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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 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 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 Biological 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 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 methyl bromide in connection 

with the development of its registration review decision for methyl bromide.

The NAS report, 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 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 stakeholder workshop held on November 15, 2013. EPA presented 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 public 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 Approaches 

for National-Level Pesticide Endangered Species Act Assessments Based on the 
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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 methyl bromide 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-HQ-OPP2012-0442-0038, 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 efficiency 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 species.

Comments submitted by the North Carolina Department of Agriculture and Consumer Services 

(NCDACS) in EPA-HQ-OPP-2013-0269-0014, the Northwest Horticultural Council (NHC) in 

EPA-HQ-OPP-2013-0269-0016, and the National Potato Council (NPC) in EPA-HQ-OPP-2013-

0269-0010. 

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. 

Response: The Agency appreciates the economic and production information and will take it 

into consideration moving forward 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 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 were provided 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 bystanders. Incidents are only one piece of the 

puzzle in the Agency’s risk assessments, so field studies, monitoring data, modeling will also 
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be 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 in labels in the field, the 

Agency does not believe the effect these measures have had on reducing exposure risks can be 

adequately evaluated at this time. 

Comments submitted by the Minor Crop Farmer Alliance (MCFA) in EPA-HQ-OPP-2013-0269-

0020 and Florida Fruit and Vegetable Association (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 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 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 registration review process. The framework for 

registration review includes milestones such as the final 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 

Chemical Review Manager in the Pesticide Re-evaluation 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 requests that EPA reconsider its decision to 

initiate registration review with regard to the soil uses of methyl bromide. 

Response: The Agency appreciates the concern for Agency resources. During registration 

review the Agency intends to evaluate all uses that 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. 
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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 bring any issues to the Agency’s attention.

Response: Since it has only been a short time since 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 committed to discussing 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 TRED. 

3. Comment: The ambient air monitoring data requirement (GDCI-053201-836) is 

mischaracterized as requiring ambient air monitoring 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 obligation 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. The required ambient air 

monitoring data are expected to represent exposures to methyl bromide from all sources, 

including facilities that frequently use methyl bromide for commodity treatments. To date, 

MBIP has not provided any information that has dispelled the Agency’s concerns regarding 

human exposure to methyl bromide. 

As the Agency has developed this plan for registration review of methyl bromide, we have 

determined that ambient air monitoring data from representative locations in Siskiyou 

County, CA, Georgia forestry nurseries, and the 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 post-harvest commodity uses is not yet 

complete. Given the remaining steps in this process, it is premature at this time to comment 

on the impact those label changes may have on applicators and commodity owners. However, 

as the Registration Review process moves forward, those impacts may come to light and 

should be considered by the Agency.

Response: The Agency acknowledges the recent efforts of the MBIP, registrants, and 

applicators to update the label language for 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 achieving real world protections for workers and 

bystanders. As revised labels are approved and introduced into the field for use, the Agency 
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is committed to discussing post-TRED label implementation whenever questions or issues 

arise. Please contact the active ingredient Chemical Review Manager in the Pesticide Reevaluation Division who will consult with the fumigant 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 Manager in the Registration Division. 

Comments submitted by the University of Florida (UF) in EPA-HQ-OPP-2013-0269-0019 and 

Florida Fruit and Vegetable Association 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 vegetable 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: The Agency acknowledges UF’s concern, as the mitigation from the REDs was 

comprehensive. There are costs associated with some of these measures, and many growers 

needed to make modifications to their application practices. However, field studies, 

monitoring data, modeling, and information from incidents 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. Given the 

widely recognized benefits of soil fumigants the Agency worked with stakeholders to make 

amendments to maintain the important protections for bystanders but increase feasibility and 

flexibility, and reduce some of the impacts of buffers on the beneficial uses 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, and incident data. This will include information from the 

time-period following the implementation of the RED mitigation.