Document ID: EPA-HQ-OPP-2015-0752-0034
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2020-05-19T04:00Z

Momfluorothrin 
                                       
                     Interim Registration Review Decision
                               Case Number 7457
                                       
                                       
                                  March 2020
                                       
                                       
                                       
			Approved by: _________
					   Elissa Reaves, Ph.D.
                                 Acting Director
                           Pesticide Re-evaluation Division

                  Date:	 -  - _____3-16-2020__________
                               Table of Contents

I.	INTRODUCTION	3
A.	Updates Since the Proposed Interim Decision was Issued	4
B.	Summary of Momfluorothrin Registration Review	5
C.	Summary of Public Comments on the Proposed Interim Decision and Agency Responses	6
II.	USE AND USAGE	7
III.	SCIENTIFIC ASSESSMENTS	7
A.	Human Health Risks	7
1. Pyrethroids FQPA Safety Factor Determination	8
2. Risk Summary and Characterization	10
3. Human Incidents and Epidemiology	11
4. Tolerances	11
5. Human Health Data Needs	11
B.	Ecological Risks	12
C.	Benefits Assessment	12
IV.	INTERIM REGISTRATION REVIEW DECISION	12
A.	Risk Mitigation and Regulatory Rationale	12
1.	Label Clarification	13
B.	Tolerance Actions	13
C.	Interim Registration Review Decision	13
D.	Data Requirements	13
V.	NEXT STEPS AND TIMELINE	13
A.	Interim Registration Review Decision	13
APPENDICES	15
Appendix A:  Labeling Changes for Momfluorothrin Products	15
Appendix B:  Endangered Species Assessment	16
Appendix C:  Endocrine Disruptor Screening Program	17

 INTRODUCTION
	
This document is the Environmental Protection Agency's (EPA or the agency) Interim Registration Review Decision (ID) for momfluorothrin (PC Code 016331, case 7457), and is being issued pursuant to 40 CFR §§ 155.56 and 155.58. A registration review decision is the agency's determination whether a pesticide continues to meet, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The agency may issue, when it determines it to be appropriate, an interim registration review decision before completing a registration review. Among other things, the interim registration review decision may require new risk mitigation measures, impose interim risk mitigation measures, identify data or information required to complete the review, and include schedules for submitting the required data, conducting the new risk assessment and completing the registration review. Additional information on momfluorothrin can be found in the EPA's public docket (EPA-HQ-OPP-2015-0752) at www.regulations.gov. 

FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandates the continuous review of existing pesticides. All pesticides distributed or sold in the United States must be registered by the EPA based on scientific data showing that they will not cause unreasonable risks to human health or to the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess and reduce risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the agency periodically re-evaluates pesticides to make sure that as these changes occur, products in the marketplace can continue to be used safely. Information on this program is provided at http://www.epa.gov/pesticide-reevaluation. In 2006, the agency implemented the registration review program pursuant to FIFRA § 3(g) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration.

The EPA is issuing an ID for momfluorothrin so that it can move forward with aspects of the registration review that are complete. Likewise, the agency will complete endocrine screening for momfluorothrin, pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA) § 408(p), before completing registration review. See Appendix C for additional information on the endocrine screening for the momfluorothrin registration review.

Momfluorothrin [2,3,5,6-Tetrafluoro-4-(methoxymethyl)benzyl (EZ)-(1RS,3RS;1RS,3SR)-3-(2-cyanoprop-1-enyl)-2,2-dimethylcyclopropanecarboxy1ate] is a Type I synthetic pyrethroid insecticide and was first registered in 2015. Momfluorothrin is used as a spot, and crack and crevice treatment targeting flying, crawling, and stinging insects and other arthropod pests. It is used in commercial and residential settings and has indoor and outdoor uses including application to indoor perimeters and mattresses. Momfluorothrin does not have agricultural uses, and products containing the active ingredient may be used by both residential and commercial handlers.

