![](media/image1.wmf){width="1.3576388888888888in"
height="1.375in"}UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

**June 9, 2008**

PC Code: 111401

DP Barcode: 348152

**[MEMORANDUM]{.underline}**

**Subject:** Registration Review: Data Call-In (DCI) Table for
Environmental Fate and Effects Data Gaps for Profenofos

**To:** Christina Scheltema, Chemical Review Manager

> Kevin Costello, Team Leader
>
> Reregistration Branch
>
> Special Review and Reregistration Division
>
> Office of Pesticide Programs

**From:** Kristina Garber, Biologist

> Anita Pease, Senior Biologist

Environmental Risk Branch 4

Environmental Fate and Effects Division

Office of Pesticide Programs

**Through:** Elizabeth Behl, Chief

Environmental Risk Branch 4

Environmental Fate and Effects Division

Office of Pesticide Programs

The Environmental Fate and Effects Division (EFED) has completed a Data
Call-in (DCI) table for the profenofos environmental fate and effects
data gaps. This DCI table is required to open the docket as part of the
registration review process for this chemical. The attached DCI table,
which includes the guideline number and study title for required data,
also provides a rationale for requiring the data, an explanation of how
the data will be used, and a brief description of how the data could
impact the Agency's future decision-making.

+-----------------------------------------------------------------------+
| **Guideline Number: 835.1240**                                        |
|                                                                       |
| **Study Title: adsorption/desorption**                                |
+-----------------------------------------------------------------------+
| **Rationale for Requiring the Data**                                  |
+-----------------------------------------------------------------------+
| Acceptable data have not been provided to quantify the                |
| adsorption/desorption characteristics of profenofos in U.S. soils.    |
| According to Code of Federal Regulations 40 (CFR40 2007) Part 158     |
| Subpart D (data requirements for pesticides) adsorption/desorption    |
| data are required for pesticides with terrestrial uses. Since         |
| profenofos use on cotton is considered to be terrestrial, an          |
| acceptable study should be submitted to fulfill OPPTS Guideline       |
| 835.1240. This study should define K~d~ and K~OC~ values of           |
| profenofos in U.S. soils. It is preferred that this study be          |
| conducted using a batch equilibrium method.                           |
+-----------------------------------------------------------------------+
| **Practical Utility of the Data**                                     |
+-----------------------------------------------------------------------+
| **How will the data be used?**                                        |
|                                                                       |
| These data are used to estimate the transport of profenofos from      |
| treatment sites to aquatic systems and ultimately to derive aquatic   |
| EECs using PRZM/EXAMS.                                                |
|                                                                       |
| **How could the data impact the Agency's future decision-making?**    |
|                                                                       |
| In the absence of these data, EFED will assume that there is no       |
| sorption of profenofos to soils or organic matter on the treatment    |
| site. In order to implement this in derivation of aquatic EECs, a     |
| K~OC~ value of 0 will be used to parameterize PRZM/EXAMS. Input of a  |
| K~OC~ value \>0 is expected to result in lower aquatic EECs. If       |
| acceptable data are provided, the uncertainties associated with this  |
| assumption will be reduced.                                           |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Guideline Number: 835.4300**                                        |
|                                                                       |
| **Study Title: Aerobic Aquatic Metabolism**                           |
+-----------------------------------------------------------------------+
| **Rationale for Requiring the Data**                                  |
+-----------------------------------------------------------------------+
| Acceptable data have not been provided to quantify the metabolism of  |
| profenofos under aerobic aquatic conditions. According to Code of     |
| Federal Regulations 40 (CFR40 2007) Part 158 Subpart D (data          |
| requirements for pesticides) aerobic aquatic metabolism are required  |
| for pesticides with terrestrial uses. Since profenofos use on cotton  |
| is considered to be terrestrial, aerobic aquatic metabolism data for  |
| profenofos should be submitted to fulfill OPPTS Guideline 835.4300.   |
+-----------------------------------------------------------------------+
| **Practical Utility of the Data**                                     |
+-----------------------------------------------------------------------+
| **How will the data be used?**                                        |
|                                                                       |
| These data are used to estimate the degradation of profenofos in      |
| aquatic systems and ultimately to derive aquatic EECs using           |
| PRZM/EXAMS.                                                           |
|                                                                       |
| **How could the data impact the Agency's future decision-making?**    |
|                                                                       |
| In the case that these data are unavailable at the time risk          |
