and is subject to change when the chemical is reviewed by the FQPA Safety Factor Committee.
Scientific Advisory Panel (SAP): December 1998 Meeting
Standard Operating Procedures for the
HED FQPA Safety Factor Committee

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