Publicly Available Consumer Product Safety Information Database, 76832-76872 [2010-30491]
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Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Rules and Regulations
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1102
Publicly Available Consumer Product
Safety Information Database
Consumer Product Safety
Commission.
ACTION: Final rule.
AGENCY:
The Consumer Product Safety
Commission (‘‘Commission,’’ ‘‘CPSC,’’ or
‘‘we’’) is issuing a final rule 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 final rule interprets
various statutory requirements
pertaining to the information to be
included in the Database and also
establishes 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: Effective Date: This rule is
effective January 10, 2011.
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:
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SUMMARY:
I. Background
Section 212 of 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
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available database. On May 24, 2010, we
published a notice of proposed
rulemaking at 75 FR 29156, which set
forth the Commission’s proposed
interpretation and implementation of
the Database provisions of section 6A of
the CPSA. The comment period on the
proposed rule ended on July 23, 2010.
After reviewing and considering
significant issues raised by the
comments, the Commission is now
promulgating a final rule on 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.
Such incident reports describe safetyrelated incidents involving 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. In addition,
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 via forms reporting on productrelated injuries or incidents.
To date, the data that the Commission
collects and maintains on product safety
have 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 them with 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
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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 section 6 notice
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.
Section 6A of the CPSA creates a new
disclosure requirement with respect to
product safety-related incident reports,
referred to as ‘‘reports of harm’’ in both
the statute and the proposed rule.
Specifically, section 6A of the CPSA
excludes any incident report submitted
for inclusion in the Database from the
notice requirements of section 6(a) and
(b) of the CPSA. Instead, section 6A of
the CPSA sets up a new framework for
collecting reports of harm, transmitting
them to the manufacturer and private
labeler for comment, and then posting
them on a Database that is accessible on
the Commission’s Web site.
The notice of proposed rulemaking
provided the public with an opportunity
to understand how the Commission is
intending to implement the new
procedures in section 6A of the CPSA,
and to provide comment. Prior to
issuing a notice of proposed rulemaking,
however, the Commission provided
stakeholders with information about
Database implementation, as well as
offered several opportunities for
stakeholder input and comment, all of
which were discussed in the preamble
to the proposed rule at 75 FR 29156–57.
Prior Commission activities related to
the Database include: Providing a
detailed implementation plan to
Congress; holding a public hearing on
Database implementation; holding a
public workshop, which sought
comments on Database implementation;
attending and speaking about the
Database at various conferences; and
creating the https://
www.saferproducts.gov Web site, where
updates on implementation of the
Database are provided. Information on
all of these Commission activities and
public comments are available on the
CPSC Web site at https://www.cpsc.gov/
about/cpsia/sect212.html.
We received 37 comments on the
proposed rule. After reviewing the
comments, the Commission made
several changes to the final rule, all of
which are discussed in detail in section
III below.
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Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Rules and Regulations
II. Statutory Authority
The Commission is issuing this 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 Final Rule,
Comments on the Proposed Rule, and
the Commission’s Responses
The final rule establishes a new 16
CFR part 1102, ‘‘Publicly Available
Consumer Product Safety Information
Database.’’ The new part consists of four
subparts:
Subpart A—Background and
Definitions;
Subpart B—Content Requirements;
Subpart C—Procedural Requirements;
Subpart D—Notice and Disclosure
Requirements.
Below, we describe and explain each
subpart and section of the final rule, as
well as describe and respond to
significant issues raised by the
comments on the proposed rule (75 FR
29156, May 24, 2010) pertaining to each
section. In addition to comments on
each of the subparts of the final rule, we
have added a section ‘‘E’’ below to
address Database implementation
comments that are not directly related to
a section of the proposed rule. To make
it easier to identify comments and the
Commission’s responses, the word
‘‘Comment’’ will appear in italics before
each comment description, and the
word ‘‘Response’’ will appear in italics
before the Commission’s response. We
have grouped comments based on the
section of the proposed rule to which
they pertain and their similarity, and we
have numbered the comments to help
distinguish between different comment
themes. The number assigned to each
comment summary is for organizational
purposes only and does not signify the
comment’s value, importance, or order
in which it was received.
A. Proposed Subpart A—Background
and Definitions
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1. Proposed § 1102.2—Purpose
Proposed § 1102.2 would describe the
purpose for a new 16 CFR part 1102
titled ‘‘Publicly Available Consumer
Product Safety Information Database,’’
which is to set forth the Commission’s
interpretation, policy, and procedures to
establish and maintain such Database.
We have finalized this section and
made one clarification, which is to add
the words ‘‘Publicly Available’’ to the
full name of the Database.
2. Proposed § 1102.4—Scope
Proposed § 1102.4 would describe the
scope of the rule to include the content,
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procedure, notice, and disclosure
requirements for all information
published in the Database.
We received one comment related to
this section. The section has been
finalized with one correction, which is
to add the words ‘‘Publicly Available’’ to
the full name of the Database.
Comment 1—One commenter states
that incident reports involving over-thecounter drugs and dietary supplements
should not be included in the Database
because food and drugs are regulated
and monitored by the U.S. Food and
Drug Administration (‘‘FDA’’). The
commenter notes that the Commission
has regulatory authority only over
product packaging, and asserts that
consumers will inadvertently submit
drug or supplement safety information
to the Commission rather than to the
manufacturer or the FDA. If the
Commission includes complaints
regarding product packaging in the
Database, the commenter states that the
Commission should not only instruct
consumers that only product packaging
complaints can be reported in the
Database, but should also regularly
monitor the Database to ensure that
complaints involve only products over
which the Commission has jurisdiction.
Response—Section 1102.10(d)(1) of
the final rule states that to be included
in the Database, a report of harm 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 report of harm that
does not identify a product or substance
over which the Commission has
jurisdiction will not be included in the
Database. Every report of harm will be
reviewed to ensure that the minimum
requirements for publication are met
before being published in the Database.
Also, as with our current online
incident report form, the Database will
describe the products that are not
within the Commission’s jurisdiction,
including food and drugs. This
information will include links to the
appropriate government agencies that
do have jurisdiction. We have no
intention of including reports of harm
solely involving products or substances
not within our jurisdiction, but will
include all products and substances that
do fall within our jurisdiction,
including complaints about drug
product packaging.
3. Proposed § 1102.6—Definitions
Proposed § 1102.6 would define
certain terms related to the
establishment and maintenance of the
Database.
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a. Proposed § 1102.6(a)—Terms Defined
in § 3 of the CPSA Apply to the
Database Rule
Proposed § 1102.6(a) would explain
that, except as provided in proposed
§ 1102.6(b), the definitions set forth in
section 3 of the CPSA apply to the
Database rule. 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.
One comment was received related to
this section, which we have finalized
without change.
Comment 2—One commenter states
that the term ‘‘private labeler’’ should be
defined in § 1102.6 of the final rule.
Response—Section 3(a)(12) of the
CPSA defines ‘‘private labeler’’ as ‘‘an
owner of a brand or trademark on the
label of a consumer product which bears
a private label.’’ Because the CPSA
defines ‘‘private labeler,’’ there is no
need to include such a definition in the
final rule.
b. Proposed § 1102.6(b)—Terms Defined
Relevant to § 1102
Proposed § 1102.6(b) would define
certain terms or, in some cases, interpret
terms already defined in section 3 of the
CPSA.
Proposed § 1102.6(b)(1) would define
‘‘additional information’’ as any
information that the Commission
determines is in the public interest to
include in the Consumer Product Safety
Information Database.
No comments were received related to
this definition, and we have finalized it
with one change, which is to add
‘‘Publicly Available’’ to the full name of
the Database.
Proposed § 1102.6(b)(2) would define
‘‘Commission’’ or ‘‘CPSC’’ as meaning the
Consumer Product Safety Commission.
No comments were received related to
this definition, and we have finalized it
without change.
Proposed § 1102.6(b)(3) would define
‘‘consumer product’’ as having the same
meaning as defined in section 3(a)(5) of
the CPSA, but would further explain
that ‘‘consumer product’’ includes any
other products or substances regulated
by the Commission. 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.
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No comments were received related to
this definition, and, for clarity, we have
added ‘‘under any other act it
administers’’ to the end of the definition.
Proposed § 1102.6(b)(4) would define
‘‘Consumer Product Safety Information
Database,’’ which is also referred to as
the ‘‘Database,’’ as the database on the
safety of consumer products required to
be established and maintained by the
Commission as described in section 6A
of the CPSA.
No comments were received related to
this definition. However, on our own
initiative, we did incorporate the
shortened name of ‘‘Database’’ in the
final rule and added the words ‘‘Publicly
Available’’ to the full name of the
Database.
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. This
definition is taken from section 6A(g) of
the CPSA, which states that ‘‘[i]n this
section, the term ‘harm’ means (1)
injury, illness, or death; or (2) risk of
injury, illness, or death, as determined
by the Commission.’’
We received several comments related
to this definition which did not lead us
to make any changes. However, we are
changing this definition to be consistent
with the statutory language.
Comment 3—Some commenters
would remove from the definition of a
report of harm the terms ‘‘or any risk of
injury, illness, or death as determined
by the Commission, relating to the use
of a consumer product.’’ The
commenters argued that such a
determination requires an arbitrary
assessment that would require
Commission resources to determine
whether the report of harm represents a
legitimate risk. According to these
commenters, reports of harm addressing
risks should come from the Commission
in recall notices only, not from the
general public.
Response—Section 6A(g) of the CPSA
defines ‘‘harm,’’ as used in this section
of the statute, as ‘‘(1) injury, illness, or
death; or (2) risk of injury, illness, or
death, as determined by the
Commission.’’ Because the definition of
‘‘harm’’ is dictated by Congress in the
statute, and Congress has plainly
expressed its intent in the statute that
the Database include reports of harm
involving risks of harm, we will not
remove this phrase from the definition
of a report of harm. Moreover, the
Database is meant to help us in our
mission to protect the public against
unreasonable risks of injury associated
with the use of consumer products. Use
of agency resources to assess risks is
essential to our mission. While
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submitters must describe an illness,
injury, or death, or risk of illness, injury,
or death on the incident report form,
each report of harm will be reviewed
before publication to ensure that it
meets the minimum requirements for
publication set forth in § 1102.10(d).
Comment 4—Some commenters
propose that ‘‘any risk of injury’’ be
defined narrowly to account for the
level of risk or the potential for injury
to exclude reports of harm that ‘‘have
near zero risk of causing injury.’’ These
commenters would strike the term ‘‘any’’
and replace it with a phrase such as
‘‘substantial risk of serious injury,’’
which they state has historically been
used by the Commission.
Response—We disagree with the
commenters because they would have
us interpret the statute in an
unnecessarily narrow manner. However,
we have stricken the word ‘‘any’’ and
changed the comma to a semicolon after
the first occurrence of the word ‘‘death’’
to make the definition consistent with
the statutory language. Section 3(a)(14)
of the CPSA already defines ‘‘risk of
injury’’ as ‘‘a risk of death, personal
injury, or serious or frequent illness.’’
We also decline to use the phrase
‘‘substantial risk of serious injury’’ to
qualify the types of harm or risk of harm
that may be placed into the Database.
Such phrase is used once in 16 CFR
1115.13(c) to describe a firm’s initial
obligation to report hazards under
section 15(b) of the CPSA. It applies to
manufacturers, importers, retailers, and
distributors who have received
information that reasonably supports
the conclusion that one of the factors in
section 15(b) of the CPSA has been met.
The phrase has no relevance to the types
of information included in a report of
harm.
Comment 5—One commenter states
that the Commission should establish
criteria for making determinations about
risks of harm, arguing that speculative
assertions or unsubstantiated opinions
that a consumer could have been
injured, without any supporting factual
information indicating a nexus between
the product or incident and a
discernable and credible risk of injury,
cannot provide the CPSC with the
necessary basis for making the required
determination to include these reports
in the Database.
Response—The Commission has
many years of experience categorizing
harm or hazards and their risks related
to the use of a consumer product based
on a reported incident scenario. We will
continue to rely on our expertise to
review reports of harm submitted for
inclusion in the Database and will
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determine whether the minimum
requirements for publication are met.
Comment 6—One commenter states
that the proposed rule does not
delineate how the Commission will
determine ‘‘harm’’ or ‘‘report of harm,’’
and it does not define ‘‘risk.’’
Response—Section 6A(g) of the CPSA
defines ‘‘harm,’’ and we will adhere to
this definition. We have maintained a
database on injuries and risks of injury
associated with the use of consumer
products for many years, and will use
our experience in reviewing reports of
harm to ensure that the minimum
requirements for inclusion in the
Database are met. ‘‘Risk,’’ by itself, is not
defined in the proposed rule or in the
CPSA, but section 3(a)(14) of the CPSA
defines ‘‘risk of injury’’ as ‘‘a risk of
death, personal injury, or serious or
frequent illness.’’
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.
No comments were received related to
this definition, and we have finalized it
with one grammatical change.
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
transmitted by the CPSC to the
manufacturer or private labeler.
No comments were received related to
this definition, and we have finalized it
without change.
