EPA737-N-96-001
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND
TOXIC SUBSTANCES
PR NOTICE 96-2
February 27, 1996
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
CHANGES TO CHILD-RESISTANT PACKAGING (CRP)
TESTING REQUIREMENTS
PURPOSE
This notice announces revisions to the effectiveness standards applicable to
child-resistant packaging (CRP). The EPA's CRP regulations at 40 CFR 157.32
reference the Consumer Product Safety Commission (CPSC) packaging standards and
testing procedures for CRP (16 CFR 1700.15(b) and 1700.20). The EPA reference to
16 CFR 1700.15(b) and 1700.20 always refers to. the most recent version of these
regulations. The CPSC has published a final rule in the Federal Register revising its
CRP packaging standards and testing procedures. 60 FR 37710 (July 21, 1995).
Consequently, the packaging standards and testing procedures pesticide registrants
are required to comply with have changed. This notice explains the CPSC revisions to
16 CFR 1700.15(b) and 1700.20 for pesticide registrants subject to CRP requirements.
This PR Notice becomes effective upon the date of signature by the Agency. All
pesticides subject to the CRP regulations and packaged and released for shipment
on or after January 21, 1998 (30 months after publication of the CPSC final rule) must
comply with the mandatory provisions of the new effectiveness standards and
protocol test procedures.
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BACKGROUND
FIFRA 25(c)(3) requires EPA's CRP standards to be consistent with those
established under the Poison Prevention Packaging Act of 1970 (PPPA). The CPSC is
authorized by the PPPA to issue requirements that certain household substances,
excluding pesticides, be sold in CRP. To avoid duplicative testing of packages for
pesticidal and nonpesticidal purposes, EPA CRP regulations reference the CPSC
regulations.
In order to comply with the CRP standards, a package must resist entry by most
young children and must not be difficult for most adults to open and properly resecure,
within a specified time period in testing. CPSC has concluded that more effective CRP
is necessary to reduce accidental ingestion of products by young children. It has been
observed that some persons, especially older persons, find certain types of CRP difficult
to open and resecure properly. Therefore, a number of people either purchase products
in packages that are not child-resistant or do not properly resecure the package after
opening it initially.
The CPSC has determined that if these difficult-to-use packages were replaced
with packages that are easier to use, more people would purchase and properly use
CRP, with a reduction in the number of poisonings to young children.
EPA is in agreement with the CPSC's conclusion that if these difficult-to-use
packages were replaced with packages that are easier to use, more people would
purchase and properly use CRP. EPA believes that adopting CPSC's revised protocol
requirements will reduce the need for duplicative testing of packages for pesticidal and
nonpesticidal purposes, improve the effectiveness of CRP, and reduce the injuries to
children from pesticides as packaged.
TEST CHANGES
The revisions to the adult test were issued to increase the use of child-resistant
packaging by making it easier for adults to open. The revisions to the adult test
substitute 100 older adults (50-70 years old) for the current adult panel. The senior
adult panel involves two test periods, 5 minutes and 1 minute. Products that must be
packaged in metal containers or in aerosol form are exempt from the senior adult panel,
but remain subject to the current 18-45 year old test panel, the younger adult panel.
The revisions to the child test include sequential testing, which will make the test easier
to perform. For all the tests, the number of subjects tested by any one tester and at any
one site are limited. Also, standardized instructions are required for the child and senior
adult tests, which make the test results more consistent without adversely affecting the
ability of the test to determine child-resistance. .
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SUMMARY OF CHANGES TO THE PACKAGING STANDARDS AND TESTING
PROCEDURES
Note: Consult the CPSC Federal Register (FR) Notice attached to this document
for the details on how to conduct the test, conditions of packages to be tested,
age and gender distribution, test instructions, screening test, number of test sites
and testers, sequential testing, numbers of package openings for child-
resistance, senior adult use effectiveness, adult-resecuring test, aerosol/metal
container exemption, and the applicability of the various tests. A brief summary of
the testing procedures is provided below.
