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Recording and Resources: Catch Up on the NAPPC Webinar - Drilling Down on EPA Regulations: What Is the Latest Buzz on Pesticides and Bees?





Explore EPA Regulations on Pesticides and Bees in this webinar. Follow a pesticide's journey from risk assessment to the marketplace, led by host Andony Melathopoulos. Gain insights into the EPA's historical and current approaches, understanding their role in safeguarding pollinators.

Since 2010, the EPA has focused on assessing pesticide risks to bees. The key question: Is the EPA effectively protecting bees? This webinar delves into this topic, exploring its impact on our environment and agriculture. Below you can watch this informative webinar, resources shared, and answers to participant questions from the EPA.

Tools/Resources Shared


Q&A with the NAPPC Pesticide Education Task Force

Q: What is the role of field studies (or semi-field studies) in regulatory process? are all pesticides going through field studies in pollinators?

A: Risk is assessed in a tiered approach, which starts with laboratory studies on individual bees. Higher tiers, in contrast, are based on field-based studies  of honey bee colonies. The overall process is intended to identify those chemicals which are not considered likely to be an issue for bees and enables the agency to better allocate resources/testing to those chemicals which appear to be problematic. This being the case, if risk can be sufficiently characterized at the lab based Tier 1, field studies may not be required.

Q: Can you clarify exactly what conditions will trigger higher tier analyses if the crop isn't bee-attractive but near something that is? How is this determined? Isn't there always some risk of off-site transport, which can include flowering vegetation?

A: Off field risk is always a consideration in the risk assessment. We did not have enough time in the presentation to explain how this is done, but briefly, the estimated environmental concentration (EEC) is estimated for field edges for each proposed use and rate. In order to estimate EEC spray drift analyses are typically conducted to determine the distance from the treated field at which the risk quotient exceeds the level of concern for honey bees.

Q:I am hoping for some discussion of otherwise unregulated materials like adjuvents and especially coated seed planting, runoff from the field to waterways and most rednetly the disposal of unused coated seed.

A: Formulated pesticides are assessed in the risk assessment. The formulations may include adjuvants. Adjuvant products that are mixed in after by the pesticide applicator (also known as tank mixing) are not registered with EPA. Some states, however, do require registration of adjuvants. To our knowledge, these states are AR, CA, ID, KY, MS, TN, UT, WA, WY.
The issue of treated seed is somewhat different. Treated seed is currently exempted from FIFRA because  treated seed meets the definition of a treated article. Treated articles cover a wide range of pesticide usage, not just seeds. For example, there are a wide range of products, from kitchen sponges to cat litter, that are treated with antimicrobial pesticides to limit the growth of bacteria, fungi and viruses. While the pesticides used on seeds (and sponges and cat litter) have been evaluated under FIFRA, the treated products are exempt from such evaluation. Nevertheless, EPA has typically included instructions on the label for the pesticide used to treat seed for both the use of the pesticide and the distribution, sale, and use of the treated seed product. EPA's registration decisions take these instructions into consideration. There is currently a proposal from EPA to improve labeling on both labeling for the pesticide being used to treat the seed and labeling on treated seed products (e.g., seed bag tags) during registration and registration review processes.
https://www.federalregister.go...products-request-for

Q: Are risk assessment data for a given pesticide available to the public?

A: Yes, risk assessment data and a description of how the data was used to characterize risk is available through the Federal Register. A good search term to include in the Federal Register is “Ecological Risk Assessments” and the name of the pesticide you are interested in.

Q: Are seed treatment exposure routes included in EECs? Not just dust-off, but exposure through nectar/pollen and soil.

A: Yes, EPA evaluates potential risk to pollinators from treated seed (via residues translocated to pollen and nectar through systemic transport by the plant).  Similar to the process used by the European Food Safety Authority, EPA relies on a default value of 1 mg/kg in pollen or 1 mg/L in nectar from seed treatments.  Measured residues in pollen and nectar from plants grown from treated seed have typically been orders of magnitude below (i.e., lower than) the default value used to assess risk.  EPA also evaluates risk to other non-target terrestrial through ingestion of treated seed and/or through runoff of residues from soil containing treated seed.  While EPA does not quantify risks from dust-off given the number of factors that can influence this phenomenon, potential risks from exposure to dust generated during the planting of seeds is qualitatively characterized.

Q: Is it also correct to say that Tier 1 studies look at pesticides one at a time, rather than mixtures?

A: Ecological risk assessments consider single pesticides, not combinations of pesticides.

