E9-30376. Establishment of a Public Consumer Product Safety Incident Database: Notice of Public Workshop

AGENCY:

Consumer Product Safety Commission.

ACTION:

Notice of public workshop.

SUMMARY:

The Consumer Product Safety Commission (“Commission” or “CPSC”) is announcing a two day staff-conducted public workshop to receive views from all interested parties on establishing a public consumer product safety incident database. The workshop, to be held on January 11 and 12, 2010 in Bethesda, Maryland, seeks input from stakeholders on five aspects of the public database: Data analysis and reporting; reports of harm; manufacturer notification and response; additional database content, and materially inaccurate information. Participation by members of the public is invited.

DATES:

The workshop will be held from 9 a.m. to 4 p.m. on January 11 and 12, 2010, with a one hour break for lunch. Requests to make oral presentations and the written text of any oral presentation must be received by the Office of the Secretary not later than 5 p.m. Eastern Standard time (EST) on January 4, 2010. Written comments must be received by the Office of the Secretary not later than 5 p.m. Eastern Standard time (EST) on January 29, 2010.

ADDRESSES:

The public workshop will be held at CPSC's headquarters, Bethesda Towers Building, 4330 East West Highway, Bethesda, Maryland 20814, in the 4th Floor Hearing Room. Persons interested in attending the workshop should register online at “www.cpsc.gov/​meetingsignup.html.” The CPSC web link also has more information about the workshop, and interested persons can request to make oral presentations online. Requests to make oral presentations also can be made by sending an electronic mail (e-mail), calling, or writing to Todd A. Stevenson, Office of the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814; e-mail [e-mail]; telephone [phone]; facsimile [phone] not later than 5 p.m. EST on January 4, 2010. Written comments and texts of oral presentations should be captioned “Public Workshop on Consumer Product Incident Database” and further captioned by one of the five workshop topics available: “Data Analysis and Reporting;” “Reports of Harm;” “Manufacturer Notification and Response;” “Additional Database Content;” and “Materially Inaccurate Information.” Written comments and the texts of oral presentations should be sent by e-mail to [e-mail], or mailed or delivered to the Office of the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814. Oral presentations must be received not later than 5 p.m. EST on January 4, 2010, and written comments must be received not later than 5 p.m. EST on January 29, 2010. The CPSC may impose time limitations on all presentations and further restrictions to avoid duplication of presentations.

FOR FURTHER INFORMATION CONTACT:

Ming Zhu, Office of Information & Technology Services, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; [e-mail]; telephone [phone].

SUPPLEMENTARY INFORMATION:

Section 212 of the Consumer Product Safety Improvement Act of 2008 (“CPSIA”) (Pub. Law 110-314) amended the Consumer Product Safety Act (“CPSA”) to create a new section 6A of the CPSA, titled “Publicly Available Consumer Product Safety Information Database.” Section 6A(a)(1) of the CPSA states that the Commission shall “establish and maintain a database on the safety of consumer products, and other products or substances regulated by the Commission * * *” The statute declares that the database must be publicly available, searchable, and accessible through the Commission's Web site.

Contents of the Public Database

The public database must contain: (i) Reports of harm, meaning reports of injury, illness, or death, or reports of any risk of injury, illness or death as determined by the Commission, relating to the use of consumer products or other products or substances regulated by the Commission; (ii) information derived by the Commission from voluntary and mandatory recall notices; and (iii) comments that a manufacturer or private labeler of a consumer product wants to include about a report of harm involving its product. Section 6A(b)(1) of the CPSA. In addition, section 6A(b)(3) of the CPSA requires the Commission to include in the database, consistent with the requirements of section 6(a) and (b) of the CPSA, any additional information it determines to be in the public interest.

Reports of Harm

Section 6A(b)(1)(A) of the CPSA requires the public database to include reports of harm received by the Commission from: (i) Consumers; (ii) local, State, or Federal government agencies; (iii) health care professionals; (iv) child service providers; and (v) public safety entities. Reports of harm submitted for inclusion in the public database must include, at a minimum: (i) A description of the consumer product (or other product or substance regulated by the Commission) concerned; (ii) identification of the manufacturer or private labeler of the consumer product (or other product or substance regulated by the Commission); (iii) a description of the harm relating to the use of the consumer product (or other product or substance regulated by the Commission); (iv) contact information for the person submitting the report; and (v) a verification by the person submitting the information that the information submitted is true and accurate to the best of the person's knowledge and that the person consents that such information be included in the database. Section 6A(b)(2)(B) of the CPSA.

