Guidance for Using Incident Data in Evaluating Listed and Non-listed Species under Registration Review

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Memorandum

October 13, 2011

SUBJECT: Guidance for Using Incident Data in Evaluating Listed and Non-listed Species under Registration Review

FROM: /s/ Donald J. Brady, Director, Environmental Fate and Effects Division, Office of Pesticide Programs

TO: All Environmental Fate and Effects Division Management and Staff

The attached guidance for using incident data in evaluating listed and non-listed species in registration review is effective immediately. The attached document provides guidance on how to conduct a search for incident reports and where to include incident information during the development of registration review products. It also provides guidance on the type of information that should be included on incidents in the Problem Formulation phase (which focuses primarily on providing a summary of the incidents), and in the Risk Assessment phase (where a complete analysis of the incidents is performed).

For purposes of this guidance, an ecological incident is defined as an event(s) in which pesticide use is known or suspected of causing the death or other adverse toxicological effect to wild animals and plants other than the intended target species. Incidents for animals may include any type of free-ranging wild animal, including birds, mammals, fish, reptiles, amphibians, and invertebrates, although incidents involving invertebrates other than bees and crayfish are rarely reported. Plant incidents may include adverse effects to any wild plant, although almost all plant incident reports EFED receives are for damage to crops and ornamentals. Incidents of adverse effects to humans, pets, and domestic animals are not considered ecological incidents for purposes of this guidance.

The attached guidance is immediately effective and should be incorporated into current work to support registration review where possible, and should be applied to all registration review work that has yet to begin. If you have any questions regarding the specific information in the attached guidance, you may seek clarification from a member of the Endangered Species Reregistration Workgroup listed at the end of the attached guidance.

Guidance for Using Incident Data in Evaluating Listed and Non-listed Species under Registration Review

October 13, 2011

  1. APPROACH FOR INCLUDING INCIDENT DATA IN PROBLEM FORMULATION

    In PF, the ecological incident sections will largely be a listing (with relevant supporting information) of the incidents that will be considered in the risk assessment. Detailed analyses of incident data should not be done for PF.

    It is important to identify, during PF, the incidents that will be included in the risk assessment. This provides stakeholders the opportunity to supply additional information on the incidents that have been identified and to identify additional incidents. It should be noted that any known incidents that occur between the time the PF document is issued and the risk assessment is performed will be included as well in the risk assessment.

    1. Searching for Wildlife Incident Data

      Currently, there are two primary sources for obtaining information on ecological incidents:

      1. the Ecological Incident Information System (EIIS, v. 2.1), and
      2. aggregate 6(a)(2) incident reports.

      How to search these two sources for information on ecological incidents is described below.

      A search of incident data should be conducted when writing the PF and again when starting the risk assessment (in case there are any incidents reported after the PF is produced). The search should include the pesticide active ingredient(s) of concern and any degradate of concern that is registered as an active ingredient. Incidents in which a degradate was detected are recorded under the name and PC code of the parent compound. The only exception would be if the degradate is itself an active ingredient; this would require a search for both the parent compound and degradate(s).

    2. Ecological Incident Information System (EIIS)

      1. Background on EIIS

        EIIS is an Office of Pesticide Program's (OPP) database, which includes information on all ecological incidents reported to the Agency prior to 1998 by pesticide registrants and all of the "major" incidents reported by pesticide registrants to the Agency since 1998. ("Major" incidents are defined in the next section.) EIIS also includes information on incident reports submitted through other sources, such as the States, regardless if they are "major" incidents or not. While the emphasis of EIIS is on ecological incidents occurring within the United States, reports that are occasionally received of incidents in other countries are also entered. Incidents of adverse effects on lawns and other ornamentals caused by direct application of pesticide products are not entered into EIIS.