Momfluorothrin is a member of the pyrethroids and pyrethrins class of insecticides, which share the same mode of action.  The pyrethroids and pyrethrins work by altering nerve function, initially causing paralysis in target insect pests (also known as "knockdown"), and eventually resulting in death.  The agency has determined that the pyrethroids and pyrethrins belong to a common mechanism group (http://www.regulations.gov; EPA-HQ-OPP-2008-0489-0006).  A screening-level cumulative risk assessment to assess human health risks was completed in 2011.  This analysis did not identify cumulative risks of concern for children and adults. For further information, please see Section III. 2. of this document and the cumulative risk assessment for the pyrethroids and pyrethrins, published on November 9, 2011 (available at http://www.regulations.gov; EPA-HQ-OPP-2011-0746).  

In September 2019 the EPA published its Pyrethroids and Pyrethrins Ecological Risk Mitigation Proposal for 23 Chemicals, which summarizes the ecological risk assessment approach and outlines EPA's mitigation to address potential ecological risks for other pyrethroids with the potential for risks to the environment. For specific information on the ecological mitigation measures for these other pyrethroids please refer to the Pyrethroids and Pyrethrins Ecological Risk Mitigation Proposal for 23 Chemicals located in the Special Docket for Pyrethroids, Pyrethrins, and Synergists located at http://www.regulations.gov (Docket #: EPA-HQ-OPP-2008-0331).

However, for momfluorothrin there is no reasonable expectation for any registered use to cause direct or indirect adverse effects to federally listed threatened and endangered species. Therefor, no adverse modification of critical habitat for federally listed species is expected from the use of momfluorothrin. Because of the low likelihood of exposure to terrestrial and aquatic organisms the EPA has made a "No Effect" (NE) finding and a "No Modification (NM)" of designated critical habitat determinations finding under the Endangered Species Act (ESA) and is not requiring any mitigation for momfluorothrin. 

This document is organized in five sections: the Introduction, which includes this summary and a summary of public comments and the EPA's responses; Use and Usage, which describes how and why momfluorothrin is used and summarizes data on its use; Scientific Assessments, which summarizes the EPA's risk and benefits assessments, updates or revisions to previous risk assessments, and provides broader context with a discussion of risk characterization; the Interim Registration Review Decision, which describes the mitigation measures to address risks of concern, if any, and the regulatory rationale for the EPA's ID; and, lastly, the Next Steps and Timeline for completion of this registration review.

 Updates Since the Proposed Interim Decision was Issued 

In November 2019, the EPA published the PID for momfluorothrin.  No comments were received on the momfluorothrin PID.  However, there were five comments received on the proposed text describing how to define a spot treatment on labels from the National Pest Management Association (NPMA), the National Association of Landscape Professionals (NALP), the Responsible Industry for a Sound Environment (RISE), Bayer CropScience, and the Pyrethroids Working Group (PWG).  These comments were submitted in the Special Docket for Pyrethroids, Pyrethrins, and Synergists (Docket #: EPA-HQ-OPP-2008-0331) in response to the Pyrethrins and Pyrethrins Ecological Risk Mitigation Proposal for 23 Chemicals.  Based on the comments received from these commenters, the momfluorothrin ID has been updated to include revised spot treatment language.

 Summary of Momfluorothrin Registration Review

Pursuant to 40 CFR § 155.50, the EPA formally initiated registration review for momfluorothrin with the opening of the registration review docket for the case. The following summary highlights the docket opening and other significant milestones that have occurred thus far during the registration review of momfluorothrin.

