89 FR 237 pgs. 99253-99257 - Pesticide Registration Review; Proposed Decisions for Several Pesticides; Notice of Availability and Request for Comment
Type: NOTICEVolume: 89Number: 237Pages: 99253 - 99257
Pages: 99253, 99254, 99255, 99256, 99257Docket number: [EPA-HQ-OPP-2024-0520; FRL-12406-01-OCSPP]
FR document: [FR Doc. 2024-28976 Filed 12-9-24; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2024-0520; FRL-12406-01-OCSPP]
Pesticide Registration Review; Proposed Decisions for Several Pesticides; Notice of Availability and Request for Comment
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Notice.
SUMMARY:
This notice announces the availability of and solicits comments on EPA's proposed decisions for the following pesticides: alpha methyl mannoside; Duddingtonia flagrans strain IAH 1297; Pepino mosaic virus, strain CH2, isolate 1906; and sheep fat. EPA is proposing that no further review is necessary for these pesticides at this time based on its previous determinations that these pesticides meet the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) standard for registration.
DATES:
Comments must be received on or before February 10, 2025.
ADDRESSES:
Submit your comments, identified by the registration review case name and number for the specific pesticide of interest provided in Table 1 of Unit II., through the Federal eRulemaking Portal at https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting and visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For pesticide-specific information, contact: The Chemical Review Manager for the pesticide of interest identified in Table 1 of Unit II.
For general information on the registration review program, contact: Jeannine Kausch, Biopesticides and Pollution Prevention Division (7511M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave, NW, Washington, DC 20460-0001; telephone number: (202) 566-1533; email address: kausch.jeannine@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this action apply to me?
This action is directed to the public in general and may be of interest to a wide range of stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, EPA has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the Chemical Review Manager identified in Table 1 of Unit II.
II. What action is the Agency taking?
Consistent with 40 CFR 155.46, this notice announces the availability of EPA's proposed registration review decisions for the pesticides shown in Table 1 and opens a 60-day public comment period on these proposed decisions. The proposed decisions for the pesticides and their associated rationale follow in Unit IV.
| Registration review case name and No. | Chemical review manager and contact information |
|---|---|
| Alpha Methyl Mannoside; Case Number 6332 | James Parker, parker.james@epa.gov , (202) 566-1594. |
| Duddingtonia flagrans strain IAH 1297; Case Number 6534 | Joseph Mabon, mabon.joseph@epa.gov , (202) 566-1535. |
| Pepino mosaic virus, strain CH2, isolate 1906; Case Number 6528 | Joseph Mabon, mabon.joseph@epa.gov , (202) 566-1535. |
| Sheep Fat; Case Number 6339 | James Parker, parker.james@epa.gov , (202) 566-1594. |
III. Registration Review Background
Section 3(g) of the FIFRA requires EPA to periodically review registered pesticides to ensure that each pesticide continues to satisfy the statutory standard for registration; that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. See 7 U.S.C. 136a(g); 40 CFR 155.40(a). Through its registration review program, EPA reevaluates each pesticide's registration based on current scientific and other knowledge about the pesticide, including its effects on human health and the environment, taking into consideration any changes in law, regulations, or policy since the last review. EPA has promulgated regulations governing the registration review process in 40 CFR part 155, subpart C.
[top] Pursuant to 40 CFR 155.46, EPA may decide that registration review is complete and additional review is not needed for certain pesticides. That regulation provides the following: "The Agency may determine that there is no need to reconsider a previous decision that a pesticide satisfies the standard of registration in FIFRA. In such cases, instead of establishing a pesticide registration review case docket as described in §?155.50, the Agency may propose that, based on its determination that a pesticide meets the FIFRA standard for registration, no further review will be necessary. In such circumstances, the Agency will publish a notice in the Federal Register announcing the availability of the proposed decision and provide a comment period of at least 60 calendar days. The Agency will publish a notice in the Federal Register announcing the availability of a final version of the decision, an explanation of any changes to the proposed decision and its response to any comments. The date of the final notice of availability would be used as the date of the latest registration
When EPA promulgated the procedural regulations for registration review in 2006 (published in the Federal Register on August 9, 2006 (71 FR 45720) (FRL-8080-4)), the Agency explained that "[t]he purpose of this provision [section 155.46] is to give the Agency flexibility to not schedule a pesticide for registration review if the pesticide has such low toxicity, exposure, or risk that another review would not change the Agency's position and would not be an effective use of resources. The Agency may also use this provision for a pesticide that has recently undergone a comprehensive review. In proposed decisions issued under §?155.46, the Agency generally would explain why it believes that no additional review is necessary and reference, as appropriate, publicly available documentation to support the Agency's position."
