[Code of Federal Regulations]
[Title 16, Volume 2]
[Revised as of January 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 16CFR1700.15]

[Page 741-742]
 
                     TITLE 16--COMMERCIAL PRACTICES
 
             CHAPTER II--CONSUMER PRODUCT SAFETY COMMISSION
 
PART 1700--POISON PREVENTION PACKAGING--Table of Contents
 
Sec.  1700.15  Poison prevention packaging standards.

    To protect children from serious personal injury or serious illness 
resulting from handling, using, or ingesting household substances, the 
Commission has determined that packaging designed and constructed to 
meet the following standards shall be regarded as ``special packaging'' 
within the meaning of section 2(4) of the act. Specific application of 
these standards to substances requiring special packaging is in 
accordance with Sec.  1700.14.
    (a) General requirements. The special packaging must continue to 
function with the effectiveness specifications set forth in paragraph 
(b) of this section when in actual contact with the substance contained 
therein. This requirement may be satisfied by appropriate scientific 
evaluation of the compatibility of the substance with the special 
packaging to determine that the chemical and physical characteristics of 
the substance will not compromise or interfere with the proper 
functioning of the special packaging. The special packaging must also 
continue to function with the effectiveness specifications set forth in 
paragraph (b) of this section for the number of openings and closings 
customary for its size and contents. This requirement may be satisfied 
by appropriate technical evaluation based on physical wear and stress 
factors, force required for activation, and other such relevant factors 
which establish that, for the duration of normal use, the effectiveness 
specifications of the packaging would not be expected to lessen.
    (b) Effectiveness specifications. Special packaging, tested by the 
method described in Sec.  1700.20, shall meet the following 
specifications:
    (1) Child-resistant effectiveness of not less than 85 percent 
without a demonstration and not less than 80 percent after a 
demonstration of the proper means of opening such special packaging. In 
the case of unit packaging, child-resistant effectiveness of not less 
than 80 percent.
    (2) Ease of adult opening. (i) Senior-adult test. Except for 
products specified in paragraph (b)(2)(ii) of this section, special 
packaging shall have a senior adult use effectiveness (SAUE) of not less 
than 90% for the senior-adult panel test of Sec.  1700.20(a)(3).
    (ii) Younger-adult test. (A) When applicable. Products that must be 
in aerosol form and products that require metal containers, under the 
criteria specified below, shall have an effectiveness of not less than 
90% for the younger-adult test of Sec.  1700.20(a)(4). The senior-adult 
panel test of Sec.  1700.20(a)(3) does not apply to these products. For 
the purposes of this paragraph, metal containers are those that have 
both a metal package and a recloseable metal closure, and aerosol 
products are self-contained pressurized products.
    (B) Determination of need for metal or aerosol container.
    (1) Criteria. A product will be deemed to require metal containers 
or aerosol form only if:
    (i) No other packaging type would comply with other state or Federal 
regulations,
    (ii) No other packaging can reasonably be used for the product's 
intended application,
    (iii) No other packaging or closure material would be compatible 
with the substance,
    (iv) No other suitable packaging type would provide adequate shelf-
life for the product's intended use, or
    (v) Any other reason clearly demonstrates that such packaging is 
required.
    (2) Presumption. In the absence of convincing evidence to the 
contrary, a product shall be presumed not to require a metal container 
if the product, or another product of identical composition, has 
previously been marketed in packaging using either a nonmetal package or 
a nonmetal closure.
    (3) Justification. A manufacturer or packager of a product that is 
in a metal container or aerosol form that the manufacturer or packager 
contends is not required to comply with the SAUE requirements of Sec.  
1700.20(a)(3) shall provide, if requested by the Commission's staff, a 
written explanation of why the product must have a metal container or be 
an aerosol. Manufacturers and packagers who wish to do so

[[Page 742]]

voluntarily may submit to the Commission's Office of Compliance a 
rationale for why their product must be in metal containers or be an 
aerosol. In such cases, the staff will reply to the manufacturer or 
packager, if requested, stating the staff's views on the adequacy of the 
rationale.
    (c) Reuse of special packaging. Special packaging for substances 
subject to the provisions of this paragraph shall not be reused.
    (d) Restricted flow. Special packaging subject to the provisions of 
this paragraph shall be special packaging from which the flow of liquid 
is so restricted that not more than 2 milliliters of the contents can be 
obtained when the inverted, opened container is taken or squeezed once 
or when the container is otherwise activated once.

(Secs. 2(4), 3, 5, 84 Stat. 1670-72; 15 U.S.C. 1471(4), 1472, 1474)

[38 FR 21247, Aug. 7, 1973, as amended at 60 FR 37734, July 21, 1995]