I
                                                      EPA 730-N-97-010
                     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
               PESTICIDE REGISTRATION (PR) NOTICE 97-9

        NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS,
                    AND REGISTRANTS OF PESTICIDES
ATTENTION:
SUBJECT:
                 Persons Responsible For Registration of Pesticides, Manufacturers
                 of Child-Resistant Packaging, and Persons Responsible for the
                 Testing of Child-Resistant Packaging

                 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.

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 (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.

 (& 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

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  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 Notice1
  on this exemption is attached (attachment 2).

  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 recertificatidn
  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.
      !(62 FR 32223, June 13, 1997), available on the internet at:
http://www.epa.gov/fedrgstr/EPA-PEST71997/June/Day-13/p15565.htm

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   f1) 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 electronically2 to eliminate the time necessary to input the data.

         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.
      2The 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.

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        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 stations3 not designed or intended to be opened or
  activated in a manner that exposes the contents to human contact.

  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 package4 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.
      3 For example ant, roach or termite bait stations.

       4When 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.

      5When 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.

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8.
9.
10.
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.

Each child shall be allowed up to 5 minutes to open/gain access to as many of
the units as possible.

 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.

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.)

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.

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.

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.

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.

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 <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 exemption6 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.

 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).
     6(62 FR 32223, June 13, 1997), available on the internet at:
http://www.epa.goV/fedrgstr/EPA-PEST/1997/June/Day-13/ p15565.htm

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   (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 version7 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.

   (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), lnternet:http://www.epa.gov/fedrgstr/ EPA-PEST/1 997
   /June/ Day-13/p1 5565.htm). No action is required to qualify for this exemption.
   However, a GRP 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, nonrefiilable 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)."
      7The 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.

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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 Parti 57.

      Applications for amendment, EPA Form 8570-1, and new CRP certification in
response to this notice must be sent to:
      Postal Service
      Document Processing Desk (AMEND)
      Office of Pesticide Programs (7504C)
      U. S. Environmental Protection Agency
      401 M St., S. W.
      Washington, D. C. 20460-0001
Personal/Courier Service
Document Processing Desk (AMEND)
Office of Pesticide Programs (7504C)
U. S. Environmental Protection Agency
Room 266A, Crystal Mall 2
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-  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
aaccount 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.

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                                                                              10

      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
                                         J^mes J. Jones* Acting Director
                                          Registration Division (7505C)

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                                                           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.

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                            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
Docno
Sample
Testsite
Testarea
Testdate
Tester
Brthdate
Type
character
character
numeric
numeric
numeric
numeric
numeric
Size
9
12
4
2
6
2
6
Format Data




MMDDYY

MMDDYY
Contents
test id= column 4-6;
package id=column 7-
9
identify the pkg for
the five minute test.
subj id adult =A,
child=C in column 9






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Variable
Age
















Sex

Timeday

Openone


Methone
Rscone









Type
numeric
















numeric

numeric

numeric


numeric
numeric









Size
2
















1

4

3


2
3









Format Data
years
















male =1
female =2
use 24 hour
clock
seconds



seconds



;


|


Contents
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
11 728/40 and the test
date is 11 720/95 the
age is 54 [95-40 = 55,
11/20<1 1/28 so 55-1
= 54]




time to open package
1 ; the 5 minute test a
failure is 301

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
16CFR
1700.20(a)(3)(iii))

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Variable
Sample2
Opentwo
Methtwo
Rsctwo
Screen
Scroneto
Scronetc
Scrone
Scrtwoto
Scrtwotc
Scrtwo
Order
Easyhrd
Testcom
Type
character
numeric
numeric
numeric
character
numeric
numeric
numeric
numeric
numeric
numeric
numeric
numeric
character
Size
12
3
2
3
5
3
3
2
3
3
2
1
1
3
Format Data

seconds

seconds

seconds
seconds

seconds
seconds




Contents
identify the pkg for
the one minute test.
subj id adult =A,
child=C in column 9
time to open package
2; the 1 minute test a
failure is 61

time to resecure
package 2; the 1
minute test a failure is
61
do screen yes or no
time open screen pkg
one a failure is 61
time close screen pkg
one a failure is 61
pass=1 fail=2 screen
pkg one
time open screen pkg
two a failure is 61
time close screen pkg
two a failure is 61
pass=1 faii=2 screen
pkg two

very easy to use=1,
easy to use=2, no
opinion=3, hard to
use=4, very hard to
use=5
tester comment