Q: Can you elaborate on how residues on plants (on foliage or nectar/pollen) will or won't support movement to Tier II? Are these incorporated into models that assess chronic exposure at lower rates?

A: In Tier I Estimated Environmental Concentration (EEC) uses a conservative approach to estimate what a bee is exposed to in the environment (see description of T-Rex tool for more detail). Data from nectar and pollen, but not foliage, can be used to “ground truth” the model prediction, refining the estimate of EEC. If risk cannot be adequately characterized at Tier I, even with the addition of pollen and nectar data, then Tier II tests will be required.

Q: Do you think the EPA will ever use data on how pesticides affect native bees to guide their decisions? It is concerning to me that allowed uses generally thought to be safe to bees (e.g., soil applications when the crop is not blooming) still harm native bees (e.g., squash bees) even if honey bees are not affected. Is there any sign that these impacts will be used in decision-making in the future?

A: Honey bees are used as a surrogate for other bees in Tier I tests in part due to the availability of these bees and the extent to which they are amenable to lab tests. But that is not to say that EPA does not evaluate data using other bee species at the Tier I phase, but that the bulk of the testing is done with honey bees. I provided an example in the webinar for fluazaindolizine where bumble bee contact and oral tests were included in the risk assessment. The risk assessment team exercises judgment, looking at the use of the products and the crops being proposed to determine whether data on other species are warranted.

Q: I have heard criticism that Fungicides are not evaluated for risk to bees. It seems this may not be true according to your talk. Can you talk about this

A: All pesticides are assessed for risk to honey bees, including fungicides. Some effects of fungicides have been shown by researchers to manifest in the presence of other pesticides, but combinations of pesticides are not currently regulated.

Q: Best recent assessments of sub-lethel effects?

A: The recent example of fluazaindolizine provided in the webinar show the assessment of sublethal effects. As I mentioned, sublethal effects are a routine piece of data collected for all Tier I tests.

Q: Do pesticide risk assessments consider the health state of the hive?

A: The recent example of fluazaindolizine provided in the webinar show the assessment of sublethal effects. As I mentioned, sublethal effects are a routine piece of data collected for all Tier I tests.

Q: While it is generally true that honey bees are not active at 50 degrees, is that true of other pollinators? Anecdotally I see other pollinators active at lower temps than honeybees. Is that an issue,

A: This is a great question. The temperature of 50℉ is meant to be an upper limit. Many studies have demonstrated that while bees that can fly at lower temperatures (e.g., bumble bees), their rate of foraging - and in turn their exposure - declines strongly as temperatures approach the 50℉.

Q: have there been studies that look at the chronic exposure and how that plays a role in the health of the bee through out its lifecycle and reproductive abilities?

A: Chronic exposure is restricted to individual bees in Tier I tests and does not take into account colony level endpoints. These effects, however, could be part of Tier II tests.

Q: Are their any tests regarding the use of fungicides?

A: All pesticides are assessed for risk to honey bees, including fungicides.

Q: Would it be possible to talk more about the quality assurance person who monitors the registrant’s testing? Does every registrant have this type of a person monitoring testing? Is it always a 3rd party? Would love to know a bit more about this.

A: Yes, quality assurance personnel are required to oversee all phases of the data gathered for risk assessment.  They ensure that the facilities, equipment, personnel, methods, practices, records, and controls are in compliance with GLP principles.

Q: does the EPA regulate incoming pesticides etc that are presented in a foreign language

A: Yes, EPA reviews and regulates all pesticides labels. However, the label must be presented in full English text (See Chapter 18 of the EPA label Review Manual). Per EPA Label Review Manual:
https://www.epa.gov/sites/defa...full-lrm_2-22-21.pdf
Chapter 3 A final printed labeling is the label or labeling of a pesticide product when it is distributed or sold. Pursuant to 40 CFR 156.10(a)(6), with certain limited exceptions, “final printed labeling must be submitted and accepted prior to registration.

Chapter 18 Foreign language labeling- Foreign language text, in addition to the full English text, is permitted in part or in its entirety on the product so long as it is a true and accurate translation of the English text. (See PR Notice 98-10) A registrant may provide bilingual labeling on any product without notification. However, if it is submitted, the Office of Pesticide Programs (OPP) currently does not review the translation for accuracy or stamp/approve it. If the foreign text is inaccurate or goes beyond the reviewed and accepted English labeling, the Office of Enforcement and Compliance Assurance may take enforcement action. Products marketed in Puerto Rico can be labeled in English only or in English and Spanish.

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