Publicly Available Consumer Product Safety Information Database

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Federal Register: May 24, 2010 (Volume 75, Number 99)

Proposed Rules

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From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr24my10-21

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Part III

Consumer Product Safety Commission

16 CFR Part 1102

Publicly Available Consumer Product Safety Information Database;

Proposed Rule

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CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1102

Publicly Available Consumer Product Safety Information Database

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Consumer Product Safety Commission (``Commission,''

``CPSC,'' or ``we'') is issuing a notice of proposed rulemaking that would establish a publicly available consumer product safety information database (``database''). Section 212 of the Consumer

Product Safety Improvement Act of 2008 (``CPSIA'') amended the Consumer

Product Safety Act (``CPSA'') to require the Commission to establish and maintain a publicly available, searchable database on the safety of consumer products, and other products or substances regulated by the

Commission. The proposed rule would interpret various statutory requirements pertaining to the information to be included in the database and also would establish provisions regarding submitting reports of harm; providing notice of reports of harm to manufacturers; publishing reports of harm and manufacturer comments in the database; and dealing with confidential and materially inaccurate information.

DATES: Written comments must be received by July 23, 2010.

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2010- 0041, by any of the following methods:

Electronic Submissions

Submit electronic comments in the following way:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

To ensure timely processing of comments, the Commission is no longer accepting comments submitted by electronic mail (e-mail) except through http://www.regulations.gov.

Written Submissions

Submit written submissions in the following way:

Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions), preferably in five copies, to: Office of the Secretary,

Consumer Product Safety Commission, Room 502, 4330 East West Highway,

Bethesda, MD 20814; telephone (301) 504-7923.

Instructions: All submissions received must include the agency name and docket number for this notice of proposed rulemaking. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to http://www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information electronically. Such information should be submitted in writing.

Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Mary Kelsey James, Director,

Information Technology Policy and Planning, Consumer Product Safety

Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504-7213; mjames@cpsc.gov.

SUPPLEMENTARY INFORMATION:

I. Background

The CPSIA requires the Commission to establish and maintain a product safety information database that is available to the public.

Specifically, section 212 of the CPSIA amended the 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 requires the Commission to establish and maintain a database on the safety of consumer products, and other products or substances regulated by the

Commission. The database must be publicly available, searchable, and accessible through the Commission's Web site. Section 6A of the CPSA sets forth specific content, procedures, and search requirements for the publicly available database. In this proposed rule, the Commission sets forth its interpretation of the statutory requirements of section 6A.

For several decades, the Commission has gathered and maintained a database of consumer complaints known as consumer product incident reports involving a description of incidents related to the use of consumer products that fall within the scope of the Commission's jurisdiction. Pursuant to section 5(a) of the CPSA, the Commission collects information related to the causes and prevention of death, injury, and illness associated with consumer products. The Commission conducts studies and investigations of deaths, injuries, diseases, other health impairments, and economic losses resulting from accidents involving consumer products. Also, pursuant to section 5(b) of the

CPSA, the Commission may conduct research, studies, and investigations on the safety of consumer products and on improving the safety of such products. Currently, the Commission obtains information about product- related deaths, injuries, and illnesses from a variety of sources, including newspapers, death certificates, consumer complaints, and hospital emergency rooms. In addition, the Commission receives information from the public through its Internet Web site through forms reporting on product-related injuries or incidents. The data that the

Commission collects and maintains on product safety has not been immediately available and searchable by the public. Before the CPSIA's enactment, the CPSA required that the Commission follow the notice provisions of section 6 of the CPSA before publicly disclosing any information that allowed the public to readily ascertain the identity of a manufacturer or private labeler of a consumer product. Section 6 of the CPSA contains requirements for giving notice of such information to the manufacturer or private labeler and providing an opportunity to comment on the information prior to public disclosure. Section 6 of the

CPSA also requires the Commission to take reasonable steps to assure that disclosure of such information is accurate, fair in the circumstances, and reasonably related to effectuating the purposes of the CPSA. The Commission has applied the requirements in section 6 of the CPSA to Freedom of Information Act (FOIA) requests as well. See

Consumer Product Safety Commission et al. v. GTE Sylvania, 447 U.S. 102

(1980). The Commission issued regulations interpreting the section 6 requirements at 16 CFR part 1101. Thus, consumers currently have access to incident data through reports and studies published by the

Commission or through information provided in response to FOIA requests.

As stated earlier in part I of this document, section 6A of the

CPSA requires the establishment and maintenance of a publicly available and searchable database. Section 6A of the CPSA specifically excludes any report submitted pursuant to the public database provisions from the notice requirements of section 6(a) and (b) of the CPSA.

Accordingly, the Commission invited input from its stakeholders before developing the proposed rule. A summary of the CPSC's work done to date on the public database, including a Report to Congress, Public

Meetings, Federal Register Notices, Commission Actions and Public

Comments, are

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available on the CPSC Web site at http://www.cpsc.gov/about/cpsia/ sect212.html.

On September 10, 2009, pursuant to section 6A(a)(2) of the CPSA, the Commission submitted a detailed implementation plan for the public database to Congress. The plan, titled ``Implementation of a Searchable

Consumer Product Safety Incident Database,'' set forth the Commission's strategy for establishing and maintaining the public database, including plans for the operation, content, maintenance, and functionality of the database. It also described the CPSC's plans for a public awareness campaign to promote the database, and contained an implementation schedule. Pursuant to section 6A(a)(3) of the CPSA, the

Commission must establish the public database no later than eighteen months after submission of its detailed implementation plan to

Congress, or by March 2011.

On November 10, 2009, the Commission held a public hearing regarding the establishment of a public consumer product safety incident database. Consumer groups, trade associations, research groups, and industry discussed their views on implementation of the public database. Written statements also were accepted. We received fourteen comments, and these comments are available on the CPSC's Web site at http://www.cpsc.gov/library/foia/foia10/pubcom/pubdb.pdf. A

Webcast of the hearing can be viewed on the CPSC's Web site at http:// www.cpsc.gov/webcast/previous.html. Issues presented at the hearing are discussed and responded to in more detail in section IV of this document below.

On January 11 and 12, 2010, the Commission staff hosted a two-day workshop to discuss implementation of section 6A of the CPSA, including data analysis and reporting; reports of harm; manufacturer notification and response; additional database content, and materially inaccurate information. A transcript of the workshops is available at http:// www.cpsc.gov/about/cpsia/pw01112010am.html, and a Webcast of the workshops is available on the CPSC's Web site at http:// saferproducts.gov/events/pw01112010.html. The CPSC also invited comments in conjunction with the workshop. We received twenty-two comments, and we summarize and respond to those comments in section IV of this document below.

II. Statutory Authority

The Commission is issuing this proposed rule pursuant to section 3 of the CPSIA which provides the Commission authority to issue regulations, as necessary, to implement the CPSIA.

III. Description of the Proposed Rule

The proposed rule would establish a new 16 CFR part 1102,

``Publicly Available Consumer Product Database.'' The new part would consist of four subparts:

Subpart A--Background and Definitions;

Subpart B--Content Requirements;

Subpart C--Procedural Requirements;

Subpart D--Notice and Disclosure Requirements

We describe the provisions in each proposed subpart in detail immediately below in section III. A through D of this document.

A. Proposed Subpart A--Background and Definitions 1. Proposed Sec. 1102.1--Purpose

Proposed Sec. 1102.1 would describe the purpose of the new

``Publicly Available Consumer Product Safety Information Database.'' In brief, the proposal would state that part 1102 sets forth the

Commission's interpretation, policy, and procedures with regard to the creation and maintenance of a Consumer Product Safety Information

Database. 2. Proposed Sec. 1102.4--Scope

Proposed Sec. 1102.4 would explain that the part 1102 applies to the content, procedure, notice, and disclosure requirements to be followed and all information published in the Consumer Product Safety

Information Database. 3. Proposed Sec. 1102.6--Definitions

Proposed Sec. 1102.6 would define certain terms. As a general matter, proposed Sec. 1102.4(a) would explain that, except as provided in proposed Sec. 1102.6(b), the definitions set forth in section 3 of the CPSA apply. For example, section 3(a)(11) of the CPSA defines a

``manufacturer'' as ``any person who manufactures or imports a consumer product.'' Because section 3(a)(11) of the CPSA defines

``manufacturer,'' any reference to ``manufacturer'' in proposed part 1102 would have the same meaning.

Proposed Sec. 1102.6(b) would define certain terms or, in some cases, interpret terms already defined in section 3 of the CPSA. For example, section 3(a)(5) of the CPSA defines ``consumer product,'' in part, as ``any article, or component part thereof, produced or distributed (i) for sale to a consumer for use in or around a permanent or temporary household or residence, a school, in recreation, or otherwise, or (ii) for the personal use, consumption or enjoyment of a consumer in or around a permanent or temporary household or residence, a school, in recreation, or otherwise * * *'' However, proposed Sec. 1102.6(b)(3) would define ``consumer product'' as having the same meaning as defined in the CPSA, but would further explain that

``consumer product'' includes any other products or substances regulated by the Commission under the CPSA, Federal Hazardous

Substances Act, Flammable Fabrics Act, the Poison Prevention Packaging

Act, the Children's Gasoline Burn Prevention Act, the Virginia Graeme

Baker Pool and Spa Safety Act, and any other statute that the

Commission enforces. This further clarification is based on the statutory requirement in section 6A(b)(1)(A) of the CPSA for submission of reports of harm relating to the use of consumer products and other products or substances regulated by the Commission.

Proposed Sec. 1102.6(b)(1) would define ``additional information'' as any information, other than reports of harm, that the Commission determines is in the public interest to include in the Consumer Product

Safety Information Database.

Proposed Sec. 1102.6(b)(2) would define ``Commission'' or ``CPSC' as meaning the Consumer Product Safety Commission.

Proposed Sec. 1102.6(b)(4) would define ``Consumer Product Safety

Information Database'' as the publicly available searchable information database on the safety of consumer products required to be established and maintained by the Commission.

Proposed Sec. 1102.6(b)(5) would define ``harm'' as any injury, illness, or death, or any risk of injury, illness or death as determined by the Commission.

Proposed Sec. 1102.6(b)(6) would define ``mandatory recall notice'' as any notice to the public ordered by the Commission pursuant to section 15(c) of the CPSA relating to action the Commission orders to be taken by any manufacturer, distributor, or retailer about a consumer product.

Proposed Sec. 1102.6(b)(7) would define ``manufacturer comment'' as a comment made by a manufacturer or private labeler in response to a report of harm received through the public database and transmitted by the CPSC to the manufacturer or private labeler.

Proposed Sec. 1102.6(b)(8) would define ``report of harm'' as any information submitted to the Commission through the manner described in

Sec. 1102.10(b) regarding an incident concerning an injury, illness or death, or any risk of

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injury, illness or death as determined by the Commission relating to the use of the consumer product.

Proposed Sec. 1102.6(b)(9) would define ``submitter of a report of harm'' as any person or entity that submits information to the

Commission through the database regarding any injury, illness, or death, or any risk of injury, illness, or death as determined by the

Commission relating to the use of a consumer product.

Proposed Sec. 1102.6(b)(10) would define ``voluntary recall notice'' to mean any notice to the public relating to a voluntary corrective action taken by a manufacturer in consultation with the

Commission where the Commission has notified the public of the manufacturer's voluntary corrective action.

B. Proposed Subpart B--Content Requirements

Proposed subpart B, ``Content Requirements,'' would describe the database's contents. In general, section 6A(b) of the CPSA states that the database must include: (1) Reports of harm; (2) information derived by the Commission from notice under section 15(c), and any notice to the public relating to a voluntary corrective action taken by a manufacturer, in consultation with the Commission, of which the

Commission has notified the public; and (3) manufacturer comments received by the Commission on a report of harm and requested for inclusion into the database. Proposed Sec. Sec. 1102.10 through 1102.14 would describe how such reports, information, and comments would become part of the database, and proposed Sec. 1102.16,

``Additional information,'' would discuss information that the CPSC may add to the database when adding such information would be in the public interest. Reports of harm that fall outside the scope of CPSC regulatory authority will be referred to an appropriate agency or entity with notification of such action to the submitter. 1. Proposed Sec. 1102.10--Reports of Harm

Proposed Sec. 1102.10 would explain who may submit reports of harm in the public database. In brief, proposed Sec. 1102.10(a) would identify those submitters specified in section 6A(b)(1)(A) of the CPSA and provide further clarification for those categories of persons that may fall within each of the identified groups. The list of persons under each group is not exclusive, and the proposed lists are intended to provide a greater understanding of the persons that could fall under each category. For example, ``consumers'' would include not only users of consumer products, but also family members, relatives, parents, guardians, friends, observers of a consumer product being used by another, and victims. The proposal would add a category of ``other'' to include those persons who may not clearly fit within the statutorily identified categories; for example, ``other'' persons would include, but not be limited to, attorneys, professional engineers, investigators, nongovernmental organizations, consumer advocates, consumer advocacy organizations, and trade associations.

Proposed Sec. 1102.10(b) would describe how a report of harm can be submitted to the database. The proposal would describe four methods

(internet, telephone, electronic mail, and paper) for submitting reports and when each submission will be construed as being complete.

For example, proposed Sec. 1102.10(b)(1) would explain that submitters using the Internet will use an electronic form specifically developed to collect the report of harm in the database. As another example, proposed Sec. 1102.10(b)(2) would explain how submissions over the telephone will be accepted and proposed Sec. 1102.10(b)(4) would explain how the Commission will deal with written submissions.

Additionally, the proposal gives the Commission the flexibility to provide other means of submission if new ways subsequently become available.

Proposed Sec. 1102.10(c) would describe potential size limits on reports of harm where the size of such reports of harm, including attachments, might negatively impact the technological or operational performance of the system.

Proposed Sec. 1102.10(d)(1) through (d)(6) would describe the minimum requirements for publication of reports of harm in the database. The proposal identifies the required criteria of information that are referenced in section 6A(b)(2)(B)(i) through (v) of the CPSA and further elaborates on the type of information included under each category. For example, proposed Sec. 1102.10(d)(1) would explain that a description of a consumer product must include a word or phrase sufficient to distinguish a product identified in a report of harm as a consumer product or a component of a consumer product or some other word or phrase to show it is a consumer product or a product or substance regulated by the Commission. This description could include the name (including the brand name) of the product. Other information, such as where the product was purchased, price paid, model, serial number, date of manufacture (if known), date code or retailer is described as information that would be helpful to the description of a consumer product.

Proposed Sec. 1102.10(d)(2) would describe that a report of harm must contain the identity of the manufacturer or private labeler in order for the report to be published. This section would further explain that the name of any company information sufficient to distinguish an entity will satisfy the minimum identification requirement and that contact information such a mailing address, phone number, or electronic mail address would satisfy the identification requirement.

Proposed Sec. 1102.10(d)(3) would explain that a description of harm should include a narrative that describes the harm or risk of harm. The proposal would contain a nonexclusive list of examples of the types of harm that could be included. The proposal would allow for a description to include a risk of harm where no actual harm occurred.

However, this proposed section would also explain that information unrelated to bodily harm or a risk of bodily harm, such as information on cost or quality of a consumer product, will not satisfy the regulatory requirement for a description of harm. Information such as the date on which the harm occurred or manifested itself, the severity of any injury or whether medical treatment was sought is identified as helpful, but not required, information to include in a description.

Proposed Sec. 1102.10(d)(4), (5), and (6) would describe the minimum requirements for contact information, verification, and consent of the report of harm by the submitter. For contact information, the proposed Sec. 1102.10(c)(4) would require that a submitter of a report of harm provide his or her first and last name and a mailing address as required contact information for the report to be published. The proposed rule would explain that submitters of reports of harm also may provide other contact information, such as an electronic mail address or a telephone number, but that such information is not required in order to publish the report.