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Variable
Adltcom
Zcodpar
Zcodta
Type
character
numeric
numeric
Size
3
12
12
Format Data



Contents
adult comment
zip code participant
zip code test area

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                                 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
Docno
Sample
Testsite
Testarea
Testdate
Tester
Brthdate
Type
character
character
numeric
numeric
numeric
numeric
numeric
Size
9
12
4
2
6
2
6
Format Data




MMDDYY

MMDDYY
Contents
test id= column 4-
6; package
id=column 7-9
subj id adult =A,
child=C in column
9






-------
Variable
Age









Sex

Timeday

Time_Ope
Method
Resecure

Easyhrd
Testcom
Adltcom
Type
numeric









numeric

numeric

numeric
numeric
numeric

numeric
character
character
Size
2









1

4

3
2
3

1
3
3
Format Data
years







i

male =1
female 2
use 24 hour
clock
seconds

seconds




Contents
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
1 1/28/60 and the
test date is
11/20/95 the age is
34 [95-60 = 35,
11/20<11/28so35-
1 =34]




time to open pkg a
failure is 301

time to resecure a
failure is 301
very easy to use=1,
easy to use=2, no
opinion=3, hard to
use=4, very hard to
use=5
tester comment
adult comment

-------
8
Variable
Zcodpar
Zcodta
Type
numeric
numeric
Size
12
12
Format Data


Contents
zip code participant
zip code test area

-------
                                    CHILD TEST1
   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.
Variable
Docno

Sample

Testsite
Testarea
Testdate
Tester
Brthdate
Age


Sex
Partners

Type
character

character

numeric
numeric
numeric
numeric
numeric
numeric


numeric
numeric

Size
9

12

4
2
6
2
6
2


1
2

Format Data
;

:



MMDDYY

MMDDYY
months


male =1 female = 2


Contents
test id= column
4-6; package
id=column 7-9
subj id adult =A,
child=C in
column 9





see 16 CFR
1700.20 for
calculation
method

# of children in
test group
(should be 2)
      3-A number of variables are only applicable to the unit dose test and would be left blah
for a reclosable package. These variables are marked with an * in the contents columrof this
table.

-------
10
Variable
Testpkg




Timeday
TimeJDpe




Method
Amount
Type
numeric




numeric
numeric




numeric
numeric
Size
2




4
3




2
3
Format Data
package = 1 or 2




use 24 hour clock
seconds






Contents
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

time to open
package [time
for first unit if
unit dose
package]
regardless of
before or after
demonstration.
A failure is 601

*Total amt of
prod access (# g
prod/pkg
multiplied by the
total No. pkges
open/access)

-------
11
Variable
Dose
Amtbdemo
Amtademo
Demo
Teeth
Result
Testcoml
Order
Zcodpar
Zcodta
Type
numeric
numeric
numeric
numeric
numeric
numeric
character
numeric
numeric
numeric
Size
3
3
3
1
1
2
3
1
12
12
Format Data










Contents
Total No. pkges
open/access and
indicate with
submission the
amount of
product and A.I.
that represents
*No. pkges
open/access
before demo
*No. pkges
open/access
after demo
demonstration
given yes= 1
no=2
told to use teeth
yes= 1 no=2 ;
*for each test
subject pass=1
fail=2 based on
tox and # pkges
open/access
Tester
Commentl

zip code
participant
zip code test
area

-------

-------
             Federal  Register / Vol. 62, No.  H4 / Friday, June 13,  1997 ( Rules and Regulations      32223
  00 A record of the total hydrocarbon
concentration, in 3-hour block averages,
for those periods when the total
hydrocarbon concentration being
monitored pursuant to  63.548(J)(2)
exceeds the relevant  limits established
in 63.543 
-------
32224      Federal Register / Vol. 62, No.  114 / Friday, June 13.  1997  /  Rules and Regulations
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 15"7. 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 June 13.1997 and
expires on June 13.2002.

