Document ID: EPA-HQ-OPP-2019-0581-0018
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2020-08-28T04:00Z

Compilation of Responses from the Consultation for the Pesticide Container-Containment Rule ICR Renewal 
                               (February 2020) 

The questions were sent to the following four industry respondents; the first two are registrants and the last two are distributors/retailers (repackagers):

 Lindsey Barnes, HSE Stewardship & Operations Manager, Syngenta: 
 Scott Warner, Bulk Manager, BASF
 David Wieties, Director, Regulatory Compliance & Engineering, Helena Agri-Enterprises 
 Rick Yabroff, Corporate EHS Manager, Land O'Lakes 

All four responded. The responses are compiled below in the same order.

A. Responses from Lindsey Barnes, Syngenta

(1) Publicly Available Data
 Is the data that the Agency seeks available from any public source, or already collected by another office at EPA or by another agency? If yes, where can you find the data?  
 
 Response: We cannot think of anything available under public sources that is required to be documented under the CCR. Everything for a refill is captured manually/electronically in site's individual systems/files. Everything created by or captured by the Syngenta is in our internal systems.

(2) Frequency of Collection 
 Can the Agency require less frequent recordkeeping and still produce the same outcome? 
 
 Response: Our assumption is that this question is directed at frequency of recordkeeping by the registrant and refillers. We don't see a possibility of capturing information less frequently, since we want to make sure we always have the most up-to-date information when requested. This helps ensure we limit the risk of data gaps. This would be true for both registrants and refillers.

(3) Clarity of Instructions   
 The ICR is intended to require that respondents keep certain records of data so that the Agency can utilize them.  

 (A) Based on the instructions (regulations, PR Notices, fact sheets, etc.), is it clear what you are required to do and what records to keep? If not, what suggestions do you have to clarify the instructions?
 
 Response: Reeducation in the ag industry is always a positive thing, due to the frequent turnover in retail management. The regulation has been out for a long time. To ensure people don't step into a new role as a location manager and not have the knowledge to comply with these rules, we suggest a training document would be helpful to manage the turnover. The retailers are nervous about misstepping in this space and are hungry for education. It is not that the regulations aren't clear, but more so that they are not in front of the retailers enough. A simple document to help new managers understand what questions to ask the registrants, and that can supplement the SEP videos created by Syngenta.
 
 (B) There is no required recordkeeping format. Does this make it difficult to comply with the requirements in the container-containment rule?  
 Response: Yes and no. It is better that there is no required format because it gives people the flexibility to capture their data how they deem appropriate. However, it would be helpful to have examples/recommendations to help clarify what is required. Since these regulations are open to interpretation, examples would help people get started on the minimum needed. This would be especially helpful for those who are more visual learners.

(4) Electronic Reporting and Record keeping 
The Government Paperwork Elimination Act requires agencies make available to the public electronic reporting alternatives to paper-based submissions by 2003, unless there is a strong reason for not doing so.  One such reason is that, at the present time, the Agency is unable to ensure the security of CBI that might be transmitted over the Internet.

 (A) What do you think about electronic alternatives to paper-based records?  
 
 Response: If a registrant or refiller has the resources and means to electronically report, we strongly agree that this is a good option. 
 
 (B) Are you keeping your records electronically?   If yes, in what format?
 
 Response: Some are electronic, some are not. Our contracts are captured in an internal electronic signature system. 
 
 Our refillers are also a mix as far as capturing electronically or on paper.

(5) Burden and Costs
 (A) Are the labor rates accurate? 
 
 Response: We don't have any information that would indicate that these rates are not accurate.
 
 (B) The Agency assumes there is no capital cost associated with this activity.  Is that correct?  
 
 Response: Correct.
 
 (C) Bearing in mind that the burden and cost estimates include only burden hours and costs associated with the paperwork involved with this ICR, e.g., the ICR does not include estimated burden hours and costs for conducting studies, are the estimated burden hours and labor rates accurate? If you provide burden and cost estimates that are substantially different from EPA's, please provide an explanation of how you arrived at your estimates.
 
 Response: Yes they are.
 
 (D) Are there other costs that should be accounted for that may have been missed?
 
