Publicly Available Consumer Product Safety Information Database, 29156-29181 [2010-11374]
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Federal Register / Vol. 75, No. 99 / Monday, May 24, 2010 / Proposed Rules
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: https://
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
https://www.regulations.gov.
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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
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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 https://
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 https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Mary Kelsey James, Director,
Information Technology Policy and
Planning, Consumer Product Safety
Commission, 4330 East West Highway,
Bethesda, MD 20814; telephone (301)
504–7213; mjames@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The CPSIA requires the Commission
to establish and maintain a product
safety information database that is
available to the public. Specifically,
section 212 of the CPSIA amended the
CPSA to create a new section 6A of the
CPSA, titled ‘‘Publicly Available
Consumer Product Safety Information
Database.’’ Section 6A(a)(1) of the CPSA
requires the Commission to establish
and maintain a database on the safety of
consumer products, and other products
or substances regulated by the
Commission. The database must be
publicly available, searchable, and
accessible through the Commission’s
Web site. Section 6A of the CPSA sets
forth specific content, procedures, and
search requirements for the publicly
available database. In this proposed
rule, the Commission sets forth its
interpretation of the statutory
requirements of section 6A.
For several decades, the Commission
has gathered and maintained a database
of consumer complaints known as
consumer product incident reports
involving a description of incidents
related to the use of consumer products
that fall within the scope of the
Commission’s jurisdiction. Pursuant to
section 5(a) of the CPSA, the
Commission collects information related
to the causes and prevention of death,
injury, and illness associated with
consumer products. The Commission
conducts studies and investigations of
deaths, injuries, diseases, other health
impairments, and economic losses
resulting from accidents involving
consumer products. Also, pursuant to
section 5(b) of the CPSA, the
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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 productrelated injuries or incidents. The data
that the Commission collects and
maintains on product safety has not
been immediately available and
searchable by the public. Before the
CPSIA’s enactment, the CPSA required
that the Commission follow the notice
provisions of section 6 of the CPSA
before publicly disclosing any
information that allowed the public to
readily ascertain the identity of a
manufacturer or private labeler of a
consumer product. Section 6 of the
CPSA contains requirements for giving
notice of such information to the
manufacturer or private labeler and
providing an opportunity to comment
on the information prior to public
disclosure. Section 6 of the CPSA also
requires the Commission to take
reasonable steps to assure that
disclosure of such information is
accurate, fair in the circumstances, and
reasonably related to effectuating the
purposes of the CPSA. The Commission
has applied the requirements in section
6 of the CPSA to Freedom of
Information Act (FOIA) requests as well.
See Consumer Product Safety
Commission et al. v. GTE Sylvania, 447
U.S. 102 (1980). The Commission issued
regulations interpreting the section 6
requirements at 16 CFR part 1101. Thus,
consumers currently have access to
incident data through reports and
studies published by the Commission or
through information provided in
response to FOIA requests.
As stated earlier in part I of this
document, section 6A of the CPSA
requires the establishment and
maintenance of a publicly available and
searchable database. Section 6A of the
CPSA specifically excludes any report
submitted pursuant to the public
database provisions from the notice
requirements of section 6(a) and (b) of
the CPSA.
Accordingly, the Commission invited
input from its stakeholders before
developing the proposed rule. A
summary of the CPSC’s work done to
date on the public database, including a
Report to Congress, Public Meetings,
Federal Register Notices, Commission
Actions and Public Comments, are
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available on the CPSC Web site at
https://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 https://www.cpsc.gov/
library/foia/foia10/pubcom/pubdb.pdf.
A Webcast of the hearing can be viewed
on the CPSC’s Web site at https://
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 https://www.cpsc.gov/about/cpsia/
pw01112010am.html, and a Webcast of
the workshops is available on the
CPSC’s Web site at https://
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
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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 § 1102.1—Purpose
Proposed § 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 § 1102.4—Scope
Proposed § 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 § 1102.6—Definitions
Proposed § 1102.6 would define
certain terms. As a general matter,
proposed § 1102.4(a) would explain
that, except as provided in proposed
§ 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 § 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
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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
§ 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 § 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 § 1102.6(b)(2) would define
‘‘Commission’’ or ‘‘CPSC’ as meaning the
Consumer Product Safety Commission.
Proposed § 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 § 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 § 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 § 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 § 1102.6(b)(8) would define
‘‘report of harm’’ as any information
submitted to the Commission through
the manner described in § 1102.10(b)
regarding an incident concerning an
injury, illness or death, or any risk of
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injury, illness or death as determined by
the Commission relating to the use of
the consumer product.
Proposed § 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 § 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.
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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 §§ 1102.10 through
1102.14 would describe how such
reports, information, and comments
would become part of the database, and
proposed § 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 § 1102.10—Reports of Harm
Proposed § 1102.10 would explain
who may submit reports of harm in the
public database. In brief, proposed
§ 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’’
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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 § 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
§ 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
§ 1102.10(b)(2) would explain how
submissions over the telephone will be
accepted and proposed § 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 § 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 § 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
§ 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
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retailer is described as information that
would be helpful to the description of
a consumer product.
Proposed § 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 § 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 § 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
§ 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 § 1102.10(d)(5) would
explain that submitters must verify the
report of harm for publication and the
verification statement follows the
statutory outline. Verification would
involve a submitter of a report of harm
affirmatively agreeing that he or she has
reviewed the information submitted in a
report of harm and then checking the
box for verifying the information the
report contains. This proposed section
would also require that as part of
verifying the report, submitters of
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reports of harm must indicate what
category they are in (consumer,
government agency, health care
professional, etc.)
Proposed § 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 § 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 § 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 § 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
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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 § 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 § 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 § 1102.12—Manufacturer
Comments
Proposed § 1102.12(a) would state
that manufacturers or private labelers
who receive a report of harm
transmitted from the CPSC may submit
comments. Proposed § 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 § 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 § 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.
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Proposed § 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 § 1102.14—Recall Notices
Proposed § 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 § 1102.16—Additional
Information
Proposed § 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 § 1102.20—Transmission of
Reports of Harm to Identified
Manufacturer or Private Labeler
Proposed § 1102.20 would explain
what information in a report of harm
will and will not be transmitted to a
manufacturer or private labeler. As set
forth in section 6A(b)(2)(B) of the CPSA,
the name and contact information of the
submitter will not be transmitted to a
manufacturer or private labeler unless
the submitter of a report of harm
consents to transmit this information.
The proposed rule also would prevent
transmission of any photographs
submitted with the report of harm
unless the submitter specifically
consents, and further explains that
medical records will not be provided
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without explicit consent from the
person to whom such records pertain, or
his or her parent, guardian or legally
authorized representative.
Proposed § 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 § 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 § 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 § 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,
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unless the Commission selects another
equally effective method of
transmission.
Proposed § 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 § 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 § 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 § 1102.24—Designation of
Confidential Information
Proposed § 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 § 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
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procedure for such assertions in a FOIA
context.
Proposed § 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 § 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 § 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 § 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
§ 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 § 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 § 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 § 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 § 1102.12(b) and
would require the requests to be
conspicuously labeled.
Proposed § 1102.24(d) would explain
that a request for confidential treatment
be made at any time after CPSC
transmission to the manufacturer of a
report of harm.
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Proposed § 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 § 1102.24(f) and (g) would
describe the procedure to notify the
manufacturer or private labeler of
determinations on the claim of
confidentiality. Proposed § 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 § 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 § 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 § 1102.26—Designation of
Materially Inaccurate Information
Proposed § 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 § 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
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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 § 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 § 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 § 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 § 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
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submit via electronic mail or written
submission directed to the Office of the
Secretary.
Proposed § 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 § 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 § 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 § 1102.26(g) and (h) would
outline the steps the Commission will
take where it has made a determination
of material inaccuracy. Proposed
§ 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 § 1102.26(h) would address
a Commission determination where
information in a report of harm or
comment has been published and would
explain that the Commission may, after
an investigation, determine that
information in a report of harm or
manufacturer comment contains
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materially inaccurate information. The
proposal would explain that the
Commission shall, no later than seven
business days of such determination: (1)
Remove the report of harm or
manufacturer comment, including any
attachments, from the database; (2)
correct the materially inaccurate
information and if other minimum
requirements for publication are met
maintain the comment or report of harm
in the database; or (3) add information
to the report of harm or comment to
correct the materially inaccurate
information and if other minimum
requirements for publication are met
maintain the comment or report of harm
in the database.
Proposed § 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
§ 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
§ 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 § 1102.26(c)(1) would explain
that given the requirement in § 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 § 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 § 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 § 1102.28—Publication of
Reports of Harm
Proposed § 1102.28 would explain
that reports of harm will be published
in the database as soon as practicable,
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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 § 1102.26.
5. Proposed § 1102.30—Publication of
Manufacturer Comments
Proposed § 1102.30 would explain
that the Commission will publish
manufacturer comments that meet the
minimum requirements in proposed
§ 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 § 1102.42—Disclaimers
Proposed § 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 § 1102.44—Applicability of
Section 6(a) and (b) of the CPSA
Proposed § 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
§ 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.
