UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 WASHINGTON, DC 20460

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION

Mefenoxam: Response of Public Comments on EPA’s “Proposed Registration of the New 

Rapeseed Seed Treatment Use Subgroup 20A” (Docket ID: EPA-HQ-OPP-2015-0014)

Summary 

This document summarizes the U.S. Environmental Protection Agency's (the Agency, EPA)

responses to public comments received through the public notification of the receipt of the

application for new uses for mefenoxam on rapeseed subgroup 20A.

On April 15th, 2015, EPA published a notice of receipt in the Federal Register for Pesticide 

Product Registration; Receipt of Application for new uses. The Notice for the proposed new use 

announced a public comment period of 30 days; two comments were received on the notice of 

receipt.

Both comments were submitted by the Center for Food Safety. The first comment provided 

information and cited abstracts. The other comments were outlined in a document submitted by 

the Center for Food Safety. The agency’s review and responses are summarized in this 

document.

Summary of Comments on Applications to Register Pesticide Products Containing 

Mefenoxam

Comments from: Center for Food Safety Document ID: EPA-HQ-OPP-2015-0014-0006 

I. EPA MUST CRITICALLY ASSESS THE IMPACTS OF THE PROPOSED NEW 

SYSTEMIC FUNGICIDES ON POLLINATOR HEALTH

 In evaluating the applications for use of mefenoxam, EPA must critically assess the 

potential adverse effects from the uses of this systemic fungicides on honey bees and 

other pollinators. Because of its systemic nature, mefenoxam poses similar dangers as

the currently widely-used neonicotinoid pesticides, for which EPA has recently moved up 

registration review in order to better assess this toxic chemicals’ impacts on pollinator 

health.

o The additional proposed outdoor uses of this systemic fungicide would create 

another stressor to honey bees and other pollinators, and further threaten the 

health of these precarious species.
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EPAs Response:

 In 2014, EPA formalized guidance for assessing pesticide risks to bees1. This guidance 

relies upon toxicity data that were not previously required for honey bees. As EPA OPP 

assesses the ecological risks of currently registered pesticides through the registration 

review process, EPA has been requiring the new data for pesticides. Because registration 

review for mefenoxam was initiated before 2014, these data have not been called in. In 

cases where the Tier 1 data was not part of an issued Registration Review DCI, the 

agency will prioritize the chemical based on the chemical’s potential for both bee 

exposure and effects and then make a decision on when another DCI will be issued. 

During this transitional time between the formalization of the guidelines and when data 

are available, EPA assesses the risks of pesticides to bees based on the available data. 

For mefenoxam, acute contact toxicity data are available. These data indicate that on a 

contact exposure basis, mefenoxam is practically non-toxic (i.e., LD50 >25ug/bee ug 

a.i./bee; MRID 43875308). At this time, acute and chronic oral (dietary) toxicity data are 

not available for adult and larval bees exposed to mefenoxam. Based on a lack of 

toxicity to adult bees from the acute oral and acute contact routes of exposure, 

mefenoxam is not among the chemicals prioritized for issuance of DCI at present. 

Existing data for mefenoxam on pollinator safety confirms that the current approaches 

and labeling polices are adequately addressed.

II. EPA MUST CONSIDER THE ECONOMIC IMPACTS AND ADVERSE 

EFFECTS ON U.S. AGRICULTURE STEMMING FROM THE PROPOSED 

USE OF MEFENOXAM

 Effects on U.S agriculture economy, and on honey bees and other terrestrial 

invertebrates, including native bees and other vital pollinator species whose existence is 

the backbone of the U.S. agricultural economy.

 Given the uncertainties and initial results that point to significant acute hazards, the 

proposed applications for new uses present unreasonable adverse effects to bee species, 

pollinators, and other beneficial organisms.

EPAs Response: 

 The Agency is actively assessing risks to honey bees generally as part of the Agency's 

registration review process for currently registered or existing pesticides. This allows the 

Agency to prioritize chemicals with potentially higher risks and to address any issues that 

arise from them. The agency is approving the rapeseed crop subgroup 20A use at 

proposed low toxicity application rates forseed treatment. The application rates on 

 

1 USEPA, 2014. Guidance for Assessing Risks to Bees. Environmental Fate and Effects Division. Office of 

Pesticide Programs. Washington, DC.
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Docket No. EPA-HQ-OPP-2015-0014

rapeseed are the same as previously approved seed treatment rates and have similar risk 

conclusions. These rates help minimizes potential risks to pollinating insects. Previous 

evaluations indicate that mefenoxam does not post a significant risk to bees, therefore, it 

is not among the list of prioritized chemicals for issuance of a DCI. Moreover, these 

crops do not require managing pollinators, however across the Federal Government 

pollinator safety is a high priority and will continue to be reviewed and addressed.

III. EPA MUST CONSIDER THE POTENTIAL ADVERSE EFFECTS ON 

ORGANISMS, SOIL HEALTH AND U.S. AGRICULTURE STEMMING 

FROM THE PROPOSED USE OF MEFENOXAM

 EPA must critically assess the potential adverse effects on beneficial soil organisms, soil 

health and their interrelated impacts on U.S. agriculture.

EPAs Response:

 The database for mefenoxam is complete according to 40 C.F.R. part 158 data 

requirements. The agency does not generally require the submission of data that 

characterizes toxicity to soil-dwelling organisms such as earthworms, soil microbes and 

fungi. EPA relies upon test data for a number of representative species and will calculate 

risk information for these species as a surrogate for other taxonomic groups. 