 November 2016--The agency announced the availability in the momfluorothrin docket of the Momfluorothrin Combined Work Plan and Draft Preliminary Risk Assessment Registration Review and the Momfluorothrin. Draft Human Health Risk Assessment for Registration Review in the Federal Register (FR) Notice, along with several support documents, for a 60-day public comment period. The agency also posted the Preliminary Comparative Environmental Fate and Ecological Risk Assessment for the Registration Review of Eight Synthetic Pyrethroids and the Pyrethrins (also referred to as the "Ecological Risk Assessment"), and the Ecological Risk Management Rationale for Pyrethroids in Registration Review (also referred to as the "Rationale Document") to the momfluorothrin docket for the 60-day public comment period. The same FR Notice (81 FR 85952) also announced the availability of the risk assessments for several other pyrethroids, and the Ecological Risk Assessment and Rationale Document, in the individual chemical dockets. The comment period was extended from January until July 2017.  
 During the public comment period, EPA received over 1,400 public comments across all the dockets of the pyrethroids.  
 Fourteen comments were received in the momfluorothrin docket (one comment, on an unrelated pesticide, was submitted to the momfluorothrin docket in error). None of these comments addressed momfluorothrin specifically and all comments were posted to other pyrethroids dockets. These comments and the agency's responses can be found in the EFED/PRD Response to Comments document, which is available at www.regulations.gov docket number EPA-HQ-OPP-2008-0331.
 None of the comments addressed momfluorothrin specifically, and none of the comments changed the ecological risk conclusions and effects determination for the momfluorothrin case.
                           
 July 2019  -  The agency published USEPA Office of Pesticide Programs' Re-Evaluation of the FQPA Safety Factor for Pyrethroids: Updated Literature and CAPHRA Program Data Review on the webpage https://www.epa.gov/sites/production/files/2019-08/documents/2019-pyrethroid-fqpa-caphra.pdf, which discusses the data and rationale underlying the agency's decision to remove the 10X FQPA safety factor for the pyrethroids, including momfluorothrin.  

 September 2019  -  The agency announced the availability of momfluorothrin PID in the momfluorothrin registration review docket (EPA-HQ-OPP-2015-0752), for a 60-day public comment period. The agency also announced the availability of the Pyrethroids and Pyrethrins Ecological Risk Mitigation Proposal for 23 Chemicals in the Special Docket for Pyrethroids, Pyrethrins, and Synergists located at http://www.regulations.gov (Docket #: EPA-HQ-OPP-2008-0331) for a 60-day public comment period. A Readers Guide - Instructions for Commenting on the Registration Review Documents in the Pyrethroids Group was also added to the chemical docket. Comments were submitted to the relevant docket to ensure timely consideration of comments (i.e., comments related to the ecological risk mitigation were submitted through the pyrethroids special docket, EPA-HQ-OPP-2008-0331).
              Along with the momfluorothrin PID, the following documents are also available in the momfluorothrin registration review docket (EPA-HQ-OPP-2015-0752):
 Momfluorothrin: Updated Human Health Draft Risk Assessment in Support of Registration Review.
 Readers Guide- Instructions for Commenting on the Registration Review Documents in Pyrethroids Group.
                  
 March 2020-The agency is now announcing the availability of the Momfluorothrin Interim Registration Review Decision.

Summary of Public Comments on the Proposed Interim Decision and Agency Responses
The agency published the momfluorothrin proposed interim decision for public comment on November 12, 2019.  The comment period closed on January 12, 2020.  During that time, the agency received no public comments for the momfluorothrin PID specifically. However, several public comments were received for Pyrethroids and Pyrethrins Ecological Risk Mitigation Proposal for 23 Chemicals and provide suggestions on the proposed text describing how to define a spot treatment on labels for momfluorothrin.  Comments were received from the National Pest management (NPMA), the National Association Landscape (NALP), the Responsible Industry for a Sound Environment (RISE), Bayer CropScience, and the Pyrethroid Working Group (PWG). The Agency's response to these comments are summarized below.
Comments Submitted by NPMA (EPA-HQ-OPP-2008-0331-0096, PWG (EPA-HQ-OPP-2008-0331-0162), Bayer CropScience (EPA-HQ-OPP-0331-0170), NALP (EPA-HQ-OPP-2008-0331-0163, and RISE (EPA-HQ-OPP-2008-0331-0085).    