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IV. Comments on the Publicly Available
Database and CPSC’s Responses
We describe and respond to
significant issues raised by the
comments. To make it easier to identify
comments and the Commission’s
responses, the word ‘‘Comment’’ will
appear before each comment
description, and the word ‘‘Response’’
will appear before the Commission’s
response. We have grouped comments
based on their similarity and have
numbered the comments to help
distinguish between different comment
themes. The number assigned to each
comment summary is for organizational
purposes and does not signify the
comment’s value, importance, or order
in which it was received.
Subpart B—Content Requirements
Section 1102.10: Reports of Harm
1. CPSC asked whether any category
of persons should be excluded from
submitting reports of harm for inclusion
in the public database, and, if so, by
what means.
Comments (Summary 1)
Two commenters responded that no
category of persons should be excluded
from submitting reports of harm.
Another commenter responded that
third party submitters may be one or
more degrees separated from the events
involved in a report and encouraged
CPSC to consider how this might affect
assessment of information that could be
materially inaccurate. This commenter
suggested that there should be
transparency regarding relationships
surrounding reports and the person
filing the report. One commenter stated
that anonymous reports should not be
published since they cannot be verified.
Two commenters proposed that only
reports from those groups specified in
Section 6A(b)(1)(A)(i)–(v) should be
considered for inclusion in the database,
and the Commission should clearly and
narrowly define these categories. One
commenter suggested that the report
form should ask submitters to identify
to which group under 6A(b)(1)(A)(i)–(v)
they belong. This commenter suggested
that the CPSC should have a method for
verifying that those filing reports are
who they say they are. To assist in this,
the commenter suggested that the CPSC
should encourage submitters to consent
to their contact information being
shared with the manufacturer or private
labeler.
Response
We note the breadth of the entities
listed in the statute and conclude that
the list is intended to be nonrestrictive.
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Accordingly, we propose that, except for
information collected through the
National Electronic Injury Surveillance
System (NEISS), which is information
collected by selected hospital
emergency rooms, and except for
information collected through Death
Certificates, all reports of harm (or
‘‘incident reports’’) related to use of a
consumer product or other substance
regulated by the Commission, be
collected through the same incident
report form, regardless of who is
submitting the report of harm, and
deposited into a central data warehouse
for such information.
We propose that product-related
incident information be collected from
all sources, including anonymous
sources, but that only those reports that
meet the statutorily required minimum
information as set forth in the statute be
published for review and access in the
publicly-searchable portion of the
database.
We propose that a completed report
for posting in the public database
include verification of the information
submitted and an indication as to
whether consent has been given
regarding the submitter’s contact
information being shared with the
manufacturer or private labeler.
2. CPSC asked whether reports of
harm submitted by telephone or paper
should meet the same statutory time
frames for submission in the public
database.
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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
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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.
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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
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, dropdown 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
We propose that the minimum contact
information that must be provided by a
submitter of a report of harm for
inclusion in the public database be the
submitter’s first name, last name, and
complete mailing address. Additionally,
submitters will be strongly encouraged
to enter an e-mail address and/or a
telephone number for follow-up
purposes.
We also propose that minors under
the age of 18 not be allowed to submit
a report of harm to the public database
without the consent of a parent or
guardian as the named contact person.
5. CPSC asked how the report form
should address the issue of the
submitter’s verification of the
information submitted.
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Comments (Summary 5)
All of the commenters agreed that
submitters should have to take
affirmative steps to verify the accuracy
of the submission. One commenter
suggested that verification and consent
should be obtained separately (e.g., two
separate questions) and that the CPSC
should employ a procedure similar to
that currently utilized by the
Clearinghouse wherein a completed
report of harm and verification would
be mailed to the consumer which the
consumer would then mail back. This
commenter also suggested that the CPSC
should consider sending an automated
verification message to the submitter’s
e-mail address when submitted online,
as this would allow the submitter to
review the report, and require the
submitter to respond to the message to
verify the report and consent to its
inclusion in database. Reports
submitted by telephone should receive
the submitter’s verification and consent
in writing, as per the current
Clearinghouse procedure.
However, one commenter suggested
that submitters who provide their
reports via telephone should be able to
verify truth and accuracy of statements
over the telephone with CPSC staff. The
same commenter proposed that
unconfirmed or anonymous reports
should, minimally, affirmatively
acknowledge verification.
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS3
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 email 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
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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.
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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.
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.
1 Completely Automated Public Turing test to tell
Computers and Humans Apart.
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9. CPSC asked whether the report
form should contain links to outside
Web sites and, if so, why.
Comments (Summary 9)
CPSC received four comments in
response to this question and all agreed
that linking to outside Web sites could
be problematic. Some commenters
agreed that links could be helpful if
such links were relevant to the product
or complaint.
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS3
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
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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
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unlimited free text incident
descriptions. One commenter also
suggested including data fields on the
report form for CPSC-validated data as
well as manufacturer/private labeler
comments.
One commenter suggested allowing
submitters to amend reports of harm as
well as allowing manufacturers to
submit comments for publication after
the report of harm has been published.
This commenter also suggested
maintaining an audit trail every time a
report is modified. One commenter
stated that claims of material inaccuracy
should be focused on the submitter and
identification of the consumer product,
and not on the reported problem with
the consumer product. This commenter
suggested that reports of harm should
not be blocked, removed, or otherwise
flagged when a manufacturer makes a
claim of material inaccuracy.
Response
We have incorporated many of these
suggestions into the system design. Each
report will have a unique identifier
number.
The incident report input screens
being developed incorporate auto-fill
functions, drop-down menus, and text
fields where appropriate. For example,
an auto-fill function will be provided for
brand name, model name or number,
manufacturer name, retailer name, and
similar fields based on information we
have collected in our database library,
which will grow over time. Drop-down
menus will be used for fields such as
product category and type; injury
severity, type, and location; and state
and country codes. Text fields will be
available for incident description and
product description.
The system will utilize drop-down
menus where possible to ensure data
quality. The system will perform quality
checks including, but not limited to,
e-mail address format, blank fields,
invalid data format (characters in a
number field), and state and zip code
match.
We are developing a process to
identify, confirm, and register
companies that wish to use the online
manufacturer portal that is being
designed to facilitate communication
between CPSC and manufacturers.
Manufacturer registration, contact/
account management, e-mail
communication, and ability to flag
information are all functionalities being
considered for the portal. Manufacturers
will be able to choose their preferred
method of communication (e-mail or
postal mail) with the CPSC.
Manufacturers will designate a point of
contact within their organization to
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WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS3
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.
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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.
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 autoreminder 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
2 Joint Explanatory Statement of the Committee of
Conference, July 28, 2008, page 6.
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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 dropdown menus where possible to ensure
data quality. The system will perform
quality checks including, but not
limited to, e-mail address format, blank
fields, invalid data format (characters in
a number field), and state and zip code
match.
15. CPSC asked what means the
agency could employ to ensure that the
correct manufacturer and/or private
labeler is identified in a report of harm.
Comments (Summary 15)
One commenter suggested that the
following information would aid in
identifying the product and the
manufacturer: brand name, product
name, type of product, model number or
name, serial number (if available),
product description, and product age.
Another commenter suggested the use of
drop-down menus in order to accurately
link manufacturers to products and vice
versa.
One commenter suggested that CPSC
should rely on the manufacturer to
confirm their identity in relation to the
product identified in the report of harm.
This commenter also suggested that
CPSC allow companies to register their
contact information with CPSC in order
to minimize agency resources. This
commenter also proposed that retailers
be treated similarly since retailers
oftentimes have as much product
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information as manufacturers, if not
more.
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS3
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, email 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
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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
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29167
required statutory elements of a
complete incident report. The form will
also inform the user about the purpose,
use, and protection of information being
collected by the CPSC and how the
manufacturer might use the information
provided he or she should choose to
release it to the manufacturer.
Section 1102.10: Reports of Harm
(Additional Comments)
17. CPSC received a number of
additional comments not in response to
any particular question but related to
the overall issue of Section 1102.10
‘‘Reports of Harm.’’
Comments (Summary 17)
Several commenters stated that the
scope of the database is limited to
reports of harm and not to reports
relating to general product quality,
service issues, or other types of quality
complaints, that the harm must relate to
the use of the consumer product, and/
or that the database is limited to the
information the Commission determines
is reasonably related to the safety of
consumer products as indicated by
specific reports of harm caused by those
products and that the CPSC should
establish guidelines to this end. Along
these lines, one commenter suggested
that the software utilized in the database
could be structured to guide or prompt
submitters to supply the information
necessary to constitute a report of harm.
One commenter suggested that
consideration should be given to
limiting the reporting of ‘‘old’’ or ‘‘stale’’
data not contemporaneously related to
the occurrence of the alleged incident.
Three commenters suggested a one-year
statute of limitations to file a report of
harm. Another commenter proposed
that the database should not contain a
statute of limitations at all. One
commenter also suggested that the
database should be engineered to
automatically publish reports within the
required ten business days of receipt.
Response
We recognize that the scope of the
database is limited to reports of harm.
Instructions and guidance throughout
will prompt the submitter to adhere to
this scope. CPSC will review all reports
of harm regardless of the date of the
incident described by the submitter.
We considered options for automatic
publishing of reports of harm. However,
considerations around publishing
personally identifiable information in
free form text boxes limited staff’s
design options in this regard.
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Section 1102.12: Manufacturer
Comments
18. CPSC asked what means the
agency should employ to allow
manufacturers and private labelers to
submit comments regarding a report of
harm or to designate confidential
information, and what issues should the
agency consider when developing such
a process.
