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 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-

0153-0013:

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 

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 Services must assess 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 listed 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 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 
3

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 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-2013-0153-0014, the Northwest Horticultural Council (NHC) in 

EPA-HQ-OPP-2013-0153-0015, the National Potato Council (NPC) in EPA-HQ-OPP-2013-

0153-0010, and the Western Growers in EPA-HQ-OPP-2013-0153-0020:

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: 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. 
4

Information regarding inspections 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 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 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 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. 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 Chloropicrin 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-2013-0153-0017:

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 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 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 
5

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 Chloropicrin Manufacturers’ Task Force (CMTF) in EPA-HQ-OPP2013-0153-0019: 

For responses to comments submitted by the CMTF in EPA-HQ-OPP-2013-0153-0019, 

please see EFED’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.,

including 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-

0017, and by an individual, Christopher Lish, in EPA-HQ-OPP-2013-0153-0011:

For responses to comments 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-2013-0153-0011.

An additional comment from the mass campaign submitted by PANNA in EPA-HQ-OPP2013-0080-0017 and Christopher Lish in EPA-HQ-OPP-2013-0153-0011, 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. Typically, the 

alternatives to a soil fumigant like chloropicrin are other soil fumigants, as noted in a number 

of the Agency’s benefits 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 soil 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 the 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 those worker and bystander risks. The 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 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 and 

Florida Fruit and Vegetable Association (FFVA) in EPA-HQ-OPP-2013-0153-0017:

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: 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 and FFVA for the information on the ongoing fumigant research 

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