              										UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                                             WASHINGTON, DC  20460


                                                      OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

                                                                 	
Penflufen: Response to Public Comments on EPA's Notice of Receipt for the proposed New Uses  of the Active Ingredient Penflufen as a Seed Treatment on Onion, bulb, subgroup 3-07A; Onion, green, subgroup 3-07B; and Sugar Beet (Docket ID: EPA-HQ-OPP-2015-0559)

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 of penflufen as a seed treatment on onion, bulb, subgroup 3-07A; onion, green, subgroup 3-07B; and sugar beet.

On March 16, 2016, EPA published a notice of receipt in the Federal Register for Pesticide Product Registration; Application for New Uses. The Notice for the proposed new use announced a public comment period of 30 days; one comment was received on the notice of receipt. 

The comment was submitted by the Center for Biological Diversity (CBD).  The agency's responses and positions are summarized in this document.  The format of these responses is based on CBD's submission format.  CBD commented about several topics including an endangered species assessment, adverse effects, synergy and cumulative uses, data requirements, and pollinators.

The Agency recently completed a risk assessment for the new use of penflufen as a seed treatment on onion, bulb, subgroup 3-07A; onion, green, subgroup 3-07B; and sugar beet.  The amendments involve the technical product (264-1118) for all uses; a flowable suspension concentrate end-use product (264-1119) for seed treatment on onion, bulb, subgroup 3-07A; onion, green, subgroup 3-07B and sugar beet; and a flowable suspension concentrate end-use product (264-1122) for seed treatment on sugar beet which also contains the active ingredients prothioconazole and metalaxyl.  

Comments and Agency Responses:

Comment 1.  Comply with duties under Section 7 of the Endangered Species Act (ESA), including completion of consultation.  

Agency 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 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, risk assessments for penflufen do not contain a complete ESA analysis that includes effects determinations for specific listed species or designated critical habitat.

When penflufen was registered in 2012, an ecological and environmental assessment was conducted. That preliminary analysis indicated that there is a potential for penflufen use to overlap with listed species and that a more refined assessment is warranted. However, an analysis has not yet been conducted.  Once the agencies have fully developed and implemented the scientific methods necessary to complete risk assessments for endangered and threatened (listed) species and their designated critical habitats, these methods will be applied to subsequent analyses for penflufen.  The application rates for the new uses are an order of magnitude below those previously assessed.

Comment 2.  The EPA must consult on the adverse effects.  Penflufen is a fungicide which, along with its two degradates, is expected to be persistent in the environment.  Penflufen is very highly toxic to fish on an acute exposure basis.  It does not appear that the EPA evaluated the effects on aquatic invertebrates.  

Agency Response:

Acute toxicity studies indicate that penflufen is moderately toxic to freshwater and estuarine/marine invertebrates on an acute exposure basis.  Degradate toxicity data on fish, aquatic invertebrates and green algae indicate that penflufen degradates are less toxic than the parent and effects are not expected at environmentally relevant concentrations.  The results of risk estimation indicate that proposed uses of penflufen are unlikely to adversely
affect fish or aquatic invertebrates or aquatic plants on either an acute or chronic
exposure basis.  Due to its low log Kow (3.3), penflufen is not expected to bioaccumulate in aquatic invertebrates or bioaccumulate up the food chain.  Please see the Agency's response to Comment #1 regarding consultation.

Comment 3.  The EPA must consult on all synergistic and cumulative uses.  

Agency Response:

There is no data to suggest that synergy impacts occur with penflufen.  The Agency does not routinely include a separate evaluation of mixtures of active ingredients, rather the focus is on assessment of individual chemicals. Tank mixing is a common practice in agriculture and the most restrictive label limitations and precautions on the label must be followed by the applicator.  If effects data are available for a formulated product for non-target organisms containing more than one active ingredient, they may be used qualitatively or quantitatively in accordance with the agency's Overview Document and the Services' Evaluation Memorandum (USEPA 2004; USFWS/NMFS/NOAA 2004).   While the Agency acknowledges that there is biological uncertainty about combination exposures, synergy effects are known to be rare.  In consideration of reliable methods there are no outstanding concerns over synergy impacts with this registration decision.  

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to penflufen and any other substances, and penflufen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that penflufen has a common mechanism of toxicity with other substances.  Please see the Agency's response to Comment #1 regarding consultation.  Amending the registration by adding these new uses would not significantly increase the risk of any unreasonable adverse effect on the environment.

Comment 4.  Require that the registrant provide all necessary data and studies.

Agency Response:

The applicant has submitted all the required data for the new uses and it has been found to be satisfactory.   The toxicology database for penflufen is complete. The end-use labels associated with these new uses have application rates (0.001-0.006 lbs.a.i./A) that are considerably lower than the seed treatment rate that was previously assessed for penflufen (0.28 lb a.i./A).  The new uses (bulb onion subgroup; green onion subgroup and sugar beet seed treatments) do not change the 2011 ecological risk conclusions [2011 New Chemical Risk Assessment (DP389672)  conducted for alfalfa, beans and peas (including soybeans), canola, mustard (oilseed and condiment), rapeseed, cotton, cereal grains, corn, sorghum, sunflower, safflower, potato seed pieces, and rice (not for application to flooded fields)].  The 2011 assessment concluded that the risk of adverse effects to non-target organisms is generally not expected.

Comment 5.  Incorporate necessary factors into evaluation and any proposed decision such as endocrine disruption and effects on pollinators. 

Agency Response:

EPA implements screening, testing and research programs to gather information the Agency uses to evaluate possible endocrine effects associated with the use of a chemical. EPA takes appropriate steps to mitigate any related risks to ensure protection of public health and the environment. An overview of the Endocrine Disruptor Screening Program (EDSP) can be found at: 
https://www.epa.gov/endocrine-disruption/endocrine-disruptor-screening-program-edsp-overview  .  Penflufen has not been identified by the agency as an endocrine disruptor.

In 2014, EPA wrote risk assessment guidance for assessing pesticide risks to bees. The assessment described in this guidance relies upon some 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 as appropriate. In cases where the full battery of 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. The regulations which establish the data requirements for bee testing have not yet been put in place.  However, during this transitional time between the formalization of new data requirements and when data are available, EPA assesses the risks of pesticides to bees based on the available data. 

Based on the acute contact and acute oral honey bee toxicity studies currently available, risk to individual adult honey bees would be considered low. Based on available information, the Agency holds the position that the acute toxicity data available, combined with the relatively minimal pollinator exposure to treated seeds and negligible pesticide systemic uptake from penflufen treated seeds supports a determination that the use of this pesticide according to label directions is unlikely to adversely affect pollinator populations.  Onions and sugar beets are not considered pollinator attractive crops and are harvested prior to bloom.

Comment 6.  Place appropriate restrictions on uses to avoid and minimize adverse effects.

Agency Response:

OPP's ecological risk assessment process is based on EPA's Guidelines for Ecological Risk Assessment (https://www.epa.gov/risk/guidelines-ecological-risk-assessment) and consists of a comprehensive, robust, and peer-reviewed process that considers extensive environmental fate and ecological effects data used to evaluate the potential ecological exposure and impacts of a pesticide in the environment. This risk assessment is conducted to support the overall decision-making for the proposed pesticidal use.  Exposures and potential risks to plant and wildlife species posed by these uses are expected to be comparable or even less than the existing pesticidal uses of penflufen.  No additional restrictions are necessary.  