      2. Defining "Major" Incidents

        Prior to 1998, registrants were required to submit information on all ecological incidents that they were aware of and that involved one of their chemicals. This was in response to 40 CFR §159.184 (toxic or adverse effect incident reports) requirements. Since 1998 (when the CFR was changed), registrants are only required to provide information on incidents considered "major" (see below). Based on the CFR, an ecological incident is considered "major" and must be submitted to the Agency by the registrant if any of the following criteria are met:

        Fish or wildlife

        1. Involves any incident caused by a pesticide currently in Formal Review1 for ecological concerns.

        2. Fish: Affected 1,000 or more individuals of a schooling species or 50 or more individuals of a non-schooling species.

        3. Birds: Affected 200 or more individuals of a flocking species, or 50 or more individuals of a songbird species, or 5 or more individuals of a predatory species.

        4. Mammals, reptiles, amphibians: Affected 50 or more individuals of a relatively common or herding species or 5 or more individuals of a rare or solitary species.

        5. Involves effects to, or illegal pesticide treatment (misuse) of a substantial tract of habitat (greater than or equal to 10 acres, terrestrial or aquatic).

        Plants

        1. The effect is alleged to have occurred on more than 45 percent of the acreage exposed to the pesticide.

        All other incidents are considered "minor". For a further discussion of minor incidents, refer to Section I.C.

        Footnote

        1 Formal Review means Special Review, Rebuttable Presumption Against Registration (RPAR), FIFRA section 6(c) suspension proceeding, or FIFRA section 6(b) cancellation proceeding, whether completed or not.

      3. Searching EIIS

        Information on reported wildlife/plant incidents involving pesticides can be found by searching the EIIS (v.2.1). This database can be accessed by the shortcut on the user's desktop or by opening the file "EIISv2.1.mdb" stored in the folder "C:\Models\EIIS." Directions for conducting a search of the EIIS can be found at:

        G:\Science Databases\EIIS (Eco Incidents)\Current Approved Version\EIIS 2.0 User Manual.doc

    3. Aggregate Incident Reports for "Minor" Incidents

      Based on the 40 CFR §159.184, information on all known "major" incidents must be submitted to the Agency by the registrant(s). All ecological incidents considered "minor" only need to be aggregately reported as quarterly counts of incidents by the registrant(s). These aggregate counts of "minor" incidents are not included in the EIIS.

      For PF, obtain the aggregate incident report(s) for your chemical(s). Aggregate incidents can be obtained using the "Aggregate Incident Reports" (v. 1.0) database located at:

      G:\Science Databases\EIIS (Eco Incidents)\Other Incident Databases\Aggregate Incidents\Aggregate Incident Reports.mdb

      To find aggregate incidents for your chemical(s) of concern:

      • Open the Access file "Aggregate Incident Reports" (double click the file icon; it will open as a "read only" file)

      • Click on "Preview Report" button

      • Enter in the PC code (in the "Enter Parameter Value" box that pops up) and press "OK" ... you will have to enter the PC code a total of three times

      • The "Aggregate Incident Report for EFED" will then appear for your chemical.

      If incidents have been aggregately reported, present the number of minor fish and wildlife (W-B), minor plant (P-B), and "other non-target" (ONT) incidents that have been reported through in the PF. Clearly state in the PF, that in the absence of additional information on these incidents, it will be assumed that the incidents are representative of currently registered uses in the risk assessment.

      A process for obtaining additional information on aggregate incidents for the risk assessment is being developed. As soon as the process has been finalized, it will be forwarded to EFED scientists.

    4. Format

      Incidents are not mentioned in the current Problem Formulation Guidance for Baseline Ecological Risk Assessments (USEPA, 2007). An incident section should be included in the section on "Receptors" (see below for details).

    5. Identifying the Incidents to Be Included in the PF

      After conducting a search (or searches) for information on ecological incidents for the pesticide active ingredient(s) of concern and any degradate of concern that is registered as an active ingredient,

      • Identify the certainty categories associated with the incidents (i.e., "unrelated", "unlikely", "possible", "probable", and "highly probable" in EIIS).

        • The certainty index in EIIS is based on the following.

          • Highly probable (4)

            Pesticide was confirmed as the cause through residue analysis or other reliable evidence, or the circumstances of the incident along with knowledge of the pesticide's toxicity or history of previous incidents give strong support that this pesticide was the cause.

          • Probable (3)

            Circumstances of the incident and properties of the pesticide indicate that this pesticide was the cause, but confirming evidence is lacking.

