Recent EPA Actions in Loss of Registraion Open for Comments - Comments Needed

This has been shared directly from IPM Centers.  The comment periods will be open until July 1, 2024. 

 

  EPA Actions Open for Comment, Consolidated on 05/10/2024 

 

The following information is an unofficial summary of recent actions released by the EPA for public comment, including registration and registration review actions. While USDA-OPMP prepares this summary to highlight issues that may be of potential interest to U.S. agricultural stakeholders, be aware that this summary document may not cover all aspects of the draft EPA actions under consideration. All EPA documents can be found directly in their respective dockets. A link to the relevant docket is provided for each case. USDA-OPMP staff contacts are also listed for each case. Contact information can be found at: https://www.usda.gov/oce/pest/office-staff.

 

Proposed decisions, assessments, and other actions related to pest management currently open for comment are listed in the table below with respective comments due dates and links to each summary section.

  

Chemical Type or Other	Action Type	Posted Date	Comments Due Date	Chemical/Action Name
Sterilant/Disinfectant	DRA	04/19/2024	06/18/2024	Formaldehyde and paraformaldehyde
Insecticide	PID	04/30/2024	07/01/2024	Acephate
Fungicide	Amended PID	04/30/2024	07/01/2024	Captan
Fungicide	Amended PID	04/30/2024	07/01/2024	Thiram
Fungicide	Amended PID	04/30/2024	07/01/2024	Ferbam
Fungicide	Amended PID	04/30/2024	07/01/2024	Ziram

Acronyms: ANPR = Advanced notice of proposed rulemaking, BE = biological evaluation, BO = biological opinion, CWP = continuing work plan, DRA = draft risk assessment, ESA = Endangered Species Act, FRN = Federal Register notice, PFD = proposed final decision, PID = proposed interim decision, PWP = preliminary workplan, RFI = request for information

Formaldehyde and Paraformaldehyde, Draft Human Health and Ecological Risk Assessments

(OPMP POC: Julie Van Alstine, Elyssa Arnold)

FR Notice: https://www.federalregister.gov/d/2024-08399

Docket: https://www.regulations.gov/docket/EPA-HQ-OPP-2015-0739

Draft RA:  https://www.regulations.gov/document/EPA-HQ-OPP-2015-0739-0011

·         Formaldehyde is used to disinfect various agricultural premises and equipment such as citrus, egg hatchery, poultry and swine confinement, and mushroom houses; as an in-can materials preservative in industrial and household consumer products such as laundry detergents, automotive cleaning products, fabric softeners, household cleaners, hand cleaners and dish detergents; and as a microbiocide/microbiostat in industrial oil and gas injection water. There is also a special local needs (SLN) registration for the use of formaldehyde in Washington State to control nematodes, insects such as greater bulb flies, mites, and certain plant pathogenic fungi on daffodil and bulbous iris.

·         Paraformaldehyde, the polymerized product of formaldehyde that exists as a solid crystallization form, is used to sterilize laboratory facilities and equipment and to disinfect leaf cutting bee nest materials. Paraformaldehyde is also a mildewcide used to fumigate structures and storage areas.

·         The following preservatives for biological specimens containing formaldehyde are exempt from FIFRA:

(1) Embalming fluids.

(2) Products used to preserve animal or animal organ specimens, in mortuaries, laboratories, hospitals, museums and institutions of learning.

(3) Products used to preserve the integrity of milk, urine, blood, or other body fluids for laboratory analysis.

·         The FIFRA draft risk assessment identifies risks to human health and the environment from the pesticidal uses of formaldehyde and describes some of the sources of uncertainties in EPA’s findings.

·         Formaldehyde is found nearly everywhere, and people can be exposed from multiple sources. Formaldehyde is produced when organic materials decay and when things burn (e.g., car exhaust, forest fires, etc.) Formaldehyde is also used to make many products (not pesticidal) evaluated in this assessment, including composite wood products and other building materials, plastics, paints, adhesives, and sealants.

·         High levels of exposures to formaldehyde can cause health problems when inhaled or absorbed into the skin. Inhaling high levels of formaldehyde for a short period of time can cause sensory irritation such as eye irritation. Inhaling formaldehyde for longer periods of time can damage the lungs and increase risk of developing asthma and allergy-related conditions, sensory irritation, reproductive toxicity, and cancer. Skin contact with products containing formaldehyde can also cause allergic reactions.  

