OFFICE OF PESTICIDE PROGRAMS STANDARD OPERATING PROCEDURE. IMPLEMENTATION of the THRESHOLD OF REGULATION POLICY

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1 OFFICE OF PESTICIDE PROGRAMS STANDARD OPERATING PROCEDURE IMPLEMENTATION of the THRESHOLD OF REGULATION POLICY BACKGROUND In the Federal Register of October 27, 1999 (64 FR 57881), the Environmental Protection Agency (EPA) announced the availability of a document entitled Threshold of Regulation Policy - Deciding Whether a Pesticide with a Food Use Pattern Needs a Tolerance. The Threshold of Regulation (TOR) Policy contains factors to consider and procedures to use when determining whether a use of a pesticide in a location and manner that has the possibility of resulting in residues in food is below the threshold of regulation. As explained in the policy notice, a use may be below the threshold of regulation if: a) using a reliable and appropriately sensitive analytical method to measure residues in the commodity, no residues are detected in the commodity under the expected conditions of use; and (b) using reasonably protective criteria, the estimated potential risk of any theoretically possible residues in food is not of concern. In PR Notice, the Office of Pesticide Programs (OPP) provided guidance to registrants and other persons on how to submit a request for a TOR decision and explained the process EPA will use in making TOR decisions in the course of pesticide registration or reregistration. A registrant or other person may submit a request for a TOR decision for a new pesticide use as part of the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) section 3 registration process or for an existing use during reregistration under FIFRA section 4 or tolerance reassessment under section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA). A State may request a TOR decision for a use that the State is considering for registration under 24(c) or as part of a request for an emergency exemption under FIFRA section 18. PR Notice stated that EPA will follow Standard Operating Procedures (SOPs) for processing TOR requests. This document is the SOP for processing TOR requests. HOW TO USE THIS SOP Part 1 of this SOP outlines OPP procedures for cradle-to-grave management of pesticide uses that are below the threshold of regulation, as described in the October 1999 policy. A TOR decision may occur in the context of either registration, reregistration or tolerance reassessment. Part 1 describes how evaluation of a TOR request fits into these processes. Part 2 of this SOP provides detailed guidance to science reviewers. It describes how to apply the criteria described in the policy notice to determine whether a use of a pesticide on or near food is below the threshold of regulation. When a TOR request is part of a registration action,

2 science reviewers should also determine whether a pesticide use poses unacceptable risk to man or the environment through exposure to pesticide residues in drinking water, occupational hazards, or ecological risk. Reviewers should rely on existing guidance for making determinations about drinking water exposures, occupational exposures or ecological risk and this guidance will not be repeated here. This SOP considers the review procedures and science policies that guide the evaluation of human health risks posed by conventional pesticides used on or near food. Accordingly, it is primarily addressed to reviewers in the Health Effects Division. However, the sequence of steps and the logic applied in the analysis may pertain to the evaluation of antimicrobial pesticides or non-conventional pesticides that may be used in a location and manner that has the possibility of resulting in pesticide residues in food. Accordingly, science reviewers in the Antimicrobial Division (AD) or Biopesticides and Pollution Prevention Division (BPPD) may adopt this guidance into their own review procedures and science policies. Part 3 of this SOP provides guidance to review managers in Special Review and Reregistration Division (SRRD) regarding the processing of requests for TOR decisions within the context of reregistration and tolerance reassessment. Page 2 of 14

3 PART 1 PROCESSING REQUESTS FOR TOR DECISIONS INTRODUCTION There are 4 stages in handling Requests for TOR Decisions: 1) Information Resources and Services Division (IRSD) in-processing; 2) Risk manager processing; 3) Science review; 4) Postreview processing by risk manager. After a TOR request has been granted, a fifth stage compliance monitoring begins and continues indefinitely. Depending on the outcome of a review of information received in the compliance monitoring stage, a sixth stage Revoking a TOR Decision may be necessary. OUTLINE OF THE TOR REVIEW PROCESS 1. IRSD Processing a. IRSD receives a TOR decision request. i. If it is a new submission, process it like a special kind of tolerance petition. (1) assign a TOR petition number (2) create petition jacket and stub PRATS entry (3) assign MRIDs to accompanying data and record petition number in PDMS. (4) follow existing procedures for checking compliance with formatting requirements. ii. If it is a resubmission, assign MRIDs to any accompanying data and record petition number in PDMS. b. Send to Risk Manager in RD, BPPD, AD or SRRD. 2. Risk Manager Processing [SRRD review managers, see Part 3 for further instructions.] a. Verify IRSD classification of the submission as a request for TOR decision. b. Consult with HED to establish appropriate decision processes for dietary exposure and for occupational exposure, including priority, milestones, timeframes and due dates. Milestones include decision meetings and written reviews. Consult with EFED regarding assessment of potential drinking water exposures and hazards to non-target organisms. c. Send to science reviewers. d. Enter appropriate action code in PRATS/OPPIN. 3. Science Review of the TOR Request. [Science reviewers, see Part 2 for details.] a. Assess whether potential exposures from the use are below the threshold of regulation. Page 3 of 14