          • Possible (2)

            The pesticide possibly could have caused the incident, but there are possible explanations that are at least as plausible. Often used when organisms were exposed to more than one pesticide.

          • Unlikely (1)

            Evidence exists that a stressor other than exposure to this pesticide caused the incident, but that evidence is not conclusive.

          • Unrelated (0)

            Conclusive evidence exists that a stressor other than exposure to the given pesticide caused the incident.

      • Review those incidents marked as "unrelated" (in EIIS) or "unlikely" (in EIIS) to determine if you agree with the "unlikely" or "unrelated" determination. If so, then the "unlikely" and "unrelated" incidents should be excluded from further consideration. If you disagree, the incidents should be included with the others, and the administrator of EIIS should be consulted about changing the certainty assignments in the database.

    6. What Type of Information Should be Included on Incidents in PF?

      This section provides suggestions for some sample text that could be used when describing incident data as well as sample tables. This text is provided as guidance only.

      1. Sample Text for the Summary of Incident Data in PF

        Begin by providing a summary paragraph(s) of the reported animal and plant incidents retrieved from the search(es) (including the aggregate reports), excluding the incidents classified as "unlikely" (EIIS) or "unrelated" (EIIS). Include a separate summary for the parent and any degradate of concern that is registered as a separate active ingredient. Discuss incidents that are known to have been caused by misuse [i.e., legality categories "misuse (intentional)", "misuse (accidental)", and "misuse"] separately from those that are not associated with misuse (i.e., legality categories "registered use" and "unknown").

        Below is sample text, provided as an example for what type of information should be included in the summary paragraph and the accompanying table(s). If all of the information described in the sample text is provided in a table(s), a more general summary, with reference to the table(s), may suffice. (See pages 8 and 9 of this guidance for the sample tables.)

        "A preliminary review on [provide the date], of the Ecological Incident Information System (EIIS, version 2.1), which is maintained by the Agency's Office of Pesticide Programs, indicates a total of X reported ecological incidents associated with the use of Pesticide A. (These incidents are summarized in Table **). [Include the following language if there are any incidents associated with the chemical(s) of concern classified as "unlikely" or "unrelated"]: This total excludes incidents classified as "unlikely" or "unrelated" and only includes those incidents with certainty categories of "possible", "probable", and "highly probable" (for EIIS). Incidents classified as "unlikely" the result of or "unrelated" to Pesticide A will not be included in this Problem Formulation or the ecological risk assessment conducted for Registration Review.

        All of the Pesticide A incidents, excluding those classified as "unlikely" or "unrelated", occurred between [provide the year of the earliest reported incident] and [provide the year of the last reported incident]. X of the Pesticide A incidents involved aquatic animals, X involved terrestrial animals, and X involved plants. [Add and eliminate taxa as necessary; provide the percent of total incidents for each taxon if there are enough incidents to make this informative]. The certainty categories regarding the likelihood that the use of Pesticide A caused the X incidents ranged from (select appropriate category) (X incidents) to [select appropriate category] (X incidents). X of the incidents was considered registered uses at the time of the incident, X involved misuses, and the legality of use was undetermined in X incidents. X of the incidents involved additional chemicals besides Pesticide A. Pesticide A residues were reported in X of the incident reports. (See Table **). The reported incidents for Pesticide A involved X uses that are no longer registered [list uses], X uses that are currently registered [list uses], and X in which the use site was not specified. The reported incidents associated with the X currently registered uses, had certainty categories of [select all of the categories that apply; incidents classified as "unlikely" are excluded].

        In the risk assessment, the incidents will be further evaluated to determine if the reported incidents represent current patterns of use for Pesticide A. Examples of additional considerations are mitigation (e.g., reduced application rates), product cancellations, and changes in use patterns that have occurred since the date of the reported incident(s)."

      2. Summary of Aggregate Reports

        If additional information is available from the aggregated reports, the following paragraph provides some sample text:

        "In addition to the incidents recorded in EIIS , additional incidents have been reported to the Agency in aggregated incident reports. Pesticide registrants report certain types of incidents to the Agency as aggregate counts of incidents occurring per product per quarter. Ecological incidents reported in aggregate reports include those categorized as "minor fish and wildlife" (W-B), "minor plant" (P-B), and "other non-target" (ONT) incidents. "Other non-target" incidents include reports of adverse effects to insects and other terrestrial invertebrates. For Pesticide A, registrants have reported X minor fish and wildlife incidents, X minor plant incidents, and X other non-target incidents. Unless additional information on these aggregated incidents becomes available, they will be assumed to be representative of registered uses of Pesticide A in the risk assessment."

