Aquatic Life Benchmarks for Registered Pesticides

This original announcement was published by the EPA on September 29, 2020. Click here for more!

Today, the U.S. Environmental Protection Agency (EPA), in collaboration with the California Department of Pesticide Regulation and the U.S. Geological Survey, released an updated aquatic life benchmarks table, which includes both new and updated aquatic life benchmark values.

Aquatic life benchmarks are estimates of the concentrations below which pesticides are not expected to present a risk of concern for freshwater organisms. State, tribal and local governments use these benchmarks in their interpretation of water monitoring data.

Comparing a measured concentration of a pesticide in water to an aquatic life benchmark can be helpful in interpreting monitoring data and in identifying and prioritizing monitoring sites that may require further investigation.

The updated aquatic life benchmarks represent newly registered pesticides or new values for previously registered pesticides and selected degradates, or new registrations. EPA’s goal is to add to these benchmarks on an annual basis; the last update was published September 30, 2019.

EPA based these benchmarks on toxicity values from scientific studies that the Agency reviewed and used in publicly accessible ecological risk assessments in support of regulatory decisions for pesticides. The table directly links the source documents for each of the benchmarks.

View the updated table on our webpage.

EPA Provides Information About Reducing Pesticide Impacts on Endangered Species

This original announcement was published by the EPA on September 23, 2020. Click here for more!

 

EPA is providing materials to help the public and pesticide applicators protect endangered species and their critical habitats.

Information on possible risk reduction measures, such as best management practices to reduce exposures and impacts to federally threatened and endangered species, can now be found on our website.

These materials came out of EPA’s consultation with the National Marine Fisheries Service (NMFS) on registrations of pesticide products containing the insecticides chlorpyrifosdiazinon and malathion.

In December 2017, NMFS issued a final biological opinion on these three chemicals as part of a consultation process. Read the biological opinion here. A biological opinion provides a view of whether the pesticide’s registered use is likely to jeopardize a species, and if so, describes alternatives to avoid jeopardy.

EPA re-initiated consultation with NMFS to allow for consideration of additional information. The Agency remains in consultation with NMFS as they revise their biological opinion.

Additional information on the re-initiated consultation is available on www.regulations.gov with the docket number EPA-HQ-OPP-2018-0141.

Review the new materials on our website.

EPA Takes Next Step in Review Process for Insecticide Chlorpyrifos, Making Draft Risk Assessments Available

This original announcement was published by the EPA on September 23, 2020. Click here for more!

Today, the U.S. Environmental Protection Agency (EPA) is taking an important step in the Agency’s review of chlorpyrifos. Meeting an important commitment made in the Agency’s July 2019 response to the related petition denial, EPA has released its draft risk assessments for chlorpyrifos for public review. These draft risk assessments are the next stage in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration review process and are not a denial or approval of the insecticide.

The draft risk assessments are the product of an extensive evaluation of available data on chlorpyrifos’s health and environmental impacts. Specific findings include:

  • The revised human health risk assessment identifies dietary (including children) and occupational handler risks of concern and incorporates the updated drinking water assessment.
  • With the limited remaining residential uses of chlorpyrifos EPA found no risks of concern, including to children’s health, when products are used according to the label instructions.
  • The Agency’s draft ecological risk assessment identifies potential adverse effects to mammals, birds, fish, and terrestrial and aquatic invertebrates.

Full details on these potential risks and EPA’s methods for estimating them can be found within the revised human health and draft ecological risk assessments located on the Agency’s website.

EPA will take public comment on the draft risk assessments (DRAs) during the same 60-day public comment period that the Agency plans to open when it issues its Proposed Interim Decision (PID) in October 2020. The PID, which is the next step in the FIFRA process, will outline potential risk management options for this insecticide to address any potential risks of concern identified in the DRAs.

By holding the comment period at the same time as the Proposed Interim Decision, the public will have access to more information on chlorpyrifos and can provide the Agency with more informed, robust comments. EPA will review and respond to comments for both documents prior to issuing an Interim Decision.

EPA will also consider the input and recommendations from the September 2020 FIFRA Scientific Advisory Panel (SAP) meeting once the SAP report is released in December 2020. Depending on the SAP’s conclusions, EPA may further revise the human health risk assessment. After a thorough review of the best available science and carefully considering scientific peer review and public comments, EPA will then determine the next steps in the registration review process for chlorpyrifos.



