EPA Questions Asked in Consultation for the 6(a)(2) ICR:
Name: Dennis Hackett __________________, Company: Syngenta Crop Protection, Inc.
Date: March 29, 2010 __________, e-mail address: [email protected]
(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?
Syngenta uses established internal processes to collect potentially adverse effects information concerning its products. We also employ contract firms to collect adverse effects information resulting from incidents involving Syngenta products. None of this information is publicly available.
If yes, where can you find the data? (Does your answer indicate a true duplication, or does the input indicate that certain data elements are available, but that they don’t meet our data needs very well?)
(Not applicable)
(2) Frequency of Collection
Can the Agency collect the information less frequently and still produce the same outcome?
In Syngenta’s opinion, the EPA could collect adverse effects information less frequently and still have an effective process. This would be especially true in cases involving less critical information that would not be of immediate concern for health or welfare.
(3) Clarity of Instructions
a) The ICR is intended to require that respondents provide certain data so that the Agency can utilize them.
Based on the instructions (regulations, PR Notices, etc.), is it clear what you are required to do and how to submit such data? If not, what suggestions do you have to clarify the instructions?
Syngenta has a clear view of process and requirements for submission of new adverse effects information. On occasion, guidance is needed to clarify reporting requirements for unique circumstances. Access to an EPA expert or web site with detailed background is often helpful. Syngenta also utilizes internal or external legal counsel to ensure compliance with FIFRA 6a2 legal requirements.
Improved content on the EPA FIFRA 6(a)(2) web page would be very helpful, including recent FIFRA 6(a)(2) submissions and a Frequently Asked Questions section. The TSCA 8e website is a good example.
Do you understand that you are required to maintain records?
Yes
Considering that there is no required submission format, is it difficult to submit information in ways that are clear, logical and easy to complete?
Syngenta has adopted a style of submitting adverse effects information utilizing standard letter correspondence and on occasion using a formal regulatory submission for study reports. We have sought guidance from the FIFRA 6a2 Office when we have had questions. To our knowledge these practices have met with EPA’s approval.
Regarding the Voluntary Incident Reporting Forms, do you use them? Are they clear, logical, and easy to complete?
Syngenta and its agents use the Voluntary Incident Reporting Forms without any significant problem.
(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. The U.S. E.P.A. Office of Pesticide Programs has a program for electronic study submissions, and is currently developing plans for systems to support electronic incident reporting. The Agency is also concerned to protect FIFRA CBI as well as personal information.
What do you think about electronic alternatives to paper-based records and data submissions? Current electronic reporting alternatives include the use of web forms/XML based submissions via the Agency’s Internet site and magnetic media-based submissions, e.g., diskette, CD-ROM, etc. Would you be interested in pursuing electronic reporting? Are you keeping your records electronically? If yes, in what format?
Syngenta is interested in using an electronic submission process for adverse effects reports. We are currently using an electronic submission process for major active ingredient registration submissions. We have the capability to use many industry-standard technologies and we would be willing to work with the EPA to implement such a process for future reports. Currently Syngenta maintains its official adverse effects information files in a paper format. Correspondence related to new adverse effects reports is generally communicated within the company in electronic format, mostly via email. We are initiating the use of a Documentum-based document management system to store regulatory correspondence to supplement our paper records storage system.
Would you be more inclined to submit CBI on diskette, CD, or DVD, or via web rather than on paper? No
What benefits would electronic submission bring you in terms of burden reduction or greater efficiency in compiling the information?
An electronic submission process would be more efficient and ease submission of information to EPA and aid distribution of information within Syngenta. At this time we do not have plans to eliminate our paper archive, which contains the official copies of adverse effects reports required by FIFRA 6(a)(2).
Burden and Costs
Are the labor rates accurate?
The labor rates look reasonable, but no attempt was made to verify accuracy.
The Agency assumes there is no capital cost associated with this activity. Is that correct?
Yes
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.
Syngenta’s costs for administering its adverse effects reporting process are generally higher than EPA’s estimates, especially for studies. Syngenta conducts studies at several of its global R&D facilities around the world. Results from these studies are reviewed by a committee of approximately 6 to 8 scientific and technical experts familiar with adverse effects reporting obligations from around the world. This committee typically meets twice per month to discuss pending issues. Scientific and regulatory staff are involved in answering questions and preparing the notification letter to EPA. We estimate that this process takes approximately 6 to 10 hours per study to complete. EPA’s estimate of the amount of time needed to report incidents (2.1 hours) is in alignment with our experience.