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]
BttJJNCI CODE BSeO-SO-F
ENVIRONMENTAL PROTECTION
AGENCY

40 CFR Part 180
[OPP-300494; FHL-5718-8]
RIN 2070-AB78

Propiconazole; Pesticide Tolerances
(or Emergency Exemptions

AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.

SUMMARY: This regulation establishes
time-limited tolerances for combined
residues of the pesticide propiconazole
In on or the raw agricultural
commodities dry beans, dry bean forage
and dry bean hay in connection with
EPA's granting of emergency
exemptions under section 18 of the
Federal Insecticide, Fungicide, and
Rodentlcide Act authorizing use of
propiconazole on dry beans in
Minnesota. North Dakota, Nebraska.
Colorado and Kansas. These tolerances
will expire and are revoked on
December 31,1998.
DATES: This regulation becomes
effective June 13.1997. Objections and
requests for hearings must be received
by EPA on or before August 12. 1997.
ADDRESSES: Written objections and
hearing requests. Identified by the
docket control number. [OPP-300494],
must be submitted to: Hearing Clerk
(1900), Environmental Protection
Agency. Rm. M3708.401 M St.. SW..
Washington. DC 20460. Fees
accompanying objections and hearing
requests shall be labeled "Tolerance
Petition Fees" and forwarded to: EPA
Headquarters Accounting Operations
Branch, OPP (Tolerance Fees), P.O. Box
360277M. Pittsburgh. PA 15251. A copy
of any objections and hearing requests
filed with the Hearing Clerk identified
by the document control number. [OPP-
300494]. must also be submitted to:
Public Information and Records
Integrity Branch. Information Resources
and Services Division (7506C). Office of
Pesticide Programs, Environmental
Protection Agency. 401 M St., SW.,
Washington, DC 20460. In person, bring
a copy of objections and hearing
requests to Rm. 1132, CM #2,1921
Jefferson Davis Hwy., Arlington, VA. A
copy of objections and hearing requests
filed with the Hearing Clerk may also be
submitted electronically by sending
electronic mail (e-mail) to:  opp-
docket@epamail.epa.gov. Such copies of
objections and hearing requests must be
submitted as an ASCII file avoiding the
use of special characters and any form
of encryption. Copies of objections and
hearing requests will also be accepted
on disks in WordPerfect 5.1 file format
or ASCII file format. All copies of
objections and hearing requests in
electronic form must be identified by
the docket control number  [OPP-
300494]. No Confidential Business
Information (CBI) should be submitted
through e-mail. Electronic copies of
objections and hearing requests on this
rule may be filed online at  many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By
mail: Olga Odiott. Registration Division
(7505W), Environmental Protection
Agency, 401 M St.. SW., Washington.
D.C. 20460. Office location, telephone
number, and e-mail: Sixth Floor, Crystal
Mall #2,1921 Jefferson Davis Highway.
.Arlington. VA 22202. (703) 308-9363. e-
mail: odiott.olga@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA. on
its own initiative, pursuant to section
408(e)  and (1)(6) of the Federal Food,
Drug, and Cosmetic Act (FFDCA). 21
U.S.C.  346a(e) and (1)(6). is establishing
tolerances for the combined residues of
the pesticide propiconazole (l-[[2-{2.4-
dichlorophenyl)-4-propyl-l,3-dioxolan-
2-yl]methyl]-lH-l .2.4-triazole)and its
metabolites determined as 2.4-
dichlorobenzoic acid (DCBA) and
expressed as parent compound, in or on
dry beans at 0.5 part per million (ppm).
in or on dry bean forage at 8.0 ppm.  and
in or on dry bean hay at 8.0 ppm. These
tolerances will expire and be revoked by
EPA on December 31,1998. After
December 31, 1998. EPA will publish a
document in the Federal Register to
remove the revoked tolerance from the
Code of Federal Regulations.
I. Background and Statutory Authority