4 i. Verify risk manager s decision that this submission is a TOR decision request. ii. Confirm timeframes, milestones and due dates. iii. Review the request and supporting data in accordance with appropriate data evaluation guidance. iv. If the review confirms that no detectable levels are expected, conduct a dietary risk assessment. v. Assess risks from potential dietary exposures, considering the guidelines set forth in the TOR Policy. b. Evaluate occupational exposure, potential for drinking water exposure or risks to non-target organisms in accordance with guidance for conducting such reviews. c. Inform risk manager of the results of these assessments. 4. Risk Manager s Post-Review Actions for TOR requests that accompany registration actions. [SRRD review managers, see Part 3 for instructions for processing TOR requests submitted during reregistration or tolerance reassessment.] a. Risk Manager verifies that the science reviews address the issues raised in his request. If not, ask the science reviewer(s) to complete their review(s). b. Risk Manager examines the TOR review and decides: i. TOR request is deficient. (1) Reject TOR request and ask for more data. (2) Defer a decision on registering the new use. (3) Enter appropriate action code in PRATS/OPPIN. ii. Use described in the TOR Decision Request exceeds the threshold of regulation, i.e., a tolerance is needed. (1) Is there is a reason why a tolerance CANNOT be granted (e.g., previous reviews show that the risk cup is already full)? (a) YES. Notify registrant that TOR request is rejected and any petition to establish a tolerance or exemption will be rejected. Do not register the use. (b) NO. Notify registrant that the TOR request is rejected, but it may be possible to establish a tolerance or exemption for the use. Defer a decision on registering the new use until the tolerance issue has been resolved. The registrant must submit a tolerance petition for the use and pay fees. Process the submission like any other tolerance petition. iii. The use is below the threshold of regulation. c. If the use is below the threshold of regulation, the risk manager examines other science reviews of the use. Does the use pose an unacceptable risk because of potential to contaminate drinking water, hazards to non-target species, occupational exposure or other reason identified in the science review? i. YES. The new use cannot be registered as proposed and no TOR determination can be made. Notify the registrant. Enter appropriate codes Page 4 of 14

5 ii. in PRATS and OPPIN. NO. Proceed as follows: (1) Publish a proposed rule in the Federal Register to establish the use as a TOR use. (2) After reviewing comments, publish a final rule in the Federal Register. (3) Decide on the amendment request (i.e., product-specific label changes to permit the TOR use) and register the use. (4) Via PRATS/OPPIN, notify IRSD of the TOR and registration decisions. (5) IRSD enters the TOR use in TIS/OPPIN. Records are stored and retained in the same way as records for tolerance decisions. 5. Compliance monitoring a. Risk Manager receives information that suggests that a TOR use may be not be below the threshold of regulation, such as: i. FDA notifies EPA that residues were found. ii. EPA receives other information relating to a TOR use such as (1) USDA s PDP data that report residues in food, or (2) FIFRA 6(a)(2) submissions that report residues in food for which no tolerance has been established. iii. EPA revises the RfD, FQPA safety factor or cancer potency factor (q*). b. Risk Manager sends new information to science reviewers for analysis. c. Risk Manager examines science reviews; decides whether the TOR decision should be allowed to stand, modified, or revoked. 6. Revoking a TOR decision. a. If examination of new information shows that a TOR use should be revoked, the risk manager will determine whether there is a reason why a tolerance CANNOT be granted (e.g., risk cup is already full). i. NO. Notify registrant to submit a tolerance petition. ii. YES. Seek cancellation of TOR use voluntary under FIFRA 6(f) or EPA-initiated under FIFRA 6(b). b. Initiate rule-making to revoke TOR decision. i. Proposal ii. Comments iii. Analyze comments iv. Final c. Via PRATS/OPPIN, notify IRSD of TOR and registration decisions. Page 5 of 14