Proposed Sec. 1102.10(d)(5) would explain that submitters must verify the report of harm for publication and the verification statement follows the statutory outline. Verification would involve a submitter of a report of harm affirmatively agreeing that he or she has reviewed the information submitted in a report of harm and then checking the box for verifying the information the report contains.

This proposed section would also require that as part of verifying the report, submitters of

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reports of harm must indicate what category they are in (consumer, government agency, health care professional, etc.)

Proposed Sec. 1102.10(d)(6) would explain that the submitter of a report of harm must consent to inclusion of the report of harm in the database in order for the report to be published. If no consent is provided by the submitter the report will not be published.

Proposed Sec. 1102.10(e) would describe the Commission's ability to seek other categories of voluntary information. The Commission seeks comment as to whether additional categories should include demographic data, such as race, or additional data about the product in question, such as whether the product still contained all of its original parts, or had been altered in any way not according to a manufacturer's instructions.

Proposed Sec. 1102.10(f) would describe the information that will not be published in the database including the name and contact information of the submitter of a report of harm; the victim's name and contact information (if provided), photographs depicting a person or injury because of privacy concerns or because the Commission has determined that they are not in the public interest; medical records without the consent of the person about whom such records pertain (or that person's parent or guardian if the person is a minor); confidential information; materially inaccurate information; reports of harm retracted by submitters who indicate in writing to the Commission that they supplied materially inaccurate information; and/or any other material submitted on or with a report of harm that the Commission determines is not in the public interest to publish. This proposed section would identify criteria and explain that the public interest determination will be based on the criteria relating to whether or not the information helps database users to identify a consumer product; identify the manufacturer or private labeler of a consumer product; understand the risk of harm related to the use of a consumer product; or understand the relationship between the submitter of a report of harm and the victim. The Commission will examine privacy concerns based on the Privacy Act of 1974, Public Law 93-579, as amended.

Proposed Sec. 1102.10(g) would state that reports of harm submitted by persons under the age of 18 must include the consent of the parent or guardian of that person. The rationale for requiring consent on reports by a minor is premised on the notion that age of legal consent in many jurisdictions is 18. Review of a report of harm by a parent or guardian will also ensure that information about a harm or risk of harm is being disclosed publicly with the parent's consent addressing concerns related to the privacy of such information.

Further, if a parent or guardian reviews the report, consent may also improve the accuracy of the information the report contains.

Proposed Sec. 1102.10(h) would explain that information received related to a report of harm that is incomplete because it does not meet the requirements for submission or publication will be maintained for appropriate Commission use.

Proposed Sec. 1102.10(i) would explain that reports of harm accepted by the Commission become official records of the Commission in accordance with 16 CFR 1015.1 and that alteration (or disposition) of these records can only be undertaken in accordance with the procedures specified in this Part. 2. Proposed Sec. 1102.12--Manufacturer Comments

Proposed Sec. 1102.12(a) would state that manufacturers or private labelers who receive a report of harm transmitted from the CPSC may submit comments. Proposed Sec. 1102.12(b) would propose that comments may be received via an online manufacturer portal where the manufacturer can register to submit comments on a secure nonpublic portal that will be provided through the Commission's database. The proposal also would specify that comments may be submitted via electronic mail or regular mail directed to the Commission's Office of the Secretary.

Proposed Sec. 1102.12(c)(1) through (c)(4) would specify that the

Commission will publish a manufacturer's comments related to a report of harm if the comment specifically relates to a report of harm, contains a unique identifier assigned to it, contains the manufacturer's verification of the truth and accuracy of their comment

(similar to the verification required of a submitter of a report of harm) as well as their consent for publication in the database. The proposed rule would require a manufacturer to affirmatively request that its comment be published and to affirmatively consent to such publication in order for the manufacturer comment to be published in the database.

Proposed Sec. 1102.12(d) would explain that the Commission will publish a manufacturer's comments and the date such comments are submitted to the CPSC in the database.

Proposed Sec. 1102.12(e) would explain that the Commission will not publish the actual consents and verifications obtained from the manufacturer for such publication. 3. Proposed Sec. 1102.14--Recall Notices

Proposed Sec. 1102.14 would state that information in a voluntary or mandatory recall notice will be made accessible and searchable to the public in the database. 4. Proposed Sec. 1102.16--Additional Information

Proposed Sec. 1102.16 would describe the criteria to be used to determine any additional information that will be published in the database consistent with the requirements of section 6(a) and (b) of the CPSA.

C. Proposed Subpart C--Procedural Requirements

Proposed subpart C, ``Procedural Requirements,'' would describe the procedural requirements set forth in section 6A(c) of the CPSA related to the manufacturer notification and transmission. This proposed subpart would explain the procedural requirements for CPSC transmission of reports of harm to an identified manufacturer or private labeler; a description of the opportunity for comment by the manufacturer or private labeler identified in reports of harm; how designations of confidential information should be submitted and the criteria for how they will be reviewed; how materially inaccurate information should be designated and what the Commission will consider in reviewing any such claim both before and after posting a report of harm in the database; the timing of posting reports of harm in the database; and the timing and posting of manufacturers' comments in the database. 1. Proposed Sec. 1102.20--Transmission of Reports of Harm to

Identified Manufacturer or Private Labeler

Proposed Sec. 1102.20 would explain what information in a report of harm will and will not be transmitted to a manufacturer or private labeler. As set forth in section 6A(b)(2)(B) of the CPSA, the name and contact information of the submitter will not be transmitted to a manufacturer or private labeler unless the submitter of a report of harm consents to transmit this information. The proposed rule also would prevent transmission of any photographs submitted with the report of harm unless the submitter specifically consents, and further explains that medical records will not be provided

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without explicit consent from the person to whom such records pertain, or his or her parent, guardian or legally authorized representative.

Proposed Sec. 1102.20(b) would describe the limitation on use of contact information by a manufacturer or private labeler. The proposed regulatory text would incorporate the limitation in section 6A of the

CPSA on the use of submitter contact information by the manufacturer for any purpose other than verification of information contained in a report of harm. The proposed rule would describe activities that will not be considered as verification including sales, promotion, marketing or warranty activities or activities relating to a commercial purpose of the manufacturer. The proposal also would describe what is considered a verification purpose by relating the statutory criteria required for a report of harm to be published. For example, proposed

Sec. 1102.20(b)(1) through (b)(4) would explain that verification could be related to the identity of the requester; the consumer product including name, serial or model number; the harm or risk of harm described in the report of harm; and/or a description of the incident related to the use of the consumer product.

Proposed Sec. 1102.20(c) would explain the timing of transmission of reports of harm to the manufacturer. The proposal would adopt the statutory language that the reports will be transmitted to the manufacturer to the extent practicable within five business days after the Commission receives a completed report of harm. The proposal would identify circumstances where transmission of a report of harm to the manufacturer within five business days may be impracticable. The circumstances include: where the identified manufacturer or private labeler is out of business with no identifiable successor; the submitter misidentified the manufacturer or private labeler; the report of harm contained inaccurate or insufficient information for identification of a manufacturer or private labeler or when the

Commission cannot locate valid contact information for a manufacturer or private labeler.

Proposed Sec. 1102.20(d) would describe a method for transmission of reports of harm to a manufacturer or private labeler based on registration by the manufacturer or private labeler in the online manufacturer portal. The proposal also would explain that where a manufacturer or private labeler has not registered for electronic transmission, the Commission will send reports of harm through the

United States mail to a firm's principal place of business, unless the

Commission selects another equally effective method of transmission.

Proposed Sec. 1102.20(e) would describe that the Commission may in its discretion limit the data size of comments, which may include attachments submitted, where such comments and attachments may negatively impact the technological or operational performance of the system.

Proposed Sec. 1102.20(f) would describe the process of manufacturer registration and explains that registrants can select a preferred method for receiving reports of harm in the database. The proposal would require that a manufacturer or private labeler provide updated contact information and allows the registrant to select a specific method to receive reports of harm.

Proposed Sec. 1102.20(g) would address manufacturer comments received after one year and would explain that a manufacturer or private labeler may comment on information received about a report of harm. The proposal would allow the Commission, in its discretion not to publish a manufacturer comment to the database that is received more than one year after transmission of the report of harm to the manufacturer or private labeler where it would not be in the public interest to do so. The proposal also would allow the Commission to limit the data size of comments, which may include attachments submitted where such comments and attachments may negatively impact the technological or operational performance of the system. 2. Proposed Sec. 1102.24--Designation of Confidential Information

Proposed Sec. 1102.24 would explain how the Commission will define

``confidential information'' and would set forth criteria which must be followed to assert a claim of confidentiality. The Commission notes that most reports of harm received from consumers will not likely contain confidential information. However, where such a claim for a portion of information on a report of harm is asserted, the proposal would require affirmative statements that would assist the Commission in an evaluation of the merits of the request.

Proposed Sec. 1102.24(a) would interpret the terms ``confidential information'' in a manner similar to that in section 6(a) of the CPSA.

The proposal would establish parameters for asserting and supporting a claim of a portion of a report of harm as confidential; these parameters follow closely the Commission's current practice and procedure for such assertions in a FOIA context.

Proposed Sec. 1102.24(b) would explain that a manufacturer may designate portions of information contained in a report of harm as confidential and would describe, at paragraphs (b)(1) through (b)(6), the statements required to support the claim of confidential information. If these statements are missing from any request, the

Commission will consider the request to be incomplete and unsupported.

For example, proposed Sec. 1102.24(b)(1) would explain that a manufacturer or private labeler is required to specifically designate those portions of the report of harm asserted to be confidential.

Proposed Sec. 1102.24(b)(2) would require information on whether the asserted confidential portion of a report has ever been released to any person who was not an employee or in a confidential relationship with the manufacturer or private labeler.

Proposed Sec. 1102.24(b)(3) would require an explanation on whether the asserted confidential portion of the report is commonly known or readily ascertainable by outside persons with a minimum of time and effort. Proposed Sec. 1102.24(b)(4) would require the manufacturer to explain the relationship, if any, between the submitter of the report of harm and the manufacturer or private labeler and how the submitter could have come into possession of such confidential information. Proposed Sec. 1102.24(b)(5) would explain that the manufacturer also must support a confidentiality claim by describing how release of the information could cause competitive harm. Any portion of information in a report of harm designated by a manufacturer to be confidential but lacking the statements and information in section Sec. 1101.24 (b)(1) through (b)(6) will not be considered confidential. Section 1101.24(b) also notes that the requester of a designation of confidential information bears the burden of proof regarding such a request.

Proposed Sec. 1102.24(c) would describe the manner of submission where confidentiality is asserted for a designated portion of a report of harm. This proposal would allow submission of confidentiality assertions in the same manner as manufacturer comments described in proposed Sec. 1102.12(b) and would require the requests to be conspicuously labeled.

Proposed Sec. 1102.24(d) would explain that a request for confidential treatment be made at any time after CPSC transmission to the manufacturer of a report of harm.

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Proposed Sec. 1102.24(e) would explain that a request for confidentiality should only be made by those who intend in good faith, and so certify in writing, to assist in the defense of confidentiality by the Commission in any later judicial proceeding that could be sought to compel disclosure. This provision is similar to one found in the

Commission's FOIA regulations concerning the assertion of confidentiality. The assertion of confidentiality must be legitimate, and the Commission believes that this provision requires firms to stand behind their assertion where the Commission is being sued to protect a firm's confidential information.

Proposed Sec. 1102.24(f) and (g) would describe the procedure to notify the manufacturer or private labeler of determinations on the claim of confidentiality. Proposed Sec. 1102.24(f) would state that, if a portion of a report is deemed confidential, the Commission will notify the manufacturer or private labeler, redact the information deemed confidential, and publish the report of harm as redacted in the database.

Proposed Sec. 1102.24(g) would state that, if a portion of a report is not deemed confidential, the Commission will notify the manufacturer or private labeler of the Commission's determination and will publish the report of harm in the database.

Proposed Sec. 1102.24(h) would explain the right of a manufacturer or private labeler to sue in the appropriate United States District

Court to seek removal of alleged confidential information published in the Consumer Product Safety Database. 3. Proposed Sec. 1102.26--Designation of Materially Inaccurate

Information

Proposed Sec. 1102.26 would contain definitions and the process for how claims of materially inaccurate information contained in reports of harm and manufacturer comments may be asserted and how they will be evaluated. Section 6A(c)(4) of the CPSA addresses materially inaccurate information in a report of harm as well as in a manufacturer's or private labeler's comments.

Proposed Sec. 1102.26(a)(1) would define ``materially inaccurate information in a report of harm'' as information that is false or misleading in a significant and relevant way that it creates or has the potential to create a substantially erroneous or substantially mistaken belief about information in a report of harm. This proposed definition would tie the ``substantially erroneous or substantially mistaken'' element to required information in a report of harm, such as the identification of a consumer product, the identification of a manufacturer or private labeler, or the harm or risk of harm related to the use of the consumer product.

Proposed Sec. 1102.26(a)(2) would define ``materially inaccurate information in a manufacturer comment'' similar to the definition used in a report of harm. This provision would explain such information as information 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 manufacturer's comment. This proposed definition would tie the

``substantially erroneous or substantially mistaken'' element to information in a manufacturer or private labeler comment that creates a substantially erroneous or substantially mistaken belief about: (1) The nature, scope, liability or cause of a harm or risk of harm related to the use of a consumer product; (2) the status of a Commission, manufacturer, or private labeler investigation; (3) the identity of the firms responsible for importation and distribution and sale of a consumer product; (4) information about the corrective action that a manufacturer or private labeler is engaging in when such corrective action has not been approved by the Commission; or (5) information in a comment about whether the manufacturer has taken or promised to take any other action with regard to the product.

Proposed Sec. 1102.26(b) would allow any person or entity to request that a report of harm or manufacturer comment or portions thereof be excluded from the database or corrected by the Commission because such report or comment contains materially inaccurate information as defined in proposed Sec. 1102.26(a). This section would require, at paragraphs (b)(1) through (b)(7), the statements required in order to support the claim of materially inaccurate information. If these statements are missing from any request, the Commission would consider the request to be incomplete and unsupported. Should the

Commission include in this section a ``burden of proof'' requirement and, if so, what should be the meaning of the term and what standard of proof would be imposed under it?

Proposed Sec. 1102.26(c) would explain the manner of submission for manufacturers and private labelers and all other requesters. This would allow manufacturers to submit a claim in the same manner as a comment is submitted and would allow all other requesters to submit via electronic mail or written submission directed to the Office of the

Secretary.

Proposed Sec. 1102.26(d) would allow a request for a determination of materially inaccurate information to be submitted at any time. If a request for determination of materially inaccurate information is submitted prior to publication in the database, the Commission may withhold a report of harm from publication in the database until it makes a determination. Absent such a determination, the Commission will generally publish reports of harm on the tenth business day after transmitting a report of harm.

Proposed Sec. 1102.26(e) would explain that a request for material inaccuracy should only be made by those who intend in good faith to assist in the defense of material inaccuracy by the Commission in any later judicial proceeding that could be sought to compel disclosure.

This provision is similar to one found in the Commission's FOIA regulations concerning the assertion of confidentiality. The assertion of material inaccuracy must be legitimate and the Commission believes that this provision requires those seeking such a determination on information in a report of harm or manufacturer or private labeler comment to stand behind their assertion where the Commission is being sued to compel disclosure of such information.

Proposed Sec. 1102.26(f) would describe the notice procedure the

Commission will follow to notify the person or firm requesting a determination regarding materially inaccurate information of its determination and method of resolution after resolving such request.

Proposed Sec. 1102.26(g) and (h) would outline the steps the

Commission will take where it has made a determination of material inaccuracy. Proposed Sec. 1102.26(g) would address a Commission determination where information in a report of harm or comment has not been published and would explain that the Commission may: (1) Decline to add the report of harm or manufacturer comment to the database; (2) correct the materially inaccurate information; or (3) add information to the report of harm to correct the materially inaccurate information.

