Attachment D- PRN 97-9

Pesticide Registration (PR) Notice 97-9:
Electronic Submission Of Child-Resistant
Packaging Test Data For All Pesticides And
Child-Resistant Testing Of Prefilled,
Nonrefillable Insecticide Bait Stations Not
Designed Or Intended To Be Opened Or
Activated In A Manner That Exposes The
Contents To Human Contact Purpose
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES
November 18, 1997
Fax-On-Demand
Telephone: (202) 401-0527
Item: 6105
NOTE: See EPA's instructions for submitting data electronically on CD-R. (1/11/06)
Notice To: Manufacturers, Producers, Formulators, and Registrants of Pesticide Products
Attention: Persons Responsible For Registration of Pesticides, Manufacturers of Child-Resistant
Packaging, and Persons Responsible for the Testing of Child-Resistant Packaging
Subject: Electronic Submission Of Child-Resistant Packaging Test Data For All Pesticides And ChildResistant Testing Of Prefilled, Nonrefillable Insecticide Bait Stations Not Designed Or Intended To Be
Opened Or Activated In A Manner That Exposes The Contents To Human Contact Purpose
This notice will address four separate issues: (1) electronic submission of
child-resistant packaging (CRP) test data for all pesticides; (2) unit packaging
- individual unit (actual bait station) must be CRP; (3) test procedures
clarification on when and how to test prefilled nonrefillable insecticide bait
stations not designed or intended to be opened or activated in a manner that
exposes the contents to human contact; and (4) exemption from the senior and
younger adult test for prefilled nonrefillable ant or roach insecticide bait
stations not designed or intended to be opened or activated in a manner that

exposes the contents to human contact. Ready-to-use rodenticide bait stations
are not a part of this PR Notice. The Rodenticide RED (Registration Eligibility
Document) will discuss ready-to-use rodenticide bait stations.
(1) ELECTRONIC SUBMISSION
When the Agency exercises its authority under 40 CFR 157.36 (Recordkeeping)
to review child-resistant packaging (CRP) protocol test data for a pesticide it
should be available upon request for inspection and copying or submission to the
Agency. With this PR-Notice the Agency is specifically requesting that this
information, whenever requested, also be made available or submitted in an
electronic format. The electronic availability of CRP protocol test data from
pesticide registrants is part of an Agency effort to expedite CRP protocol test
data review by having the data in a format compatible with computer assisted
data analysis. This notice describes the electronic format requirements
essential for the computer program to recognize the data for computer analysis.
(2) UNIT PACKAGING
Under 40 CFR 157.27, (Unit Packaging) either the outer retail package or
the individual unit package of a pesticide product distributed or sold as an
aggregate of one or more unit packages must qualify as CRP, if the pesticide
product meets the criteria of 40 CFR 157.22. Prefilled, nonrefillable
insecticide bait stations not designed or intended to be opened or activated in
a manner that exposes the contents to human contact are placed for prolonged
periods of time (e.g. more than 24 hours) in locations that may be accessible to
children. Consequently, the individual units themselves (actual bait stations)
rather than the outer packaging must comply with the standards in 40 CFR 157.32
to reduce the risk of accidental injury or illness to children. Products for
which the outer retail package, but not the individual bait stations meet the
standards in 40 CFR 157.32 will be deemed noncompliant.
(3) TEST PROCEDURES CLARIFICATION
This notice also clarifies how the child-resistant packaging protocol test
applies to prefilled, nonrefillable insecticide bait stations not designed or
intended to be opened or activated in a manner that exposes the contents to
human contact. This notice will discuss the condition of the package to be
tested, how to test the package, the number of units and how they are given to
the child at the beginning of the test, whether or not a demonstration of how to
open or activate the package is necessary, the definition of a test failure, the