6 PART 2 GUIDANCE FOR SCIENCE REVIEWERS IN REVIEWING TOR REQUESTS INTRODUCTION On October 18, 1999 the Office of Pesticide Programs (OPP) issued a document entitled THRESHOLD OF REGULATION POLICY - DECIDING WHETHER A PESTICIDE WITH A FOOD USE PATTERN NEEDS A TOLERANCE. This policy was developed to address food uses of pesticides which pose minimal ( essentially zero ) risk, but for which a tolerance could not be established due to the aggregate risk for the chemical being unacceptable (i.e., the risk cup is full). For a use to be considered below the threshold of regulation (TOR) it generally needs to produce no detectable residues with an analytical method having a limit of quantitation (LOQ) of 0.01 ppm (10 ppb) or less. On a case-by-case basis the LOQ may need to be <0.01 ppm or could be allowed to exceed that level. In addition, the dietary risks from the treated food posed by the use generally need to be 1/1000 or less of the Agency s normal acceptable level. This means that the risk from the use of a potentially carcinogenic pesticide (i.e., those for which EPA has used a linear model to analyze dose response) generally has to be 1 x 10E-9 or less. With respect to acute and chronic effects, the dietary risks from the tr eated food would generally have to be equal to or less than 0.1% of the acute population adjusted dose (PAD) and chronic PAD, respectively. The residue level used in the risk assessment will usually be half the limit of detection (LOD). If appropriate data are available supporting use of a lower residue level, that value may be used to calculate the dietary risks. Where uses are consistent with these considerations, EPA generally will not require a tolerance or exemption from a tolerance under Section 408 of the FFDCA and generally will not include any theoretical exposure from the use in the aggregate or cumulative risk assessments for the pesticide. However, it should be noted that the use will also need to be evaluated under FIFRA to determine that there are not unacceptable risks to wildlife and workers before it can be registered. In addition, the Agency should determine whether residues in drinking water attributable to the proposed use pose an unreasonable risk. For those uses shown to be below the threshold of regulation, the Agency will seek public comment by publishing a proposed rule in the Federal Register describing the intended use, the information relied upon for the decision, and the analytical method for quantifying residues in the food. After examining public comments a final rule, if appropriate, will be published in 40 CFR for the TOR decision specifying the pesticide, conditions of use, and the analytical method. In summary, use of a pesticide that results in no detectable residues and essentially zero risk (generally1/1000 of normally acceptable risk) is eligible for consideration under the TOR policy. For uses found to be below the TOR, EPA generally will not establish a tolerance or exemption from a tolerance and generally will not include any theoretical exposure from the use in the aggregate or cumulative risk assessments for the pesticide. This policy does not apply to or impact non-food uses such as applications to non-bearing fruit trees a year or more prior to Page 6 of 14