EPA Finalizes Methodologies to Improve Drinking Water Assessments for Conventional Pesticides

This original announcement was published by the EPA on September 19, 2020. Click here for more.

After a thorough review of the best available science and carefully considering scientific peer review and public comments, EPA has released the final version of three new methodologies to improve drinking water assessments for conventional pesticides. Collectively, these new methods use advanced modeling approaches to incorporate the best available surface water modeling, spatial and historical data on pesticide use. These methods are designed to improve the accuracy, consistency and transparency of pesticide drinking water modeling.

Specifically, the new methods:

  • Build new scenarios (a combination of crop, soil type, and weather data) for use in EPA’s Pesticide in Water Calculator, the standard water exposure model for both drinking water and aquatic wildlife;
  • Better account for variability in the agricultural area within a watershed that may contribute to a drinking water intake (Percent Cropped Area (PCA)) and incorporate data on the amount of a pesticide applied within a watershed for each use (Percent Crop Treated (PCT));
  • Outline methods to confidently use surface water monitoring data;
  • Derive and integrate pesticide-specific sampling bias factors to address temporal challenges with available monitoring data; and,
  • Use a weight-of-evidence approach to evaluate the relevance of monitoring sites to drinking water watersheds to address spatial limitations with available monitoring data.

Approaches for the Quantitative Use of Surface Water Monitoring Data in Drinking Water Assessments were presented to the Federal Insecticide Fungicide and Rodenticide Act Scientific Advisory Panel in Fall 2019 and the other two methods underwent contract peer review and public comment this past winter. EPA plans to incorporate these new methods into future drinking water assessments when appropriate.

In addition to finalizing these methods to improve drinking water assessments, EPA is also releasing a Framework for Conducting Pesticide Drinking Water Assessments for Surface Water, which describes EPA’s robust, tiered process designed to efficiently screen out pesticides that do not pose a potential risk to human health from those requiring more highly refined analyses to better understand potential risks.

Read about the new methodologies on our webpage.

EPA Releases Draft Risk Assessments for Mosquito Control Tool

This original announcement was published by the EPA on September 8, 2020. Click here for more!

 

Today, as part of the U.S. Environmental Protection Agency’s (EPA) efforts to protect public health and the environment, the agency is releasing draft human health and ecological risk assessments for naled – a critical tool for mosquito-borne disease control – for a 60-day public comment period.

Naled is registered for public health wide-area mosquito control, as well as insect control, at a variety of agricultural sites and food-processing facilities. It has been used safely and successfully to control mosquitos in the United States since 1959. More information about naled’s use to control mosquitos, including guidance for aerial spraying by mosquito control professionals in local governments and mosquito control districts can be found on EPA’s website.

The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires EPA to periodically review pesticides to ensure that risk assessments reflect the best available science. The draft risk assessment is the first step in a multi-step process that is designed to both identify risk and then identify actions that can mitigate those risks.

EPA has identified both health and environmental risks associated with naled in the draft risk assessment. The draft assessment—which is intentionally conservative to ensure that it is protective of health and completed at the highest exposures—does show that estimated exposure from aerial application exceed EPA’s level of concern for children ages 1-2 years for up to four hours following spraying. EPA is actively working with mosquito control districts to encourage that they notify residents at least 24 hours prior to spraying so that residents can take protective actions. In addition, EPA has provided mosquito control professionals in local governments and mosquito control districts with advice on naled aerial spraying to reduce risks.

Both naled and the insecticide trichlorfon both degrade to form the insecticide DDVP. Draft human health risk assessments for trichlorfon and DDVP are also now available for public comment. After reviewing and considering public comments received and other information, EPA will issue proposed interim decisions (PIDs) proposing any potential risk management options for naled, DDVP and trichlorfon. The PIDs will also be available for public comment.

The draft risk assessments are available in each chemical’s registration review docket – EPA-HQ-OPP-2009-0209 (DDVP), EPA-HQ-OPP-2009-0053 (naled) and EPA-HQ-OPP-2009-0097 (trichlorfon) at www.regulations.gov. The comment period expires in 60 days on November 9, 2020.