Syngenta spends significant time training its staff in adverse effects reporting requirements. A typical training session takes up to 4 hours for a new employee and approximately 1 hour for bi-annual refresher training. It appears that EPA did not include the time trainees spend in training programs as a cost. The cost for Syngenta is relatively high, compared to EPA estimates, because of the large number of people that must be trained.
Are there other costs that should be accounted for that may have been missed? No
EPA Questions Asked in Consultation for the 6(a)(2) ICR:
Name _Wayne Scott________________________, Company _Clorox__________________
Date _April 9, 2010________________, e-mail address _[email protected] _____
(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?
The data the Agency seeks is generally not available from any public source, or already collected with regard to our submissions.
If yes, where can you find the data? (Does your answer indicate a true duplication, or does the input indicate that certain data elements are available, but that they don’t meet our data needs very well?)
(2) Frequency of Collection
Can the Agency collect the information less frequently and still produce the same outcome?
We believe the Agency can collect information less frequently and still produce the same outcome. Specifically, we believe information for moderate and minor incidents can be reported in 6 month intervals with no adverse impact to the program; major incidents should continue to be reported as presently required.
(3) Clarity of Instructions
a) The ICR is intended to require that respondents provide certain data so that the Agency can utilize them.
Based on the instructions (regulations, PR Notices, etc.), is it clear what you are required to do and how to submit such data? If not, what suggestions do you have to clarify the instructions?
It is clear what we are required to do with regard to data submissions.
Do you understand that you are required to maintain records?
We understand the requirement to maintain records.
Considering that there is no required submission format, is it difficult to submit information in ways that are clear, logical and easy to complete?
It is not difficult to submit information to the Agency.
Regarding the Voluntary Incident Reporting Forms, do you use them? Are they clear, logical, and easy to complete?
We do not use the Voluntary Incident Reporting Forms.
(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. The U.S. E.P.A. Office of Pesticide Programs has a program for electronic study submissions, and is currently developing plans for systems to support electronic incident reporting. The Agency is also concerned to protect FIFRA CBI as well as personal information.
What do you think about electronic alternatives to paper-based records and data submissions? Current electronic reporting alternatives include the use of web forms/XML based submissions via the Agency’s Internet site and magnetic media-based submissions, e.g., diskette, CD-ROM, etc. Would you be interested in pursuing electronic reporting? Are you keeping your records electronically? If yes, in what format?
We think electronic alternatives to paper-based records and data submissions are a good idea. We are highly interested in pursuing electronic reporting options. We do keep records electronically in both .pdf and .doc format.
Would you be more inclined to submit CBI on diskette, CD, or DVD, or via web rather than on paper?
We would be more inclined to submit CBI via the web through secure access.
What benefits would electronic submission bring you in terms of burden reduction or greater efficiency in compiling the information?
Electronic submissions would allow real time (i.e. instantaneous) submission of information for the Agency to review and yield standardized format(s) for filing.
Burden and Costs
Are the labor rates accurate?
We believe the labor rates are fairly accurately reflected.
The Agency assumes there is no capital cost associated with this activity. Is that correct? The Agency is correct to assume there is no capital cost associated with this activity.
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.
We believe the estimated burden hours and labor rates to be accurately reflected.
Are there other costs that should be accounted for that may have been missed?
There are no additional costs we feel should be accounted for.
EPA Questions Asked in Consultation for the 6(a)(2) ICR:
Name __Richard Cottrell_________, Company _ Sysco Corporation___________
Date_ __April 07, 2010_____, e-mail address __[email protected]____
(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?
No, not that I know of.
If yes, where can you find the data? (Does your answer indicate a true duplication, or does the input indicate that certain data elements are available, but that they don’t meet our data needs very well?)
(2) Frequency of Collection
Can the Agency collect the information less frequently and still produce the same outcome?
Perhaps, but the reporting frequency is not particularly burdensome to us.
(3) Clarity of Instructions
a) The ICR is intended to require that respondents provide certain data so that the Agency can utilize them.
Based on the instructions (regulations, PR Notices, etc.), is it clear what you are required to do and how to submit such data? If not, what suggestions do you have to clarify the instructions?
Yes. We use the reporting format developed by PROSAR.
Do you understand that you are required to maintain records?
Yes.
Considering that there is no required submission format, is it difficult to submit information in ways that are clear, logical and easy to complete?
No.
Regarding the Voluntary Incident Reporting Forms, do you use them? Are they clear, logical, and easy to complete?
If those are the PROSAR forms, Yes. But PROSAR completes the forms for us. So such questions should probably go to them.
