From: Frederick Betz <fbetz@agraquest.com> 

To: Robert Forrest/DC/USEPA/US@EPA, "bstoneman@biopesticideindustryalliance.org" 

<bstoneman@biopesticideindustryalliance.org> 

Cc: "Olav <omesserschmidt@comcast.net> (omesserschmidt@comcast.net)"

 <omesserschmidt@comcast.net>, "Sue MacIntosh <macintosh.associates@me.com> 

(macintosh.associates@me.com)" <macintosh.associates@me.com> 

Date: 02/09/2012 09:31 AM 

Subject: RE: Consultation process for the New and Amended Registration ICR 

Rob,   

  

On behalf of the Biopesticide Industry Alliance (BPIA) ‐ here's our response and input on the ICR

Attachment G.   

  

Please note ‐ this response is the combined input of 3 BPIA members and the document has been

shared with the BPIA Regulatory Committee (and Bill Stoneman) for their input.  So, I am wondering if

the more appropriate point of contact to be listed would be Bill Stoneman, BPIA Executive Director – as

indicated below.    Bill are you OK with this?  

  

Bill Stoneman | BPIA | Executive Director | PO Box 465, McFarland, WI  53558 ‐ 0465 | Ph: (202) 536‐

4602 | e‐mail: bstoneman@biopesticideindustryalliance.org | http://biopesticideindustryalliance.org

  

Best Regards,

Fred  

  

Frederick S. Betz

Director of Global Regulatory Affairs

AgraQuest, Inc.

Better food.  Better world.

922 Melvin Road, Annapolis, MD 21403, U.S.A.

+1 (410) 268‐0015

fbetz@agraquest.com  

www.agraquest.com
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OMB Control Number 2070-0060; EPA ICR Number 0277.15

ICR ATTACHMENT G

Consultation Questions

1. Publicly Available Data

(1) Is the data that the Agency seeks available from any public source or already

collected by another office at EPA or by another agency? 

In some instances (such as commodity chemicals that are widely used for a variety of purposes), 

certain data may be available in the public literature. However for the most part, such 

information is not available publically or collected by another agency. 

(2) If yes, where can you find the data? 

Public literature, MSDS, chemical manufacturer of commodity chemicals, government and 

university databases. 

2. Frequency of Collection

Can the Agency collect the information less frequently and still produce the same outcome? 

No. Studies and information for new and amended registrations are generally submitted once to 

fulfill data requirements; EPA keeps the data on file (MRIDs) and the registrant can cite the 

MRID in future as needed (e.g., for another new registration or amendment of the same 

product/active ingredient). 

3. Clarity of Instructions

 (1) The ICR is intended to require that respondents provide certain data so that the

Agency can utilize them.

(a) Based on the instructions (regulations, PR Notices, etc.), is it clear what you are 

required to do and how to submit the data? 

Generally yes, but there is significant room for improvement and more detailed guidance. 

(b) If not, what suggestions do you have to clarify the instructions? 

List out and discuss status and progress to initiate / complete process improvements. Update and 

publish (on website) existing checklists; compile additional checklists as needed. Update and 

complete the DER templates; publish on EPA website. Evaluate role of Ombudsman and how

the position might add further value. Update EPA website and review organization to make 

more user friendly. 

 (2) Do you understand that you are required to maintain records? YES

 (3) Considering that there is no required submission format, is it difficult to submit information 

in ways that are clear, logical and easy to complete? 

There is a required submission format – set forth in PR Notice 2011-3. There are GLP 

regulations that address specific formatting requirements for studies submitted to fulfill data 

requirements for registrations and amendments. DER and waiver templates, etc. most of which is 
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guidance – some required. Most requirements for formatting are published, but not all; making 

specific, user-friendly formatting requirements (guidance) would be very helpful.

 (4) Regarding the any [specific program] forms, do you use them? YES. Are they clear, 

logical, and easy to complete? Can be challenging and many issues often arise. CSF for

example. EPA – Industry CSF workgroup has recently updated and upgraded the documents and 

likely much improved. It would be great if all forms could be available in MS Word format.

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.

(1) What do you think about electronic alternatives to paper-based records and data 

submissions? Full electronic submissions are long overdue and much needed. 

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? YES. Are you keeping your records electronically? Yes for company 

internal records – that we also submit in paper. If yes, in what format? Various 

formats – but ultimately all documents saved as PDF (searchable if possible).

(2) Although the Agency does not offer an electronic reporting option for CBI-related 

data at this time, would you be more inclined to submit CBI on diskette than on 

paper? YES if a secure option were available. And options MUST be out there –

given all the secure information that flows over the internet. Not being able to 

transmit electronically is a significant and unnecessary burden on information 

collection. The Canadian PMRA has successfully used electronic submissions for 

years. It would be useful to learn what is liked and not liked with the PMRA system. 

(3) What benefits would electronic submission bring you in terms of burden reduction or 

greater efficiency in compiling the information? Ease and speed of initial 

submission. Durable and easily transmitted record. Ease and speed to discuss, 

update, revise and resend to Agency. Saves significant time and money for both 

sides. 

5. Burden and Costs

(1) Are the labor rates accurate? NO. The rates are too low – total costs about half of 

typical. Current regulatory consultants charge at least $150 - $250/hr that would cover 

both the Management and Technical (Table 1-B). Clerical may be fine. The number of 

hours are also close to what is required at 194.Consultant experience indicates a 

minimum of 160 hrs is required for an entire package, including oversight of all 

regulatory studies. 160 hours is a reasonable estimate for a microbial because there are 

likely to be many requirements that warrant “waiver requests” (satisfaction of data 

requirement by rationale/literature). but at least 50% more time (240 hours) should be 
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the time estimate for a biochemical product (Type A). Also, 4 hours management time 

to compile a label (de novo) is substantially underestimated. The time required is 

typically closer to 30 to 40 hours.

(2) The Agency assumes there is no capital cost associated with this activity. Is that 

correct? NO. At a minimum, there must be office space, regardless if it is a company or 

a regulatory consultant working from home, an office is required. If a company generates 

its own product chemistry data – that requires a laboratory; equipped to do work in 

accordance with GLP – which is a significant additional investment beyond normal lab 

operations. That said it’s understood that the latter capital cost (laboratory) is out of the 

scope considered in this question. 

(3) 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. From above, item (5.1), the 160 to 240 hrs is not CONDUCTING a 

study, but all the paperwork and oversight required to conduct a study. The 160 to 240 

hrs is for a company where all the studies were done at external labs.

(4) Are there other costs that should be accounted for that may have been missed? The 

only extra is material costs – paper, binders, printing costs (ink, etc.), but that is pretty 

minimal.