Comment: The organizations listed above commented on the proposed language ("Spot treatments must not exceed two feet in size (2ft. by 1 ft.) other than ant mound treatment, not to exceed 10% of the treatment area") for outdoor, non-agriculture spot treatment applications of pyrethroid products. The commenters stated that the proposed language is confusing as written and difficult to understand.  Additionally, the commenters stated that the proposal differs from spot treatment language previously provided by the agency. In particular, the commenters objected to the statement limiting spot treatments to a total of 10% of the entire treatment area because (1) there is a lack of data to support this number, (2) spot treatments are generally considered to comprise approximately 20% of the area to be treated, and  (3) they also expressed concern about the need for flexibility to address areas outside of the normal treatment area to ensure control of target pests. 

EPA Response:  The agency acknowledges and thanks these organizations for these comments.  Based on the feedback received, EPA has revised the spot treatment language to reduce confusion and allow for flexibility to control pests outside of the application area, to read as follows: 

      "Individual spot treatments must not exceed two square feet in size (2ft. by 1 ft.)."
 USE AND USAGE

Like other pyrethroids, momfluorothrin acts to prevent sodium channels in an organism's neuronal membranes from closing, resulting in paralysis and eventual death. The Insecticide Resistance Action Committee (IRAC, 2018) categorizes momfluorothrin and other synthetic pyrethroids in Mode of Action Group 3A.

Momfluorothrin is used in both residential and commercial settings, including application to indoor perimeters and mattresses. The products for momfluorothrin are all ready-to-use sprays. EPA has very limited usage data for momfluorothrin because the pesticide usage data available to the agency covers agricultural uses, and momfluorothrin has no agricultural uses. Nationally, residential consumers purchased around 100,000 lbs of pyrethroid insecticides for indoor use in 2016.  However, the extent to which momfluorothrin is a component of this usage is not known.   Momflourothrin products are marketed for use against a variety of flying, crawling, and stinging insects and other arthropods such as flies, mosquitoes, wasps, hornets, yellow jackets, roaches, ticks, bed bugs, centipedes, scorpions, and certain species of ants and spiders.

SCIENTIFIC ASSESSMENTS

 Human Health Risks 

A summary of the agency's human health risk assessment is presented below. The agency used the most current science policies and risk assessment methodologies to prepare a risk assessment in support of the registration review of momfluorothrin.  For additional details on the human health assessment for momfluorothrin, see Momfluorothrin: Draft Human Health Risk Assessment for Registration Review, Momfluorothrin: Human Health Risk Assessment for a Use of the New Active Ingredient in Indoor Residential Settings and Outdoors in Commercial/Residential Settings, and Momfluorothrin: Updated Human Health Draft Risk Assessment in Support of Registration Review, which are available in the momfluorothrin registration review docket EPA-HQ-OPP-2015-0752.

 1. Pyrethroids FQPA Safety Factor Determination

The Food Quality Protection Act (1996) requires EPA to apply a ten-fold margin of safety (10X FQPA safety factor) for infants, children, and women of child-bearing age to account for potential juvenile sensitivity to pesticides, unless there are reliable data to reduce this safety factor. The agency considers the FQPA safety factor as having two components: 3X assigned to pharmacokinetic (PK) differences and 3X to pharmacodynamic (PD) differences. The PK component depicts the process of chemicals being absorbed, distributed, metabolized, and excreted from and in the body. The PD component determines how a chemical brings about target tissue responses at a given dose. 