As stated in section 155.46, the final notice serves as the date for the registration review cycle for the specified pesticide(s) and is used for purposes of scheduling the next registration review under FIFRA section 3(g). The next round of registration review for any chemical that goes through the 40 CFR 155.46 process would need to be completed within 15 years after the final determination.
IV. EPA's Proposed Decisions
EPA has determined that the pesticides identified in Table 1 of Unit II. (alpha methyl mannoside; Duddingtonia flagrans strain IAH 1297; Pepino mosaic virus, strain CH2, isolate 1906; and sheep fat) present very low toxicity, exposure, and risks to human health and the environment. No human health or environmental incidents have been reported since the registration of the first products containing these pesticides. Additionally, each of the listed pesticides underwent a comprehensive review during the registration of products containing those pesticides, in which EPA concluded that the products met the FIFRA standard for registration. No changes in use pattern, exposure, or toxicity have occurred, no new data have become available, and no other data have been identified since the first products containing these pesticides were registered that would result in changes in the risk profile of the pesticides. Accordingly, the Agency has determined that there is no need to reconsider those previous decisions. Since another review would not change the Agency's position and would not be an effective use of resources, EPA is proposing that further review is unnecessary at this time and that the registration review for alpha methyl mannoside; Duddingtonia flagrans strain IAH 1297; Pepino mosaic virus, strain CH2, isolate 1906; and sheep fat be completed. The specific proposed decision for each pesticide is described below.
A. Alpha Methyl Mannoside (Case Number 6332)
Alpha methyl mannoside is a naturally occurring mannoside carbohydrate present in a variety of plant-based foods in the form of mannose polymers. As a pesticide, it is used as a plant regulator to increase growth in a variety of plants such as vegetable, fruit, peanut, and bulb and root crops; ornamentals, potted plants, bedding plants, and cut flowers in greenhouses; and turfgrass.
EPA has determined its previous decision for two products containing alpha methyl mannoside does not need to be reconsidered. That decision document and supporting documents are posted to docket identification (ID) number EPA-HQ-OPP-2017-0419 on https://www.regulations.gov. As stated in that document, EPA determined that use of the pesticide would not cause unreasonable adverse effects to human health or the environment, based primarily on the low toxicity and exposure expected from the pesticide as described below:
1. FIFRA-Human Health Risk. The database of studies required to support the assessment of risk to human health of alpha methyl mannoside is complete. EPA does not expect dietary (food and drinking water) or other non-occupational risks from use of alpha methyl mannoside as an active ingredient in pesticide products. Data demonstrated that alpha methyl mannoside is of low toxicity through all routes of exposure, and no toxicological endpoints have been identified. No risks of concern are expected from occupational exposures when used according to label directions. Residues of alpha methyl mannoside are exempt from the requirement of a tolerance in or on all raw agricultural commodities under 40 CFR 180.1352. The pesticide is of low risk to humans (including pesticide handlers and people exposed post-application) due to both low toxicity and exposure. No additional risk assessments are needed.
2. FIFRA-Ecological Risk. No risks of concern were identified in the previous ecological assessment. Risks of concern are not anticipated to birds, mammals, freshwater fish, aquatic invertebrates, nontarget plants, or nontarget insects (including honey bees) from the pesticidal use of alpha methyl mannoside as a plant regulator to increase growth. Since the products were registered, there has been no change in use patterns that would prompt reevaluation of risk. The pesticide is of low risk to nontarget species due to both low toxicity and exposure. No additional risk assessments are needed.
3. 155.46 Proposal. EPA has determined that the products containing alpha methyl mannoside satisfy the FIFRA standard for registration. The pesticide is of such low toxicity, exposure, and risk that additional review would not be an effective use of Agency resources. All applicable data requirements have been satisfied. There have been no changes in use pattern, exposure, or toxicity since the first products containing this pesticide were registered, nor have any new data been identified that would result in changes in the risk profile of the pesticide. In addition, no human health or environmental incidents have been reported since the registration of the first products containing this pesticide. Finally, EPA is not aware of any changes in law, regulation, or policy in relation to this pesticide that need to be considered at this time. Therefore, EPA is proposing that no further review of alpha methyl mannoside is necessary and registration review can be completed at this time because the pesticide continues to meet the FIFRA registration standard.
