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Proposed Rule

Substantial Product Hazard Reports

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Consumer Product Safety Commission.

ACTION:

Proposed revision to interpretative rule.

SUMMARY:

Section 15(b) of the Consumer Product Safety Act, 15 U.S.C. 2064(b), requires manufacturers, distributors, and retailers of consumer products to report potential product hazards to the Commission. The Consumer Product Safety Commission publishes a proposed revision to its interpretative rule advising manufacturers, distributors, and retailers how to comply with the requirements of section 15(b). The proposed revision points out that information concerning products manufactured or sold outside of the United States that may be relevant to the existence of potential defects and hazards associated with products distributed within the United States should be evaluated and may lead to a report under section 15(b).

DATES:

Comments from the public are due no later than July 9, 2001.

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FOR FURTHER INFORMATION CONTACT:

Marc Schoem, Director, Division of Recalls and Compliance, Consumer Product Safety Commission, Washington, DC 20207, telephone—(301) 504-0608, ext. 1365, fax.—(301) 504-0359, E-mail address—mschoem@cpsc.gov.

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SUPPLEMENTARY INFORMATION:

Section 15(b) of the Consumer Product Safety Act (CPSA), 15 U.S.C. 2064(b) requires manufacturers, distributors, and retailers of consumer products to report potential product hazards to the Commission. In 1978, the Commission published an interpretative rule, 16 CFR 1115, that clarified the Commission?s understanding of this requirement and that established policies and procedures for filing such reports and proffering remedial actions to the Commission. That rule talks generally about the types of information a firm should evaluate in considering whether to report, but does not specifically address information about experience with products manufactured or sold outside of the United States. Neither the statute, nor the rule itself, suggests that firms need not evaluate such information and, when appropriate, report to the Commission under section 15(b).

Over the past several years, the Commission has received section 15(b) reports that have included information on experience with products abroad. When appropriate, the agency has initiated recalls based in whole or in part on that experience. In addition, the Firestone tire recall of 2000 focused public attention on the possible relevance of information generated abroad to the safety of products used in the United States. Accordingly, to assure that firms who obtain information generated abroad are aware that they should consider such information in deciding whether there is a need to report under section 15(b), the staff recommended that the Commission issue a policy statement to this effect. On January 3, 2001, the Commission solicited comments on a proposed policy statement summarizing the Commission's position that, under section 15(b), information concerning products sold outside of the United States may be relevant to defects and hazards associated with products distributed within the United States.

On May 17, 2001, after receiving and analyzing the comments, the Commission voted to issue a final policy stating that information concerning products manufactured or sold outside of the United States which may be relevant to the existence of potential defects and hazards associated with products distributed within the United States should be evaluated and may be reportable under section 15(b). The Commission's analysis of those comments and the final policy statement are published elsewhere in this edition of the Federal Register.

The Commission believes that members of the public should fully understand their obligations under the law. In the context of the obligation to evaluate and, if necessary, to report information from outside the United States under section 15(b), the Commission believes that it can best accomplish this objective by amending the existing interpretative rule to reflect the substance of the policy statement. Accordingly, the Commission proposes to amend the interpretative rule as Start Printed Page 30656specified below. Although the Commission previously accepted and analyzed public comment on this subject when it issued the policy statement, the policy statement did not offer a specific amendment to the interpretative reporting rule. The Commission has, therefore, elected to solicit public comment on the proposed amendment, even though, as an amendment to an interpretative rule, notice and comment is not required under the Administrative Procedure Act. To assist members of the public who wish to comment, the Commission has included the text of the final policy statement in this notice.

