Tag Archive for: EPA

EPA Hosts Conference to Discuss Animal Testing Alternatives

This original announcement was published by the EPA on October 20, 2020. Click here for more info!

 

Today, U.S. Environmental Protection Agency (EPA) Administrator Andrew Wheeler kicked off the agency’s Second Annual Conference on the State of the Science on Development and Use of New Approach Methods (NAMs) for Chemical Safety Testing. More than 1,000 experts from EPA, other governmental agencies, academia, and industry are gathering virtually to hear presentations about scientific advancements in the NAMs field, enabling participants to develop a better understanding of the state of the science and develop scientific confidence in alternative test methods.

“Working together, the federal government, private sector, and scientific community can have a real impact reducing the use of animal testing,” said EPA Administrator Andrew Wheeler. “This conference shows that we can not only achieve my goal to eliminate all testing on mammals by 2035, but show leadership on the international stage and advance cutting-edge science.”

This year, the conference will:

  • Highlight advances in the development of NAMs and addressing their limitations.
  • Report results of various case studies on applying NAMs to EPA’s decision making and Unilever’s risk assessment process.
  • Summarize strategies identified in EPA’s NAMs Work Plan.
  • Outline progress on incorporating NAMs under the Toxic Substances Control Act (TSCA).

Over the past several years, EPA has made significant scientific advancements in NAMs and led efforts to reduce, replace and refine its animal testing requirements. EPA will continue to lead the way among federal agencies in the United States and internationally.

The public can register to participate in the virtual conference via webinar here.

To view the Administrator’s opening remarks, visit here.

Background

In September 2019, Administrator Wheeler issued a directive calling for the Agency to reduce mammal testing and funding 30 percent by 2025 and eliminate it by 2035. In support of this directive, EPA has taken many steps since then to reduce, replace, and refine testing requirements:

  • In September 2019, EPA announced $4.25 million in funding for five universities to research and develop alternative test methods for evaluating chemical safety.
  • In December 2019, EPA convened a conference  for achieving reduced animal testing in chemical safety research and updated its list of NAMs that could be used in the agency’s work under the amended TSCA , including adding 21 new test guidelines related to health and ecological effects and six additional EPA policies that reduce the use of animal testing.
  • In January 2020, EPA launched an EPA NAMs website – a one-stop shop for getting updates about our efforts to reduce the use of animal testing.
  • In February 2020, EPA issued guidance waiving pesticide testing on birds when the information yielded is unnecessary to support a decision. This action is expected to save 720 test animals annually.
  • In June 2020, EPA released the NAMs Work Plan, which outlines the objectives, strategies and deliverables that are important guideposts in reaching the 2035 goal. EPA also convened a meeting of the Science Advisory Board to offer advice on using NAMs to help reinvent the cancer bioassay.
  • In July 2020, EPA released guidance that reduces unnecessary testing on fish in the pesticide registration process. This is expected to save 240 test animals annually.
  • In October 2020, EPA released new guidance expanding the opportunity for waivers for dermal toxicity studies for pesticides, which is expected to save 750 test animals annually.
  • As required under TSCA Section 4, EPA regularly maintains and updates a list of NAMs and plan to release a draft proposal for selecting which NAMs will be included on future versions of the list. This draft proposal will be released for public comment at the end of 2020 or early 2021.

To learn more about EPA efforts to reduce animal testing, visit: https://www.epa.gov/research/efforts-reduce-animal-testing-epa

Andrew Wheeler Announces Expedited Pathway for Companies to Claim “Long-Lasting” Efficacy for Antiviral Products

This original announcement was published by the EPA on October 15, 2020. Click here for more information.

 

Today, U.S. Environmental Protection Agency (EPA) Administrator Andrew Wheeler announced a major step forward in the Trump Administration’s efforts to ensure that Americans have access to as many tools as possible to clean and disinfect surfaces and protect their families against the novel coronavirus. Through draft guidance released today, companies will now be able to demonstrate that their products have “long-lasting” or “residual” effectiveness on surfaces against viruses like SARS-CoV-2, the coronavirus that causes COVID-19.

“EPA is providing an expedited path for our nation’s manufacturers and innovators to get cutting-edge, long-lasting disinfecting products into the marketplace as safely and quickly as possible,” said EPA Administrator Andrew Wheeler. “As we continue to re-open our schools, workplaces, and other public spaces, it is important Americans have as many tools as possible to slow the spread of COVID-19.”