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS3
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
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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
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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 predatabase incident data into the new
system. Along these lines, one
commenter suggested that NEISS data
should be included in the database,
while another commenter responded
that CPSC should not add categories of
information beyond that required by the
CPSIA but, rather, should focus its
efforts on ensuring the quality of, and
timely reporting of, required
information. Finally, one commenter
felt that the CPSC should accept
information submitted anonymously by
whistleblowers and, if the information
was determined to be valid, the
information should be part of the public
database.
Response
The incident report form will be
designed to collect the following
information regarding the report of
harm, including: Name of manufacturer
or private labeler; type of product;
product brand; model number; serial
number; date of purchase; manufacturer
code date; place of purchase; date of
incident; location of incident; whether
the manufacturer or private labeler was
contacted prior to submission of the
report of harm and, if not, whether there
is a plan to contact them; a brief
description of the circumstances of the
incident; a description of harm incurred
during the incident; the types of
symptoms or injuries sustained; and the
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type of medical care sought, if
applicable.
After the user successfully submits
the report of harm, the system will alert
the user of any recalls that are related
to the incident reported and provide
options for the user to subscribe to the
recalls.gov subscription list and
possibly other lists, web services, or
agency publications.
The incorporation of CPSC technical
research, reports on emerging hazards,
and other staff-generated research into
the public database is being studied for
future releases of the system.
The database will accept information
submitted anonymously but we propose
that anonymous reports not be
published.
20. CPSC asked what, if any,
information could not be included in
the public database pursuant to the
statute and why.
Comments (Summary 20)
Several commenters stated that the
database should exclude reports filed
under section 15(b) of the CPSA. One
commenter also stated that information
received under any other mandatory or
voluntary reporting program established
between retailer, manufacturer, or
private labeler and the CPSC could not
be included in the database, as well as
information exempt from disclosure
under FOIA, trade secrets, and other
confidential information.
Two commenters stated that reports of
harm and/or comments involving
products that fall outside the scope of
CPSC regulatory authority should not be
included in the database. One
commenter was concerned that the
status of CPSC investigations, including
the existence of the investigation,
should not be included in the database.
This commenter also felt that the
database should not contain the
resolution and/or remedy provided to
individual submitters and that status
updates should be allowed only by
manufacturers providing comments.
Finally, this commenter stated that
third-party comments would not be
appropriate for the database.
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS3
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.
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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
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required disclaimer consistently on each
report on the database.
One commenter was concerned about
a disclaimer for materially inaccurate
information. This commenter suggested
that when a report is claimed to contain
materially inaccurate information, the
report should be marked on every page
to indicate it as such. When an existing
report is removed or corrected because
of a claim of materially inaccurate
information, public notice should be
made to those who already viewed the
report. Finally, one commenter
suggested that printed reports of harm
from the database should contain a print
date in order to reduce confusion
between versions of reports of harm or
manufacturer comments.
Response
The Commission does not guarantee
the accuracy, completeness or adequacy
of the contents of the public database.
The public database will contain a
notice to this effect. Additionally, we
propose that such notice be placed in
the following locations, at minimum:
• On the entrance screen for public
users
• On all search result displays
• On all reports printed from the
public database
Printed reports of harm will contain a
print date.
Subpart C—Procedural Requirements
Section 1102.20: Transmission of
Reports of Harm to the Identified
Manufacturer or Private Labeler
23. CPSC asked whether, given the
statutory timeframe for notification,
manufacturers and private labelers
should be able to ‘‘register’’ contact
information with the Commission for
the purpose of notification of a report of
harm and, if so, what form of contact
information should be acceptable, i.e.,
electronic mail only. CPSC also wanted
to know what other issues along these
lines should be considered.
Comments (Summary 23)
The majority of the commenters who
responded to this question agreed that
registration would help facilitate
manufacturer notification. One
commenter responded that electronic
mail only would be acceptable.
Response
We propose that the Commission
provide a mechanism for manufacturers
and private labelers to register their
contact information and their preferred
method of contact by the Commission.
24. CPSC asked how the agency could
ensure that manufacturers and/or
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private labelers do not use a submitter’s
contact information for purposes other
than verification of a report of harm,
and by what means could CPSC enforce
such a provision.
Comments (Summary 24)
Two commenters suggested that CPSC
could emphasize that misuse of contact
information would not be tolerated and
that CPSC would take any necessary
action to prosecute violators. One
commenter proposed that CPSC reiterate
the restrictions and appropriate uses for
consumer contact information in all
forms sent to manufacturers, while
another commenter proposed that CPSC
publish a list of uses of contact
information that would be deemed
abuses of that information. This
commenter also suggested that CPSC
could create a webpage for submitters to
report abuse.
Response
We conclude that the intent of the
statute to provide contact information
for the submitter to the manufacturer is
for the sole purpose of verifying the
report of harm. The Commission may, at
its discretion, determine means by
which it will enforce this provision.
Subpart B—Content Requirements
Section 1102.22: Opportunity for
Manufacturer Comment
25. CPSC asked what means the
agency should employ to notify
manufacturers and private labelers
regarding a report of harm within the
five day statutory time frame.
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS3
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
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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
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harm should not restart the ten-day
statutory time period for posting of
other information in the report form.
One commenter felt that once the CPSC
has received a claim of materially
inaccurate information contained in a
report of harm, it should have a limited
time to issue a decision or, in the
alternative, it should remove the report
of harm until it does. Finally, one
commenter felt that the CPSC could use
its discretion to permit an extension of
the ten-day period for publication in the
database in circumstances where there
is a challenge to the accuracy of the
report.
Response
We propose that if a claim of
materially inaccurate information is
timely submitted, the Commission may
withhold the report of harm from
publication in the public database until
a determination is made regarding such
claim. Absent such a determination, the
Commission will generally publish
reports of harm on the tenth business
day after transmitting a report of harm.
We also propose that if the Commission
determines that the designated
information in a report of harm or
manufacturer comment contains
materially inaccurate information before
it is published, the Commission should
in its discretion do the following:
Decline to add the materially inaccurate
report of harm or manufacturer
comment to the public database; redact
the information, and if the minimum
requirements for publication are met,
publish the report of harm or
manufacturer comment in the database;
correct the materially inaccurate
information, and if the minimum
requirements for publication are met,
publish the report of harm or
manufacturer comment in the database;
or, add the information to the report of
harm or the manufacturer comment to
correct the materially inaccurate
information, and, if the minimum
requirements for publication are met,
publish the report of harm or
manufacturer comment in the public
database.
Should the Commission make a
determination of material inaccuracy
after publication, we propose the
following: Removal of the entire
materially inaccurate report of harm or
manufacturer comment from the public
database, including all associated
documents, photographs, or comments;
redaction of the materially inaccurate
information and if the minimum
requirements for publication are met,
maintain the report of harm or
manufacturer comment in the public
database; correction of the materially
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inaccurate information and, if the
minimum requirements are met,
maintain the report of harm or
manufacturer comment in the public
database; or, add the information to the
report of harm or the manufacturer
comment to correct the materially
inaccurate information and, if the
minimum requirements for publication
are met, maintain the report of harm or
manufacturer comment in the public
database.
28. CPSC asked whether the agency’s
responsibility with regard to materially
inaccurate information is limited to
reports of harm and manufacturer
comments and why or why not.
Comments (Summary 28)
CPSC received one comment in
response to this question which stated
that CPSC should exclude materially
inaccurate information regardless of the
source.
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS3
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
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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 factbased 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.
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30. CPSC asked how the agency
should process a claim that a report of
harm or a manufacturer comment
contains materially inaccurate
information, both before and after such
information has been made available in
the public database.
Comments (Summary 30)
The majority of commenters agreed
that CPSC should develop a transparent
and efficient process for handling a
claim of materially inaccurate
information in a report of harm,
including how redactions, corrections
and/or removal of a report of harm will
be addressed. Correspondingly, many
commenters also felt that CPSC should
develop a parallel procedure for the
inclusion of reports of harm in the
database wherein CPSC staff would
make affirmative verification that the
report of harm was true and accurate.
Several commenters felt that a report of
harm could not be published in the
database until the CPSC had verified
that it was true and accurate.
Two commenters felt that CPSC
should follow the procedures specified
in the statute wherein upon a claim that
a report of harm or a comment contains
materially inaccurate information, the
CPSC must make a determination as to
the accuracy of that report or comment
and that the report or comment should
not be published until such
determination is made. Similarly, three
commenters suggested that the CPSC
should decline to post a report of harm
involving a claim of material inaccuracy
until an appropriate investigation of the
claim had been made.
Another commenter proposed that the
CPSC adopt a trial procedure during
which it would permit extensions to the
ten-day period for publication of reports
of harm to the database where there has
been a claim of material inaccuracy.
This commenter suggested that the
CPSC provide a means for
manufacturers and private labelers to
flag information in a report as being
materially inaccurate and also provide a
means to flag materially inaccurate
information after it has been published
to the database. This commenter
recommended that the CPSC establish
timeframes during which claims of
material inaccuracy will be resolved.
