ICR Attachment C - Record of ICR Consultations

Attachment C
Consultation Contacts for OPP ICR Compliance Requirement for Child-Resistant
Packaging____ Technology Sciences Group, Inc.______(OMB Control # 2070-0_052__)
•

List name, address and phone number (or e-mail) of at least 3 persons (entitles contacted)
whose names will be listed in the ICR document. (Make sure the contacts understand
that their names and contact numbers will appear in a publically available document).
Amy Plato Roberts, Technology Sciences Group, Inc., 712 5th Street, Suite A, Davis, CA
95616, telephone (530) 757-1432, email ARoberts@TSGUSA.COM

Updated ICR Document:
A list of the consultation questions asked and the responses thereto become a part of the
electronic public comment docket for this ICR renewal. Thus, a list of questions asked the
respondents and the responses received, either written comments, verbal responses or email, etc. will become a part of the electronic public comment docket for this ICR renewal.

EPA Questions asked in Consultation
(1)

(2)

Publicly Available Data
$

Is the Child-Resistant Packaging (CRP) data that the Agency seeks for your
product(s) available from any public source, or already collected by another office
at EPA or by another agency? No.

$

If yes, where can you find the CRP data? (Does your answer indicate a true
duplication, or does the input indicate that certain data elements are available, but
that they are not specific to your package/bait station?)

Frequency of Collection
$

(3)

Is submitting CRP certification with/without data when a change in packaging
occurs too frequent? No.

Clarity of Instructions
$

CRP regulations require respondents provide CRP certifications, CRP test data,
and CRP exemption requests to ensure that the Agency can ascertain if CRP is
protecting children from serious illness or injury resulting from handling, using,
or ingesting certain products.

$

Based on the regulations, PR Notices, CRP webpage, etc., is it clear what type of
CRP information you are required to submit (e.g. CRP certification with/without
data, etc.) and how to submit such data? If not, what suggestions do you have to
clarify the instructions? Yes it is clear.

$

Do you understand that you are required to maintain CRP records for the life of
the pesticide product registration? Yes.

1

$

(4)

Attachment C
There are no forms associated with CRP. Is the submission format for CRP
certifications and/or CRP data, clear, logical, and easy to complete? Yes,
however, it might be clearer if there was a specific form that is completed.

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.

(5)

$

Currently CRP data may be submitted electronically in addition to a hard copy to
expedited data analysis. What do you think about this option? Other electronic
reporting alternatives include the use of Aweb forms@/XML based submissions
via the Agency=s Internet site and magnetic media-based submissions, e.g.,
diskette, CD-ROM, etc. Electronic submission is helpful, however it would be
easier if it was a directly electronic submission through a e-index builder type
format.

$

Are you keeping your records electronically? If yes, in what format? Yes and
generally in MSWord or PDF documents that are scanned in.

Burden and Costs
•

Are the clerical and technical burden hours in the 2 tables below accurate? These figures
are based on 2009 projections. Table I associates the various types of CRP actions a
respondent may do and the number of technical hours and clerical hours per event.
Please note this table reflects 2006 comments regarding burden hours per CRP action and
projections for an increase in burden hours per CRP action for 2009. Please remember
this burden may cover more than one product registration. Table II spreads out a 5.6
hour burden per action in 0.1 hour increments. This not the time for self-certification
without data or any other specific CRP type action. This is the time average based on
registration actions spread out over self certification, certification with data, exemptions,
etc. The time per action multiplied by the number of actions, and the sum of all
registration actions time spent divided by the number of actions. For example using
burden estimates say 10 registration actions with say 6 being self certifications @1.5 hr
=9, 3 certification with data @ 11 hr =33, and 1 exemption at 5.9 hr. This would provide
47.9 hrs for 10 registration actions with an average time per action being 4.8 hr. The
question in Table II is then how would you divide the 4.8 hr (5.6 hr in the chart)
between the various steps in collection action such as read instructions, prepare
submission etc. If you could please provide input to Table II I would appreciate it. The
estimates seem accurate.

