2 risks and benefits when determining whether to cancel or restrict pesticides or chemicals used in agricultural production; and consider actual use data in the risk assessment process and not make decisions based on worst

- case as sumptions.

Response: The Agency thanks AFB for its comment on the registration review process. The Agency uses the best available data in making its decisions, which includes actual use and usage information, field studies, monitoring data, modeling, a nd information from incidents. The Agency considered both the risks and benefits of soil fumigants during the reregistration process, and those decisions were issued in 2008 and amended in 2009. During registration review of the soil fumigants, the Agency is looking at what has changed since the last assessments, how significant these changes are

, if there is a need for any new information or studies to conduct the risk assessments , and if the Agency’s regulatory position is likely to change as a result of any new information.

C omments submitted by the Center for Biological Diversity (CBD) in EPA

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1 . Comment: Under the Endangered Species Act, it is EPA’s duty to consult with the U.S. Fish and Wildlife Service and National Marine F isheries Service on the reregistration of dazomet and approval of all dazomet end

- use product labels

. In addition, the EPA must make defensible “Not Likely to Adversely Affect” and “Likely to Adversely Affect ” determinations as a prerequisite for defensibl e “Jeopardy” and “No Jeopardy” determinations. EPA and the services must assess the adverse impacts of dazomet in critical habitat.

Response: EPA plans to address many of the concerns raised in the comments from Center for Biological Diversity as part of the implementation plan for assessing the risks of pesticides to listed species based on the recommendations of the April 2013 National Academy of Sciences (NAS) report. EPA will address concerns specific to dazomet in connection with the development o f its registration review decision for dazomet

. The NAS report, available at http://www.nap.edu/catalog.php?record_id=18344 , outlines recommendations on specific scientific and technical iss ues related to the development of pesticide risk assessments that are compliant with the Endangered Species Act and the Federal Insecticide, Fungicide, and Rodenticide Act. In November, the EPA, along with the U.S. Fish & Wildlife Service (USFWS), the Nat ional 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 de veloped in response to the NAS' recommendations and reflect a common approach to risk assessment shared by the Agencies as a way of addressing scientific differences between EPA and the Services. The joint Interim Approaches were released prior to the sta keholder workshop held on November 15, 2013. EPA present ed the joint Interim Approaches at the December 2013 PPDC and SFIREG meetings, allowing additional opportunities for stakeholders to comment on the Interim Approaches. The Agencies will consider publ ic comments on the Interim Approaches prior to implementing them. The Agencies intend to jointly implement these approaches as part of a phased iterative process. EPA will refine its listed species risk assessments based on these interim approaches. The details of the joint Interim Approaches are contained in the white paper "Interim Approaches3 for National

- Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report," dated Novemb er 1, 2013, available at http://www.epa.gov/espp/2013/nas.html

. Regarding the Center for Biological Diversity's request for EPA to begin informal consultation with the Services immediately after the w orkplan for dazomet is finalized, EPA plans to follow the March 2013 stakeholder engagement paper ("Enhancing Stakeholder Input in the Pesticide Registration Review and ESA Consultation Processes and Development of Economically and Technologically Feasible Reasonable and Prudent Alternatives") to identify the appropriate time for initiation of consultation, either formal or informal, with the Services. The stakeholder engagement paper, jointly developed by the EPA, USDA, and the Services and available at http://www.regulations.gov/#!documentDetail;D=EPA

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- 0038 , allows for early interaction with the Services under informal consultation. EPA and the Se rvices acknowledge that early interaction as part of informal consultation may result in refinements to EPA's effects determinations that can improve the efficiency of the ESA compliance process. For example, EPA may involve the Services at the earliest s tages of registration review. In general, EPA plans to initiate formal ESA consultation, if necessary, at the final decision stage in the registration review process. Consulting later in the process allows the EPA to develop more refined ecological risk assessments and to engage stakeholders in discussions that should result in more focused consultation packages that may include risk mitigation for listed species.

Comments submitted by the North Carolina Department of Agriculture and Consumer Services ( NCDACS) in EPA

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1. Comment: NCDACS stated t he use of soil fumigants plays a critical role in North Carolina’s crop production. NHC stated the use of soil fu migants is critical in the Pacific Northwest’s deciduous fruit tree industry. Agricultural statistics were submitted in support of these

comments.

Response: The Agency appreciates the economic and production information and will take it into consideratio n moving forward in registration review.

2

. Comment: NCDA C S recognizes the importance of a conservative approach in evaluating new pesticides; but since soil fumigants have been registered for decades, they suggested the information gained through the e xperience of using them, the regulations, use directions, and training programs that have been developed are effective at mitigating the exposure risks. Information regarding inspections and incidents that were provided to support the current

measures are effective.

Response: The soil fumigant mitigation that went into effect in December 2012 as a result of the Agency’s reregistration eligibility decisions (REDs) were intended to reduce the risk of fumigant exposure to workers and bystanders. Incidents are only one piece of the puzzle in the Agency’s risk assessments, so field studies, monitoring data, modeling will also be4 evaluated during registration review, and the Agency’s risk conclusions and mitigation strategies will take all of this information into account. In addition, since it has only been a short time since the full suite of mitigation measures appeared o n labels in the field, the Agency does not believe the effect these measures have had on reducing risks can be adequately evaluated at this time.

Comments submitted by the Minor Crop Farmer Alliance (MCFA) in EPA

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1. Comment: The MCFA is anticipating the need to move forward with interim changes to the most current product labels to address problems that users are ex periencing.

Response: The Agency is committed to discussing progress on post

- RED label implementation whenever questions or issues arise. Please contact the active ingredient chemical review manager in the Pesticide Re

- evaluation Division who will consu lt with the fumigant review team on the appropriate path forward for any issues with labeling required by the RED

. For other label changes, please contact the appropriate Product Manager in the Registration Division.

