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Comments submitted by the Almond Board of California in EPA-HQ-OPP-2013-0156-0012 

1. Comment: The Almond Board of California submitted information on the almond 

industry/market and the use of PPO to treat almonds for microbial contamination and insect 

pests, including details on the treatment process, rates, and available alternatives.

Response: The Agency thanks the Almond Board of California for this information and will 

consider it during the registration review process. 

Comments submitted by the American Farm Bureau (AFB) in EPA-HQ-OPP-2013-0156-0008 

1. Comment: The EPA should base its implementation of FIFRA on credible scientific 

information; test pesticides based on realistic levels of exposure or consumption; consider the 

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 American Spice Trade Association (ASTA) in EPA-HQ-OPP-2013-

0156-0014 

1. Comment: McDermott, Will & Emery submitted comments on behalf of the ASTA, 

emphasizing the importance of PPO to prevention of pests and microbial contaminants in 

spices; expressing concern regarding the potential impact of data requirements on the 

continued availability of PPO for use on spices; and the intention of ASTA to be involved in 

the registration review process, including participating in a focus meeting to confirm use 

practices. 

Response: The Agency thanks the ASTA for their comment on the spice uses of PPO. A 

focus meeting was held on May 2, 2013 before the docket opened with the PPO registrant 

ABERCO and stakeholders to discuss the upcoming registration review process, anticipated 

data needs, clarification of label uncertainties, current use patterns, and treatment methods. A 

summary of the meeting is available in the docket at EPA-HQ-OPP-2013-0156-0015. Focus 

meetings can be held at any time in the registration review process. 
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Comments submitted by the Minor Crop Farmer Alliance (MCFA) in EPA-HQ-OPP-2013-0156-

0009 

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 active ingredient chemical review manager in the Pesticide Reevaluation Division. 

Comments submitted by Physicians Committee for Responsible Medicine in EPA-HQ-OPP2013-0156-0010 

1. Comment: PCRM commented that with regard to the acute inhalation toxicity study, in vitro 

models using nasal epithelial cells, while not available commercially, may provide a potential 

human-relevant model with which to investigate the non- lethal effects of PPO... Multiple nonanimal airway models exist... Because of established techniques for air-liquid interface (ALI) 

exposure, it is possible to understand the dosimetry of the cells in a way that would mimic very 

closely the dose that might be seen in actual human exposure situations. Airway epithelial 

cells grown at the ALI retain many of the characteristics found in vivo; these models and 3-D 

tissues such as the examples provided above may be able to provide the mechanistic 

information or histopathological observations that the Agency is interested in receiving. A 

comparison of such in vitro results with in vivo results obtained in tests with PPO or 

mechanistically-similar airborne chemicals could provide a “weight-of-evidence” estimate of 

doses at which key nonlethal effects are seen.” Further, a read across strategy with ethylene 

oxide (ETO) or other structurally or mechanistically similar chemical should be considered.

Response: The requirement of a special acute inhalation study was based on a weight of 

evidence (WOE) approach. Inhalation is the primary route of exposure and there is a lack of 

non-lethal histopathology data (respiratory tract). Therefore, the special acute inhalation 

study would include respiratory tract histology, glutathione (GSH) measurements (i.e., nose) 
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and kinetics/tissue dosimetry (time course) that would directly inform the acute occupational 

and residential bystander assessments. Although the guidelines have not formally adopted in 

vitro methods, the registrant has the option of submitting to the Agency and the HED Hazard 

and Science Policy Council (HASPOC) an alternative approach/method that would 

specifically address all of the acute inhalation study data requirements. 

While a read across strategy was suggested, the Agency wants to clarify that the special acute 

inhalation toxicity study is different from the standard acute inhalation toxicity study which 

measures lethality (LC50). Special acute inhalation studies have been required of all the 

commodity and soil fumigants. The parameters being requested for the special acute 

inhalation toxicity study are not included as measurements in any of the current acute 

inhalation toxicity studies, including those for ETO. If the registrant wishes to submit a formal 

waiver request citing other data with all pertinent worker and bystander exposure information, 

then the HASPOC would consider this additional information for a weight-of-evidence 

determination. 

Comments submitted by the University of Florida (UF) in EPA-HQ-OPP-2013-0156-0013 

1. Comment: UF is concerned about the impact of further increases in regulatory costs or the 

loss of chemical fumigants 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 soil fumigants off-gas and move away 

from treated fields at concentrations that have the potential to cause adverse effects. The RED 

mitigation for the soil fumigants 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, structural, and commodity fumigants, the Agency is 

considering what has changed since the last risk assessments and will apply the same process 

to reach a regulatory decision. While this includes a review of new data and policies, it also 

includes updated use and usage information, incident data, and benefits information. 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.