For the pyrethroids that went through reregistration, which did not include momfluorothrin, EPA determined the toxicological database provided reliable information to reduce the 3X FQPA PD component of the safety factor for all populations to 1X.  While there was enough information to reduce the 3X FQPA PK safety factor for women of child-bearing age to 1X, some uncertainty remained for infants and children because available animal data indicated an increase in sensitivity to pyrethroids for juvenile rats compared to adult rats.  EPA required developmental neurotoxicity studies (DNTs) with the intention of addressing this uncertainty; however, after a 2009 review of the pyrethroids toxicological database, which considered all the available reproductive and developmental studies, the agency determined that the DNT did not provide sufficient information related to the susceptibility of infants and children. Therefore, EPA notified registrants that they could satisfy outstanding DCI requirements for pyrethroids DNT studies by citing the previously submitted DNT studies for six pyrethroids.  In addition, in order to address the uncertainty of comparative life-stage sensitivity, EPA solicited protocols from all pyrethroid companies in 2010, requesting interested parties submit a protocol for a study designed to identify and quantify potential juvenile sensitivity. A majority of the pyrethroid registrants formed a group called the Pyrethroid and Pyrethrins Technical Working Group (PPTWG) and they were ultimately the only group to submit a protocol for review. 

In July 2010, the FIFRA Scientific Advisory Panel (SAP) convened to review the PPTWG protocol, which using a combination of in vitro studies, targeted in vivo studies, and physiologically based pharmacokinetic (PBPK) models to evaluate the life-stage sensitivity of pyrethroids.  The SAP supported PBPK modeling as an appropriate path forward for addressing juvenile sensitivity, and some elements of the proposal were modified following SAP and EPA recommendations. The PPTWG was eventually expanded and became the Council for the Advancement of Pyrethroid Human Risk Assessment (CAPHRA).  
Between late 2010 and early 2015, CAPHRA's efforts were focused on development of the overall approach using data for deltamethrin and permethrin to first develop the PBPK model parameterized for these two active ingredients (Type II and Type I pyrethroids, respectively).  By May 2015, the CAPHRA knowledge-base for deltamethrin and permethrin was robust enough for critical evaluation of the approach, including their intended use of the data for read-across along with computational approaches for modeling other pyrethroids.  The SAP encouraged the CAPHRA to address certain deficiencies in the dataset and PBPK model but were generally supportive of the PBPK approach.

Following the 2015 SAP, the EPA and the CAPHRA continued to meet regularly to work through technical issues, as well as discuss updates on the status of the research program.  By spring 2018, the CAPHRA submitted the in vitro and in vivo studies, as well as the PBPK model code and a related white paper to the EPA. The CAPHRA white paper described the integration of multiple data streams and the modeling approach to determine the key contributors to age-related toxicokinetic difference. The October 2018 peer review noted deficiencies in the white paper, as well as opportunities for further testing of the model parameters.  In addition, the peer review panel requested full model documentation and recommended an independent quality assurance (QA) review after CAPHRA addressed these issues identified by the panel.  

The EPA worked with the CAPHRA to discuss the white paper updates, model testing, and additional information necessary for EPA's evaluation of the weight of evidence (WOE).  CAPHRA completed this work in July 2019, and EPA determined it could proceed with its WOE determination, which included review of the open literature and well as data generated by CAPHRA.  

EPA has concluded that no new information of suitable quality was available on the age-related PD properties of the pyrethroids. Therefore, the previous conclusion that the PD contribution to the FQPA safety factor is 1X remains the same. With regard to PK, recent data including human PBPK models, as well as in vivo and in vitro data on protein binding, enzyme ontogeny and metabolic clearance, support the conclusion that the PK contribution to the FQPA safety factor is 1X for all populations. In December 2019, EPA determined that while the use of a PBPK model is appropriate to evaluate the potential for differential sensitivity of pyrethroids, as a class, between juveniles and adults, the model is not robust enough to be used for the development of chemical-specific uncertainty factors in the risk assessments for individual pyrethroids except those on which the model was conducted (deltamethrin and permethrin). 

EPA's full evaluation, USEPA Office of Pesticide Programs' Re-Evaluation of the FQPA Safety Factor for Pyrethroids: Updated Literature and CAPHRA Program Data Review (July 2019), is available at www.regulations.gov (EPA-HQ-OPP-2008-0331). 