IV. EPA MUST CONSULT ON THE POTENTIAL IMPACTS OF THE 

PROPOSED PESTICIDE PRODUCTS AS REQUIRED UNDER THE ESA

 EPA must comply with the agency’s duty under the ESA and consult the expert agencies 

on the potential effects of three active ingredients on listed species or their critical 

habitats.

EPA Response: 

 In November 2013, the EPA, along with the U.S. Fish & Wildlife Service (USFWS), the 

National Marine Fisheries Service (NMFS) (collectively, the Services), and the U.S. 

Department of Agriculture (USDA) released a summary of their joint Interim Approaches 

for assessing risks to listed species from pesticides. The Interim Approaches were 

developed jointly by the agencies in response to the National Academy of Sciences’ 

(NAS) recommendations and reflect a common approach to risk assessment shared by the 
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Docket No. EPA-HQ-OPP-2015-0014

agencies as a way of addressing scientific differences between the EPA and the 

Services. The NAS report outlines recommendations on specific scientific and technical 

issues related to the development of pesticide risk assessments that EPA and the Services 

must conduct in connection with their obligations under the Endangered Species Act 

(ESA) and FIFRA. 

The joint Interim Approaches were released prior to a stakeholder workshop held on 

November 15, 2013. In addition, the EPA presented the joint Interim Approaches at the 

December 2013 Pesticide Program Dialogue Committee (PPDC) and State-FIFRA Issues 

Research and Evaluation Group (SFIREG) meetings, and held a stakeholder workshop in 

April 2014, allowing additional opportunities for stakeholders to comment on the Interim 

Approaches. As part of a phased, iterative process for developing the Interim 

Approaches, the agencies will also consider public comments on the Interim Approaches 

in connection with the development of upcoming Registration Review decisions. The 

details of the joint Interim Approaches are contained in the white paper “Interim 

Approaches for National-Level Pesticide Endangered Species Act Assessments Based on 

the Recommendations of the National Academy of Sciences April 2013 Report,” dated 

November 1, 2013. 

Given that the agencies are continuing to develop and work toward implementation of the 

Interim Approaches to assess the potential risks of pesticides to listed species and their 

designated critical habitat, this preliminary risk assessment for mefenoxam does not 

contain a complete ESA analysis that includes effects determinations for specific listed 

species or designated critical habitat. Although EPA has not yet completed effects 

determinations for specific species or habitats, for this preliminary assessment EPA 

conducted a screening-level assessment for all taxa of non-target wildlife and plants that 

assumes for the sake of the assessment that listed species and designated critical habitats 

may be present in the vicinity of the application of mefenoxam .This screening level 

assessment will allow EPA to focus its future evaluations on the types of species where 

the potential for effects exists once the scientific methods being developed by the 

agencies have been fully vetted.

Existing product labels for mefenoxam contain mitigations to reduce aquatic exposures 

(1) vegetative filter strips and (2) buffer zones. Such mitigation measures are designed to 

minimize the potential exposure of mefenoxam-treated areas to water bodies and include 

the requirement of buffer zones for both aerial and ground applications, vegetative buffer 

strips, spray drift reduction advisory, surface and ground water advisories, and 

environmental hazard warnings. Given the mefenoxam risk assessment is conservative, 

since the label restrictions are established to minimize risk and are considered appropriate 

risk mitigation measures

V. EPA SHOULD ALLOW OPPORTUNITY FOR SUBSTANTIVE PUBLIC 

COMMENT ON THE AGENCY’S DECISION-MAKING DOCUMENTS, 
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INCLUDING RISK ASSESSMENTS AND ANY OTHER SUPPORTING 

DOCUMENTATION

 EPA should give the public and interested parties an opportunity to give substantive input 

into EPA’s decision-making process by publishing and allowing for comments on the 

registrants’ application materials, EPA’s risk assessments, and EPA’s proposed 

registration decisions prior to issuing EPA’s final decisions.

EPAs Response:

 EPA provides several ways for public participation in the pesticide registration process. 

In response to President Obama’s directive on transparency and open government, EPA’s 

Pesticide Program explored opportunities for expanding the openness of the process and 

accordingly, in October of 2009, began implementing a public participation process for 

certain registration actions. By establishing this process, the Agency has increased 

opportunities for the public to comment on risk assessments and proposed registration 

actions. Both EPA and the public will benefit from a public participation process because 

the public will help to inform the risk assessment and risk management processes 

associated with registration. Such input can add to the understanding potential risks and 

benefits, contribute to meaningful protective measures, and improve the public dialogue 

on pesticide registration decisions. The agency intends to use the public participation 

process for the following types of applications: new active ingredients, first food uses, 

first outdoor uses, first residential uses, and other actions of significant interest. 

 In reference to Mefenoxam, pursuant to the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA § 3(c)(4)), the agency is required to publish a notice of receipt 

for all applications for pesticides containing “any new active ingredient or if [the 

application] would entail a changed use pattern.”. For the current rapeseed new use, the 

Agency made the notice of receipt available for public comments for 30 days as required. 

This document is the response to comments received on that notice. Further, EPA 

publishes a Notice of Filing for tolerance petitions filed for food uses. These notices 

address the necessary approaches for transparency called for under FIFRA and the 

Administrative Procedures Act.