| assessments are conducted, PRZM/EXAMS input parameter guidance        |
| default values will be employed to account for aerobic aquatic        |
| metabolism. For this parameter, the input parameter guidance          |
| indicates that the value should be 0.5X the aerobic soil metabolism   |
| half-life.                                                            |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Guideline Number: 850.2100**                                        |
|                                                                       |
| **Study Title: Avian Acute Oral Toxicity Test**                       |
+-----------------------------------------------------------------------+
| **Rationale for Requiring the Data**                                  |
+-----------------------------------------------------------------------+
| Acceptable acute avian oral toxicity data were submitted for          |
| exposures of mallard duck to profenofos; however, data are not        |
| available for a passerine species, which is now required under the 40 |
| CFR Part 158 (CFR 40 2007) data requirements for conventional         |
| pesticides. The new Part 158 data requirements specify that acute     |
| avian oral toxicity data be submitted for either mallard duck or      |
| bobwhite quail AND a passerine species. Based on the results of       |
| previous ecological risk assessments for profenofos and derivation of |
| preliminary RQs in the registration review problem formulation, risks |
| are expected for non-listed and listed birds due to acute exposures   |
| to profenofos. In addition, avian data for other organophosphate (OP) |
| insecticides, including dimethoate, show that a passerine species,    |
| such as the red-winged blackbird, are one order of magnitude more     |
| sensitive than other tested bird species to acute OP insecticide      |
| exposure. Therefore, an avian oral toxicity test is required for      |
| passerine birds, as specified in 40 CFR Part 158. A passerine study   |
| protocol must be submitted for review by the Agency prior to          |
| initiation of this study.                                             |
+-----------------------------------------------------------------------+
| **Practical Utility of the Data**                                     |
+-----------------------------------------------------------------------+
| **How will the data be used?**                                        |
|                                                                       |
| Acute avian oral toxicity data for passerine species will be used to  |
| refine the screening-level assessment by determining whether there    |
| are differences in avian species sensitivity to profenofos between    |
| passerines and upland game and waterfowl species. Based on the        |
| currently submitted acute avian data, profenofos is classified as     |
| moderately toxic to birds on an acute oral basis and highly toxic on  |
| a sub-acute dietary exposure basis. If oral acute toxicity data are   |
| not submitted for passerines, risk will be assumed for all passerine  |
| species.                                                              |
|                                                                       |
| **How could the data impact the Agency's future decision-making?**    |
|                                                                       |
| If future endangered species risk assessments are performed without   |
| these data, the Agency would have to assume that profenofos "may      |
| affect" birds directly (and listed species from other taxa            |
| indirectly), and use of profenofos may need to be restricted in areas |
| where listed species could be exposed. The lack of these data will    |
| limit the flexibility the Agency and registrants have in coming into  |
| compliance with the Endangered Species Act and could result in use    |
| restrictions for profenofos which are unnecessarily severe.           |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Guideline Number: 850.1400**                                        |
|                                                                       |
| **Study Title: Fish Early Life Stage Toxicity Test**                  |
+-----------------------------------------------------------------------+
| **Rationale for Requiring the Data**                                  |
+-----------------------------------------------------------------------+
| Chronic toxicity data are not available for estuarine and marine      |
| fish. In the absence of these data, an acute-to-chronic ratio (ACR)   |
| would normally be derived; and the chronic toxicity to estuarine and  |
| marine fish would be estimated based on the ACR for freshwater fish.  |
| However, an ACR cannot be derived because the freshwater fish data    |
| necessary for calculating the ACR are not available. Chronic data are |
| not available for the most acutely sensitive freshwater species       |
| (bluegill sunfish; *Lepomis macrochirus*), and definitive acute data  |
| are not available for the most chronically sensitive freshwater       |
| species (fathead minnow; *Pimephales promelas*). Based on the results |
| of previous ecological risk assessments for profenofos and derivation |
| of preliminary aquatic RQs in the registration review problem         |
| formulation, risks are expected for non-listed and listed fish due to |
| chronic exposures to profenofos in aquatic habitats. In addition, the |
| majority of reported ecological incidents associated with the use of  |
| profenofos have involved fish kills. Therefore, an estuarine/marine   |
| fish early life-stage toxicity test is required in order to fulfill   |
| the data requirement.                                                 |
+-----------------------------------------------------------------------+