•

Bearing in mind that the burden and cost estimates include only burden hours and costs
associated with the paperwork involved with CRP, e.g., the document does not include
estimated burden hours and costs for conducting studies. If you provide burden estimates
substantially different from EPA=s, please provide an explanation of how you arrived at
your estimates.
2

Attachment C

Table I
Type of Response

CRP certification
CRP certification
with data
exempt from CRP due
large package size
exempt from CRP
lack toxicity,
packaging, no
residential use,
lower product
toxicity

Technical
Burden

#
Respondent

0

Hours
Per
Event
1

0

Aggregate
Burden

0

Hours
Per
Event
0.5

0

0

8

0

3

0

0

0

0

0

0

0

0

3

4

12

1.9

5.7

17.7

12

n/a

5.7

17.7

TOTAL

3

n/a

Total

Clerical
Burden
Total

,
Table II
(Based on 2009 Projection Total Burden 5.6 Hrs/Respondent Acn)

COLLECTION ACTIVITIES
Read instructions

Tech.
$60.39/hr.
0

Burden Hours
%
Clerical
$35.89/hr.
0
0

%
0

Plan activities

0.71

0.13

0

0

Create information
including electronic
format of data
Process, compile, and
complete written
compliance document
Review submission

1.63

0.29

0

0

1.45

0.26

1

0.18

0.41

0.07

0

0

0

0

0.4

0.07

4.2

0.75

1.4

0.25

Store, submit, file, or
maintain data
TOTAL

3

Attachment C
Consultation Contacts for OPP ICR Compliance Requirement for Child-Resistant
Packaging_Product & Regulatory Associates, LLC_________(OMB Control # 2070-0_052__)
•

List name, address and phone number (or e-mail) of at least 3 persons (entitles contacted)
whose names will be listed in the ICR document. (Make sure the contacts understand
that their names and contact numbers will appear in a publically available document).
John F. Wright Product & Regulatory Associates, LLC, P. O. Box 1683, Voorhees, NJ
08043-9998, telephone 856-424-1528, email JwrightCH@comcast.net

Updated ICR Document:
A list of the consultation questions asked and the responses thereto become a part of the
electronic public comment docket for this ICR renewal. Thus, a list of questions asked the
respondents and the responses received, either written comments, verbal responses or email, etc. will become a part of the electronic public comment docket for this ICR renewal.

EPA Questions asked in Consultation
(1)

(2)

Publicly Available Data
$

Is the Child-Resistant Packaging (CRP) data that the Agency seeks for your
product(s) available from any public source, or already collected by another office
at EPA or by another agency? No.

$

If yes, where can you find the CRP data? (Does your answer indicate a true
duplication, or does the input indicate that certain data elements are available, but
that they are not specific to your package/bait station?)

Frequency of Collection
$

(3)

Is submitting CRP certification with/without data when a change in packaging
occurs too frequent? No.

Clarity of Instructions
$

CRP regulations require respondents provide CRP certifications, CRP test data,
and CRP exemption requests to ensure that the Agency can ascertain if CRP is
protecting children from serious illness or injury resulting from handling, using,
or ingesting certain products.

$

Based on the regulations, PR Notices, CRP webpage, etc., is it clear what type of
CRP information you are required to submit (e.g. CRP certification with/without
data, etc.) and how to submit such data? My experience here has to be based on
the type of submissions. For the small unit dose, prefilled, ready to use bait
stations, yes there is sufficient information to prepare and submit the required
certification or exemption. For CRP certification of multi use containers, I am not
sure that I would full understand what is to be submitted. Or what data is to be
generated. If not, what suggestions do you have to clarify the instructions? More
examples of the pesticide formulations rather than general terms. For a small
1

Attachment C
container to hold a liquid or granular product, does the certificate need to be
conducted with the actual product in place or will a generalized placebo be
acceptable? The actual certificate is now required with the specific container and
closure to be specified?

(4)

$

Do you understand that you are required to maintain CRP records for the life of
the pesticide product registration? Yes.