4. Other Actions.
[top] i. Endangered Species Act (ESA). EPA is making a "May Affect, Not Likely to Adversely Affect" determination for listed plants for products containing alpha methyl mannoside because (1) there is potential for beneficial effects to listed plants within the spray drift zone due to alpha methyl mannoside's effect as a plant regulator, and (2) EPA does not expect any contemporaneous adverse effects to listed species based on low toxicity and limited environmental exposure. This potential for beneficial effects is based on alpha methyl mannoside's mode of action, and EPA has determined that any such effects are likely to be negligible. EPA is developing an assessment to support informal consultation under ESA section 7(a)(2) for the products that contain active ingredients with the potential for beneficial effects, including alpha methyl mannoside. EPA will complete this informal consultation before or concurrent with issuing a final registration review decision for alpha methyl mannoside.
ii. The Endocrine Disruptor Screening Program (EDSP). Because the available data indicate that the substance is not anticipated to produce any effect in humans similar to an effect produced by a naturally occurring estrogen, EPA intends to seek consensus from its internal peer review process to determine whether an exemption from the requirements of the EDSP under Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(p)(4) is appropriate. If so, EPA will issue that exemption before or concurrent with issuing a final registration review decision for alpha methyl mannoside.
B. Duddingtonia Flagrans Strain IAH 1297 (Case Number 6534)
Duddingtonia flagrans strain IAH 1297 is an animal feed-through fungal pesticide that forms filamentous structures that trap/kill nematodes in manure. This limits the presence of parasitic nematodes in pastureland, thereby reducing the cycle of nematode infection in grazing animals.
EPA has determined that its previous registration decision for two products containing Duddingtonia flagrans strain IAH 1297 does not need to be reconsidered. That decision document and supporting documents are posted to docket ID number EPA-HQ-OPP-2017-0276 on https://www.regulations.gov. As stated in that document, EPA determined that use of the pesticide would not cause unreasonable adverse effects to human health or the environment, based primarily on the low toxicity/pathogenicity and exposure expected from the pesticide as described below:
1. FIFRA-Human Health Risk. The toxicology database required to support the assessment of risk to human health is complete and demonstrates that Duddingtonia flagrans strain IAH 1297 is not associated with significant toxicity, irritation, pathogenicity, or other adverse effects. EPA does not expect dietary (food or drinking water) or other non-occupational risks from use of Duddingtonia flagrans strain IAH 1297 due to low toxicity/pathogenicity and exposure potential. No risks of concern are expected from occupational exposures when used according to label directions. Duddingtonia flagrans strain IAH 1297 is also exempt from the requirement of a tolerance in or on all food commodities under 40 CFR 180.1355. The pesticide is of low risk to humans (including pesticide handlers and people exposed post-application) due to both low toxicity/pathogenicity and exposure. No additional risk assessments are needed.
2. FIFRA-Ecological Risk. The Duddingtonia flagrans strain IAH 1297 database of studies and information required to support the ecological risk assessment is complete and deemed adequate for making a risk determination. Duddingtonia flagrans is a ubiquitous organism that will not be present above background levels, except during application, at which point it is then expected to rapidly degrade and return to background levels. Duddingtonia flagrans also has a high host specificity for certain nematodes, proliferates poorly in soil, and does not spread well beyond treated locations. Based on low exposure from feed-through applications, as well as specificity to nematodes and lack of effects to other taxa, risks of concern to nontarget organisms are not anticipated from the use of the pesticide products containing Duddingtonia flagrans strain IAH 1297. The pesticide is of low risk to nontarget species due to both low toxicity/pathogenicity and exposure. No additional risk assessments are needed.
3. 155.46 Proposal. EPA has determined that products containing Duddingtonia flagrans strain IAH 1297 satisfy the FIFRA standard for registration. The pesticide is of such low toxicity/pathogenicity, exposure, and risk that additional review would not be an effective use of Agency resources. All applicable data requirements have been satisfied. There have been no changes in use pattern, exposure, or toxicity/pathogenicity since the first products containing this pesticide were registered, nor have any new data been identified that would result in changes in the risk profile of the pesticide. In addition, no human health or environmental incidents have been reported since the registration of the first products containing the pesticide. Finally, EPA is not aware of any changes in law, regulation, or policy in relation to this pesticide that need to be considered at this time. Therefore, EPA is proposing that no further review of Duddingtonia flagrans strain IAH 1297 is necessary and registration review can be completed at this time because the pesticide continues to meet the FIFRA registration standard.
4. Other Actions.
i. ESA. EPA is making a "No Effect" determination under the ESA for the labeled uses of Duddingtonia flagrans strain IAH 1297 based on the low toxicity/pathogenicity of and limited environmental exposure to the pesticide. The reasons for this determination are the same grounds as those described in review of the first products containing Duddingtonia flagrans strain IAH 1297 registered by EPA (see the decision document and supporting ecological risk assessment posted to docket ID number EPA-HQ-OPP-2017-0276 on https://www.regulations.gov ).
ii. EDSP. Because the available data indicate that the substance is not anticipated to produce any effect in humans similar to an effect produced by a naturally occurring estrogen, EPA intends to seek consensus from its internal peer review process to determine whether an exemption from the requirements of the EDSP under FFDCA section 408(p)(4) is appropriate. If so, EPA will issue that exemption before or concurrent with issuing a final registration review decision for Duddingtonia flagrans strain IAH 1297.