 2. Risk Summary and Characterization
A human health risk assessment for momfluorothrin, Momfluorothrin: Human Health Risk Assessment for a Proposed Use of the New Active Ingredient in Indoor Residential Settings and Outdoors in Commercial/Residential Settings, was completed in 2014 for proposed uses of 
momfluorothrin. There have been no new uses proposed since the 2014 assessment but the most recent human health risk assessment for momfluorothrin, Momfluorothrin: Updated Human Health Draft Risk Assessment in Support of Registration Review, has updated risk estimates and serves as the draft risk assessment for the purposes of registration review. No exposure from food is anticipated and drinking water exposure is also not expected from the registered uses of momfluorothrin so a dietary exposure and risk assessment was not conducted. As no dermal endpoint of concern was identified, residential handler, residential post-application, occupational handler, and occupational post-application scenarios are based on inhalation exposures only.  All inhalation scenarios resulted in margins of exposure (MOE) greater than the level of concern and are not of concern. Momfluorothrin is not registered for use on sites that are likely to result in spray drift exposure to bystanders. There are currently no existing or proposed food uses for momfluorothrin and residues of momfluorothrin are not expected in drinking water from the proposed uses of momfluorothrin; therefore, a quantitative aggregate risk assessment is not required. There are no risks of concern for dietary (food and water), residential handler and post-application, residential bystander, aggregate exposure, and occupational handler and post-application scenarios.  

For more information on the human health risks of momfluorothrin, refer to the Momfluorothrin: Updated Human Health Draft Risk Assessment in Support of Registration Review, Momfluorothrin: Draft Human Health Risk Assessment for Registration Review and Momfluorothrin: Human Health Risk Assessment for a Proposed Use of the New Active Ingredient in Indoor Residential Settings and Outdoors in Commercial/Residential Settings, which are available in the public docket.

Cumulative Risks

The agency is required to consider the cumulative risks of chemicals sharing a common
mechanism of toxicity. The agency has determined that the pyrethroids and pyrethrins belong to a common mechanism group (http://www.regulations.gov; EPA-HQ-OPP-2008-0489-0006) with respect to human health. The members of this group share the ability to interact with voltage-gated sodium channels in the nervous system, which ultimately leads to neurotoxicity. A cumulative risk assessment for the pyrethroids and pyrethrins was published on Nov. 9, 2011 and is available at http://www.regulations.gov; EPA-HQ-OPP-2011-0746. No cumulative risks of concern were identified at that time. For information regarding EPA's efforts to evaluate the human health risk of exposure to pyrethroids, refer to http://www.epa.gov/oppsrrd1/reevaluation/pyrethroids-pyrethrins.html.  After all of the chemical-specific interim decisions have been completed for the pyrethroids class of pesticides, an update of the cumulative risk assessment may be performed in association with registration review. 

 3. Human Incidents and Epidemiology
No human health incidents have been reported for momfluorothrin since the time products containing the active ingredient were first registered in 2015. It is possible, at least in part, that the lack of incident data is related to the relatively recent introduction of the products and limited adoption of the products by consumers because they are new.

The Agricultural Health Study (AHS) is a high quality, prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer. Momfluorothrin is not included as an analyte in the AHS so the study does not provide information specific for momfluorothrin.

An epidemiological report was developed to assess the association between exposure to the pyrethroids in humans and adverse carcinogenic and non-carcinogenic outcomes, as well as select individual pyrethroid chemicals, including momfluorothrin. Overall, the epidemiological report found little substantive evidence to suggest a clear, associative, or causal relationship between exposure to pyrethroids and cancer and non-cancer health endpoints in the studies, including the AHS. For further information, please see Pyrethroids: Tier II Epidemiological Report dated April 30, 2019.   

 4. Tolerances
There are no registered food/feed uses and no established tolerances for residues of momfluorothrin.

 5. Human Health Data Needs
There are no data deficiencies for the registration review of momfluorothrin in regard to the toxicology, residue chemistry, and occupational and residential exposure data requirements. 
Ecological Risks
 
 The agency concluded that potential risks to non-target aquatic and terrestrial organisms, including pollinators, are highly unlikely given the limited potential for exposure from momfluorothrin. The EPA also made a "No Effect" determination for all listed (threatened and endangered) species and a "No Habitat Modification" determination for all designated critical habitats for momfluorothrin.