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 any
injury, illness, or death, or any risk of
injury, illness, or death as determined
by the Commission relating to the use of
the consumer product.
We received comments regarding the
definition of ‘‘harm’’ used in the
proposed rule. As noted above in
response to Comments 3 through 6, we
are making minor modifications to the
definition of ‘‘harm’’ as contained in
section 6A(g) of the CPSA. Thus, we
have finalized the definition of ‘‘report
of harm’’ with one grammatical change,
changing ‘‘an injury’’ to ‘‘any injury.’’ We
also changed the comma to a semicolon
after the first occurrence of the word
‘‘death’’ and inserted a comma after the
second occurrence of the word ‘‘death’’
to ensure that the definition in the final
rule is more consistent with the
definition of ‘‘harm’’ in the statute.
Proposed § 1102.6(b)(9) would define
‘‘submitter of a report of harm’’ as any
person or entity that submits a report of
harm.
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No comments were received related to
this definition, and we have finalized it
without change.
Section 1102.6(b)(10) of the proposed
rule would define ‘‘voluntary recall
notice’’ to mean 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.
No comments were received related to
this definition, and we have finalized it
without change.
Comment 7—One commenter objects
to use of the term ‘‘victim’’ in the
proposed rule. The commenter states
that the use of such a term implies a
criminal or civil wrong, and suggests
use of the word ‘‘consumer’’ as a more
neutral term.
Response—We will not remove the
term ‘‘victim’’ in the final rule, but agree
that the term may be confusing to some
without further clarification. We have
used the term ‘‘victim’’ for many years to
describe persons actually suffering a
harm or risk of harm related to the use
of a consumer product as compared to
others who simply may have purchased
or observed the product being used. The
term ‘‘victim’’ is used on the current
incident reporting form to collect
information about the individual who
was injured or exposed to a possible
product related hazard. In the context of
that form, the use of the term ‘‘victim’’
does not imply a criminal or a civil
wrong. Thus, for purposes of this rule,
‘‘victim’’ continues to refer to any
individual exposed to harm or risk of
harm related to a possible product
related hazard, and the term does not
imply that the product caused an
incident.
B. Proposed Subpart B—Content
Requirements
1. Proposed § 1102.10—Reports of Harm
Proposed § 1102.10 would explain the
requirements for reports of harm to be
included in the Database.
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a. Proposed § 1102.10(a)—Who May
Submit
Proposed § 1102.10(a) would identify
the category of submitters specified in
section 6A(b)(1)(A) of the CPSA and
further clarify the persons who may fall
within each of the identified groups.
The list of persons under each category
is not exclusive, and the proposed lists
are intended to provide a greater
understanding of the type of person or
entity that could fall within each
category of submitter.
Proposed § 1102.10(a)(1) would state
that the term ‘‘consumers’’ includes not
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only users of consumer products, but
also family members, relatives, parents,
guardians, friends, and observers of a
consumer product being used.
We received one comment related to
this section, and other comments
relating to the definitions under
proposed § 1102.10(a) resulting in a
revision to the definition of ‘‘consumers’’
as described in response to Comment 8
through 17.
Comment 8—Several commenters
state that the interpretation of
‘‘consumer’’ should not be so broad as to
include those persons who were not
injured by the product or who are not
reliable reporters of the incident, such
as those persons lacking firsthand
knowledge of the product, its
manufacturer, or the injury. The
commenters also state that the proposed
interpretation of ‘‘consumer’’ expands
the potential for inaccurate information
in the Database and goes beyond a
reasonable interpretation of the term.
Some commenters note, however, that
information from these sources could be
collected for the Commission’s use, but
should not be included in the Database.
Response—The plain statutory
language does not require a submitter of
a report of harm to have ‘‘firsthand
knowledge.’’ We have chosen an
interpretation of ‘‘consumer’’ that
comports with our experience in
maintaining a database of consumer
product incident reports. Historically,
we have received reports of harm from
any and all consumers in order to
protect individuals who may use or
enjoy consumer goods. Currently,
parents, guardians, and family members
are a major and important source of
information collected for the most
vulnerable segments of the population.
In the most basic example, if the user of
a consumer product is killed or
seriously injured in the incident, or is
an infant, he or she will be unable to
enter the incident report. Parents, for
example, may enter information related
to consumer products used by their
children, regardless of whether they
personally witnessed the incident or
purchased the product. Other
consumers may possess important
product safety information and, as a
practical matter, the Commission does
not have the resources to ascertain
whether every submitter of a report of
harm has firsthand knowledge or
actually used the product. Therefore,
following our current practice of
receiving reports of harm from any and
all consumers serves the purpose and
intent of the Database and of our
primary statutory mission, which is to
protect consumers from unsafe
products. Furthermore, a manufacturer
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is free to post a comment indicating
whether they know if the submitter had
firsthand knowledge or not. For these
reasons, we disagree that inclusion of
inaccurate information will necessarily
result from our definition of
‘‘consumer.’’ Moreover, everyone who
submits reports of harm to the Database
is legally obligated to provide truthful
and accurate information as evidenced
by their verification that they have done
so.
We also note that reports of harm
received from individuals in some of the
other statutory categories, such as other
government agencies, health care
professionals, and public safety entities,
will likely lack firsthand knowledge
about an incident. For example, a
physician who treats an individual who
was injured by a consumer product is
unlikely to have witnessed how or when
the injury occurred, but the statute
permits the physician to submit a report
of harm. If we find that false and
fraudulent reports are being submitted
for inclusion in the Database, we will
consider what legal actions to take to
address the problem and proceed
accordingly.
Proposed § 1102.10(a)(2) would state
that the definition of ‘‘local, state, or
federal government agencies’’ includes,
but is 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.
No comments were received on this
provision, and we have finalized it with
only typographical changes.
Proposed § 1102.10(a)(3) would state
that the definition of ‘‘health care
professionals’’ includes, but is not
limited to, medical examiners, coroners,
physicians, nurses, physician’s
assistants, hospitals, chiropractors, and
acupuncturists.
No comments were received on this
provision, and we have finalized it with
one grammatical change.
Proposed § 1102.10(a)(4) would state
that the definition of ‘‘child service
providers’’ includes, but is not limited
to, day care centers, day care providers,
pre-kindergarten school, and child care
providers.
No comments were received on this
provision, and we have finalized it with
minor modifications changing ‘‘day
care’’ to ‘‘child care.’’
Proposed § 1102.10(a)(5) would state
that the definition of ‘‘public safety
entities’’ includes, but is not limited to,
police, fire, ambulance, emergency
medical services, federal, state, and
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local law enforcement entities, and
other public safety officials.
No comments were received on this
provision, and we have finalized it with
one change for clarity. In response to
comments relating to the definitions
under proposed § 1102.10(a)(6), we
added ‘‘and professionals, including
consumer advocates and individuals
who work for nongovernmental
organizations, consumer advocates,
consumer advocacy organizations, and
trade associations so long as they have
a public safety purpose’’ to the end of
the definition.
Proposed § 1102.10(a)(6) would add
‘‘Others’’ to the list of submitters. The
‘‘Others’’ category is intended to include
those persons who may not fit clearly
within an identified category, but who
may otherwise file a report as a
‘‘consumer.’’ The ‘‘Others’’ category
would include, but is not limited to,
attorneys, professional engineers,
investigators, nongovernmental
organizations, consumer advocates,
consumer advocacy organizations, and
trade associations.
We received several comments on
proposed § 1102.10(a)(6). Many
commenters misinterpreted the proposal
as an expansion of the list of people
who can submit reports. This was not
the intention. The proposal states, the
five statutory categories of submitters
are quite broad and, given that breadth,
we had concluded that the list was
intended to be nonrestrictive. See 75 FR
at 29162. Currently, persons listed as
examples under ‘‘Others’’ file reports of
harm with us using our online incident
reporting form by self-reporting as
‘‘consumers.’’ However, anyone can be
classified as a consumer even if they are
also acting as a doctor, lawyer,
investigator, consumer advocate, or
trade complainant. Moreover, many
individuals who report to us work for
organizations with a public health and
safety purpose and, thus may be
included under the category ‘‘public
safety entity.’’ Since most if not all of the
people listed in the ‘‘Others’’ category
can fit in the categories Congress listed,
we have deleted reference to ‘‘Others’’ in
response to the comments.
Comment 9—Some commenters state
that adding ‘‘Others’’ is contrary to the
plain meaning of the statute. The
commenters argue that section
6A(b)(1)(A) of the CPSA expressly limits
who may submit reports, so the
Commission is acting outside its
authority by adding an ‘‘Others’’
category.
Response—Congress listed five broad
categories of submitters and we have the
authority to interpret these categories.
As discussed above, the term
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‘‘consumer’’ is quite broad, and we have
consistently interpreted it in this
rulemaking to include any and all
consumers. This interpretation
comports with our mission to protect
individuals who may use or enjoy
consumer products. Most of the persons
and entities captured in the ‘‘Others’’
category are covered by the five broad
categories of submitter listed in the
statute. We have decided to delete the
reference to ‘‘Others.’’
Comment 10—Some commenters
argue that section 6A(b)(2)(B) of the
CPSA, which establishes the minimum
requirements for reports of harm to be
included in the Database, uses the
phrase ‘‘at a minimum’’ to set a floor to
which the Commission may add
requirements. Because this ‘‘at a
minimum’’ language is missing from
section 6A(b)(1)(A) of the CPSA, the
commenters claim that we cannot add
‘‘Others’’ as a category of submitters.
Response—The five categories of
submitters set forth in section
6A(b)(1)(A) of the CPSA are so broad
that they include most submitters,
eliminating the need to state that these
categories are ‘‘at a minimum.’’
Nevertheless, the category of ‘‘Others’’
will be deleted.
Comment 11—Some commenters state
that adding an ‘‘Others’’ category
contradicts existing regulations that
require incident reports to be verified by
those with personal or firsthand
knowledge. The commenters argue that
including reports from those without
such knowledge would reduce the
Database to a blog consisting of hearsay
reports from people without personal
knowledge who have a vested interest in
increasing the number and severity of
negative reports. The commenters state
that there is no indication that Congress
intended to override the Commission’s
long-standing requirements for
verification of information it intends to
make public.
Response—Congress provided a clear
indication that the requirement in
section 6(b) to take reasonable steps to
assure accuracy does not apply to
reports of harm included in the
Database. Section 6A(f)(1) of the CPSA
specifically provides that the provisions
of sections 6(a) and (b) of the CPSA do
not apply to reports of harm. Instead,
verification is required for reports of
harm as described in section 6A(b)(B)(v)
of the CPSA, where a person submitting
a report must verify that it is ‘‘true and
accurate to the best of the person’s
knowledge.’’ This requirement is set
forth in § 1102.10(d)(7) of the final rule.
Moreover, Congress intended for the
Database to include reports by those
without ‘‘firsthand knowledge’’ or
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‘‘personal knowledge,’’ as the statute
expressly allows reports of harm to be
submitted by those unlikely to have
personal knowledge, such as other
government agencies and public safety
entities. However, Congress
implemented three mechanisms to help
control inaccuracies: The ability of the
manufacturer to comment as set forth in
section 6A(c)(2)(A) of the CPSA; the
ability to remove material inaccuracies
as set forth in section 6A(c)(4) of the
CPSA; and the disclaimer requirement
provided in section 6A(b)(5) of the
CPSA.
Comment 12—Some commenters state
that, other than consumers, the other
categories of submitters listed in
sections 6A(b)(1)(A)(2) through
(b)(1)(A)(5) of the CPSA have various
legal obligations to accurately and
objectively record and report safety
incidents, injuries, and suspected child
abuse as part of their professional
responsibilities. The commenters claim
that adding an ‘‘Others’’ category will
increase inaccurate reports of harm
being entered into the Database and will
also increase the possibility of
duplicative reports being entered about
the same incident.
Response—Everyone who reports
information to the Database, whether a
consumer, governmental entity, health
care professional, child care provider or
public safety entity, has a legal
obligation to provide accurate
information and will be required to
verify that they have done so. For
example, attorneys are subject to
numerous ethical obligations and are
likely to have a legal obligation to
submit a report of harm if the client
directs them to do so. As another
example, 18 U.S.C. 1001 makes the
knowing and willful submission of a
materially false, fictitious or fraudulent
report to a government agency criminal.
In our experience, the category of
submitter is more indicative of the type
of detail that can be provided about an
incident, rather than the quality or
veracity of the data entered. Moreover,
nothing in section 6A of the CPSA
dictates that the individual who enters
reports of harm be someone who
purchased or used a product or who has
a legal responsibility to report safety
incidents to another government agency.
Such a limitation would not serve the
purpose of the Database. For these
reasons and because the categories of
‘‘consumer’’ and ‘‘public safety entity’’
include most of the persons and entities
listed in the proposed rule as reporting
under the ‘‘Others’’ category, the
commenters’ concerns are unpersuasive.
