1 Consultation Questionnaire for OPP ICR : Compliance Requirement for Child

- Resistant Packaging

OMB Control # 2070

- 0 052 )

• C ompleted by: Amy Plato Roberts Technology Sciences Group, Inc.

712 5 th Street, Suite A, Davis, CA 95616,

T elephone : (530) 757

- 1432,

E mail : ARoberts@TSGUSA.COM

Updated ICR Document:

A list of the consultation questions asked and the responses thereto become a part of the electronic pu blic 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 agenc y? No not that I am aware of.

$ 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

$ I s 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 e xemption 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 w hat 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 would be helpful to have more a clear process on2 dete rmining if a product is subject to CPR. A decision tree that works through the criteria and exemptions (much like the PRIA decision tree) would be very helpful.

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

$ There are no forms associated with CRP

. I s the submission format for CRP

certifications and/or CRP data

, clear, logical, and easy to complete? Yes, but it would be helpful for EPA to post example for reference.

(4) Elec tronic 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 thi nk about this option ? Other electronic reporting alternatives include the use of A web forms @ /XML based submissions via the Agency = s Internet site and magnetic media

- based submissions, e.g.,
diskette, CD

- ROM, etc. Electronic submission via portal would be preferred. Electronic submission via a CD ROM works fine though.

$ Are you keeping your records electronically? If yes, in what format? Adobe Acrobat (pdf)

(5) Burden and Costs

• Are the clerical and technical burden hour s in the 2 table s below accura te? These figures

are based on 20 13 projections

. T able 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 20 10 comments regarding burden hour s per CRP action

. Please remember this burden may cover more than one product registration. Table II spreads out a 4.2 hour burden per action in 0.1 hour increments

. This not the time for

self

- certification without data or any other specific CRP type act ion . 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 acti ons 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 ( 4.2 hr in the chart) between the various steps in collection action such as read instructions, prepare

submission etc.

• Bearing in mind th at the burden and cost estimates include only burden hours and costs associated with the paperwork involved with CRP , e.g., the document does not include3 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 (Average estimated industry burden per response type)

Type of Response No. of Responses Technical

Burden Clerical

Burden Total Hours per Event

H ours Per

Event Hours Per

Event

CRP certification 798 1.0 0.5 1.5

CRP certification with data 296 8.0 3.0 11.0

Exempt from CRP due to large package size 34 1 .0 0.0 1.0

Exempt from CRP due to lack of toxicity, packaging, no residential use, lower produ ct toxicity 37 8 .0 3. 0 11.0

Table II ( Distribution of Burden among various activities.

Based on p rojection Total Burden 4

. 2 Hrs/Respondent Action )

COLLECTION ACTIVITIES Burden Hours TOTAL

Tech. $ 6 0.39 /hr. Clerical $ 35.89 /hr. Burden

Hours Cost

Read instructions 0. 18 0.0 0 0.18 $10.57

Plan activities 0.2 2 0.0 0 0.2 2 $1 3

. 29

Create information including

electronic format of data 1.2 0 0.0 0 1.2 0 $7 2

. 47

Process, compile, and complete written compliance document 1.1 0 0.9 0 1.9 0 $9 8

. 73

Review subm ission 0. 30 0.0 0 0.4 0 $ 18.12

Store, submit, file, or maintain

data 0.0 0 0.3 0 0.3 0 $1 0

. 77

TOTAL 3.0 0 1.2 0 4.2 0 $22 3

. 9441 Consultation Questionnaire for OPP ICR : Compliance Requirement for Child

- Resistant Packaging

OMB Control # 2070

- 0 052 )

• C ompleted by: Mark Jernigan Regulatory Affairs Manager

Bio

- Lab, Inc. Telephone: 678

- 502

- 4149

Email: mark.jernigan@chemtura.com

Updated ICR Document:

A list o f 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) avai lable 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 availa ble, but that they are not specific to your package/bait station ?)

(2) Frequency of Collection

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

(3) Clarity of Instructions

$ CRP regulations re quire 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 i nstructions? It would be helpful if EPA maintained a list of packages/closures for which data has been reviewed and accepted. This would allow registrants to know that data not required when certification submitted for2 these packages/closures. Appendix A of PR Notice 97

- 9 should be updated to include Microsoft Excel files (xlsx) as acceptable format

.

