![[logo] US EPA](../gif/logo_epaseal.gif){kind=logo}
OPP-OW Common Effects Assessment Methodology
Comments and Feedback from Regional Stakeholder Meetings
OPP-OW Common Effects Assessment Methodology
EPA held six public meetings to solicit input on methods and approaches being evaluated by the Office of Pesticide Programs (OPP) and the Office of Water (OW) to ensure that pesticide effects on aquatic organisms and plants are characterized consistently between these offices. At these public meetings, EPA provided presentations that detailed its initial thinking for developing common methodologies and solicited input from the public. Comments from these six public meetings are summarized below, with responses where available.
On this page
Region 1, Region 2, Region 3 Stakeholder Meeting; Edison, NJ (January 11, 2010)
Region 4 Stakeholder Meetings, Atlanta, GA (January 12, 2010)- General topics addressed in stakeholder comments
- Specific stakeholder questions/concerns/comments
Region 5 Stakeholder Meeting; Chicago, Il (January 14, 2010)
Region 7 Stakeholder Meeting, Kansas City, KS (January 19, 2010)
Region 10 Stakeholder Meeting, Seattle, WA (January 21, 2010)- General topics addressed in stakeholder comments
- Specific stakeholder questions/concerns/comments
Region 9 Stakeholder Meeting, Oakland, CA (January 22, 2010)
- General topics addressed in stakeholder comments
- Specific stakeholder questions/concerns/comments
Region 1, Region 2, Region 3 Stakeholder Meeting; Edison, NJ (January 11, 2010)
Region 4 Stakeholder Meetings, Atlanta, GA (January 12, 2010)
| Regions | Presenters |
|---|---|
| R1/2/3 | Betsy Behl, Office of Pesticide Programs (OPP) Joe Beaman, Office of Water (OW) Anita Pease, Office of Pesticide Programs (OPP) Walter Berry, Office of Research and Development (ORD) Charlie Delos, Office of Water (OW) |
| R4 | Betsy Behl, Office of Pesticide Programs (OPP) Joe Beaman, Office of Water (OW) Sandy Raimondo, Office of Research and Development (ORD) Keith Sappington, Office of Pesticide Programs (OPP) Laura Dobbins, Office of Water (OW) |
The New Jersey and Georgia meetings included well-informed participants, representing diverse interests, including representatives from industry (FMC, DOW), academia, Federal and State regulatory agencies, consultants, and a law firm. The feedback from participants at these meetings was generally positive, and stakeholders appreciated the effort that EPA was making to reach out to them. Regional managers indicated that the presentations clearly summarized the methodologies used by OPP and OW.
General topics addressed in stakeholder comments
(Regions 1, 2, 3, 4)
Participants were interested in the schedule for this project and wanted to know when the white papers would be available in draft form.
Questions were raised concerning the consistency of criteria used to evaluate open literature in OW and OPP and the databases that the two offices rely on in their analyses.
Specific stakeholder questions/concerns/comments
(Regions 1, 2, 3, 4)
One participant asked about a petition filed by the Center for Biological Diversity, requesting OW to establish water quality criteria for compounds identified as endocrine disruptors. The question concerned the role of the harmonization effort in responding to the petition.
Consistent review and acceptability of open literature data by both program offices was raised as a concern. It was felt that OW and OPP should evaluate the available data in the same way. A New York state representative (NYSDEC) indicated that for derivation of water quality criteria in their state, they require that raw data be reviewed unless it is a guideline study submitted to OPP. NYSDEC also indicated that they viewed OPP's Data Evaluation Records (DERs) as very high quality. Other questions were asked about accessing OPP's DERs and the level to which the two program offices document reviews of the open literature. In response to these questions, Anita Pease (OPP) indicated that open literature summary reviews are completed for all open literature studies that are used qualitatively and/or quantitatively in OPP's risk assessments. Betsy Behl (OPP) added that both program offices rely on ECOTOX to query the available open literature and that the OPP benchmarks website has links to risk assessments and DERs that were used to develop each benchmark.
One participant asked about the level of protection that EPA is seeking in light of the different statutes under which OPP and OW operate. Are we trying to protect all individuals in the population or 95% of the population? Betsy Behl and Joe Beaman indicated that the EPA's goal in both programs is to ensure that we characterize effects for sensitive aquatic species consistently; however, the way the two program offices achieve that goal is slightly different. Although protection goals are policy and risk management decisions, this project focuses on characterization of effects. Another stakeholder was also concerned about how the common effects methodology would work given that "pesticides are designed to kill and standards are designed to protect." Differences in FIFRA and CWA regarding the risk-benefit nature of FIFRA relative to the CWA (which is not based on risk-benefits) were discussed. Betsy Behl and Joe Beaman re-emphasized that the focus of this project was on effects characterization.