C. Pepino Mosaic Virus, Strain CH2, Isolate 1906 (Case Number 6528)
Pepino mosaic virus, strain CH2, isolate 1906 is an attenuated strain of the plant pathogen Pepino mosaic virus that causes a heightened defense response in treated plants, resulting in resistance when those treated plants encounter more pathogenic strains of Pepino mosaic virus. Applications of Pepino mosaic virus, strain CH2, isolate 1906 are made only to tomato plants in greenhouses.
EPA has determined that its previous registration decision for one product containing Pepino mosaic virus, strain CH2, isolate 1906 does not need to be reconsidered. That decision document and supporting documents are posted to docket ID number EPA-HQ-OPP-2017-0527 on https://www.regulations.gov. As stated in that document, EPA determined that use of the pesticide would not cause unreasonable adverse effects to human health or the environment, based primarily on the low toxicity/pathogenicity and exposure expected from the pesticide as described below:
[top] 1. FIFRA-Human Health Risk. The database required to support the assessment of risk to human health is complete, and the data demonstrate that Pepino mosaic virus, strain CH2, isolate 1906 is not associated with significant toxicity, irritation, pathogenicity, or other adverse effects. EPA does not expect dietary (food and drinking water) or other non-occupational risks from use of Pepino mosaic virus, strain CH2, isolate 1906 as an active ingredient in the pesticide product. No risks of concern are expected from occupational exposures when used according to label directions. Pepino mosaic virus, strain CH2, isolate 1906 is also exempt from the requirement of a tolerance in or on tomato under 40 CFR 180.1361. The pesticide is of low risk to humans
2. FIFRA-Ecological Risk. The Pepino mosaic virus, strain CH2, isolate 1906 database of studies and information required to support the ecological risk assessment is complete. Further, environmental exposure is anticipated to be very low since Pepino mosaic virus, strain CH2, isolate 1906 is for use in greenhouses only with a label requirement to disinfect greenhouse drainage water. Based on the low exposure potential, supporting data, and acceptable scientific rationale, risks of concern are not anticipated for nontarget organisms as a result of the labeled uses of the product containing Pepino mosaic virus, strain CH2, isolate 1906. The pesticide is of low risk to nontarget species due to both low toxicity and exposure. No additional risk assessments are needed.
3. 155.46 Proposal. EPA has determined that the product containing Pepino mosaic virus, strain CH2, isolate 1906 satisfies the FIFRA standard for registration. The pesticide is of such low toxicity/pathogenicity, exposure, and risk that additional review would not be an effective use of Agency resources. All applicable data requirements have been satisfied. There have been no changes in use pattern, exposure, or toxicity/pathogenicity since the first product containing this pesticide was registered, nor have any new data been identified that would result in changes in the risk profile of the pesticide. In addition, no human health or environmental incidents have been reported since the registration of the first product containing the pesticide. Finally, EPA is not aware of any changes in law, regulation, or policy in relation to this pesticide that need to be considered at this time. Therefore, EPA is proposing that no further review of Pepino mosaic virus, strain CH2, isolate 1906 is necessary and registration review can be completed at this time because the pesticide continues to meet the FIFRA registration standard.
4. Other Actions.
i. ESA. EPA is making a "No Effect" determination under the ESA for the labeled uses of Pepino mosaic virus, strain CH2, isolate 1906 based on the low toxicity/pathogenicity of and limited environmental exposure to the pesticide. The reasons for this determination are the same grounds as those described in review of the first product containing Pepino mosaic virus, strain CH2, isolate 1906 registered by EPA (see the decision document and supporting ecological risk assessment posted to docket ID number EPA-HQ-OPP-2017-0527 on https://www.regulations.gov ).
ii. EDSP. Because the available data indicate that the substance is not anticipated to produce any effect in humans similar to an effect produced by a naturally occurring estrogen, EPA intends to seek consensus from its internal peer review process to determine whether an exemption from the requirements of the EDSP under FFDCA section 408(p)(4) is appropriate. If so, EPA will issue that exemption before or concurrent with issuing a final registration review decision for Pepino mosaic virus, strain CH2, isolate 1906.