type of information needed, and when a package should be tested.
(4) EXEMPTION
On June 13, 1997 a five year exemption was granted from the senior-adult
test and younger-adult test effectiveness specifications, described in 16 CFR
1700.15(b)(2) (Ease of adult opening), for prefilled, nonrefillable ant or roach
insecticide bait stations not designed or intended to be opened or activated in
a manner that exposes the contents to human contact. No action is required to
qualify for this exemption. However, the CRP certification for products relying
on this exemption must specify that the package is exempt from compliance with
the senior and younger adult effectiveness specifications per this exemption.
Products qualifying for this exemption must still fully comply with all other
CRP effectiveness, compatibility, and durability standards, as well as all other
requirements of 40 CFR Part 157. A copy of the Federal Register Notice (*1)
on this exemption is attached (attachment 2).
(*1) (62 FR 32223, June 13, 1997), available on the internet at:
http://www.epa.gov/fedrgstr/EPA-PEST/1997/Day-13/p15565.htm
EFFECTIVE DATE
This PR Notice becomes effective upon the date of signature by the Agency.
These policies (as described in this document) apply to all pesticide products
subject to the CRP regulations. The actions discussed in this PR Notice are
supplemental to the CRP requirements of PR 96-2 (regarding the senior friendly
CRP and recertification to CRP by January 21, 1998).
BACKGROUND
FIFRA 25(c) (3) requires EPA's CRP standards to be consistent with those of
the Consumer Product Safety Commission (CPSC). The CPSC is authorized by the
Poison Prevention Packaging Act of 1970 (PPPA) to issue requirements that
certain household chemical products, prescription drugs, and over the counter
pharmaceutical products be sold in CRP.
The CRP protocol test, 16 CFR 1700.20, was designed to measure the child
resistance and adult effectiveness of reclosable and nonreclosable (unit-dose)
packages. The nonreclosable (unit-dose) packages considered when the CRP
protocol test was designed were single packages whose entire contents were
intended to be used at the time of initial opening, and packages consisting of
one or more individually packaged units intended to be used sequentially (e.g.

nonreclosable flexible packaging (strip/pouch), rigid, or semi-rigid packaging
(blister)).
The CRP regulations for pesticides resulted in the development of several
different types of nonreclosable packages that were not considered when the CRP
protocol test was designed. An example is ant and roach bait stations, which
generally use multiple units at one time. Each unit contains the product, which
is placed in use for prolonged periods of time (more than 24 hours) in locations
that may be accessible to children (e.g. on the floor).
These pesticide packages must comply with the effectiveness standards and
protocol testing procedures specified in 40 CFR 157.32 and the Recordkeeping
requirements in 40 CFR 157.36. There may still be a number of questions for
these packages such as what effectiveness standards apply, should the unit
package or the outer retail package be child-resistant; and exactly how should
these types of packages be tested? This PR Notice is intended to answer these
questions.
(1) ELECTRONIC DATA SUBMISSION
The CRP Recordkeeping requirements in 40 CFR 157.36 prescribe that
registrants retain records supporting their CRP certification. Upon request by
the Agency, these records should be available for inspection and copying, or
submission. The Agency conducts a computer assisted analysis of the CRP
protocol test data. In an effort to streamline CRP data analysis and respond
expeditiously to pesticide registrants the Agency requests that CRP data be made
available to the Agency as both a hard copy and electronically(*2) to eliminate
the time necessary to input the data.
(*2) The electronic availability of CRP data is voluntary. Anyone who
would like to comply and is unable to provide all the data
described in this PR Notice should contact Rosalind L. Gross to
ascertain if some type of electronically formatted submission may
be arranged.
Appendix A to this notice contains detailed format instructions that should
be used. The CRP protocol test data is requested to be in the following format:
a hard copy and an electronic version on a 3.5 inch high density computer disk
in an IBM compatible electronic dbf, wk1, or wk3 data base format (e.g. dBASE,
lotus, paradox, Quattro pro) using the field format specifications in the
attached tables (appendix A). Note the dbf format is the preferred format, if a
wk1 or wk3 file can be converted to a dbf file, please do so. All fields in the