Although momfluorothrin does not have ecological risks of concern, it is one of the 23 pyrethroids noted in the Ecological Risk Management Rationale for Pyrethroids in Registration Review, a companion piece to the 2016 Preliminary Comparative Environmental Fate and Ecological Risk Assessment for Registration Review of Eight Synthetic Pyrethroids and the Pyrethrins. This rationale document summarized potential risk concerns for the pyrethroids excluded from the quantitative ecological assessment. Chemicals noted in the Rationale Document include: cyphenothrin, d‐phenothrin, etofenprox, flumethrin, imiprothrin, momfluorothrin, prallethrin, tau‐fluvalinate, tefluthrin, and tetramethrin. 

For additional details on the ecological assessment for the pyrethroids, see the Preliminary Comparative Environmental Fate and Ecological Risk Assessment for Registration Review of Eight Synthetic Pyrethroids and the Pyrethrins, the Ecological Risk Management Rationale for Pyrethroids in Registration Review, and the Environmental Fate and Ecological Risk Assessment for the Section 3 New Chemical Registration of the Pyrethroid Insecticide Momfluorothrin, which are available in the public docket under Docket Number EPA-HQ-OPP-2015-0752.

Benefits Assessment

While many of the arthropods that momfluorothrin can be used to control are nuisance pests, a few, such as some ant species and ticks, are considered public health threats. 

Some other synthetic pyrethroids can serve as alternatives to momfluorothrin. For ants and cockroaches, non-pyrethroid alternatives also exist, such as hydramethylnon, indoxacarb, and abamectin. A number of pyrethroid and non-pyrethroid pesticides are also used to control fleas and ticks.

For information on the benefits of pyrethroids in general, refer to the Pyrethroids Ecological Risk Mitigation Proposal, also available in the public docket (EPA-HQ-OPP-2008-0331).

INTERIM REGISTRATION REVIEW DECISION

 Risk Mitigation and Regulatory Rationale

The agency has determined that there are no risks of concern associated with the registered use of momfluorothrin.  As a result, the agency is not requiring additional mitigation measures beyond those needed to clarify, update, and improve consistency of labeling for all momfluorothrin products and uses. 

 Label Clarification

The agency is requiring the inclusion of a general statement on spot treatment guidance stating the following: "Individual spot treatments in, on, or around man-made structures must not exceed two square feet in size (2ft. by 1 ft.)." This clarification will define what a spot treatment is to help the user of momfluorothrin apply products appropriately.

Tolerance Actions 

Since there are no registered food/feed uses and no established tolerances for residues of momfluorothrin, no changes to the tolerance levels, crop listings, or the tolerance expression are necessary at this time.  

Interim Registration Review Decision 

In accordance with 40 CFR §§ 155.56 and 155.58, the agency is issuing this ID. Except for the Endocrine Disruptor Screening Program (EDSP) of this case, the agency has made the following interim decision: (1) no additional data are required at this time; and (2) changes to the affected registrations and their labeling are needed at this time, as described in Section IV. A and Appendix A of this document. 

In this ID, the agency is making no human health or environmental safety findings associated with the EDSP screening of momfluorothrin. The agency's final registration review decision for momfluorothrin will be dependent upon the result of the agency's EDSP FFDCA § 408(p) determination.

Data Requirements

The agency does not anticipate calling-in additional data for the registration review of momfluorothrin at this time.
NEXT STEPS AND TIMELINE   
 Interim Registration Review Decision

A Federal Register Notice will announce the availability of this ID for momfluorothrin. However, a final decision for momfluorothrin may be issued without the agency having previously issued an interim decision. A final decision on the momfluorothrin registration review case will occur after an EDSP FFDCA § 408(p) determination.

