From: Frederick Betz <fbetz@agraquest.com>

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

<bstoneman@biopesticideindustryalliance.org>

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

<omesserschmidt@comcast.net>, "Sue Ma cIntosh <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.com1 **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 a vailable 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 chemical s , 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 ame ndment 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

re quired 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 sta tus and progress to initiate / complete pro cess 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 O m budsman 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. D ER and waiver templates, etc. most of which is2 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 e lectronic

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

– give n 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 w ould 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. Durabl e 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 .C onsultant experience indicates a

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

regulatory studies

. 160 h ou rs is a reasonable estimate for a microbial because there are

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

requ irement by rationale/literature ). but at least 50% more time (240 hours) should be3 the time estimate for a biochemical product (Type A)

. Also, 4 hours management time

to compile a la bel (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

accorda nce 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 over sight 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.