By Lisa M. Campbell and Susan M. Kirsch
On February 15, 2018, the U.S. Environmental Protection Agency (EPA) added resources to its website regarding the Worker Protection Standard (WPS) and the Application Exclusion Zone (AEZ) requirements of the WPS. As of January 2, 2018, full compliance is required with all of the AEZ-related requirements in the WPS. The new EPA website resources include:
While many welcome EPA’s guidance on the many thorny issues presented by the WPS and AEZ requirements, some believe that in places, the newly issued guidance raises additional questions and leaves some significant questions unaddressed. Given the controversy over this rule, this new guidance should be reviewed closely.
More information on the WPS, including EPA’s December 2017 announcement of its intention to revise the AEZ and other WPS provisions, and current implementation deadlines can be found on our blog under key word WPS and key phrase Worker Protection Standard.
By Lisa M. Campbell and James V. Aidala
On January 3, 2018, officials with the Arkansas State Plant Board (Plant Board) voted 11 to 3 to uphold its statewide ban of dicamba. The vote came after a subcommittee of the state's legislative council asked the board to reevaluate its earlier decision. The subcommittee will revisit the Plant Board's decision again on January 16, 2018. That the subcommittee plans to revisit its decision in just two weeks is noteworthy and illustrates the controversy surrounding this and other similar state bans.
Given the panel will meet again in the next few weeks, this may indicate that the legislature is urging some greater flexibility -- that is, a longer application window that would allow some growers to use the herbicide, along with consideration of any data about the newer formulations designed to reduce the likelihood of drift.
Whether any “flexibility” or additional data will be sufficient to convince the Plant Board that the product can be used without expecting drift incidents in the future is not clear, especially since the issue has become a point of intense political debate.
More information on dicamba issues is available on our blog under key word dicamba.
By James V. Aidala, Lisa M. Campbell, and Timothy D. Backstrom
On December 14, 2017, the Missouri Department of Agriculture (MDA) announced that it issued and collected the first round of fines resulting from investigations regarding the pesticide dicamba. The news release states that the first wave of civil penalties issued to applicators, all from Dunklin County, were issued as “a result of investigations of complaints during the 2016 growing season,” and the “civil penalties, ranging from $1,500 to $62,250, were issued for pesticide misuse (off label use and drift).” Further, in 2016, “Department staff conducted and completed 121 complainant investigations. Those complainants named approximately 60 applicators, who were investigated as a result of complaints. In addition, the Department investigated nearly 100 non-Dicamba related incidents.”
This is the first group of what is anticipated to be a large number of dicamba-related enforcement cases, given the extensive number of, and publicity concerning, the reported incidents involving dicamba. Reported incidents in Arkansas were even more numerous than those in Missouri. About one-third of the reported incidents in Missouri have now been attributed to only six applicators. One applicator alone was cited for 149 discrete violations, which indicates that problems with the new dicamba formulations may be less widespread than some originally feared based on the large number of reported incidents. Moreover, some of the states where the new dicamba products were widely used have reported very few incidents. In the aggregate, this data suggests that better stewardship training accompanied by rigorous enforcement may be sufficient to greatly reduce the future incidence of unexpected off-site movement of the new dicamba formulations.
More information on dicamba issues is available in our blog.
By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala
On October 13, 2017, the U.S. Environmental Protection Agency (EPA) announced that it had reached an agreement with Monsanto, BASF, and DuPont on measures “to further minimize the potential for drift to damage neighboring crops from the use of dicamba formulations used to control weeds in genetically modified cotton and soybeans,” and “new requirements for the use of dicamba ‘over the top’ (application to growing plants) will allow farmers to make informed choices for seed purchases for the 2018 growing season.”
EPA states that in a series of discussions, it “worked cooperatively with states, land-grant universities, and the pesticide manufacturers to examine the underlying causes of recent crop damage in the farm belt and southeast,” “sought extensive input from States and [U.S. Department of Agriculture (USDA)] cooperative extension agents from across the country, as well as the pesticide manufacturers, on the underlying causes of damage,” and “reviewed all available information carefully and developed tangible regulatory changes for the 2018 growing season.”