With regard to duplicative reports, we
note that the statutory list of submitters
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allows for the submission of multiple
reports of harm about the same incident
because a consumer can submit a report
as well as their health professional. In
the Joint Explanatory Statement of the
Committee of Conference on the CPSIA,
the Conferees recognized the value of
possible multiple reports regarding the
same incident because they ‘‘could
provide different relevant details and
that information from those reports
could be helpful to the public.’’ The
Database system software is designed to
look for potential duplicates and
multiple reports and to display them to
staff. Commission staff will review
potential duplicate and multiple reports
and ‘‘associate’’ them, where
appropriate, so that all reports on one
incident will be reflected. As explained
more fully below under § 1102.10(d), we
are adding one more required field:
‘‘Incident date’’ so that Database users
are provided a date, or approximate
date, of the incident. We are also
clarifying the field, ‘‘Category of
submitter,’’ by separating it from the
verification requirement and displaying
it in the Database as another required
field so that Database users can see the
category of submitter of the report of
harm. We already had required this field
in the NPR, but now we are separating
it from the required verification. Such
information should make the
perspective of the submitter transparent
and assist the agency in locating
duplicate reports.
Comment 13—Some commenters state
that adding an ‘‘Others’’ category of
submitter is unreasonable and contrary
to sound public policy. The commenters
claim that the Database’s purpose is to
advance public safety by better
informing consumers of potential
product hazards, and that Congress
selected reporters who contribute to this
purpose—‘‘those who use or observe the
use of the consumer product (and thus
the resulting harm or risk of harm) and
those who may be involved in treating
or responding to the harm.’’ Congress
chose to exclude those persons who
may be commercially or financially
motivated to submit reports of harm.
Response—Having decided that the
five statutory categories of submitters
include most of those individuals who
had previously been included in the
‘‘Others’’ category, these persons shall be
permitted to submit reports to the
Database. The purpose of the Database
is to provide timely access to safetyrelated consumer product incidents.
The timeliness of the data release is a
crucial aspect of the Database. Congress
has expressed a public policy favoring
prompt disclosure of these incidents in
the interest of public safety. Indeed,
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Congress would not have us refuse to
publish reports of harm involving
deaths and serious injuries simply
because the report was submitted by the
consumer’s counsel or the consumer’s
survivors. Accordingly, our evaluation
of what is ‘‘unreasonable and contrary to
sound public policy’’ differs from the
commenters’ evaluation. Our goal is to
provide the public with timely product
safety information, which would not be
served by excluding valid reports of
harm based on criteria that have little or
nothing to do with the quality or
validity of a report.
Nothing in the statute states that
product safety information can come
only from those who ‘‘use or observe the
use’’ of the consumer product, and/or
those who may be involved ‘‘in treating
or responding’’ to the harm. Creating an
artificial limitation that is not present in
the statute would conflict with our
experience in maintaining a database on
the safety of consumer products. As
explained above, not all submitters will
personally use the consumer product or
view the incident; however, that does
not make their report invalid (i.e.,
parents of minor children, relatives of
victims who died or were seriously
injured as a result of the incident,
friends and family of elderly or disabled
persons, and attorneys whose clients
were killed or seriously injured may
also submit reports). Persons included
in the ‘‘Others’’ category may not have
viewed the incident, but still may have
a distinct, educated, and valuable
understanding of the facts, either
learned from the victim, or derived from
investigation and analysis. Moreover, as
a practical matter, the Commission
cannot research every submission to the
Database to determine who submitted it,
whether they used or observed the use
of the product, or whether they have
some other bias or financial interest.
The fact that a submitter may have a
professional interest in the report does
not negate the truth of the report. If the
Commission determines that a report is
false, it will be removed or corrected. If
the Commission determines that false
incident reports are being filed, we will
consider what legal actions to take to
address the problem and proceed
accordingly.
Comment 14—Some commenters say
that limiting submitters to the five
statutorily enumerated categories is
supported by the legislative history of
section 6A of the CPSA. The
commenters state that the House and
Senate versions of the bill were different
regarding who could submit reports of
harm. The Senate version originally
permitted ‘‘other nongovernmental
sources’’ to submit reports of harm for
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inclusion in the Database, but this
version was not incorporated into the
final bill. Thus, the commenters suggest
that the removal of this provision
indicates the intent to exclude ‘‘Others’’
from submitting reports of harm.
Response—We have previously noted
the breadth of the entities listed in the
statute that can file a report of harm and
our conclusion that the list is intended
to be nonrestrictive. 75 FR at 29162. The
original Senate version of the bill also
stated that health care professionals
include ‘‘physicians, hospitals, and
coroners’’ and that public safety entities
include ‘‘police and fire fighters.’’ All of
these entities were removed in the final
legislation. Nevertheless, we are
unwilling to interpret section 6A of the
CPSA as prohibiting physicians,
hospitals, coroners, police, and fire
fighters from submitting reports of
harm. Having decided to remove the
‘‘Others’’ category, we conclude this
comment is now moot.
Comment 15—Some commenters state
that if the Commission intends to use
section 6A(b)(3) of the CPSA [pertaining
to additional information] to add reports
of harm from ‘‘Others’’ to the Database,
then the Commission must find that
inclusion of those reports of harm are
‘‘in the public interest,’’ and that the
reports must also meet the requirements
of sections 6(a) and (b) of the CPSA.
Adding an ‘‘Others’’ category under
section 6A(b)(1)(A) of the CPSA, the
commenters allege, improperly evades
the requirements for including
additional information under section
6A(b)(3) of the CPSA, and makes that
section superfluous.
Response—We interpret section
6A(b)(3) of the CPSA to mean that, in
addition to the information required to
be in the Database, including reports of
harm, manufacturer comments, and
recall notices, any additional categories
of information must be in the public
interest and subject to sections 6(a) and
(b) of the CPSA. This interpretation is
set forth in § 1102.16, which includes
other categories of information in the
Database other than reports of harm,
manufacturer comments, and recall
notices. Our interpretation is that
additional information does not refer to
reports of harm because all reports of
harm meeting the minimum
requirements for publication already are
included in the Database. Additional
categories of information could include,
for example, internal CPSC reports, such
as in-depth investigations, and product
safety assessments.
Comment 16—Some commenters state
that if the Commission includes reports
of harm in the Database submitted by
those in the proposed ‘‘Others’’ category,
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then the increase in such submissions
will ‘‘significantly increase the costs and
burdens on both the Commission and
manufacturers and distributors of
consumer products to review, verify,
and respond to the filings.’’
Response—This comment is
speculative and contrary to our research
and experience. We review every report
of harm and send the reports to
manufacturers for comment under
section 6(c) of the CPSA. Thus, even if
we could choose to exclude reports of
harm from ‘‘Others’’ in the Database, we
would still collect this information for
our use, and would still send it to
manufacturers under section 6(c) of the
CPSA. Accordingly, we do not believe
that the submission of reports of harm
by ‘‘Others’’ would have significantly
increased costs or burdens, and we will
receive such reports from most of those
submitters under one of the five
enumerated categories in the statute.
Comment 17—Several commenters
state that while reports of harm from
those in an ‘‘Others’’ category may not be
placed in the Database, the Commission
may collect and use such reports for
other hazard analysis purposes.
Response—As explained above, we
believe that reports of harm submitted
by most of those included in the
‘‘Others’’ category should be included in
the Database under the five categories
enumerated by the statute. We do not
have the authority to exclude valid
reports of harm from the Database. No
valid public health and safety reason
exists to exclude data that meet the
minimum requirements for inclusion in
the Database. Such an action would be
contrary to the purpose and intent of the
Database. We are focusing on the quality
of the data submitted, as opposed to
who submitted the report. Preserving
reports of harm submitted by consumers
in the ‘‘Others’’ category strictly for
Commission use would not serve the
purpose of timely providing the public
with access to product safety
information.
b. Proposed § 1102.10(b)—Manner of
Submission
Proposed § 1102.10(b) would describe
how a report of harm can be submitted
for inclusion in the Database. Section
6A(b)(2)(A) of the CPSA requires that
the Commission establish electronic,
telephonic, and paper-based means for
submitting a report of harm for
inclusion in the Database. Accordingly,
proposed § 1102.10(b) would describe
four methods (Internet, telephone,
electronic mail, and paper) for
submitting reports. Proposed
§ 1102.10(b)(1) also would explain that
submitters using the Internet will use an
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electronic form specifically developed
to collect the report of harm in the
Database. Proposed § 1102.10(b)(2)
would further explain how submissions
over the telephone will be accepted.
Proposed § 1102.10(b)(3) and (b)(4)
would explain how the Commission
will deal with email, facsimile, and
written submissions. Proposed
§ 1102.10(b)(5) would give the
Commission the flexibility to provide
other means of submission if new means
become available.
The proposed rule left open for the
final rule the office names and contact
information to use for email, facsimile,
and paper submissions of reports of
harm. Accordingly, § 1102.10(b) has
been finalized with several additions.
First, we included the appropriate office
names and contact information in
§ 1102.10(b)(3) and (b)(4). Second, we
made a grammatical correction to use
the short name for the Database adopted
in § 1102.6(b)(4).
c. Proposed § 1102.10(c)—Size Limits of
Reports of Harm
Proposed § 1102.10(c) would impose
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.
No comments were received on this
section, which we have finalized
without change.
d. Proposed § 1102.10(d)—Minimum
Requirements for Publication
Proposed § 1102.10(d)(1) through
(d)(6) would describe the minimum
requirements for publication of reports
of harm in the Database. The proposal
would identify the minimum required
categories of information stated in
sections 6A(b)(2)(B)(i) through (v) of the
CPSA, and further elaborate on the type
of information included under each
category.
We received several comments
generally related to the minimum
requirements for publication, which
resulted in no substantive changes to
the final rule. On our own initiative,
however, we have made a grammatical
correction to the full name of the
Database and added the words ‘‘Publicly
Available’’ to the full name of the
Database.
Comment 18—One commenter states
that the Commission should remind
submitters to only file reports of harm
for incidents of which they have
firsthand knowledge, and actively
should discourage complaints based on
hearsay.
Response—For the reasons set forth in
response to Comment 8 above, we will
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not restrict submissions of reports of
harm for inclusion in the Database to
only those who have firsthand
knowledge. Reports of harm that meet
the statutory minimum requirements for
inclusion, and the requirements as set
forth in § 1102.10(d) of the final rule,
will be included in the Database.
Comment 19—Some commenters
suggest that the final rule impose a time
limit on when reports of harm may be
included in the Database, to exclude old
or stale data. Several commenters
suggest a time limit of one year from the
incident date, claiming that over time,
data becomes inherently suspect.
Response—As a matter of statutory
interpretation, we have decided to allow
submitters to enter reports of harm
about product related incidents
regardless of when the incident
occurred because Congress imposed no
limitation in section 6A of the CPSA.
Because many consumer products have
a long use period, and many consumer
products are purchased second hand or
used rather than new, it is important to
collect and maintain information on
these products over time. Moreover, in
our experience, consumers sometimes
fail to submit a report of harm until after
a recall is announced in the media.
Regardless of the date of occurrence and
the date of entry, all reports of harm
must meet the minimum requirements
for inclusion in the Database as set forth
in section 6A of the CPSA and
§ 1102.10(d) of the final rule. Moreover,
as set forth in response to Comment 30
below, the Commission has decided to
require the incident date, or an
approximate incident date, to include a
report of harm in the Database. Users
can determine for themselves what
weight to accord an incident that is
entered long after the date of
occurrence. If a manufacturer or private
labeler believes that the date of the
incident is relevant to users of the
Database, it may highlight this fact in its
comment to the report of harm.
Comment 20—Several commenters
note that the proposed rule does not
indicate how long reports of harm and
associated comments will remain in the
Database. The commenters state that the
final rule should impose a time limit
after which information will be removed
from the Database to ensure that the
information remains helpful. The
commenters also state that unless data
has a time limit or sunset period, the
Database may become overloaded with
outdated information. The commenters
suggest that if no recall occurs within
one year of a report being entered, then
the information should be removed but
remain available through a FOIA
request. Alternatively, the commenters
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suggest that the Commission could tag
information as ‘‘active reports’’ and
‘‘resolved reports.’’
Response—Setting a time limit or
expiration date for reports of harm and
related comments is inconsistent with
the purpose of the Database. Certain
hazard patterns may not emerge from
the data within a specific time limit.
Many consumer products have a long
use period, and many consumer
products are purchased used.
Accordingly, it is important to collect
and maintain information on products
over time.
Moreover, there is no easy way to
determine across all industries and all
products when data about products may
lose importance. For example, durable
infant products, which may be
purchased used, may become the
subject of incident reports years after a
product was purchased or even recalled.
We have several examples of children
being seriously injured by products that
were recalled for the defect many years
before. Consumers should have access
to all data that the Commission has on
file when they research recalls and
reports of harm made about consumer
products in the Database. As for the
suggestion of making information
available through FOIA, we believe that
such a change would be contrary to the
purpose and intent of the Database and
would compel us to allocate resources
to respond to FOIA requests concerning
data that should be made available in
the Database. Finally, as set forth in
§ 1102.10(i) of the final rule, all reports
of harm submitted to the Commission
become official records of the
Commission in accordance with 16 CFR
§ 1015.1 and will be treated in
accordance with that regulation, which
defines agency records for purposes of
the FOIA.