      3. Additional Information

        If few incidents have been reported or no recent incidents have been documented, the following paragraph is an example of the type of language to use:

        "Incident reports for Pesticide A have not been received by the Agency since [provide the year of the last reported incident] AND/OR only X incidents have been reported to the Agency, the absence of reported incidents should not be construed as the absence of incidents. Incident reports for non-target organisms typically provide information only on mortality events and plant damage. Sublethal effects in organisms such as abnormal behavior, reduced growth and/or impaired reproduction are rarely reported, except for phytotoxic effects in terrestrial plants. EPA's changes in the registrant reporting requirements for incidents in 1998 may account for a reduced number of reported incidents. Registrants are now only required to submit detailed information on "major" fish, wildlife, and plant incidents. Minor fish, wildlife, and plant incidents, as well as all other non-target incidents, are generally reported aggregately and are not included in EIIS. In addition, there have been changes in state monitoring efforts due to a lack of resources. However, the incident data that are available suggest/do not suggest that exposure pathways for Pesticide A are complete and that exposure levels are sufficient to result in field-observable effects."

      4. Sample Tables

        The following tables, which are for guidance only, provide samples of the type of tables that could be used to summarize incident data. Adjust the format of the table, and the grouping and sorting of rows, as appropriate for your case. If there are a substantial number of incidents, the table(s) could be moved to an appendix.

        Table X
        Ecological Incidents Associated with Pesticide A1
        Chemical Name [delete if there is only one] Incident Number (Source) Taxa Involved Magnitude Year Location Use Legality of Use Certainty Category2 Residues Other Chemicals Involved
        Pesticide X [provide incident # from EIIS] [provide taxon: e.g., aquatic animal, terrestrial plant, terrestrial animal] [provide number of individuals or acres involved; provide species names if available] [provide the year of the reported incident] [provide the state - or country (if not in the U.S.)- where the incident occurred] [provide the use site, if known] [provide the legality of use: i.e., misuse, registered use, or unknown ] [provide the certainty category: i.e., possible, probable, or highly probable (EIIS)] [provide the residue results, if available: e.g., 8.3 - 12 ppb in affected water] Pesticide Y
        Pesticide Z
        Add a new line for each incident                  

        1 "Minor" incidents aggregately reported by the registrant(s) are not included in this table.

        2Incidents classified as "unrelated" and "unlikely" are excluded.

        If there are a substantial number of incidents associated with the chemical(s) of concern, it might be appropriate to separate the incidents by use site, taxon affected, product formulation, formulation type, or some other category considered relevant to the chemical(s) being considered. If there are a substantial number of incidents, a table similar to the following example may also be useful to include in the PF. Also, different tables may be needed to separate EIIS data since the certainty categories are not identical across the databases:

        Table X
        Summary of Ecological Incidents Associated with Pesticide A
        Incident Type Legality Certainty
        All Possible Probable Highly Probable
        Fish and Aquatic Invertebrates Registered Use or Unknown 9 4 4 1
        Known Misuse 7 1 4 2
        All 16 5 8 3
        Wildlife Registered Use or Unknown 5 3 0 2
        Known Misuse 2 2 0 0
        All 7 5 0 2
        Plants Registered Use or Unknown 1 1 0 0
        Known Misuse 1 1 0 0
        All 2 2 0 0
        Bees Registered Use or Unknown 1 1 0 0
        Known Misuse 1 1 0 0
        All 2 2 0 0