7 harvest. Such uses also do not require a tolerance. However, unlike TOR uses, a dietary risk assessment is not conducted and the long-term toxicology studies can usually be waived for these non-food uses. The purpose of this document is to describe the tasks required during data review and risk assessment for both proposed and registered uses with respect to determining whether the TOR policy applies to such pesticide treatments. Although any pesticide use being reviewed for registration (including Section 18 emergency exemptions and Section 24(c) special local need registrations), reregistration, and tolerance reassessment may potentially qualify for the TOR policy, science reviewers should determine TOR eligibility only in those cases where a registrant specifically requests a use be registered or reregistered using this approach. On a case-by-case basis, EPA may assess, on its own initiative, whether a use requested under Section 18 is below the threshold of regulation. ROLE OF TOXICOLOGIST The tasks for the toxicologist should not be impacted by the process for determining whether a food use qualifies for the TOR policy. As described above, a dietary risk assessment is generally used to assess TOR eligibility. Therefore, as with most any other food use, the complete toxicology data base including the chronic studies should be reviewed to establish the reference dose(s) and whether the pesticide is carcinogenic. The FQPA safety factor will also need to be addressed. It is thus anticipated that the toxicologist for the chemical will need to participate in the standard committee processes (hazard identification, cancer if necessary, FQPA safety factor). ROLE OF RESIDUE CHEMIST The key task of the residue chemist is to determine whether the use (proposed or, in the case of tolerance reassessment, registered) results in no detectable residues. The first step of this process is to ascertain whether the analytical method is sufficiently sensitive for a TOR decision. The petitioner or registrant should provide evidence that the LOQ of the method is 0.01 ppm or less. If there are multiple analytes which generate separate responses in the procedure, the LOQ should be 0.01 ppm or less for each one. On a case-by-case basis an LOQ >0.01 ppm may be acceptable. One such case which was suggested in public comments was a pesticide which did not possess any heteroatoms such as nitrogen, sulfur or a halogen. This compound would be unlikely to be sufficiently sensitive for detection at 0.01 ppm in food matrices. Petitioners should clearly explain how the LOQ and LOD of the method were determined and cite data or literature references describing such procedures. For LOQ s >0.01 ppm the petitioner should provide a rationale why it is acceptable. For recent guidance on the determination of LOQ/LOD for analytical methods, refer to the 3/23/2000 OPP document ASSIGNING VALUES TO NON- DETECTED/NON-QUANTIFIED PESTICIDE RESIDUES IN HUMAN HEALTH FOOD EXPOSURE ASSESSMENTS. As a general matter, the LOD for a method will be about one third the LOQ. Page 7 of 14

8 Because the determination that residues are undetectable is so critical to a TOR decision, the analytic method for the tolerance should be carefully examined. The method should be successfully validated by an independent laboratory as well as the petitioner. Unless the method is very specific (e.g., MS/MS detection), a confirmatory method should also be provided. The method(s) should be sent to OPP s Analytical Chemistry Branch (ACB) for review. Depending on the results of toxicology studies and risk assessments, the ACB may run the analytical method to confirm the results used to demonstrate the lack of residues and the LOD/LOQ determination, as part of the TOR determination. If the method is adequate, the chemist next should review the magnitude of the residue studies relevant to the proposed use. The reviewer should examine all submitted raw data (e.g., peak heights/areas) and chromatograms for the field trials to see whether residues reflecting the maximum proposed use are truly not detectable (<LOD as opposed to just <LOQ) in all raw agricultural commodities of the crop as specified in Table 1 of Guideline In general, all treated samples should have residues <LOD for all the residues of concern. As to treated samples that have responses/peaks at the analyte s retention time, reviewers should examine on a case by case basis whether it is clear that residues are being detected. The reviewer should examine chromatograms for both control and treated samples. If there is a low level interference in control samples, the treated samples may have similar responses and still be considered not to have detectable residues. The numbers of field trials and samples should conform with those recommended in Guideline Monitoring or market basket data will generally be of little usefulness for TOR determinations because it can not be ascertained whether samples have been treated with the pesticide. Data translation should be considered on a case-by-case basis taking into account both the appropriateness of the translation and the feasibility of obtaining more crop-specific data. The crop grouping concept in 40 CFR may also be applicable to TOR decisions. If residues are <LOD for all the representative commodities of a crop group, it may be appropriate to assume that residues are <LOD in all other members of that group, provided that conditions of use are similar. In addition to assessing whether residues will be present in the RAC s, the chemist should determine whether detectable residues could occur in processed commodities from the crop (again, those items specified in Table 1 of ). In those cases where the processing study has been waived due to the absence of quantifiable residues in the RAC from a 5x application rate, it generally can be concluded that detectable residues will not occur in the processed commodities. If a processing study has been conducted, the reviewer should examine the raw data and chromatograms to assess whether detectable residues are present. Residues in studies which have been conducted at an exaggerated rate may be adjusted to account for that factor before deciding whether residues would be detectable in the processed items following use of the pesticide at the 1x rate. Crops for which particular attention should be paid include citrus and mint. Due to the high potential concentration factors for the oils of these crops, non-detectable residues in the RAC may lead to detectable residues in the oils. Page 8 of 14