Comment 21—Several commenters
state that the minimum information
required to submit a report of harm for
inclusion in the Database in
§ 1102.10(d) is not detailed enough to
allow those reviewing the report to
understand the incident adequately, to
weed out duplicate reports, and to
promote investment in the report and
Commission activities by the submitter.
One commenter states that, without
more detailed information,
manufacturers will not be able to
respond meaningfully to reports of
harm, which will mean that the
Database contains inaccurate
information about their products. Thus,
in cases where the incident details are
insufficient to make a determination of
why an event occurred, one commenter
believes that the Commission should
not publish the report in the Database.
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Response—We decline to amend the
rule as suggested by the commenters.
Determining why an incident occurred
can sometimes be a time-consuming
process; yet section 6A of the CPSA
established procedural requirements
that are measured in days. Congress is
requiring us to create an ‘‘incident’’
database of ‘‘reports of harm,’’ not
causation determinations. Section 6A of
the CPSA requires reports of harm to be
posted in the Database quickly. Thus,
we cannot refrain from processing or
publishing reports of harm to determine
why an incident occurred.
In response to comments on the
proposed rule, however, we are
clarifying that one additional minimum
field requirement was added in the
proposed rule, and has been maintained
in the final rule, the ‘‘Category of
submitter.’’ We have considered
comments on this issue, as described
below, and decided to display this field
in the Database. Also, in response to
comments, we have decided to require
an additional field ‘‘Incident date’’ for
inclusion in the Database. These two
additional field requirements will assist
users in distinguishing duplicate or
multiple reports and in determining
what, if any, weight to give a particular
report of harm. Moreover, these two
additional pieces of information should
be readily available and typically
known by submitters of a report about
a consumer product. On balance, those
additional requirements should not
deter a submitter from entering a
legitimate report of harm.
Proposed § 1102.10(d)(1),
‘‘Description of the consumer product,’’
would require a word or phrase
sufficient to distinguish a product
identified in a report of harm as a
consumer product, a component of 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 identified as information that
would be helpful to the description of
a consumer product, but not required.
We received several comments about
this section of the proposed rule, and for
clarity we have finalized the rule with
grammatical changes to reflect the
original intent of the provision that
certain information in the description of
the consumer product will be optional.
Comment 22—Some commenters state
that the proposed rule does not require
a product name, model number,
manufacture date, date code, date of
purchase, or other descriptive
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76839
information about a product. The
commenters assert that the statute
requires that the Database be searchable
by date, product description, model
name, and manufacturer’s name to the
extent practicable; therefore, at a
minimum, a report of harm must
contain a model number and a product
name. Some commenters state that poor
product identification will make it
impossible for a manufacturer to
comment, and that requiring that the
information be included will make the
Database more useful and less
misleading.
Response—We agree that the more
information included about a product,
the easier it will be for the Commission
and Database users to identify the
product. Accordingly, the Database will
prompt submitters for additional
information about the product at issue,
including, for example, product brand,
model number, serial number, and date
of manufacture. We encourage
submitters to enter additional, helpful
information for product identification in
their reports of harm; however, we will
not require submitters to provide all of
the information suggested by the
commenters. We have amended
§ 1102.10(d)(1) to reflect this position.
Requiring too much detail about a
product may deter individuals from
submitting reports. In addition, we note
that section 6A(b)(2)(B)(i) of the CPSA
states that reports that provide a
‘‘description of the consumer product’’
meet the statutory minimum for product
identification. We will review each
report of harm to ensure that a
consumer product over which the
Commission has jurisdiction is
identified. Section 1102.10(d)(1) states
that ‘‘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.’’ Thus, if we cannot
identify a consumer product over which
we have jurisdiction based on
information in the report of harm, then
the report will not meet the minimum
requirements for publication.
As for the commenters’ argument
regarding the searchability of the
Database, section 6A(b)(4) of the CPSA
does not set forth minimum field
requirements; rather it describes how
users must be able to access data that
already exists within the Database. In
addition, section 6A(b)(4) of the CPSA
requires that the Commission
‘‘categorize the information available in
the Database in a manner consistent
with the public interest and in such
manner as it determines to facilitate
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easy use by consumers and shall ensure,
to the extent practicable, that the
Database is sortable and accessible by
* * * (B) the name of the consumer
product * * *; [and] (C) the model
name * * *.’’ (emphasis added). We
interpret this language to mean that
when a report of harm contains
information such as a model number, it
should be ‘‘sortable and accessible’’ by
such information. Thus, if a report of
harm contains a model name or number,
users will be able to search and sort
based on this information.
Comment 23—Some commenters state
that the description of a consumer
product should be detailed enough so
that the CPSC, the manufacturer, and a
user of the Database will be able to
identify the product.
Response—We agree that a
description of the consumer product
should be detailed enough to identify
the product. Section 1102.10(d)(1) states
that ‘‘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.’’ Each report of harm
will be reviewed before entry into the
Database.
Comment 24—Some commenters ask
us to clarify: (1) What information is
required for a sufficient product
description, and (2) how the staff will
determine what the product is, and
whether to post the report of harm in
the Database.
Response—Section 1102.10(d)(1)
establishes the minimum requirements
for a description of the consumer
product, and is consistent with section
6A(b)(2)(B)(i) of the CPSA, which
simply requires that the report of harm
contain ‘‘a description of the consumer
product (or other product or substance
regulated by the Commission) * * *.’’
We will review each report of harm
before entry into the Database. If we
cannot distinguish the item described in
a report of harm as a consumer product
within the Commission’s jurisdiction,
then the report of harm will not satisfy
the minimum requirements for
inclusion in the Database.
Comment 25—Several commenters
state that a product UPC Code should be
required for entry into the Database.
Another commenter suggested using
Global Trade Item Numbers.
Response—We are interested in
refining the ability of the Database to
identify consumer products using these
automatic identification technologies
and our information technology staff
currently is evaluating automatic
identification technologies for use in
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future software versions of the Database.
The rule is drafted broadly enough to
enable such future operational change.
Proposed § 1102.10(d)(2) titled
‘‘Identity of the manufacturer or private
labeler,’’ would describe that a report of
harm must name a manufacturer or
private labeler for the report to be
published.
One comment related to this section
of the rule was received, which resulted
in no changes to the final rule. However,
on our own initiative, we clarified in the
second sentence of the description that
additional contact information may be
provided for a manufacturer or private
labeler, but is not required. Accordingly,
the second sentence now states: ‘‘In
addition to a firm name, identification
of a manufacturer or private labeler may
include, but is not limited to, a mailing
address, phone number, or electronic
mail address.’’
Comment 26—One commenter would
require submitters to include
traceability information in a report of
harm. If the traceability information
does not match to the stated importer,
manufacturer, or retailer records, the
name of that entity should not appear in
the Database without further
investigation and proof that the subject
product belongs to the named firm, the
commenter argued.
Response—We interpret this comment
to mean that if a consumer product
cannot be verified as belonging to a
particular manufacturer or private
labeler, then the name of such entity
should not be included in the Database.
Section 6A of the CPSA requires that if
a report of harm meets all of the
minimum requirements for publication,
including identification of a
manufacturer or private labeler, it must
be transmitted to the manufacturer or
private labeler identified. Such
manufacturer or private labeler may
comment on the report of harm,
including identifying materially
inaccurate information. If the product
does not belong to the identified
manufacturer or private labeler, the
manufacturer or private labeler should
inform us immediately, and if we are
unable to determine the true identity of
the manufacturer or private labeler, the
report of harm will not be published in
the Database.
The incident report form allows
submitters to include additional details
to help identify the consumer product.
For example, the incident report form
also asks the submitter for a description
of the product (prompting for product
name), brand name, model name or
number, serial number, and
manufacturer date code. The form also
allows the submitter to upload photos or
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other attachments that may help us or
the manufacturer or private labeler to
identify the product.
Proposed § 1102.10(d)(3) titled
‘‘Description of the harm,’’ would
explain the requirements for describing
a harm for a report of harm to be
included in the Database. ‘‘Harm’’ as
provided in section 6A(g) of the CPSA
and in § 1102.6(b)(5), is an illness,
injury, or death, or a risk of illness,
injury, or death. The proposed rule
contained a nonexclusive list of
examples of the types of harm that
could be included. Additionally, this
section would explain that reports of
harm, which relate solely to cost or
quality of a product, without identifying
any discernable bodily harm or risk of
bodily harm, would not constitute
‘‘harm’’ for purposes of this part. A
description of harm may include
additional information, such as the
severity of the injury.
We received several comments on this
section of the proposed rule. We have
finalized this section of the rule with
corrections. We removed part of a
sentence stating that the date on which
the incident occurred is an example of
the type of description that may be
entered. We removed this language
because ‘‘incident date,’’ or an
approximation of the incident date, is
now a required field, as described in
response to Comment 30 below. In
addition, the rule has been revised to
conform to the definition of ‘‘harm’’ in
the statute.
Comment 27—Some commenters
would remove the terms ‘‘risk of bodily
harm’’ and ‘‘risk of injury’’ from
§ 1102.10(d)(3), and anywhere else in
the proposed rule, because ‘‘[t]his
database must be based on concrete
instances and not on issues or injuries
that may (or may not) occur.’’
Response—Section 6A(g) of the CPSA
defines ‘‘harm’’ as used in this section of
the statute as ‘‘(1) injury, illness, or
death; or (2) risk of injury, illness, or
death, as determined by the
Commission’’ (emphasis added).
Because Congress intended that risks of
harm be included in the Database, we
decline to revise the rule as suggested
by the commenters. The Database is
meant to help the Commission protect
the public against unreasonable risks of
injury associated with the use of
consumer products. Submitters must
describe an illness, injury, or death, or
risk of illness, injury, or death on the
incident report form. We will review
each report of harm before publishing it
in the Database to ensure that it meets
the minimum requirements for
publication.
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Comment 28—Some commenters state
that the severity of risk, meaning
whether and what type of medical
treatment was sought, should be a
required field on a report of harm if the
report of harm is to be included in the
Database. The commenters argue that,
without knowing the severity of the risk,
the public, the Commission, or a
manufacturer cannot judge the
magnitude of the risk presented and, in
turn, assess the appropriate response to
that risk.
Response—Consistent with section
6A(b)(2)(B)(iii) of the CPSA, the final
rules require the submitter to enter a
description of the harm, which means
the identification of a discernable
illness, injury, or death, or risk of
illness, injury, or death related to the
use of a consumer product. While we
agree that understanding whether
medical treatment was sought is useful
in determining the severity of a harm or
risk of harm, the statute, by referring to
risk of injury, illness, or death in
defining ‘‘harm,’’ does not require injury,
illness, or death to have occurred.
Accordingly, we will not require
specific information about whether
medical treatment was sought for a
report of harm to be included in the
Database. The incident report form,
however, will allow for entry of such
information.
Comment 29—Several commenters
would define an incident causing harm
more explicitly in § 1102.10(d)(3) by
excluding reports of harm that relate
solely to the cost, quality, customer
satisfaction, or warranty disputes, or
those that fail to state any discernable
bodily harm or risk of bodily harm. The
commenters state that Commission staff
should review reports of harm and
exclude those that do not address a
safety issue so that the Commission and
industry can focus on reports containing
actual or potential harm. One
commenter would limit harm to include
both an actual incident and an injury as
set forth in 16 CFR 1117.3 (which
pertains to reporting requirements for
choking incidents involving marbles,
small balls, latex balloons, and other
small parts).
Response—The proposed rule already
would exclude reports relating solely to
cost or quality. We agree that a report
of harm that identifies only quality or
cost issues and does not identify a
bodily harm or risk of bodily harm does
not meet the minimum requirements for
inclusion in the Database. ‘‘Harm’’ is
defined in § 1102.6(b)(5), consistent
with section 6A of the CPSA, as ‘‘injury,
illness or death; or risk of injury, illness
or death, as determined by the
Commission.’’ Thus, reports of harm
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containing no discernable injury,
illness, or death, or risk thereof, will not
meet the minimum requirements for
inclusion in the Database. Therefore,
§ 1102.10(d)(3) continues to state that
‘‘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.’’
We will not make the reporting
requirements in 16 CFR 1117.3 for
choking incidents involving marbles,
small balls, latex balloons, and other
small parts applicable to reports of harm
for inclusion in the Database. Section
1117.3 creates a reporting requirement
for firms that become aware of both an
incident and, as a result of the incident,
that a child died, suffered a serious
injury, ceased breathing for any length
of time, or was treated by a medical
professional. In contrast, section 6A of
the CPSA, through the definition of
‘‘harm’’ in section 6A(g) of the CPSA,
covers a broader range of adverse
events. The statute goes beyond ‘‘injury,
illness, or death’’ (terms that would
seem to encompass the events in
§ 1117.3) by adding ‘‘risk of injury,
illness, or death * * *.’’ Thus, imposing
the reporting requirement in § 1117.3
onto § 1102.10(d) would be inconsistent
with section 6A of the CPSA.