SENIOR ADULT TEST
o Senior adult test panel consists of 100 seniors 50-70 years old (50-54 years old
25%, 55-59 years old 25%, 60-70 years old 50%), 70% of whom are female.
o The test includes a 5 minute test period followed by a 1 minute test period. The
senior adult use effectiveness (SAUE) must be >90%.
o Subjects who do not open the test package in the first 5 minutes are screened
with two non-CR packages (a snap and a continuous-threaded plastic closure)
and are given 1 minute to open and properly reclose each of the two non-CRs.
Only persons who pass the non-CR screening test (open and properly reclose
both non-CRs) are included in the panel.
o A pass on the Senior Adult Test involves opening the test package in the 5
minute test period and opening and properly resecuring the test package in the
second 1 minute test period. A pass for unit dose packaging involves opening a
single (unit) package during both test periods.
o Adults are tested individually. A new identical package is used for the second 1
minute test period. The adults shall receive only such printed instructions on
opening and properly resecuring the CRP as will appear on or accompany it to
the consumer.
o Numbers of testers and test sites are limited such that there is a maximum of
24% senior adults/site and 35% senior adults/tester.
This test does not apply to pesticides that must be packaged in metal containers
or in aerosol form that meet specific criteria. Those pesticides will remain subject to the
younger adult test requirements.
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YOUNGER ADULT TEST
o The younger adult test panel consists of 100 adults 18-45 years old, 70% of
whom are female. Participants are given a 5 minute test period to open and
properly resecure the package. The younger adult use effectiveness (YAUE)
shall be > 90%.
o A pass involves successfully opening the CRP and properly resecuring it (if
appropriate) in a 5 minute test period. In trie case of unit packaging, a pass
involves the successful opening of a single package.
o The younger adults are tested individually. The adults shall receive only such
printed instructions on opening and properly resecuring the CRP as will appear
on or accompany it to the consumer.
o Numbers of testers and test sites are limited such that there is a maximum of
35% younger adults/site and 35% younger adults/tester.
CHILD TEST
o The sequential child test uses 1-4 groups of 50 children 42-51 months old (may
total 200 children) with no more than a 10% preponderance of either gender
within each age group. Each group of 50 children must contain an age
distribution of 42-44 months (30%), 45-48 months (40%), and 49-51 months
(30%).
o The test consists of allowing the children 5 minutes to open the package or gain
access to its contents. If either child has not opened his or her package, the
tester shall demonstrate how to open the package. If the children have not tried
to use their teeth they are told they may do so, and a second 5 minutes is
allowed to open the package or gain access to its contents. A sequential chart
on when to pass/fail/continue the testing is given in the FR.
o The child-resistant effectiveness shall be >85% without a demonstration and >
80% with a demonstration. In the case of unit packaging, child-resistant
effectiveness shall be > 80% (when 200 children are tested).
o A failure is when the child opens the package or gains access to its contents.
For a unit dose, a failure is when a sufficient number of packages are opened or
gained access to which constitute the amount that may produce serious personal
injury or illness (based on a 25 pound/11.4 kg child) or more than 8 individual
units, whichever number is lower, during the 10 minute test. The number of units
that a child opens or gains access to is interpreted as the individual units from
which the product has been or can be removed in whole or in part.
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o The children are tested in groups of 2 in a location familiar to them. No child
shall test more than 2 packages and they shall be a different ASTM type.
o Numbers of testers and test sites in each sequential group of 50 such that
there is a maximum of 30% children/tester and 20% children/site.
OTHER CHANGES
ADULT-RESECURING TEST
o An adult resecuring test for CRP is recommended when an objective
determination cannot be made that the package is properly resecured (visual or
mechanical observations are not reliable, e.g., continuously threaded closures).
o The adult resecuring test involves taking the packages from the senior adult test
or the younger adult test which appear to be resecured and subjecting them to a
child test.
o The CPSC regulations discuss adult use effectiveness for this test in paragraph
3.a. of section 1700.20(d)(2), which states:
"1. The number of adult opening and resecuring failures, plus the number
of packages that were opened by the children during the full 10-minute
test that exceeds 20% of the apparently-resecured packages, equals the
total number of failures.