On the other hand, two commenters
felt that publication of a report of harm
should take priority over verifying
claims of materially inaccurate
information. Additionally, one
commenter suggested that the party
contending the material inaccuracy
bears the burden of demonstrating the
material inaccuracy and that CPSC
should reject efforts to delay or deny
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posting of information based upon
unsubstantiated claims of materially
inaccuracy. One commenter felt that if
the CPSC publishes a report of harm
over the manufacturer or private
labeler’s objections, the CPSC should
provide the reasons for doing so. One
commenter wanted an opportunity to
examine the consumer product in
question during the pendency of an
investigation into materially inaccurate
information in a report of harm.
One commenter felt that if an
inaccurate report was inadvertently
published, it should be removed as soon
as possible and that a simple retraction
would not suffice, while another
commenter felt that the CPSC could
internally investigate it and post a
clarification/disclaimer or delete the
materially inaccurate information from
the report of harm.
One commenter suggested that when
a report of harm has been determined to
contain materially inaccurate
information, it should be marked on
every page to indicate it was removed or
corrected. When existing reports are
removed or corrected because they
contain materially inaccurate
information, public notice should be
made to those who already viewed the
report of harm. This commenter also
suggested that if the CPSC receives a
subpoena or FOIA request regarding a
report of harm that has been corrected
or removed, the CPSC should provide
notice in accordance with Section 6(b)
to the manufacturer or private labeler.
Response
We propose that if the Commission
makes a determination of materially
inaccurate information prior to
publication of a report of harm, it shall
either decline to add the report of harm
or manufacturer comment to the public
database or, redact or correct the
materially inaccurate information and if
the minimum requirements for
publication are met, publish the report
of harm or manufacturer comment in
the public database. We propose the
Commission favor correction over
exclusion.
If the Commission makes a
determination of material inaccuracy
after publication of a report of harm or
manufacturer comment, the
Commission shall, no later than seven
business days after making such
determination, remove the report of
harm or manufacturer comment from
the public database or, redact or correct
the report of harm or manufacturer
comment and if the minimum
requirements for publication are met,
publish the report of harm or
manufacturer comment. We propose the
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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
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materially inaccurate information or
confidential information, the
Commission shall, in its discretion,
decline to add the report of harm to the
database, correct the materially
inaccurate information in the report or
add information to the report to correct
it. We propose to favor correction/
addition over exclusion.
34. CPSC asked what data sets,
including information from reports of
harm and mandatory and voluntary
recall notices, should be made available
for public search and reporting and
why.
Comments (Summary 34)
Some commenters agreed that all of
the information submitted to the
database except for personal and/or
contact information contained in reports
of harm should be made available for
public search and reporting. One
commenter wanted to make it clear that
personal and/or contact information
should never be disclosed to the public
and only to a manufacturer or private
labeler where there has been consent.
Several commenters agreed that
voluntary and mandatory recall notices,
and/or information derived as a result of
such recall notices, should be
searchable as well. One commenter
would like to be able to search the
CPSC’s NEISS data.
Two commenters wanted to be able to
search for manufacturer and private
labeler comments provided in response
to a report of harm. One commenter also
suggested being able to search CPSC’s
‘‘closed investigations’’ which the staff is
interpreting as pertaining to
investigations conducted by the Office
of Compliance and Field Operations
staff. One commenter would like to be
able to search staff research. One
commenter noted that recall information
should be provided separate from
reports of harm, stating that recalls are
often limited in scope and there is a risk
that reports of harm could be
inappropriately or inaccurately linked
to recall information, while another
commenter wanted searching to be
limited to what the statute requires in as
simple and accurate a format as
possible.
Response
We propose that all information and
data sets that will be made available in
the public database should be made
searchable and sortable. The
incorporation of additional categories of
information into the public database is
being studied for future releases of the
system software.
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35. CPSC asked in what formats the
agency should make data available to
the public and why.
Comments (Summary 35)
Several commenters agreed that the
data should be downloadable and/or
searchable in common, readily-available
formats that do not require the purchase
of specific, proprietary software. One
commenter suggested providing the data
in downloadable formats that would
facilitate use by manufacturers in their
own tracking systems.
Commenters would like to be able to
search by general word entry, including
advanced searches for data using search
terms connected by both the words
‘‘AND’’ and ‘‘OR,’’ and/or also by type/
category of product, brand name, model
name, model number, type of injury and
other harm, approximate date of
purchase, and product manufacturer
information.
Two commenters recommended
making raw data available.
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS3
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-touse 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
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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
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29173
aspect of the proposed rule. Comments
should be submitted in accordance with
the instructions in the ADDRESSES
section at the beginning of this notice.
VI. Environmental Impact
The Commission’s regulations at 16
CFR 1021.5(a) are considered to ‘‘have
little or no potential for affecting the
human environment,’’ and
environmental assessments and impact
statements are not usually prepared. See
16 CFR 1021.5(c). The proposed rule
contains the Commission’s
interpretation of the statutory
requirements set forth in section 6A of
the CPSA, as added by section 212 of
the CPSIA, for the inclusion of
information related to reports of harm
involving the use of consumer products
or other products or substances
regulated by the Commission in a
publicly available and searchable
database. As such, the proposed rule is
not expected to have an adverse impact
on the environment. The Commission
concludes that no environmental
assessment or environmental impact
statement is required.
VII. Paperwork Reduction Act
This proposed rule contains
information collection requirements that
are subject to public comment and
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). We describe the provisions in
this section of the document with an
estimate of the annual reporting burden.
Our estimate includes the time for
reviewing instructions, searching
existing data sources, gathering and
maintaining the data needed, and
completing and reviewing each
collection of information.
We particularly invite comments on:
(1) Whether the collection of
information is necessary for the proper
performance of the CPSC’s functions,
including whether the information will
have practical utility; (2) the accuracy of
the CPSC’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
Title: Publicly Available Consumer
Product Safety Information Database.
Description: The proposed rule would
allow consumers to submit reports of
harm involving the use of consumer
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products or other products or
substances regulated by the CPSC and
also allow manufacturers of such
products or substances to comment on
the reports of harm. The reports and
comments would be part of a public
database operated and maintained by
the CPSC. A manufacturer identified in
a report of harm and who receives a
report of harm from CPSC may request
that portions of the report be designated
as confidential information. Any person
or entity reviewing a report of harm or
manufacturer comment may request that
the report or comment, or portions
thereof, be excluded from the database
or corrected by the CPSC because it
contains materially inaccurate
information.
Description of Respondents: Persons
who wish to submit reports of harm
involving the use of consumer products
or other products or substances
regulated by the CPSC and
manufacturers of such products or
substances who wish to comment on
those reports of harm, pursuant to
section 6A of the Consumer Product
Safety Act (CPSA) (15 U.S.C. 2055a). In
addition, any person or entity reviewing
a report of harm or manufacturer
comment, either before or after
publication in the database, may request
that the report of harm or manufacturer
comment, or portions thereof, be
excluded from the database or corrected
by the CPSC because it contains
materially inaccurate information.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
16 CFR
section
Number of
respondents
Frequency of
responses
Total annual
responses
Minutes per
response
Total burden,
in hours
11,534
3,329
277
1
1
1
11,534
3,329
277
12
10
20
2,307
555
92
5,753
1,817
1
1
5,753
1,817
255
270
24,450
8,177
345
1
345
15
86
109
1
109
30
54
1,726
1
1,726
30
863
545
1
545
60
545
Total ..............................................................................
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16 CFR 1102.10(b)(1), (3) Reports of harm—electronic .....
16 CFR 1102.10(b)(2) Reports of harm—telephone ...........
16 CFR 1102.10(b)(4) Reports of harm—paper .................
16 CFR 1102.12(b)(1), (2) Manufacturer comments—electronic .................................................................................
16 CFR 1102.12(b)(3) Manufacturer comments—paper .....
16 CFR 1102.24 Requests to treat information as confidential—electronic ..........................................................
16 CFR 1102.24 Requests to treat information as confidential—paper ................................................................
16 CFR 1102.26 Requests to treat information as materially inaccurate—electronic ...............................................
16 CFR 1102.26 Requests to treat information as materially inaccurate—paper ......................................................
........................
........................
........................
........................
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
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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 ×
12 minutes per report) + (3,329
telephone reports × 10 minutes per
report) + (277 paper reports × 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
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as many total manufacturer comments
as reports of harm (15,140 reports of
harm × 0.5 manufacturer comments per
report of harm = 7,570 manufacturer
comments). In terms of the manner of
commenting, we do not currently keep
track of how many manufacturer
comments are submitted electronically
versus in paper form. Because the
public database will be online, we will
assume that most manufacturers will
utilize electronic options for
participating in the database, especially
when the public database (unlike the
current incident reporting system) will
not give manufacturers the option of
submitting their comments by phone.
However, to ensure that we avoid
inadvertently underestimating the
burden, we will assume that
manufacturers would submit
electronically at the same rate. That
equates to an estimate of 5,753
manufacturer comments submitted
electronically and 1,817 submitted on
paper.