Comment 30—Several commenters
would make the date of the incident a
required field to help develop a
response, minimize duplication, and
reduce the likelihood of counterfeit
reports being added to the database. For
the same reasons, some commenters
also would require the location of the
incident to be noted. The commenters
state that the burden on submitters is
low, while manufacturers have only 10
days to respond. Accordingly, the
commenters assert that requiring this
information will help screen out
duplicate reports.
Response—We agree that requiring
the date of the incident or the
approximate date of an incident to be
included will help in associating reports
of harm submitted concerning the same
incident, without deterring submission
of reports. The incident date, or an
approximation, should be information
that is readily known and, on balance,
likely will be helpful to the
Commission, Database users, and those
who investigate incidents. For example,
the incident date will help us locate and
associate multiple reports of harm
submitted about the same incident.
Reports of harm submitted by different
persons about the same incident will
not be deleted, but will be associated so
that Database users can discern that
only one incident occurred, for
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example, as opposed to two or three if
several reports are filed concerning the
same incident. Gathering information
from different sources may assist the
Commission and other users in
understanding the nature of the
incident, the product involved, and any
injuries sustained. Additionally,
because we will not restrict reports of
harm to recent incidents, the ability to
display both an incident date and the
report filing date will help users assess
that report. Accordingly, we have
revised § 1102.10(d)(4) to require an
‘‘Incident date,’’ or an approximation, to
be entered to display a report of harm
in the Database.
As for the location of the incident, the
form allows, but does not require,
submitters to enter the location of the
incident. Information regarding the
location of the incident is not critical to
product or hazard identification.
Nevertheless, because the incident date
and incident location fields are located
adjacently on the form, we anticipate
that submitters will be sufficiently
prompted to include such information.
Proposed § 1102.10(d)(4) titled
‘‘Contact information’’ would require a
submitter of a report of harm to provide
his or her first and last name and a
mailing address for the report to be
published. Submitters also may provide
other contact information, such as an
email address or a telephone number,
but such information is not required in
order to publish the report.
We received several comments on this
section, which we have finalized
without substantive modification.
‘‘Contact information’’ has been
renumbered in the final rule to
§ 1102.10(d)(6) to accommodate the
addition of ‘‘Incident date’’ and
‘‘Category of submitter.’’
Comment 31—Several commenters
address reports of harm by anonymous
submitters. Some commenters state that
we should not include these reports of
harm in the Database. Some commenters
state that we should not maintain
anonymous reports for Commission use
because veracity and trustworthiness are
at issue and that such reports should not
be used for compliance or enforcement
proceedings because firms have no
opportunity to investigate or refute the
claims.
Response—Reports of harm submitted
anonymously do not meet the minimum
requirements for inclusion in the
Database and will be excluded. Section
6A(b)(2)(B)(iv) of the CPSA requires that
the report contain ‘‘contact information
for the person submitting the report’’;
therefore, an anonymous report would
not satisfy this statutory requirement.
Although the submitter’s contact
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information will not be published in the
Database, it must be included for the
report of harm to meet the minimum
qualifications for inclusion in the
Database.
As for our use of anonymous reports,
the Commission has accepted incident
reports submitted anonymously for
many years, and we will not change this
practice now. Accordingly, we will
maintain anonymous reports of harm for
internal use. The Commission is
concerned with product safety,
regardless of who submits the
information to the agency, and we
cannot assume that anonymous reports
of harm will not contain real and
significant product safety issues. While
it is preferable to have contact
information to enable us to follow up
and investigate incident reports with
greater ease, the absence of contact
information does not prevent us from
investigating a consumer product as
long as the product is identifiable.
With regard to the use in enforcement
proceedings of reports submitted
anonymously, this issue involves the
Commission’s exercise of enforcement
power and discretion and our
consideration of specific facts. Such
information will continue to be
considered on a case-by-case basis.
Comment 32—One commenter states
that when consent is given, a
submitter’s contact information should
be provided to the manufacturer to
facilitate evaluation of the complaint.
This same commenter states that we
should require contact information to be
given to the Commission to prevent
fraud.
Response—When a submitter of a
report of harm gives consent, his or her
name and contact information will be
provided to the manufacturer or private
labeler. This provision, contained in
§ 1102.20(a)(1), is consistent with
section 6A(b)(6) of the CPSA.
Anonymous reports will not meet the
minimum requirements for inclusion in
the Database and will be excluded. As
set forth above, we will continue to
accept and maintain anonymously
submitted reports for our own use, and
we decline to make contact information
required information for submission of
such reports to the Commission.
Comment 33—One commenter
suggests that we require every submitter
to provide a phone number, and that
Commission staff affirm the legitimacy
of every report filed, and verify the
contact information submitted in order
for a report of harm to meet the
minimum requirements for publication
in the Database.
Response—We decline to revise the
rule as suggested by the commenter.
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Section 6A(b)(5) of the CPSA and
§ 1102.42 direct us to provide clear and
conspicuous notice to Database users
that we do not guarantee the accuracy,
completeness, or adequacy of the
contents of the Database, and Section
6A(b)(2)(B)(v) of the CPSA and
§ 1102.10(d)(7) specify the form of
verification required from submitters of
reports of harm. No additional
verification is required by the statute
and would be contrary to the intent of
6A to provide prompt public release of
reports of harm that otherwise meet the
requirements for posting in the
Database.
Comment 34—Several commenters
state that the Database should encourage
the release of contact information to
manufacturers to enhance accuracy and
product safety. One commenter states
that consent to release contact
information to manufacturers should be
required to post a report of harm
because it is the only way that
manufacturers can resolve complaints
and determine whether products are
counterfeit. Another commenter notes
that absence of contact information for
the submitter is a complete bar to a
manufacturer’s ability to respond to a
report of harm.
Response—We will transmit contact
information to the manufacturer or
private labeler pursuant to section
6A(b)(2)(B)(iv) of the CPSA. The statute
does not permit us to disclose the name,
address, or other contact information of
a submitter of a report of harm without
the submitter’s express written consent.
Neither transmission of a report of harm
to a manufacturer or private labeler nor
publication of a report in the Database
is conditioned on a submitter agreeing
to provide contact information to the
manufacturer or private labeler.
Consequently, we are not amending the
rule to create such a requirement. We do
not agree that the absence of contact
information on a particular report
prevents a manufacturer from
commenting on a report of harm.
Manufacturers may have received
similar claims from other consumers. In
fact, manufacturers often receive far
more incident reports directly from
consumers than the CPSC receives. In
those cases, manufacturers and private
labelers may be able to distinguish
product issues more quickly than the
CPSC and may be in a better position
than the CPSC to respond, regardless of
whether contact information is
provided.
With regard to counterfeit products,
neither section 6A of the CPSA nor the
final rule addresses counterfeit
products. We previously have
conducted recalls on counterfeit
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products. A product’s status as
counterfeit does not change the safety
implications and the potential need to
remove such a product from the hands
of consumers. We work with
manufacturers to ascertain the true
manufacturer of such counterfeit
products when there is an issue
concerning consumer safety.
Comment 35—One commenter would
require identification of the victim by
name for a report of harm to appear in
the Database, although the information
would be provided only to the
Commission and would not be
published. The commenter explains that
identifying the victim would allow the
Commission to cross-check data and
prevent duplication, especially where
different people report the same
incident. The victim’s identification
would allow the Commission to clarify
which reports are about the same
incident if multiple reports are
submitted.
Response—Section 6A(b)(2)(B) of the
CPSA does not require identification of
the victim by name, and we are not
revising the rule as suggested by the
commenter. Although knowing the
victim’s name would help associate
reports of harm for the same incident,
we can appreciate how a submitter
might consider such information to be
private. For example, some parents,
while eager to report an incident and to
provide details about the injury
sustained and the age and gender of
their child, may not want to provide the
child’s name. Likewise, other
submitters, such as health care
professionals or government agencies,
may want to report details about a
victim’s injury, age, and gender, but
may not know the victim’s name or may
have a legal obligation to keep the
victim’s name confidential. To help
identify and associate duplicate reports,
we have decided to add ‘‘Incident date,’’
or an approximation, as a required
minimum field. Providing such
information should not be burdensome
because typically it would be known or
could be approximated.
Comment 36—Some commenters
would require the submitter of a report
of harm to provide either an e-mail
address or a phone number as part of
the required contact information in
§ 1102.10(d)(4) to allow for timely
contact of the submitter and verification
of the report of harm. The commenters
argue that, without this information, it
will be impossible for manufacturers to
have a meaningful chance to verify the
report of harm within the required 10
business days.
Response—Section 6A(b)(6) of the
CPSA does not require the Commission
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to release contact information to the
manufacturer or private labeler unless
the submitter provides written consent
to do so. Accordingly, manufacturers
and private labelers are not entitled to
verify the report of harm with the
submitter before they submit comments
or before the report of harm is posted in
the Database. We recognize, however,
that when a submitter does consent to
release his or her contact information to
the manufacturer or private labeler,
having an e-mail address or a phone
number is the preferred method for
contacting the submitter because of the
time limitations imposed by section 6A
of the CPSA. Thus, when a submitter
consents to releasing his or her contact
information to a manufacturer or private
labeler, the Database will ask, but not
require, the submitter to provide an
e-mail address or phone number to
allow for timely follow up.
Proposed § 1102.10(d)(5), entitled
‘‘Verification,’’ would require submitters
to verify that they have reviewed the
report of harm and that the information
contained in the report is true and
accurate to the best of the submitters’
knowledge, information, and belief. As
originally proposed, this section also
required, as part of the verification
process, that submitters of reports of
harm indicate into what category they
fit (i.e., consumer, government agency,
health care professional).
We received several comments related
to this section. We have finalized the
first two sentences without
modification. We deleted the last two
sentences regarding the category of
submitter, as discussed below in
response to Comment 40, and this
section has been renumbered to
1102.10(d)(7).
Comment 37—Several commenters
state that the final rule should require
submitters to make an affirmation or
oath regarding the truth of the
information submitted in order to be
included in the Database.
Response—We agree. This is already
a statutory requirement, and we have
required this in § 1102.10(d)(7).
Comment 38—Several commenters
state that the incident report form
should include a notation regarding the
penalties for filing a false report to
ensure that accurate information is
submitted. The commenters say that the
Commission should take an aggressive
stance to discourage malicious and false
information from being submitted and
pursue enforcement actions, including
seeking monetary penalties.
Response—If we receive false reports,
we will take all appropriate actions
available to remove materially
inaccurate information from the
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Database and seek appropriate legal
remedies against those involved. We
have declined to add a reference about
penalties because we agree with some of
our public hearing participants who
indicated that such a statement could
chill or intimidate a submitter from
filing a legitimate report. We reviewed
other agency databases like Safercar.gov
and noted that no such statement exists
on their incident reporting forms.
Therefore, we determined that to make
the Database user friendly to all
submitters of reports of harm, we would
not include the notation.
Comment 39—Several commenters
state that a report to Congress, which
included a mock up of the incident
report form, displayed a static,
noncheckable verification of the report
of harm. These commenters assert that
the Database should require consumers
to make an attestation by clicking on a
button in the online incident report
form. One commenter states that
submitters should be able to ‘‘opt in’’ to
submitting their contact information to
the manufacturer or private labeler, and
that, if they do not agree to provide the
information, then we should collect
statistical information on the reasons for
refusal.
Response—We agree that submitters
should be required to affirmatively
check a box for verification of the report
of harm. However, the commenters
appear to have been examining an early
mockup of Database screens that were
meant solely as an illustration and not
an actual representation of the Database.
Submitters of reports of harm will, in
fact, be required to select or check a box
to identify that they are verifying the
report of harm in the online incident
report form. Submitters will also be able
to affirmatively select, or ‘‘opt in,’’ to
send their contact information to the
manufacturer. If such an option is not
selected, however, we will not collect
statistical information on the reasons for
refusal. Congress gave submitters the
option of whether to provide their
contact information to manufacturers
and private labelers, and we believe it
would be an unproductive use of CPSC
resources to collect data on a submitter’s
reasons for refusing to submit their
contact information to manufacturers
and private labelers.
Comment 40—One commenter would
require the category of person
submitting the report of harm for a
report to be included in the Database.
The commenter states that such
information would provide context for
database users who may place different
weight on the report based on this
information. The commenter adds that it
is important to distinguish multiple
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reports of harm submitted on the same
incident and to see the value and insight
provided by each reporter.
Response—Proposed § 1102.10(d)(5)
would include the category of submitter
as a minimum field requirement.
Although identification of the category
of submitter is required information, the
proposed rule stated that the
information would not be published in
the Database. We agree that the category
of submitter is an important piece of
information to collect and display so
that Database users can better
understand not only who submitted the
report of harm but also the relationship
of the submitter to the victim. It is
especially important to help users
understand the submitter’s perspective
when the Database may include
multiple reports on the same incident.
Accordingly, to clarify that ‘‘Category of
submitter’’ is a minimum requirement
for inclusion of a report of harm in the
Database, we have revised the final rule
to create a new § 1102.10(d)(5) titled
‘‘Category of submitter,’’ and the
‘‘Verification’’ section previously at
§ 1102.10(d)(5) has been renumbered as
§ 1102.10(d)(7). Section 1102.10(d)(5)
now reads as follows: ‘‘Category of
submitter. Indication of which category
the submitter is in (consumer,
government agency, health care
professional, etc. * * *) from
§ 1102.10(a).’’ We have removed similar
language from the ‘‘Verification’’ section.