$

There are no forms associated with CRP. Is the submission format for CRP
certifications and/or CRP data, clear, logical, and easy to complete? The
submission of CRP certification is clear but not the format for the data. Since
some CRP data is generated outside of the pesticide regulations, many vendors do
not know how to conduct a study under GLP guidelines or prepare the final report
in PR Notice 86-5 format. A section to clarify these points needs to be presented.

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.

(5)

$

Currently CRP data may be submitted electronically in addition to a hard copy to
expedited data analysis. What do you think about this option? This is an
acceptable format. Most of the contract laboratories conducting the studies
understand the proper formatting protocol. The registrant, however, would not
have the general understanding of this format. Thus the data need to be in hard
copy format for their storage requirements. Other electronic reporting alternatives
include the use of Aweb forms@/XML based submissions via the Agency=s
Internet site and magnetic media-based submissions, e.g., diskette, CD-ROM, etc.

$

Are you keeping your records electronically? No. Once the study is finalized, hard
copies of the data are archived. In that hard copy archive, there will be a copy of
CD submitted to the Agency. The reason for this is that most small companies do
not have the infrastructure to maintain a GLP electronic archiving system. If yes,
in what format?

Burden and Costs
•

Are the clerical and technical burden hours in the 2 tables below accurate? These figures
are based on 2009 projections. Table I associates the various types of CRP actions a
respondent may do and the number of technical hours and clerical hours per event.
Please note this table reflects 2006 comments regarding burden hours per CRP action and
projections for an increase in burden hours per CRP action for 2009. Please remember
this burden may cover more than one product registration. Table II spreads out a 5.6
hour burden per action in 0.1 hour increments. This not the time for self-certification
without data or any other specific CRP type action. This is the time average based on
registration actions spread out over self certification, certification with data, exemptions,
etc. The time per action multiplied by the number of actions, and the sum of all
registration actions time spent divided by the number of actions. For example using
2

Attachment C
burden estimates say 10 registration actions with say 6 being self certifications @1.5 hr
=9, 3 certification with data @ 11 hr =33, and 1 exemption at 5.9 hr. This would provide
47.9 hrs for 10 registration actions with an average time per action being 4.8 hr. The
question in Table II is then how would you divide the 4.8 hr (5.6 hr in the chart)
between the various steps in collection action such as read instructions, prepare
submission etc. If you could please provide input to Table II I would appreciate it.
•

Bearing in mind that the burden and cost estimates include only burden hours and costs
associated with the paperwork involved with CRP, e.g., the document does not include
estimated burden hours and costs for conducting studies. If you provide burden estimates
substantially different from EPA=s, please provide an explanation of how you arrived at
your estimates.
Table I

Type of Response

CRP certification
CRP certification
with data
exempt from CRP due
large package size
exempt from CRP
lack toxicity,
packaging, no
residential use,
lower product
toxicity

Technical
Burden

#
Respondent

352

Hours
Per
Event
1

295

Aggregate
Burden

352

Hours
Per
Event
0.5

176

528

8

2360

3

885

3245

28

1A

0

0

0

28

8

TOTAL

703

A

n/a

Total

Clerical
Burden
Total

0

112

1.9

53.2

165.2

2824

n/a

1114.2

3938.2

The time to document these items is too low. One must provide a review of the pesticide
label, manufacturing records, marketing options or research data to support the
justifications for the exemption.
A

Table II
(Based on 2009 Projection Total Burden 5.6 Hrs/Respondent Acn)

COLLECTION ACTIVITIES
Read instructions

Tech.
$60.39/hr.
0

Burden Hours
%
Clerical
$35.89/hr.
0
0

%
0

Plan activitiesB

0.71

0.13

0

0

Create information
including electronic
format of data
Process, compile, and
complete written
compliance document

1.63

0.29

0

0

1.45

0.26

1

0.18

3

Attachment C
COLLECTION ACTIVITIES
Review submission
Store, submit, file, or
maintain data
TOTAL

