Pesticide Registration (PR) Notice 97-9 

 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) 

 PESTICIDE REGISTRATION (PR) NOTICE 97-9 

 

 NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS, 

 AND REGISTRANTS OF PESTICIDES 

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 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 

 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 Gross.Rosalind@EPAMAIL.EPA. 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: 

gross.rosalind@epamail.epa.gov. 

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 

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