The label changes that certain registrants of dicamba products have agreed to impose additional requirements for "over the top" use of these products next year. These new requirements include:
- Classifying products as "restricted use," permitting only certified applicators with special training, and those under their supervision, to apply them; dicamba-specific training for all certified applicators to reinforce proper use;
- Requiring farmers to maintain specific records regarding the use of these products to improve compliance with label restrictions;
- Limiting applications to when maximum wind speeds are below 10 mph (from 15 mph) to reduce potential spray drift;
- Reducing the times during the day when applications can occur;
- Including tank clean-out language to prevent cross contamination; and
- Enhancing susceptible crop language and recordkeeping with sensitive crop registries to increase awareness of risk to especially sensitive crops nearby.
This announcement follows two compliance advisories issued by EPA in August 2016 and July 2017 on what EPA described as the high number of complaints received regarding crop damage from the alleged misuse of herbicides containing the active ingredient dicamaba. EPA’s August 2016 compliance advisory stated that the Missouri Department of Agriculture received 117 complaints alleging misuse of pesticide products containing dicamba, and Missouri growers estimated that more than 42,000 acres of crops had been adversely affected. Further, that similar complaints alleging misuse of dicamba products were received by Alabama, Arkansas, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Tennessee and Texas. In the spring of 2016, EPA issued a proposal to register dicamba to control weeds in cotton and soybean that have been genetically engineered to tolerate dicamba. In November 2016, EPA issued a conditional registration for dicamba on dicamba-tolerant cotton and soybean to Monsanto for its Xtendimax product; and EPA recently approved a label amendment made by Monsanto for Xtendimax which includes “additional restrictions further minimizing off-field movement of the active ingredient dicamba.”
EPA’s July 2017 compliance advisory states that by early July, EPA had received reports of hundreds of complaints to state agencies in Arkansas, Missouri, and Tennessee, a significant increase from 2016; lists the three new conditional registrations issued late last year (including Xtendimax); and states that only these new registered products may be lawfully applied over-the-top of growing soybeans and cotton. It discusses what it describes as unlawful applications of dicamba products, and states that “[e]xcept for the new conditionally registered dicamba products, application of a dicamba product during either the cotton or soybean crop growing season is unlawful under FIFRA.”
EPA’s July 2017 compliance advisory further states that each of the conditionally approved dicamba herbicide products has labeling that provides mandatory directions for use, restrictions, and special precautions that must be followed, and that the labels of the new products require specific and rigorous drift mitigation measures to further reduce the potential for exposure from spray drift including:
- No application from aircraft;
- No application when wind speed is over 15 mph;
- Application only with approved nozzles at specified pressures; and
- Buffer zones to protect sensitive areas when the wind is blowing toward them.
The reports of and concerns about potential damage to crops in connection with the application of dicamba illustrate a problem that has long been discussed, which is the potential for unintended impact when a pesticide that has been specifically designed for use with one or more crops that have been genetically engineered to be tolerant to the pesticide is applied in close proximity to other crops that do not share these tolerant characteristics.
The dicamba case also illustrates the differing views on potential misuse issues. Some observers have questioned whether all of the reported dicamba incidents were due to misuse or misapplication of the product. Although the 2018 label changes are designed to mitigate the potential for damage to sensitive crops, some question whether some unanticipated or as yet not completely understood factor may be at play in some of the incident reports. One issue raised by some researchers concerns potential unexpected volatility of the product even when applied according to the label directions by well-trained applicators. The registrants have disputed this suggestion, but it is an area which will likely be more thoroughly researched over the next few growing seasons.
More information on EPA’s regulatory action on dicamba is available on EPA’s website.
By Lisa M. Campbell and Susan Hunter Youngren, Ph.D.
The California Department of Pesticide Regulation (DPR) announced on February 26, 2015, a revision to the process for evaluation of the potential for a pesticide to move off-site into surface water when the pesticide is used in an urban area. The former evaluation method followed the U.S. Environmental Protection Agency (EPA) approach with California specific parameters. This revision will continue to use the EPA approach but allow incorporation of a module specific for California urban settings.