Proposed Sec. 1102.26(h) would address a Commission determination where information in a report of harm or comment has been published and would explain that the Commission may, after an investigation, determine that information in a report of harm or manufacturer comment contains

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materially inaccurate information. The proposal would explain that the

Commission shall, no later than seven business days of such determination: (1) Remove the report of harm or manufacturer comment, including any attachments, from the database; (2) correct the materially inaccurate information and if other minimum requirements for publication are met maintain the comment or report of harm in the database; or (3) add information to the report of harm or comment to correct the materially inaccurate information and if other minimum requirements for publication are met maintain the comment or report of harm in the database.

Proposed Sec. 1102.26(i)(1) would state that the Commission's policy with respect to removing, correction, or adding information to correct materially inaccurate information is to preserve the integrity of the information received for publication in the database and that the Commission will favor correction and addition to correction, over exclusion of reports in the database. Proposed Sec. 1102.26(i)(2) would create a means for expedited determinations of claims of materially inaccurate information for those requesters staying within the five page limit recommended at Sec. 1102.26(c)(1) by stating that the Commission shall, where practicable, make an expedited determination after receipt of the manufacturer's request for a correction or exclusion. Additionally, proposed Sec. 1102.26(c)(1) would explain that given the requirement in Sec. 6A of the CPSA that reports of harm be published, the Commission will generally publish reports of harm on the tenth business day after transmitting a report of harm where either the recommended page limit has been exceeded or where the Commission is otherwise unable to make a determination regarding a claim of material inaccuracy prior to the statutorily mandated publication date.

Proposed Sec. 1102.26(j) would explain that the Commission will notify the requester and publish the report of harm or manufacturer comment (if not already published) if it meets the minimum requirements.

Proposed Sec. 1102.26(k) would provide the Commission the discretion to review a report of harm or a manufacturer comment for materially inaccurate information on its own initiative following the same notices and procedures set forth in (g) through (j). 4. Proposed Sec. 1102.28--Publication of Reports of Harm

Proposed Sec. 1102.28 would explain that reports of harm will be published in the database as soon as practicable, but no later than ten days after such report of harm is transmitted by the CPSC to the manufacturer or private labeler. This provision would explain that reports may be published beyond the ten day time frame when the report of harm misidentifies or fails to identify all manufacturers or private labelers. The information would have to be corrected through the procedures for materially inaccurate information at proposed Sec. 1102.26. 5. Proposed Sec. 1102.30--Publication of Manufacturer Comments

Proposed Sec. 1102.30 would explain that the Commission will publish manufacturer comments that meet the minimum requirements in proposed Sec. 1102.12(c) at the same time as a report of harm is published or as soon as practicable thereafter. The proposal would provide examples of circumstances which may make it impracticable to publish a manufacturer comment: (1) The Commission did not receive the comment until on or after the publication date of the report of harm or

(2) the Commission is resolving a claim that the manufacturer comment contains materially inaccurate information.

D. Proposed Subpart D--Notice and Disclosure Requirements

This subpart would contain information on the disclaimers that will be part of the database and any information viewed on it as well as the applicability of section 6(a) and (b) of the CPSA. 1. Proposed Sec. 1102.42--Disclaimers

Proposed Sec. 1102.42 would set forth the type of disclaimer that will be used on the database and documents generated from it. This provision would require that the disclaimer be prominently and conspicuously displayed and that it be transmitted on any documents that are printed from the database. 2. Proposed Sec. 1102.44--Applicability of Section 6(a) and (b) of the

CPSA

Proposed Sec. 1102.44(a) would explain that section 6(a) and (b) of the CPSA do not apply to the submission, disclosure, and publication of information provided in a report of harm. Proposed Sec. 1102.44(b) would apply section 6(a) and (b) of the CPSA to information received by the Commission pursuant to section 15(b) of the CPSA and to information received by the Commission pursuant to any other voluntary or mandatory reporting program established between a retailer, manufacturer or private labeler.

IV. Comments on the Publicly Available Database and CPSC's Responses

We describe and respond to significant issues raised by the comments. To make it easier to identify comments and the Commission's responses, the word ``Comment'' will appear before each comment description, and the word ``Response'' will appear before the

Commission's response. We have grouped comments based on their similarity and have numbered the comments to help distinguish between different comment themes. The number assigned to each comment summary is for organizational purposes and does not signify the comment's value, importance, or order in which it was received.

Subpart B--Content Requirements

Section 1102.10: Reports of Harm 1. CPSC asked whether any category of persons should be excluded from submitting reports of harm for inclusion in the public database, and, if so, by what means.

Comments (Summary 1)

Two commenters responded that no category of persons should be excluded from submitting reports of harm. Another commenter responded that third party submitters may be one or more degrees separated from the events involved in a report and encouraged CPSC to consider how this might affect assessment of information that could be materially inaccurate. This commenter suggested that there should be transparency regarding relationships surrounding reports and the person filing the report. One commenter stated that anonymous reports should not be published since they cannot be verified. Two commenters proposed that only reports from those groups specified in Section 6A(b)(1)(A)(i)-(v) should be considered for inclusion in the database, and the Commission should clearly and narrowly define these categories. One commenter suggested that the report form should ask submitters to identify to which group under 6A(b)(1)(A)(i)-(v) they belong. This commenter suggested that the CPSC should have a method for verifying that those filing reports are who they say they are. To assist in this, the commenter suggested that the CPSC should encourage submitters to consent to their contact information being shared with the manufacturer or private labeler.

Response

We note the breadth of the entities listed in the statute and conclude that the list is intended to be nonrestrictive.

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Accordingly, we propose that, except for information collected through the National Electronic Injury Surveillance System (NEISS), which is information collected by selected hospital emergency rooms, and except for information collected through Death Certificates, all reports of harm (or ``incident reports'') related to use of a consumer product or other substance regulated by the Commission, be collected through the same incident report form, regardless of who is submitting the report of harm, and deposited into a central data warehouse for such information.

We propose that product-related incident information be collected from all sources, including anonymous sources, but that only those reports that meet the statutorily required minimum information as set forth in the statute be published for review and access in the publicly-searchable portion of the database.

We propose that a completed report for posting in the public database include verification of the information submitted and an indication as to whether consent has been given regarding the submitter's contact information being shared with the manufacturer or private labeler. 2. CPSC asked whether reports of harm submitted by telephone or paper should meet the same statutory time frames for submission in the public database.

Comment (Summary 2)

CPSC received five comments, including two from the same commenter, responding that regardless of the means of transmission, all reports of harm should adhere to the same statutory time frames for submission in the public database.

Response

We propose that in order to be included in the public database, all reports of harm, regardless of how they are received by the Commission, must meet certain minimum requirements, which includes, among other things, that reports be verified by the submitter for accuracy and that the submitter consent to inclusion of the report in the public database. We propose that paper submissions which do not follow the incident report form being developed for the CPSC Web site, be returned to the submitter for further completion, verification and consents.

We propose that the ``not later than five business days'' time frame for notifying a manufacturer or private labeler of a report of harm involving one of its consumer products will not start to run until the CPSC receives a verified report of harm from the submitter of the report of harm. 3. CPSC asked what a description of the consumer product should entail and why.

Comment (Summary 3)

For the most part, all of the commenters responded that some combination of the following would provide a description of the consumer product: Brand name, category of product (using an auto-fill function or drop-down menus), model number, serial number, and a text description of the product. One commenter responded that the brand name

(incl. ``unknown''), category of product (auto-fill list), model number, serial number, serial/series number/code, manufacturer's identification, the date the item was purchased, where the item was purchased, country of origin, manufacturer/distributor/private labeler name, UPC code, and a text description of the product should be included. Two commenters suggested that industry should be encouraged to provide CPSC with product-identification information that can be incorporated into the database because the greater the specificity in product identification, the greater the ability of CPSC and manufacturers to identify trends and patterns in the reports it receives. Three commenters suggested that the database should permit submitters to upload photos and/or supporting documentation of the products related to the incident. One commenter suggested that CPSC should work with stakeholders to develop guidelines as to types of photos and/or supporting documentation that would and would not be permitted to be included in the database.

Response

We agree with the majority of the comments and have begun incorporating many of the recommendations into the development of the public database. The incident report input screens being developed incorporate auto-fill functions, drop-down menus, and text fields where appropriate. For example, an auto-fill function will be provided for brand name, model name or number, manufacturer name, retailer name, and similar fields based on information we have collected in our database library, which will grow over time. Drop-down menus will be used for fields such as product category and type; injury severity, type, and location; and state and country codes. Text fields will be available for incident description and product description.

The incident report form is being designed to provide on-line help to assist submitters with locating the product identification information such as brand name, model number, manufacturer name, and manufacture date code. The staff explored the feasibility of collecting detailed product identification information from the industry but ultimately decided that given the pace of change and dynamic nature of the consumer product universe, central maintenance of such information would be infeasible. The incident report will allow submitters to attach photos and other approved file formats to supplement their report. 4. CPSC asked what contact information must be provided, at minimum, to meet the statutory requirement for inclusion in the database.

Comment (Summary 4)

All of the commenters agreed that a submitter should provide a name and address. Some of the commenters suggested that submitters should have to provide a telephone number and/or an e-mail address as a secondary means of contact. One commenter also stated that when submitted online, the submitter should be asked to submit an e-mail address, and that when submitted via telephone, the submitter should be asked to provide a telephone number, but that submitters should be encouraged to submit a phone number and/or an e-mail address regardless of the method of submission. This commenter also stated that if a report is made on behalf of a minor, the information provided should be provided by the parent or guardian of that minor.

Response

We propose that the minimum contact information that must be provided by a submitter of a report of harm for inclusion in the public database be the submitter's first name, last name, and complete mailing address. Additionally, submitters will be strongly encouraged to enter an e-mail address and/or a telephone number for follow-up purposes.

We also propose that minors under the age of 18 not be allowed to submit a report of harm to the public database without the consent of a parent or guardian as the named contact person. 5. CPSC asked how the report form should address the issue of the submitter's verification of the information submitted.

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Comments (Summary 5)

All of the commenters agreed that submitters should have to take affirmative steps to verify the accuracy of the submission. One commenter suggested that verification and consent should be obtained separately (e.g., two separate questions) and that the CPSC should employ a procedure similar to that currently utilized by the

Clearinghouse wherein a completed report of harm and verification would be mailed to the consumer which the consumer would then mail back. This commenter also suggested that the CPSC should consider sending an automated verification message to the submitter's e-mail address when submitted online, as this would allow the submitter to review the report, and require the submitter to respond to the message to verify the report and consent to its inclusion in database. Reports submitted by telephone should receive the submitter's verification and consent in writing, as per the current Clearinghouse procedure.

However, one commenter suggested that submitters who provide their reports via telephone should be able to verify truth and accuracy of statements over the telephone with CPSC staff. The same commenter proposed that unconfirmed or anonymous reports should, minimally, affirmatively acknowledge verification.

Response

We propose that for each incident report submitted on-line, the submitter be prompted to affirmatively check a box indicating that they have reviewed the report and that they are verifying that the information contained in the report is true and accurate to the best of their knowledge. This same or similar statement mechanism will appear on e-mail and paper-based forms for verification purposes, although the paper-based form may also require the submitter's signature. We propose that in the case of telephone submissions, CPSC mail or e-mail the completed form to the submitter for review and verification, including requiring the submitter's verification. 6. CPSC asked how the report form should address the submitter's consent for: (i) Inclusion in the public database; and (ii) release of contact information to the manufacturer or private labeler, and whether there were any other issues related to the user's consent that the CPSC should consider.

Comment (Summary 6)

All of the commenters on this issue suggested that CPSC should utilize simple check boxes on the report form. Specifically, one commenter proposed that consent for inclusion should be required but release of contact information should be optional. This commenter also stated that the report form should clearly state that contact information will not be released to the public. This commenter also suggested that next to the check box for release of contact information to the manufacturer, the report form should include a statement that

CPSC encourages consumers to cooperate with investigations.

Response

We propose that consent of release of information be obtained separately from verification. We propose the following consents be obtained separately on the form: Consent to include information in the public database; consent to release of contact information to the manufacturer or private labeler; and, for requests received through

FOIA, consent to release contact information to the general public. 7. CPSC asked what, if any, measures should the agency employ to prevent the submission of fraudulent reports of harm while not discouraging the submission of valid reports.

Comments (Summary 7)

All of the commenters on this issue expressed concern about the prevention of fraudulent reports of harm. Several commenters suggested a check box function expressly certifying the accuracy of the information in the report of harm but with reminders of the implications for submitting fraudulent or inaccurate information.

Two commenters were concerned about Web-based robots spamming the database, and one suggested a security feature similar to those used on ticket Web sites (e.g., requiring the user to type a combination of letters and numbers appearing on screen) to ensure that an automated

``robot'' is not spamming the database with bogus information. One commenter suggested that submitters should be required to affirmatively include a verification statement in narrative format as part of their description of the incident. One commenter stated that CPSC should have a method of verifying that a submitter is who they say they are and not a competitor, interest group, or other person motivated to ``salt'' the database, and that CPSC should run system checks to see whether multiple reports are received from the same person.

Response

We agree that preventing fraudulent reports is a high priority in the development of the public database. The development team has incorporated the following to address the issue. In the new incident report form, the user must check a box that indicates they certify their incident report to be true and accurate to the best of their knowledge. This screen captures ``Verification by Submitter'' as one of the five types of information required by CPSIA, at a minimum, to publish incidents of harm in the public database. Once the ``certify'' box is checked, the ``Submit'' button becomes available at the bottom of the screen. The user clicks the ``Submit'' button to officially submit their incident report to the CPSC.

The database implementation team is working closely with the enterprise information security team to ensure the system utilizes industry best practices as well as complies with Federal and CPSC specific security requirements. We are considering implementation of

CAPTCHA \1\ types of challenge-response tests to ensure that the incident report form is not being generated by a computer. We will also examine technical options to detect if multiple reports are submitted from the same IP address.

\1\ Completely Automated Public Turing test to tell Computers and Humans Apart.

8. CPSC asked whether the agency should design the online reporting form to ensure the capture of data that can be used in scientific statistical analysis and, if so, how.

Comments (Summary 8)

Two commenters agreed that the database could facilitate statistical analysis, stating that the data could be used to calculate incident rates, identify emerging hazard trends, improve CPSC's ability to identify risks and respond quickly, determine the effectiveness of safety standards and regulations, and further CPSC's IT modernization plan. One commenter responded that the database would not support the use of the data for scientific statistical analysis because of concerns regarding the validity of the data.

Response

We are designing database reporting options into the system that will enable public users to extract data sets of published incident report information. The extracted fields on these reports may be user- defined and exportable in a variety of standard file formats that will enable use with popular data analysis tools.

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9. CPSC asked whether the report form should contain links to outside Web sites and, if so, why.

Comments (Summary 9)

CPSC received four comments in response to this question and all agreed that linking to outside Web sites could be problematic. Some commenters agreed that links could be helpful if such links were relevant to the product or complaint.

Response

We agree with these comments and conclude that the report form should not contain links to outside, non-CPSC Web sites at this time. 10. CPSC asked how the agency should design the report form so that it is clear and easy for users to complete.