9 The chemist also should determine whether the proposed use could result in detectable residues in rotational crops. For this purpose the plantback intervals on the label and the results of the confined (and, if available, field) rotational crop studies are the key elements. If the plantback intervals have been chosen such that rotational crop tolerances are not necessary in conjunction with the maximum application rate proposed for approval under the threshold of regulation policy, this generally should be sufficient for the purposes of the TOR policy to conclude that residues will not occur. If rotational crop tolerances are required with that rate, the use probably would not be eligible for TOR since the determination that tolerances are needed presumably would have been based on the fact that residues were detected in rotated crops. The chemist must be sure to consider the rate of application for the specific proposed use when making this determination. It is possible that rotational crop tolerances are needed for higher rate uses on other crops, while the rate proposed for the potential TOR use does not require such tolerances. A question may arise as to possible dietary risks associated with livestock feed items. However, given the Agency s experience on this issue, if a use results in no detectable residues in all the crop parts of regulatory concern, it is highly unlikely that detectable residues will occur in meat, milk, poultry and eggs as a result of ingestion of the feed items derived from that crop. Therefore, an assessment of potential residues in livestock commodities generally will not be needed for TOR determinations. In the area of tolerances for meat, milk, poultry and eggs to cover those uses which do not qualify for TOR, it should be noted that the TOR policy does not affect the procedures already in place (see 10/30/97 memo from Chemistry Science Advisory Council, file mmpe-tol.001). The need for tolerances in these commodities will still be based on feeding or dermal treatment studies conducted at a 10x rate. If residues are not quantifiable in the livestock commodities from such a rate, tolerances are not required (40 CFR 180.6(a)(3)). A dietary risk assessment is not necessary to make this determination (unlike TOR decisions for uses on crops). If the chemist s analysis shows that the use may be eligible for TOR status from the method and residue perspective, the chemist should inform the dietary risk assessor (DEEM analyst) of the crop and the appropriate residue level so risks can be calculated. The normal residue level to be inserted would be ½ the LOD. The reasons for selecting such a value are discussed in the aforementioned 3/23/2000 science policy paper. The TOR policy notes that a level <½ LOD may be used based on looking at all the available data (e.g., metabolism studies, exaggerated rate data). However, at this time a tiered approach should be used in this regard. In other words, the first DEEM analysis should be based on one half LOD residues. If the risk for any population in DEEM exceeds the TOR guideline (with the exception of carcinogenic risk where only the overall U.S. population is considered), the chemist will then see if the ½ LOD value can be refined. For this purpose the reviewer should consider the results of the radiolabeled plant metabolism studies, crop field trials conducted at exaggerated rates, and any residue decline data generated at application rates and/or preharvest intervals different from the proposed or registered use. Refined residue levels (i.e., <½ LOD) should be given to the DEEM analyst for Page 9 of 14

10 another dietary risk assessment. Although the tiered approach described above should generally be followed, if the registrant petitioning for the TOR decision has proposed use of a residue level <½ LOD, the chemist should look into that refinement before giving any values to the DEEM analyst. The chemist should also inform the DEEM analyst which default adjustment factors can be reduced to one. In many cases this may be possible for commodities which are included in the processing studies (e.g., fruit juice). For commodities not analyzed in these studies (e.g., many dried fruit), the default adjustment factor should not be reduced to one. For fruit juice concentrate it will often be necessary to account for the possibility of residues increasing from juice to the concentrate even if it can be concluded that residues do not concentrate in the juice itself. Once the chemist has completed all the above analyses, the conclusions reached regarding the TOR eligibility from the method and residue perspective should be documented in writing. If the analysis shows that there is no need to assess the potential dietary risk, this will be the only memo prepared on the TOR eligibility question. This document is analogous to the residue chemistry review of a tolerance petition and should be sent to the appropriate risk manager. It will be filed under the chemistry directory for the pesticide. If the chemist s analysis shows that the use may be eligible for TOR status from the method and residue perspective, the written conclusions of the chemist will become part of the document prepared by the lead risk assessor. Regardless of where the discussion is placed, the chemist should document the decisions on the analytical method and residues in RAC s, processed commodities, and rotational crops. ROLE OF DIETARY RISK ASSESSOR (DEEM ANALYST) The DEEM analyst will be responsible for calculating the dietary risks using the residue information from the chemist, the reference dose(s), and the FQPA safety factor. As with any other risk assessment, the final risk estimates can not be made until the appropriate committees (e.g., HIARC) have completed their work. For those cases where uses on more than one crop result in no detected residues, each crop should be run individually (or the output be formatted to show each crop individually) since the TOR eligibility decision is made on a crop-by-crop basis. Each crop should be assumed to be 100% treated. The analysis should not include any crops which exceed the threshold of regulation because of residue chemistry considerations. Default adjustment factors in DEEM should not be reduced to one unless processing data are available for that specific commodity showing residues do not concentrate (see discussion in the Role of Residue Chemist section). The expected product from the DEEM analyst is a list of the chronic and, if applicable, acute and/or carcinogenic risks from each crop for all the populations normally included in dietary risk assessments. The chronic risks should be in terms of the % of the chronic PAD, the acute risks in terms of the % of the acute PAD at 95 th percentile of per capita exposure, and carcinogenic risks in probabilistic terms (if q*) or as a margin of exposure (MOE) (if threshold). [Note that OPP has not yet addressed what the MOE should be for a threshold carcinogen to qualify for the TOR policy.] The list of risks should be given to the residue chemist Page 10 of 14