  The Food Quality Protection Act of
1996 (FQPA) (Pub. L. 104-170) was
signed into law August 3. 1996. FQPA
amends both the Federal Food. Drug,
and Cosmetic Act  (FFDCA). 21 U.S.C.
301 ef seq.. and the Federal Insecticide.
Fungicide, and Rodenticide Act
(FIFRA). 7 U.S.C. 136 et seq. Among
other things, FQPA amends FFDCA to
bring all EPA pesticide tolerance-setting
activities under section 408 with a new
safety standard and new procedures.
These activities are described below and
discussed in greater detail in the final
rule establishing the time-limited
tolerance associated with the emergency
exemption for use of propiconazole on
sorghum (61 FR 58135, November 13,
1996) (FRL-5572-9).
  New section 408(b)(2)(A)(I)ofthe
FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide
chemical residue in or on a food) only
if EPA determines that the tolerance is
"safe." Section 408(b)(2)(A)(li) defines
"safe" to mean that "there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information." This Includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) requires EPA to give special
consideration to exposure of infants and
children to the pesticide chemical
residue in establishing a tolerance and
to "ensure that there is a reasonable
certainty that no harm will result to
infants and children from aggregate
exposure to the pesticide chemical
residue...."
  Section 18 of FIFRA authorizes EPA
to exempt any Federal or State agency
from any provision of FIFRA, if EPA
determines that "emergency conditions
exist which require such exemption."
This provision was not amended by
FQPA. EPA has established regulations
governing such emergency exemptions
in 40 CFR part 166. Section 408(1)(6) of
the FFDCA requires EPA to establish a
time-limited tolerance or exemption
from the requirement for a tolerance for
pesticide chemical residues in food that
will result from the use of a pesticide
under an emergency exemption granted
by EPA under section 18 of FIFRA.  Such
tolerances can be established without

-------
 32224      Federal Register / Vol. 62. No.  114 / Friday. June 13. 1997  / Rules and Regulations
 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 June 13, 1997 and
 expires on June 13.2002.

 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 5-12-97; 8:45 ami
 BRJ.MQ CODE 6560-SO-F
ENVIRONMENTAL PROTECTION
AGENCY

40 CFR Part 180
[OPP-300494; FRL-5718-8]
RIN 2070-AB78

Propiconazole; Pesticide Tolerances
for Emergency Exemptions

AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.

SUMMARY: This regulation establishes
time-limited tolerances for combined
residues of the pesticide propiconazole
in on or the raw agricultural
commodities dry beans, dry bean forage
and dry bean hay in connection with
EPA's granting of emergency
exemptions under section 18 of the
Federal Insecticide, Fungicide, and
Rodenticide Act authorizing use of
propiconazole on dry beans in
Minnesota, North Dakota, Nebraska,
Colorado and Kansas. These tolerances
will expire and are revoked on
December 31,1998.
DATES: This regulation becomes
effective June 13.1997. Objections and
requests for hearings must be received
by EPA on or before August 12, 1997.
ADDRESSES: Written objections and
hearing requests, identified by the
docket control number. [OPP-300494].
must be submitted to: Hearing Clerk
 (1900), Environmental Protection
 Agency. Rm. M3708.401 M St.. SW.,
 Washington. DC 20460. Fees
 accompanying objections and hearing
 requests shall be labeled  "Tolerance
 Petition Fees" and forwarded to: EPA
 .Headquarters Accounting Operations
 Branch, OPP (Tolerance Fees), P.O. Box
 360277M, Pittsburgh, PA 15251. A copy
 of any objections and hearing requests
 filed with the Hearing Clerk identified
 by the document control  number, [OPP-
 300494}. must also be submitted to:
 Public Information and Records
 Integrity Branch. Information Resources
 and Services Division (7506C). Office of
 Pesticide Programs, Environmental
 Protection Agency. 401 M St., SW.,
 Washington, DC 20460. In person, bring
 a copy of objections and hearing
 requests to Rm. 1132. CM #2, 1921
 Jefferson Davis Hwy., Arlington, VA. A
 copy of objections and hearing requests
 filed with the Hearing Clerk may also be
 submitted electronically by sending
 electronic mail (e-mail) to: opp-
 docket@epamail.epa.gov. Such copies of
 objections and hearing requests must be
 submitted as an ASCII file avoiding the
 use of special characters and any form
 of encryption. Copies of objections and
 hearing requests will also be accepted
 on disks in WordPerfect 5.1  file format
 or ASCII file format. All copies of
 objections and hearing requests in
 electronic form must be identified by
 the docket control number [OPP-
 300494]. No Confidential  Business
 Information (CBI) should be submitted
 through e-mail. Electronic copies of
 objections and hearing requests on this
 rule  may be filed online at many Federal
 Depository Libraries.
 FOR FURTHER INFORMATION CONTACT: By
 mail: Olga Odiott. Registration Division
 (7505W). Environmental Protection
 Agency, 401 M St., SW., Washington.
 D.C.  20460. Office location, telephone
 number, and e-mail: Sixth Floor. Crystal
 Mall #2, 1921 Jefferson Davis Highway,
 Arlington. VA 22202. (703) 308-9363. e-
 mail: odion.olga@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on
 its own initiative, pursuant to section
 408(e) and (1)(6) of the Federal Food.
 Drug, and Cosmetic Act (FFDCA). 21
 U.S.C. 346a(e) and (1)(6). is establishing
tolerances for the combined residues of
the pesticide propiconazole (1 -[[2-(2.4-
dichIorophenyl)-4-propyl-l,3-dioxolan-
2-yl)methyl]-lH-l ,2,4-triazole)and its
metabolites determined as 2.4-
dichlorobenzoic acid (DCBA) and
expressed as parent compound, in or on
dry beans  at 0.5 part per million (ppm),
in or on dry bean forage at 8.0 ppm. and
in or on dry bean hay at 8.0 ppm. These
tolerances will expire and be revoked by
 EPA on December 31. 1998. After
 December 31.1998. EPA will publish a
 document in the Federal Register to
 remove the revoked tolerance from the
 Code of Federal Regulations.