Comments (Summary 10)

Many of the commenters agreed that for ease of use the report form should contain as many drop-down menus, pop-up windows, help features, reminders, and auto-fill fields as possible and/or that required fields should be marked with an asterisk. Some commenters felt that the database should distinguish (statutorily) required fields from optional fields. Some commenters felt that the database should have as few required fields as possible, but provide additional fields that can be filled in if the submitter so chooses. Some commenters suggested it could be useful to allow narrative responses when seeking a description of a product or incident. Others provided more basic suggestions for the design of the report form, such as the report form should use a large, easy-to-read font and language. In addition, one commenter suggested that CPSC should provide easy access to information about the database, including its purpose, its potential uses, and a guide on how to access information in the database and should include CPSC contact information, such as e-mail address and phone number, in plain sight for users who need assistance with the database. One commenter proposed that submitters should have the option to review and edit the submission at any point in the process of filling out the report form.

Response

We agree with these comments and are incorporating many of the recommendations in the public database. The incident report input screens being developed incorporate auto-fill functions, drop-down menus, and text fields where appropriate. For example, an auto-fill function will be provided for brand name, model name or number, manufacturer name, retailer name, and similar fields based on information we have collected in our database library, which will grow over time. Drop-down menus will be used for fields such as product category and type; injury severity, type, and location; and state and country codes. Text fields will be available for incident description and product description.

The incident report form is being designed to provide on-line help to assist submitters with locating the product identification information such as brand name, model number, manufacturer name, and manufacture date code. The staff explored the feasibility of collecting detailed product identification information from the industry but ultimately decided that given the pace of change and dynamic nature of the consumer product universe, central maintenance of such information would be infeasible. The form will also inform the user about the purpose and use of the information collected as well as how it will be protected. 11. CPSC asked how the agency could ensure the accuracy of submitted data, from a system design perspective.

Comments (Summary 11)

Two commenters suggested that a report of harm be assigned a unique identifier. One commenter suggested that a report of harm could utilize two unique identifiers, one viewable in the public database and one viewable only to submitters, manufacturers or private labelers, and the

CPSC for the purposes of collecting further information regarding a report of harm. One commenter suggested that anyone submitting a report of harm should be required to provide contact information. Submitters should be asked to create a user ID and password that can be linked to each report submitted by the user.

One commenter suggested that a submitter should identify to what group they belong when filing a report of harm, for example, consumer, government agency, or health care professional. Several commenters suggested the use of drop-down menus and/or auto-fill features for as many categories of information as possible throughout the report form to assist submitters in providing complete and accurate information.

For instance, one commenter suggested using hazard codes similar to those used in the NEISS database and brand names using data already in

CPSC's other databases, and creating a registry for manufacturers and others to provide their contact information. One commenter suggested unlimited free text incident descriptions. One commenter also suggested including data fields on the report form for CPSC-validated data as well as manufacturer/private labeler comments.

One commenter suggested allowing submitters to amend reports of harm as well as allowing manufacturers to submit comments for publication after the report of harm has been published. This commenter also suggested maintaining an audit trail every time a report is modified. One commenter stated that claims of material inaccuracy should be focused on the submitter and identification of the consumer product, and not on the reported problem with the consumer product.

This commenter suggested that reports of harm should not be blocked, removed, or otherwise flagged when a manufacturer makes a claim of material inaccuracy.

Response

We have incorporated many of these suggestions into the system design. Each report will have a unique identifier number.

The incident report input screens being developed incorporate auto- fill functions, drop-down menus, and text fields where appropriate. For example, an auto-fill function will be provided for brand name, model name or number, manufacturer name, retailer name, and similar fields based on information we have collected in our database library, which will grow over time. Drop-down menus will be used for fields such as product category and type; injury severity, type, and location; and state and country codes. Text fields will be available for incident description and product description.

The system will utilize drop-down menus where possible to ensure data quality. The system will perform quality checks including, but not limited to, e-mail address format, blank fields, invalid data format

(characters in a number field), and state and zip code match.

We are developing a process to identify, confirm, and register companies that wish to use the online manufacturer portal that is being designed to facilitate communication between CPSC and manufacturers.

Manufacturer registration, contact/account management, e-mail communication, and ability to flag information are all functionalities being considered for the portal. Manufacturers will be able to choose their preferred method of communication (e-mail or postal mail) with the CPSC. Manufacturers will designate a point of contact within their organization to

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receive notification from the CPSC. An audit trail will be maintained for all changes made in the system.

The incident report form was designed with the minimum number of required fields, marked by an asterisk, while encouraging the user to supply additional information. For example, only after the user selects the option of posting the incident report to the public database does the system checks for the five required statutory elements of a complete incident report. The user is encouraged but not required to register with an e-mail address and password. We propose making the user's contact information optional for submitting an incident to the

CPSC and a requirement for posting the incident report in the public database. 12. CPSC asked what the agency could do to ensure the ongoing and perpetual integrity of submitted data, from a system design perspective.

Comments (Summary 12)

Two commenters suggested that CPSC should use software ``filters'' to sort out redundancies and multiple submissions from the same source and to group multiple discrete reports for the same problem. One commenter suggested that the CPSC publish the data in PDF format or other format not capable of manipulation. One commenter stated that

CPSC should ensure the database is a closed-loop that allows for feedback on, and modification of published data. Two commenters agreed that the database should allow for the ability to remove falsified or erroneous data. One commenter proposed that manufacturer/private labeler's comments be aligned with, and published simultaneously with, the report of harm.

One commenter suggested that CPSC could generate notices, and/or seek comments, in relation to events that could occur with reports of harm, such as closure, retention time, and/or archiving. Another commenter believes that information should remain in the database indefinitely. One commenter also stated that CPSC should provide notice to database users on every page, including printed copies, that the agency does not guarantee the accuracy, completeness, or adequacy of the database, and that printed pages should bear a date to reduce confusion between versions of reports. One commenter stated that CPSC should establish guidelines for agency staff or contractors who will be interacting with the database. One commenter proposed that any changes to the database should require ample public notice and accommodate new data in ways that will not alter prior data structures.

Response

The incident report input screens being developed incorporate auto- fill functions, drop-down menus, and text fields where appropriate. For example, an auto-fill function will be provided for brand name, model name or number, manufacturer name, retailer name, and similar fields based on information we have collected in our database library, which will grow over time. Drop-down menus will be used for fields such as product category and type; injury severity, type, and location; and state and country codes.

The system will feature tools for CPSC to perform redundancy and deduplication functions. Software is being designed to sort and select potential duplicates based on predefined criteria. Matches will automatically be flagged for CPSC staff review. The CPSIA conferees recognized that ``multiple reports of the same incident could provide different relevant details and that information from those reports could be helpful to the public and should, therefore, remain in the database.'' \2\ Therefore, those different, relevant details will be captured in the database. The public database will feature prominent notice that the agency does not guarantee the accuracy, completeness, or adequacy of the contents of the database.

\2\ Joint Explanatory Statement of the Committee of Conference,

July 28, 2008, page 6.

13. CPSC asked how the agency should address incomplete reports of harm, from a system design perspective.

Comments Summary (13)

CPSC received a variety of comments in response to this question.

Some commenters suggested that incomplete reports of harm (i.e., those lacking the requisite minimum information) should not be included in the database and/or submitters should be cued via an auto-reminder function when required fields are incomplete. Other commenters proposed that CPSC should accept forms with incomplete information and/or seek to fill gaps through further research. Two commenters suggested that the CPSC can and should, if appropriate, act on information in these submissions.

Response

We are designing the system to prompt the submitter when the required information for inclusion in CPSC's public database has not been completed. In addition, staff recommends including language in the public database to encourage submitters to complete the minimally required information for inclusion in the public database. Although incomplete reports will not be published in the public database, we propose that incomplete reports be stored for appropriate Commission use. 14. CPSC asked whether the report form should check for inaccurate information and, if so, how.

Comments (Summary 14)

One commenter responded that the CPSC need not check for inaccurate information if it utilizes a security feature such as those that require a user to type a combination of letters and numbers appearing on screen. Another commenter suggested that in order to check for inaccurate information, e-mail addresses could be validated for proper format and against illegitimate use, database fields could be validated

(e.g., system check for blank fields, etc.), and by the use of drop- down menus to accurately link a manufacturer to a brand and vice versa.

Response

We agree with these recommendations. One of the security features under consideration is using CAPTCHA types of challenge-response tests to ensure that the incident report form is not being generated by a computer. The system will utilize drop-down menus where possible to ensure data quality. The system will perform quality checks including, but not limited to, e-mail address format, blank fields, invalid data format (characters in a number field), and state and zip code match. 15. CPSC asked what means the agency could employ to ensure that the correct manufacturer and/or private labeler is identified in a report of harm.

Comments (Summary 15)

One commenter suggested that the following information would aid in identifying the product and the manufacturer: brand name, product name, type of product, model number or name, serial number (if available), product description, and product age. Another commenter suggested the use of drop-down menus in order to accurately link manufacturers to products and vice versa.

One commenter suggested that CPSC should rely on the manufacturer to confirm their identity in relation to the product identified in the report of harm. This commenter also suggested that CPSC allow companies to register their contact information with CPSC in order to minimize agency resources. This commenter also proposed that retailers be treated similarly since retailers oftentimes have as much product

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information as manufacturers, if not more.

Response

The incident report input screens being developed incorporate auto- fill functions, drop-down menus, and text fields where appropriate. For example, an auto-fill function will be provided for brand name, model name or number, manufacturer name, retailer name, and similar fields based on information we have collected in our database library, which will grow over time. Drop-down menus will be used for fields such as product category and type; injury severity, type, and location; and state and country codes. Text fields will be available for incident description and product description.

The system will utilize drop-down menus where possible to ensure data quality. The system will perform quality checks including, but not limited to, e-mail address format, blank fields, invalid data format

(characters in a number field), and state and zip code match.

We explored the feasibility of collecting product identification information from the industry to link manufacturers to products and ultimately propose that manufacturers maintain that information to provide better data quality and consistency. One key piece of relevant feedback received from manufacturers during the staff workshop was that manufacturers themselves often have difficulty keeping their model/ product database accurate and up to date. Having CPSC maintain a copy of this information would introduce additional complexity and risk.

We agree with comments regarding company registration and are developing a process to identify, confirm, and register companies. 16. CPSC asked what, if any, instructions to users should be included on the report form.

Comments (Summary 16)

Some commenters suggested that the instructions should be simple, identify all required information, and/or state that the form cannot be processed without the required information. Some commenters suggested that the report form contain pop-up boxes or links providing more detailed explanations of the types of information sought. Other commenters suggested that the report form should notify submitters when required fields are left blank. Three commenters proposed that the report form should instruct the submitter to answer questions as thoroughly and completely as possible, as well as of the importance of providing full and complete information, and instruct submitters to reference any documents associated with the purchase and use of the product while filling out the form.

One commenter proposed that the report form should indicate what information is required to make a report of harm eligible for inclusion in the database. One commenter suggested that the report form should include a clear explanation of the privacy protections of the submitted information and the importance of these reports to the CPSC. This commenter suggested that the report form should make clear to consumers that they have the right to decline consent to sharing their contact information with the manufacturer and that doing so does not affect the ability of a report to be published.

Several commenters proposed that the instructions on the report form should inform the submitter of the benefits of allowing the manufacturer to contact them to verify the report and also encourage submitters to do so. One commenter proposed the following script be included on the report form:

Manufacturers sometimes find it helpful to speak directly with consumers to investigate safety issues and obtain information regarding reported incidents with their products. May we disclose your name and contact information to the manufacturer or private labeler?

Another commenter suggested that if a submitter declines to share contact information with a manufacturer, there should be a field indicating as much on the report form. Other commenters felt that the submitters should be provided with this option but without bias, allowing consumers to make their own choice.

Response

We agree with the comments regarding making the form simple and easy to use. The incident report form will provide online help to assist submitters with locating the product identification information such as brand name, model number, and manufacturer name and date code.

We explored the feasibility of collecting product identification information from the industry and propose that having manufacturers maintain that information will provide better data quality and consistency.

The form was designed with the minimum number of required fields, marked by an asterisk, while encouraging users to supply additional information. For example, only after the user selects the option of posting the incident report to the public database does the system check for the five required statutory elements of a complete incident report. The form will also inform the user about the purpose, use, and protection of information being collected by the CPSC and how the manufacturer might use the information provided he or she should choose to release it to the manufacturer.

Section 1102.10: Reports of Harm (Additional Comments) 17. CPSC received a number of additional comments not in response to any particular question but related to the overall issue of Section 1102.10 ``Reports of Harm.''

Comments (Summary 17)

Several commenters stated that the scope of the database is limited to reports of harm and not to reports relating to general product quality, service issues, or other types of quality complaints, that the harm must relate to the use of the consumer product, and/or that the database is limited to the information the Commission determines is reasonably related to the safety of consumer products as indicated by specific reports of harm caused by those products and that the CPSC should establish guidelines to this end. Along these lines, one commenter suggested that the software utilized in the database could be structured to guide or prompt submitters to supply the information necessary to constitute a report of harm. One commenter suggested that consideration should be given to limiting the reporting of ``old'' or

``stale'' data not contemporaneously related to the occurrence of the alleged incident. Three commenters suggested a one-year statute of limitations to file a report of harm. Another commenter proposed that the database should not contain a statute of limitations at all. One commenter also suggested that the database should be engineered to automatically publish reports within the required ten business days of receipt.

Response

We recognize that the scope of the database is limited to reports of harm. Instructions and guidance throughout will prompt the submitter to adhere to this scope. CPSC will review all reports of harm regardless of the date of the incident described by the submitter.

We considered options for automatic publishing of reports of harm.

However, considerations around publishing personally identifiable information in free form text boxes limited staff's design options in this regard.

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Section 1102.12: Manufacturer Comments 18. CPSC asked what means the agency should employ to allow manufacturers and private labelers to submit comments regarding a report of harm or to designate confidential information, and what issues should the agency consider when developing such a process.

Comments (Summary 18)

In response to this question, CPSC received one comment stating that CPSC should allow electronic submissions accommodating text, photos, and other documents as attachments. One commenter suggested that CPSC should ensure that only the applicable manufacturer or private labeler should be able to submit comments regarding a report.

This commenter suggested that electronic means would be expected to facilitate making comments. This commenter also suggested that unique identifying information associated with a report should be available only to submitters, manufacturers or private labelers, and CPSC, and it should be a requirement for offering comments and, also, that different types of users could have different ``views'' of the data. Finally, this commenter suggested that the database should provide a mechanism for designating confidential information, redacting, and exchanging redacted versions of reports. Two commenters requested a clearly identified process with criteria to determine whether certain content is confidential business information. This commenter also suggested that CPSC should consider allowing manufacturers to ``flag'' reports that are believed to contain confidential business information.

Similarly, one commenter stated that the CPSC should establish a means for submitting comments and designating confidential information.

The report of harm and a manufacturer's comments should be aligned so that the manufacturer's comments appear in same field as (alongside) the submitter's. This commenter also suggested that a manufacturer should be able to designate the information it believes is materially inaccurate or confidential via a clear method (e.g., flag system) and, if the Commission reviews a manufacturer's confidentiality request and determines the report contains confidential information, it must redact that information from the report of harm, and must not publish the report to the database until it makes a determination as to confidentiality; if the CPSC determines it is not confidential, it must notify the manufacturer. This commenter also suggested that CPSC should establish a means for manufacturers to submit proposed redactions of confidential information and, if it is determined that it is indeed confidential, the agency should have a method for ensuring information remains confidential (e.g., not disclosed under the FOIA). One commenter stated that if confidential business information does happen to be submitted for posting, manufacturers and private labelers must demonstrate confidentiality and submit supporting information to show that the requested material is entitled to confidential treatment. This commenter also stated that a manufacturer's comments to a report of harm should also contain a verification of truth and accuracy by the manufacturer.

One commenter stated that accuracy should start and end with the submitter and the product identification, and that the CPSC should not verify the accuracy of, and should not allow manufacturers to comment on, the report of harm.

Response

We agree with many of the comments and have taken the suggestions into consideration in the following ways:

The system will allow users to submit text, photo, and other approved types of documents as attachments.