(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. The U.S. E.P.A. Office of Pesticide Programs has a program for electronic study submissions, and is currently developing plans for systems to support electronic incident reporting. The Agency is also concerned to protect FIFRA CBI as well as personal information.
What do you think about electronic alternatives to paper-based records and data submissions? Current electronic reporting alternatives include the use of web forms/XML based submissions via the Agency’s Internet site and magnetic media-based submissions, e.g., diskette, CD-ROM, etc. Would you be interested in pursuing electronic reporting? Are you keeping your records electronically? If yes, in what format?
Electronic submission (e.g. pdf file attachments to e-mails) would be preferable.
We retain electronically the PROSAR reports for a period of time. PROSAR keeps them for a much longer period.
Would you be more inclined to submit CBI on diskette, CD, or DVD, or via web rather than on paper?
Via the web, using pdf file attachments to e-mails. We would merely forward the information as received from PROSAR.
What benefits would electronic submission bring you in terms of burden reduction or greater efficiency in compiling the information?
Use of electronic submission would minimize the time burden for us. However, that
time burden is not substantial at present for Sysco. Again, most of the time burden
is borne by PROSAR. They are already submitting electronically to us, so changing
the form of reporting from Sysco to the EPA would not materially affect PROSAR.
Burden and Costs
Are the labor rates accurate?
Not certain; don’t feel qualified to comment on that.
The Agency assumes there is no capital cost associated with this activity. Is that correct?
Yes.
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.
Again, don’t feel qualified to judge that. Suggest asking PROSAR those questions.
Are there other costs that should be accounted for that may have been missed?
Other than the cost of submitting the reports by Certified Mail, no other unidentified costs come to mind.
EPA Questions Asked in Consultation for the 6(a)(2) ICR:
Name John Wiegand , Company Canberra Corporation
Date April 5, 2010 , e-mail address [email protected]
(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? NOT TO OUR KNOWLEDGE
If yes, where can you find the data? (Does your answer indicate a true duplication, or does the input indicate that certain data elements are available, but that they don’t meet our data needs very well?)
(2) Frequency of Collection
Can the Agency collect the information less frequently and still produce the same outcome? CURRENT COLLECTION SCHEDULE IS ACCEPTABLE
(3) Clarity of Instructions
a) The ICR is intended to require that respondents provide certain data so that the Agency can utilize them.
Based on the instructions (regulations, PR Notices, etc.), is it clear what you are required to do and how to submit such data? If not, what suggestions do you have to clarify the instructions? INSTRUCTIONS ARE CLEAR
Do you understand that you are required to maintain records? YES
Considering that there is no required submission format, is it difficult to submit information in ways that are clear, logical and easy to complete? NO
Regarding the Voluntary Incident Reporting Forms, do you use them? Are they clear, logical, and easy to complete? YES TO BOTH.
(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. The U.S. E.P.A. Office of Pesticide Programs has a program for electronic study submissions, and is currently developing plans for systems to support electronic incident reporting. The Agency is also concerned to protect FIFRA CBI as well as personal information.
What do you think about electronic alternatives to paper-based records and data submissions? Current electronic reporting alternatives include the use of web forms/XML based submissions via the Agency’s Internet site and magnetic media-based submissions, e.g., diskette, CD-ROM, etc. Would you be interested in pursuing electronic reporting? Are you keeping your records electronically? If yes, in what format? ELECTRONIC REPORTING IS PREFERABLE, BUT WE HAVE NOT BEEN SUCCESSFUL USING XML SCEMA ON OTHER EPA eSUBMISSIONS (LABELING); WE KEEP OUR FILES IN WORD DOCUMENTS
Would you be more inclined to submit CBI on diskette, CD, or DVD, or via web rather than on paper? CD
What benefits would electronic submission bring you in terms of burden reduction or greater efficiency in compiling the information? RETRIEVING RECORDS WOULD BE AIDED SUBSTANTIALLY
Burden and Costs
Are the labor rates accurate? YES
The Agency assumes there is no capital cost associated with this activity. Is that correct? YES
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. YES
Are there other costs that should be accounted for that may have been missed?
COMMUNICATION TO AND TRAINING OF DISTRIBUTORS' RESPONSIBILITIES IS SUBSTANTIAL
| File Type | application/msword |
| File Title | EPA Questions Asked in Consultation for the 6(a)(2) ICR: |
| Author | ctsuser |
| Last Modified By | Cameo smoot |
| File Modified | 2010-07-01 |
| File Created | 2010-07-01 |