Potential adverse impacts on surface water from use of pesticides are assessed in California by DPR’s Environmental Monitoring Branch’s Surface Water Protection Program (SWPP) using EPA methodology. The SWPP uses the EPA evaluation method for proposed agricultural pesticide registrations based on PE5 (PRZM-EXAMS version 5) and Tier 2 modeling scenarios but there have been no consistent methods for assessing potential pesticide runoff on impervious surfaces in an urban setting. The new California urban module includes the following improvements that are designed to be further representative of urban conditions in California:
* Introduction of four types of surfaces by permeability and water sources;
* Consideration of pesticide transport induced by dry-weather runoff from impervious surfaces;
* Separation of impervious and pervious portions in the modeling scenarios;
* Use of prescheduled lawn irrigation;
* Characterization of residential and commercial/industrial areas to reflect California urban conditions; and
* Aggregations of water, sediment, and pesticide yields for the urban watershed.
The urban model is designed particularly for evaluating pesticides applied outdoors in areas with large amounts of impervious surfaces such as residential areas, commercial/industrial facilities, and highway and road rights-of-way applications. Pesticide products of interest would be those that have the potential for impact to surface waters through overspray to impervious surfaces in these areas
By Lisa M. Campbell, James V. Aidala, and Susan Hunter Youngren, Ph.D.
The U.S. Environmental Protection Agency’s (EPA) January 5, 2015, release for public comment of the revised human health risk assessment of chlorpyrifos (http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2008-0850-0195) reflects another step taken to implement its new spray drift and volatilization policies. These policies were long in the making and the subject of significant discussion and controversy over the years. EPA, with this assessment, has also taken a very public step to implement its controversial policy, announced in December 2009, to apply, effectively, Food Quality Protection Act (FQPA) risk assessment techniques to pesticide uses not subject to FQPA, as part of its commitment to environmental justice.
The spray drift and volatilization policies were discussed in an October 2014 webinar and discussed in our September 17, 2014, memorandum. EPA’s Revised Risk Assessment Methods for Workers, Children of Workers in Agricultural Fields, and Pesticides with No Food Uses, issued in 2009, is discussed in our December 8, 2009, memorandum.
Spray Drift and Volatilization
EPA had been assessing spray drift and volatilization for chlorpyrifos for a number of years, and many of the EPA-derived spray drift and volatilization tools are based on chlorpyrifos data. The January 5 assessment updates the assessment conducted in 2011. This document assesses both potential risks to workers (mixing/loading/applying and re-entry) as well as potential risks to residents (bystanders and food/water consumption). The bystander assessment uses the new tools that EPA released in Spring 2014 to assess potential risks from volatilization and spray drift (as discussed in the B&C webinar). The buffer zones EPA had previously estimated to mitigate spray drift are reduced in the new assessment. The risks noted in the assessment were for workers and specific water areas.
FQPA Risk Assessment Methods Use for Non-FQPA Assessment
In addition to implementing its spray drift and volatilization policies, EPA also assessed exposure in a manner that appears intended to implement the 2009 policy that was the subject of much concern when released for public comment. In that policy, EPA stated its intent to apply risk assessment techniques developed in implementing FQPA’s “extra safety factor” to any pesticide product’s risk assessment, regardless of whether it falls under FQPA, “so long as application of the risk assessment technique is consistent with good scientific practice and is not otherwise prohibited by law.” EPA stated then that this would include “using an additional safety/uncertainty factor to protect children,” as well a number of other factors. EPA announced this policy originally as part of its commitment to considerations of environmental justice.
The chlorpyrifos assessment is based on a physiologically-based, pharmacokinetic-pharmacodynamic (PBPK-PD) model to estimate the toxicologic Points of Departure (POD), thus deriving different toxicological values of concern based on the age, sex, and duration of exposure. The PBPK-PD model is also used to estimate intra-species uncertainty factors (UF), as there is no need for inter-species factors because the model estimates human red blood cell (RBC) acetylcholinesterase/cholinesterase (AChE/ChE) inhibition. Based on the PBPK-PD model, a 10X intra-species factor was used for females of childbearing years whereas it was 4X for all other groups assessed.