  2. APPROACH FOR ADDRESSING INCIDENT INFORMATION IN THE RISK ASSESSMENT

    1. General Information

      Unlike in PF which includes a listing of the reported incidents, the risk assessment should include a detailed analysis of available ecological incident data. Information on reported incidents should be included under Risk Description in the Risk Characterization section of the risk assessment. This information on incidents should be considered as a line of evidence in making risk conclusions for the chemical being assessed along with any of its degradates of toxicological concern that are also registered as separate active ingredients. [Incidents in which a degradate was detected are recorded under the name and PC code of the parent compound with the exception of those degradates which are also active ingredients; parent compounds that have a degradate(s) that is also an active ingredient require a search for both the parent compound and degradate(s).] For any new wildlife or plant incidents reported since the PF (including any additional information submitted on aggregate incidents), provide the details as described for PF. If no new incidents have been reported since the PF, refer to the incident descriptions provided in the PF for details. Provide a table of all of the known incidents similar to the example table provided earlier in this guidance. Include in the Risk Description a general summary of all of the reported incidents for the parent chemical and any degradate(s) as described above.

      Because incident data are not reported or collected systematically, a lack of reported incidents cannot be used as evidence that incidents could not or do not exist from registered uses of the chemical(s) being considered. Incident reports for non-target organisms typically provide information only on mortality events and plant damage. Except for phytotoxic effects in terrestrial plants, sublethal effects, such as abnormal behavior, reduced growth or impaired reproduction, are rarely reported.

      As discussed in Section B of this guidance, EPA's changes in the registrant reporting requirements for incidents in 1998 likely partially account for a reduced number of reported incidents. Registrants are now only required to submit detailed information on "major" fish, wildlife, and plant incidents (see Section B). Minor fish, wildlife, and plant incidents, as well as all other non-target incidents, are generally reported aggregately and are not included in EIIS. In addition, there have been reductions in state monitoring efforts due to lack of resources.

      However, the incident data that are available can provide evidence that exposure pathways for a particular pesticide are complete and that exposure levels are sufficient to result in field-observable effects. If the registered use of the chemical being assessed cannot be logically excluded from being responsible for an incident(s), then the incident data should be used as evidence that the taxon or taxa involved in the incident(s) are at potential risk of direct effects from the registered use of the chemical.

      Considerations for determining if registered uses of the chemical can be "logically excluded" from being directly responsible for the incident(s) are provided in Appendix A.

      In the risk assessment clearly describe why any reported incidents, if any, are excluded from further consideration (again, see Appendix A). For those reported incidents not excluded (i.e., those potentially caused by a currently registered use or representative of a currently registered use), provide details on the species involved in the incident(s), if provided, in addition to a generation description of the incident.

      Make special note of any Federally listed (endangered and/or threatened) species involved in the incident(s). To do this, cross check the list of species involved in the incident(s) with the listed species provided at the following website:

      U.S. Fish & Wildlife Service Endangered Species Program

      In addition to deciding which incidents to exclude from consideration, you should conduct a weight-of-the-evidence analysis of the combined knowledge obtained from all of the "included" incidents. Characterize the certainty of the incident information in identifying exposure pathways that lead to risk to plants and animals in the field. Factors to consider in this analysis include:

      • Certainty level of the incidents

      • Legality determination of incidents

      • Number of incidents

      • Number of animals and plants affected in the incidents

      • Evidence of exposure revealed through residues measured in tissue and environmental samples

      • The agreement of observed incidents with risks predicted by risk assessments

      • The agreement of observed incidents with risks predicted by laboratory and field studies

      • Patterns of certain types of uses causing certain types of incidents

      • Evidence that incidents occurred from typical circumstances versus unusual circumstances

    2. Obtaining Additional Information

      If you need additional information on a particular incident than is provided in the EIIS report, obtain copies of the actual incident reports. Incident reports obtained by the Agency since January 2002 can be found on the OPP SAN drive at:

      \\W2032pccth016\incidents

      This folder may also be accessed through a link in R:\Ecological Incidents. Older incidents with "I" numbers may be obtained through the document service center. Older incidents with "B" numbers may be obtained from the EFED SAN drive at R:\Ecological Incidents. Hardcopies of most pre-2002 incidents are also available by incident number in the files in EFED Conference Room 4 (room S-12881).