2. The total number of packages tested by adults (which is 100) minus the
total number of failures equals the percent adult-use effectiveness."
AEROSOL/METAL CONTAINER EXEMPTION
o Aerosol products that are self-contained pressurized products and metal
containers that consist of a metal package and metal closure are exempt from
the senior adult test provided they meet certain criteria (see section 1700.15(b)
(2) (ii) (B) (1)). Manufacturers of products or packages should have proof of why
a product qualifies for this exemption.
o These aerosol and metal container products must comply with the younger adult
test (16 CFR 1700.20(a)(4)) and have an effectiveness of > 90%. These
products are still subject to the revised child test.
o Certain products may not qualify for the metal container exemption if the product
or another product with identical composition has been or is being marketed in
packaging or a closure that is not metal, in this case, it is presumed that such a
product does not require a metal container.
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CONDITION OF PACKAGES TO BE TESTED is described in section 1700.20(a)(1)(ii)
of the CPSC regulations, page 37735 of the FR.
COMPLIANCE PATES AND AGENCY ACTION
o Effective dates for the new requirements as they pertain to products under CPSC
jurisdiction are set out at page 37734 of the FR notice.
o Rather than using the four different effective dates for implementing the revisions
to 16 CFR 1700.15(b) and 1700.20 as indicated in the CPSC FR Notice, EPA will
utilize one effective date. The rationale for EPA employing one effective date is
to allow for the worse case scenario, i.e., a package needs to be tested for
compliance with the senior adult test first, then the package is tested for
resecuring (if applicable) and child-resistance.
o All pesticides subject to the CRP regulations and packaged and released for
shipment on or after January 21,1998 (30 months after publication of the
CPSC FR Notice) must comply with the mandatory provisions of the new
effectiveness standards and protocol test procedures.
An adequate supply of CRP in compliance with the new effectiveness standards
and protocol test procedures is expected to be developed in response to the CPSC
regulations. The majority of pesticide products use the same CRP as that used by
products under the CPSC jurisdiction. It is expected that CRP in compliance with the
new effectiveness standards and protocol test procedures will be technically feasible,
practicable, and appropriate (as defined in 40 CFR Part 157).
Existing CRP and their certifications will not be grandfathered into compliance.
Anyone who has a pesticide subject to CRP requirements and cannot obtain CRP in
compliance with the new effectiveness standards and protocol test procedures by
January 21,1998 may request an exemption under 40 CFR 157.24. The exemption
request should be sent to Rosalind L. Gross at the address given below. The registrant
should provide information (as described in 40 CFR 157.24) justifying the exemption
request along with toxicity information regarding which of the toxicity criteria (including
numeric values and MRID numbers) under 40 CFR 157.22 necessitate the product to
be in CRP. The Agency will evaluate these exemption requests and notify the registrant
of its decision.
If necessary, any generic questions which result from this PR Notice will be
addressed in a subsequent PR Notice.
REGISTRANT ACTION
Pesticide registrants subject to the CRP regulations should review their packages
to see if they comply already, need to test their CRP, and/or need to acquire packages
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that meet the new effectiveness standards and protocol test procedures by January 21,
1998.
To ensure that all registrants are in compliance with the revised effectiveness
standards and protocol test procedures, by January 21,1998 all registrants subject
to CRP (unless exempted under 40 CFR 157.24), including those whose products
are currently registered with certifications on file, must submit an application for
amendment (EPA Form 8570-1) and a new certification pursuant to 40 CFR 152.44
and 157.34. The application for amendment should be marked on the top right hand
corner in capital letters "CRP".
If no change in packaging is required for compliance with the revised
effectiveness standards and protocol test procedures only a new CRP certification is
needed. The CRP certification should be sent to Rosalind L. Gross at the address
given under the section for additional information. The certification should be marked
on the top right hand comer in capital letters "CRP CERTIFICATION NO PACKAGE
CHANGE".
Before January 21,1998 any new pesticide registrations subject to the CRP
regulations may comply with the new effectiveness standards and protocol test
procedures at the time of registration. If a registrant decides to comply at the time of
registration the CRP certification should be sent to Rosalind L. Gross at the
address given under the section for additional information. The certification should be
marked on the top right hand comer in capital letters "NEW CRP CERTIFICATION".