Comment 41—One commenter would
have us provide the category of
submitter for a report of harm to
manufacturers. The commenter notes
that § 1102.10(d)(5) states that the
information will be required at
verification but will not be published in
the Database. The commenter also
claims that there is no reason or
justification for depriving Database
users of this information.
Response—As set forth above in
response to the previous comment, the
category of submitter remains a required
field, and has been removed from the
‘‘Verification’’ section to § 1102.10(d)(5)
of the final rule. For the reasons
discussed above, information on the
category of submitter will be transmitted
to the manufacturer or private labeler,
and will be displayed in the Database.
Comment 42—Some commenters
suggest using e-mail verification and
validation to ensure that reports of harm
are not ‘‘spam’’ (i.e., a form of e-mail
where the same message is sent in large
quantities to multiple parties). The
commenters state that a report of harm
should not be published unless the
report can be validated.
Response—We considered using
e-mail verification and validation
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technologies, but decided not to
incorporate these features because we
did not want to deter submitters by
creating additional steps, external to the
incident report form, for them to enter
a report of harm. However, we have
incorporated other software design
features to minimize computergenerated reports of harm, such as
implementing Completely Automated
Public Turing test to tell Computers and
Humans Apart (‘‘CAPTCHA’’) challengeresponse tests. CAPTCHA is a
technology intended to enable a
computer system to distinguish between
humans and computers. The computer
challenges the user to complete a test
(such as retyping text that has been
distorted); a human will be able to
complete the test, but a computer would
not. As new technologies become
available, we will incorporate them
consistent with industry and federal
government best practices.
Proposed § 1102.10(d)(6) titled
‘‘Consent’’ would explain that the
submitter of a report of harm must
consent to inclusion of the report of
harm in the Database for the report to
be published. If no consent is provided
by the submitter, then the report will
not be published in the Database.
Several comments were received,
resulting in no substantive changes to
the final rule. We renumbered ‘‘Consent’’
in the final rule to § 1102.10(d)(8), to
accommodate the addition of ‘‘Incident
date’’ and ‘‘Category of submitter.’’
Comment 43—One commenter
suggests that, on the incident report
form, the language related to consents
be consistent and suggests using ‘‘May
we’’ for the consent to provide contact
information to manufacturers as well as
the consent to include the report of
harm in the Database. The commenter
states that this language may encourage
consumers to provide contact
information to manufacturers to
enhance consumer safety and would
allow for proper investigation of the
complaint.
Response—The commenter is
focusing on language contained on a
draft of the incident report form rather
than language in the proposed rule
itself. We agree that it would be
appropriate to make the language
consistent for the consents collected
from submitters of reports of harm;
therefore, we have changed the language
on the incident report form so that both
of the consents collected begin with
‘‘May we.’’
Comment 44—One commenter states
that the term ‘‘verification’’ implies a
level of CPSC validation of reports of
harm that is unlikely to exist and that
is in contrast to the disclaimer. The
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commenter suggests using the term
‘‘self-verification.’’
Response—Section 6A(b)(2)(B)(v) of
the CPSA uses the term ‘‘verification’’ to
explain that the submitter must state
that the information is true and accurate
to the best of the person’s knowledge.
One dictionary definition of ‘‘verify’’ is
‘‘to confirm or substantiate by oath.’’ See
https://www.merriam-webster.com/
dictionary/verify. Because the term is
correctly applied, easy to understand,
and consistent with section
6A(b)(2)(B)(v) of the CPSA, we are not
amending the rule as suggested by the
comment.
e. Proposed § 1102.10(e)—Additional
Information Requested on a Report of
Harm
Proposed § 1102.10(e), regarding
‘‘Additional information requested on a
report of harm,’’ would describe the
Commission’s ability to seek other
categories of voluntary information. In
the preamble to the proposed rule, we
invited comment on 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 that was not in accordance
with a manufacturer’s instructions.
Several comments were received
related to this section, which has been
finalized with a clarification as to the
appropriate consent for minors.
Comment 45—One commenter states
that the Commission should request, but
not require, the following information
on a report of harm to substantiate the
claim: (1) Verification that the label
instructions were followed; (2) the date
on which the harm occurred; (3) a brief
description of the incident, including
how the product was being used, where
it was being used, a description of what
happened, whether other products were
being used, how much product was
used over time; and (4) whether the
manufacturer was contacted before
submitting the report of harm.
Response—We will collect more
information about an incident on a
report of harm than is minimally
required to include the report in the
Database. We will display such
additional information, if consent is
provided. For example, the current
online incident report form asks
whether the manufacturer has been
contacted before filing a report of harm.
We will continue to collect this
information on the new reporting form.
Also, as set forth in response to
Comment 30, we have decided to make
the incident date, or an approximate
incident date, required information on a
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report of harm. The detail of an incident
has been, and will continue to be,
important information on a report of
harm. The incident report form will
have space for a narrative description of
the incident, with guidance on the types
of information that should be included.
Finally, we will not specifically ask
whether label instructions were read or
followed because it unnecessarily
implies that the consumer may be at
fault. Manufacturers must evaluate
safety with respect to the intended use,
as well as the reasonably foreseeable
misuse of a product.
Comment 46—One commenter states
that the Commission should require the
submitter to retain the product for at
least one year.
Response—Currently, we request, but
do not require, that a submitter retain
the product for at least 30 days so that
a CPSC investigator can review and
inspect the product, if necessary. We
will continue to advise submitters on
the new version of the incident report
form to retain the product for at least 30
days. We do not believe that section 6A
of the CPSA gives us the authority to
impose product retention requirements
on individuals as a condition of their
submitting reports of harm to the
Database.
f. Proposed § 1102.10(f)—Information
Not Published
Proposed § 1102.10(f), ‘‘Information
not published,’’ 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. In making
such a public interest determination, the
Commission will consider whether the
information is related to a product
safety purpose served by the Database,
including whether the information
helps Database users to identify a
consumer product; identify the
manufacturer or private labeler of a
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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.
Several comments were received
related to this section. We changed
‘‘materially inaccurate information’’ to
‘‘information determined to be
materially inaccurate’’ to be consistent
with the statute. We have also made two
grammatical changes, one to (f)(7),
changing it from ‘‘Submitters of reports
of harm may retract reports at any time
* * *’’ to ‘‘Reports of harm retracted at
any time by the submitters of those
reports,’’ and one to (f)(8) deleting the
words ‘‘to publish.’’ In addition, we
added language clarifying that the
Commission will exclude from
publication in the Database consents
and verifications associated with the
submission of a report of harm. This
change reflects our response to
comment 65 and is consistent with
§ 1102.12(e).
Comment 47—One commenter states
that § 1102.10(f)(3) should limit
photographs to pictures of whole
products, solely for identification
purposes. The commenter asserts that
the Commission should prohibit
photographs of injuries, components, or
people, and states that such pictures are
not in the public interest and should not
be published.
Response—We agree that, for product
identification purposes, photographs of
the whole product are often the most
useful. However, close-up photographs
of the product labeling or the defect at
issue may involve photographing a
component part of the product. We also
have jurisdiction over component parts
of consumer products. Accordingly, we
are not revising the rule as suggested by
the commenter.
Section 1102.10(f)(3) provides that
photographs that the Commission
determines are not in the public interest
will not be published, ‘‘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.’’ Upon reflection, we will not
and cannot, prevent submitters from
uploading photographs and documents
that may be helpful to the Commission
in any subsequent investigation,
including photographs of injuries.
However, we recognize that some
photographs may be inappropriate for
publishing in the Database. Therefore,
we will review every photograph and
attachment to determine whether it is
relevant to the report of harm, violates
any person’s privacy, and is in the
public interest to publish. Product
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photographs are likely to always be
found to be in the public interest to
display. Photographs from which a
person can be identified will not be
published, unless the photograph is
altered in such a way that it could not
be used to identify a person.
Photographs of injuries where a person
cannot be identified may be published.
Thus, we changed ‘‘photographs that
depict a person or injury or constitute
an invasion of personal privacy’’ to
‘‘photographs that could be used to
identify a person or photographs that
would constitute an invasion of
personal privacy.’’ This change reflects
the Commission’s desire to allow
photographs of injuries to be published,
including those that depict or represent
an image of a person, as long as the
image could not be used by a Database
user to determine the identity of the
individual in the picture. The
Commission will still exercise
discretion and may decline to post a
picture it determines is not in the public
interest because it is too gruesome.
Comment 48—Some commenters
approve of the Commission’s use of
criteria under proposed § 1102.10(f)(8)
when exercising discretion regarding
what goes into the Database when it is
in the ‘‘public interest.’’ The commenters
state that the proposed criteria will
ensure that a wide variety of
information will be published.
Response—We agree and have
finalized this section with one
grammatical change deleting the word
‘‘determination.’’
Comment 49—One commenter states
that, if the Commission publishes
attachments to a report of harm, the
Commission should ensure that a
submitter’s or a victim’s private
information is not published in the
Database.
Response—Consistent with
§ 1102.10(f), we will not publish a
submitter or victim’s name or personally
identifying information contained in
any attachment, or any other
information inconsistent with the
Privacy Act of 1974, or the public
interest, without the appropriate legal
consents. Each attachment will be
reviewed for content, and if necessary,
not displayed or will be redacted before
publication to exclude such
information.
Comment 50—Some commenters ask
whether a submitter can withdraw a
report of harm.
Response—As set forth in
§ 1102.10(f)(7), a submitter may retract a
report at any time, if he or she indicates,
in writing, to the Commission that he or
she supplied materially inaccurate
information. The reason that we are not
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permitting submitters to freely
withdraw a report of harm is our
concern that submitters may be subject
to external pressure to withdraw reports
of harm for any number of reasons,
including settlement agreements with
manufacturers conditioned on such
withdrawal.
g. Proposed § 1102.10(g)—Reports of
Harm From Persons Under the Age of 18
Proposed section 1102.10(g), entitled
‘‘Reports of harm from persons under
the age of 18,’’ would state that the
Commission will not accept reports of
harm submitted by persons under the
age of 18 years without the consent of
the parent or guardian of that person.
The rationale for requiring consent on
reports by a minor is the fact that age
of legal consent in many jurisdictions is
18 years old. 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, which addresses
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 that the report contains.
Two comments were received related
to this section, which has been finalized
without change.
Comment 51—One commenter says
that the minimum age to submit a report
of harm should be 18 years old. Reports
regarding injuries to minors should be
submitted by a parent or guardian rather
than the injured minor to ensure a
degree of maturity in submitters and to
increase accuracy.
Response—We agree. l This
requirement is already contained in
§ 1102.10(g). No one under 18 may
submit a report of harm without a
parent or guardian submitting his or her
own contact information and approving
the submission.
Comment 52—One commenter states
that the proposed rule does not require
a reporter to provide his or her age, but
does restrict those under 18 from
submitting a report of harm. The
commenter states that, while the CPSC
may intend to include this in the
reporting form, age and consent are
omitted from § 1102.10(d)(4).
Response—The language in
§ 1102.10(g) accurately reflects the
intended requirement and how the
information is conveyed on the
reporting form. Age of the submitter of
a report of harm is not, and was not
intended to be, a required field.
However, submitters will be prompted
to certify that they are 18 years old or
older. If they are not, a parent or
guardian must provide a name and
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complete mailing address, and submit
the report of harm. A submitter cannot
complete a report of harm without
certifying that he or she is 18 years of
age or older.
h. Proposed § 1102.10(h)—Incomplete
Reports of Harm
Proposed § 1102.10(h) on ‘‘Incomplete
reports of harm’’ 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 internal use.
Several comments were received
related to this section, which has been
finalized without modification.
Comment 53—Several commenters
address incomplete reports of harm in
proposed § 1102.10(h). The commenters
claim that incomplete reports of harm
should not be published in the
Database. Some commenters suggest
that consumers be able to return to
incomplete reports of harm to finish
them at a later date. The commenters
also state that the Commission may keep
incomplete reports of harm for its own
use, but other commenters state that the
Commission should not maintain
incomplete reports of harm for its own
use.
Response—The comments raised a
point of clarification regarding reports
of harm. An abandoned report of harm
is a report that may be complete or is
incomplete but is never ‘‘submitted’’ by
the consumer by pressing the ‘‘submit’’
button in the online form. Abandoned
reports will not be kept by the
Commission. In contrast to an
abandoned report, an incomplete report
of harm is submitted by pressing the
‘‘submit’’ button in the online form.
