[Federal Register: June 7, 2001 (Volume 66, Number 110)]
[Proposed Rules]               
[Page 30655-30656]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jn01-7]                         

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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1115

 
Substantial Product Hazard Reports

AGENCY: Consumer Product Safety Commission.

ACTION: Proposed revision to interpretative rule.

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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.

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.

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

[[Page 30656]]

specified 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.

List of Subjects in 16 CFR Part 1115

    Administrative practice and procedure, Business and industry, 
Consumer protection, Reporting and recordkeeping requirements.
    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:

PART 1115--SUBSTANTIAL PRODUCT HAZARD REPORTS

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

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

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


Sec. 1115.12  Information which should be reported; evaluating 
substantial product hazards.

* * * * *
    (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:
* * * * *

    Dated: June 1, 2001.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
[FR Doc. 01-14298 Filed 6-6-01; 8:45 am]
BILLING CODE 6355-01-P