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 assumptions. 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, and 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 t here is a need for any new information or studies to conduct updated 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 EP A - HQ - OPP - 2013 - 0153 - 00 1 3 : 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 Fisheries Service on the reregistration of chloropicrin and approval of all chloropicrin 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 defensible “Jeopardy” and “No Jeopardy” determinations. EPA and the S ervices must asse ss the adverse impacts of chloropicrin 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 liste d species based on the recommendations of the April 2013 National Academy of Sciences (NAS) report. EPA will address concerns specific to chloropicrin in connection with the development of its registration review decision for chloropicrin . The NAS repo rt, available at http://www.nap.edu/catalog.php?record_id=18344 , outlines recommendations on specific scientific and technical issues 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 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 in response to the NAS' recommendations and reflect a commo n 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 stakeholder workshop held on November 15, 2013. EPA present ed the join t 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 public comments on the Interim Approaches prior to implementing them. The3 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 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, 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 workplan for chloropicrin is finalized, EPA plans to follow the March 2 013 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 appropriat e 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 - HQ - OPP 2012 - 0442 - 0038 , allows for early interaction with the Services under informal consultation. EPA and the Services acknowledge that early interaction as part of informal consultation may result in refinements to EPA's effects determinations that can improve the effi ciency of the ESA compliance process. For example, EPA may involve the Services at the earliest stages 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 spe cies. Comments submitted by the North Carolina Department of Agriculture and Consumer Services (NCDACS) in EPA - HQ - OPP - 2013 - 0153 - 001 4 , the Northwest Horticultural Council (NHC) in EPA - HQ - OPP - 2013 - 0153 - 001 5 , the National Potato Council (NPC) in EPA - HQ - OPP - 2013 - 0153 - 00 10 , and the Western Growers in EPA - HQ - OPP - 2013 - 0153 - 00 20 : 1 . Comment: NCDACS stated the use of soil fumigants plays a critical role in North Carolina’s crop production. NHC stated the use of soil fumigants is critical in the Pacific Northwest’s deciduous fruit tree industry. NPC stated the use of soil fumigants is indispensable to the commercial potato growers in the United States. Agricultural statistics were submitted in support of these comments . Western Growers stated the use of chloropicrin as a critical tool for the specialty crop sector, and stated its support the current mitigation measures on labels and for continued use. Response: The Agency appreciates the economic and production information and will take it into consideration 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 regis tered for decades, they suggested the information gained through the experience of using them, the regulations, use directions, and training programs that have been developed are effective at mitigating the exposure risks.4 Information regarding inspection s and incidents 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, and modeling will also be evaluated during registration review, and the Agency’s risk con clusions 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 in labels in the field, the Agency does not believe the effect these me asures have had on reducing exposure can be adequately evaluated at this time. 3. Comment: Western Growers provided comments on reports from California Department of Pesticide Regulation regarding the carcinogenic effects of chloropicrin. Response: The Agency uses the best available data in making its risk management decisions . 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 r egistration 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 updated risk assessments, and if the Agency’ s regulatory position is likely to change as a result of any new information. Please see the response to comment 3 regarding the carcinogenicity of chloropicrin in The Health Effects Division’s Response to Pesticide Action Network North America on the Chlo ropicrin Registration Review Scoping Document for Human Risk Assessment. Comments submitted by the Minor Crop Farmer Alliance (MCFA) in EPA - HQ - OPP - 2013 - 0153 - 0016 and Florida Fruit and Vegetable Association (FFVA) in EPA - HQ - OPP - 2013 - 0153 - 001 7 : 1 . Comment: The MCFA and FFVA are anticipating the need to move forward with interim changes to the most current product labels to address problems that users are experiencing . 