 Response: Development and storage of documentation associated with United Nations authorized packaging creates a significant cost burden for pesticide registrants. These costs may be associated with either in-house testing and data maintenance or contracted to third party test labs. 
 
 B. Responses from Scott Warner, BASF
 
(1) Publicly Available Data
 Is the data that the Agency seeks available from any public source, or already collected by another office at EPA or by another agency? If yes, where can you find the data?  
 
 Response: Not that I am aware of.

(2) Frequency of Collection 
 Can the Agency require less frequent recordkeeping and still produce the same outcome? 
 
 Response: Possibly.

(3) Clarity of Instructions   
 The ICR is intended to require that respondents keep certain records of data so that the Agency can utilize them.  

 (A) Based on the instructions (regulations, PR Notices, fact sheets, etc.), is it clear what you are required to do and what records to keep? If not, what suggestions do you have to clarify the instructions?  
 
 Response: It is clear as a manufacturer is concerned.

 (B) There is no required recordkeeping format. Does this make it difficult to comply with the requirements in the container-containment rule?  
 
 Response: I believe this is good from retailer standpoint as everyone has their owns systems.

(4) Electronic Reporting and Record keeping 
The Government Paperwork Elimination Act requires agencies make available to the public electronic reporting alternatives to paper-based submissions by 2003, unless there is a strong reason for not doing so.  One such reason is that, at the present time, the Agency is unable to ensure the security of CBI that might be transmitted over the Internet.

 (A) What do you think about electronic alternatives to paper-based records? 
 
 Response:  Security of information is a concern.
 
 (B) Are you keeping your records electronically?   If yes, in what format? 
 
 Response: Excel at the plants.

(5) Burden and Costs 

Response:  I'm not really involved on this portion but do think some Distributor Partners from the AASA Board may have an opinion.  I will say I have heard no negative feedback from our Bulk Customers.

 (A) Are the labor rates accurate? 
 
 Response: N/A
 
 (B) The Agency assumes there is no capital cost associated with this activity.  Is that correct?  
 
 Response: N/A
 
 (C) Bearing in mind that the burden and cost estimates include only burden hours and costs associated with the paperwork involved with this ICR, e.g., the ICR does not include estimated burden hours and costs for conducting studies, are the estimated burden hours and labor rates accurate? If you provide burden and cost estimates that are substantially different from EPA's, please provide an explanation of how you arrived at your estimates.  
 
 Response: N/A
 
 (D) Are there other costs that should be accounted for that may have been missed? 
 
 Response: N/A
 
C. Responses from David Wieties, Helena Agri-Enterprises

(1) Publicly Available Data
 Is the data that the Agency seeks available from any public source, or already collected by another office at EPA or by another agency? If yes, where can you find the data?  
 
 Response: No, the required record keeping, inspection reports and training are not required to be submitted to any agency therefore there is no public record (data base) available.

(2) Frequency of Collection 
 Can the Agency require less frequent recordkeeping and still produce the same outcome? 
 
 Response: No, the current record keeping requirement is adequate and should not be adjusted one way or the other.

(3) Clarity of Instructions   
 The ICR is intended to require that respondents keep certain records of data so that the Agency can utilize them.  

 (A) Based on the instructions (regulations, PR Notices, fact sheets, etc.), is it clear what you are required to do and what records to keep? If not, what suggestions do you have to clarify the instructions? 
 
 Response: The rules are very clear as what record must be kept. 

 (B) There is no required recordkeeping format. Does this make it difficult to comply with the requirements in the container-containment rule?  
 
 Response: While there is no required format, the rules are clear as to what data must be collected. The fact that the format is left up to the refiller allows us to collect the data in a matter that works for each location. 

(4) Electronic Reporting and Record keeping 
The Government Paperwork Elimination Act requires agencies make available to the public electronic reporting alternatives to paper-based submissions by 2003, unless there is a strong reason for not doing so.  One such reason is that, at the present time, the Agency is unable to ensure the security of CBI that might be transmitted over the Internet. 

Response: Any electronic records maintained would be stored in house and not submitted to an agency.

 (A) What do you think about electronic alternatives to paper-based records? 
  