·         EPA found that workers who may be exposed to formaldehyde used to preserve cleaning products are at risk from inhaling formaldehyde after it is released into the air or by making skin contact with the preserved materials. EPA also found that workers who may use formaldehyde or paraformaldehyde to fumigate various agricultural, commercial, industrial, or institutional areas are at risk of sensory irritation from inhaling formaldehyde and allergic reactions of the skin.  

·         Additionally, EPA found that consumers who use automotive cleaning products and household cleaners that are preserved with formaldehyde are at risk of sensory irritation and allergic reactions of the skin and at an increased risk of developing certain types of cancer. However, a person’s risk from these products depends on how long and how frequently the products are used, and in many cases, exposures from these products are at the same or lower levels than exposures from other sources of formaldehyde in the home such as candles or cooking.  

·         EPA also evaluated formaldehyde’s impact on the environment and found the potential for risk to terrestrial organisms from the registered pesticidal uses of formaldehyde and paraformaldehyde to fumigate various agricultural, commercial, and industrial areas. In addition, it is possible that uses to treat ornamental bulbs could result in exposures to terrestrial and aquatic environments that are of concern. EPA is asking for more information on this use of formaldehyde to treat ornamental bulbs to refine this risk conclusion. There is low potential for risks to aquatic organisms for the other pesticidal uses of formaldehyde.

 

Acephate, Proposed Interim Decision

(OPMP POC: Clayton Myers)

FR Notice: https://www.federalregister.gov/d/2024-09181

Docket: https://www.regulations.gov/docket/EPA-HQ-OPP-2008-0915

PID: https://www.regulations.gov/document/EPA-HQ-OPP-2008-0915-0069

•        Acephate is a systemic and contact-active organophosphate (OP) insecticide that is registered for use on both agricultural and non-agricultural use sites.

•        It is registered on field and vegetable crops, on non-bearing fruit and tree nuts, and as a seed treatment on cotton and peanut. Non-agricultural uses include grass/turf; ornamental plants; in and around commercial, industrial, and institutional facilities; and other non-crop areas such as ditch banks and roadsides.

•        The second revised Human Health Draft Risk Assessment (DRA) and Drinking Water Assessment (DWA) were published in August 2023 and public comments will also be accepted on these assessments during the PID comment period. The revised DWA focused on the high usage crops cotton and soybean. Acephate exceeds the dietary risk cup based on current application rates and labeled use patterns.

•        Occupational risks of concern are estimated for aerial, chemigation, groundboom, tractor drawn spreader, and handheld equipment applications, and for seed treatment. There are post-application worker risks of concern and bystander risks of concern. Residential handler risks of concern identified for use on fire ants.

•        Risks of concern are estimated for mammals, birds, terrestrial invertebrates, freshwater and saltwater invertebrates, and fish.

•        The benefit conclusions found high benefits for tobacco and peanuts; medium to high for soybean; medium for mint, celery and cotton; low to medium for seed crops; and low benefits for cranberries, lettuce, fresh lima bean, pepper cauliflower, Brussel sprout, turf, ornamental and trees.

•        The proposed mitigation is to cancel all uses except tree injection because a safety finding cannot be made based on current registrations. Tree injection is the only use pattern that does not contribute to dietary risks of concern and can therefore be retained with the following FIFRA interim ecological mitigation (IEM): Bulletins Live! 2, ecological incident reporting, pollinator advisories, and pollinator best management practices (BMPs).

•        Registrants and other stakeholders are encouraged to work with the Agency to identify critical uses of acephate for consideration as it works towards the Interim Registration Review Decision or ID.

Captan, Proposed Interim Decision

(OPMP POC: Julius Fajardo)

FR Notice: https://www.federalregister.gov/d/2024-09181

Docket: https://www.regulations.gov/docket/EPA-HQ-OPP-2013-0296

Amended PID: https://www.regulations.gov/document/EPA-HQ-OPP-2013-0296-0339

·         Captan is a multisite, nonsystemic, broad-spectrum fungicide registered for use on a variety of orchard crops, berries, grapes, ornamentals; as a seed treatment; as a preplant root dip; and as a post-harvest fruit dip.