An industry representative asked if the community-level benchmarks developed as part of this project could have application in the proposed general NPDES permits. Betsy Behl and Joe Beaman indicated that the first NPDES pesticide general permit is scheduled to be issued April 2011. The approaches described in these public meetings are not likely to be finalized until after the first general permit is issued.
A state representative suggested that fate characteristics (i.e., persistence) should be considered in developing benchmarks. Joe Beaman reiterated that the project is intended to focus only on the effects (not exposure) methodology.
One participant suggested that field data be utilized (in addition to the available EC50 data) to set benchmarks for plants. Reliance on EC50 values from lab studies as benchmarks does not approximate "real world" conditions and risks should not be assumed when concentrations exceed EC50 values.
In response to a question about how OW considers endangered species in AWQC derivation, Joe Beaman indicated that OW is required to consult with the Services under the ESA and is attempting to consult on a nationwide basis for AWQC derivation.
Anita Pease responded to a comment on the lack of sediment data for pesticides and stated that OPP is requesting sediment data as part of the pesticide registration review process. The pesticide data requirements for the revised 40 CFR Part 158 state that sediment testing is required to characterize risk to benthic invertebrates (see subsection 158.630 in that document).
A NYSDEC representative voiced a comment in support of using the Tier II Great Lakes Initiative (GLI) methodology to derive pesticide water quality criteria.
A stakeholder (NYSDEC) also commented that OW should relax the criteria for open literature related to limiting data to North American species. Joe Beaman responded that OW is accepting data for specific tests of non-North American species if guideline studies exist and if the Europeans have accepted the data for global reviews. When a non-North American species is the most sensitive species, further analyses may be necessary to conclude that the species in question is a reasonable surrogate for a resident species not represented in the database, and that the species sensitivity is similar to other related representative taxa that are resident species present in the US. Anita Pease indicated that OPP considers data for both North American and non-North American species in its review of the open literature.
In response to a question about when final documentation of the common effects methodology would be available, EPA stated that approximately two years from now was a reasonable timeframe.
One participant suggested that EPA expand this effort to harmonize on the human health side (MCLs). Joe Beaman and Betsy Behl commented that this expansion would involve a separate effort.
A FWS participant commented that criteria should take into account exposure to animals that eat aquatic organisms (e.g., a mammal that eats fish). Betsy Behl indicated that we do take secondary exposure into account in terrestrial exposure assessments.
Region 5 Stakeholder Meeting; Chicago, Il (January 14, 2010)
Region 7 Stakeholder Meeting, Kansas City, KS (January 19, 2010)
Region 10 Stakeholder Meeting, Seattle, WA (January 21, 2010)
| Regions | Presenters |
|---|---|
| R 5 | Betsy Behl, Office of Pesticide Programs (OPP) Joe Beaman, Office of Water (OW) Anita Pease, Office of Pesticide Programs (OPP) Dale Hoff, Office of Research and Development (ORD) Laura Dobbins, Office of Water (OW) |
| R7 | Betsy Behl, Office of Pesticide Programs (OPP) Joe Beaman, Office of Water (OW) Cindy Roberts, Office of Research and Development (ORD) Sujatha Sankula, Office of Pesticide Programs (OPP) |
| R10 | Betsy Behl, Office of Pesticide Programs (OPP) Joe Beaman, Office of Water (OW) Wade Lehman, Office of Water (OW) Tom Steeger, Office of Pesticide Programs (OPP) |
Like the first regional meetings, the participant mix was diverse and well-informed, and participants appreciated the fact that EPA was reaching out to them. Participants included representatives from industry, academia, state and federal regulatory agencies, and consultants. In addition, Region 10 established video links for state representatives in Idaho and Oregon for both agricultural and water staff.
General topics addressed in stakeholder comments
(Regions 5, 7, 10)
Participants asked a number of questions about the project schedule, including the national meeting, next steps, and opportunities for more input.
A number of questions were asked about the consistency of criteria used to evaluate open literature in OW and OPP.
Participants asked several questions on how sublethal effects and endocrine disruption would be addressed in this project.
Representatives of the Copper Council and American Chemistry Council asked questions related to the use and quality assurance of the biotic-ligand model (BLM), especially for marine species. Commenters pointed out that OPP has adopted the model and urged the OW to as well. The Office has adopted the BLM for freshwater criteria for copper, and was not fully aware of the status of the marine copper BLM until these meetings.
Several questions were asked about the use of OPP benchmarks for criteria development. Further information on the benchmark is available on the website EPA has established for this project, Office of Pesticide Programs' Aquatic Life Benchmarks and is referenced on the website for the OPP-OW Common Effects Assessment Methodology project.
Specific stakeholder questions/concerns/comments
(Regions 5, 7, 10)
One participant wanted to know how data from terrestrial plants will be used to address aquatic plants and if EPA was considering the use of data other than herbicides in analysis of plant effects. EPA indicated data from terrestrial plants will be looked at as surrogates. EPA also indicated that herbicide effects would be a focus of this paper since these pesticides have large datasets available; other data will be evaluated as well.