format specified in Appendix A for the electronic data submission are essential
for the computer program to recognize the data for electronic analysis.
Additionally, if the file is wk format, the following conditions are integral to
data recognition for computer analysis:
Specify whether the file is a wk1 or wk3
One worksheet per file named "sheet 1"
The variables have a maximum length of 20 characters
Column headings in row 1
A maximum of one row for the titles/column headings
Start the actual data at row 3
Alpha and numeric characters should not be mixed in one field
Row 3 may not be blank
(2) UNIT PACKAGING
Under 40 CFR 157.27, (Unit Packaging) either the outer retail package or
the individual unit package of a pesticide product distributed or sold as an
aggregate of one or more unit packages must qualify as CRP, if the pesticide
product meets the criteria of 40 CFR 157.22. Prefilled, nonrefillable
insecticide bait stations not designed or intended to be opened or activated in
a manner that exposes the contents to human contact are placed for prolonged
periods of time (e.g. more than 24 hours) in locations that may be accessible to
children. Consequently, the individual units themselves (actual bait stations)
rather than outer packaging must comply with the standards in 40 CFR 157.32 to
reduce the risk of accidental injury or illness to children.
Prefilled, nonrefillable insecticide bait stations not designed or intended
to be opened or activated in a manner that exposes the contents to human contact
that are subject to CRP regulations and are packaged and released for shipment
on or after January 21, 1998 must be packaged in individual units (actual bait
stations) that comply with the standards in 40 CFR 157.32, which requires CRP
when tested by the protocol specified in 16 CFR 1700.20 shall meet the
effectiveness specifications in 16 CFR 1700.15(b) as well as the compatibility
and durability standards (40 CFR 157.32(b) and (c)). Products for which the
outer retail package, but not the individual bait stations meet the standards in
40 CFR 157.32 will be deemed noncompliant.
(3) TEST PROCEDURES CLARIFICATION
The testing procedures outlined below are intended to clarify the

procedural requirements described at 16 CFR 1700.20 as they pertain to
prefilled, nonrefillable insecticide bait stations(*3) not designed or intended
to be opened or activated in a manner that exposes the contents to human
contact.
(*3) For example ant, roach or termite bait stations.
Testing Procedure for Child Test
Prefilled, nonrefillable insecticide bait stations not designed or intended
to be opened or activated in a manner that exposes the contents to human contact
must satisfy all the requirements described at 16 CFR 1700.20. The following
directions are intended to clarify the child testing procedures for prefilled,
nonrefillable insecticide bait stations. Please consult 16 CFR 1700.20 in
addition to the specific procedures discussed below to ensure that you have met
all requirements.
1. Remove the outer packaging so that the individual units (actual bait
stations) are immediately available to the child.
2. All the units in a retail package (*4) are to be given to the child at the
beginning of the test (*5). If the units are attached to a removable frame
or other units in the retail package, they are given to the child as they
are found in the retail package.
(*4) When the label of a pesticide product advocates the use of more
than one retail package per single treatment of a residence, EPA
recommends that, at the beginning of the child test, the children
be given the total number of units in the number of retail
packages suggested for a single treatment of the residence.
(*5) When the number of bait stations in the retail package (retail
package size) varies a registrant may want to consider a testing
scheme as an alternative to testing each retail package size. In
those instances, the Agency should be contacted to ascertain
whether or not this approach will satisfy the requirements of 40
CFR Part 157.
3. If a component such as a stake or plastic frame is included in the retail
package this component is given to the child with the unit packages at the
beginning of the test.
4. Each child shall be allowed up to 5 minutes to open/gain access to as many
of the units as possible.

5. At the end of the first 5 minutes, the tester shall not demonstrate how to
open the package because the package is not designed or intended to be
opened or activated in a manner that exposes the contents to human contact.
6. A second 5 minutes is allowed for all subjects to open/gain access to as
many of the unit packages as they can. If one or both children have not
used their teeth to try to open the unit packages during the first 5
minutes, the tester shall instruct the children, before the start of the
second 5 minute period, that they are permitted to use their teeth if they
so desire. (See 16 CFR 1700.20(a) (2) (iv) (25) for details.)
7. A test failure is defined as any child who gains access to an amount of the
pesticide product that may produce serious personal injury or illness, or a
child who opens or gains access to the contents of more than 8 individual
units, whichever number is lower, during the full 10 minutes of testing.
The determination of the amount of a substance that may produce serious
personal injury or illness shall be based on a 25 pound (11.4 kg) child.
8. In addition to the recommendations in 16 CFR 1700.20(d), the test data
report should include information regarding:
whether or not the children were told to use their teeth
the total number of unit packages opened or accessed for the full ten
minute (two 5 minute) time period.
the method used to open or access each unit
for each unit was the package damaged and how
for each unit was the product exposed or accessed and quantify amount
exposed or accessed.
9. Retesting of the unit package is required if there is a change in the
package or pesticide formulation which could affect its child-resistance
e.g., film thickness, package materials, package seal, package or
formulation color change, pesticide formulation more crumbly, pesticide
formulation more fluid, etc.
10. The compatibility and durability standards in 40 CFR 157.32 still apply to
prefilled, nonrefillable insecticide bait stations. If the bait stations
are used outdoors, registrants are reminded to take into consideration the
effects of weather and temperature on the ability of the pesticide product
as packaged to continue to meet the effectiveness and compatibility