$ 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 w ith CRP

. I s the submission format for CRP

certifications and/or CRP data

, clear, logical, and easy to complete? CRP

certification

– guidance acceptable. CRP data

– It would be helpful to have an electronic template of fields with sample data for guidance

.

(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. W hat do you think about this option ? Other electronic reporting alternatives include the use of A web forms @ /XML based submissions via the Agency = s Internet site and magnetic media

- based submissions, e.g.,
diskette, CD

- ROM, etc. No experience with electron ic submission to provide

comment.

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

(5) Burden and Costs

• Are the clerical and technical burden hour s in the 2 table s below accurate? These figures

are based on 20 13 projections

. T able 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 20 10 comments regarding burden hours per CRP action

. Please remember this burden may cover more than one product registration. Table II spreads out a 4.2 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 registratio n 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 ( 4.2 hr in the chart) between the various steps in collection action such as read instructions, prepare

submission etc.

• Bearing in mind that the burden and cost estimates include only burd en hours and costs associated with the paperwork involved with CRP , e.g., the document does not include3 estimated burden hours and costs for conducting studies

. If you provide burden estimates substantially different from EPA ’ s, please provide an explanati on of how you arrived at your estimates.

Table I (Average estimated industry burden per response type)

Type of Response No. of Responses Technical

Burden Clerical

Burden Total Hours per Event

Hours Per

Event Hours Per

Event

CRP certification 798 1.0 0.5 1.5

CRP certification with data 296 8.0 3.0 11.0

Exempt from CRP due to large package size 34 1 .0 0.0 1.0

Exempt from CRP due to lack of toxicity, packaging, no residential use, lower product toxicity 37 8 .0 3. 0 11.0

Table II ( Distribu tion of Burden among various activities.

Based on p rojection Total Burden 4

. 2 Hrs/Respondent Action )

COLLECTION ACTIVITIES Burden Hours TOTAL

Tech. $ 6 0.39 /hr. Clerical $ 35.89 /hr. Burden

Hours Cost

Read instructions 0. 18 0.0 0 0.18 $10.57

Plan ac tivities 0.2 2 0.0 0 0.2 2 $1 3

. 29

Create information including

electronic format of data 1.2 0 0.0 0 1.2 0 $7 2

. 47

Process, compile, and complete written compliance document 1.1 0 0.9 0 1.9 0 $9 8

. 73

Review submission 0. 30 0.0 0 0.4 0 $ 18.12

Store, submit, file , or maintain

data 0.0 0 0.3 0 0.3 0 $1 0

. 77

TOTAL 3.0 0 1.2 0 4.2 0 $22 3

. 944 Child

- Resistant Packaging Information Collection Request (ICR)

Annual Respondent Burden by Response Type

**Type of Response No. of** 

**Responses Technical** 

**Burden Clerical** 

**Burden Aggreg**  **ate**

**Burden**

**Hours**

**Per**

**Event Tota** 

**l Hours** 

**Per**

**Event Tota** 

**l**

CRP certification 13 2 26

CRP certification

with data 3 6 18

Exempt from CRP
due to large
package size 0

Exempt from CRP

due to lack of
toxicity,
packaging, no

residential use,

lower product
toxicity 0

TOTAL 16 44

Annual Respondent Burden/ Cost Estimates

COLLECTION

ACTIVITIES **Burden Hours TOTAL** 

**Tech.**
**$ 60.39**  **/h**

**r. Clerical** 
**$ 35.89**  **/hr**

**. Burden** 

**Hours Cost** 

Read instructions 0.2 0.00 0. 2

Plan activities 0.2 0.00 0.2

Cre ate information
including

electronic format

of data 0.9 0.00 0.9
Process, compile,

and complete
written compliance

document 1. 0 0 1. 0

Review submission 0.3 0 0. 3

Store, submit,

file, or maintain

data 0.2 0 0. 2

TOTAL 2.8 0 2.81 Consultation Questionnaire for OPP ICR : Compliance Requirement for Child

- Resistant Packaging

OMB Control # 2070

- 0 052 )

• Complete by:

James L. Kunstman Ph.D. Craig Martens Director of Regulatory Services Federal Registrations Manager

PBI/Gordon Corporation PBI/Gordon Corporation

1217 W. 12 th Street 1217 W. 12 th Street Kansas City, MO 64101 Kansas City, MO 64101 jkunstman@pbigordon.com cmartens@pb igordon.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 receive d, 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? Response: Our sources of information are the catalogs/ publications/literature provided by the packaging su ppliers. The format of this information may be written documents or may be presented on the company’s websites.

