2 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 AFBF for its comment on the registration review process. The Agency uses the best available data in maki ng 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 benefi ts 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 ch anged 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.

Comments submitted by the Center for Biol ogical Diversity (CBD) in EPA-HQ-OPP-2013-

0269-0013.

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 methyl bromide and approval of all methyl bromide 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 services must assess the adverse impacts of methyl bromide in critical habitat.

Response: EPA plans to address many of the concer ns raised in the comments from Center for Biological Diversity as part of the implementa tion plan for assessing the risks of pesticides to listed species based on the recommenda tions of the April 2013 National Academy of Sciences (NAS) report. EPA will address concer ns specific to methyl bromide in connection with the development of its registrati on review decision for methyl bromide.

The NAS report, available at http://www.nap.edu/cat alog.php?record_id=18344 , outlines recommendations on specific scientific and tech nical issues related to the development of pesticide risk assessments that are compliant with the Endangered Species Act and the Federal Insecticide, Fungicide, and Roden ticide Act. In November, the EPA, along with the U.S. Fish & Wildlife Service (USFWS), the National Mari ne Fisheries Service (NMFS) (collectively, the Services), and the U.S. Department of Agri culture (USDA), released a summary of their joint Interim Approaches for asse ssing risks to listed species from pesticides. The Interim Approaches were developed in response to the NAS’ recommendations and reflect a common approach to risk assessment shared by the Ag encies 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 Novemb er 15, 2013. EPA presente d the joint Interim Approaches at the December 2013 PPDC and SFIREG meetings, allowing additional opportunities for stakeholders to comment on th e Interim Approaches. The Agencies will consider public comments on the Interim A pproaches prior to implementing them. The Agencies intend to jointly implement these appro aches as part of a phased iterative process. EPA will refine its listed species risk assessm ents based on these interim approaches. The details of the joint Interim Approaches are c ontained in the white pape r “Interim Approaches for National-Level Pesticide Endangered Species Act Assessments Based on the3 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 Bi ological Diversity’s request for EPA to begin informal consultation with the Services immediately after the workplan for methyl bromide is finalized, EPA plans to follow the March 2013 stakeholder engagement paper (“Enhancing Stakeholder Input in the Pesticide Regist ration Review and ESA Consultation Processes and Development of Economically and Technologically Feasible Reasonable and Prudent Alternatives”) to identify the appropriate time for initiation of co nsultation, 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-OPP2012-0442-0038 , allows for early interaction with th e Services under informal consultation. EPA and the Services acknowledge that early inte raction as part of in formal consultation may

result in refinements to EPA’s effects determin ations that can improve the efficiency of the ESA compliance process. For example, EPA may involve the Services at the earliest stages of registration review. In general, EPA pl ans to initiate formal ESA consultation, if necessary, at the final decision st age in the registration review pr ocess. Consulting later in the process allows the EPA to develop more refine d 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-HQ-OPP-2013-0269-0014, the Nort hwest Horticultura l Council (NHC) in EPA-HQ-OPP-2013-0269-0016, and the National Po tato Council (NPC) in EPA-HQ-OPP-2013-

0269-0010.

1. Comment: NCDACS stated the use of soil fumigants pl ays a critical role in North Carolina’s crop production. NHC stated the use of soil fumi gants is critical in the Pacific Northwest’s deciduous fruit tree industry. NPC stated the use of soil fumig ants is indispensable to the commercial potato growers in the United States. Agricultural statistic s were submitted in support of these comments.

Response: The Agency appreciates the economic a nd production information and will take it into consideration moving forw ard in registration review.

2. Comment: NCDACS 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 experience of us ing them, the regulations, use directions, and training programs that have been developed are effective at mitigating the exposure risks. Information regarding inspecti ons and incidents were prov ided to support the current measures are effective.

Response: The soil fumigant mitigation measures 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 bysta nders. Incidents are only one piece of the
puzzle in the Agency’s risk assessments, so fi eld studies, monitoring data, modeling will also4 be evaluated during registration review, and th e 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 in labels in the field, the
Agency does not believe the effect these measur es have had on reducing exposure risks can be
adequately evaluated at this time.

Comments submitted by the Minor Crop Farm er Alliance (MCFA) in EPA-HQ-OPP-2013-0269- 0020 and Florida Fruit and Vegetable Asso ciation (FFVA) in EPA-HQ-OPP-2013-0269-0017.

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 labeling specified
by the RED. For other label changes, please co ntact the appropriate Product Manager in the
Registration Division.

2. Comment: The MCFA and FFVA would appreciate peri odic 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 registra tion review process. The framework for registration review includes m ilestones such as the final wo rk plans, preliminary risk assessments, and proposed decisions which w ill be posted to the chemical docket at www.regulations.gov. Information from external meetings on registra tion review cases will also be posted to the docket. For any othe r updates, please contact the active ingredient Chemical Review Manager in the Pesticide Re-evalu ation Division.