    3. Sample Text

      Below is an example of text for the Risk Assessment. This provides an example of the type of information to include/consider. The chemicals and incident numbers provided in the example below are for illustrative purposes only and do not represent real chemicals or incident numbers:

      "Although risks to fish are not expected based on the available toxicity data and exposure models, there are nine reported fish kills associated with Chem X in the EIIS database. They occurred between 1983 and 1995 and involved from an "unknown" number of dead freshwater fish to "thousands". (See Appendix K). Therefore, to explore further the potential impact of Chem X use on fish, a more detailed evaluation of the nine reported fish kills associated with Chem X was conducted. In eight of the nine reported fish kill incidents involving Chem X, other chemicals known to be highly toxic to fish were also involved in the incidents and are the more likely cause of the fish kills (i.e., I000XXX-003, B000XXX-001, I000XXX-009, I00XXXX-008, I0000XX-001, I00XXX-017, I00XXXX-001, and I000XX-012).

      In the remaining reported incident (I000XXY-001), no other pesticides besides Chem X were associated with the fish kill. In this incident, a fish kill in a "fish tank" occurred 3.5 weeks following the application of Product Y to a 165-acre agricultural field. Both perch and bass, but not catfish, were affected. Federally listed species were not associated with this incident. No water or fish tissues were analyzed for residues. The legality of use for this incident was classified as "undetermined". Therefore, in one of the nine reported fish kill incidents, a registered use of Chem X could not be excluded as a potential cause of the incident. Because of the relatively low toxicity of Chem X to fish and the timing of the incident (i.e., it occurred 3.5 weeks after the Chem X use), it is unlikely that the fish were directly affected by Chem X. A more likely scenario is that the Chem X impacted the aquatic plant community of the "fish tank", which in turn affected the water quality parameters in the tank (e.g., dissolved oxygen) and indirectly affected the fish.

      Therefore, the weight of evidence based on the currently available data suggests that direct effects to fish are not expected from the use of Chem X. The potential for indirect effects to fish is evaluated in Section 5.2.2."

Questions, Workgroup, Reference

Any questions should be directed to Melissa Panger or other members of the Workgroup.

Endangered Species Reregistration Workgroup

Mark Corbin, EFED
Kevin Costello, SRRD
William Eckel, EFED
Stephanie Irene, EFED
Edward Odenkirchen, EFED (Co-Chair)
Melissa Panger, EFED
Anita Pease, EFED
Mohammed Ruhman, EFED
Dana Spatz, EFED
Thomas Steeger, EFED
Ingrid Sunzenauer, EFED (Co-Chair)
Michelle Thawley, EFED
Katrina White, EFED

Reference

USEPA (2007). Problem Formulation Guidance for Baseline Ecological Risk Assessments. Environmental Fate and Effects Division, Office of Pesticide Programs, United States Environmental Protection Agency. Washington, DC. August 9, 2007.

APPENDIX A
Considerations for Determining if Registered Uses of a Chemical Can Be "Logically Excluded" from Being Directly Responsible for an Incident(s)

Considerations for determining if registered uses of the chemical can be "logically excluded" from being directly responsible for the incident(s) include, but are not limited to:

[NOTE: This is for guidance purposes only. Some of the following things to consider may or may not be relevant to each specific chemical or incident. The reasons for excluding incidents should be considered on a case-by-case basis]

  1. Under the "legality" of use, is the incident reported as a "misuse" (either intentional or accidental)?

    • Intentional misuses (e.g., illegal baiting with contaminated bait) can normally (not always) be excluded from further consideration in the ecological risk assessment since they do not involve a "registered" use.

    • Incidents involving accidental misuse can often (not always) be excluded because they do not represent risk from a registered use. Accidental misuses involve incidents in which applications did not exactly conform to label instructions, but there was no obvious intent of harm by the user.

      • Sometimes the determination of being a misuse may be based on a technicality that does not exclude the incident from being representative of an exposure pathway that could occur from registered uses. For example, if a "Restricted Use" pesticide was applied by a non-certified applicator, with the chemical being applied otherwise as directed on the label, this would be considered an "accidental misuse". However, in terms of the actual application, it could be representative of a registered use.

    • If the chemical being assessed is involved in several "misuses" (either "accidental" or "intentional"), the assessor should highlight this in the assessment for the risk managers as it may indicate issues with the labels or cultural practices with the chemical.

