16 CFR § 1700.15 - Poison prevention packaging standards.

§ 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 § 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 § 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 § 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 § 1700.20(a)(4). The senior-adult panel test of § 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 § 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 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]