standards for the lifetime of the package.
(4) EXEMPTION
A registrant requested an exemption from the senior-adult test and
younger-adult test effectiveness specifications, described in 16 CFR
1700.15(b)(2) for prefilled, nonrefillable ant or roach insecticide bait
stations not designed or intended to be opened or activated in a manner that
exposes the contents to human contact. The registrant argued that it was
unnecessary to test the ability of adults to open and resecure a package that is
not designed or intended to be opened. Such packages do not present the risk
associated with difficult to open packages of being disabled or left unsecured
by an adult to avoid the need to reopen them. It is unlikely that the contents
of such packages will be left accessible to children due to the actions of an
adult. Instead, from a child safety standpoint, the only relevant question
regarding such packages is whether they can prevent a child from gaining access
to the bait.
The Agency has authority under 40 CFR 157.24 (b) (3) to grant an exemption
from any CRP requirement, including the testing requirements, based on technical
considerations. EPA has granted a five year exemption(*6) from the senior-adult
test and younger-adult test effectiveness specifications described in 16 CFR
1700.15(b)(2) for prefilled, nonrefillable ant or roach insecticide bait
stations not designed or intended to be opened or activated in a manner that
exposes the contents to human contact. The Agency has granted the exemption
because it is unnecessary to test the ability of a senior-adult or younger-adult
to open and properly resecure a package not designed or intended to be opened or
activated. No benefits in terms of improved child safety would be gained by
such testing. In accordance with 40 CFR 157.24(b), no registrant action is
necessary to qualify for this exemption. However, CRP certification for
products relying on this exemption must specify that this package is exempt from
compliance with the senior and younger adult effectiveness specifications per
this exemption. Furthermore, registrants are reminded that pesticides subject
to the CRP regulations in 40 CFR Part 157 must still comply with child-resistant
effectiveness, compatibility, and durability standards, as well as all other
requirements of 40 CFR Part 157.
(*6) (62 FR 32223, June 13, 1997), available on the internet at:
http://www.epa.gov/fedrgstr/EPA-PEST/1997/Day-13/p15565.htm
REGISTRANT ACTION, COMPLIANCE DATE, AND APPLICABILITY

This PR Notice becomes effective upon the date of signature by the Agency.
These policies (as described herein) apply to all pesticide products subject to
the CRP regulations. Ready-to-use rodenticide bait stations are not a part of
this PR Notice. The Rodenticide RED (Registration Eligibility Document) will
discuss ready-to-use rodenticide bait stations. Note the actions discussed in
this PR Notice are supplemental to the CRP requirements of PR Notice 96-2
(regarding the senior friendly CRP and recertification to CRP by January 21,
1998).
(1) ELECTRONIC SUBMISSION
Within 90 days of the effective date of this PR Notice CRP protocol test
data made available to the Agency is requested to be in the following format: a
hard copy and an electronic version (*7) on a 3.5 inch high density computer disk
in an IBM compatible electronic dbf, wk1, or wk3 data base format using the
field format specifications in the attached tables (appendix A). All fields in
the format specified in Appendix A for the electronic data submission are
essential for the computer program to recognize the data for electronic
analysis.
(*7) The electronic availability of CRP data is voluntary. Anyone who
would like to comply and is unable to provide all the data
described in this PR Notice should contact Rosalind L. Gross to
ascertain if some type of electronically formatted submission may
be arranged.
(2) UNIT PACKAGING & (3) TEST PROCEDURES CLARIFICATION
Prefilled, nonrefillable insecticide bait stations subject to the CRP
regulations that are not designed or intended to be opened or activated in a
manner that exposes the contents to human contact, which are packaged and
released for shipment on or after January 21, 1998 must be packaged in
individual units themselves (actual bait stations) rather than outer packaging
that comply with the standards in 40 CFR 157.32. Products for which only the
outer retail package, but not the individual bait stations meet the standards in
40 CFR 157.32 will be deemed noncompliant.
(4) EXEMPTION
A five year exemption from senior-adult test and younger-adult test
effectiveness specifications, described in 16 CFR 1700.15(b) (2) for prefilled,
nonrefillable ant or roach insecticide bait stations not designed or intended to