Background

In September 2020, EPA plans to convene a FIFRA Scientific Advisory Panel (SAP) meeting to discuss new approach methodologies (NAM) that could have implications for organophosphate pesticides, including naled, DDVP and trichlorfon. These NAMs could reduce reliance on default uncertainty factors for human health risk assessment and reduce animal testing. Following the SAP meeting, if EPA determines that adjustments to the uncertainty factors for naled, DDVP, and/or trichlorfon are appropriate, the Agency will update the draft risk assessments.

EPA Seeks Public Comment – Pest Resistance for Plant-Incorporated Protectants

This original announcement was published by the EPA on September 4, 2020. Click here for more!

EPA is accepting comments on a draft proposal to improve current insect resistance management (IRM) strategies for pests affecting Bacillus thuringiensis (Bt) corn and cotton plant-incorporated protectants (PIPs).

Bt PIPs are pesticidal substances that have been genetically engineered into corn and cotton plants. These modified plants then produce Bt proteins that are harmful to certain insect pests. This has been accomplished by transferring specific genetic material from a bacterium, Bacillus thuringiensis (Bt), to the plant’s genome. The genetic material encodes these proteins that have specific toxicity to certain insect pests, but do not affect mammals or non-target organisms. Beginning in 1995, EPA has registered numerous cotton and corn PIPs that have since been widely adopted by growers in the United States and other countries.

This draft proposal provides an improved IRM framework that will help farmers prolong the durability of Bt PIPs from pests. The Agency is proposing to implement many of the recommendations from a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel — as well as stakeholder groups — to create the draft proposal.

EPA is specifically interested in feedback from grower organizations, crop consultants, state and local extension agencies, state departments of agriculture and USDA.

After the comment period closes, EPA will modify the proposal as appropriate and work with registrants to finalize a new IRM framework for Bt corn and cotton PIP registrations.

The public comment period will be open for 60 days in docket EPA-HQ-OPP-2019-0682 at www.regulations.gov and will close on Nov. 7, 2020. Read the FIFRA Scientific Advisory Panel report for more information on this action, and visit EPA’s website to learn more about Bt PIPs and IRM strategies in general.

EPA Supports Technology to Benefit America’s Farmers, Improve Sustainability

This original message was published by the EPA on September 2, 2020. Click here for more!

WASHINGTON (September 1, 2020) — In another effort to remove barriers to innovation, the U.S. Environmental Protection Agency (EPA) has proposed a rule that will streamline the regulation of certain plant-incorporated protectants (PIPs) that pose no risks of concern to humans or the environment. This action – which will be available for public comment for 60 days – delivers on a key directive under President Trump’s Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products.

“This new rule will provide critical new tools for America’s farmers as they work to increase agricultural productivity, improve the nutritional value and quality of crops, fight pests and diseases, and boost food safety,” said EPA Administrator Andrew Wheeler. “Embracing this technology through a transparent, consistent and science-based process is long overdue, and will secure benefits to American agriculture well into the future.”

Specifically, EPA is proposing exemptions under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA) for certain PIPs created through biotechnology. The Agency has preliminarily determined that these substances meeting the exemption criteria have no risks of concern to humans or the environment.

EPA’s proposed exemptions for PIPs created through biotechnology seek to facilitate the development of new tools for American farmers to protect their crops and control agricultural pests. By reducing antiquated regulations that restrict access to the market for biotechnology products, these types of agricultural innovations will become far more accessible to American farmers. These improvements will have the potential to increase America’s food supply.

PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the pesticidal substance. The existing regulatory exemption for PIPs is limited to those created through conventional breeding. The proposed exemption would allow for PIPs created through biotechnology to also be exempt from existing regulations if they 1) pose no greater risk than PIPs that meet EPA safety requirements, and 2) could have been created through conventional breeding.

Under the proposed exemption, EPA would require developers of PIPs to submit either a self-determination letter or a request for EPA confirmation that their PIP meets the criteria for exemption. For increased flexibility in bringing PIPs to market, a developer could also submit both.

To learn more about the proposed exemption and to submit comments visit: https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/pesticides-exemptions-certain-plant-incorporated

Trump EPA Approves First-Ever Long-Lasting Antiviral Product for Use Against COVID-19

This original announcement was published by EPA on August 25, 2020. Click here for more. 