While traditional disinfectants only kill viruses and bacteria that are on the surface at the time they are used, surfaces treated with residual antimicrobial products kill pathogens that come into contact with the surface days, weeks, or years after the product is applied. EPA will begin expediting the registration process for these products immediately and may revise the guidance after the 60-day public comment period ends.

The guidance specifies scientific testing requirements for two different types of products: supplemental residual antimicrobial products and residual disinfectants. Supplemental residual antimicrobial products work within two hours of a virus or bacteria coming into contact with a surface and can remain effective for weeks to years. These products can supplement, but do not replace, routine cleaning and disinfection using products from EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (COVID-19). Approved supplemental residual antimicrobial products are not eligible for inclusion on List N but will be added to a separate List N appendix.

Residual disinfectants, by contrast, must clear a higher standard of efficacy. These products are effective within 10 minutes of a virus or bacteria contacting a surface and remain effective for up to 24 hours. Surfaces treated with residual disinfectants do not require additional cleaning or disinfection during this window. These products are eligible to be added to List N.

Presently, there are no EPA-registered products available to the public that inactivate viruses that land on previously treated surfaces. While EPA approved one product to be used on a time-limited basis at specific locations in Texas, that product is for commercial, not household, use.

Cleaning and disinfecting products that claim to kill viruses must be registered with EPA before they can be legally sold or distributed. Through the registration process, EPA reviews laboratory testing data to ensure that products work as intended without causing unreasonable risks when they are used according to the label directions.

In addition to releasing the draft residual efficacy protocols, EPA has also released an updated draft testing protocol for evaluating a copper surface’s ability to kill bacteria and a draft protocol for evaluating the efficacy of antimicrobial surface coatings. These laboratory testing methods act as a foundation for EPA’s interim guidance to registrants regarding residual effectiveness.

To read today’s draft guidance, visit https://www.epa.gov/pesticide-registration/interim-guidance-expedited-review-products-adding-residual-efficacy-claims

EPA Hosts Webinar to Address Proper Disinfecting Protocols for Learning Environments

This original announcement was published on October 5, 2020. Click here for more! 

As schools reopen, it is critically important that students and children return to clean and healthy learning environments. On Oct. 13, EPA will host a webinar dedicated to best management practices for cleaning and disinfecting schools, day cares and universities.

The webinar, Addressing Disease Mitigation in Schools, Daycare Centers and Universities with Sanitizers and Disinfectants, will provide participants with cleaning and disinfection recommendations to fight pathogens such as SARS-CoV-2, the novel coronavirus that causes COVID-19.

Participants will learn:

  • how educational institutions are implementing cleaning and disinfecting protocols;
  • how to properly clean high-touch surfaces;
  • how to interpret product labels for proper use, safety and personal protection; and
  • how to use EPA web-based resources to select disinfectants approved for use against SARS-CoV-2 (COVID-19).

EPA will engage with stakeholders such as administrators, facility managers, custodial staff and nurses at schools, day cares and universities. This information will also be helpful to health departments and pest management professionals.

Featured speakers include:

  • Janet Hurley, Extension Program Specialist at Texas A&M AgriLife Extension Service;
  • Brian Burden, Executive Director and Vice President at Mooring USA;
  • Kenneth McPherson, Pesticide Safety and Integrated Pest Management in Schools Coordinator at EPA Region 6; and
  • Kristen Willis, Ph.D., Senior Scientist at EPA’s Office of Pesticide Programs Antimicrobials Division.

Register for the webinar here: Addressing Disease Mitigation in Schools, Daycare Centers and Universities with Sanitizers and Disinfectant – Oct. 13 | 2 p.m. – 3:30 p.m. EDT

This webinar represents the latest in EPA’s ongoing efforts to keep Americans safe during the COVID-19 pandemic. Learn more about EPA’s response here.

Read the jointly developed guidance from the Centers for Disease Control and Prevention and EPA for Cleaning and Disinfecting Public Spaces, Workplaces, Businesses, Schools and Homes.

View our infographic that demonstrates how to use disinfectants safely and effectively.

Visit List N: EPA’s list of disinfectant products expected to kill SARS-CoV-2 (COVID-19).

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 chlorpyrifos, diazinon 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