Incomplete reports of harm are
considered incomplete reports because
they do not meet the minimum
requirements for publication in the
Database, as set forth in § 1102.10(d),
and therefore, will not be published in
the Database. Under section 5(a)(1) of
the CPSA, we have an obligation to
‘‘maintain an Injury Information
Clearinghouse to collect, investigate,
analyze, and disseminate injury data,
and information, relating to the causes
and prevention of death, injury, and
illness associated with consumer
products.’’ Because of this mandate, for
many years we have maintained a
database on consumer product safety
incidents, including information
submitted online. The incident report
form for reports of harm developed for
the Database, both online and paper
formats, will replace the incident report
form currently in use. Regardless of
whether reports of harm meet all of the
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requirements for submission into the
Database, we will continue to maintain
useful data for internal use under
section 5(a)(1) of the CPSA as long as
such information is submitted. A report
that is not eligible for inclusion in the
Database may still contain important
information. For example, some reports
will not meet publication requirements
because the submitter failed to enter a
required field. Other submitters may
enter all of the substantively required
fields, but the report may fail to qualify
for inclusion in the Database because
the submitter did not consent to
publication.
Regarding the ability to save a report
of harm, submitters who register a
password will be able to save a report
of harm, and to return to the report for
up to 30 days to edit and submit it.
Once the submitter presses ‘‘submit,’’ the
report of harm is deemed officially
submitted. Once the report has been
submitted, we will review the report to
determine whether the minimum
requirements for publication have been
met. Reports of harm that are not
submitted within 30 days of initiating
the report are considered abandoned,
and will not be maintained by the
Commission.
Comment 54—Some commenters ask
whether we will notify a manufacturer
if an incomplete report of harm is filed.
Response—Reports of harm that do
not meet the minimum qualifications for
publication in the Database will not be
sent to the manufacturer or private
labeler pursuant to section 6A of the
CPSA. However, such reports of harm
may be sent to the manufacturer or
private labeler pursuant to section 6(c)
of the CPSA. We are currently
considering whether notices under
section 6(c) of the CPSA will be sent to
the manufacturer through the Business
Portal being developed for notices under
section 6A of the CPSA. Regardless of
how they are transmitted, a notice of
incident report under section 6(c) of the
CPSA will follow the time frames in
existence now, and will not be subject
to the shorter time frames for notices
under section 6A of the CPSA.
i. Proposed § 1102.10(i)—Official
Records of the Commission
Proposed § 1102.10(i), ‘‘Official
records of the Commission,’’ 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.
No comments were received related to
this section, which has been finalized
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with one modification to reflect that
reports ‘‘submitted to’’ the Commission
will become official records of the
Commission.
2. Proposed § 1102.12—Manufacturer
Comments
Proposed § 1102.12 would identify
the process for who may submit
manufacturer comments in response to
receiving a report of harm.
a. Proposed § 1102.12(a)—Who May
Submit
Proposed § 1102.12(a) would state
that manufacturers or private labelers
who receive a report of harm from the
CPSC may submit a comment if the
report of harm identifies such
manufacturer or private labeler.
We received several comments related
to this section, which has been finalized
without change.
Comment 55—One commenter felt
that industry members, other than those
specifically identified in the report of
harm, should be able to submit
comments on a report of harm.
According to this commenter, § 1102.16
authorizes the Commission to include in
the Database any additional information
it determines to be in the public
interest.
Response—We are not revising the
proposed rule as suggested by the
commenter. Section 6A(c)(1) of the
CPSA contains the procedural
requirements for transmission of a
report of harm to a manufacturer or
private labeler. Transmission is required
when a report contains the minimum
requirements for publication, as set
forth in section 6A(b)(2)(B) and
§ 1102.10(d) of the final rule. If these
minimum requirements are satisfied,
then the statute requires the
Commission, to the extent practicable,
to transmit the report to the
manufacturer or private labeler
identified in the report. If the
Commission transmits such report to a
manufacturer or private labeler pursuant
to section 6A(c)(1) of the CPSA, the
manufacturer or private labeler who
receives the report from the Commission
may submit comments to the
Commission on the information
contained in such report, pursuant to
section 6A(c)(2) of the CPSA (containing
the procedural requirements for
submitting comments in response to a
report of harm). Therefore, based upon
a plain reading of the statute, we believe
that the procedural requirements of
section 6A(c) of the CPSA, concerning
both transmission and commenting, are
unambiguous, and relate only to
manufacturers or private labelers who
are identified in a report of harm and
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allowing only that manufacturer or
private labeler to post a responsive
comment.
Comment 56—One commenter
suggests that the Database present only
anonymous, aggregated information
regarding the submitters, but allow the
named, registered manufacturer to see
the information on the submitter for
follow up purposes. The commenter
states that withholding submitter
contact information would inhibit
premature litigation by shielding
submitters from general searches by
unsolicited law firms, and at the same
time allow submitters to seek and retain
counsel at their own initiative, if
necessary.
Response—We agree but for reasons
other than those offered by the
commenter. We believe that the statute
is unambiguous in its exclusion from
the Database of a submitter’s contact
information; therefore, we will not make
a submitter’s contact information
publicly available in the Database.
Section 6A(b)(6) of the CPSA expressly
prohibits the disclosure of the name,
address, or other contact information of
any individual or entity that submits a
report of harm to the Commission. The
only exception to this is where the
submitter consents, for verification
purposes, to provide his or her contact
information to the manufacturer or
private labeler identified in the report of
harm. In such a case, this information
will be provided to the manufacturer or
private labeler identified in the report of
harm.
Comment 57—One commenter states
that manufacturers and private labelers
should have sufficient opportunity to
comment on reports of harm in the
Database. The commenter is concerned
that the private labeler should have the
opportunity to comment on a report of
harm, regardless of whether a
manufacturer identified in such report
provides comments or not.
Additionally, this commenter asks for
additional time to comment on reports
of harm.
Response—Where both a
manufacturer and private labeler are
identified in a report of harm, we will
provide the opportunity to comment to
each. Prior to publication, each entity
will then have up to 10 days to provide
comments on the report of harm. If we
receive comments from both the
manufacturer and private labeler, along
with the consent to publish such
comments, we will publish both
comments in the Database. If
transmission is made to both a
manufacturer and a private labeler, yet
we only receive comments from one
entity, along with the consent to publish
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such comments in the Database, we will
publish those comments in the
Database. However, we disagree that
additional time to comment is necessary
or even permitted under the statute,
given that simultaneous transmission
will be made to any identified
manufacturer or private labeler in a
report of harm, and the existence of
unambiguous statutory timeframes for
transmission of reports of harm and
publication of such reports to the
Database.
Comment 58—One commenter asks
whether licensors would be considered
private labelers and, if so, what would
be the procedure for handling reports of
harm relating to a consumer product
with multiple licenses.
Response—We do not consider
licensors to be separately addressed by
the statute, so a licensor must be
identified as either a private labeler or
manufacturer in order to receive a report
of harm for comment.
b. Proposed § 1102.12(b)—How To
Submit
Proposed § 1102.12(b) would provide
the mechanism by which comments
would be submitted; it would be via an
online Business Portal, where the
manufacturer would be able to register
to submit comments on a secure,
nonpublic portal provided through the
Commission’s Database. The proposal
also would allow comments to be
submitted by electronic mail or regular
mail directed to the Commission’s
Office of the Secretary.
Several comments were received
related to this section, resulting in no
substantive changes to the final rule. On
our own initiative, we made two
corrections in the final rule. We
corrected an internal citation error in
§ 1102.12(b)(1), changing the citation
from § 1102.20(e) to (f), and we updated
§ 1102.12(b)(2) to include an email
address for the Office of the Secretary.
Comment 59—One commenter
suggests that manufacturers or private
labelers be allowed to designate more
than one employee or representative to
comment on their behalf.
Response—We have designed the
Business Portal such that transmission
of a report of harm will be made to the
registered account user and additional
recipients who can receive the
notification of that transmission.
Through the Business Portal, we will
permit businesses to designate multiple
email recipients, but allow only one
account holder to submit a response.
This will enable notification to more
than one person per account in the
event that someone is out of the office
or not available; at the same time it will
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ensure that duplicate or multiple reports
are not received from the same
manufacturer/private labeler.
Comment 60—One commenter
suggests that manufacturers or private
labelers be able to group common
reports of harm found in the Business
Portal, and provide a single response
that can be tied to all of such reports of
harm.
Response—The ability of a
manufacturer or private labeler to group
common reports of harm and provide a
single response is not currently a design
feature of the Database software
program. However, we are currently
evaluating how this may be
incorporated into the technology for
inclusion in a subsequent release of the
software. The rule is drafted with
sufficient flexibility to accommodate
such a future modification without
requiring revision of the rule.
C. Proposed § 1102.12(c)—What Must
Be Submitted
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
the report; includes the manufacturer’s
verification of the truth and accuracy of
its comment; includes a manufacturer’s
affirmative request that its comment be
published; and consents to such
publication. These requirements must
be met for the manufacturer’s comment
to be published in the Database.
We received no comments on this
provision. On our own initiative,
however, we have finalized this section
with clarifications. Section 1102.12(c)
has been corrected to state that
manufacturer comments will be
published subject to § 1102.24 (on
confidential information) and § 1102.26
(on materially inaccurate information).
In addition, § 1102.12(c)(2) clarifies that
every report of harm has a unique
identifier that must be stated by the
manufacturer or private labeler
submitting a comment on a report of
harm.
d. Proposed § 1102.12(d)—Information
Published
Proposed § 1102.12(d) would explain
that the Commission will publish a
manufacturer’s comments and the date
such comments were submitted to the
CPSC in the Database.
No comments were received on this
section of the proposed rule. However,
on our own initiative, we clarified that
a manufacturer’s comments will be
published in the Database subject to
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§ 1102.24 (on confidential information)
and § 1102.26 (on materially inaccurate
information).
e. Proposed § 1102.12(e)—Information
not Published
Proposed § 1102.12(e) would explain
that the Commission will not publish
the actual consents and verifications
obtained from the manufacturer for such
publication.
We received no comments on this
provision, and have finalized it without
change.
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.
We received one comment on this
section of the rule, which we have
finalized without modification.
Comment 61—One commenter states
that mixing recall information with
incident report information may cause
confusion, and that recall information
must be clearly identified.
Response—Including recall
information in a product search is vital
to Database users, so that they can
immediately see whether a product has
been recalled, in addition to viewing
reports of harm involving the product.
Accordingly, the search display screen
will clearly identify recall information.
Reports also will be displayed in a
manner that identifies the nature of
such information. Both will be clearly
distinguishable as separate items in the
Database.
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4. Proposed § 1102.16—Additional
Information
Proposed § 1102.16 would state that
in addition to reports of harm,
manufacturer comments, and recall
notices required to be in the Database
pursuant to section 6A(b)(1) of the
CPSA, the Database will include any
additional information that we
determine is in the public interest,
consistent with the requirements of
section 6(a) and (b) of the CPSA.
Several comments were received
related to this section, which has been
finalized without modification.
Comment 62—One commenter states
that this provision does not specify who
may submit the additional information
that the CPSC decides to include in the
Database. The commenter states that
this section provides the ideal location
for industry members—other than the
named company or other professional
organization—to comment on the
incident or injury.
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Response—Section 6A(b)(3) of the
CPSA states that, in addition to the
reports of harm received by the
Commission, the Database shall include,
consistent with the requirements of
Section 6(a) and (b) of the CPSA, any
additional information that we
determine to be in the public interest.
The statute does not require that
manufacturers or private labelers, other
than those who are identified in a report
of harm, be able to submit comments on
that report of harm. Therefore, we are
not revising the rule as suggested by the
commenter. However, where
information is not contained in a report
of harm, but is contained in other
material that we may be reviewing for
release under the FOIA, we will follow
the provisions of section 6(a) and (b) of
the CPSA for any proposed disclosure of
such information.
Comment 63—Some commenters say
that we should act expeditiously to
include staff reports, research, and other
relevant information in the Database
pursuant to section 6A(b)(3) of the
CPSA and proposed § 1102.16.
Response—The initial Database
requirements are set up so that the
initial Database launch will only
include the statutorily required
contents, including reports of harm,
manufacturer comments, and recall
information. This provides us with the
opportunity to observe and analyze the
operation of the Database, and to assess
how many reports of harm are actually
submitted; how many meet minimum
requirements and are sent to
manufacturers for comment; and how
many, and in what time frame, reports
are posted to the Database. Therefore,
the decision to include additional
information in the Database under this
provision, such as staff research reports,
reports of epidemiologic in-depth
investigations, or any other information,
will be determined based on the
operational requirements of the
Database, and after sections 6(a) and (b)
of the CPSA have been followed. Note,
however, that many Commission staff
research and reports are already
publicly available on the Commission’s
Web site at https://www.cpsc.gov and
will continue to be available at this site.
C. Proposed Subpart C—Procedural
Requirements
1. Proposed § 1102.20—Transmission of
Reports of Harm to Identified
Manufacturer or Private Labeler
Proposed § 1102.20 would describe
the information contained in a report of
harm that would and would not be
transmitted to a manufacturer or private
labeler.
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a. Proposed § 1102.20(a)—Information
Transmitted
Proposed § 1102.20(a) would state
that the name and contact information
of the submitter of a report of harm,
photographs, and medical records will
not be transmitted to the manufacturer
or private labeler without consent of the
submitter and any other legally
responsible person (in the case of
photographs and medical records).
We received several comments on this
section, which resulted in no changes.