We also will assume that that there
are two actions involved in a
manufacturer comment: First, the
research and preparation necessary to
comment, and second, the act of
providing the comment. To estimate
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how much time manufacturers will
spend researching and preparing to
comment, we contacted three
manufacturers that have experience
submitting comments in response to
incident reports. The manufacturers
each reported a range of time, because
time required in preparing a comment
can vary greatly. The three ranges were
15 minutes to 4 hours, 10 minutes to 5
hours, and 10 minutes to 3 hours. For
purposes of estimating the burden, we
used the average high end of these
ranges, 4 hours, for that portion of the
burden estimate. Based on our
experience with the current
manufacturing comment process, we
estimate that manufacturers will spend
between 5 and 30 minutes actually
providing the comment, depending on
the length and complexity of their
comment. For the purposes of this
estimate, we use the high end of that
range for paper submissions (30
minutes) and the midpoint for
electronic (15). Thus, the estimated
burden associated with manufacturer
comments is approximately 32,607
hours (((5,753 electronic comments ×
255 minutes per comment) + (1,817
paper comments × 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 (§ 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 × 76 percent electronic
submission) to arrive at an estimate of
345 electronic requests and 109 paper
requests. We multiplied 345 electronic
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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] × 10 percent). The
proposed rule would specify what must
be included in such a request
(§ 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
(§ 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 × 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 × 30 minutes
= 51,780 minutes, or 863 burden hours).
Similarly, 545 paper requests (2,271
requests × 24 percent paper = 545), at 60
minutes each to complete, results in a
burden of 545 hours (545 paper requests
× 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
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29175
in clear language the preemptive effect,
if any, of new regulations. This
regulation is issued under the authority
of the CPSA, wherein preemption is
discussed in section 26 of the CPSA.
Section 26 of the CPSA only addresses
the preemptive effect of consumer
product safety standards under the
CPSA. The current rule is not a
consumer product safety standard under
the CPSA. Accordingly, the Commission
has determined that this rule does not
contain requirements that impact the
States.
IX. Regulatory Flexibility Act
The Regulatory Flexibility Act
(‘‘RFA’’) generally requires that agencies
review proposed rules for their potential
economic impact on small entities,
including small businesses. Section 603
of the RFA calls for agencies to prepare
and make available for public comment
an initial regulatory flexibility analysis
describing the impact of the proposed
rule on small entities and identifying
impact-reducing alternatives. 5 U.S.C.
603. Section 605(b) of the RFA,
however, states that this requirement
does not apply if the head of the agency
certifies that the rule will not, if
promulgated, have a significant
economic impact on a substantial
number of small entities, and the agency
provides an explanation for that
conclusion.
Preliminary analysis shows the
proposed rule will have little or no
effect on small businesses. The rule
would implement the statutory
requirements set forth in section 6A of
the CPSA for the establishment and
maintenance of a publicly available
database containing reports of harm
involving the use of consumer products,
as well as comments received by
manufacturers regarding such reports of
harm identifying their products. The
agency anticipates that the new database
will likely increase the number of
consumer-generated reports over the
number of incident reports currently
filed with the Commission. However,
because of their smaller sales volumes,
we believe small manufacturers are less
likely to receive an incident report and,
hence, to experience any impacts.
Moreover, even if a small firm does
choose to respond to an incident report,
we believe the amount of time to do so
would not likely be more than a few
hours, on average. Before the
Commission can certify that the rule
will not have a significant economic
impact on a substantial number of small
entities additional information on these
points would be helpful. Therefore, the
Commission invites comment on this
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analysis and preliminary certification
statement.
Subpart A—Background and
Definitions
X. Effective Date
§ 1102.2
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.
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.
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
Purpose.
Scope.
Definitions.
Subpart B—Content Requirements
1102.10
1102.12
1102.14
1102.16
Reports of harm.
Manufacturer comments.
Recall notices.
Additional information.
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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.
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Scope.
This part applies to the content,
procedure, notice, and disclosure
requirements of the Consumer Product
Safety Information Database, including
all information published therein.
§ 1102.6
List of Subjects in 16 CFR Part 1102
Sec.
1102.2
1102.4
1102.6
§ 1102.4
Purpose.
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 § 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.
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(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
§ 1102.10
Reports of harm.
(a) Who may submit. The following
persons or entities may submit reports
of harm:
(1) Consumers including, but not
limited to, users of consumer products,
family members, relatives, parents,
guardians, friends, and observers of the
consumer products being used;
(2) Local, State, or Federal
government agencies including, but not
limited to, local government agencies,
school systems, social services, child
protective services, State attorneys
general, State agencies, and all
executive and independent Federal
agencies as defined in Title 5 of the
United States Code;
(3) Health care professionals
including, but not limited to, medical
examiners, coroners, physicians, nurses,
physician’s assistants, hospitals,
chiropractors, acupuncturists;
(4) Child service providers including,
but not limited to, day care centers, day
care providers, pre-kindergarten school,
and child care providers;
(5) Public safety entities including,
but not limited to, police, fire,
ambulance, emergency medical services,
Federal, State, and local law
enforcement entities, and other public
safety officials; and
(6) Others including, but not limited
to, attorneys, professional engineers,
investigators, nongovernmental
organizations, consumer advocates,
consumer advocacy organizations, and
trade associations.
(b) Manner of submission. To be
entered into the publicly accessible
database, reports of harm must be
submitted to the CPSC using one of the
following methods:
(1) Internet submissions through the
CPSC’s Internet Web site on an
electronic incident report form
specifically developed to collect such
information.
(2) Telephonic submissions through a
CPSC call center where the information
is entered on the electronic incident
form.
(3) Electronic mail or facsimile
directed to the [Name of office will
appear in final rule], provided that the
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submitter completes the incident report
form available for download on the
CPSC’s Internet Web site specifically
developed to collect such information.
(4) Written submissions through the
[Office and address will appear in final
rule]. The Commission will accept only
those written reports of harm that use
the incident report form developed for
the CPSC’s Internet Web site; or
(5) Other means the Commission
subsequently makes available.
(c) Size limit of reports of harm. The
Commission may, in its discretion, limit
the data size of reports of harm, which
may include attachments submitted
where such reports of harm and
attachments may negatively impact the
technological or operational
performance of the system.
(d) Minimum requirements for
publication. Subject to §§ 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
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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 § 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 § 1102.24;
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(6) Materially inaccurate information
as set forth in § 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.
§ 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 § 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
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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 § 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
§ 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.
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§ 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.
§ 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,
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consistent with the requirements of
section 6(a) and (b) of the CPSA.
Subpart C—Procedural Requirements
§ 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
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of the report of harm impracticable
within five business days include, but
are not limited to:
(1) The manufacturer or private
labeler is out of business with no
identifiable successor;
(2) The submitter misidentified a
manufacturer or private labeler; or
(3) The report of harm contained
inaccurate or insufficient contact
information for a manufacturer or
private labeler; or
(4) The Commission cannot locate
valid contact information for a
manufacturer or private labeler.
(d) Method of transmission. The
Commission will use the method of
transmission and contact information
provided by the manufacturer or private
labeler. The Commission will transmit
reports of harm to a manufacturer or
private labeler who has registered with
the Commission as described in
paragraph (e) of this section. If a
manufacturer or private labeler has not
registered with the Commission, the
Commission will send reports of harm
through the United States mail to the
firm’s principal place of business unless
the Commission selects another equally
effective method of transmission.
(e) Size limits of manufacturer
comments. The Commission may, in its
discretion, limit the data size of
comments, which may include
attachments submitted, where such
comments and attachments may
negatively impact the technological or
operational performance of the system.
(f) Manufacturer registration.
Manufacturers and private labelers may
register with the Commission to select a
preferred method for receiving reports
of harm which identify such firm as the
manufacturer or private labeler.
Manufacturers and private labelers that
choose to register with the Commission
must:
(1) Register with the Commission
through a process identified for such
registration;
(2) Provide and maintain updated
contact information for the firm,
including the name of the firm, title of
a person to whom reports of harm
should be directed, complete mailing
address, telephone number, electronic
mail address, and Web site address (if
any); and
(3) Select a specified method to
receive reports of harm that identify the
firm as the manufacturer or private
labeler of a consumer product.
(g) Manufacturer comments received
after one year. A manufacturer or
private labeler who receives a report of
harm from the CPSC may comment on
the information contained in such
report of harm. The Commission, in its
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discretion, where it determines it is in
the public interest, may choose not to
publish a manufacturer comment to the
Database if such comment is received
more than one year after transmission of
the report of harm to the manufacturer
or private labeler.
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§ 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 § 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
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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.
§ 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
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(iii) The harm or risk of harm related
to use of the consumer product.
(2) Materially inaccurate information
in a manufacturer comment means
information that is false or misleading
in a significant and relevant way that
creates or has the potential to create a
substantially erroneous or substantially
mistaken belief in a Database user
relating to:
(i) The nature, scope, liability, or
cause of a harm or risk of harm related
to the use of a consumer product;
(ii) The status of a Commission,
manufacturer, or private labeler
investigation;
(iii) The identity of the firm or firms
responsible for the importation,
manufacture, distribution, sale, or
holding for sale a consumer product;
(iv) Whether the manufacturer or
private labeler is engaging in a
corrective action (when such action has
not been approved by the Commission);
or
(v) Whether the manufacturer has
taken, or promised to take, any other
action with regard to the product.