·         The proposed interim decision (PID) was completed in April 2022; this amendment updates the PID to incorporate (1) a revised human health risk assessment for seed treatment (based on new data and science policies), (2) revised mitigation for orchard crops, and (3) FIFRA interim ecological mitigation (IEM), as well as changes resulting from new information received during or after the public comment period on the PID.

·         Overall, there are potential human health risks of concern for pesticide handlers and other workers who are exposed to captan while treating, packaging, or loading/planting seeds and cleaning out seed treatment equipment and for workers who are mixing, loading, or applying captan to fruit and nut crops and re-entering treated areas. There are also risk concerns for fruit packing house workers.

·         There are potential ecological risk concerns for birds, mammals, and terrestrial invertebrates.

·         Proposed mitigation:

o   For seed treatment uses includes cancellation of numerous uses and, for remaining uses, the requirement of PF10 respirators.

o   For orchard crops, the revised mitigation includes enclosed cabs to address applicator inhalation risk rather than allowing growers a choice between using an enclosed cab or reducing the area treated. It also includes cancelation of the post-harvest fruit dip use.

o   The FIFRA IEM revises the proposed rain restriction to address stakeholder concerns while addressing potential runoff and protecting surface water; adds spray drift reduction measures to measure wind speed, labeling requirements for seed bag tags to address any spilled treated seeds, and new pollinator stewardship labeling; revises ecological incident reporting requirements; and requires users of captan products to check Bulletins Live! Two before use.

Thiram, Proposed Interim Decision

(OPMP POC: Julius Fajardo)

FR Notice: https://www.federalregister.gov/d/2024-09181

Docket: https://www.regulations.gov/docket/EPA-HQ-OPP-2015-0433

Amended PID: https://www.regulations.gov/document/EPA-HQ-OPP-2015-0433-0610

·         Thiram is a dimethyldithiocarbamate fungicide currently registered for use as a foliar spray on peaches and strawberries to control many fungal pests. It is also registered for use as a seed treatment for a variety of crops including field crops such as soybeans, peanuts, and sugar beets and small-seeded or dry-seeded vegetables. Registered non-agricultural fungicidal uses for thiram include coniferous/evergreen/softwood trees, flowering and non-flowering plants, shrubs/bushes/vines, trees (non-food), as well as a commercial dip treatment for ornamental seeds and bulbs. Thiram is also used as an animal repellent on ornamentals, shrubs/bushes/vines, and trees when applied to tree trunks.

·         EPA identified exposure concerns to occupational handlers and post application risks in the draft risk assessment DRA and received new dermal toxicity data submitted by the Thiram Task Force. The dermal absorption factor (DAF) was revised after the new dermal data was reviewed; therefore, the Agency has re-evaluated the dermal exposure and risk estimates and revised the human health DRA. At the same time, the Agency updated its assessment of seed treatments.

·         There are potential risks from thiram uses for fish (both freshwater and estuarine/marine) aquatic invertebrates, mammals, terrestrial invertebrates, birds, and aquatic and terrestrial plants.

·         In the December 2021 PID, the Agency proposed the cancellation of all non-seed treatment uses such as strawberries, peaches, non-bearing trees, shrubs, nursery stock, ornamentals, on various seed treatments uses, and limiting the animal repellency use.

·         The Agency is amending the 2021 PID for seed treatment to propose cancellation for all commercial seed treatment uses and only allow on-farm seed treatment for liquid formulations, and with the use of a PF10 respirator for some crops.

·         The Agency is also proposing to limit animal repellency use to be applied by manually pressurized handgun in nursery settings (ornamentals, vegetables, trees, container stock) for only two products.

·         The amended PID also incorporates updated EDSP template language and propose FIFRA Interim Ecological Mitigation (IEM) that includes pesticide incident reporting, Bulletins Live! Two (BLT), and seed treatment language.

Ferbam, Proposed Interim Decision

(OPMP POC: Julius Fajardo)

FR Notice: https://www.federalregister.gov/d/2024-09181

Docket: https://www.regulations.gov/docket/EPA-HQ-OPP-2015-0567

Amended PID: https://www.regulations.gov/document/EPA-HQ-OPP-2015-0567-0059

·         Ferbam is a dimethyldithiocarbamate fungicide registered for use on apples, citrus, cranberries, mangoes, pears, peaches, and nectarines.