Although contact information for the person submitting a report of harm is required in order for the report to be included in the database, section 6A(b)(6) of the CPSA provides that the Commission, under this section, may not disclose the name, address, or other contact information of any individual or entity that submits a report of harm. However, the Commission may provide such contact information to the manufacturer or private labeler of the product with the express written consent of the person who submitted the report of harm. Consumer information provided to a manufacturer or private labeler under this section may not be used or disseminated to any other party for any purpose other than verifying a report of harm.

Unless the Commission determines that a report of harm or manufacturer comment submitted for inclusion in the database contains materially inaccurate information, all such reports of harm and comments that meet the criteria set forth in the statute must be included in the public database not later than the tenth business day after the date on which the report of harm was transmitted to the manufacturer or private labeler. Section 6A(c)(3)(A) of the CPSA. Section 6(a) and (b) of the CPSA do not apply to the disclosure of reports of harm in the public database. Section 6A(f)(1) of the CPSA.

Manufacturer Notification and Response

To the extent practicable, the Commission must transmit a report of harm to the manufacturer or private labeler identified in the report not later than 5 business days after receiving a report that meets all of the minimum qualifications for inclusion in the public database set forth in section 6A(b)(2)(B). Section 6A(c)(1) of the CPSA. A manufacturer or private labeler may comment on the information contained in such report, and may request the comment to be included in the public database. Section 6A(c)(2)(A)-(B) of the CPSA. Unless the Commission determines the comment to be materially inaccurate, the Commission must include the comment in the public database at the same time as the report of harm or as soon as practicable thereafter. Section 6A(c)(3)(B) of the CPSA.

Moreover, a manufacturer or private labeler may review a report of harm for confidential information and request that portions of the report be designated confidential. If the Commission determines that the report does contain trade secret, commercial or confidential information as set forth in the statute, the Commission must redact such information in the report before it is placed in the database. Section 6A(c)(2)(C)(i)-(ii) of the CPSA. If, however, the Commission determines that the designated information is not confidential, the Commission must notify the manufacturer or private labeler and include the information in the public database. A manufacturer or private labeler must bring suit against the agency in an appropriate U.S. district court in order to seek removal of the information. Section 6A(c)(2)(C)(iii) of the CPSA.

Materially Inaccurate Information/Disclaimer

If the Commission determines that a report of harm or manufacturer comment contains materially inaccurate information before it is made available in the public database, the Commission, under section 6A(c)(4)(A) of the CPSA, must: (i) Decline to add the materially inaccurate information; (ii) correct the materially inaccurate information; or (iii) add information to correct the materially inaccurate information. For information already available in the public database, if, after investigation, the Commission determines that such information is materially inaccurate or duplicative, the Commission must, within seven business days of such determination: (i) Remove such information from the public database; (ii) correct such information; or (iii) add information to correct inaccurate information in the public database. Section 6A(c)(4)(B) of the CPSA.

Database users must be provided with clear and conspicuous notice that the Commission does not guarantee the accuracy, completeness, or adequacy of the database contents. Section 6A(b)(5) of the CPSA.

Data Analysis and Reporting

Under section 6A(b)(4) of the CPSA, the CPSC must categorize information available in the public database in a manner consistent with the public interest and in a manner to facilitate easy use by consumers. To the extent practicable, the database must be sortable and accessible by: (i) The date on which the information is submitted for inclusion in the database; (ii) the name of the consumer product (or other product or substance regulated by the Commission); (iii) the model name; (iv) the manufacturer's or private labeler's name; and (v) such other elements as the Commission considers in the public interest.

CPSC Workshop Details

The CPSC will hold the workshop on January 11 and 12, 2010, focusing on five aspects of the public database: data analysis and reporting; reports of harm; manufacturer notification and response; additional database content; and dealing with materially inaccurate information.

Monday, January 11, 2010

Workshop 1—Data Analysis and Reporting 9 a.m.-12 p.m.

The CPSC staff invites discussion and comment on data analysis and reporting from the public database, including comments on the following topics:

• Should the CPSC design the online incident reporting form to ensure the capture of data that can be used in scientific statistical analysis? If so, how?
• What can the CPSC do, from a system design perspective, to ensure the accuracy of submitted data?
• What can the CPSC do, from a system design perspective, to ensure the ongoing and perpetual integrity of submitted data?
• In what formats should the CPSC make data available to the public? Please explain your reasoning.
• What types of data analysis and reporting tools are being used by third-party analysts in the public and industry? What are these tools' relative merits and drawbacks?
• What data sets, including information from reports of harm and mandatory and voluntary recall notices, should be made available for public search and reporting? Why?

Workshop 2—Reports of Harm (Incident Report Form) 1 p.m.-4 p.m.

