Document ID: EPA-HQ-OPP-2013-0742-0015
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-09-16T04:00Z

EPA Questions Asked in Consultation for the 6(a)(2) ICR:

Name:  Nina E. Heard,			 Company: _Syngenta Crop Protection, LLC

Date:  March 12, 2014			e-mail address:   nina.heard@syngenta.com 

(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 Be 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), but we have now instituted an
electronic system as a back-up.

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 expertsfamiliar with
adverse effects reporting obligations from around the world. This
committee typically meets twice per month to   discuss pending issues.  
 Scientific and regul.  atory 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
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

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