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 consult with the fumigant review team on the appropriate path forward for any issues with labe ling required by the RED . For other label changes, please contact the appropriate Product Manager in the Registration Division. 2. Comment: The MCFA and FFVA would appreciate periodic updates regarding the progress being made, and any information needs t hat 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 registration review process. The framework for registration review includes milestones suc h as the final work plans, preliminary risk5 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 an y other updates, please contact the active ingredient chemical review manager in the Pesticide Re - evaluation Division. Comments submitted by the Chloropicrin Manufacturers’ Task Force (CMTF) in EPA - HQ - OPP 2013 - 0153 - 00 19: For responses to c omments submitted by the CMTF in EPA - HQ - OPP - 2013 - 0153 - 00 19, please see EFE D’s Response to Comments on the Chloropicrin Problem Formulation for Registration Review . Comments submitted by the Pesticide Action Network of North America (PANNA) , et al . , inclu ding signatures from representatives in 34 organizations in EPA - HQ - OPP - 2013 - 0153 - 0018 , from a mass campaign of 5,645 signatures submitted by PANNA in EPA - HQ - OPP - 2013 - 0080 - 001 7, and by an individual, Christopher Lish , in EPA - HQ - OPP - 2013 - 0153 - 00 1 1: For resp onses to c omments submitted by PANNA , et al. , in EPA - HQ - OPP - 2013 - 0153 - 0018 , please see The Health Effects Division’s Response to Pesticide Action Network North America on the Chloropicrin Registration Review Scoping Document for Human Risk Assessment . This memorandum also addresses comments from the mass campaign submitted by PANNA in EPA - HQ - OPP - 2013 - 0800 - 0017 and Christopher Lish in EPA - HQ - OPP - 2013 - 0153 - 001 1 . An a dditional c omment from the mass campaign submitted by PANNA in EPA - HQ - OPP 2013 - 0080 - 001 7 and C hristopher Lish in EPA - HQ - OPP - 2013 - 0153 - 00 1 1 , not addressed in the Health Effects Division’s response to comments is addressed below : 1 . Comment: PANNA and Mr. Lish urge EPA to develop and implement a plan to support farmers in transitioning away from the use of fumigant pesticides by 2020. PANNA and Mr. Lish are concerned about the health of communities across the country and state that 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 their use provides benefits to both food consumers and growers. T ypically, the alternatives to a soil fumigant like chloropicrin are other soil fumigants, as noted in a number of the Agency’s benef its assessments associated with the 2008 REDs. However, PANNA and Mr. Lish are correct that non - chemical alternatives are being explored and developed as has been noted in the critical use exemption responses to the methyl bromide phase - out. Anaerobic so il disinfestation (ASD), soil substrate amendments, steam treatment, and others have potential for replacing some portion of currently fumigated land. For a comprehensive listing of the Agency’s soil fumigant benefits assessments, please see page 22 of th e 2008 chloropicrin reregistration eligibility decision ( http://www.epa.gov/oppsrrd1/REDs/chloropicrin - red.pdf ).6 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 measures were finalized in the 2009 amended soil fumigant REDs, and are now required on chloropicrin , dazomet, metam - sodium, metam - potassium, and methyl bromide labels. The measures rang e from making all fumigants restri cted use, requiring Good Agricultural Pract ices, establishing buffer zones around fumigated fields, and requiring site - 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 registration rev iew, 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 Universit y of Florida (UF) in EPA - HQ - OPP - 2013 - 0244 - 0014 and Florida Fruit and Vegetable Association (FFVA) in EPA - HQ - OPP - 2013 - 0153 - 001 7 : 1 . Comment: UF is concerned about further increases in regulatory costs , or the loss of chemical fumigants , impact on the fruit and veget able industries of Florida and other support industries. A summary of some UF fumigant research was provided. FFVA provided similar comments and endorsed those submitted by UF. 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 concentrations 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. Using all of this information, the Agency worked with stakeholders to make changes in the way soil f umigants were applied to protect bystanders while striving to maintain the important benefi ts of soil fumigants. During registration review of the soil fumigants, 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 information from the time - period following the implementation of the RED mitigation. EPA thanks UF and FFVA for the information on the ongoing fumigant research and plans to consider this information as we move through the registration review process.