be opened or activated in a manner that exposes the contents to human contact
became effective June 13, 1997 ((62 FR June 13, 1997, p32223),
Internet:http://www.epa.gov/fedrgstr/EPA-PEST/1997/June/Day-13/p15565.htm). No
action is required to qualify for this exemption. However, a CRP certification
or CRP recertification per PR Notice 96-2 for products relying on this exemption
must specify that the package is exempt from compliance with the senior and
younger adult effectiveness specifications per this exemption. The statement:
"I certify that the individual unit packaging used for this product meets
the standards of 40 CFR 157.32, including the revised effectiveness
specifications in 16 CFR 1700.15(b) when tested by the revised testing
procedures in 16 CFR 1700.20. The packaging used is a prefilled,
nonrefillable ant or roach insecticide bait station that is not designed or
intended to be opened or activated in a manner that exposes the contents to
human contact and as such is exempt from compliance with the senior-adult
test and younger-adult test effectiveness specifications as described in 16
CFR 1700.15(b) (2), (Ease of adult opening)."
will suffice for this purpose. It should be noted that products relying on this
exemption must still fully comply with all other child-resistant packaging
effectiveness, compatibility, and durability standards, as well as all other
requirements of 40 CFR Part 157.
Applications for amendment, EPA Form 8570-1, and new CRP certification in
response to this notice must be sent to:
Postal Service Personal/Courier Service
Document Processing Desk (AMEND) Document Processing Desk (AMEND)
Office of Pesticide Programs (7504C) Office of Pesticide Programs (7504C)
U. S. Environmental Protection Agency U. S. Environmental Protection Agency
401 M St., S. W. Room 266A, Crystal Mall 2
Washington, D. C. 20460-0001 1921 Jefferson Davis Highway
Arlington, VA 22202-4501
Comments or questions regarding one or more of these policies should be
clearly identified as pertaining to PR 97-9 and state each issue discussed in
this PR Notice to which the submission pertains. Comments or questions should
be accompanied by supporting data. These comments and/or questions should be
addressed to Rosalind L. Gross (see address below) within 60 days of this PR
Notice.

Failure to comply with the terms of 40 CFR 157.32 is a violation of FIFRA
because the pesticide product is misbranded pursuant to FIFRA Section
2(q)(1)(B). It shall be unlawful under FIFRA Section 12(a) (1) (E) for any person
to sell or distribute a misbranded pesticide product that does not comply with
40 CFR Section 157.32. Such an unlawful act may subject the person to a civil
penalty under FIFRA Section 14. It is a violation of 18 U.S.C. Section 1001 to
knowingly and willfully make a false statement or representation in any matter
within the jurisdiction of any department or agency of the United States.
PAPERWORK REDUCTION ACT NOTICE
The annual public burden for the collection of information associated with
the CRP requirements at 40 CFR Part 157 are approved by the Office of Management
and Budget (OMB) under OMB Control No. 2070-0052 (EPA ICR #616), and is
estimated at 1.7 hours per response. The revised burden to accommodate the
voluntary electronic submission of CRP data as described in this PR-Notice, is
estimated to be 1.9 hours per response. The Agency has therefore adjusted the
burden hours under OMB Control No. 2070-0052 to account for the slight increase
in burden associated with making this information available electronically.
According to the Paperwork Reduction Act, "burden" means the total time, effort,
or financial resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For this collection
it includes the time needed to review instructions; acquire CRP in compliance
with the regulations, certify to CRP, collecting, verifying, and maintaining
information. An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a currently valid
OMB control number. The OMB control numbers for EPA's regulations, after
initial display in the final rule, are listed in 40 CFR part 9.
Send comments on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including through the use of automated collection techniques
to the Director, OPPE Regulatory Information Division, U.S. Environmental
Protection Agency (Mail Code 2137), 401 M Street, S.W., Washington, D.C. 20460.
Include the OMB control number in any correspondence, but do not submit the
requested information to this address. The requested information should be
submitted in accordance with the instructions in this PR Notice.
ADDITIONAL INFORMATION
For further information about this notice, please contact:

Rosalind L. Gross
Technical Review Branch
Registration Division (7505C)
EPA
401 M Street, SW
Washington, D.C. 20460-0001
(703) 308-7368
Internet [email protected]. GOV

signed by James J. Jones
James J. Jones, Acting Director
Registration Division (7505C)

===============================================================
=================
APPENDIX A
NOTE CRP TEST DATA ELECTRONIC SUBMISSION