The CPSC staff invites discussion and comment on issues related to reports of harm, including comment on the following topics:

• How should the CPSC design the incident report form so that it is clear and easy for users to complete?
• From a design perspective, how should the CPSC deal with incomplete reports of harm?
• Should the incident report form check for inaccurate information? How?
• What, if any, instruction to users should be included on the incident reporting form?
• Should the incident report form contain links to outside websites? Please explain your reasoning.
• What, if any, disclaimers or qualifications should appear on the incident report form?
• Should any category of persons be excluded from submitting reports of harm for inclusion in the public database, and, if so, by what means?
• Should reports of harm submitted by telephone or paper meet the same statutory time frames for submission in the public database?
• What should a description of the consumer product entail and why?
• What means can the CPSC employ to ensure that the correct manufacturer and/or private labeler are identified in a report of harm?
• What contact information must be provided, at minimum, to meet the statutory requirement for inclusion in the database?
• How should the incident report form address the submitter's verification of the information submitted?
• How should the incident report form address the submitter's consent for: (i) inclusion in the public database; and (ii) release of contact information to the manufacturer or private labeler? Are there any other issues related to the user's consent that the CPSC should consider?

Tuesday, January 12, 2010

Workshop 3—Manufacturer Notification and Response 9 a.m.-12 p.m.

The CPSC staff invites discussion and comment on manufacturer notification and response with regard to reports of harm, including comment on the following topics:

• What means should the CPSC employ to notify manufacturers and private labelers regarding a report of harm within the five day statutory time frame?
• Given the statutory timeframe for notification, should manufacturers and private labelers be able to “register” contact information with the Commission for the purposes of notification of a report of harm? Please explain your reasoning. What form of contact information should be acceptable, i.e., electronic mail only? What other issues should the CPSC consider?
• What, if any, authority does the CPSC have to withhold a report of harm from the public database if a manufacturer or private labeler claims the report contains materially inaccurate or confidential information?
• What means should the CPSC employ to allow manufacturers and private labelers to submit comments regarding a report of harm or to designate confidential information? What issues should the CPSC take into consideration when developing such process?
• If a manufacturer or private labeler requests that a comment associated with the report of harm be made available in the public database, what, if any, circumstances should prevent such comment from inclusion in the public database?
• What, if any, circumstances may arise which restart any timeframes contemplated in the statute with regard to manufacturer notification and responses?
• How can the CPSC ensure that manufacturers and/or private labelers do not use a submitter's contact information for purposes other than verification of a report of harm? By what means can the CPSC enforce such provision?

Workshop 4—Additional Database Content 1 p.m.-2:20 p.m.

The CPSC staff invites discussion and comment on what additional information, other than reports of harm, manufacturer comments, and information derived from mandatory and voluntary recall notices, the Commission should include in the public database, including comment on the following topics:

• What additional categories of information should the CPSC include in the public database and why?
• What, if any, information cannot be included in the public database pursuant to the statute and why?
• Under what circumstances are the provisions of section 6(a) and (b) of the CPSA relevant to the provisions of section 6A of the CPSA, especially with regard to additional categories of information that may be included in the public database?

Workshop 5—Materially Inaccurate Information 2:30 p.m.-4 p.m.

The CPSC staff invites discussion and comment on dealing with materially inaccurate information contained in reports of harm and manufacturer comments, including comment on the following topics:

• Is the CPSC's responsibility with regard to materially inaccurate information limited to reports of harm and manufacturer comments? Why or why not?
• What, if any, measures should the CPSC employ to prevent the submission of fraudulent reports of harm while not discouraging the submission of valid reports?
• What types of information constitute materially inaccurate information? Please explain your reasoning.
• How should the CPSC process a claim that a report of harm or a manufacturer comment contains materially inaccurate information, both before and after such information has been made available in the public database?
• How should the CPSC allow a submitter or others to claim that a manufacturer has submitted materially false information?
• Given the statutory timeframe, how should the CPSC review claims of materially inaccurate information?
• What specific disclaimers should the CPSC make with regard to the accuracy of the information contained in the public database and why? Where should such disclaimers appear and why?

Please refer to the Dates and Addresses sections above for more information on relevant dates and times, how to register to attend the workshop, how to submit written comments, and how to request to make an oral presentation at the workshop. The Commission staff may hold additional public workshops in the coming months to follow up on issues discussed at the January 11 and 12, 2010 workshop and to solicit input on additional aspects of the publicly searchable database from stakeholders.

Dated: December 16, 2009.

Todd A. Stevenson,

Secretary, Consumer Product Safety Commission.