·         Ferbam and ziram have a common degradate—thiram. Support for the conversion of ferbam to thiram comes from a series of environmental fate studies that indicate that ferbam is rapidly converted to thiram and the anion of dimethyldithiocarbamic acid (DCC).

·         In December 2021, EPA published a PID for ferbam. Despite the updates and recommendations presented during the public comment period for the 2021 PID, no change to the previous risk picture and proposal for cancellations has been made. EPA is proposing the same measures that were presented in the 2021 PID that includes termination of uses (apple, citrus, pear, cranberry and mango); removal of certain application methods (backpack sprayer, airblast, chemigation, groundboom), addition of PPE (PF50 respirator), and restriction of applications to dormant period for peach and nectarine; and advisory spray drift language.

·         In this amended PID, the Agency has made two changes to the 2021 PID: 1) Cancellation of all uses on cranberries and 2) implementation of FIFRA Interim Ecological Mitigation (IEM) measures for ferbam. Due to newly proposed cancellation for use on cranberries, the Agency is no longer revising the re-entry interval (REI) for ferbam that was previously proposed.

·         The 2021 PID proposed that the occupational post-application risks are not of concern when imposing an REI of 22 days for cranberries. Based on public comments received, an REI of 22 days is not feasible for growers unless modified PPE could be considered for the duration of the REI. Due to the extended REI and additional PPE not being feasible mitigation measures, EPA is proposing termination of the use on cranberries.

·         EPA considered the information provided by USDA and others on ferbam's use, usage, benefits, alternatives, fungicide resistance management, and the impacts of proposed risk mitigation measures in developing this amended PID. EPA agrees that ferbam has a different mode of action than other registered fungicides on citrus, mango, and cranberry to control fungal pests. Therefore, ferbam can play a role in fungicide resistance management due to its multisite mode of action and activity against multiple fungal pests. The information provided did not change the regulatory decision on registration review of ferbam for use on citrus, mango, and cranberry.

·         EPA developed the FIFRA IEM measures to reduce exposure to nontarget species, including listed species, based on the risks and benefits of ferbam. Because EPA is proposing to retain the use of ferbam solely in peach and nectarine and allow applications only by mechanically pressurized handgun equipment, most IEM measures will not be necessary. EPA is proposing the following specific FIFRA IEM measures for ferbam: Bulletins Live! Two labeling, Ecological Incident Reporting Label Language, Advisory Pollinator Stewardship Language

Ziram, Proposed Interim Decision

(OPMP POC: Julius Fajardo)

FR Notice: https://www.federalregister.gov/d/2024-09181

Docket: https://www.regulations.gov/docket/EPA-HQ-OPP-2015-0568

Amended PID: https://www.regulations.gov/document/EPA-HQ-OPP-2015-0568-0111

·         Ziram is a conventional fungicide and an antimicrobial materials preservative (all non-agricultural uses). It is registered for conventional agricultural use on almond, apple, apricot, blueberry, cherry, filbert (hazelnut), grapes, nectarine, peach, pear, pecan, and tomato. Non-agricultural conventional registered uses of ziram are coniferous/evergreen/softwood trees, flowering plants, shrubs/bushes/vines, and ornamentals.

·         The amended PID focuses on conventional uses of ziram. The 2021 PID proposed mitigation measures for antimicrobial uses, and there are no changes to those proposed mitigations.

·         The 2020 HH DRA found occupational handler risks of concern, both dermal and inhalation. The Ziram Task Force submitted new dermal absorption data for ziram to the Agency, which resulted in reduction of the dermal absorption factor (DAF) from 10% to 2% and a revised HH DRA. However, despite the updates and recommendations presented during the public comment period for the 2021 PID, it did not change the previous risk picture and proposal. The amended PID is still proposing cancellation of all conventional uses.

·         USDA’s comment on the 2021 PID suggested reduced application rates and reduced acres treated per day. EPA responded that total acreage limits are likely to render the use of ziram infeasible for large commercial farms. The acreage limitations may be feasible for very small farms but the personal protective equipment (PF50 respirator, closed mixing/loading system, enclosed cab) that would be required along with the acreage limitations could be prohibitively costly for most of the small farms. Therefore, EPA has decided not to propose these requirements to mitigate the occupational risks.