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

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

Product Registration ; Receip t 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

Comment s from : Cente r for Food Safety Document ID: EPA

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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 th is systemic fungicides on honey bees and other pollinators. Because of its systemic nature, mefenoxam pose s similar dangers as the currently widely

- used neonicotinoid pesticides, for which EPA has recently moved up registration review in order to bet ter assess this toxic chemicals’ impacts on pollinator

health.

o The additional proposed outdoor uses of th is systemic fungicide would create another stressor to honey bees and other pollinators, and further threaten the health of these precarious species.Page 2 of 5

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EPAs Response:

 In 2014, EPA formalized guidance for assessing pesticide risks to bees 1 . 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 formaliz ation 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 prac tically 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 o ral 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

 E ffects 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

propose d applications for new uses present unreasonable adverse effects to bee sp ecies, 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

. T he agency is approving the rapeseed crop subgroup 20A use at proposed low toxicity application rates for seed 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.Page 3 of 5

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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 , t herefore, it is not among the list of prioritized chemicals for issuance of a DCI. Moreover

, these crops do not require managing poll inators, however across the Federal G overnment 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 t heir 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 PES T I CIDE PRODUCTS AS REQUIRED UNDER THE ESA

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

on th e 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 thePage 4 of 5

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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 (ES A) 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 developi ng 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 mefeno xam 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 a ssessment 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 mefeno xam .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 requiremen t 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 labe l 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

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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 assessment s, 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 o pen 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 int ends 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 us e 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.