If the registrant decides not to comply with the new effectiveness standards and
protocol test procedures at the time of registration, the registrant may do so provided
the product is in compliance by January 21,1998. Then, the registrant should follow the
procedures for filing an application for amendment and a new CRP certification as
previously discussed.
For existing and new registrations the new certification should indicate:
1 Name and EPA registration number of the product;
2 Registrant's name and address;
3 Date and the name, title, and signature of the company official making the
certification;
4 A certification that the product as packaged meets the revised standards in 16
CFR 1700.15(b) when tested by the revised testing procedures in 16 CFR
1700.20, as published in 60 FR 37710 (July 21,1995), and that the product as
packaged will continue to meet the effectiveness, compatibility, and durability
standards of 40 CFR 157.32. The statement, "I certify that the packaging
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used for this product meets the standards of 40 CFR 157.32, including the revised
standards in 16 CFR 1700.15(b), when tested by the revised testing procedures in
16 CFR 1700.20, as published in 60 FR 37710 (July 21, 1995]," will suffice for this
purpose.
5 A statement describing the type of package used and its designation using the
American Society for Testing and Materials (ASTM) Standard D3475-95
"Standard Classification of Child-Resistant Packages". The ASTM standard
D3475-95 provides uniform terminology and universal descriptions of various
types of CRP. For example, the following statement will suffice for this purpose:
"The type of package is a two piece reclosable continuously threaded
closure with a random push down while turning, ASTM Type IA with a
round plastic bottle and is package name A manufactured by Company B."
(Package and company name are optional): [Note: If multiple package types
are involved, indicate the package sizes associated with each package type,]
Copies of the ASTM Standard (copyright ASTM) are available from the American
Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken,
PA 19428. If you have any problems in identifying the ASTM Standard D3475-
95 designation for a CRP, send a sample package and inquiry to Rosalind L.
Gross at the address given below.
6 A statement that the product must be in aerosol form or is a product that requires
a metal container, and is therefore exempt from the senior adult panel test (if
applicable). Specify whether the package is an aerosol or a metal container with
a reclosable metal closure.
Amendment forms and CRP certifications that do not contain the aforementioned
information may be returned to the submitter for the necessary revisions.
The application for amendment, EPA Form 8570-1, and new CRP certification
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
APPLICABILITY
This PR Notice becomes effective upon the date of signature by the Agency. All
pesticides sub ect to the CRP regulations and packaged and released for shipment on
or after January 21,1998 (30 months after publication of the CPSC final rule) must
comply with the mandatory provisions of the new effectiveness standards and
protocol test procedures. All registrants of pesticide products subject to CRP
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(unless exempted under 40 CFR 157.24) must submit a new CRP certification for
their products prior to their release for shipment.
If a registrant complies with the mandatory provisions of the new effectiveness
standards and protocol test procedures and submits their CRP certification to the
Agency prior to the effective date (January 21,1998), then all of the requirements
specified in 60 FR 37710 July 21,1995 will become effective. Registrants are reminded
that the new CRP certification indicates compliance with all the provisions of the revised
standards, 16 CFR 1700.15(b) when tested by the revised testing procedures, 16 CFR
1700.20 pursuant to 60 FR 37710 July 21,1995.
It is a violation of 18 U.S.C. Sec. 1001 to knowingly and willfully make any false
statement or representation in any matter within the jurisdiction of any department or
agency of the United States. A failure to comply with the terms of 40 CFR 157.32
including the revised standards, 16 CFR 17Q0.15(b) when tested by the revised testing
procedures, 16 CFR 1700.20 as published in 60 FR 37710 July 21,1995 shall be in
violation of FIFRA and subject to enforcement action and penalties under FIFRA
sections 12 and 14.
ADDITIONAL INFORMATION
For further information about this notice please contact:
Rosalind L. Gross
Registration Support Branch
Registration Division (7505-W)
EPA
401 M Street, S.W.
Washington, D.C. 20460
(703)308-8354
in, Director
on (7505-C)
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