Comments submitted by the Methyl Bromide Industry Panel (MBIP) in EPA-HQ-OPP-2013- 0269-0015 (Pre-Plant Soil Uses)

1. Comment: MBIP urges EPA to consider whether scarce Agency resources should be expended over the next 7 years to re-evaluate the soil uses of methyl bromide when those uses have just been through the reregistration process and will continue to dwindle in the next few years. By the time EPA anticipates completing the registration review process, all non-QPS soil uses will likely have ceased. The MBIP requ ests that EPA reconsider its decision to initiate registration review with regard to the soil uses of methyl bromide.

Response: The Agency appreciates the concern fo r Agency resources. During registration review the Agency intends to evaluate all uses th at are registered at the time of the preparation

of the risk assessments. If uses cease and no longer appear on product labels prior to the preparation of the Agency’s assessments, they will not be included in the assessments.5 2. Comment: Reregistration was completed very recently and applicators and growers are still getting accustomed to the new requirements. It is premature to evaluate the effect of the new labels on the registrants, applicators, and growers and to provide comments on label implementation issues, but will promptly bri ng any issues to the Agency’s attention

.

Response: Since it has only been a short time si nce the full suite of mitigation measures appeared on labels in the field in December 2012, the Agency understands that the effect these measures have had on registrants, applicators, and growers may not be adequately evaluated at this time. However, the Agency is committe d to discussing post-RED label implementation whenever questions or issues arise. Please contact the active ingredient Chemical Review Manager in the Pesticide Re-evaluation Divisi on who will consult with the fumigant review team on the appropriate path forward for any issues with labeling specified by the TRED.

3. Comment: The ambient air monitoring data requirement (GDCI-053201-836) is mischaracterized as requiring ambient air m onitoring near commodity fumigation sites. Until such time as EPA issues a new DCI for monitoring studies for post-harvest commodity or structural uses, there is no legal obligati on for the registrants to conduct such studies.

Response: The Agency’s position as stated in the PWP remains unchanged. As we have explained previously, the Agency has concerns regarding the potential for community-based methyl bromide exposures to cause unreasonable adverse effects. Th e required ambient air monitoring data are expected to represent exposures to methyl bromide from all sources, including facilities that freque ntly use methyl bromide for commodity treatments. To date, MBIP has not provided any information that ha s dispelled the Agency’s concerns regarding human exposure to methyl bromide.

As the Agency has developed this plan for regi stration review of methyl bromide, we have determined that ambient air monitoring data from representative locations in Siskiyou County, CA, Georgia forestry nurseries, and th e Maritime Exchange Region for the Delaware River and Bay are necessary for the human health risk assessment for all registered uses.

Comments submitted by the Methyl Bromide Industry Panel (MBIP) in EPA-HQ-OPP-2013- 0269-0015 (Post Harvest Uses)

1. Comment: Reregistration of methyl bromide for pos t-harvest commodity uses is not yet complete. Given the remaining steps in this pr ocess, it is premature at this time to comment on the impact those label changes may have on a pplicators and commodity owners. However, as the Registration Review process moves fo rward, those impacts may come to light and should be considered by the Agency

.

Response: The Agency acknowledges the recent e fforts of the MBIP, registrants, and applicators to update the label language fo r post-harvest methyl bromide products to incorporate risk mitigation measures identified in the 2006 Tolerance Reassessment and Risk Management Decision (TRED). The February 12, 2014 agreement on the post-harvest label table language was a key milestone in achievi ng real world protections for workers and bystanders. As revised labels are approved and introduced into the field for use, the Agency6 is committed to discussing post-TRED label im plementation whenever questions or issues arise. Please contact the active ingredient Ch emical Review Manager in the Pesticide Reevaluation Division who will consult with the fu migant review team on the appropriate path forward for any issues with labeling specified by the TRED. For other label changes, please contact the appropriate Product Mana ger in the Registration Division.

Comments submitted by the University of Florida (UF) in EPA-HQ-OPP-2013-0269-0019 and Florida Fruit and Vegetable Asso ciation in EPA- HQ-OPP-2013-0269-0017

1. Comment: UF is concerned about further increases in regulatory costs’, or the loss of chemical fumigants’, impact on the fruit and vege table industries of Fl orida and other support industries. A summary of some UF fumigant research was provided. FFVA provided similar comments and endorsed those submitted by UF.

Response: The Agency acknowledges UF’s concer n, as the mitigation from the REDs was comprehensive. There are costs associated wi th some of these measures, and many growers needed to make modifications to their app lication practices. Howe ver, field studies, monitoring data, modeling, and information from incidents support a conclusion that these fumigants off-gas and move away from treated fiel ds at concentrations th at have the potential to cause adverse effects. The RED mitigation wa s developed to reduce these risks. Given the widely recognized benefits of soil fumigants the Agency worked with stakeholders to make amendments to maintain the important protecti ons for bystanders but in crease feasibility and flexibility, and reduce some of th e impacts of buffers on the benefi cial uses of soil fumigants.

During registration review of the soil fumigant s, 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, and incident da ta. This will include information from the time-period following the implementation of the RED mitigation.