Only the registered contact from a manufacturer or private labeler can submit comments regarding a report.

Each report will have a unique identifier.

There will be role-based access and views into the data.

Manufacturers will have the ability to flag for CPSC review those reports they believe contain confidential information.

Section 1102.16: Additional Information 19. CPSC asked what additional categories of information should be included in the public database and why.

Comments (Summary 19)

Two commenters proposed that information regarding the product, such as manufacturer, the type of product, the product brand, model number or name, serial number, UPC code, date of purchase, product code date or equivalent designation on the product, and place of purchase; date of incident; location of incident; whether manufacturer or private labeler was contacted prior to submission of the report; verification that the label instructions were followed when using the product; and a brief description of the circumstances of the incident (including how the product was being used at the time of the reported incident, a description of what happened, whether the submitter used any other products or devices along with the product involved in the incident), how much the product was used over what period of time (if applicable), description of harm incurred during the incident, the types of symptoms or injuries sustained, and the type of medical care sought, if applicable. Two commenters proposed that recalls be included in the database, while another commenter proposed that the database include information derived by the Commission from CPSA Section 15 reports.

Two commenters were in favor of including CPSC technical research, reports on emerging hazards, and other staff-generated research that will improve the public's understanding of consumer product safety. One commenter stated that the Commission should make all staff research completed within the past five years publicly accessible within 30 days of completion and, if not in the database itself, linked in the database.

One commenter suggested that CPSC should address how it will integrate pre-database incident data into the new system. Along these lines, one commenter suggested that NEISS data should be included in the database, while another commenter responded that CPSC should not add categories of information beyond that required by the CPSIA but, rather, should focus its efforts on ensuring the quality of, and timely reporting of, required information. Finally, one commenter felt that the CPSC should accept information submitted anonymously by whistleblowers and, if the information was determined to be valid, the information should be part of the public database.

Response

The incident report form will be designed to collect the following information regarding the report of harm, including: Name of manufacturer or private labeler; type of product; product brand; model number; serial number; date of purchase; manufacturer code date; place of purchase; date of incident; location of incident; whether the manufacturer or private labeler was contacted prior to submission of the report of harm and, if not, whether there is a plan to contact them; a brief description of the circumstances of the incident; a description of harm incurred during the incident; the types of symptoms or injuries sustained; and the

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type of medical care sought, if applicable.

After the user successfully submits the report of harm, the system will alert the user of any recalls that are related to the incident reported and provide options for the user to subscribe to the recalls.gov subscription list and possibly other lists, web services, or agency publications.

The incorporation of CPSC technical research, reports on emerging hazards, and other staff-generated research into the public database is being studied for future releases of the system.

The database will accept information submitted anonymously but we propose that anonymous reports not be published. 20. CPSC asked what, if any, information could not be included in the public database pursuant to the statute and why.

Comments (Summary 20)

Several commenters stated that the database should exclude reports filed under section 15(b) of the CPSA. One commenter also stated that information received under any other mandatory or voluntary reporting program established between retailer, manufacturer, or private labeler and the CPSC could not be included in the database, as well as information exempt from disclosure under FOIA, trade secrets, and other confidential information.

Two commenters stated that reports of harm and/or comments involving products that fall outside the scope of CPSC regulatory authority should not be included in the database. One commenter was concerned that the status of CPSC investigations, including the existence of the investigation, should not be included in the database.

This commenter also felt that the database should not contain the resolution and/or remedy provided to individual submitters and that status updates should be allowed only by manufacturers providing comments. Finally, this commenter stated that third-party comments would not be appropriate for the database.

Response

We propose that all reports of harm meeting the minimum statutory requirements be included in the public database. All other reports of harm should be collected for appropriate Commission use. Reports of harm that fall outside the scope of CPSC regulatory authority will be referred to the appropriate agency or entity with notification of such action to the submitter. 21. CPSC asked what, if any, disclaimers or qualifications should appear on the report form.

Comments (Summary 21)

Comments in response to this question fell into two categories. The first category of comments concerned the need for a disclaimer either on all screen views during the process of submitting a report form or at least at the end on the completed report form. Commenters felt that that the disclaimer should inform users of the database that CPSC has not verified the truth or accuracy of reports in the database. One commenter felt that there should be an acknowledgment check box for the submitter to select upon completion of a report to certify the truth and accuracy of the report prior to submission.

The second category of comments concerned the need to inform users how reports of harm, and specifically any personal information contained therein, would be used by CPSC. One commenter suggested that users should be informed that the report of harm itself would be contained in a publicly viewable database. Other commenters were concerned that users should be informed that their contact information would never be publicly available and would only be shared with manufacturers if submitters gave express consent.

Response

We propose that notice, consistent with statutory requirements, should be provided to users of the public database that the Commission does not guarantee the accuracy, completeness, or adequacy of the contents of the database and that the submitters of a report of harm verify that the information they have provided is accurate to the best of their knowledge.

We also propose that the public database include detailed information for submitters regarding how their contact information will be used. 22. CPSC also asked what specific disclaimers the agency should make with regard to the accuracy of the information contained in the public database and why, and where should such disclaimers appear and why.

Comments (Summary 22)

CPSC received a variety of comments in response to this question.

Several commenters felt that all publicly viewable pages in the database should contain a disclaimer that CPSC has not verified the truth or accuracy of the reports in the database.

One commenter recommended that that Commission use the statutorily required disclaimer consistently on each report on the database.

One commenter was concerned about a disclaimer for materially inaccurate information. This commenter suggested that when a report is claimed to contain materially inaccurate information, the report should be marked on every page to indicate it as such. When an existing report is removed or corrected because of a claim of materially inaccurate information, public notice should be made to those who already viewed the report. Finally, one commenter suggested that printed reports of harm from the database should contain a print date in order to reduce confusion between versions of reports of harm or manufacturer comments.

Response

The Commission does not guarantee the accuracy, completeness or adequacy of the contents of the public database. The public database will contain a notice to this effect. Additionally, we propose that such notice be placed in the following locations, at minimum:

On the entrance screen for public users

On all search result displays

On all reports printed from the public database

Printed reports of harm will contain a print date.

Subpart C--Procedural Requirements

Section 1102.20: Transmission of Reports of Harm to the Identified

Manufacturer or Private Labeler 23. CPSC asked whether, given the statutory timeframe for notification, manufacturers and private labelers should be able to

``register'' contact information with the Commission for the purpose of notification of a report of harm and, if so, what form of contact information should be acceptable, i.e., electronic mail only. CPSC also wanted to know what other issues along these lines should be considered.

Comments (Summary 23)

The majority of the commenters who responded to this question agreed that registration would help facilitate manufacturer notification. One commenter responded that electronic mail only would be acceptable.

Response

We propose that the Commission provide a mechanism for manufacturers and private labelers to register their contact information and their preferred method of contact by the Commission. 24. CPSC asked how the agency could ensure that manufacturers and/ or

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private labelers do not use a submitter's contact information for purposes other than verification of a report of harm, and by what means could CPSC enforce such a provision.

Comments (Summary 24)

Two commenters suggested that CPSC could emphasize that misuse of contact information would not be tolerated and that CPSC would take any necessary action to prosecute violators. One commenter proposed that

CPSC reiterate the restrictions and appropriate uses for consumer contact information in all forms sent to manufacturers, while another commenter proposed that CPSC publish a list of uses of contact information that would be deemed abuses of that information. This commenter also suggested that CPSC could create a webpage for submitters to report abuse.

Response

We conclude that the intent of the statute to provide contact information for the submitter to the manufacturer is for the sole purpose of verifying the report of harm. The Commission may, at its discretion, determine means by which it will enforce this provision.

Subpart B--Content Requirements

Section 1102.22: Opportunity for Manufacturer Comment 25. CPSC asked what means the agency should employ to notify manufacturers and private labelers regarding a report of harm within the five day statutory time frame.

Comments (Summary 25)

The majority of commenters agreed that electronic mail notification would be the most effective means of notification. Although others felt that it should be according to the preference (electronic mail, telephone, fax) of the manufacturer or private labeler. Two commenters were concerned that notification should reach the intended recipient and suggested that CPSC develop procedures for when electronic mail is undeliverable and/or to confirm that individuals receiving notification are authorized contacts for the manufacturers and private labelers.

Response

As part of the public outreach effort, we are developing a process to identify, confirm, and register companies. A manufacturer portal is being designed to facilitate communication between CPSC and manufacturers. Manufacturer registration, contact/account management, e-mail communication, and the ability to flag information that may be confidential or materially inaccurate are all functionalities being considered for the portal. Manufacturers will be able to choose their preferred method of communication (e-mail or postal mail) with the

CPSC. Manufacturers will designate a point of contact within their organization to receive notification from the CPSC. We are working closely with enterprise information security experts to secure electronic communication. 26. CPSC asked what, if any, circumstances could arise which could restart any of the timeframes contemplated in the statute with regard to manufacturer notification and responses.

Comments (Summary 26)

One commenter suggested that if a submitter provides new or supplemental information to CPSC before the initial report is published, this would delay publication of the report of harm in the database. Another commenter suggested that if there is a valid claim by the manufacturer that a report of harm is invalid, incomplete, or inaccurate, the CPSC should take steps to suspend any statutory time limits until the claim could be adjudicated by the Commission. One commenter proposed that the Commission ``restart'' the statutory timeframes if notification goes to the wrong manufacturer or private labeler, if incomplete information is provided in the report form, or if the submitter corrects the original report form, especially where information in a required field has been changed.

Response

We propose that in cases where a claim of materially inaccurate or confidential information is under review, the Commission, in its discretion, may withhold a report of harm in part or in full until such a determination is made. Absent such a determination, the Commission will generally publish reports of harm on the tenth business day after transmitting a report of harm.

Section 1102.26: Designation of Materially Inaccurate Information 27. CPSC asked, given the statutory timeframe, how the agency should review claims of materially inaccurate information.

Comments (Summary 27)

Two commenters felt that there should be a process for reviewing, modifying, or removing materially inaccurate information. One commenter felt that a claim of materially inaccurate information contained in a report of harm should not restart the ten-day statutory time period for posting of other information in the report form. One commenter felt that once the CPSC has received a claim of materially inaccurate information contained in a report of harm, it should have a limited time to issue a decision or, in the alternative, it should remove the report of harm until it does. Finally, one commenter felt that the CPSC could use its discretion to permit an extension of the ten-day period for publication in the database in circumstances where there is a challenge to the accuracy of the report.

Response

We propose that if a claim of materially inaccurate information is timely submitted, the Commission may withhold the report of harm from publication in the public database until a determination is made regarding such claim. Absent such a determination, the Commission will generally publish reports of harm on the tenth business day after transmitting a report of harm. We also propose that if the Commission determines that the designated information in a report of harm or manufacturer comment contains materially inaccurate information before it is published, the Commission should in its discretion do the following: Decline to add the materially inaccurate report of harm or manufacturer comment to the public database; redact the information, and if the minimum requirements for publication are met, publish the report of harm or manufacturer comment in the database; correct the materially inaccurate information, and if the minimum requirements for publication are met, publish the report of harm or manufacturer comment in the database; or, add the information to the report of harm or the manufacturer comment to correct the materially inaccurate information, and, if the minimum requirements for publication are met, publish the report of harm or manufacturer comment in the public database.

Should the Commission make a determination of material inaccuracy after publication, we propose the following: Removal of the entire materially inaccurate report of harm or manufacturer comment from the public database, including all associated documents, photographs, or comments; redaction of the materially inaccurate information and if the minimum requirements for publication are met, maintain the report of harm or manufacturer comment in the public database; correction of the materially

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inaccurate information and, if the minimum requirements are met, maintain the report of harm or manufacturer comment in the public database; or, add the information to the report of harm or the manufacturer comment to correct the materially inaccurate information and, if the minimum requirements for publication are met, maintain the report of harm or manufacturer comment in the public database. 28. CPSC asked whether the agency's responsibility with regard to materially inaccurate information is limited to reports of harm and manufacturer comments and why or why not.

Comments (Summary 28)

CPSC received one comment in response to this question which stated that CPSC should exclude materially inaccurate information regardless of the source.

Response

Only one commenter opined that the agency has a responsibility for materially inaccurate information regardless of the source. We believe that new section 6A of the CPSA sets forth requirements for the

Commission to review such information in reports of harm and manufacturer comments in the context of the database. We recommend that our responsibility be for those two identified instances. For other information not in the database, CPSC follows other requirements under section 6 of the CPSA for ensuring that information it discloses is accurate and not misleading and that the Commission has taken reasonable steps with respect to the accuracy of information. 29. CPSC asked what types of information would constitute materially inaccurate information.

Comments (Summary 29)

CPSC received numerous, specific examples of what could constitute materially inaccurate information contained in a report of harm, including: Misidentification of the manufacturer or private labeler, misidentification of persons involved, or misidentification of the consumer product itself (including misidentification of brand name or model number or misuse/modification of the product); and inaccuracy in the description of the incident.

Some commenters were also concerned that materially inaccurate information could comprise opinion statements about a consumer product's design or general safety, information not directly related to the incident such as conclusory or unsupported statements about product design, information in contradiction with generally accepted scientific principles, legal opinions, and reports of an injury or hazard caused by something other than the product identified in the report of harm.

One commenter felt that any information that the staff determines to be falsified as well as any information that is inflammatory or invective could also constitute materially inaccurate information.

Several commenters also felt that the database should be a repository for fact-based information only. Similarly, one commenter felt that information that could not be substantiated, such as documentation or information supporting a report of harm, would constitute materially inaccurate information. Others provided more general comments stating that materially inaccurate information would be inaccurate information that is substantial and important. Along these lines, some commenters suggested that CPSC provide a definition for ``materially inaccurate information.''

Response

We agreed on the following definition of materially inaccurate information in a report of harm: information 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 in a database user about information in a report of harm relating to: (1) The identification of a consumer product; (2) the identification of a manufacturer or private labeler; or (3) the harm or risk of harm related to the use of the consumer product.

We agreed on the following definition of materially inaccurate information in a manufacturer comment: Information 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 in a database user relating to: (1) The nature, scope, liability, or cause of a harm or risk of harm related to the use of a consumer product; (2) the status of a Commission, manufacturer, or private labeler investigation; (3) the identity of the firm or firms responsible for the importation, manufacture, distribution, sale, or holding for sale a consumer product; (4) whether the manufacturer or private labeler is engaging in a corrective action (when such action has not been approved by the Commission); or (5) whether the manufacturer has taken, or promised to take, any other action with regard to the product. 30. CPSC asked how the agency should 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.

Comments (Summary 30)

The majority of commenters agreed that CPSC should develop a transparent and efficient process for handling a claim of materially inaccurate information in a report of harm, including how redactions, corrections and/or removal of a report of harm will be addressed.

Correspondingly, many commenters also felt that CPSC should develop a parallel procedure for the inclusion of reports of harm in the database wherein CPSC staff would make affirmative verification that the report of harm was true and accurate. Several commenters felt that a report of harm could not be published in the database until the CPSC had verified that it was true and accurate.

Two commenters felt that CPSC should follow the procedures specified in the statute wherein upon a claim that a report of harm or a comment contains materially inaccurate information, the CPSC must make a determination as to the accuracy of that report or comment and that the report or comment should not be published until such determination is made. Similarly, three commenters suggested that the

CPSC should decline to post a report of harm involving a claim of material inaccuracy until an appropriate investigation of the claim had been made.

Another commenter proposed that the CPSC adopt a trial procedure during which it would permit extensions to the ten-day period for publication of reports of harm to the database where there has been a claim of material inaccuracy. This commenter suggested that the CPSC provide a means for manufacturers and private labelers to flag information in a report as being materially inaccurate and also provide a means to flag materially inaccurate information after it has been published to the database. This commenter recommended that the CPSC establish timeframes during which claims of material inaccuracy will be resolved.