    • Incidents that classify the legality of use as a "registered use" or as "undetermined" should not be excluded from further consideration.

  2. Under the "certainty" category, is the incident reported as "unlikely" or "unrelated"? The reviewer should review these incidents to determine if they agree with the "unlikely"/"unrelated" determination. If so, then the "unlikely"/"unrelated" incidents should be excluded from further consideration.

  3. Did the incident involve a formulation and use site representative of current registrations?

    • Is the product formulation type involved in the incident no longer registered in the U.S.?

      • For example, if an incident involved a granular use and only flowable formulations are currently registered, then incidents involving granular uses may be excluded from further consideration, unless it is determined that the formulation type was not relevant to the incident.

    • Is the product formulation involved in the incident currently registered for use in the U.S.?

      • If the incident involved a product no longer registered for use in the U.S., are there toxicity data available for the formulation involved in the incident?

        • If toxicity data are available and the formulation is not more toxic than the TGAI, then the incident should not be excluded on the basis of the formulation (because it could still be "representative" of current formulations).

      • If it involved a product no longer registered for use in the U.S., is it representative of (i.e., similar to) current registered formulations?

        • Contact the chemical team members in RD and SRRD for assistance in determining whether or not the formulation involved in the incident is representative of current formulations.

        • If additional information regarding the formulation involved in the incident is not available (or the formulation is not specified in the incident), then assume that the formulation involved in the incident is representative of current registrations. Clearly state this assumption in the risk assessment.

    • Does the incident involve a currently registered use or a use representative of current uses?

      • If the use site is not specified in the incident, then assume that it represents a current use. Clearly state this assumption in the risk assessment.

      • If the use site is specified in the incident, is the use currently registered or representative of currently registered uses (consider the application rate, application method, time of application, etc.)? If so, then the incident should not be excluded from further consideration on the basis of use site.

      • If the application rate was reported and was substantially greater than the maximum rate allowed by current labels, then the use associated with the incident may not represent current uses.

    • Have any mitigation measures been put in place for the chemical of concern since the reported incident?

      • Contact the chemical team members in SRRD for assistance in determining whether or not there have been substantial mitigation measures put in place for the chemical of concern since the date of the incident(s).

        • "Substantial mitigation measures" are those that may be expected to impact incidents (e.g., a reduction in application rate, application restrictions, vegetative buffers, etc).

        • Determine if the mitigation measure(s) was in place at the time of the incident.

        • Ensure that the mitigation measures were applied to the specific use involved in the incident(s)

      • If additional information regarding potential mitigation measures is not available, then assume that the incident is representative of current registrations. Clearly state this assumption in the risk assessment.

  4. Was another chemical(s) that is known to be more toxic to the taxa affected in the incident also involved in the incident? If so, then it could be reasonably assumed that the more toxic chemical was more likely the cause of the incident, especially if this is supported by residue data.

    • For example, if an herbicide with low toxicity to fish is involved in a fish kill with an insecticide known to be highly toxic to fish, it is reasonable to assume that the insecticide was more likely the cause of the fish kill.

    • Note that those entering the incident data into EIIS may or may not have been aware of the relative toxicity of the multiple chemicals linked to an incident, and, thus, this factor may or may not be reflected in the certainty categorization. Look at the certainty discussion printed on Part B of the EIIS incident reports for information on what was taken into consideration when the certainty category was assigned.

  5. Due to the mode of action, the toxicity of the chemical, its fate properties, etc., is it reasonable to assume that the chemical involved in the incident(s) did not cause direct effects to the taxa involved in the incident?

    • For example, if an herbicide with low toxicity to fish was involved in a fish kill in a pond that occurred 2 - 3 weeks after the herbicide was applied, it might be reasonable to assume that the herbicide did not directly affect the fish, but impacted the aquatic vegetation in the pond. This ultimately altered the water quality parameters of the pond (e.g., dissolved oxygen), which led to the death of fish. In this example, the fish mortality would be due to indirect effects and not direct toxic effects of the chemical.

    • Such incidents should be considered as evidence of the potential for indirect effects, but should not be used as evidence for direct effects to a specific taxon.

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