(b) Request for designation of
materially inaccurate information. Any
person or entity reviewing a report of
harm or manufacturer comment, either
before or after publication in the
Database, may request that the report of
harm or manufacturer comment, or
portions of such report of harm or
manufacturer comment, be excluded
from the Database or corrected by the
Commission because it contains
materially inaccurate information. A
requester seeking an exclusion or
correction must:
(1) State the unique identifier of the
report of harm or manufacturer
comment to which the request for a
determination of materially inaccurate
information pertains;
(2) Specifically identify the exact
portion(s) of the report of harm or the
manufacturer comment claimed to be
materially inaccurate;
(3) State the basis for the allegation
that such information is materially
inaccurate;
(4) Provide evidence, which may
include documents, statements,
electronic mail, internet links,
photographs, or any other evidence,
sufficient for the Commission to make a
determination that the designated
information is materially inaccurate;
(5) State what relief the requester is
seeking: exclusion of the entire report of
harm or manufacturer comment;
redaction of specific information;
correction of specific information; or the
addition of information to correct the
material inaccuracy;
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(6) State whether and how an alleged
material inaccuracy may be corrected
without removing or excluding an entire
report of harm or manufacturer
comment; and/or
(7) State whether the person
submitting the allegation of material
inaccuracy is authorized to make claims
of material inaccuracy on behalf of the
person or organization concerned.
(c) Manner of submission—Length of
request and expedited review. The
Commission strongly recommends
requesters seeking an expedited review
of claims of materially inaccurate
information to limit the length of the
request described in § 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
§ 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
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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 §§ 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 §§ 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 §§ 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 §§ 1102.10(c) and 1102.12(c) are met,
maintain the report of harm or
manufacturer comment in the Database.
(i) Commission discretion.
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(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 §§ 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
§ 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
§ 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
§§ 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.
§ 1102.28
Publication of reports of harm.
(a) Timing. Subject to §§ 1102.10,
1102.24, and 1102.26, the Commission
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will publish reports of harm that meet
the requirements for publication in the
Database. The Commission will publish
reports of harm as soon as practicable
but not later than the tenth business day
after such report of harm is transmitted
to the manufacturer or private labeler by
the CPSC.
(b) Exceptions. The Commission may
publish a report of harm that meets the
requirements of § 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 § 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.
§ 1102.30 Publication of manufacturer
comments.
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(a) Timing. Subject to §§ 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
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requirements set forth in § 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
§ 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
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will be prominently and conspicuously
displayed on the database and on any
documents that are printed from the
database.
§ 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
§ 1102.10(c), in the Consumer Product
Safety Information Database.
(b) Limitation on construction.
Section 1102.42(a) shall not be
construed to exempt from the
requirements of sections 6(a) and 6(b) of
the CPSA information received by the
Commission pursuant to:
(1) Section 15(b) of the CPSA; or
(2) Any other mandatory or voluntary
reporting program established between a
retailer, manufacturer, or private labeler
and the Commission.
Dated: May 7, 2010.
Todd A. Stevenson,
Secretary.
[FR Doc. 2010–11374 Filed 5–21–10; 8:45 am]
BILLING CODE 6355–01–P
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Agencies
[Federal Register Volume 75, Number 99 (Monday, May 24, 2010)]
[Proposed Rules]
[Pages 29156-29181]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11374]
[[Page 29155]]
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Part III
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16 CFR Part 1102
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Publicly Available Consumer Product Safety Information Database;
Proposed Rule
Federal Register / Vol. 75 , No. 99 / Monday, May 24, 2010 / Proposed
Rules
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1102
Publicly Available Consumer Product Safety Information Database
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of proposed rulemaking.
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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: https://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 https://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 https://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 https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Mary Kelsey James, Director,
Information Technology Policy and Planning, Consumer Product Safety
Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301)
504-7213; mjames@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The CPSIA requires the Commission to establish and maintain a
product safety information database that is available to the public.
Specifically, section 212 of the CPSIA amended the CPSA to create a new
section 6A of the CPSA, titled ``Publicly Available Consumer Product
Safety Information Database.'' Section 6A(a)(1) of the CPSA requires
the Commission to establish and maintain a database on the safety of
consumer products, and other products or substances regulated by the
Commission. The database must be publicly available, searchable, and
accessible through the Commission's Web site. Section 6A of the CPSA
sets forth specific content, procedures, and search requirements for
the publicly available database. In this proposed rule, the Commission
sets forth its interpretation of the statutory requirements of section
6A.
For several decades, the Commission has gathered and maintained a
database of consumer complaints known as consumer product incident
reports involving a description of incidents related to the use of
consumer products that fall within the scope of the Commission's
jurisdiction. Pursuant to section 5(a) of the CPSA, the Commission
collects information related to the causes and prevention of death,
injury, and illness associated with consumer products. The Commission
conducts studies and investigations of deaths, injuries, diseases,
other health impairments, and economic losses resulting from accidents
involving consumer products. Also, pursuant to section 5(b) of the
CPSA, the Commission may conduct research, studies, and investigations
on the safety of consumer products and on improving the safety of such
products. Currently, the Commission obtains information about product-
related deaths, injuries, and illnesses from a variety of sources,
including newspapers, death certificates, consumer complaints, and
hospital emergency rooms. In addition, the Commission receives
information from the public through its Internet Web site through forms
reporting on product-related injuries or incidents. The data that the
Commission collects and maintains on product safety has not been
immediately available and searchable by the public. Before the CPSIA's
enactment, the CPSA required that the Commission follow the notice
provisions of section 6 of the CPSA before publicly disclosing any
information that allowed the public to readily ascertain the identity
of a manufacturer or private labeler of a consumer product. Section 6
of the CPSA contains requirements for giving notice of such information
to the manufacturer or private labeler and providing an opportunity to
comment on the information prior to public disclosure. Section 6 of the
CPSA also requires the Commission to take reasonable steps to assure
that disclosure of such information is accurate, fair in the
circumstances, and reasonably related to effectuating the purposes of
the CPSA. The Commission has applied the requirements in section 6 of
the CPSA to Freedom of Information Act (FOIA) requests as well. See
Consumer Product Safety Commission et al. v. GTE Sylvania, 447 U.S. 102
(1980). The Commission issued regulations interpreting the section 6
requirements at 16 CFR part 1101. Thus, consumers currently have access
to incident data through reports and studies published by the
Commission or through information provided in response to FOIA
requests.
As stated earlier in part I of this document, section 6A of the
CPSA requires the establishment and maintenance of a publicly available
and searchable database. Section 6A of the CPSA specifically excludes
any report submitted pursuant to the public database provisions from
the notice requirements of section 6(a) and (b) of the CPSA.
Accordingly, the Commission invited input from its stakeholders
before developing the proposed rule. A summary of the CPSC's work done
to date on the public database, including a Report to Congress, Public
Meetings, Federal Register Notices, Commission Actions and Public
Comments, are
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available on the CPSC Web site at https://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 https://www.cpsc.gov/library/foia/foia10/pubcom/pubdb.pdf. A
Webcast of the hearing can be viewed on the CPSC's Web site at https://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 https://www.cpsc.gov/about/cpsia/pw01112010am.html, and a Webcast of the
workshops is available on the CPSC's Web site at https://saferproducts.gov/events/pw01112010.html. The CPSC also invited
comments in conjunction with the workshop. We received twenty-two
comments, and we summarize and respond to those comments in section IV
of this document below.
II. Statutory Authority
The Commission is issuing this proposed rule pursuant to section 3
of the CPSIA which provides the Commission authority to issue
regulations, as necessary, to implement the CPSIA.
III. Description of the Proposed Rule
The proposed rule would establish a new 16 CFR part 1102,
``Publicly Available Consumer Product Database.'' The new part would
consist of four subparts:
Subpart A--Background and Definitions;
Subpart B--Content Requirements;
Subpart C--Procedural Requirements;
Subpart D--Notice and Disclosure Requirements
We describe the provisions in each proposed subpart in detail
immediately below in section III. A through D of this document.
A. Proposed Subpart A--Background and Definitions
1. Proposed Sec. 1102.1--Purpose
Proposed Sec. 1102.1 would describe the purpose of the new
``Publicly Available Consumer Product Safety Information Database.'' In
brief, the proposal would state that part 1102 sets forth the
Commission's interpretation, policy, and procedures with regard to the
creation and maintenance of a Consumer Product Safety Information
Database.
2. Proposed Sec. 1102.4--Scope
Proposed Sec. 1102.4 would explain that the part 1102 applies to
the content, procedure, notice, and disclosure requirements to be
followed and all information published in the Consumer Product Safety
Information Database.
3. Proposed Sec. 1102.6--Definitions
Proposed Sec. 1102.6 would define certain terms. As a general
matter, proposed Sec. 1102.4(a) would explain that, except as provided
in proposed Sec. 1102.6(b), the definitions set forth in section 3 of
the CPSA apply. For example, section 3(a)(11) of the CPSA defines a
``manufacturer'' as ``any person who manufactures or imports a consumer
product.'' Because section 3(a)(11) of the CPSA defines
``manufacturer,'' any reference to ``manufacturer'' in proposed part
1102 would have the same meaning.
Proposed Sec. 1102.6(b) would define certain terms or, in some
cases, interpret terms already defined in section 3 of the CPSA. For
example, section 3(a)(5) of the CPSA defines ``consumer product,'' in
part, as ``any article, or component part thereof, produced or
distributed (i) for sale to a consumer for use in or around a permanent
or temporary household or residence, a school, in recreation, or
otherwise, or (ii) for the personal use, consumption or enjoyment of a
consumer in or around a permanent or temporary household or residence,
a school, in recreation, or otherwise * * *'' However, proposed Sec.
