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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 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. 

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

0080-0011

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 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 defensible “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 of 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 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 
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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 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-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-2013-0080-0012 and the Northwest Horticultural Council (NHC) 

in EPA-HQ-OPP-2013-0269-0016

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. 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 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 be 
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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 on 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-HQ-OPP-2013-0080-

0013

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 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 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 registration 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 Chemical Review Manager in the Pesticide 

Re-evaluation Division.

Comments submitted by AMVAC Chemical Company (AMVAC) in EPA-HQ-OPP-2013-0080-

0016

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 problem formulation outline the Agency’s 

intention for requiring data and conducting risk assessments in registration review. The 

registration review framework provides ample opportunity for registrants, growers, and other 

stakeholders to have their comments evaluated prior to the Agency requesting data and 

beginning work on the risk assessments. The data call-in is typically sent to registrants 
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shortly after the issuance of the final work plan, and the clock for study submission begins at 

that time. Barring unforeseen complexities, the 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-HQ-OPP-2013-0080-0017

1. Comment: 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 consideration 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 occupational 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, dazomet.

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 results 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 distance 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 urges 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 the 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. Typically, 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 the 
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Agency’s soil fumigant benefits assessments, please 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 those worker and bystander risks. The new measures 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 range from making all 

fumigants restricted use, requiring Good Agricultural Practices, 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 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 University of Florida (UF) in EPA-HQ-OPP-2013-0244-0014

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.

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 fumigants were applied to protect bystanders while striving to 

maintain the important benefits 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 for the information on the ongoing fumigant research and plans to 

consider this information as we move through the registration review process.