The worker of concern in the assessment is defined to be a female of childbearing years due to concern of not only RBC AChE/ChE inhibition, but also the potential for neurodevelopmental effects as seen in epidemiological studies. The epidemiological studies are controversial because there have been many questions about actual exposure to chlorpyrifos, particularly as two studies measured a biomarker that can be seen from exposure to other organophosphates (OP). The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Science Advisory Panel (SAP) reviewed EPA’s assessments of these studies in 2008 and 2012. The SAP concluded that “chlorpyrifos likely played a role” in the observed neurodevelopmental outcomes. EPA determined that based on the weight of evidence (WOE) from animal studies and epidemiological studies, reduction of the 10x “FQPA Safety Factor (SF)” was not appropriate. The residential dietary assessments were compared to a Margin of Exposure (MOE) of 100 (10X FQPA SF x 10X intra-species factor) for women and an MOE of 40 (10X FQPA SF x 4X intra-species factor) for all other ages. The occupational assessments were compared to an MOE of 100 for women and 40 for all other age groups (with no explanation of the reasoning behind those values).
This is noteworthy and should be examined closely because EPA has effectively used an additional “FQPA factor” as a safety factor for occupational assessments. EPA stated in its press release announcing the assessment that potential restrictions may be necessary to protect workers and water.
There is a 60-day comment period for this document, which are due on or before March 16, 2015. Among the issues commenters are likely to address include:
Use of the PBPK-PD model to estimate PODs;
Use of the PBPK-PD model to estimate intra-species uncertainty factors;
Use of the epidemiological data; and
Use of a 10X SF for occupational exposure.
The full impact of this assessment is not yet clear, but it raises many issues of interest to registrants.
By Susan Hunter Youngren, Ph.D.
On October 15, 2014, the Office of Pesticide Programs (OPP) announced a voluntary program to document the effectiveness of agricultural pesticide spray application technologies on reducing pesticide spray drift. Under the Drift Reduction Technology (DRT) Program, agricultural equipment manufacturers would conduct (or make arrangements for a testing facility to conduct) studies to determine the percent drift reduction according to a verification protocol. Once completed, the manufacturer would submit the study to the U.S. Environmental Protection Agency (EPA) for review and evaluation. As verified, these reductions could then be quantitatively credited in the environmental risk assessments used to develop the drift reduction measures appearing on the label of the pesticide product. EPA will then review the manufacturers’ studies and, based on these data, it will assign spraying devices a rating on a four-star scale:
* Four stars: Device can reduce spray drift by 90 percent or more.
* Three stars: Device can reduce spray drift by between 75 percent to 89 percent.
* Two stars: Device can reduce spray drift by between 50 percent to 74 percent.
* One star: Device can reduce spray drift by between 25 percent to 49 percent.
* No stars: Device can reduce spray drift by less than 25 percent.
EPA allows pesticide manufacturers to include labeling on their products that contain dual-use instructions, one for farmers using devices that have received stars through the DRT program and another for those using devices that do not have a DRT rating.
By: Lisa M. Campbell and Susan Hunter Youngren, Ph. D.
Spray drift and volatilization issues increasingly are significant issues in pesticide product risk assessments. Earlier this year, the U.S. Environmental Protection Agency (EPA) issued drafts of key guidance documents, which focused on issues that were key in the chlorpyrifos petition response, and more recently, at least one registration review decision that reflects current and still evolving EPA policy on spray drift and volatilization issues.
How potential for spray drift and for volatilization are identified and then managed are likely to be key elements of ongoing and future risk assessments underlying forthcoming EPA registration and reregistration, with significant potential impact on these decisions. Registrants should monitor closely the policies, EPA decisions implementing them, and their potential impact on their products, particularly given the public interest in these issues.
The EPA documents issued in the past eight or so months are significant, particularly given the years of controversy and difficulty in past attempts to propose a clear and “simple” definition of “drift.” The perception by some advocacy groups is that EPA is not adequately addressing alleged harms posed by drift, and resulting appeals for court intervention will undoubtedly complicate the matrix of considerations influencing EPA’s policy. These reasons alone make monitoring the development of these policies critical for registrants.