On May 24, 2010, the Consumer Product Safety Commission (“CPSC” or “Commission”) published a notice of proposed rulemaking[1] to establish a publicly-available consumer product safety information database in compliance with requirements set forth in the Consumer Product Safety Improvement Act (“CPSIA”). The new database will become operational, by statutory mandate, by March 2011. The proposed rule addresses submission of reports of harm, notice to manufacturers, procedures to handle comments from manufacturers, and procedures to handle confidential and materially inaccurate information, including the potential need for a “burden of proof” requirement for materially inaccurate information. Implementation of the database could present numerous hurdles for manufacturers, importers, and retailers, such as a short timeframe to respond to incident reports and the potential distribution of inaccurate information. Comments on the proposed rule must be received by July 23, 2010.

Background

Section 212 of the CPSIA directs the Commission to establish an online, publicly-available consumer product safety database that is searchable by date, product name, model, and manufacturer. The database is intended to avoid what critics claim is an unnecessary delay in the CPSC’s response to Freedom of Information Act (“FOIA”) requests, as well as to address the current difficulty in accessing information on the prior record of specific products. The Commission “anticipates that the new database will likely increase the number of consumer-generated reports over the number of incident reports currently filed with the Commission.”[2]

Submission of Reports of Harm

Pursuant to the proposed rule, the database would include “reports of harm,” which are defined as “any information submitted to the Commission . . . regarding an injury, illness, or death, or any risk of injury, illness, or death . . . relating to the use of a consumer product.” Anyone able to verify the accuracy of the report, not just the user of the consumer product, could submit a report of harm. For example, family members, observers of a consumer product being used by another, health care professionals, attorneys, and consumer advocates could submit reports. Submitters must affirmatively verify that the information contained in the report is true and accurate to the best of their knowledge.

For the report to be published it must contain a description including: name of the product, where it was purchased, price paid, model, and other identifiable information. It must also contain the identity of the manufacturer, a description of the harm, and verification as to the accuracy of the report.

A submitter’s contact information would not be published in the database, and manufacturers would not have access to that information unless the submitter consents to its release. If the submitter consents, the manufacturer may only use the contact information to verify the accuracy of the information contained in the report of harm, limiting the manufacturer’s ability to address reports directly with a submitter.

Manufacturer Notification

The Commission would notify manufacturers, including importers and private labelers, that they are named in a report of harm within five business days after the Commission receives a completed report of harm. To facilitate notification and communication with manufacturers, the Commission intends to create a “manufacturer portal.” Manufacturers would be able to select a preferred method to receive notice of a report of harm and designate a point of contact. The report of harm would be published in the database as soon as practicable, but not later than the tenth business day after the report is transmitted to the manufacturer. The Commission may, at its discretion, withhold an unpublished report of harm from the database until a determination is made regarding confidential treatment or material inaccuracy.

Manufacturer’s Response

Upon receipt of a notice of a report of harm, manufacturers would need to decide how to respond. They could: (1) ask the Commission for a determination of the material accuracy of the information contained in the report of harm; (2) request that portions of the report of harm be designated as confidential information; or (3) submit a comment on the report of harm. There is however, no requirement that the CPSC delay publishing the report simply because a claim of inaccuracy or confidentiality is made. A company requesting a determination of materially inaccurate or confidential information must be prepared to assist the Commission in defense of any judicial proceeding that might be brought to compel disclosure of information determined to be materially inaccurate or confidential.

Materially Inaccurate Information

A manufacturer could request a determination regarding materially inaccurate information either before or after a report of harm or manufacturer comment is published and must specify the desired relief. “Materially inaccurate information in a report of harm” would be defined as:

[I]nformation that is false or misleading in a significant and relevant way that creates or has the potential to create a substantially erroneous or substantially mistaken belief . . . about information in a report of harm relating to: (i) The identification of a consumer product; (ii) The identification of a manufacturer or private labeler; or (iii) The harm or risk of harm related to use of the consumer product.

Information determined materially inaccurate will be removed from the report or corrected no later than seven days after a determination. The Commission will favor correction of materially inaccurate reports over exclusion of entire reports of harm.

The database will include a general disclaimer that the accuracy of the contents of the database is not guaranteed. The Commission believes the disclaimer should protect manufacturers from having reports of harm admitted into evidence. There is however, no requirement that the CPSC delay publishing the report simply because a claim is made.

Confidential Information

Requests for redaction of confidential information must identify the specific portion of the report claimed to be confidential, state whether the information claimed to be confidential has ever been released to any person not in a confidential relationship with the manufacturer, state whether information is commonly known within the industry or otherwise readily ascertainable by outside persons, state how the release of the information would cause substantial harm to the company’s competitive position, and state whether the person submitting the request for confidential treatment is authorized to make claims of confidentiality on behalf of the organization. If the Commission determines that information in a report of harm is confidential, it will redact such confidential information and publish the report.

Manufacturer Comments

A manufacturer may submit comments related to a report of harm and must verify that it has reviewed the report of harm and that the information contained in the comment is true and accurate to the best of its knowledge. The manufacturer can request that this comment be included in the database. Comments received more than one year after transmission of the report of harm to the manufacturer will be published at the Commission’s discretion.

Requests for Comments to the Proposed Rule

The Commission is still working out the technical details of how the database will function and what specific search functionality will be provided and invites comments on any aspect of the proposed rule. The Commission specifically invites comment on whether the Commission should include in the materially inaccurate information section a “burden of proof” requirement and, if so, what would be the meaning of the term and what standard of proof would be imposed under it.

Steps for Manufacturers to Consider

Implementation of the publicly-available database will require many manufacturers, including importers and private labelers, to make significant adjustments to the way they review and respond to consumer incident reports. These reports will have to be considered in a manufacturer’s ongoing monitoring of product safety and whether a Section 15(b) report is required. Manufacturers will need to weigh the risks of commenting or not commenting on any particular report of harm. They must recognize that correspondence and comments will be publicly available and consider how their actions will impact on public perception of product safety. In anticipation of a final rule, manufacturers should consider the following:

Identifying an individual or department that would be registered with the Commission to receive notification of reports of harm.
Developing procedures to incorporate information from the CPSC database with internal information on product safety.
Developing or expanding a team to review and respond to consumer incident reports.
Improving information coordination with customer service to identify consumer incidents early so that the company is not starting its review from scratch once it receives a report of harm from the Commission and has only ten days to respond.
Reviewing any existing procedures for responding to incident reports from the National Injury Information Clearinghouse. The same procedures might be used to respond to reports of harm.
Establishing a process to track any relationships between reports of harm and product liability litigation.

Kelley Drye & Warren LLP

Kelley Drye & Warren’s Consumer Product Safety practice group is experienced in providing advice on the difficult issues of how and when potentially hazardous consumer products must be reported to the CPSC. If product recalls are necessary, we work with our clients and CPSC staff to quickly develop and implement cost-effective communications programs that satisfy product liability concerns and minimize potential penalties. When the CPSC threatens or brings enforcement actions, we advise our clients on appropriate strategies. For more information about this client advisory, please contact:

Christie Grymes Thompson
(202) 342-8633
cgthompson@kelleydrye.com

Mark L. Austrian
(202) 342-8495
maustrian@kelleydrye.com

[1] Publicly Available Consumer Product Safety Information Database; Proposed Rule, 75 Fed. Reg. 29,156 (May 24, 2010).

[2] Id. at 29,175.