Burden Hours
Tech.
%
Clerical
$60.39/hr.
$35.89/hr.
0.07
0.41
0

%
0

0

0

0.4

0.07

4.2

0.75

1.4

0.25

When a registrant evaluates the need for or an exemption of the CRP data requirements
for the registration, the time in assembling and documenting all the facts is missing from
the activities above. Also the planning option is significantly low when one needs to
configure the various marketing options and their implications. This should be at least 3-4
X higher.
B

4

Attachment C
Consultation Contacts for OPP ICR Compliance Requirement for Child-Resistant
Packaging__name________________(OMB Control # 2070-0_052__)
•

List name, address and phone number (or e-mail) of at least 3 persons (entitles contacted)
whose names will be listed in the ICR document. (Make sure the contacts understand
that their names and contact numbers will appear in a publically available document).
Merial Limited, 3239 Satellite Blvd., Duluth, GA 30096,
Contributors
1. Karen C. Cunningham, Head, Regulatory Affairs Lifecycle Management, Phone: 678638-3138, Email: karen.cunningham@merial.com
2. Karen Mardis, Senior Manager Regulatory Affairs Lifecycle Management, Phone:
678-638-3706, Email: karen.Mardis@Merial.com
3. Timothy A. Dotson, Director, Regulatory Affairs New Products, Phone: 678-638-3713,
Email: timothy.dotson@merial.com

Updated ICR Document:
A list of the consultation questions asked and the responses thereto become a part of the
electronic public comment docket for this ICR renewal. Thus, a list of questions asked the
respondents and the responses received, either written comments, verbal responses or email, etc. will become a part of the electronic public comment docket for this ICR renewal.

EPA Questions asked in Consultation
(1)

(2)

Publicly Available Data
$

Is the Child-Resistant Packaging (CRP) data that the Agency seeks for your
product(s) available from any public source, or already collected by another office
at EPA or by another agency? No.

$

If yes, where can you find the CRP data? (Does your answer indicate a true
duplication, or does the input indicate that certain data elements are available, but
that they are not specific to your package/bait station?)

Frequency of Collection
$

(3)

Is submitting CRP certification with/without data when a change in packaging
occurs too frequent? No.

Clarity of Instructions
$

CRP regulations require respondents provide CRP certifications, CRP test data,
and CRP exemption requests to ensure that the Agency can ascertain if CRP is
protecting children from serious illness or injury resulting from handling, using,
or ingesting certain products.
1

Attachment C

(4)

$

Based on the regulations, PR Notices, CRP webpage, etc., is it clear what type of
CRP information you are required to submit (e.g. CRP certification with/without
data, etc.) and how to submit such data? If not, what suggestions do you have to
clarify the instructions? It is clear.

$

Do you understand that you are required to maintain CRP records for the life of
the pesticide product registration? Yes.

$

There are no forms associated with CRP. Is the submission format for CRP
certifications and/or CRP data, clear, logical, and easy to complete? Yes.

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.

(5)

$

Currently CRP data may be submitted electronically in addition to a hard copy to
expedited data analysis. What do you think about this option? Other electronic
reporting alternatives include the use of Aweb forms@/XML based submissions
via the Agency=s Internet site and magnetic media-based submissions, e.g.,
diskette, CD-ROM, etc. The only alternative Merial is aware of is submitting data
on durable media like CD-ROM. A separate cost is incurred in this case and it is
not clear if there is a benefit to this.

$

Are you keeping your records electronically? Yes. If yes, in what format? All
hard copy reports are scanned into *.pdf format and placed in a central database,
and copies of CRP data on CD-ROM are also kept.