 Implementation of Mitigation Measures  

Once the Interim Registration Review Decision is issued, the momfluorothrin registrants must submit amended labels that include the label changes described in Appendix A. The revised labels and requests for amendment of registrations must be submitted to the agency for review within 60 days following issuance of the Interim Registration Review Decision in the docket. 

Registrants must submit a cover letter, a completed Application for Registration (EPA form 8570-1) and electronic copies of the amended product labels. Two copies for each label must be submitted, a clean copy and an annotated copy with changes. In order for the application to be processed, registrants must include the following statement on the Application for Registration (EPA form 8570-1):

"I certify that this amendment satisfies the requirements of the momfluorothrin Interim Registration Review Decision and EPA regulations at 40 CFR Section 152.44, and no other changes have been made to the labeling of this product. I understand that it is a violation of 18 U.S.C. Section 1001 to willfully make any false statement to EPA. I further understand that if this amendment is found not to satisfy the requirements of the Momfluorothrin Interim Registration Review Decision and 40 CFR Section 152.44, this product may be in violation of FIFRA and may be subject to regulatory and/or enforcement action and penalties under FIFRA."

Within the required timeframe, registrants must submit the required documents to the EPA's Pesticide Submission Portal (PSP), which can be accessed through the EPA's Central Data Exchange (CDX) using the following link: https://cdx.epa.gov/. Registrants may instead send paper copies of their amended product labels, with an application for a fast-track, agency initiated non-PRIA label amendment to Veronica Dutch at one of the following addresses, so long as the labels and application are submitted within the required timeframe:

      VIA US Mail
USEPA Office of Pesticide Programs 
Pesticide Re-evaluation Division  
Mail Code 7508P
1200 Pennsylvania Ave NW 
Washington, DC 20460-0001
      
      VIA Courier 
Pesticide Re-evaluation Division 
c/o Front End Processing
Room S-4910, One Potomac Yard 
2777 South Crystal Drive 
Arlington, VA 22202-4501

 
 APPENDICES
 Appendix A:  Labeling Changes for Momfluorothrin Products
                                  Description
                  Label Language for Momfluorothrin Products
                              Placement on Label

                               End Use Products 
                                       

Spot Treatment Statement 
"Individual spot treatments must not exceed two square feet in size (2ft. by 1 ft.)."
Directions for use

 Appendix B:  Endangered Species Assessment

The agency has determined there is no reasonable expectation for any registered use of momfluorothrin to cause direct or indirect adverse effects to threatened and endangered species. No adverse modification of critical habitat is expected from the use of momfluorothrin. The agency has based these determinations on the current limited use pattern for momfluorothrin, which results in a very limited potential of exposure for non-target terrestrial and aquatic organisms. Because EPA has made a "No Effect" determination under the Endangered Species Act (ESA) for all listed species and designated critical habitat for such species, consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service under ESA § 7(a)(2) is not required.

 Appendix C:  Endocrine Disruptor Screening Program
      
As required by FIFRA and FFDCA, the EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, sub-chronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, the EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of its most recent registration decision for momfluorothrin, the EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA § 408(p), momfluorothrin is subject to the Endocrine Disruptor Screening Program (EDSP). 

The EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a "naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." The EDSP employs a two-tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where the EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine-related effects caused by the substance and establish a dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA § 408(p), the agency must screen all pesticide chemicals. Between October 2009 and February 2010, the EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. The agency has reviewed all of the assay data received for the List 1 chemicals and the conclusions of those reviews are available in the chemical-specific public dockets. A second list of chemicals identified for EDSP screening was published on June 14, 2013, and includes some pesticides scheduled for registration review and chemicals found in water. Neither of these lists should be construed as a list of known or likely endocrine disruptors. Momfluorothrin is not on either list. For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit the EPA website.  

In this ID, the EPA is making no human health or environmental safety findings associated with the EDSP screening of momfluorothrin. Before completing this registration review, the agency will make an EDSP FFDCA § 408(p) determination.