[Federal Register Volume 75, Number 99 (Monday, May 24, 2010)]
[Proposed Rules]
[Pages 29156-29181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-11374]
[[Page 29155]]
-----------------------------------------------------------------------
Part III
Consumer Product Safety Commission
-----------------------------------------------------------------------
16 CFR Part 1102
-----------------------------------------------------------------------
Publicly Available Consumer Product Safety Information Database;
Proposed Rule
Federal Register / Vol. 75 , No. 99 / Monday, May 24, 2010 / Proposed
Rules
[[Page 29156]]
-----------------------------------------------------------------------
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; [email protected].
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
[[Page 29157]]
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
[[Page 29158]]
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
[[Page 29159]]
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
[[Page 29160]]
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.
[[Page 29161]]
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
[[Page 29162]]
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.
[[Page 29163]]
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.
[[Page 29164]]
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.
[[Page 29165]]
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
[[Page 29166]]
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
[[Page 29167]]
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.
[[Page 29168]]
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
[[Page 29169]]
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
[[Page 29170]]
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
[[Page 29171]]
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
[[Page 29172]]
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.
[[Page 29173]]
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
[[Page 29174]]
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
[[Page 29175]]
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
[[Page 29176]]
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
[[Page 29177]]
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
[[Page 29179]]
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;
[[Page 29180]]
(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
[[Page 29181]]
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