D. Sheep Fat (Case Number 6339)
Sheep fat is derived from the body fat of slaughtered sheep. Due to its rancid odor and taste, this active ingredient is used to repel deer, rabbits, elk, and moose. It is applied as a spray in a variety of use sites, e.g., agricultural areas, nurseries, forests, and commercial and residential landscapes.
EPA has determined that its previous registration decision for two products containing sheep fat does not need to be reconsidered. That decision document and supporting documents are posted to docket ID number EPA-HQ-OPP-2019-0410 on https://www.regulations.gov. As stated in that document, EPA determined that use of the pesticide would not cause unreasonable adverse effects to human health or the environment, based primarily on the low toxicity and exposure expected from the pesticide as described below:
1. FIFRA-Human Health Risk. The database of information required to support the assessment of risk to human health of sheep fat is complete. EPA does not expect dietary (food and drinking water) or other non-occupational risks from use of sheep fat as an active ingredient in pesticide products. Data demonstrated that sheep fat is of low acute toxicity through all routes of exposure, and no toxicological end points have been identified. No risks of concern are expected from occupational exposures when used according to label directions. Residues of sheep fat are exempt from the requirement of a tolerance in or on all food commodities under 40 CFR 180.950(c). The pesticide is of low risk to humans (including pesticide handlers and people exposed post-application) due to both low toxicity and exposure. No additional risk assessments are needed.
2. FIFRA-Ecological Risk. No risk concerns were identified in previous ecological assessments based primarily on the low toxicity and natural occurrence of components in sheep fat. The application methods include hand-held, knapsack, or garden sprayers with a flat fan or cone nozzle to directly treat impacted plants and therefore greatly limit the exposure of nontarget taxa to sheep fat. EPA further noted that the active ingredient has a nontoxic mode of action, its components (fatty acids) are ubiquitous in the environment, and its components have a history of exposure with no adverse effects to nontarget organisms. Risks of concern are not anticipated for nontarget organisms as a result of the labeled uses of the pesticide products containing sheep fat. The pesticide is of low risk to nontarget species due to both low toxicity and exposure. No additional risk assessments are needed.
3. 155.46 Proposal. EPA has determined that the products containing sheep fat satisfy the FIFRA standard for registration. The pesticide is of such low toxicity, exposure, and risk that additional review would not be an effective use of Agency resources. All applicable data requirements have been satisfied. There have been no changes in use pattern, exposure, or toxicity since the first products containing this pesticide were registered, nor have any new data been identified that would result in changes in the risk profile of the pesticide. In addition, no human health or environmental incidents have been reported since the registration of the first products containing the pesticide. Finally, EPA is not aware of any changes in law, regulation, or policy in relation to this pesticide that need to be considered at this time. Therefore, EPA is proposing that no further review of sheep fat is necessary and registration review can be completed at this time because the pesticide continues to meet the FIFRA registration standard.
4. Other Actions.
i. ESA. EPA is making a "No Effect" determination under the ESA for the labeled uses of sheep fat based on the low toxicity of and limited environmental exposure to the pesticide. The reasons for this determination are the same grounds as those described in review of the first products containing sheep fat registered by EPA (see the decision document and supporting ecological risk assessment posted to docket ID number EPA-HQ-OPP-2019-0410 on https://www.regulations.gov ).
[top] ii. EDSP. Because the available data indicate that the substance is not anticipated to produce any effect in humans similar to an effect produced by a naturally occurring estrogen, EPA intends to seek consensus from its
V. What is EPA's authority for taking this action?
EPA is issuing these proposals pursuant to 40 CFR 155.46 to comply with its statutory mandate to periodically review all registered pesticides under section 3(g) of FIFRA. 7 U.S.C. 136a(g).
VI. What should I consider as I prepare comment for EPA?
1. Submitting CBI. Do not submit CBI to EPA through email or https://www.regulations.gov. If you wish to include CBI in your comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
2. Tips for Preparing Your Comments. When preparing and submitting your comments, see the commenting tips at: https://www.epa.gov/dockets/commenting-epa-dockets.
3. Environmental Justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, EPA seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document, compared to the general population.
All comments should be submitted using the method in ADDRESSES and must be received by EPA on or before the closing date. These comments will become part of the docket for the pesticides included in Table 1 in Unit II. EPA will consider all comments received by the closing date and may respond to comments in a "Response to Comments Memorandum" in the docket and/or in any subsequent final registration review decision, as appropriate.
Authority:
7 U.S.C. 136 et seq.
Dated: December 4, 2024.
Edward Messina,
Director, Office of Pesticide Programs.
[FR Doc. 2024-28976 Filed 12-9-24; 8:45 am]
BILLING CODE 6560-50-P