 I. Background and Statutory Authority

   The Food Quality Protection Act of
 1996 (FQPA) (Pub. L. 104-170)|was
 signed into law August 3. 1996. FQPA
 amends both the Federal Food.! Drug,
 and Cosmetic Act (FFDCA). 21'U.S.C.
 301 ef seq.. and the Federal Insecticide.
 Fungicide, and Rodenticide Act
 (FIFRA). 7 U.S.C. 136 etseq. Among
 other things. FQPA amends FFDCA to
 bring all EPA pesticide tolerance-setting
 activities under section 408 with a new
 safety standard and new procedures.
 These activities are described below and
 discussed in greater detail in the final
 rule establishing the time-limited
 tolerance associated with the emergency
 exemption for use of propiconazole on
 sorghum (61 FR 58135, November 13,
 1996) (FRL-5572-9).
  New section 408(b) (2) (A) (I)of the
 FFDCA allows EPA to establish a
 tolerance (the legal limit for a pesticide
 chemical residue in or on a food) only
 if EPA determines that the tolerance is
 "safe." Section 408(b)(2)(A)(ii) defines
 "safe" to mean that "there is a
 reasonable certainty that no harm will
 result from aggregate exposure to the
 pesticide chemical residue, including
 all anticipated dietary exposures and all
 other exposures for which there is
 reliable information." This includes
 exposure through drinking water and in
 residential settings, but does not include
 occupational exposure. Section
 408(b)(2)(C) requires EPA to give special
 consideration to exposure of infants and
 children to the pesticide chemical
 residue in establishing a tolerance and
 to "ensure that there is a reasonable
 certainty that no harm will result to
 infants and children from aggregate
 exposure to the pesticide chemical
 residue...."
  Section 18 of FIFRA authorizes EPA
 to exempt any Federal or State agency
 from any provision of FIFRA, if EPA
 determines that "emergency conditions
 exist which require such exemption."
 This provision was not amended by
 FQPA. EPA has established regulations
 governing such emergency exemptions
 in 40 CFR part 166. Section 408(l)(6) of
the FFDCA requires EPA to establish a
time-limited tolerance or exemption
from the requirement for a tolerance for
pesticide chemical residues in food that
will result from the use of a pesticide
under an emergency exemption granted
by EPA under section 18 of FIFRA. Such
tolerances can be established without

-------
             Federal  Register / Vol. 62. No.  114 / Friday. June  13. 1997  / Rules and Regulations     32223
  (II) A record of the total hydrocarbon
concentration. In 3-hour block averages,
for those periods when the total
hydrocarbon concentration being
monitored pursuant to 63.548(j)(2)
exceeds the relevant limits established
in 63.543 
-------

-------

-------