Attachment C_Record of Consultations

Consultation Questionnaire for OPP ICR:
Compliance Requirement for Child-Resistant Packaging
OMB Control # 2070-0052)

•

Completed by:
Amy Plato Roberts
Technology Sciences Group, Inc.
712 5th Street, Suite A,
Davis, CA 95616,
Telephone: (530) 757-1432,
Email: [email protected]

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 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?)

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? It would be helpful to have more a clear process on
1

determining 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.

(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? Yes, but it
would be helpful for EPA to post example for reference.

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 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)

Burden and Costs
•

Are the clerical and technical burden hours in the 2 tables below accurate? These figures
are based on 2013 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 2010 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 collection 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
2

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

Hours Per
Event

Hours Per
Event

Total 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
(Distribution of Burden among various activities.
Based on projection Total Burden 4.2 Hrs/Respondent Action)

Burden Hours
COLLECTION ACTIVITIES

TOTAL

Tech.
$60.39/hr.

Clerical
$35.89/hr.

Burden
Hours

Cost

Read instructions

0.18

0.00

0.18

$10.57

Plan activities

0.22

0.00

0.22

$13.29

Create information including
electronic format of data

1.20

0.00

1.20

$72.47

Process, compile, and complete
written compliance document

1.10

0.90

1.90

$98.73

Review submission

0.30

0.00

0.40

$18.12

Store, submit, file, or maintain
data

0.00

0.30

0.30

$10.77

TOTAL

3.00

1.20

4.20

$223.94

3

4

Consultation Questionnaire for OPP ICR:
Compliance Requirement for Child-Resistant Packaging
OMB Control # 2070-0052)
•

Completed by:
Mark Jernigan
Regulatory Affairs Manager
Bio-Lab, Inc.
Telephone: 678-502-4149
Email: [email protected]

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? 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 for
1

these packages/closures. Appendix A of PR Notice 97-9 should be updated to
include Microsoft Excel files (xlsx) as acceptable format.

(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? CRP
certification – guidance acceptable. CRP data – It would be helpful to have an
electronic template of fields with sample data for guidance.

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. No experience with electronic submission to provide
comment.

$

Are you keeping your records electronically? No 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 2013 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 2010 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 collection 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
2

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

Hours Per
Event

Hours Per
Event

Total 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
(Distribution of Burden among various activities.
Based on projection Total Burden 4.2 Hrs/Respondent Action)

Burden Hours
COLLECTION ACTIVITIES

TOTAL

Tech.
$60.39/hr.

Clerical
$35.89/hr.

Burden
Hours

Cost

Read instructions

0.18

0.00

0.18

$10.57

Plan activities

0.22

0.00

0.22

$13.29

Create information including
electronic format of data

1.20

0.00

1.20

$72.47

Process, compile, and complete
written compliance document

1.10

0.90

1.90

$98.73

Review submission

0.30

0.00

0.40

$18.12

Store, submit, file, or maintain
data

0.00

0.30

0.30

$10.77

TOTAL

3.00

1.20

4.20

$223.94

3

Child-Resistant Packaging Information Collection Request (ICR)

Annual Respondent Burden by Response Type
Type of Response

No. of
Responses

CRP certification
CRP certification
with data
Exempt from CRP
due to large
package size
Exempt from CRP
due to lack of
toxicity,
packaging, no
residential use,
lower product
toxicity
TOTAL

13

Technical
Burden
Hours
Tota
Per
l
Event
2
26

3

6

Clerical
Burden
Hours
Tota
Per
l
Event

Aggregate
Burden

18

0

0

16

44

Annual Respondent Burden/ Cost Estimates
COLLECTION
ACTIVITIES

Burden
Tech.
$60.39/h
r.

Hours
Clerical
$35.89/hr
.

Burden
Hours

Read instructions

0.2

0.00

0.2

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

0.2

0.00

0.2

0.9

0.00

0.9

1.0

0

1.0

Review submission
Store, submit,
file, or maintain
data

0.3

0

0.3

0.2

0

0.2

TOTAL

2.8

0

2.8

4

TOTAL
Cost

Consultation Questionnaire for OPP ICR:
Compliance Requirement for Child-Resistant Packaging
OMB Control # 2070-0052)
•

Complete by:
James L. Kunstman Ph.D.
Director of Regulatory Services
PBI/Gordon Corporation
1217 W. 12th Street
Kansas City, MO 64101
[email protected]

Craig Martens
Federal Registrations Manager
PBI/Gordon Corporation
1217 W. 12th Street
Kansas City, MO 64101
[email protected]

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?
Response: Our sources of information are the catalogs/ publications/literature
provided by the packaging suppliers. 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 our Child Resistant Packaging (CRP)
information from the representative of the packaging supplier or from the
supplier’s websites.

Frequency of Collection
$

Is 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-refillable plastic containers with standardized closures. So,
we believe that providing this information to the Agency for these types of
1

household products at the time of registration and/or registration review is
adequate and additional or new certifications should 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 containers
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 formulation or a change in the packaging, then additional or new
certifications for packaging are unnecessary.
(3)

(4)

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 provided 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. Is 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
Pesticide Registration Notice (PRN) 96-2 is adequate and offers the registrant
more flexibility than a new form.

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.
2

$

(5)

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.

Burden and Costs
•

Are the clerical and technical burden hours in the 2 tables below accurate? These figures
are based on 2013 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 2010 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 collection 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 burden per response type)
Type of Response

No. of
Responses

Technical
Burden

Clerical
Burden

Hours Per
Event

Hours Per
Event

Total Hours
per Event

CRP certification

798

1.0

0.5

1.5

CRP certification with data

296

8.0

3.0

11.0

34

1.0

0.0

1.0

Exempt from CRP due to
large package size

3

Exempt from CRP due to
lack of toxicity, packaging,
no residential use, lower
product toxicity

8.0

37

3.0

11.0

Table II
(Distribution of Burden among various activities.
Based on projection Total Burden 4.2 Hrs/Respondent Action)

Burden Hours
COLLECTION ACTIVITIES

TOTAL

Tech.
$60.39/hr.

Clerical
$35.89/hr.

Burden
Hours

Cost

Read instructions

0.18

0.00

0.18

$10.57

Plan activities

0.22

0.00

0.22

$13.29

Create information including
electronic format of data

1.20

0.00

1.20

$72.47

Process, compile, and complete
written compliance document

1.10

0.90

1.90

$98.73

Review submission

0.30

0.00

0.40

$18.12

Store, submit, file, or maintain
data

0.00

0.30

0.30

$10.77

TOTAL

3.00

1.20

4.20

$223.94

4