2. Comment: The MCFA would appreciate periodic updates regarding the progress being made, and any information needs that could be supplied by its’ members.

Response: The Agency appreciates the offer for assistance with information, and will keep this in mind moving forward in the registrati on review process. The framework for registration review includes numerous opportunities for stakeholder participation at various milestones such as the preliminary work plans, preliminary risk assessments, and proposed decisions

, which will be posted to the chemical docket at www.regulations.gov. Information from external meetings on registration review cases will also be posted to the docket. For any other updates, please contact the active ingredient C hemical R eview M anager in the Pesticide Re

- evaluat ion Division.

Comments submitted by AMVAC Chemical Company (AMVAC) in EPA

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1. Comment: AMVAC will address issues related to data requirements, post

- RED implementation, and anticipated human health and environmental fate and effects assessments at a later time.

Response: The Agency appreciates AMVAC’s notice of forthcoming materials. The Agency is available to discuss any questions or concerns regarding these items as they arise. The preliminary work plan, scoping document, and p roblem formulation outline the Agency’s intention for requiring data and conducting risk assessments in registration review. Th e registration review framework provides ample opportunity for registrants, growers, and other stakeholders to have their comme nts evaluated prior to the Agency requesting data and beginning work on the risk assessments. The data call

- in is typically sent to registrants5 shortly after the issuance of the final work plan, and the clock for study submission begins at that time. Barr ing unforeseen complexities, t he Agency will maintain the registration review timeframe as listed in the final work plan.

Comments submitted by the Pesticide Action Network of North America (PANNA) and 5,645 signatories in EPA

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1. C omment: EPA should re

- evaluate levels of concern for residential and occupational handler exposure based on levels outlined in the California Review and the EPA Human Subject Review Panel.

Response: The EPA’s human health risk assessment takes into cons ideration the best available data at the time that surrounds pesticides and their use. The fumigants are a class of pesticides that have an extensive toxicological and exposure database. EPA will re

- evaluate the previously finalized residential and occup ational exposure assessments for dazomet and its degradate methyl isothiocyanate (MITC) during the registration review process if data becomes available that significantly changes the prior health and safety conclusions for use of the active ingredient, da zomet.

2. Comment: EPA should re

- evaluate buffer zones to better protect communities, especially kids, living near agricultural fields where fumigants are applied.

Response: In the REDs, the Agency used a weight of evidence approach to develop the buffer zone distances which included consideration of the hazard profile of the fumigants, information from incident reports, monitoring data, stakeholder comments along with comprehensive analysis of results from PERFUM modeling and consideration of resu lts using other models. The analysis of PERFUM results considered distances at various percentiles of the whole field and maximum distance distributions, and predicted MOEs for various distances. EPA’s goal for risk management was to achieve a buffer dis tance where associated risks were below target concentration levels at high percentiles of exposure.

In registration review, the Agency will consider any new information that becomes available, including flux studies, and will incorporate any pertinent information into the updated risk
assessments.

3. Comment: PANNA urge s EPA to develop and implement a plan to support farmers in transitioning away from the use of fumigant pesticides by 2020. PANNA is concerned about the health of communities across t he country and states there are viable alternatives to support a thriving agricultural economy.

Response: The soil fumigants have been among the most widely used pesticides in the US, and its use provides benefits to both food consumers and growers. T yp ically, the alternatives to a soil fumigant like dazomet are other soil fumigants, as noted in a number of the Agency’s benefits assessments associated with the 2008 REDs. For a comprehensive listing of the6 Agency’s soil fumigant benefits assessments, ple ase see page 17 of the 2008 dazomet reregistration eligibility decision ( http://www.epa.gov/oppsrrd1/REDs/dazomet

- red.pdf ).

While the Agency acknowledges the many benefits of soil fumigant use, it also identified potential human health risks of concern in the RED risk assessments. During an extensive public participation process, the Agency developed and proposed mitigation measures to mitigate th ose worker and bystander risks . T he new me asures were finalized in the 2009 amended soil fumigant REDs, and are now required on dazomet, chloropicrin, metam

- sodium,
metam

- potassium, and methyl bromide labels. The measures rang e from making all fumigants restri cted use, requiring Good Agricultural Practices, establishing buffer zones around fumigated fields, and requiring s ite

- specific fumigant management plans. In addition, the Agency required confirmatory data following the REDs and will include these, and as well as data required for registrati on review, in the registration review risk assessment. Through the registration review process, the Agency will revisit the mitigation measures from the REDs and update any benefits and alternatives assessments as needed

. Comments submitted by the Univ ersity of Florida (UF) in EPA

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1. Comment: UF is concerned about further increases in regulatory costs ’ , or the loss of chemical fumigants ’ , impact on the fruit and vegetable industries of Florida and other support industries. A sum mary of some UF fumigant research was provided.

Response: During the RED process EPA used field studies, monitoring data, modeling, and information from incidents to support a conclusion that these fumigants off

- gas and move away from treated fields at c oncentrations that have the potential to cause adverse effects

. The RED mitigation was developed to reduce these risks. EPA also completed numerous assessments looking at the benefits and alternatives available for a number of fumigated commodities. Usi ng all of this information, the Agency worked with stakeholders to make changes in the way soil fumigants were applied to protect bystanders while striving to maintain the important benefi ts of soil fumigants.

During registration review of the soil fumi gants, the Agency is looking at what has changed since the last risk assessments. While this includes a review of new data and policies, it also includes updated use and usage information

, incident data , and benefits information . This will include inform ation from the time

- period following the implementation of the RED mitigation. EPA thanks UF for the information on the ongoing fumigant research and plans to consider this information as we move through the registration review process.