| **Practical Utility of the Data**                                     |
+-----------------------------------------------------------------------+
| **How will the data be used?**                                        |
|                                                                       |
| The estuarine/marine early life stage fish data would allow the       |
| Agency to refine its screening-level risk assessment by considering   |
| chronic exposure and potential toxicity and risk to estuarine/marine  |
| fish. In addition, these data would allow the Agency to determine     |
| whether chronic exposure to profenofos may potentially impact listed  |
| species in estuarine/marine environments, either by direct effects on |
| fish or by indirect effects via reduction of prey. By refining the    |
| assessment, the Agency would be able to determine whether mitigation  |
| imposed as part of the reregistration process was appropriate. In the |
| absence of chronic toxicity data for estuarine and marine fish, EFED  |
| will assume chronic risk to these taxa.                               |
|                                                                       |
| **How could the data impact the Agency's future decision-making?**    |
|                                                                       |
| If the data indicate that profenofos poses a significant chronic risk |
| to fish inhabiting estuarine/marine water bodies, the Agency may      |
| explore additional decision options to minimize the risk of           |
| profenofos to estuarine/marine fish. If future endangered species     |
| risk assessments are performed without these data, the Agency would   |
| have to assume that profenofos "may affect" estuarine/marine fish     |
| directly (and listed species from other taxa indirectly), and use of  |
| profenofos may need to be restricted in areas where listed species    |
| could be exposed. The lack of these data will limit the flexibility   |
| the Agency and registrants have in coming into compliance with the    |
| Endangered Species Act and could result in use restrictions for       |
| profenofos which are unnecessary.                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Guideline Number: 850.4400**                                        |
|                                                                       |
| **Study Title: Aquatic plant toxicity (Tier I)**                      |
+-----------------------------------------------------------------------+
| **Rationale for Requiring the Data**                                  |
+-----------------------------------------------------------------------+
| Profenofos toxicity data for vascular and non-vascular aquatic plants |
| are not available. Based on the 40 CFR Part 158 data requirements,    |
| Tier I level non-target aquatic plant data are required for all       |
| insecticides. In addition, available data for non-target terrestrial  |
| plants show impacts to cucumber seedling emergence at a concentration |
| less than the maximum single application rate for profenofos.         |
| Therefore, non-target aquatic plant data for algae and vascular       |
| plants are required for profenofos at the Tier I level.               |
+-----------------------------------------------------------------------+
| **Practical Utility of the Data**                                     |
+-----------------------------------------------------------------------+
| **How will the data be used?**                                        |
|                                                                       |
| Data from Tier I aquatic plant toxicity studies will be used to       |
| estimate potential risks to aquatic vascular and non-vascular plants  |
| associated with the use of profenofos. The data will reduce           |
| uncertainties associated with the current risk assessment for aquatic |
| plants and will improve the Agency's understanding of the potential   |
| effects of profenofos on aquatic plants. In the absence of Tier I     |
| data, risks for both vascular and non-vascular aquatic plants will be |
| presumed.                                                             |
|                                                                       |
| **How could the data impact the Agency's future decision-making?**    |
|                                                                       |
| Because aquatic vascular and non-vascular plants form the basis of    |
| the food chain for aquatic habitats and significantly contribute to   |
| overall water quality, a solid understanding of the potential risks   |
| to aquatic plants is essential for sound environmental risk           |
| management decision-making. Without aquatic plant data for            |
| profenofos, the Agency cannot determine if the current application    |
| rate of profenofos on cotton may result in direct adverse effects to  |
| aquatic plants and/or indirect effects resulting from reduction in    |
| the prey base and/or loss of habitat/cover. If future endangered      |
| species risk assessments are performed without these data, the Agency |
| would have to assume that profenofos "may affect" aquatic plants      |
| directly (and listed species from other taxa indirectly via reduction |
| in prey base and/or habitat), and use of profenofos may need to be    |
| restricted in areas where listed species could be exposed. The lack   |
| of these data will limit the flexibility the Agency and registrants   |
| have in coming into compliance with the Endangered Species Act and    |
| could result in use restrictions for profenofos which are             |
| unnecessarily severe.                                                 |
+-----------------------------------------------------------------------+