On the other hand, two commenters felt that publication of a report of harm should take priority over verifying claims of materially inaccurate information. Additionally, one commenter suggested that the party contending the material inaccuracy bears the burden of demonstrating the material inaccuracy and that CPSC should reject efforts to delay or deny

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posting of information based upon unsubstantiated claims of materially inaccuracy. One commenter felt that if the CPSC publishes a report of harm over the manufacturer or private labeler's objections, the CPSC should provide the reasons for doing so. One commenter wanted an opportunity to examine the consumer product in question during the pendency of an investigation into materially inaccurate information in a report of harm.

One commenter felt that if an inaccurate report was inadvertently published, it should be removed as soon as possible and that a simple retraction would not suffice, while another commenter felt that the

CPSC could internally investigate it and post a clarification/ disclaimer or delete the materially inaccurate information from the report of harm.

One commenter suggested that when a report of harm has been determined to contain materially inaccurate information, it should be marked on every page to indicate it was removed or corrected. When existing reports are removed or corrected because they contain materially inaccurate information, public notice should be made to those who already viewed the report of harm. This commenter also suggested that if the CPSC receives a subpoena or FOIA request regarding a report of harm that has been corrected or removed, the CPSC should provide notice in accordance with Section 6(b) to the manufacturer or private labeler.

Response

We propose that if the Commission makes a determination of materially inaccurate information prior to publication of a report of harm, it shall either decline to add the report of harm or manufacturer comment to the public database or, redact or correct the materially inaccurate information and if the minimum requirements for publication are met, publish the report of harm or manufacturer comment in the public database. We propose the Commission favor correction over exclusion.

If the Commission makes a determination of material inaccuracy after publication of a report of harm or manufacturer comment, the

Commission shall, no later than seven business days after making such determination, remove the report of harm or manufacturer comment from the public database or, redact or correct the report of harm or manufacturer comment and if the minimum requirements for publication are met, publish the report of harm or manufacturer comment. We propose the Commission favor correction over exclusion. 31. CPSC asked how the agency should allow a submitter or others to claim that a manufacturer has submitted materially false information.

Comments (Summary 31)

Two commenters recommended that CPSC assign a unique identifier to each report of harm to assist in making a claim of material inaccuracy, while another commenter suggested there is no need to highlight reports of harm whose accuracy is doubted since CPSIA contains reasonable protections to safeguard against inaccurate information.

Response

We propose incorporating the suggestion of a unique identifier into the design of the public database.

Section 1102.28: Publication of Reports of Harm 32. CPSC asked if a manufacturer or private labeler requested that a comment associated with the report of harm be made available in the public database, what, if any, circumstances would prevent such comment from inclusion in the public database.

Comments (Summary 32)

One commenter replied that CPSC should not publish any comments that are found to be falsified, inflammatory, invective, or legal opinions or comprise information patently violating generally accepted scientific principles. Another commenter replied that all comments should be included in the database as long as they do not contain trade secret or confidential information.

Response

We agree that all comments that are requested for publication be included in the public database unless the Commission determines publication of the comment is not in the public interest. 33. CPSC asked what, if any, authority does the agency 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.

Comments (Summary 33)

One commenter responded that CPSC is permitted to withhold a report of harm from the database if it agrees with the manufacturer or private labeler's claim.

Response

We propose that should the Commission make a determination of materially inaccurate information or confidential information, the

Commission shall, in its discretion, decline to add the report of harm to the database, correct the materially inaccurate information in the report or add information to the report to correct it. We propose to favor correction/addition over exclusion. 34. CPSC asked what data sets, including information from reports of harm and mandatory and voluntary recall notices, should be made available for public search and reporting and why.

Comments (Summary 34)

Some commenters agreed that all of the information submitted to the database except for personal and/or contact information contained in reports of harm should be made available for public search and reporting. One commenter wanted to make it clear that personal and/or contact information should never be disclosed to the public and only to a manufacturer or private labeler where there has been consent. Several commenters agreed that voluntary and mandatory recall notices, and/or information derived as a result of such recall notices, should be searchable as well. One commenter would like to be able to search the

CPSC's NEISS data.

Two commenters wanted to be able to search for manufacturer and private labeler comments provided in response to a report of harm. One commenter also suggested being able to search CPSC's ``closed investigations'' which the staff is interpreting as pertaining to investigations conducted by the Office of Compliance and Field

Operations staff. One commenter would like to be able to search staff research. One commenter noted that recall information should be provided separate from reports of harm, stating that recalls are often limited in scope and there is a risk that reports of harm could be inappropriately or inaccurately linked to recall information, while another commenter wanted searching to be limited to what the statute requires in as simple and accurate a format as possible.

Response

We propose that all information and data sets that will be made available in the public database should be made searchable and sortable. The incorporation of additional categories of information into the public database is being studied for future releases of the system software.

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35. CPSC asked in what formats the agency should make data available to the public and why.

Comments (Summary 35)

Several commenters agreed that the data should be downloadable and/ or searchable in common, readily-available formats that do not require the purchase of specific, proprietary software. One commenter suggested providing the data in downloadable formats that would facilitate use by manufacturers in their own tracking systems.

Commenters would like to be able to search by general word entry, including advanced searches for data using search terms connected by both the words ``AND'' and ``OR,'' and/or also by type/category of product, brand name, model name, model number, type of injury and other harm, approximate date of purchase, and product manufacturer information.

Two commenters recommended making raw data available.

Response

We agree with a number of the comments and the system will provide search capabilities that include those suggested by the comments such as ``fuzzy matching'', search/sort by product category, manufacturer/ private labeler/retailer (including common misspellings), model, date/ type/location/severity of the product and hazard. The system will also provide downloadable access the data in multiple common formats. 36. CPSC asked what types of data analysis and reporting tools are being used by third party analysts in the public and industry, and what are those tools' relative merits and drawbacks.

Comments (Summary 36)

One commenter stated that it uses COGNOS Powerplay to analyze its data because it allows both Web- and desktop-based access to data in its proprietary databases from an easy-to-use front-end. Also, data accessed via COGNOS Powerplay can be exported to Excel or other programs. This commenter indicated that the drawbacks include limited graphing capabilities and the need for a programmer to build COGNOS cubes that allow access to data.

One commenter responded that commercial software programs developed by Intertek and Safety Research and Strategies facilitate large database searches and result analysis. This commenter stated that

Intertek's software is a Web-based software package that enables users to easily analyze product injury data and is currently part of NEISS.

This commenter recommended that CPSC utilize a software program that allows keyword searching, year-to-year comparisons, and trend analysis across all variables that NEISS tracks (injury type, body part, environment, age, outcome). One commenter responded that the CPSC need not, and should not, facilitate third-party organizations in analyzing preliminary data.

Response

We recognize the power of ``crowd sourcing.'' The system will make the data available in multiple common formats for download so researchers and partner organizations can work with us to identify hazards and analyze trends. We are also planning to partner with research institutions to develop advanced algorithms for early warning and pattern recognition so smarter decisions can be made to better protect consumers.

Subpart D--Notice and Disclosure Requirements

Section 1102.44: Applicability of Section 6(a) and (b) of the CPSA 37. CPSC asked under what circumstances the provisions of section 6(a) and (b) of the CPSA would be 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.

Comments (Summary 37)

Two commenters responded that the provisions of section 6(b) were not relevant/applicable to the database. Two commenters responded that only reports of harm are exempt from sections 6(a) and (b) and any additional information included in the public database would have to comply with those sections.

Response

The Commission has to follow the provisions of section 6(a) and (b) of the CPSA when determining what additional information is in the public interest to include in the database.

V. Request for Comments

The CPSC has already invited comments on the publicly available database through a public hearing held on November 10, 2009 and through a series of public workshops held on January 11 and 12, 2010, and we considered the comments in developing this proposed rule. This proposed rule would establish content and procedural requirements for the inclusion of information in the publicly available database. All interested persons are invited to submit comments on any aspect of the proposed rule. Comments should be submitted in accordance with the instructions in the ADDRESSES section at the beginning of this notice.

VI. Environmental Impact

The Commission's regulations at 16 CFR 1021.5(a) are considered to

``have little or no potential for affecting the human environment,'' and environmental assessments and impact statements are not usually prepared. See 16 CFR 1021.5(c). The proposed rule contains the

Commission's interpretation of the statutory requirements set forth in section 6A of the CPSA, as added by section 212 of the CPSIA, for the inclusion of information related to reports of harm involving the use of consumer products or other products or substances regulated by the

Commission in a publicly available and searchable database. As such, the proposed rule is not expected to have an adverse impact on the environment. The Commission concludes that no environmental assessment or environmental impact statement is required.

VII. Paperwork Reduction Act

This proposed rule contains information collection requirements that are subject to public comment and review by the Office of

Management and Budget (OMB) under the Paperwork Reduction Act of 1995

(44 U.S.C. 3501-3520). We describe the provisions in this section of the document with an estimate of the annual reporting burden. Our estimate includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

We particularly invite comments on: (1) Whether the collection of information is necessary for the proper performance of the CPSC's functions, including whether the information will have practical utility; (2) the accuracy of the CPSC's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Title: Publicly Available Consumer Product Safety Information

Database.

Description: The proposed rule would allow consumers to submit reports of harm involving the use of consumer

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products or other products or substances regulated by the CPSC and also allow manufacturers of such products or substances to comment on the reports of harm. The reports and comments would be part of a public database operated and maintained by the CPSC. A manufacturer identified in a report of harm and who receives a report of harm from CPSC may request that portions of the report be designated as confidential information. Any person or entity reviewing a report of harm or manufacturer comment may request that the report or comment, or portions thereof, be excluded from the database or corrected by the

CPSC because it contains materially inaccurate information.

Description of Respondents: Persons who wish to submit reports of harm involving the use of consumer products or other products or substances regulated by the CPSC and manufacturers of such products or substances who wish to comment on those reports of harm, pursuant to section 6A of the Consumer Product Safety Act (CPSA) (15 U.S.C. 2055a).

In addition, any person or entity reviewing a report of harm or manufacturer comment, either before or after publication in the database, may request that the report of harm or manufacturer comment, or portions thereof, be excluded from the database or corrected by the

CPSC because it contains materially inaccurate information.

We estimate the burden of this collection of information as follows:

Table 1--Estimated Annual Reporting Burden

Number of

Frequency of

Total annual

Minutes per

Total burden, 16 CFR section

respondents

responses

responses

response

in hours

16 CFR 1102.10(b)(1), (3)

11,534

1

11,534

12

2,307

Reports of harm--electronic.... 16 CFR 1102.10(b)(2) Reports of

3,329

1

3,329

10

555 harm--telephone................ 16 CFR 1102.10(b)(4) Reports of

277

1

277

20

92 harm--paper.................... 16 CFR 1102.12(b)(1), (2)

5,753

1

5,753

255

24,450

Manufacturer comments-- electronic..................... 16 CFR 1102.12(b)(3)

1,817

1

1,817

270

8,177

Manufacturer comments--paper... 16 CFR 1102.24 Requests to treat

345

1

345

15

86 information as confidential-- electronic..................... 16 CFR 1102.24 Requests to treat

109

1

109

30

54 information as confidential-- paper.......................... 16 CFR 1102.26 Requests to treat

1,726

1

1,726

30

863 information as materially inaccurate--electronic......... 16 CFR 1102.26 Requests to treat

545

1

545

60

545 information as materially inaccurate--paper..............

Total....................... .............. .............. .............. ..............

37,129

There are no capital costs or operating and maintenance costs associated with this collection of information.

Our estimates are based on the following:

The CPSC is in the process of developing the forms that will be used by consumers and manufacturers to submit reports and comments for inclusion in the database. Because those forms are still under development, for present purposes we based our burden estimates on our experience with similar forms and processes, and on information gleaned from manufacturers. Specifically, the CPSC currently has an incident report form that consumers and others use to report consumer safety incidents to the agency. The CPSC provides most of those consumer complaints to the manufacturer, and the manufacturer may provide comments to the agency.

For present purposes, we assume that the public database will receive the same number of reports of harm as the CPSC received of incident reports in fiscal year 2009 and that the numbers by manner of submission to the CPSC (i.e., electronic, telephone, paper) will be the same. Thus, using the data from fiscal year 2009, we estimate that we will receive a total of 15,140 reports of harm (11,534 by electronic means, 3,329 by telephone, and 277 by paper submissions). We had already estimated the time associated with the electronic and telephone submission of incident reports at 12 and 10 minutes respectively and so used those figures for present purposes as well. We estimate that the time associated with a paper form would be 20 minutes on average. Thus, we estimate the total burden hours associated with the submission of reports of harm to be 2,954 hours ((11,534 electronic report x 12 minutes per report) + (3,329 telephone reports x 10 minutes per report)

+ (277 paper reports x 20 minutes per report) = 177,238 minutes or approximately 2,954 hours)).

In 2008, manufacturers submitted comments to the CPSC in response to a consumer complaint forwarded to the manufacturer about 40 percent of the time. We estimate that the response rate will increase in the case of the public database; currently, neither the incident reports nor manufacturer comments are routinely public. We estimate that the manufacturer response rate will increase 25 percent, up to a 50 percent response rate. Therefore we expect to receive half as many total manufacturer comments as reports of harm (15,140 reports of harm x 0.5 manufacturer comments per report of harm = 7,570 manufacturer comments). In terms of the manner of commenting, we do not currently keep track of how many manufacturer comments are submitted electronically versus in paper form. Because the public database will be online, we will assume that most manufacturers will utilize electronic options for participating in the database, especially when the public database (unlike the current incident reporting system) will not give manufacturers the option of submitting their comments by phone. However, to ensure that we avoid inadvertently underestimating the burden, we will assume that manufacturers would submit electronically at the same rate. That equates to an estimate of 5,753 manufacturer comments submitted electronically and 1,817 submitted on paper.

We also will assume that that there are two actions involved in a manufacturer comment: First, the research and preparation necessary to comment, and second, the act of providing the comment. To estimate

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how much time manufacturers will spend researching and preparing to comment, we contacted three manufacturers that have experience submitting comments in response to incident reports. The manufacturers each reported a range of time, because time required in preparing a comment can vary greatly. The three ranges were 15 minutes to 4 hours, 10 minutes to 5 hours, and 10 minutes to 3 hours. For purposes of estimating the burden, we used the average high end of these ranges, 4 hours, for that portion of the burden estimate. Based on our experience with the current manufacturing comment process, we estimate that manufacturers will spend between 5 and 30 minutes actually providing the comment, depending on the length and complexity of their comment.

For the purposes of this estimate, we use the high end of that range for paper submissions (30 minutes) and the midpoint for electronic

(15). Thus, the estimated burden associated with manufacturer comments is approximately 32,607 hours (((5,753 electronic comments x 255 minutes per comment) + (1,817 paper comments x 270 minutes per comment)

= 1,957,605 minutes or approximately 32,627 hours).

Regarding requests to designate information confidential, we anticipate that there are very limited circumstances under which confidential information will be included in a report of harm; by its very nature, such information is not available to the public.

Accordingly we assigned a value of 3 percent to our estimation of the rarity with which we expect to receive such requests. Three percent of the total number of reports of harm estimated (15,140) results in an estimate of 454 requests to designate information as confidential. The proposed rule would specify what must be included in such a request

(Sec. 1102.24(b)); it is concrete information that we expect will be known or readily attainable by the entity filing the request. We estimate that it will take 15 minutes to submit such a request electronically. Because it would take longer to convey the necessary information on paper, and to avoid inadvertently underestimating the burden, we estimate that it will take twice as much time, or 30 minutes, to submit the request on paper. We employed the same assumptions as used above to predict how many requests will be submitted electronically (454 requests x 76 percent electronic submission) to arrive at an estimate of 345 electronic requests and 109 paper requests. We multiplied 345 electronic requests by 15 minutes, resulting in 5,175 minutes, or about 86 burden hours for the electronic requests. Similarly, we multiplied 109 paper requests by 30 minutes, resulting in 3,270 minutes, or about 54 burden hours for the paper requests.