The Environmental Protection Agency (EPA) does a computer assisted analysis
of the child-resistant packaging (CRP) protocol test data. In an effort to
streamline CRP data analysis and respond expeditiously to pesticide registrants
the Agency requests that CRP data be submitted as a hard copy and electronically
to eliminate the time necessary to input the data. Electronic retention of CRP
data is not mandatory at this time. The EPA regulates pesticide registrants and
not CRP manufacturers and CRP testing organizations. Nonetheless, pesticide
registrants, CRP manufacturers, and CRP testing organizations are requested to
store CRP protocol test data in the following format: a hard copy and an
electronic version on a 3.5 inch high density computer disk in an IBM compatible
electronic dbf, wk1, or wk3 data base format (e.g. dbase, lotus, paradox,
quattro pro) using the field format specifications in the attached tables. Note
the dbf format is the preferred format, if a wk1 or wk3 file can be converted to
a dbf file, please do so. All fields in the format specified on the attached
sheets for the electronic data submission are essential for the computer program
to recognize the data for electronic analysis. Additionally, if the file is wk
format, the following conditions are integral to data recognition for computer

analysis:
Specify whether the file is a wk1 or wk3
One worksheet per file named "sheet 1"
The variables have a maximum length of 20 characters
Column headings in row 1
A maximum of one row for the titles/column headings
Start the actual data at row 3
Alpha and numeric characters should not be mixed in one field
Row 3 may not be blank
If two child tests are done on the same subjects the second test should be
a separate data file. The adult and child tests should be submitted as separate
files, rather than using the sample field to identify them.

SENIOR ADULT TEST
Note: when numeric codes are assigned to variables that are words (e.g. test
area, sex, tester) a list of the numbers assigned to each value (e.g. male =1
female = 2) must also be included. The adult and child tests should be
submitted as separate files rather than using the sample field to identify them.
Variable Type Size Format Contents
Data
Docno character 9 test id=column 4-6; package id=column 7-9
Sample character 12 identify the pkg for the five minute test.
subj id adult=A, child=C in column 9
Testsite numeric 4
Testarea numeric 2
Testdate numeric 6 MMDDYY
Tester numeric 2
Brthdate numeric 6 MMDDYY
Age numeric 2 years The age of senior adults is calculated by
subtracting the test date year from the birth
date year. If the test date month and day is
less than the birth date month and day, then
one is subtracted from the age. For example,
if the birth date is 11/28/40 and the test
date is 11/20/95 the age is 54 [95-40 = 55,
11/20<11/28 so 55-1 = 54]

Sex numeric 1 male=1, female=2
Timeday numeric 4 use 24 hour clock
Openone numeric 3 seconds time to open package #1; the 5 minute test-a
failure is 301
Methone numeric 2
Rscone numeric 3 seconds time to resecure package #1; the 5 minute
test-a failure is 301 (NOTE a failure to
resecure pkg #1 should not be construed as a
senior adult test failure see 16 CFR
1700.20(a)(3)(iii))
Sample2 character 12 identify the pkg for the one minute test.
subj id adult=A, child=C in column 9
Opentwo numeric 3 seconds time to open package #2; the 1 minute test-a
failure is 61
Methtwo numeric 2
Rsctwo numeric 3 seconds time to resecure package 2; the 1 minute test
a failure is 61
Screen character 5 do screen yes or no
Scroneto numeric 3 seconds time open screen pkg one; a failure is 61
Scronetc numeric 3 seconds time close screen pkg one; a failure is 61
Scrone numeric 2 pass=1 fail=2, screen pkg one
Scrtwoto numeric 3 seconds time open screen pkg two a failure is 61
Scrtwotc numeric 3 seconds time close screen pkg two a failure is 61
Scrtwo numeric 2 pass=1 fail=2, screen pkg two
Order numeric 1
Easyhrd numeric 1 very easy to use=1, easy to use=2, no
opinion=3, hard to use=4, very hard to use=5
Testcom character 3 tester comment
Adltcom character 3 adult comment
Zcodpar numeric 12 zip code participant
Zcodta numeric 12 zip code test area

ADULT TEST
Note: when numeric codes are assigned to variables that are words (e.g. test
area, sex, tester) a list of the numbers assigned to each value (e.g. male =1
female = 2) must also be included. The adult and child tests should be
submitted as separate files rather than using the sample field to identify them.
Variable Type Size Format Contents