A question was asked about the "narrowness" of the data included in the determination of safety factors in the GLI Tier 2, noting that only data from ambient water quality criteria documents available at the time were used to develop the GLI Tier II factors. EPA responded that we would be re-examining some aspects of the GLI Tier 2 analysis, based on data available.
Another question was asked about the uncertainty in using tools to estimate surrogate data. EPA responded that part of this project is to look at the uncertainty in values derived using a given tool.
One participant asked about previous collaboration between OW and OPP on criteria development. The acrolein example was pointed out as an example of on-going collaborations in addition to this project.
There was a question about the perspective of NOAA on this effort, and EPA indicated that they would try to keep them informed of our efforts.
A question was asked about how this project would address endangered species (ES). EPA responded that data from ES would be used when and where available for this project. Separate efforts are underway with Office of Water and Office of Pesticide Programs and the Services to address endangered species issues.
Region 9 Stakeholder Meeting, Oakland, CA (January 22, 2010)
| Regions | Presenters |
|---|---|
| R9 | Betsy Behl, Office of Pesticide Programs (OPP) Joe Beaman, Office of Water (OW) Wade Lehman, Office of Water (OW) Tom Steeger, Office of Pesticide Programs (OPP) Patti TenBrook (EPA Region 9) |
This meeting had the largest turnout with about 70 people in attendance. The audience included representatives from the pesticide industry, academia, federal and state regulatory agencies, consultants, vector control companies, NOAA Fisheries, and irrigation system operators. Several storm water managers (CASQA) and water system managers participated in the meeting and represented counties and municipalities (large and small) from San Diego to San Francisco. Feedback on EPA's attempt to reach out to the public on this issue was positive.
General topics addressed in stakeholder comments
(Region 9)
Comments in California focused less on the specifics of this project and more on overall water quality concerns related to pesticides, although they did indicate broad support for the collaboration between the two offices and provided specific suggestions for this project.
Many commenters raised concerns about the costs cities and municipalities are incurring in addressing aquatic pesticide issues. They highlighted differences in test species required in NPDES permits versus those required in FIFRA requirements, indicating that species tested for NPDES compliance are significantly more sensitive to some pesticides than species used to meet testing required by OPP. They urged the EPA to consider this difference in registrant test requirements. Several commentators expressed frustration that FIFRA data requirements are not always fulfilled and are sometimes waived for aquatic species.
Some stakeholders cited examples of significant costs (ranging from thousands to several millions of dollars) incurred by cities and municipalities resulting from their efforts to comply with NPDES permitting, the requirement for monitoring and chemical analysis to identify sources of contamination, and outreach efforts. They provided examples of toxicity in compliance monitoring attributed to pesticides, primarily pyrethroids in urban areas, and expressed concern that testing was identifying toxicity in samples at levels below detection, using available methods. Several commenters pointed to a lack of analytical methods for pesticides.
One commenter noted that in California's 303d listing for 2010, there are 160 impairments due to pesticides, making up about a quarter of the list.
Commenters repeatedly focused on occurrence of pyrethroid compounds in water and sediment in urban areas. EPA asked commenters to identify specific compounds, if possible, which a few did (permethrin and bifenthrin, primarily). Occurrence of these compounds was reported in water, sediment, and fish tissue.
Several commenters noted that pesticides, which had been cancelled in urban areas (diazinon and chlorpyrifos), were no longer being detected. One commenter indicated that it took approximately two years before levels could no longer be detected. Another commenter indicated they did not see reductions in environmental samples until use of the compounds was no longer allowed.
Several questions were raised about the use of OPP benchmarks for criteria development, especially for atrazine.
Specific stakeholder questions/concerns/comments
(Region 9)
CASQA commented that they are very supportive of this effort, and that it was good to see OW and OPP working together. They mentioned that they were focusing on a few "big misses" in the pesticide registration decisions, which are costing states and municipalities significantly. They also expressed some frustration about the immediacy of their problems and the time for regulatory decision-making for pesticides.
The Regional Water Quality Control Board representative pointed to the additive and synergistic effects of chemicals. He supported the use of safety factors to be protective and meet OW anti-degradation standards. He also referred to fipronil toxicity found in some areas of California.
One commenter pointed to a similar lack of EPA guidance on the human health side for pesticides (MCLs). EPA noted that this is outside the scope of the current project, which focuses on ecological effects.
Another commenter suggested EPA work on exposure methods for urban areas. EPA thanked the commenter and noted that exposure is assessed for pesticides in OPP assessments.
One commenter suggested involving additional outside experts. EPA pointed to the multiple future opportunities for involvement and public comment (national stakeholder meeting, and a science advisory panel or board meeting).