 

WASHINGTON (August 24, 2020) — Today, U.S. Environmental Protection Agency (EPA) Administrator Andrew Wheeler announced a groundbreaking development in the Trump Administration’s efforts to combat the novel coronavirus. In a first-of-its kind step, EPA has issued an emergency exemption to the state of Texas permitting it to allow American Airlines and Total Orthopedics Sports & Spine to use a new product that kills coronavirus like the SARS-CoV-2 virus on surfaces for up to seven days. After carefully reviewing the available data and information, the agency has determined that the product helps to address the current national emergency. This product is expected to provide longer-lasting protection in public spaces, increasing consumer confidence in resuming normal air travel and other activities.

“There is no higher priority for the Trump Administration than protecting the health and safety of Americans and I want to thank those who have worked with us to achieve this major milestone,” said EPA Administrator Andrew Wheeler. “Since day one, I have been committed to ensuring that Americans have as many tools as possible to protect their families and today we are delivering on that promise by approving the first-ever long-lasting antiviral product that will help fight the spread of the novel coronavirus.”

“Texas is proud to once again step up and join the fight against this virus,” said Texas Agriculture Commissioner Sid Miller.  “This Section 18 exemption gives businesses another tool to protect consumers as we try to bring our economy back. Thank you President Trump and EPA Administrator Wheeler for your commitment to the safety of the American people and to ending this pandemic that is choking our economy and our way of life.”

“We are very grateful for Administrator Wheeler and the many hardworking professionals at the EPA who rigorously evaluated SurfaceWise2 to safeguard our customers and team members from viruses, such as the flu and coronavirus,” said American Airlines Chief Operating Officer David Seymour. “SurfaceWise2 will make the travel experience even safer for those who are ready to return to the skies and reopen our country for business.”

“We are thrilled to work closely with the EPA on approval for SurfaceWise2, which enables people to get back to living their lives,” said Allied BioScience CEO Michael Ruley. “This initial EPA approval clears the way to effectively protect people against COVID-19 as a residual solution proven to provide long-term, non-toxic surface protection from viruses, including coronaviruses. We know how tirelessly the EPA has worked to evaluate a litany of innovative products, and we are excited to provide this added layer of defense for our country.”

EPA is approving the emergency exemption requests submitted under Section 18 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). SurfaceWise2—a product manufactured by Allied BioScience completely in the United States—is a surface coating that inactivates viruses and bacteria within two hours of application and continues to work against them for up to seven days. EPA’s approval will allow Texas to permit American Airlines airport facilities and planes at specific locations and two Total Orthopedics Sports & Spine Clinics to use SurfaceWise2 under certain conditions.

Over the coming months, Allied BioScience will pursue a non-emergency approval under FIFRA Section 3 by submitting additional data to meet EPA’s registration requirements as an antiviral surface coating. If the full registration process is completed, the product would become available for purchase by members of the public.

EPA anticipates posting information for companies or individuals who are interested in pursuing a FIFRA Section 3 registration for antiviral surface coatings in the coming weeks. In the interim, states or federal agencies interested in pursuing a Section 18 Emergency Exemption Request for products that claim residual efficacy against viruses for up to seven days should be prepared to include efficacy data demonstrating that the product is durable and effective against viruses in their applications. Durability and efficacy should both be evaluated. For example, antiviral efficacy should be assessed using coated surfaces that have been exposed to physical touches/abrasion and treatment with disinfectants. EPA will review the results of these studies to ensure that surface coatings remain effective under the anticipated proposed conditions of use.

For more information, please visit: https://www.epa.gov/pesticide-registration/section-18-emergency-exemption-requests-and-coronavirus-covid-19

Background

SurfaceWise2 is meant to inactivate viruses that land on a surface between regular cleanings. This product is not a replacement for routine cleaning and disinfection with products from EPA’s List N: Disinfectants for Use Against SARS-CoV-2, the virus that causes COVID-19. EPA recommends that facilities continue to follow the cleaning and disinfection recommendations from the Centers for Disease Control and Prevention (CDC). Please note that according to the CDC, while “it may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes,” the virus is thought to spread mainly through close contact between individuals.

The approved Section 18 emergency requests are effective for a year. As new data emerge, EPA may alter the terms of the product’s emergency uses.