Data
Docno character 9 test id=column 4-6; package id=column 7-9
Sample character 12 subj id adult=A, child=C in column 9
Testsite numeric 4
Testarea numeric 2
Testdate numeric 6 MMDDYY
Tester numeric 2
Brthdate numeric 6 MMDDYY
Age numeric 2 years The age of younger adults is calculated by
subtracting the test date year from the birth
date year. If the test date month and day is
less than the birth date month and day, then
one is subtracted from the age. For example,
if the birth date is 11/28/60 and the test
date is 11/20/95 the age is 34 [95-60 = 35,
11/20<11/28 so 35-1 = 34]
Sex numeric 1 male=1, female=2
Timeday numeric 4 use 24 hour clock
Time_Ope numeric 3 seconds time to open pkg; a failure is 301
Method numeric 2
Resecure numeric 3 seconds time to resecure; a failure is 301
Easyhrd numeric 1 very easy to use=1, easy to use=2, no
opinion=3, hard to use=4, very hard to use=5
Testcom character 3 tester comment
Adltcom character 3 adult comment
Zcodpar numeric 12 zip code participant
Zcodta numeric 12 zip code test area

CHILD TEST
Note: when numeric codes are assigned to variables that are words (e.g. test
area, sex, tester) a list of the numbers assigned to each value (e.g. male =1
female = 2) must also be included. If two child test are done on the same
subjects the second test should be a separate data file. The adult and child
tests should be submitted as separate files rather than using the sample field
to identify them. (A number of variables are only applicable to the unit dose
test and would be left blank for a reclosable package. These variables are
marked with an * in the contents column of this table.)
Variable Type Size Format Contents

Data
Docno character 9 test id= column 4-6; package id=column 7-9
Sample character 12 subj id adult=A, child=C in column 9
Testsite numeric 4
Testarea numeric 2
Testdate numeric 6 MMDDYY
Tester numeric 2
Brthdate numeric 6 MMDDYY
Age numeric 2 months (see 16 CFR 1700.20 for calculation method)
Sex numeric 1 male=1 female= 2
Partners numeric 2 # of children in test group (should be 2)
Testpkg numeric 2 package=1 or 2. Indicates whether the child
tested the package first or second (a child
may test 2 different packages per 16 CFR
1700.20(a) (2) (iv) (29)). If only one package
is tested, package=1
Timeday numeric 4 use 24 hour clock
Time_Ope numeric 3 seconds time to open package [time for first unit if
unit dose package] regardless of before or
after demonstration. A failure is 601
Method numeric 2
Amount numeric 3 *Total amt of prod access (# g prod/pkg
multiplied by the total No. pkges
open/access)
Dose numeric 3 *Total No. pkges open/access and indicate
with submission the amount of product and
A.I. that represents
Amtbdemo numeric 3 *No. pkges open/access before demo
Amtademo numeric 3 *No. pkges open/access after demo
Demo numeric 1 demonstration given; yes=1 no=2
Teeth numeric 1 told to use teeth; yes=1 no=2
Result numeric 2 *for each test subject pass=1 fail=2 based on
tox and # pkges open/access
Testcom1 character 3 Tester Comment 1
Order numeric 1
Zcodpar numeric 12 zip code participant
Zcodta numeric 12 zip code test area
===============================================================
=================

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 157
[OPP-250123; FRL-5720-5]
Ant or Roach Insecticide Bait Stations;
Exemption From Adult Portion of Child-Resistant Testing Specifications
AGENCY: Environmental Protection Agency (EPA).
ACTION: Rule related notice.
SUMMARY: This document grants a 5-year exemption from the senior-adult test and
younger-adult test effectiveness specifications, described in 16 CFR
1700.15(b)(2) (Ease of adult opening), for prefilled, nonrefillable ant or roach
insecticide bait stations not designed or intended to be opened or activated in
a manner that exposes the contents to human contact. Products qualifying for
this exemption must still fully comply with all other child-resistant packaging
(CRP) effectiveness, compatibility, and durability standards, as well as all
other requirements of 40 CFR part 157. CRP certification for products relying on
this exemption must specify that the package does not comply with the senior and
younger adult effectiveness specifications per this exemption. This exemption
was requested by S.C. Johnson & Son, Inc., which argued that a package that does
not require opening or activation to put into use should not require adult ease
of opening testing.
DATES: This exemption becomes effective on [insert date of publication in the
Federal Register] and expires on [insert date 5 years after date of publication
in the Federal Register].
FOR FURTHER INFORMATION CONTACT: Rosalind L. Gross, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460, Telephone number: (703) 308-7368, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: S.C. Johnson & Son, Inc. requested an exemption from
the senior-adult test and younger-adult test effectiveness specifications,
described in 16 CFR 1700.15(b)(2) (Ease of adult opening), for prefilled,
nonrefillable ant or roach insecticide bait stations that are not designed or
intended to be opened or activated in a manner that exposes the contents to