$ 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 ?) Response: As a registrant , we obtain o ur Child Resistant Packaging (CRP)

information from the representative of the packaging supplier or from the supplier’s websites.

(2) Frequency of Collection

$ I s submitting CRP certification with/without data when a change in packaging occurs too frequent ? Response: Our current residential product lineup is narrow, our products are substantially similar to existing products, most of our individual products do not meet the toxicity criteria defined in 40 CFR Part 157, and our packaging is described as rigid, non

- refillabl e plastic containers with standardized closures. So, we believe that providing this information to the Agency for these types of2 household products at the time of registration and/or registration review is adequate and additional or new certifications shou ld not be needed. Our current products for occupational users are substantially similar to existing products and within the scope of the Child Resistant Packaging requirements. Again, our CRP packaging is described as rigid, non

- refillable plastic containe rs with standardized closures. We submit certification statements for each registration that the container design and closures meet the CRP requirements when the product is distributed and sold. Unless there is good cause such as a change in the formulatio n or a change in the packaging, then additional or new certifications for packaging are unnecessary.

(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? Response: The information provide d by the Agency is clear and accurate.

$ Do you understand that you are required to maintain CRP records for the life of the pesticide product registration ? Response: We understand record

- keeping requirements as stated in 40 CFR Part

157.

$ There are no forms associated with CRP

. I s the submission format for CRP

certifications and/or CRP data

, clear, logical, and easy to complete? Response: We believe that a cover letter with a certification statement and the Application for Pesticide Amendment (EPA Form 8570

- 1) as described in

Pesticid e Registration Notice (PRN) 96

- 2 is adequate and offers the registrant more flexibility than a new form.

(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 A web forms @ /XML based submissions via the Agency = s I nternet site and magnetic media

- based submissions, e.g.,
diskette, CD

- ROM, etc.3 $ Are you keeping your records electronically? If yes, in what format? Response: We currently keep all records in .pdf format, housed in a searchable

database

.

(5) Burden and Costs

• Are the clerical and technical burden hour s in the 2 table s below accurate? These figures

are based on 20 13 projections

. T able 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 20 10 comments regarding burden hours per CRP action

. Please remember this burden may cover more than one product registration. Table II spreads out a 4.2 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 ( 4.2 hr in the chart) between the various steps in co llection action such as read instructions, prepare

submission etc.

• 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 (Average estimated industry bu rden per response type)

Type of Response No. of Responses Technical

Burden Clerical

Burden Total Hours per Event

Hours Per

Event Hours Per

Event

CRP certification 798 1.0 0.5 1.5

CRP certification with data 296 8.0 3.0 11.0

Exempt from CRP due to large package size 34 1 .0 0.0 1.04 Exempt from CRP due to lack of toxicity, packaging, no residential use, lower product toxicity 37 8 .0 3. 0 11.0

Table II ( Distribution of Burden among various activities.

Based on p rojection Total Burden 4

. 2 Hrs/Respondent Action )

COLLECTION ACTIVITIES Burden Hours TOTAL

Tech. $ 6 0.39 /hr. Clerical $ 35.89 /hr. Burden

Hours Cost

Read instructions 0. 18 0.0 0 0.18 $10.57

Plan activities 0.2 2 0.0 0 0.2 2 $1 3

. 29

Create information including

electronic format of data 1.2 0 0.0 0 1.2 0 $7 2

. 47

Process, compile, and complete written compliance document 1.1 0 0.9 0 1.9 0 $9 8

. 73

Review submission 0. 30 0.0 0 0.4 0 $ 18.12

Store, submit, file, or maintain

data 0.0 0 0.3 0 0.3 0 $1 0

. 77

TOTAL 3.0 0 1.2 0 4.2 0 $22 3

. 94