1102.6(b)(3) would define ``consumer product'' as having the same
meaning as defined in the CPSA, but would further explain that
``consumer product'' includes any other products or substances
regulated by the Commission under the CPSA, Federal Hazardous
Substances Act, Flammable Fabrics Act, the Poison Prevention Packaging
Act, the Children's Gasoline Burn Prevention Act, the Virginia Graeme
Baker Pool and Spa Safety Act, and any other statute that the
Commission enforces. This further clarification is based on the
statutory requirement in section 6A(b)(1)(A) of the CPSA for submission
of reports of harm relating to the use of consumer products and other
products or substances regulated by the Commission.
Proposed Sec. 1102.6(b)(1) would define ``additional information''
as any information, other than reports of harm, that the Commission
determines is in the public interest to include in the Consumer Product
Safety Information Database.
Proposed Sec. 1102.6(b)(2) would define ``Commission'' or ``CPSC'
as meaning the Consumer Product Safety Commission.
Proposed Sec. 1102.6(b)(4) would define ``Consumer Product Safety
Information Database'' as the publicly available searchable information
database on the safety of consumer products required to be established
and maintained by the Commission.
Proposed Sec. 1102.6(b)(5) would define ``harm'' as any injury,
illness, or death, or any risk of injury, illness or death as
determined by the Commission.
Proposed Sec. 1102.6(b)(6) would define ``mandatory recall
notice'' as any notice to the public ordered by the Commission pursuant
to section 15(c) of the CPSA relating to action the Commission orders
to be taken by any manufacturer, distributor, or retailer about a
consumer product.
Proposed Sec. 1102.6(b)(7) would define ``manufacturer comment''
as a comment made by a manufacturer or private labeler in response to a
report of harm received through the public database and transmitted by
the CPSC to the manufacturer or private labeler.
Proposed Sec. 1102.6(b)(8) would define ``report of harm'' as any
information submitted to the Commission through the manner described in
Sec. 1102.10(b) regarding an incident concerning an injury, illness or
death, or any risk of
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injury, illness or death as determined by the Commission relating to
the use of the consumer product.
Proposed Sec. 1102.6(b)(9) would define ``submitter of a report of
harm'' as any person or entity that submits information to the
Commission through the database regarding any injury, illness, or
death, or any risk of injury, illness, or death as determined by the
Commission relating to the use of a consumer product.
Proposed Sec. 1102.6(b)(10) would define ``voluntary recall
notice'' to mean any notice to the public relating to a voluntary
corrective action taken by a manufacturer in consultation with the
Commission where the Commission has notified the public of the
manufacturer's voluntary corrective action.
B. Proposed Subpart B--Content Requirements
Proposed subpart B, ``Content Requirements,'' would describe the
database's contents. In general, section 6A(b) of the CPSA states that
the database must include: (1) Reports of harm; (2) information derived
by the Commission from notice under section 15(c), and any notice to
the public relating to a voluntary corrective action taken by a
manufacturer, in consultation with the Commission, of which the
Commission has notified the public; and (3) manufacturer comments
received by the Commission on a report of harm and requested for
inclusion into the database. Proposed Sec. Sec. 1102.10 through
1102.14 would describe how such reports, information, and comments
would become part of the database, and proposed Sec. 1102.16,
``Additional information,'' would discuss information that the CPSC may
add to the database when adding such information would be in the public
interest. Reports of harm that fall outside the scope of CPSC
regulatory authority will be referred to an appropriate agency or
entity with notification of such action to the submitter.
1. Proposed Sec. 1102.10--Reports of Harm
Proposed Sec. 1102.10 would explain who may submit reports of harm
in the public database. In brief, proposed Sec. 1102.10(a) would
identify those submitters specified in section 6A(b)(1)(A) of the CPSA
and provide further clarification for those categories of persons that
may fall within each of the identified groups. The list of persons
under each group is not exclusive, and the proposed lists are intended
to provide a greater understanding of the persons that could fall under
each category. For example, ``consumers'' would include not only users
of consumer products, but also family members, relatives, parents,
guardians, friends, observers of a consumer product being used by
another, and victims. The proposal would add a category of ``other'' to
include those persons who may not clearly fit within the statutorily
identified categories; for example, ``other'' persons would include,
but not be limited to, attorneys, professional engineers,
investigators, nongovernmental organizations, consumer advocates,
consumer advocacy organizations, and trade associations.
Proposed Sec. 1102.10(b) would describe how a report of harm can
be submitted to the database. The proposal would describe four methods
(internet, telephone, electronic mail, and paper) for submitting
reports and when each submission will be construed as being complete.
For example, proposed Sec. 1102.10(b)(1) would explain that submitters
using the Internet will use an electronic form specifically developed
to collect the report of harm in the database. As another example,
proposed Sec. 1102.10(b)(2) would explain how submissions over the
telephone will be accepted and proposed Sec. 1102.10(b)(4) would
explain how the Commission will deal with written submissions.
Additionally, the proposal gives the Commission the flexibility to
provide other means of submission if new ways subsequently become
available.
Proposed Sec. 1102.10(c) would describe potential size limits on
reports of harm where the size of such reports of harm, including
attachments, might negatively impact the technological or operational
performance of the system.
Proposed Sec. 1102.10(d)(1) through (d)(6) would describe the
minimum requirements for publication of reports of harm in the
database. The proposal identifies the required criteria of information
that are referenced in section 6A(b)(2)(B)(i) through (v) of the CPSA
and further elaborates on the type of information included under each
category. For example, proposed Sec. 1102.10(d)(1) would explain that
a description of a consumer product must include a word or phrase
sufficient to distinguish a product identified in a report of harm as a
consumer product or a component of a consumer product or some other
word or phrase to show it is a consumer product or a product or
substance regulated by the Commission. This description could include
the name (including the brand name) of the product. Other information,
such as where the product was purchased, price paid, model, serial
number, date of manufacture (if known), date code or retailer is
described as information that would be helpful to the description of a
consumer product.
Proposed Sec. 1102.10(d)(2) would describe that a report of harm
must contain the identity of the manufacturer or private labeler in
order for the report to be published. This section would further
explain that the name of any company information sufficient to
distinguish an entity will satisfy the minimum identification
requirement and that contact information such a mailing address, phone
number, or electronic mail address would satisfy the identification
requirement.
Proposed Sec. 1102.10(d)(3) would explain that a description of
harm should include a narrative that describes the harm or risk of
harm. The proposal would contain a nonexclusive list of examples of the
types of harm that could be included. The proposal would allow for a
description to include a risk of harm where no actual harm occurred.
However, this proposed section would also explain that information
unrelated to bodily harm or a risk of bodily harm, such as information
on cost or quality of a consumer product, will not satisfy the
regulatory requirement for a description of harm. Information such as
the date on which the harm occurred or manifested itself, the severity
of any injury or whether medical treatment was sought is identified as
helpful, but not required, information to include in a description.
Proposed Sec. 1102.10(d)(4), (5), and (6) would describe the
minimum requirements for contact information, verification, and consent
of the report of harm by the submitter. For contact information, the
proposed Sec. 1102.10(c)(4) would require that a submitter of a report
of harm provide his or her first and last name and a mailing address as
required contact information for the report to be published. The
proposed rule would explain that submitters of reports of harm also may
provide other contact information, such as an electronic mail address
or a telephone number, but that such information is not required in
order to publish the report.
Proposed Sec. 1102.10(d)(5) would explain that submitters must
verify the report of harm for publication and the verification
statement follows the statutory outline. Verification would involve a
submitter of a report of harm affirmatively agreeing that he or she has
reviewed the information submitted in a report of harm and then
checking the box for verifying the information the report contains.
This proposed section would also require that as part of verifying the
report, submitters of
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reports of harm must indicate what category they are in (consumer,
government agency, health care professional, etc.)
Proposed Sec. 1102.10(d)(6) would explain that the submitter of a
report of harm must consent to inclusion of the report of harm in the
database in order for the report to be published. If no consent is
provided by the submitter the report will not be published.
Proposed Sec. 1102.10(e) would describe the Commission's ability
to seek other categories of voluntary information. The Commission seeks
comment as to whether additional categories should include demographic
data, such as race, or additional data about the product in question,
such as whether the product still contained all of its original parts,
or had been altered in any way not according to a manufacturer's
instructions.
Proposed Sec. 1102.10(f) would describe the information that will
not be published in the database including the name and contact
information of the submitter of a report of harm; the victim's name and
contact information (if provided), photographs depicting a person or
injury because of privacy concerns or because the Commission has
determined that they are not in the public interest; medical records
without the consent of the person about whom such records pertain (or
that person's parent or guardian if the person is a minor);
confidential information; materially inaccurate information; reports of
harm retracted by submitters who indicate in writing to the Commission
that they supplied materially inaccurate information; and/or any other
material submitted on or with a report of harm that the Commission
determines is not in the public interest to publish. This proposed
section would identify criteria and explain that the public interest
determination will be based on the criteria relating to whether or not
the information helps database users to identify a consumer product;
identify the manufacturer or private labeler of a consumer product;
understand the risk of harm related to the use of a consumer product;
or understand the relationship between the submitter of a report of
harm and the victim. The Commission will examine privacy concerns based
on the Privacy Act of 1974, Public Law 93-579, as amended.
