ICR Attachment C - Record of ICR Consultations

Record of Consultations Between the U.S. Environmental Protection Agency and

Respondents to the Information Collection Request:

“Compliance Requirement for Child-Resistant Packaging”

1. Mark Jernigan; Bio-Lab, Inc.

2. Amy Plato Roberts; Technology Sciences Group Inc.

3. Stuart McArthur; S. C. Johnson & Son, Inc.

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

(10/30/06)

Mark Jernigan

Federal Registration Manager

Bio-Lab, Inc.

P.O. Box 300002

Lawrenceville, GA 30049

678-502-4149

• 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 e-mail, 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?) Not Applicable

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

• 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? Bio-Lab, Inc. only submits hard copy. 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 If yes, in what format?

(5) Burden and Costs

• Are the clerical and technical burden hours in the 2 tables below accurate? Yes These figures are based on 2003 information. 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 your 2003 comments regarding burden hours per CRP action. Please remember this burden may cover more than one product registration. Table II spreads out a 3 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 your burden estimates say 10 registration actions with say 7 being self certifications @1.5 hr =10.5, 2 certification with data @ 11 hr =22, and 1 exemption at 4.1 hr. This would provide 36.6 hrs for 10 registration actions with an average time per action being 3.7 hr. The question in Table II is then how would you divide the 3.7 hr (3hr 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	# Respondent	Technical Burden		Clerical Burden		Aggregate Burden
		Hours Per Event	Total	Hours Per Event	Total
CRP certification	456	1	456	0.5	228	684
CRP certification with data	78	8	624	3	234	858
exempt from CRP due large package size	70	0	0	0	0	0
exempt from CRP lack toxicity, packaging, no residential use, lower product toxicity	99	4	396	1.9	188.1	584.1
TOTAL	703	-	1476	-	650.1	2126.1

Table II

(Based on 2003 Figures Total Burden 3 Hrs/Respondent Acn)

COLLECTION ACTIVITIES	Burden Hours
	Tech. $88/hr.	%	Clerical $40/hr.	%
Read instructions	0	0	0	0
Plan activities	0.25	8.3	0	0
Create information including electronic format of data	0.87	29	0	0
Process, compile, and complete written compliance document	0.75	25	0.63	21
Review submission	0.25	8.3	0	0
Store, submit, file, or maintain data	0	0	0.25	8.3
TOTAL	2.12	71	0.88	29

Consultation for OPP ICR Compliance Requirement for Child-Resistant Packaging

(11/02/06)

Amy Plato Roberts

Technology Sciences Group Inc.

1150 18th Street, NW, Suite 1000

Washington, DC 20036

Direct Dial: (202) 828-8964; E-Mail: [email protected]; Website: www.tsgusa.com

EPA Questions:

(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? I am not aware of any public source or other agency that collects this data on my products.

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? Yes. If not, what suggestions do you

have to clarify the instructions?

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 in that the data must be submitted like any other data, formatted per PR Notice 86-5.

(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? Electronic submission is preferred. Other electronic reporting

alternatives include the use of web forms/XML based

submissions via the Agencys Internet site and magnetic

media-based submissions, e.g., diskette, CD-ROM, etc.

Are you keeping your records electronically? If yes, in what

format? Yes. CRP and related data are maintained electronically as pdf files.

(5) Burden and Costs

Are the clerical and technical burden hours in the following table

accurate? Yes

| |

| Burden |

COLLECTION ACTIVITIES | Hours |

------------------------------+-------------+-----------------

| |

| Technical | Clerical

| |

| |

------------------------------+-------------+-----------------

| |

Read instructions | 0 | 1

| |

------------------------------+-------------+-----------------

| |

Plan activities | 2 | 2

| |

------------------------------+-------------+-----------------

| |

Create information | 6 | 1

including electronic format | |

of data | |

------------------------------+-------------+-----------------

| |

Process, compile, and | 0 | 1

complete written compliance | |

document | |

------------------------------+-------------+-----------------

| |

Review submission | 0 | 2

------------------------------+-------------+-----------------

| |

Store, submit, file, or | 0 | 1

maintain data | |

------------------------------+-------------+-----------------

| |

TOTAL | 6 | 8

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

(08/07/06)

• 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).

Stuart McArthur, Sr. Registration Spec., S. C> Johnson & Son, Inc., Howe St., Racine, WI, 53402. Tel. No. 262/260-2405

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 e-mail, 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, not available from public sources.

• 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?)

N/A

(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.

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

It is clear and logical, I wouldn’t call it “easy.”

(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.

Our CR test facility produces the electronic media, so would be better prepared to answer this question.

• Are you keeping your records electronically? If yes, in what format?

No, I keep paper records.

(5) Burden and Costs

The burdens and costs in the tables below seem reasonable to me.

• Are the clerical and technical burden hours in the 2 tables below accurate? These figures are based on 2003 information. 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 your 2003 comments regarding burden hours per CRP action. Please remember this burden may cover more than one product registration. Table II spreads out a 3 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 your burden estimates say 10 registration actions with say 7 being self certifications @1.5 hr =10.5, 2 certification with data @ 11 hr =22, and 1 exemption at 4.1 hr. This would provide 36.6 hrs for 10 registration actions with an average time per action being 3.7 hr. The question in Table II is then how would you divide the 3.7 hr (3hr 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	# Respondent	Technical Burden		Clerical Burden		Aggregate Burden
		Hours Per Event	Total	Hours Per Event	Total
CRP certification	456	1	456	0.5	228	684
CRP certification with data	78	8	624	3	234	858
exempt from CRP due large package size	70	0	0	0	0	0
exempt from CRP lack toxicity, packaging, no residential use, lower product toxicity	99	4	396	1.9	188.1	584.1
TOTAL	703	-	1476	-	650.1	2126.1

Table II

(Based on 2003 Figures Total Burden 3 Hrs/Respondent Acn)

COLLECTION ACTIVITIES	Burden Hours
	Tech. $88/hr.	%	Clerical $40/hr.	%
Read instructions	0	0	0	0
Plan activities	0.25	8.3	0	0
Create information including electronic format of data	0.87	29	0	0
Process, compile, and complete written compliance document	0.75	25	0.63	21
Review submission	0.25	8.3	0	0
Store, submit, file, or maintain data	0	0	0.25	8.3
TOTAL	2.12	71	0.88	29