Guidance Document on Reporting Information Under 15 U.S.C. 2064(b) About Potentially Hazardous Products Manufactured or Distributed Outside the United States

Section 15(b) of the Consumer Product Safety Act (CPSA), 15 U.S.C. 2064(b), imposes specific reporting obligations on manufacturers, importers, distributors and retailers of consumer products distributed in commerce. A firm that obtains information that reasonably supports the conclusion that such a product:

  • Fails to comply with an applicable consumer product safety rule or with a voluntary consumer product safety standard upon which the Commission has relied under section 9 of the CPSA,
  • Contains a defect that could create a substantial product hazard as defined in section 15(a)(2) of the CPSA, 15 U.S.C. 2064(a)(2), or
  • Creates an unreasonable risk of serious injury or death must immediately inform the Commission unless the firm has actual knowledge that the Commission has been adequately informed of the failure to comply, defect, or risk.

The purpose of reporting is to provide the Commission with the information it needs to determine whether remedial action is necessary to protect the public. To accomplish this purpose, section 15(b) contemplates that the Commission receive, at the earliest time possible, all available information that can assist it in evaluating potential product hazards. For example, in deciding whether to report a potential product defect, the law does not limit the obligation to report to those cases in which a firm has finally determined that a product in fact contains a defect that creates a substantial product hazard or has pinpointed the exact cause of such a defect. Rather, a firm must report if it obtains information which reasonably supports the conclusion that a product it manufactures and/or distributes contains a defect which could create such a hazard or that the product creates an unreasonable risk of serious injury or death. 15 U.S.C. 2064(b)(2) and (3); 16 CFR 1115.4 and 6. Nothing in the reporting requirements of the CPSA or the Commission's interpretive regulation at 16 CFR part 1115 limits reporting to information derived solely from experience with products sold in the United States. The Commission's interpretative rule enumerates, at 16 CFR 1115.12(f), examples of the different types of information that a firm should consider in determining whether to report. The regulation does not exclude information from evaluation because of its geographic source. The Commission interprets the statutory reporting requirements to mean that, if a firm obtains information that meets the criteria for reporting listed above and that is relevant to a product it sells or distributes in the U.S., it must report that information to the CPSC, no matter where the information came from. Such information could include incidents or experience with the same or a substantially similar product, or a component thereof, sold in a foreign country.

Over the past several years, the Commission has received reports under section 15(b) that have included information on experience with products abroad, and, when appropriate, has initiated recalls based in whole or in part on that experience. Thus, a number of companies already view the statutory language as the Commission does. However, with the expanding global market, more firms are obtaining this type of information, but many may be unfamiliar with this aspect of reporting. Therefore, the Commission issues this policy statement to assist those firms in complying with the requirements of section 15(b) of the Consumer Product Safety Act.

Proposed Effective Date: The Commission proposes that this revision become effective 30 days after the date of publication of the revised final intepretative rule in the Federal Register.

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List of Subjects in 16 CFR Part 1115

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In accordance with the procedures of 5 U.S.C. 553 and under the authority of the Consumer Product Safety Act, 15 U.S.C. 2051 et seq., the Commission proposes to amend part 1115 of title 16, Chapter II, of the Code of Federal Regulations as follows:

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PART 1115—SUBSTANTIAL PRODUCT HAZARD REPORTS

1. The authority citation for part 1115 continues to read as follows:

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Authority: 15 U.S.C. 2061, 2064, 2065, 2066(a), 2068, 2070, 2071, 2073, 2076, 2079 and 2084.

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2. Section 1115.12(f) introductory text is revised to read as follows:

Information which should be reported; evaluating substantial product hazards.
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(f) Information which should be studied and evaluated. Paragraphs (f)(1) through (7) of this section are examples of information which a subject firm should study and evaluate in order to determine whether it is obligated to report under section 15(b) of the CPSA. Such information may include information about product experience, performance, design, or manufacture outside the United States that is relevant to products sold or distributed in the United States. All information should be evaluated to determine whether it suggests the existence of a noncompliance, a defect, or an unreasonable risk of serious injury or death:

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Dated: June 1, 2001.

Sadye E. Dunn,

Secretary, Consumer Product Safety Commission.

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[FR Doc. 01-14298 Filed 6-6-01; 8:45 am]

BILLING CODE 6355-01-P