Proposed Sec. 1102.10(g) would state that reports of harm
submitted by persons under the age of 18 must include the consent of
the parent or guardian of that person. The rationale for requiring
consent on reports by a minor is premised on the notion that age of
legal consent in many jurisdictions is 18. Review of a report of harm
by a parent or guardian will also ensure that information about a harm
or risk of harm is being disclosed publicly with the parent's consent
addressing concerns related to the privacy of such information.
Further, if a parent or guardian reviews the report, consent may also
improve the accuracy of the information the report contains.
Proposed Sec. 1102.10(h) would explain that information received
related to a report of harm that is incomplete because it does not meet
the requirements for submission or publication will be maintained for
appropriate Commission use.
Proposed Sec. 1102.10(i) would explain that reports of harm
accepted by the Commission become official records of the Commission in
accordance with 16 CFR 1015.1 and that alteration (or disposition) of
these records can only be undertaken in accordance with the procedures
specified in this Part.
2. Proposed Sec. 1102.12--Manufacturer Comments
Proposed Sec. 1102.12(a) would state that manufacturers or private
labelers who receive a report of harm transmitted from the CPSC may
submit comments. Proposed Sec. 1102.12(b) would propose that comments
may be received via an online manufacturer portal where the
manufacturer can register to submit comments on a secure nonpublic
portal that will be provided through the Commission's database. The
proposal also would specify that comments may be submitted via
electronic mail or regular mail directed to the Commission's Office of
the Secretary.
Proposed Sec. 1102.12(c)(1) through (c)(4) would specify that the
Commission will publish a manufacturer's comments related to a report
of harm if the comment specifically relates to a report of harm,
contains a unique identifier assigned to it, contains the
manufacturer's verification of the truth and accuracy of their comment
(similar to the verification required of a submitter of a report of
harm) as well as their consent for publication in the database. The
proposed rule would require a manufacturer to affirmatively request
that its comment be published and to affirmatively consent to such
publication in order for the manufacturer comment to be published in
the database.
Proposed Sec. 1102.12(d) would explain that the Commission will
publish a manufacturer's comments and the date such comments are
submitted to the CPSC in the database.
Proposed Sec. 1102.12(e) would explain that the Commission will
not publish the actual consents and verifications obtained from the
manufacturer for such publication.
3. Proposed Sec. 1102.14--Recall Notices
Proposed Sec. 1102.14 would state that information in a voluntary
or mandatory recall notice will be made accessible and searchable to
the public in the database.
4. Proposed Sec. 1102.16--Additional Information
Proposed Sec. 1102.16 would describe the criteria to be used to
determine any additional information that will be published in the
database consistent with the requirements of section 6(a) and (b) of
the CPSA.
C. Proposed Subpart C--Procedural Requirements
Proposed subpart C, ``Procedural Requirements,'' would describe the
procedural requirements set forth in section 6A(c) of the CPSA related
to the manufacturer notification and transmission. This proposed
subpart would explain the procedural requirements for CPSC transmission
of reports of harm to an identified manufacturer or private labeler; a
description of the opportunity for comment by the manufacturer or
private labeler identified in reports of harm; how designations of
confidential information should be submitted and the criteria for how
they will be reviewed; how materially inaccurate information should be
designated and what the Commission will consider in reviewing any such
claim both before and after posting a report of harm in the database;
the timing of posting reports of harm in the database; and the timing
and posting of manufacturers' comments in the database.
1. Proposed Sec. 1102.20--Transmission of Reports of Harm to
Identified Manufacturer or Private Labeler
Proposed Sec. 1102.20 would explain what information in a report
of harm will and will not be transmitted to a manufacturer or private
labeler. As set forth in section 6A(b)(2)(B) of the CPSA, the name and
contact information of the submitter will not be transmitted to a
manufacturer or private labeler unless the submitter of a report of
harm consents to transmit this information. The proposed rule also
would prevent transmission of any photographs submitted with the report
of harm unless the submitter specifically consents, and further
explains that medical records will not be provided
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without explicit consent from the person to whom such records pertain,
or his or her parent, guardian or legally authorized representative.
Proposed Sec. 1102.20(b) would describe the limitation on use of
contact information by a manufacturer or private labeler. The proposed
regulatory text would incorporate the limitation in section 6A of the
CPSA on the use of submitter contact information by the manufacturer
for any purpose other than verification of information contained in a
report of harm. The proposed rule would describe activities that will
not be considered as verification including sales, promotion, marketing
or warranty activities or activities relating to a commercial purpose
of the manufacturer. The proposal also would describe what is
considered a verification purpose by relating the statutory criteria
required for a report of harm to be published. For example, proposed
Sec. 1102.20(b)(1) through (b)(4) would explain that verification
could be related to the identity of the requester; the consumer product
including name, serial or model number; the harm or risk of harm
described in the report of harm; and/or a description of the incident
related to the use of the consumer product.
Proposed Sec. 1102.20(c) would explain the timing of transmission
of reports of harm to the manufacturer. The proposal would adopt the
statutory language that the reports will be transmitted to the
manufacturer to the extent practicable within five business days after
the Commission receives a completed report of harm. The proposal would
identify circumstances where transmission of a report of harm to the
manufacturer within five business days may be impracticable. The
circumstances include: where the identified manufacturer or private
labeler is out of business with no identifiable successor; the
submitter misidentified the manufacturer or private labeler; the report
of harm contained inaccurate or insufficient information for
identification of a manufacturer or private labeler or when the
Commission cannot locate valid contact information for a manufacturer
or private labeler.
Proposed Sec. 1102.20(d) would describe a method for transmission
of reports of harm to a manufacturer or private labeler based on
registration by the manufacturer or private labeler in the online
manufacturer portal. The proposal also would explain that where a
manufacturer or private labeler has not registered for electronic
transmission, the Commission will send reports of harm through the
United States mail to a firm's principal place of business, unless the
Commission selects another equally effective method of transmission.
Proposed Sec. 1102.20(e) would describe that the Commission may in
its discretion limit the data size of comments, which may include
attachments submitted, where such comments and attachments may
negatively impact the technological or operational performance of the
system.
Proposed Sec. 1102.20(f) would describe the process of
manufacturer registration and explains that registrants can select a
preferred method for receiving reports of harm in the database. The
proposal would require that a manufacturer or private labeler provide
updated contact information and allows the registrant to select a
specific method to receive reports of harm.
Proposed Sec. 1102.20(g) would address manufacturer comments
received after one year and would explain that a manufacturer or
private labeler may comment on information received about a report of
harm. The proposal would allow the Commission, in its discretion not to
publish a manufacturer comment to the database that is received more
than one year after transmission of the report of harm to the
manufacturer or private labeler where it would not be in the public
interest to do so. The proposal also would allow the Commission to
limit the data size of comments, which may include attachments
submitted where such comments and attachments may negatively impact the
technological or operational performance of the system.
2. Proposed Sec. 1102.24--Designation of Confidential Information
Proposed Sec. 1102.24 would explain how the Commission will define
``confidential information'' and would set forth criteria which must be
followed to assert a claim of confidentiality. The Commission notes
that most reports of harm received from consumers will not likely
contain confidential information. However, where such a claim for a
portion of information on a report of harm is asserted, the proposal
would require affirmative statements that would assist the Commission
in an evaluation of the merits of the request.
Proposed Sec. 1102.24(a) would interpret the terms ``confidential
information'' in a manner similar to that in section 6(a) of the CPSA.
The proposal would establish parameters for asserting and supporting a
claim of a portion of a report of harm as confidential; these
parameters follow closely the Commission's current practice and
procedure for such assertions in a FOIA context.
Proposed Sec. 1102.24(b) would explain that a manufacturer may
designate portions of information contained in a report of harm as
confidential and would describe, at paragraphs (b)(1) through (b)(6),
the statements required to support the claim of confidential
information. If these statements are missing from any request, the
Commission will consider the request to be incomplete and unsupported.
For example, proposed Sec. 1102.24(b)(1) would explain that a
manufacturer or private labeler is required to specifically designate
those portions of the report of harm asserted to be confidential.
Proposed Sec. 1102.24(b)(2) would require information on whether the
asserted confidential portion of a report has ever been released to any
person who was not an employee or in a confidential relationship with
the manufacturer or private labeler.
Proposed Sec. 1102.24(b)(3) would require an explanation on
whether the asserted confidential portion of the report is commonly
known or readily ascertainable by outside persons with a minimum of
time and effort. Proposed Sec. 1102.24(b)(4) would require the
manufacturer to explain the relationship, if any, between the submitter
of the report of harm and the manufacturer or private labeler and how
the submitter could have come into possession of such confidential
information. Proposed Sec. 1102.24(b)(5) would explain that the
manufacturer also must support a confidentiality claim by describing
how release of the information could cause competitive harm. Any
portion of information in a report of harm designated by a manufacturer
to be confidential but lacking the statements and information in
section Sec. 1101.24 (b)(1) through (b)(6) will not be considered
confidential. Section 1101.24(b) also notes that the requester of a
designation of confidential information bears the burden of proof
regarding such a request.
Proposed Sec. 1102.24(c) would describe the manner of submission
where confidentiality is asserted for a designated portion of a report
of harm. This proposal would allow submission of confidentiality
assertions in the same manner as manufacturer comments described in
proposed Sec. 1102.12(b) and would require the requests to be
conspicuously labeled.
Proposed Sec. 1102.24(d) would explain that a request for
confidential treatment be made at any time after CPSC transmission to
the manufacturer of a report of harm.
[[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