EPA Opens Public Comment Period on Cuprous Iodide Draft Ecological Risk Assessment

This original announcement was published by the EPA on August 14, 2020. Click here for more!

The U.S. Environmental Protection Agency (EPA) is accepting comments on its determination that cuprous iodide, when used in a materials preservative embedded in specific fibers, plastics and films, is not expected to pose a discernable threat to terrestrial and aquatic organisms.

Cuprous iodide is an active ingredient in the material preservative Cupron Cuprous Iodide Masterbatch, a material preservative that suppresses the growth of algae, mold, mildew, fungi and bacteria from manufactured products such as bedding, carpets, floor coverings, upholstery, shoes, gloves, sails and awnings.

This determination is in response to a 2019 lawsuit filed by the Center of Biological Diversity (CBD) alleging that EPA violated the Endangered Species Act (ESA). CBD expressed concern that Cupron Cuprous Iodide Masterbatch could jeopardize threatened and endangered species and their habitats.

To address these issues, Cupron submitted a label amendment that removed the use of cuprous iodide in frequently washed material goods. The remaining uses include certain fibers, plastics and films not expected to create down-the-drain discharge. After assessing the label amendments and completing a draft ecological risk assessment, EPA does not anticipate unreasonable adverse effects from the revised use of cuprous iodide.

Comments are accepted in docket EPA-HQ-OPP-2013-0433 at www.regulations.gov for 30 days, closing on Sept. 14, 2020.

Nootkatone Now Registered by EPA

This original announcement was published by the EPA on August 11, 2020. Click here for more! 

 

A new active ingredient, discovered and developed by the Centers for Disease Control and Prevention (CDC), has been registered by the Environmental Protection Agency (EPA) for use in insecticides and insect repellents.

Studies show that when products are formulated from the new ingredient, nootkatone, they may repel and kill ticks, mosquitoes, and a wide variety of other biting pests. Nootkatone is responsible for the characteristic smell and taste of grapefruit and is widely used in the fragrance industry to make perfumes and colognes. It is found in minute quantities in Alaska yellow cedar trees and grapefruit skin.

Nootkatone can now be used to develop new insect repellents and insecticides for protecting people and pets. CDC’s licensed partner, Evolva, is in advanced discussions with leading pest control companies for possible commercial partnerships. Companies interested in developing brand name consumer products will be required to submit a registration package to EPA for review, and products could be commercially available as early as 2022.

“CDC is proud to have led the research and development of nootkatone,” said Jay C. Butler, MD, Deputy Director for Infectious Diseases. “Providing new alternatives to existing bite-prevention methods paves the way to solving one of biggest challenges in preventing vector-borne diseases—preventing bites.”

Studies show that when nootkatone is formulated into insect repellents, they may protect from bites at similar rates as products with other active ingredients already available and can provide up to several hours of protection.

Having a new effective ingredient for insecticide available will assist in addressing the growing levels of insecticide-resistance to other products currently in use, according to EPA.

“EPA is pleased to be continuing our partnership with CDC on registering nootkatone, which provides another tool to help protect the American public from biting insects and ticks,” said Alexandra Dapolito Dunn, EPA Assistant Administrator for the Office of Chemical Safety and Pollution Prevention. “This new active ingredient has the potential to be used in future insect repellents and pesticides that will protect people from disease. In many areas of the United States, mosquitoes have become resistant to currently available pesticides. A new active ingredient in our toolbox will help vector-control programs.”

Mosquito- and tickborne diseases are a growing threat in every U.S. state and territory. The number of reported cases of mosquito- and tickborne diseases doubled from 2004 to 2018. Tickborne diseases represent almost 8 in 10 of all reported vector-borne disease cases in the U.S. Increasing risk from these diseases means increasing demands on federal, state, and local health departments and vector control agencies.

CDC has partnered with Evolva since 2014. In 2017, Evolva was awarded a Biomedical Advanced Research and Development Authority (BARDA) contract with the key objective of advancing the development of nootkatone and nootkatone-based products for protection against mosquito-borne diseases, including dengue and Zika. This work has been supported with federal funds from CDC and managed by the Office of the Assistant Secretary for Preparedness and Response (ASPR), BARDA, under Contract No. HHSO100201700015C.