Burden and Costs
•

Are the clerical and technical burden hours in the 2 tables below accurate? These figures
are based on 2009 projections. Table I associates the various types of CRP actions a
respondent may do and the number of technical hours and clerical hours per event.
Please note this table reflects 2006 comments regarding burden hours per CRP action and
projections for an increase in burden hours per CRP action for 2009. Please remember
this burden may cover more than one product registration. Table II spreads out a 5.6
hour burden per action in 0.1 hour increments. This not the time for self-certification
without data or any other specific CRP type action. This is the time average based on
registration actions spread out over self certification, certification with data, exemptions,
etc. The time per action multiplied by the number of actions, and the sum of all
registration actions time spent divided by the number of actions. For example using
burden estimates say 10 registration actions with say 6 being self certifications @1.5 hr
=9, 3 certification with data @ 11 hr =33, and 1 exemption at 5.9 hr. This would provide
47.9 hrs for 10 registration actions with an average time per action being 4.8 hr. The
question in Table II is then how would you divide the 4.8 hr (5.6 hr in the chart)
between the various steps in collection action such as read instructions, prepare
submission etc. If you could please provide input to Table II I would appreciate it. No
2

Attachment C
comments for either table.
•

Bearing in mind that the burden and cost estimates include only burden hours and costs
associated with the paperwork involved with CRP, e.g., the document does not include
estimated burden hours and costs for conducting studies. If you provide burden estimates
substantially different from EPA=s, please provide an explanation of how you arrived at
your estimates.

Table I
Type of Response

CRP certification
CRP certification
with data
exempt from CRP due
large package size
exempt from CRP
lack toxicity,
packaging, no
residential use,
lower product
toxicity

Technical
Burden

#
Respondent

352

Hours
Per
Event
1

295

Aggregate
Burden

352

Hours
Per
Event
0.5

176

528

8

2360

3

885

3245

28

0

0

0

0

28

4

112

1.9

53.2

2824

n/a

1114.2

TOTAL

703

n/a

Total

Clerical
Burden
Total

0
165.2

3938.2

Table II
(Based on 2009 Projection Total Burden 5.6 Hrs/Respondent Acn)

COLLECTION ACTIVITIES
Read instructions

Tech.
$60.39/hr.
0

Burden Hours
%
Clerical
$35.89/hr.
0
0

%
0

Plan activities

0.71

0.13

0

0

Create information
including electronic
format of data
Process, compile, and
complete written
compliance document
Review submission

1.63

0.29

0

0

1.45

0.26

1

0.18

0.41

0.07

0

0

3

Attachment C
COLLECTION ACTIVITIES
Store, submit, file, or
maintain data
TOTAL

Burden Hours
Tech.
%
Clerical
$60.39/hr.
$35.89/hr.
0
0
0.4
0.75

4.2

4

1.4

%
0.07
0.25

Attachment C
Response from: Mark Jernigan, Bio-Lab, Inc. (EPA Company # 5185)
Consultation Contacts for OPP ICR Compliance Requirement for Child-Resistant
Packaging_ _________(OMB Control # 2070-0_052__)
•

List name, address and phone number (or e-mail) of at least 3 persons (entitles contacted)
whose names will be listed in the ICR document. (Make sure the contacts understand
that their names and contact numbers will appear in a publically available document).

Updated ICR Document:
A list of the consultation questions asked and the responses thereto become a part of the
electronic public comment docket for this ICR renewal. Thus, a list of questions asked the
respondents and the responses received, either written comments, verbal responses or email, etc. will become a part of the electronic public comment docket for this ICR renewal.

EPA Questions asked in Consultation
(1)

(2)

Publicly Available Data
$

Is the Child-Resistant Packaging (CRP) data that the Agency seeks for your
product(s) available from any public source, or already collected by another office
at EPA or by another agency? No

$

If yes, where can you find the CRP data? (Does your answer indicate a true
duplication, or does the input indicate that certain data elements are available, but
that they are not specific to your package/bait station?)

Frequency of Collection
$

(3)

Is submitting CRP certification with/without data when a change in packaging
occurs too frequent? No

Clarity of Instructions
$

CRP regulations require respondents provide CRP certifications, CRP test data,
and CRP exemption requests to ensure that the Agency can ascertain if CRP is
protecting children from serious illness or injury resulting from handling, using,
or ingesting certain products.