Regarding requests to designate information materially inaccurate, roughly 10 percent of the manufacturer comments that we currently receive contain a claim that the incident report contained inaccurate information. We used that figure to estimate that the number of requests to treat information as materially inaccurate will be 10 percent of the total number of reports of harm and manufacturer comments that we expect, or 2,271 ([15,140 reports + 7,570 comments] x 10 percent). The proposed rule would specify what must be included in such a request (Sec. 1102.26(b)); most of the information will be known or readily attainable by the person or entity filing the request, but we estimate it will take longer to file a request to treat information as materially inaccurate than to file a request to treat information as confidential because with a request related to material inaccuracy one must provide evidence of the inaccuracy (Sec. 1102.26(b)(4)). We anticipate this will double the amount of time it takes to file the request, or 30 minutes for an electronic request and 60 minutes for a paper request. Employing the same assumptions concerning the method of submission, we estimate that there will be 1,726 electronic requests to treat information as materially inaccurate

(2,271 total requests x 76 percent electronic = 1,726). As each electronic request is estimated to take 30 minutes, we estimate the resulting burden to be 863 hours (1,726 requests x 30 minutes = 51,780 minutes, or 863 burden hours). Similarly, 545 paper requests (2,271 requests x 24 percent paper = 545), at 60 minutes each to complete, results in a burden of 545 hours (545 paper requests x 60 minutes = 32,700 minutes, or 545 hours).

The total estimated burden, therefore, is 37,129 hours.

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), we have submitted the information collection requirements of this rule to OMB for review. Interested persons are requested to fax comments regarding information collection by June 23, 2010, to the

Office of Information and Regulatory Affairs, OMB (see ADDRESSES).

VIII. Executive Order 12988

According to Executive Order 12988 (February 5, 1996), agencies must state in clear language the preemptive effect, if any, of new regulations. This regulation is issued under the authority of the CPSA, wherein preemption is discussed in section 26 of the CPSA. Section 26 of the CPSA only addresses the preemptive effect of consumer product safety standards under the CPSA. The current rule is not a consumer product safety standard under the CPSA. Accordingly, the Commission has determined that this rule does not contain requirements that impact the

States.

IX. Regulatory Flexibility Act

The Regulatory Flexibility Act (``RFA'') generally requires that agencies review proposed rules for their potential economic impact on small entities, including small businesses. Section 603 of the RFA calls for agencies to prepare and make available for public comment an initial regulatory flexibility analysis describing the impact of the proposed rule on small entities and identifying impact-reducing alternatives. 5 U.S.C. 603. Section 605(b) of the RFA, however, states that this requirement does not apply if the head of the agency certifies that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities, and the agency provides an explanation for that conclusion.

Preliminary analysis shows the proposed rule will have little or no effect on small businesses. The rule would implement the statutory requirements set forth in section 6A of the CPSA for the establishment and maintenance of a publicly available database containing reports of harm involving the use of consumer products, as well as comments received by manufacturers regarding such reports of harm identifying their products. The agency 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.

However, because of their smaller sales volumes, we believe small manufacturers are less likely to receive an incident report and, hence, to experience any impacts. Moreover, even if a small firm does choose to respond to an incident report, we believe the amount of time to do so would not likely be more than a few hours, on average. Before the

Commission can certify that the rule will not have a significant economic impact on a substantial number of small entities additional information on these points would be helpful. Therefore, the Commission invites comment on this

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analysis and preliminary certification statement.

X. Effective Date

The Administrative Procedure Act (``APA'') generally requires that the effective date of a rule be at least 30 days after publication of a final rule. 5 U.S.C. 553(d). The Commission intends that any final rule based on this proposal will become effective 30 days after the date of publication of a final rule in the Federal Register. However, as the database is still being developed, and the requirements set forth in this rule will only be applicable once the public database is established, the Commission intends to state, in the final rule, when the database will become operational.

List of Subjects in 16 CFR Part 1102

Administrative practice and procedure, Business and industry,

Consumer protection, Reporting and recordkeeping requirements.

For the reasons stated above, the Commission proposes to amend

Title 16 of the Code of Federal Regulations by adding a new part 1102 to read as follows:

PART 1102--PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION

DATABASE

Subpart A--Background and Definitions

Sec. 1102.2 Purpose. 1102.4 Scope. 1102.6 Definitions.

Subpart B--Content Requirements 1102.10 Reports of harm. 1102.12 Manufacturer comments. 1102.14 Recall notices. 1102.16 Additional information.

Subpart C--Procedural Requirements 1102.20 Transmission of reports of harm to the identified manufacturer or private labeler. 1102.24 Designation of confidential information. 1102.26 Designation of materially inaccurate information. 1102.28 Publication of reports of harm. 1102.30 Publication of manufacturer comments.

Subpart D--Notice and Disclosure Requirements 1102.42 Disclaimers. 1102.44 Applicability of sections 6(a) and (b) of the CPSA.

Authority: 15 U.S.C. 2051, 2051 note, 2052, 2055, 2055a, 2065, 2068, 2070, 2071, 2072, 2076, 2078, 2080, 2087.

Subpart A--Background and Definitions

Sec. 1102.2 Purpose.

This part sets forth the Commission's interpretation, policy, and procedures with regard to the establishment and maintenance of a

Consumer Product Safety Information Database (also referred to as the

``Database'') on the safety of consumer products and other products or substances regulated by the Commission.

Sec. 1102.4 Scope.

This part applies to the content, procedure, notice, and disclosure requirements of the Consumer Product Safety Information Database, including all information published therein.

Sec. 1102.6 Definitions.

(a) Except as specified in paragraph (b) of this section, the definitions in section 3 of the Consumer Product Safety Act (CPSA) (15

U.S.C. 2052) apply to this part.

(b) For purposes of this part, the following definitions apply:

(1) Additional information means any information that the

Commission determines is in the public interest to include in the

Consumer Product Safety Database.

(2) Commission or CPSC means the Consumer Product Safety

Commission.

(3) Consumer product means a consumer product as defined in section 3(a)(5) of the CPSA and also includes any other products or substances regulated by the Commission.

(4) Consumer Product Safety Information Database means the database on the safety of consumer products established and maintained by the

CPSC as described in section 6A of the CPSA.

(5) Harm means any injury, illness, or death, or any risk of injury, illness, or death, as determined by the Commission.

(6) Mandatory recall notice means any notice to the public required of a firm pursuant to order issued by the Commission under section 15(c) of the CPSA.

(7) Manufacturer comment means a comment made by a manufacturer or private labeler of a consumer product in response to a report of harm transmitted to such manufacturer or private labeler.

(8) Report of harm means any information submitted to the

Commission through the manner described in Sec. 1102.10(b) regarding an injury, illness, or death, or any risk of injury, illness, or death as determined by the Commission, relating to the use of a consumer product.

(9) Submitter of a report of harm means any person or entity that submits a report of harm.

(10) Voluntary recall notice means any notice to the public by the

Commission relating to a voluntary corrective action, including a voluntary recall of a consumer product taken by a manufacturer in consultation with the Commission.

Subpart B--Content Requirements

Sec. 1102.10 Reports of harm.

(a) Who may submit. The following persons or entities may submit reports of harm:

(1) Consumers including, but not limited to, users of consumer products, family members, relatives, parents, guardians, friends, and observers of the consumer products being used;

(2) Local, State, or Federal government agencies including, but not limited to, local government agencies, school systems, social services, child protective services, State attorneys general, State agencies, and all executive and independent Federal agencies as defined in Title 5 of the United States Code;

(3) Health care professionals including, but not limited to, medical examiners, coroners, physicians, nurses, physician's assistants, hospitals, chiropractors, acupuncturists;

(4) Child service providers including, but not limited to, day care centers, day care providers, pre-kindergarten school, and child care providers;

(5) Public safety entities including, but not limited to, police, fire, ambulance, emergency medical services, Federal, State, and local law enforcement entities, and other public safety officials; and

(6) Others including, but not limited to, attorneys, professional engineers, investigators, nongovernmental organizations, consumer advocates, consumer advocacy organizations, and trade associations.

(b) Manner of submission. To be entered into the publicly accessible database, reports of harm must be submitted to the CPSC using one of the following methods:

(1) Internet submissions through the CPSC's Internet Web site on an electronic incident report form specifically developed to collect such information.

(2) Telephonic submissions through a CPSC call center where the information is entered on the electronic incident form.

(3) Electronic mail or facsimile directed to the [Name of office will appear in final rule], provided that the

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submitter completes the incident report form available for download on the CPSC's Internet Web site specifically developed to collect such information.

(4) Written submissions through the [Office and address will appear in final rule]. The Commission will accept only those written reports of harm that use the incident report form developed for the CPSC's

Internet Web site; or

(5) Other means the Commission subsequently makes available.

(c) Size limit of reports of harm. The Commission may, in its discretion, limit the data size of reports of harm, which may include attachments submitted where such reports of harm and attachments may negatively impact the technological or operational performance of the system.

(d) Minimum requirements for publication. Subject to Sec. Sec. 1102.24 and 1102.26, the Commission will publish in the Consumer

Product Safety Database reports of harm containing all of the following information:

(1) Description of the consumer product. The description of the consumer product must, at a minimum, include a word or phrase sufficient to distinguish the product as a consumer product, a component part of a consumer product, or a product or substance regulated by the Commission. A description of a consumer product includes, but is not limited to, the name including the brand name of the consumer product, model, serial number, date of manufacture (if known) or date code, date of purchase, price paid, retailer, or any other descriptive information about the product.

(2) Identity of the manufacturer or private labeler. The name of one or more manufacturers or private labelers of the consumer product.

Identification of a manufacturer or private labeler includes, but is not limited to, a mailing address, phone number, or electronic mail address.

(3) Description of the harm. A brief narrative description of an illness, injury, or death, or risk of illness, injury, or death related to use of the consumer product. Examples of a description of harm or risk of harm include but are not limited to: death, asphyxiation, lacerations, burns, abrasions, contusions, fractures, choking, poisoning, suffocation, amputation, or any other narrative description relating to a bodily harm or risk of bodily harm. Incident reports that relate solely to the cost or quality of a consumer product, with no discernable bodily harm or risk of bodily harm, do not constitute

``harm'' for purposes of this part. A description of harm may, but need not, include the date on which the harm occurred or manifested itself, and the severity of any injury and whether any medical treatment was received.

(4) Contact information. The submitter's first name, last name, and complete mailing address. Although this information will not be published in the database it is required information for the report of harm. Submitters also may, but are not required to, provide an electronic mail address and a phone number to allow for efficient and timely contact regarding a report of harm when necessary.

(5) Verification. A submitter of a report of harm must affirmatively verify that he or she has reviewed the report of harm and that the information contained therein is true and accurate to the best of the submitter's knowledge, information and belief. Verification procedures for each method of submission will be specified. As part of verifying the report, submitters of reports of harm must indicate which category they are in (consumer, government agency, health care professional etc.) Although this information will not be published in the database it is required information for the report of harm.

(6) Consent. A submitter of a report of harm must consent to publication of the report of harm in the Database if he or she wants the information to be included in the Database.

(e) Additional information requested on report of harm. The minimum requirements (at Sec. 1102.10(d)) for publication of a report of harm in the Database do not restrict the Commission from choosing to seek other categories of voluntary information in the future.

(f) Information not published. The Commission will exclude the following information provided on a report of harm from publication in the Database:

(1) Name and contact information of the submitter of a report of harm;

(2) Victim's name, if the victim has not provided consent, and contact information;

(3) Photographs that in the determination of the Commission are not in the public interest, including photographs that depict a person or injury or constitute an invasion of personal privacy based on the

Privacy Act of 1974, Public Law 93-579 as amended.

(4) Medical records without the consent of the person about whom such records pertain or without the consent of his or her parent, guardian, or appropriate legally authorized representative;

(5) Confidential information as set forth in Sec. 1102.24;

(6) Materially inaccurate information as set forth in Sec. 1102.26;

(7) Submitters of reports of harm may retract reports at any time, if they indicate in writing to the Commission that they supplied materially inaccurate information; and/or

(8) Any other information submitted on or with a report of harm the inclusion of which in the Database the Commission determines is not in the public interest to publish. The Commission's determination shall consider whether the information is related to a product safety purpose served by the Database including whether or not the information helps

Database users to:

(i) Identify a consumer product;

(ii) Identify a manufacturer or private labeler of a consumer product;

(iii) Understand a harm or risk of harm related to the use of a consumer product; or

(iv) Understand the relationship between a submitter of a report of harm and the victim.

(g) Reports of harm from persons under the age of 18. The

Commission will not accept any report of harm when the report of harm is or was submitted by anyone under the age of 18 without consent of the parent or guardian of that person.

(h) Incomplete reports of harm. Any information received by the

Commission related to a report of harm that does not meet the requirements for submission or publication will not be published but will be maintained for internal use.

(i) Official records of the Commission. All reports of harm that are accepted by the Commission become official records of the

Commission in accordance with 16 CFR 1015.1. Alteration (or disposition) of any such records will only be in accordance with the procedures specified in this part.

Sec. 1102.12 Manufacturer comments.

(a) Who may submit. A manufacturer or private labeler may submit a comment related to a report of harm if the report of harm identifies such manufacturer or private labeler.

(b) How to submit. A manufacturer or private labeler may submit comments to the CPSC using one of the following methods:

(1) A manufacturer or private labeler who registers with the

Commission as described in Sec. 1102.20(e) may submit comments through a manufacturer portal maintained on the CPSC's Internet Web site;

(2) A manufacturer or private labeler may submit comments by electronic mail, directed to the Office of the

Page 29178

Secretary at [e-mail address will appear in final rule]; or

(3) A manufacturer or private labeler may submit written comments directed to the Office of the Secretary at 4330 East West Highway,

Bethesda, MD 20814-4408.

(c) What must be submitted. Subject to Sec. 1102.24, the

Commission will publish manufacturer comments related to a report of harm transmitted to a manufacturer or private labeler in the Database if such manufacturer comment meets the following requirements:

(1) Manufacturer comment relates to report of harm. The manufacturer or private labeler's comment must relate to information contained in a specific report of harm that identifies such manufacturer or private labeler and that is received in the Database.

(2) Unique identifier. A manufacturer comment must state the unique identifier provided by the CPSC.

(3) Verification. A manufacturer or private labeler must verify that it has reviewed the report of harm and the comment related to the report of harm and that the information contained in the comment is true and accurate to the best of the firm's knowledge, information, and belief.

(4) Request for publication. When a manufacturer or private labeler submits a comment regarding a report of harm, it may request that the

Commission publish such comment in the Database. A manufacturer or private labeler must affirmatively request publication of the comment, and consent to such publication in the Database, for each comment submitted to the CPSC.

(d) Information published. Subject to Sec. 1102.24, the Commission will publish a manufacturer comment and the date of its submission to the CPSC in the Database if the comment meets the minimum requirements for publication as described in paragraph (c) of this section.

(e) Information not published. The Commission will not publish in the Database consents and verifications associated with a manufacturer comment.

Sec. 1102.14 Recall notices.

All information presented in a voluntary or mandatory recall notice that has been made available to the public shall be accessible and searchable in the Database.

Sec. 1102.16 Additional information.

In addition to reports of harm, manufacturer comments, and recall notices, the CPSC shall include in the Database any additional information it determines to be in the public interest, consistent with the requirements of section 6(a) and (b) of the CPSA.

Subpart C--Procedural Requirements

Sec. 1102.20 Transmission of reports of harm to the identified manufacturer or private labeler.