 Response: We use electronic means to store inspection and training documents in house.  We tried using electronic means for the tracking/record keeping (scanning bar codes) of containers and that doesn't work as well. The areas where containers are refilled are typically exposed to more harsh conditions that aren't compatible with electronics. The electronics seem to have issues (break down) which slows the refilling process and result in manual records being used.
 
 (B) Are you keeping your records electronically?   If yes, in what format? 
 
 Response: The records stored electronically are in .pdf format or stored within our Oracle data base.

(5) Burden and Costs
 (A) Are the labor rates accurate? 
 
 Response: Yes, the labor rates are accurate.
 
 (B) The Agency assumes there is no capital cost associated with this activity.  Is that correct?  
 
 Response: There is a small capital invest for tracking supplies.  Approximately $20.00 per location that refills.  300 locations x $20 = $6,000 per year
 
 (C) Bearing in mind that the burden and cost estimates include only burden hours and costs associated with the paperwork involved with this ICR, e.g., the ICR does not include estimated burden hours and costs for conducting studies, are the estimated burden hours and labor rates accurate? If you provide burden and cost estimates that are substantially different from EPA's, please provide an explanation of how you arrived at your estimates. 
 
 Response:  N/A
 
 (D) Are there other costs that should be accounted for that may have been missed? 
 
 Response: No.

D. Responses from Rick Yabroff, Land O'Lakes
 
(1) Publicly Available Data
 Is the data that the Agency seeks available from any public source, or already collected by another office at EPA or by another agency? If yes, where can you find the data?  

Response: No

(2) Frequency of Collection 
 Can the Agency require less frequent recordkeeping and still produce the same outcome? 

Response:  Collecting data every other year instead of every year will likely produce the same data.

(3) Clarity of Instructions   
 The ICR is intended to require that respondents keep certain records of data so that the Agency can utilize them.  

 (A) Based on the instructions (regulations, PR Notices, fact sheets, etc.), is it clear what you are required to do and what records to keep? If not, what suggestions do you have to clarify the instructions?

Response: The requirements are clear.

 (B) There is no required recordkeeping format. Does this make it difficult to comply with the requirements in the container-containment rule?  

Response: No.

(4) Electronic Reporting and Record keeping 
The Government Paperwork Elimination Act requires agencies make available to the public electronic reporting alternatives to paper-based submissions by 2003, unless there is a strong reason for not doing so.  One such reason is that, at the present time, the Agency is unable to ensure the security of CBI that might be transmitted over the Internet.

 (A) What do you think about electronic alternatives to paper-based records?  
 
 Response: Electronic recordkeeping tends to be more secure and transmittable to other internal resources.
 
 (B) Are you keeping your records electronically?   If yes, in what format?

Response: Some of our facilities maintain paper records and others maintain electronic records.

(5) Burden and Costs
 (A) Are the labor rates accurate? 
 
 Response: Yes. The burden hourly rates are reasonable.
 
 (B) The Agency assumes there is no capital cost associated with this activity.  Is that correct?  
 
 Response: No. Many facilities and companies install bar codes on refillable and non-refillable containers so they can scan the bar codes and collect the required information. These type of electronic scanning and recordkeeping systems are essential at large facilities because of the number of containers which are filled. They are becoming required and are expensive. This summary does not take those systems into consideration.
 
 (C) Bearing in mind that the burden and cost estimates include only burden hours and costs associated with the paperwork involved with this ICR, e.g., the ICR does not include estimated burden hours and costs for conducting studies, are the estimated burden hours and labor rates accurate? If you provide burden and cost estimates that are substantially different from EPA's, please provide an explanation of how you arrived at your estimates.
 
 Response: The estimated burden hours are not accurate. The recordkeeping requirements require more time unless it is automated and also monthly management review to ensure the data is being collected correctly. Because of turnover in employees, new employees must be trained several times per year which increases management time.
 
 (D) Are there other costs that should be accounted for that may have been missed?
 
 Response: There is a cost associated with maintaining repackaging agreements and cleaning instructions for refillers. Registrants do not always make this information readily available so management time must be spent contacting registrants to receive the required documents. Products change frequently at many facilities and retailers and wholesalers must constantly review and update repackage agreements and cleaning procedures.