$

Based on the regulations, PR Notices, CRP webpage, etc., is it clear what type of
CRP information you are required to submit (e.g. CRP certification with/without
data, etc.) and how to submit such data? If not, what suggestions do you have to
clarify the instructions? Yes

$

Do you understand that you are required to maintain CRP records for the life of
the pesticide product registration? Yes

1

$

(4)

Attachment C
There are no forms associated with CRP. Is the submission format for CRP
certifications and/or CRP data, clear, logical, and easy to complete? Yes, although
a form may be helpful so that responses are structured.

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.

(5)

$

Currently CRP data may be submitted electronically in addition to a hard copy to
expedited data analysis. What do you think about this option? Other electronic
reporting alternatives include the use of Aweb forms@/XML based submissions
via the Agency=s Internet site and magnetic media-based submissions, e.g.,
diskette, CD-ROM, etc.

$

Are you keeping your records electronically? If yes, in what format? No

Burden and Costs
•

Are the clerical and technical burden hours in the 2 tables below accurate? These figures
are based on 2009 projections. Table I associates the various types of CRP actions a
respondent may do and the number of technical hours and clerical hours per event.
Please note this table reflects 2006 comments regarding burden hours per CRP action and
projections for an increase in burden hours per CRP action for 2009. Please remember
this burden may cover more than one product registration. Table II spreads out a 5.6
hour burden per action in 0.1 hour increments. This not the time for self-certification
without data or any other specific CRP type action. This is the time average based on
registration actions spread out over self certification, certification with data, exemptions,
etc. The time per action multiplied by the number of actions, and the sum of all
registration actions time spent divided by the number of actions. For example using
burden estimates say 10 registration actions with say 6 being self certifications @1.5 hr
=9, 3 certification with data @ 11 hr =33, and 1 exemption at 5.9 hr. This would provide
47.9 hrs for 10 registration actions with an average time per action being 4.8 hr. The
question in Table II is then how would you divide the 4.8 hr (5.6 hr in the chart)
between the various steps in collection action such as read instructions, prepare
submission etc. If you could please provide input to Table II I would appreciate it.

•

Bearing in mind that the burden and cost estimates include only burden hours and costs
associated with the paperwork involved with CRP, e.g., the document does not include
estimated burden hours and costs for conducting studies. If you provide burden estimates
substantially different from EPA=s, please provide an explanation of how you arrived at
your estimates.
Numbers presented in tables I and II for Burden Hours appear reasonable.

2

Attachment C
Table I
Type of Response

CRP certification
CRP certification
with data
exempt from CRP due
large package size
exempt from CRP
lack toxicity,
packaging, no
residential use,
lower product
toxicity

Technical
Burden

#
Respondent

352

Hours
Per
Event
1

295

Aggregate
Burden

352

Hours
Per
Event
0.5

176

528

8

2360

3

885

3245

28

1

0

0

0

28

8

112

1.9

53.2

2824

n/a

1114.2

TOTAL

703

n/a

Total

Clerical
Burden
Total

0
165.2

3938.2

Table II
(Based on 2009 Projection Total Burden 5.6 Hrs/Respondent Acn)

COLLECTION ACTIVITIES
Read instructions

Tech.
$60.39/hr.
0

Burden Hours
%
Clerical
$35.89/hr.
0
0

%
0

Plan activities

0.71

0.13

0

0

Create information
including electronic
format of data
Process, compile, and
complete written
compliance document
Review submission

1.63

0.29

0

0

1.45

0.26

1

0.18

0.41

0.07

0

0

0

0

0.4

0.07

4.2

0.75

1.4

0.25

Store, submit, file, or
maintain data
TOTAL

3

Attachment C

RE: Child-Resistant Packaging , ICR
t
Jernigan, Mark o Scott Drewes
:

05/10/2010 01:21 PM

Cc: Ian Blackwell
History:

This message has been replied to.