11 and the lead risk assessor for the pesticide. The residue chemist may need to look at refining some of the residue values, while the lead risk assessor should issue a memo to the risk manager outlining whether the use(s) is (are) eligible for the TOR policy. Once the final DEEM runs have been completed (i.e., taking into account possible refinement of residues below half the LOD), a short memo should be prepared to document the analyses with the outputs attached per the usual procedures. The memo will be filed under the chemistry directory for the pesticide. ROLE OF OCCUPATIONAL RESIDENTIAL EXPOSURE ASSESSOR No tasks are anticipated for occupational and residential exposure assessors in determining TOR eligibility since the only factors considered in determining TOR status are the detectability of residues in food and the dietary risk associated with the use. However, if the use does qualify for TOR, an occupational risk assessment will be needed under FIFRA before the use would be registered. This assessment would be prepared as a separate document from that prepared by the lead risk assessor on TOR eligibility. If the use is not eligible for TOR, it may come back as a tolerance petition in which case a residential exposure assessment may be required (as part of aggregate assessment) in addition to the occupational risk determination. ROLE OF LEAD RISK ASSESSOR The lead risk assessor will be responsible for preparing a document for the risk manager concerning the potential qualification of the use for TOR (unless the use fails on the method/residue considerations in which case the residue chemist prepares the review). In the case of a use associated with reregistration or tolerance reassessment, the discussion on TOR eligibility can be put in the health effects RED chapter as opposed to a separate memo. Although the document should address dietary risks, evaluation by the Risk Assessment Review Committee (RARC) will not be required. The no detectable residue consideration should be addressed with text provided by the chemist. In those cases where the method was sent to the OPP/BEAD laboratory for validation and that testing has not been completed, the risk assessor s conclusion on adequacy of the method should be contingent on those results. The risk consideration should also be discussed based on the output(s) from the DEEM analyst. With regard to toxicology, the memo should have only a summary of the dietary endpoints selected by the Hazard Identification Assessment Review Committee, including the cancer potency factor if applicable. If the use does qualify for TOR, the analytical method should be described briefly (including LOQ and LOD) along with providing the full title and MRID number. This information will be used in the FR notice seeking public comment on the proposed TOR regulation. As noted earlier, a use qualifying for TOR generally will not be included in the aggregate risk assessment for the pesticide. For those food uses not eligible for TOR, a tolerance and inclusion in an aggregate risk assessment would be needed for the use to be registered. However, an aggregate assessment should not be conducted including such uses at this stage. Instead, the Page 11 of 14

12 risk assessor should just inform the risk manager of the ineligibility and the reasons therefore. Risk managers will then decide how to proceed with the TOR decision request. If it is converted to a tolerance petition, it would be reviewed under existing procedures. It is understood that the TOR policy applies to tolerance setting review under the FFDCA in order to approve the registration of new pesticide uses or to permit the continuation of existing registrations where the use leaves no measured residue on food and any residue that may be theoretically present poses 'essentially zero' risk. A tolerance is not needed for a use that qualifies under the TOR policy. Accordingly, there is no need to assess the aggregate human health risk posed by the pesticide as is required under the FFDCA when establishing or reassessing a tolerance. Some scenarios can be envisioned in which a use could qualify as being below the threshold of regulation but could still potentially result in the pesticide entering surface water sources for drinking water, e.g., pre-bloom application of pesticides to orchard crops. Even though OPP would not be required to quantify the human health risk from drinking water exposure for a use that is below the threshold of regulation under the FFDCA, environmental risk assessors should evaluate under FIFRA the potential of the pesticide use to result in human exposure via drinking water. If pesticide concentrations in drinking water become an issue for a use that is below the threshold of regulation under the FFDCA, science reviewers and risk managers would have to determine what should be done from a human health risk assessment perspective and the risk managers should address the issue in their regulatory decision making process under FIFRA. In the near future, environmental risk assessors are expecting to complete a policy paper which describes a tiered screening approach for estimating pesticide concentrations in drinking water for use in human health aggregate risk assessment. This policy will be peered reviewed by the Scientific Advisory Panel and will also be made available for public comment. The policy paper will be accompanied by a Standard Operating Procedure which will describe step wise procedures on how these drinking water assessments will be carried out. Page 12 of 14

