1

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) 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?) 

 

(2) Frequency of Collection 

$ Is submitting CRP certification with/without data when a change in packaging 

occurs too frequent? No.

 

(3) 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.

 
2

$ 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.

 

(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. 

$ 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.

 

(5) 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. 
3

Table I 

Technical 

Burden 

Clerical 

Burden 

Type of Response # 

Respondent 

Hours 

Per 

Event 

Total Hours 

Per 

Event 

Total 

Aggregate 

Burden 

CRP certification 0 1 0 0.5 0 0 

CRP certification 

with data 

0 8 0 3 0 0 

exempt from CRP due 

large package size 

0 0 0 0 0 0 

exempt from CRP 

lack toxicity, 

packaging, no 

residential use, 

lower product 

toxicity 

3 4 12 1.9 5.7 17.7 

TOTAL 3 n/a 12 n/a 5.7 17.7 

, 

 

Table II 

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

Burden Hours 

COLLECTION ACTIVITIES Tech. 

$60.39/hr. 

% Clerical 

$35.89/hr. 

% 

Read instructions 0 0 0 0 

Plan activities 0.71 0.13 0 0 

Create information 

including electronic 

format of data 

1.63 0.29 0 0 

Process, compile, and 

complete written 

compliance document 

1.45 0.26 1 0.18 

Review submission 0.41 0.07 0 0 

Store, submit, file, or 

maintain data 

0 0 0.4 0.07 

TOTAL 4.2 0.75 1.4 0.25 
1

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) 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?) 

 

(2) Frequency of Collection 

$ Is submitting CRP certification with/without data when a change in packaging 

occurs too frequent? No.

 

(3) 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 
2

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?

 

$ 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. 

 

(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. 

$ 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? 

 

(5) 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 
3

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 

Technical 

Burden 

Clerical 

Burden 

Type of Response # 

Respondent 

Hours 

Per 

Event 

Total Hours 

Per 

Event 

Total 

Aggregate 

Burden 

CRP certification 352 1 352 0.5 176 528 

CRP certification 

with data 

295 8 2360 3 885 3245 

exempt from CRP due 

large package size 

28 1A

0 0 0 0 

exempt from CRP 

lack toxicity, 

packaging, no 

residential use, 

lower product 

toxicity 

28 8 A 112 1.9 53.2 165.2 

TOTAL 703 n/a 2824 n/a 1114.2 3938.2 

A

 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.

 

Table II 

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

Burden Hours 

COLLECTION ACTIVITIES Tech. 

$60.39/hr. 

% Clerical 

$35.89/hr. 

% 

Read instructions 0 0 0 0 

Plan activitiesB 0.71 0.13 0 0 

Create information 

including electronic 

format of data 

1.63 0.29 0 0 

Process, compile, and 

complete written 

compliance document 

1.45 0.26 1 0.18 
4

Burden Hours 

COLLECTION ACTIVITIES Tech. 

$60.39/hr. 

% Clerical 

$35.89/hr. 

% 

Review submission 0.41 0.07 0 0 

Store, submit, file, or 

maintain data 

0 0 0.4 0.07 

TOTAL 4.2 0.75 1.4 0.25 

B 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.
1

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: 678-

638-3138, 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) 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?) 

 

(2) Frequency of Collection 

$ Is submitting CRP certification with/without data when a change in packaging 

occurs too frequent? No.

 

(3) 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. 
2

$ 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.

 

(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. 

$ 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. 

 

(5) 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 
3

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 

Technical 

Burden 

Clerical 

Burden 

Type of Response # 

Respondent 

Hours 

Per 

Event 

Total Hours 

Per 

Event 

Total 

Aggregate 

Burden 

CRP certification 352 1 352 0.5 176 528 

CRP certification 

with data 

295 8 2360 3 885 3245 

exempt from CRP due 

large package size 

28 0 0 0 0 0 

exempt from CRP 

lack toxicity, 

packaging, no 

residential use, 

lower product 

toxicity 

28 4 112 1.9 53.2 165.2 

TOTAL 703 n/a 2824 n/a 1114.2 3938.2 

 Table II 

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

Burden Hours 

COLLECTION ACTIVITIES Tech. 

$60.39/hr. 

% Clerical 

$35.89/hr. 

% 

Read instructions 0 0 0 0 

Plan activities 0.71 0.13 0 0 

Create information 

including electronic 

format of data 

1.63 0.29 0 0 

Process, compile, and 

complete written 

compliance document 

1.45 0.26 1 0.18 

Review submission 0.41 0.07 0 0 
4

Burden Hours 

COLLECTION ACTIVITIES Tech. 

$60.39/hr. 

% Clerical 

$35.89/hr. 

% 

Store, submit, file, or 

maintain data 

0 0 0.4 0.07 

TOTAL 4.2 0.75 1.4 0.25 
1

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) 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?) 

 

(2) Frequency of Collection 

$ Is submitting CRP certification with/without data when a change in packaging 

occurs too frequent? No 

 

(3) 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 

 
2

$ 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. 

 

(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. 

$ 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 

 

(5) 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.
3

Table I 

Technical 

Burden 

Clerical 

Burden 

Type of Response # 

Respondent 

Hours 

Per 

Event 

Total Hours 

Per 

Event 

Total 

Aggregate 

Burden 

CRP certification 352 1 352 0.5 176 528 

CRP certification 

with data 

295 8 2360 3 885 3245 

exempt from CRP due 

large package size 

28 1 0 0 0 0 

exempt from CRP 

lack toxicity, 

packaging, no 

residential use, 

lower product 

toxicity 

28 8 112 1.9 53.2 165.2 

TOTAL 703 n/a 2824 n/a 1114.2 3938.2 

Table II 

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

Burden Hours 

COLLECTION ACTIVITIES Tech. 

$60.39/hr. 

% Clerical 

$35.89/hr. 

% 

Read instructions 0 0 0 0 

Plan activities 0.71 0.13 0 0 

Create information 

including electronic 

format of data 

1.63 0.29 0 0 

Process, compile, and 

complete written 

compliance document 

1.45 0.26 1 0.18 

Review submission 0.41 0.07 0 0 

Store, submit, file, or 

maintain data 

0 0 0.4 0.07 

TOTAL 4.2 0.75 1.4 0.25 
RE: Child-Resistant Packaging, ICR

Jernigan, Mark 

t

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.
Thanks again for your assistance. We appreciate the time you have

already spent on this activity.

 Table 

1

 

 | | | | | 

| 

 Type of Response | # | Technica | | Clerica | 

| Aggregate 

 | Respondent | l Burden | | l | 

| Burden 

 | | | | 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, | | | | | 
| 

 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" <Mark.Jernigan@chemtura.com> 

 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. I didn't expect this so soon. We really

appreciate your help!

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