Dear Scott:
I have no additional comment based on your indicated change.
Best regards,
Mark
Mark Jernigan
Regulatory Affairs Manager
Bio-Lab, Inc., A Chemtura Company
678-502-4149 (voice)
678-502-4764 (fax)
Mark.Jernigan@chemtura.com
-----Original Message----From: Drewes.Scott@epamail.epa.gov [mailto:Drewes.Scott@epamail.epa.gov]
Sent: Monday, May 10, 2010 12:43 PM
To: Jernigan, Mark
Cc: blackwell.ian@epamail.epa.gov
Subject: Fw: Child-Resistant Packaging, ICR
Mark,
I was on the phone call with you and Ian Blackwell last week to discuss
the burden hours for submitting CRP applications. I noticed later that
there was an error in Table 1. I am sending this email to ask if you
could take a few moments to review the corrected table below.
Table 1 should have appeared as it does below (and in the attached
document). In particular, the burden hours for CRP exemptions due to
large package size and exempt from CRP for lack of toxicity, etc. should
have read 0 and 4 hrs per event respectively. In the table you reviewed
they were listed as 1 and 8 hrs; these higher number were based on
consultations with another registrant and may not reflect the amount of
time that your organization spends, on average, processing CRP
exemptions. EPA's estimates are based on the following assumptions: 1)
Applicants exempt from CRP requirements based on large package size
require no time because the CRP regulations require no action on their
part and 2) Less data is required to be submitted for exemptions due to
lack of toxicity, etc. We would appreciate it if you could comment on
these corrected numbers. If your estimates differ, can you please
provide your assumptions? Feel free to respond directly to this email,
or enter your comments in the attached document. I would be happy to
call you if I can provide further clarification.

Attachment C

Thanks again for your assistance. We appreciate the time you have
already spent on this activity.
Table
1
|

|

|

|

|

|

Technica |

|

Clerica |

|

Respondent |

l Burden |

|

l

|

|

|

|

|

Burden

|

|
|
|

Type of Response
Aggregate

|

#

Burden

|
----------------------+-------------+-----------+----------+----------+---------+-----------|
|
|
|
|
|
|
|
Hours
|
Total |
Hours |
Total |
|
|
Per
|
|
Per
|
|
|
|
Event
|
|
Event |
|
----------------------+-------------+-----------+----------+----------+---------+-----------| 352
|
1
| 352
|
0.5
| 176
|
528
CRP certification
|
|
|
|
|
|
----------------------+-------------+-----------+----------+----------+---------+-----------| 295
|
8
| 2360
|
3
| 885
|
3245
CRP certification
|
|
|
|
|
|
with data
|
|
|
|
|
|
----------------------+-------------+-----------+----------+----------+---------+-----------| 28
|
0
|
|
0
|
|
0
exempt from CRP due |
|
| 0
|
| 0
|
large package size |
|
|
|
|
|
----------------------+-------------+-----------+----------+----------+---------+-----------| 28
|
4
| 112
|
1.9
| 53.2
|
165.2
exempt from CRP
|
|
|
|
|
|
lack toxicity,
|
|
|
|
|

Attachment C

|
packaging, no

|

|

|

|

|

residential use,

|

|

|

|

|

lower product

|

|

|

|

|

toxicity

|

|

|

|

|

|
|
|
|
----------------------+-------------+-----------+----------+----------+---------+-----------TOTAL
|
703
|
n/a
| 2824
|
n/a
| 1114
|
3938

(See attached file: consultationquest.doc)
Scott Drewes
Environmental Protection Specialist
Field and External Affairs Division
Office of Pesticide Programs
703-347-0107
----- Forwarded by Scott Drewes/DC/USEPA/US on 05/10/2010 12:07 PM ----From:

Ian Blackwell/DC/USEPA/US

To:

"Jernigan, Mark"

Cc:

Scott Drewes/DC/USEPA/US@EPA

Date:

04/30/2010 03:44 PM

Subject:

Re: FW: Child-Resistant Packaging, ICR

Mark,
Thanks so much.
appreciate your help!

I didn't expect this so soon.

Sincerely,
Ian Blackwell
Chemistry and Toxicology Team
Product Science Branch
Antimicrobials Division (7510P)
Office of Pesticide Programs
Office of Chemical Safety and Pollution Prevention (OCSPP)
U.S. Environmental Protection Agency
2777 S. Crystal Drive
Arlington, VA 22202

We really