13 PART 3 GUIDANCE FOR SRRD IN ESTABLISHING TOR USES DURING REREGISTRATION IDENTIFYING POTENTIAL TOR USES SRRD s mission is to review existing registrations and reassess existing tolerances. While performing the tasks to carry out this mission, SRRD chemical review managers have opportunities to identify pesticide uses that have the potential to become TOR uses. Examples of potential TOR uses include: uses for which the tolerance is set at non-detectable or zero, uses for which tolerances were not required when the use was registered but are now considered to be food uses, or uses where reducing the application rate has resulted in residue levels that are below the level of detection. It is likely that case managers will discover other examples of potential TOR uses. As a matter of policy, the Pesticides Program will not review potential TOR uses on its own initiative. However, chemical review managers should remind registrants or other stakeholders that they may request TOR status for particular uses under the 1999 TOR policy. Chemical review managers may provide this information at SMART meetings and in letters transmitting the results of residue chemistry data reviews. Chemical review managers may be aware of other opportunities for alerting stakeholders to the availability of the TOR decision procedures. Registrants and other interested parties are responsible for requesting TOR status for a particular use. SRRD is responsible for processing TOR requests that arise through reregistration and tolerance reassessment. SRRD follows up on their requests, assures that the use is appropriately evaluated by HED, and whenever possible, folds this activity into the RED process. SRRD must track the TOR requests and maintain communication with requesters about TOR status. Every effort should be made to see that TOR requests are reviewed along with other pertinent data that needs to be reviewed for reregistration purposes. REVIEW OF TOR REQUESTS DURING RED DEVELOPMENT 1. Use the Agency tracking system to show receipt and progress toward the TOR decision. IRSD has assigned a code for TOR requests so that they can be tracked separately from or in addition to the RED process and decision. [There will be a new system in OPPIN that will track the decision logic for TORs]. There are no fees associated with this activity. 2. Consult with HED to establish an appropriate process for assessing risks from the dietary (i.e., food) exposure resulting from the use and for occupational exposure associated with the use. Page 13 of 14

14 3. If HED finds that the use is not below the threshold of regulation, SRRD will treat this use like any other food use in the reregistration or tolerance reassessment case. 4. If HED finds that the use is below the threshold of regulation, consult with EFED regarding assessment of potential drinking water exposures associated with the TOR use. Additionally, confirm with EFED that the TOR use does not pose environmental risks of concern. 5. If a use is below the threshold of regulation and is deemed eligible for reregistration, SRRD will establish a TOR decision for the use through rule-making. CRMs will draft a proposal to establish a regulation in a special subpart of 40 CFR 180 created to record TOR decisions. Additionally, if there is an existing tolerance for the TOR use, SRRD should propose to revoke the tolerance. After the comment period, SRRD should, if appropriate, issue final regulations and revocations. 6. TOR decisions will be counted as completely reassessed tolerances. Dietary exposure from food that is attributable to the TOR use is not included in aggregate or cumulative exposure assessments for the pesticide. The TOR use generally will be treated like a nonfood use when HED assesses the aggregate or cumulative exposure to the pesticide. 7. The RED will include history of TOR activity that happens in conjunction with RED development. POST-RED ACTIVITIES 1. If the TOR is identified late in the RED process (e.g. during risk mitigation discussions), PRB will become responsible for following up and documenting all TOR activities. If additional FR notices are needed, SRB will generate and track them ( Joe Nevola). 2. Include TOR proposals and rules in administrative records. 3. When PRB refers a reregistration case to RD, it will identify the TOR use and describe conditions of use for the TOR use that should be placed on the amended label. Page 14 of 14