human contact.
I. Background
FIFRA 25(c) (3) requires EPA's CRP standards to be consistent with those of
the Consumer Product Safety Commission (CPSC). EPA's CRP regulations at 40 CFR
157.32 require that CRP for pesticides meet the CPSC packaging standards
(effectiveness specifications) and testing procedures set forth in 16 CFR
1700.15(b) and 17000.20. The CPSC Poison Prevention Packaging Standards in 16
CFR 1700.15(b) provide that CRP, when tested by the method described in 16 CFR
1700.20, shall meet certain child-resistant test, senior-adult test, and
younger-adult test effectiveness specifications. In 16 CFR 1700.15(b)(2), the
senior-adult test and younger-adult test effectiveness specifications are
discussed with reference to the senior-adult panel test of 16 CFR 1700.20(a)(3)
and the younger-adult panel test of 16 CFR 1700.20(a)(4), respectively.
The EPA CRP regulations provide that exemptions from compliance may be
requested on a case-by-case basis for specific products based on technical
factors (40 CFR 157.24(b) (3)). The regulations further provide that any such
exemption decision will be published in the Federal Register, will be for a
specified length of time, and will be applicable to any product with
substantially similar composition and intended uses.
II. Requested Grounds for Exemption
As support for its exemption request, S.C. Johnson & Son, Inc. advanced the
following arguments:
The purpose of adult testing is to ensure that CRP is not difficult for
adults to use properly. If CRP is difficult for adults to open, the concern
arises that the package may be disabled or left unsecured to eliminate the
difficulty of reopening it. Under such circumstances the contents would be
accessible to children. In the case of prefilled, nonrefillable ant or roach
insecticide bait stations not designed or intended to be opened, this concern
does not arise. There is no risk that an adult will disable or fail to resecure
a difficult to open package, because the packages need not be opened or
activated in order to function properly. As there is no concern that an adult
will disable or fail to resecure such a package, there is also no concern that
the contents of disabled or unsecured packages will be accessible to children.
Instead, from a child safety standpoint, the only relevant question regarding
such packages is whether they can prevent a child from gaining access to the

bait.
III. Agency Determination
The Agency has considered the S.C. Johnson & Son, Inc. exemption request
and the basis therefore and agrees that it is unnecessary to test the ability of
a senior-adult or younger-adult to open and properly resecure a package not
designed or intended to be opened or activated. No benefits in terms of improved
child safety would be gained by such testing. Therefore, the Agency hereby
grants a 5-year exemption from the senior-adult test and younger-adult test
effectiveness specifications, described in 16 CFR 1700.15(b)(2) for prefilled,
nonrefillable ant or roach insecticide bait stations not designed or intended to
be opened or activated in a manner that exposes the contents to human contact.
The Agency has authority under 40 CFR 157.24(b) (3) to grant an exemption from
any CRP requirement, including the testing requirements, based on technical
considerations.
IV. Exemption
A 5-year exemption is granted from the senior-adult test and younger-adult
test effectiveness specifications, described in 16 CFR 1700.15(b)(2), for
prefilled, nonrefillable ant or roach insecticide bait stations not designed or
intended to be opened or activated in a manner that exposes the contents to
human contact. Products that qualify for this exemption must fully comply with
all other CRP effectiveness, compatibility, and durability standards as well as
all other requirements of 40 CFR part 157. CRP certification for products
relying on this exemption must specify that the package does not comply with the
senior and younger adult effectiveness specifications per this exemption. This
exemption becomes effective on [insert date of publication in the Federal
Register and expires on [insert date 5 years after date of publication in the
Federal Register].
List of Subjects in 40 CFR Part 157
Administrative practice and procedure, Infants and children, Packaging and
containers, Pesticides and pest, Reporting and recordkeeping requirements.
Dated: June 4, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.

[FR Doc. 97-15565 Filed 6-12-97; 8:45 am]
BILLING CODE 6560-50-F