(a) Information transmitted. Except as provided in paragraphs

(a)(1) through (a)(3) of this section, the Commission will transmit all information provided in a report of harm which meets the minimum requirements for publication in the Database to the manufacturer or private labeler identified in a report of harm. The following information will not be transmitted to a manufacturer or private labeler:

(1) Name and contact information for the submitter of the report of harm, unless such submitter provides express written consent to provide such information to the manufacturer or private labeler;

(2) Photographs that depict a person or an injury unless the submitter of the report of harm consents, in writing, to provide such photograph(s) to the manufacturer or private labeler;

(3) Medical records, unless the person about whom such records pertain, or his or her parent, guardian, or appropriate legally authorized representative, consents to providing such records to the manufacturer or private labeler.

(b) Limitation on use of contact information. A manufacturer or private labeler who receives name and contact information for the submitter of a report of harm and/or a victim must not use or disseminate such information to any other party for any other purpose other than verification of information contained in a report of harm.

Verification of information contained in a report of harm must not include activities such as sales, promotion, marketing, warranty, or any other commercial purpose. Verification of information contained in a report of harm is limited to verification of the:

(1) Identity of the submitter and/or the victim, including name, location, age and gender;

(2) Consumer product, including serial or model number, date code, color, or size;

(3) Harm or risk of harm related to the use of the consumer product; and/or

(4) Description of the incident related to use of the consumer product.

(c) Timing. To the extent practicable, the Commission will transmit a report of harm to the manufacturer or private labeler within five business days of submission of the completed report of harm. Examples of circumstances that may arise that may make transmission of the report of harm impracticable within five business days include, but are not limited to:

(1) The manufacturer or private labeler is out of business with no identifiable successor;

(2) The submitter misidentified a manufacturer or private labeler; or

(3) The report of harm contained inaccurate or insufficient contact information for a manufacturer or private labeler; or

(4) The Commission cannot locate valid contact information for a manufacturer or private labeler.

(d) Method of transmission. The Commission will use the method of transmission and contact information provided by the manufacturer or private labeler. The Commission will transmit reports of harm to a manufacturer or private labeler who has registered with the Commission as described in paragraph (e) of this section. If a manufacturer or private labeler has not registered with the Commission, the Commission will send reports of harm through the United States mail to the firm's principal place of business unless the Commission selects another equally effective method of transmission.

(e) Size limits of manufacturer comments. The Commission may, in its discretion, limit the data size of comments, which may include attachments submitted, where such comments and attachments may negatively impact the technological or operational performance of the system.

(f) Manufacturer registration. Manufacturers and private labelers may register with the Commission to select a preferred method for receiving reports of harm which identify such firm as the manufacturer or private labeler. Manufacturers and private labelers that choose to register with the Commission must:

(1) Register with the Commission through a process identified for such registration;

(2) Provide and maintain updated contact information for the firm, including the name of the firm, title of a person to whom reports of harm should be directed, complete mailing address, telephone number, electronic mail address, and Web site address (if any); and

(3) Select a specified method to receive reports of harm that identify the firm as the manufacturer or private labeler of a consumer product.

(g) Manufacturer comments received after one year. A manufacturer or private labeler who receives a report of harm from the CPSC may comment on the information contained in such report of harm. The

Commission, in its

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discretion, where it determines it is in the public interest, may choose not to publish a manufacturer comment to the Database if such comment is received more than one year after transmission of the report of harm to the manufacturer or private labeler.

Sec. 1102.24 Designation of confidential information.

(a) For purposes of this section, ``confidential information'' is considered to be information that contains or relates to a trade secret or other matter referred to in 18 U.S.C. 1905 or that is subject to 5

U.S.C. 552(b)(4).

(b) A manufacturer or private labeler identified in a report of harm and who receives a report of harm from the CPSC may review such report of harm for confidential information and request that portions of the report of harm be designated as confidential information. Each requester seeking such a designation of confidential information bears the burden of proof and must:

(1) Specifically identify the exact portion(s) of the report of harm claimed to be confidential;

(2) State whether the information claimed to be confidential has ever been released in any manner to a person who was not an employee or in a confidential relationship with the company;

(3) State whether the information so specified is commonly known within the industry or is readily ascertainable by outside persons with a minimum of time and effort;

(4) State the company's relationship with the victim and/or submitter of the report of harm and how the victim and/or submitter of the report of harm came to be in possession of such allegedly confidential information;

(5) State how the release of the information would be likely to cause substantial harm to the company's competitive position; and

(6) State whether the person submitting the request for treatment as confidential information is authorized to make claims of confidentiality on behalf of the person or organization concerned.

(c) Manner of submission. Requests for designation of confidential information may be submitted in the same manner as manufacturer comments as described in Sec. 1102.12(b). A request for designation of confidential treatment must be conspicuously marked.

(d) Timing of submission. A request for designation of confidential information must be received by the Commission in a timely manner. If a request for confidential treatment is submitted in a timely fashion, the Commission may, in its discretion, withhold a report of harm from publication in the Database until it makes a determination regarding confidential treatment.

(e) Assistance with defense. No request to redact confidential information from a report of harm pursuant to 5 U.S.C. 552(b)(4) should be made by any person who does not intend in good faith, and so certifies in writing, to assist the Commission in the defense of any judicial proceeding that might thereafter be brought to compel the disclosure of information that the Commission has determined to be a trade secret or privileged or confidential commercial or financial information.

(f) Commission determination of confidentiality. If the Commission determines that information in a report of harm is confidential, the

Commission shall:

(1) Notify the manufacturer or private labeler;

(2) Redact such confidential information in the report of harm; and

(3) Publish the report of harm in the Database without such confidential information.

(g) Commission determination of no confidentiality. If the

Commission determines that a report of harm does not contain confidential information, the Commission shall:

(1) Notify the manufacturer or private labeler; and

(2) Publish the report of harm, if not already published, in the

Database.

(h) Removal of confidential information. As stated at 6A(c)(1)(C)(iii) of the CPSA, to seek removal of alleged confidential information that has been published in the Database, a manufacturer or private labeler may bring an action in the district court of the United

States in the district in which the complainant resides, or has its principal place of business, or in the United States District Court for the District of Columbia.

Sec. 1102.26 Designation of materially inaccurate information.

(a) For purposes of this section, the following definitions apply:

(1) Materially inaccurate information in a report of harm means information 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 in a Database user 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.

(2) Materially inaccurate information in a manufacturer comment means information 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 in a Database user relating to:

(i) The nature, scope, liability, or cause of a harm or risk of harm related to the use of a consumer product;

(ii) The status of a Commission, manufacturer, or private labeler investigation;

(iii) The identity of the firm or firms responsible for the importation, manufacture, distribution, sale, or holding for sale a consumer product;

(iv) Whether the manufacturer or private labeler is engaging in a corrective action (when such action has not been approved by the

Commission); or

(v) Whether the manufacturer has taken, or promised to take, any other action with regard to the product.

(b) Request for designation of materially inaccurate information.

Any person or entity reviewing a report of harm or manufacturer comment, either before or after publication in the Database, may request that the report of harm or manufacturer comment, or portions of such report of harm or manufacturer comment, be excluded from the

Database or corrected by the Commission because it contains materially inaccurate information. A requester seeking an exclusion or correction must:

(1) State the unique identifier of the report of harm or manufacturer comment to which the request for a determination of materially inaccurate information pertains;

(2) Specifically identify the exact portion(s) of the report of harm or the manufacturer comment claimed to be materially inaccurate;

(3) State the basis for the allegation that such information is materially inaccurate;

(4) Provide evidence, which may include documents, statements, electronic mail, internet links, photographs, or any other evidence, sufficient for the Commission to make a determination that the designated information is materially inaccurate;

(5) State what relief the requester is seeking: exclusion of the entire report of harm or manufacturer comment; redaction of specific information; correction of specific information; or the addition of information to correct the material inaccuracy;

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(6) State whether and how an alleged material inaccuracy may be corrected without removing or excluding an entire report of harm or manufacturer comment; and/or

(7) State whether the person submitting the allegation of material inaccuracy is authorized to make claims of material inaccuracy on behalf of the person or organization concerned.

(c) Manner of submission--Length of request and expedited review.

The Commission strongly recommends requesters seeking an expedited review of claims of materially inaccurate information to limit the length of the request described in Sec. 1102.26(b) to no more than five pages, including attachments, to allow for the expedited review of the request. Regardless of length, all submissions will be reviewed.

(1) Manufacturers and private labelers. A manufacturer or private labeler may request a Commission determination of materially inaccurate information related to a report of harm in the same manner as described in Sec. 1102.12(b). Such requests should be conspicuously marked.

(3) All other requests. All other requests for a Commission determination of materially inaccurate information contained in a report of harm or manufacturer comment made by any other person or firm must be submitted to the CPSC using one of the methods listed below.

The request seeking a Commission determination of materially inaccurate information may be made through:

(i) Electronic mail. By electronic mail directed to the Office of the Secretary at [e-mail address will appear in final rule]; or

(ii) Paper-Based. Written submission directed to the Office of the

Secretary at [mailing address will appear in final rule].

(d) Timing of submission. A request for a Commission determination regarding materially inaccurate information may be submitted at any time. If a request for determination of materially inaccurate information is submitted prior to publication in the database, the

Commission may withhold a report of harm from publication in the

Database until it makes a determination. Absent such a determination, the Commission will generally publish reports of harm on the tenth business day after transmitting a report of harm.

(e) Assistance with defense. No request for a determination of materially inaccurate information should be made by any person who does not intend in good faith, and so certifies in writing, to assist the

Commission in the defense of any judicial proceeding that might thereafter be brought to compel the disclosure of information that the

Commission has determined to be materially inaccurate information.

(f) Notice. The Commission shall notify the person or firm requesting a determination regarding materially inaccurate information of its determination and method of resolution after resolving such request.

(g) Commission determination of material inaccuracy before publication. If the Commission determines that the requested information in a report of harm or manufacturer comment is materially inaccurate information before it is published in the Database, the

Commission may:

(1) Decline to add the materially inaccurate report of harm or manufacturer comment to the Database;

(2) Correct the materially inaccurate information, and, if the minimum requirements for publication as set forth in Sec. Sec. 1102.10(c) and 1102.12(c) are met, publish the report of harm or manufacturer comment in the Database; or

(3) Add information to the report of harm or the manufacturer comment to correct the materially inaccurate information, and, if the minimum requirements for publication as set forth in Sec. Sec. 1102.10(c) and 1102.12(c) are met, publish the report of harm or manufacturer comment in the Database.

(h) Commission determination of material inaccuracy after publication. If the Commission determines, after an investigation, that the requested designated information in a report of harm or manufacturer comment contains materially inaccurate information after the report of harm or manufacturer comment has been published in the

Database, the Commission shall, no later than seven business days after such determination:

(1) Remove the report of harm or manufacturer comment from the

Database, including any associated documents, photographs, or comments;

(2) Correct the information, and, if the minimum requirements for publication as set forth in Sec. Sec. 1102.10(c) and 1102.12(c) are met, maintain the report of harm or manufacturer comment in the

Database; or

(3) Add information to the report of harm or the manufacturer comment to correct the materially inaccurate information, and, if the minimum requirements for publication as set forth in Sec. Sec. 1102.10(c) and 1102.12(c) are met, maintain the report of harm or manufacturer comment in the Database.

(i) Commission discretion.

(1) In exercising its discretion to remove, correct or add information to correct materially inaccurate information contained in a report of harm or manufacturer comment, the Commission shall preserve the integrity of information received for publication in the Database whenever possible. Subject to Sec. Sec. 1102.10(c) and 1102.12(c), the

Commission shall favor correction and addition to correction over exclusion of entire reports of harm and manufacturer comments where possible.

(2) Expedited determinations. Where a manufacturer has filed a request for a correction or exclusion within the recommended page limit in Sec. 1102.26(c)(1), the Commission shall attempt, where practicable, to make an expedited determination of a claim of material inaccuracy. Given the requirement of section 6A of the CPSA that reports of harm be published, the Commission will generally publish reports of harm on the tenth business day after transmitting a report of harm where either the recommended page limit of comments has been exceeded or where the Commission has been otherwise unable to make a determination regarding a claim of material inaccuracy prior to the statutorily mandated publication date. In such instances, the

Commission will make any necessary correction, exclusion, or addition not later than 7 business days after making a determination that there is materially inaccurate information in the report of harm.

Manufacturer comments will be published at the same time as the report of harm is published or as soon as practicable thereafter as described in Sec. 1102.30.

(j) Commission determination of no material inaccuracy. If the

Commission determines that the requested information in a report of harm does not contain materially inaccurate information, the Commission will:

(1) Notify the requester of its determination;

(2) Publish the report of harm or manufacturer comment, if not already published, in the Database if it meets the minimum requirements set forth in Sec. Sec. 1102.10, 1102.12 and 1102.24.

(k) Commission action in absence of request. The Commission may review a report of harm or manufacturer comment for materially inaccurate information on its own initiative, following the same notice and procedural requirements set forth in paragraphs (g) through (j) of this section.

Sec. 1102.28 Publication of reports of harm.

(a) Timing. Subject to Sec. Sec. 1102.10, 1102.24, and 1102.26, the Commission

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will publish reports of harm that meet the requirements for publication in the Database. The Commission will publish reports of harm as soon as practicable but not later than the tenth business day after such report of harm is transmitted to the manufacturer or private labeler by the

CPSC.

(b) Exceptions. The Commission may publish a report of harm that meets the requirements of Sec. 1102.10(c) in the Database beyond the ten business day time frame set forth in paragraph (a) of this section if the Commission determines a report of harm misidentifies or fails to identify all manufacturers or private labelers. Such information must be corrected through the procedures set forth in Sec. 1102.26 for materially inaccurate information in a report of harm. Once a manufacturer or a private labeler has been identified correctly, the time frame set forth in paragraph (a) of this section shall apply.

Sec. 1102.30 Publication of manufacturer comments.

(a) Timing. Subject to Sec. Sec. 1102.12 and 1102.26, the

Commission will publish in the Database manufacturer comments submitted in response to a report of harm that meet the minimum requirements set forth in Sec. 1102.12(c). This publication will occur at the same time as the report of harm is published or as soon as practicable thereafter. Examples of circumstances that may make it impracticable to publish a manufacturer comment at the same time as a report of harm include, but are not limited to:

(1) The Commission did not receive the comment until on or after the publication date of the report of harm; or

(2) The Commission is resolving a claim that the manufacturer comment contains materially inaccurate information.

Subpart D--Notice and Disclosure Requirements

Sec. 1102.42 Disclaimers.

The Commission does not guarantee the accuracy, completeness or adequacy of the contents of the Consumer Product Safety Information

Database, particularly with respect to the accuracy, completeness, or adequacy of information submitted by persons outside of the CPSC. The

Consumer Product Safety Information Database will contain a notice to this effect that will be prominently and conspicuously displayed on the database and on any documents that are printed from the database.

Sec. 1102.44 Applicability of sections 6(a) and (b) of the CPSA.

(a) Generally. Sections 6(a) and 6(b) of the CPSA shall not apply to the submission, disclosure and publication of information provided in a report of harm that meets the minimum requirements for publication in Sec. 1102.10(c), in the Consumer Product Safety Information

Database.

(b) Limitation on construction. Section 1102.42(a) shall not be construed to exempt from the requirements of sections 6(a) and 6(b) of the CPSA information received by the Commission pursuant to:

(1) Section 15(b) of the CPSA; or

(2) Any other mandatory or voluntary reporting program established between a retailer, manufacturer, or private labeler and the

Commission.

Dated: May 7, 2010.

Todd A. Stevenson,

Secretary.

FR Doc. 2010-11374 Filed 5-21-10; 8:45 am

BILLING CODE 6355-01-P

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