2 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 al monds 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 regist ration 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 bas ed on realistic levels of exposur e or consumption; consider the risks and benefits when determini ng 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 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 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 Tr ade 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 preventio n of pests and microbial contaminants in spices; expressing concern regarding the pot ential impact of dat a 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 par ticipating in a focus m eeting 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 th e docket opened with the PPO registrant ABERCO and stakeholders to discuss the upcom ing registration review process, anticipated data needs, clarificati on of label uncertainties, current us e 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.3 Comments submitted by the Minor Crop Farm er 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 pr oblems 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 co ntact 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 registra tion review process. The framework for registration review includes numerous opportunities for stakehol der 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 ca ses will also be posted to the docket. For any other updates, please contact activ e 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 epit helial cells, while not av ailable 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 estab lished techniques for air-liquid interface (ALI) exposure, it is possible to understand the dosime try 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 char acteristics found in vivo; these models and 3-D tissues such as the examples provided abov e 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 “wei ght-of-evidence” estimate of doses at which key nonlethal effe cts are seen.” Further, a read across strategy with ethylene oxide (ETO) or other structural ly or mechanistically similar chemical should be considered.

Response: The requirement of a special acute i nhalation study was based on a weight of evidence (WOE) approach. Inhala tion is the primary route of e xposure and there is a lack of non-lethal histopathology data (r espiratory tract). Therefore, the special acute inhalation study would include respir atory tract histology, gl utathione (GSH) measurements (i.e., nose)4 and kinetics/tissue dosimetry ( time course) that would directly inform the acute occupational and residential bystander assessments. Although th e 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 diffe rent from the standard acute inhalation toxicity study which measures lethality (LC 50 ). Special acute inhalation studies have been required of all the commodity and soil fumigants. The paramete rs being requested for the special acute inhalation toxicity study are not included as measurements in any of the current acute inhalation toxicity studies, incl uding those for ETO. If the regist rant wishes to submit a formal waiver request citing other data with all pert inent worker and bystander exposure information,

then the HASPOC would consider this additio nal 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 im pact of further increases in regulatory costs or the loss of chemical fumigants on the fruit and vegetable industrie s 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 conclu sion 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 info rmation, the Agency worked with stakeholders to make changes in the way soil fumigants were applied to protect bysta nders while striving to maintain the important benefits of soil fumigants.

During registration review of the soil, structur al, and commodity fumigants, the Agency is considering what has changed since the last ri sk assessments and will apply the same process to reach a regulatory decision. While this includ es a review of new data and policies, it also includes updated use and usage information, inci dent data, and benefits information. EPA thanks UF for the information on the ongoing fumi gant research and plans to consider this information as we move through th e registration review process.