However, on our own initiative, we
clarified the opening sentence of this
section to clearly state that
manufacturers and private labelers will
receive all information on a report of
harm, provided that the report meets the
minimum requirements for publication.
We also clarified (a)(1) to indicate that
written consent could be in the form of
checking a box on a report of harm. We
also revised the discussion of
‘‘photographs that will not be
transmitted’’ to conform the language
used to the change to 1102.10(f)(3)
discussed in response to comment 47
above.
Comment 64—Some commenters ask
whether manufacturers will be notified
when an incomplete report of harm is
filed.
Response—Although the comment
does not explain the reference to
incomplete reports of harm, we interpret
the commenter’s statement as asking
whether manufacturers will be notified
if an incomplete report of harm is filed.
Under section 6A(b)(2) of the CPSA, we
would not notify a manufacturer or
private labeler if a report of harm does
not contain the minimum requirements
for publication as set forth in the statute
and § 1102.10(d). Therefore, we would
not transmit such a report to the
manufacturer or private labeler for
comment, nor publish such a report in
the Database. However, under section
6(c) of the CPSA, the Commission has
adopted a practice of notifying
identified manufacturers in incident
reports that it receives from submitters,
based on the requirement in section 6(c)
of the CPSA to ‘‘communicate to the
extent practicable information as to any
significant risk of injury associated with
such product.’’ Therefore, to the extent
that a specific product and
manufacturer is identified in an
incomplete report of harm, we will
continue to follow the practice of
notifying the manufacturer pursuant to
section 6(c) of the CPSA. Although such
information will not be published in the
Database, the information will continue
to be transmitted to the manufacturer for
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possible comment and release under
section 6(b) of the CPSA.
Comment 65—One commenter states
that the consumer’s consent about
whether his or her contact information
should be provided to the manufacturer
should be displayed in the Database.
The commenter says that providing
such information is important, and that
the absence of consent for contact
information to be transmitted to the
manufacturer may indicate less
capability to verify the report. The
commenter claims that the preamble to
the proposed rule stated that this
information would be displayed, but the
codified text did not.
Response—We are not revising the
rule as suggested by the commenter. We
recognize that section 6A(b)(2)(B)(iv) of
the CPSA requires a report of harm
submitted for inclusion into the
Database to include contact information
for the person submitting the report, and
that section 6A(b)(3) of the CPSA
authorizes the Commission to include in
the Database ‘‘any additional
information it determines to be in the
public interest.’’ However, it is difficult
to see how a submitter’s decision not to
transmit his or her contact information
to a manufacturer or private labeler
could be sufficiently in the public
interest to display in the Database.
Submitters may have a variety of
reasons for withholding their consent to
transmit contact information, including
simply an unwillingness to talk to the
manufacturer. In any case, the
submitter’s refusal to consent to the
transmission of his or her contact
information does not necessarily reflect
on the accuracy or truthfulness of the
information presented in the report of
harm. Given that a submitter’s reasons
for withholding consent may be varied,
we do not see any public interest in
having the Database declare whether the
submitter of a report of harm consented
to the transmission of his or her contact
information to the manufacturer or
private labeler. Thus, we have chosen
not to display this information.
Absence of submitter contact
information is not a bar to an
investigation, but we recognize that the
absence of contact information may
make it more difficult for firms to
investigate specific reports of harm.
However, if a manufacturer or private
labeler believes that such information
would have been helpful, it can address
that fact in a comment on the report of
harm.
b. Proposed § 1102.20(b)—Limitation on
Use of Contact Information
Proposed § 1102.20(b) would follow
the statutory limitation in section
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6A(b)(6) of the CPSA on the use of a
submitter’s contact information by the
manufacturer or private labeler for
verification only and no other purpose.
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.
We have finalized this provision by
deleting the words ‘‘and/or’’ after
proposed § 1102.20(b)(3); and adding a
new (b)(5) Incident Date; and a new
(b)(6) Category of submitter, consistent
with the changes to § 1102.10(d) for
minimum requirements of information
contained in a report of harm; by
replacing the words ‘‘is limited to’’ to
‘‘may include;’’ and making
typographical changes.
Comment 66—Some commenters state
that we should discourage
manufacturers, retailers, distributors
and their representatives from harassing
or intimidating submitters of reports
because the consumer will suffer harm
from misuse of the contact information.
The commenters claim that the
Commission should set the expectation
that serious consequences will occur if
a manufacturer misuses such
information. In contrast, another
commenter states that the Commission
should make the submitter’s name and
contact information available if
requested by the manufacturer or
retailer, and that contact of a consumer
by a manufacturer should not be
restricted once the consumer consents.
Commenters argue that the language is
inflexible in this sense.
Response—With regard to the
comment on making a submitter’s name
and contact information available if
requested by a manufacturer or retailer,
or not restricting contact between a
manufacturer and submitter after the
submitter has consented to have his or
her contact information sent to the
manufacturer, the commenter may have
misinterpreted the statute. Section
6A(b)(6) of the CPSA explicitly
prohibits us from disclosing a
submitter’s contact information if the
submitter has not consented; and, as
explained immediately above, it also
declares that the consumer information
provided to a manufacturer may not be
used or disseminated to any other party
for any purpose other than verifying a
report. We agree that the manufacturer
can verify any information in the report
of harm transmitted to them. We have
revised the rule to ensure consistency
with the statute. For the same reason,
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76849
however, we are not revising the rule to
allow manufacturers to use the
information it receives from the
consumer for purposes unrelated to
verifying the report (such as offering a
remedy to the consumer). However, we
believe that section 6A(b)(6) of the
CPSA and the final rule do not prohibit
a consumer from asking the
manufacturer to provide a remedy.
Further, Section 6A(d) of the CPSA
requires the Commission to report to
Congress annually on the Database. The
report must include information on the
Database’s operation, content,
maintenance, functionality, and cost.
Therefore, we intend, as part of our
review of the Database’s operation and
functionality, to determine if a
manufacturer or private labeler has
treated contact information transmitted
to them according to the verification
parameters outlined in section 6A(b)(6)
of the CPSA. Section 6A(b)(6) of the
CPSA expressly states, in part, that
‘‘Consumer information provided to a
manufacturer or private labeler * * *
may not be used or disseminated to any
other party for any purpose other than
verifying a report’’ submitted under
section 6A(b)(1)(A) of the CPSA.
c. Proposed § 1102.20(c)—Timing
Proposed § 1102.20(c) would explain
the timing of the transmission of reports
of harm to the manufacturer. The
proposal would identify circumstances
where transmission of a report of harm
to the manufacturer within five business
days may be impracticable. The
circumstances would 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.
We received no comments on this
provision. We have finalized this
section with modification, adding a
sentence to reiterate that if the
Commission cannot determine the
identity of the manufacturer or private
labeler of a product from the report of
harm, or otherwise, the report of harm
will not be included in the Database. We
have also made typographical changes
and a grammatical correction to remove
the additional ‘‘or’’ at the end of
§ 1102.20(c)(2).
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d. Proposed § 1102.20(d)—Method of
Transmission
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 Business Portal. The proposal
would explain that if a manufacturer or
private labeler has not registered for
electronic transmission, we will send
reports of harm through the United
States mail to its principal place of
business, unless the Commission selects
another equally effective method of
transmission.
One comment was received related to
this section, which has been finalized
without substantive modification. On
our own initiative, we have corrected an
erroneous cross reference in this
provision by changing (e) to (f), and
finalized this section with that
typographical change.
Comment 67—One commenter states
that the final rule should allow for input
and comments from licensors so that
timely and accurate notification can be
made to the correct product
manufacturer or product labeler. The
commenter explains that the proposed
rule does not account for the fact that
many consumer products on the market
are licensed products that are
manufactured by entities other than the
brand owner. A licensor owns
intellectual property, such as characters
and logos, which it licenses for use on
consumer products. The commenter
states that most consumers will
misidentify a licensor as a manufacturer
or private labeler, noting that the brand
owner is not necessarily the product
manufacturer. The commenter asserts
that false information will be published
in the 10 day time frame when licensors
are incorrectly identified and no
comment regarding misidentification is
made in a timely fashion.
Response—We disagree regarding the
transmission of reports of harm to
licensors who do not fall within the
definition of a ‘‘manufacturer’’ or
‘‘private labeler’’ as set forth in the
CPSA. Section 6A(c)(1) of the CPSA
requires the Commission to transmit
reports of harm that meet the minimum
requirements for publication to ‘‘the
manufacturer or private labeler
identified in the report.’’ Under section
3(a)(11) of the CPSA, a ‘‘manufacturer’’
is defined as ‘‘any person who
manufactures or imports a consumer
product.’’ Section 3(a)(12)(A) of the
CPSA defines a ‘‘private labeler’’ as ‘‘an
owner of a brand or trademark on the
label of a consumer product which bears
a private label.’’ The CPSA further
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clarifies that ‘‘[a] consumer product
bears a private label if (i) the product (or
its container) is labeled with the brand
or trademark of a person other than a
manufacturer of the product, (ii) the
person with whose brand or trademark
the product (or container) is labeled has
authorized or caused the product to be
so labeled, and (iii) the brand or
trademark of a manufacturer of such
product does not appear on such label.’’
Thus, a licensor who meets the
definition of a manufacturer or private
labeler may register with the
Commission to receive notice of reports
of harm. If a licensor is named by the
submitter of a report of harm, and the
named entity appears to be a
manufacturer or private labeler, it will
receive notice of a report of harm.
With regard to the ‘‘wrong’’ firm
receiving notice of a report of harm,
firms are free to make their own
agreements regarding when they must
inform certain business partners of
reports of harm. We also encourage
firms receiving notice of a report of
harm that incorrectly identifies them as
the responsible manufacturer or private
labeler of a product to immediately
inform the Commission so that we can
stop the 10 day clock for publication of
the report in the Database, if
appropriate. Timing is critical here
because if the recipient of the report of
harm is not the manufacturer or private
labeler, the Commission can decide not
to post the report either because it is
materially inaccurate or because it has
determined that the report of harm is
missing one of the minimum
requirements for publication. Given our
experience with the incident reporting
system, we recognize that consumers
may misidentify the product
manufacturer or private labeler, and
such claims of material inaccuracy
generally are resolved quickly and
easily if the receiving firm provides
sufficient information. Firms have an
incentive to immediately report errors to
prevent reports of harm from being
published in the Database that
misidentify them as the manufacturer or
private labeler.
e. Proposed § 1102.20(e)—Size Limits of
Manufacturer Comments
Proposed § 1102.20(e) would state
that we may, in our discretion, limit the
data size of comments, including
attachments, where such comments and
attachments may negatively impact the
technological or operational
performance of the system.
No comments were received on this
section, which has been finalized
without modification.
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f. Proposed § 1102.20(f)—Manufacturer
Registrations
Proposed § 1102.20(f) would describe
the process of manufacturer registration
in the Business Portal and would
require a manufacturer or private labeler
to provide updated contact information.
Several comments were received on
this section, resulting in no changes to
the final rule.
Comment 68—One commenter states
that we should adopt procedures to
ensure and confirm that the correct
manufacturer received the report of
harm and actively promote registration
by manufacturers. The commenter also
suggests developing and adopting
procedures informing unintended
recipients to notify the CPSC
immediately to stop the clock so that the
report of harm does not get posted
without a chance for the correct
manufacturer to comment. The
commenter notes that we should
develop a procedure to verify that a
manufacturer is notified and that
transmitted incident reports are actually
received by the manufacturer
verification in the Business Portal.
Response—A manufacturer or private
labeler that registers a user account with
us will receive an email transmission of
batched reports of harm to its registered
users and will have user privileges to
the Web based Business Portal where
further details of the reports of harm
will be accessible. Manufacturer or
private labeler users will be enabled
through the Business Portal to notify us
if the product is not their own.
Manufacturers or private labelers should
notify us immediately so that we may
determine disposition of the report of
harm. Additionally, the manufacturer or
private labeler may invoke the
provisions governing materially
inaccurate information as described in
§ 1102.26. We cannot identify any
procedure that would ensure that the
correct manufacturer or private labeler
received notice of a report of harm when
we use an electronic transmission of
such report. Support of email received
or read notification depends on the
email client 1 used by the manufacturer
or private labeler. Many popular email
clients do not support this feature.
There are security and permission
considerations even for email clients
that do support this feature. Therefore,
it is currently not feasible to develop a
meaningful validation procedure for
manufacturer or private labeler receipt
verification for electronically
1 An e-mail client is software used to manage a
user’s e-mail.
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transmitted notifications of a report of
harm.
Comment 69—One commenter asks
whether a foreign corporation can
register in the Business Portal or
whether registration would be limited to
domestic entities only.
Response—We encourage registration
by foreign manufacturers and private
labelers of consumer products. The
statute does not contain any restrictions
related to the incorporation status of a
manufacturer or private labeler.
Registration by foreign manufacturers
and private labelers will facilitate
communication of potentially important
product safety information to the entity
with the most knowledge about the
product identified in a particular report
of harm. The transmission of reports of
harm to foreign manufacturers and
private labelers, combined with the
resulting opportunity to comment,
including the opportunity to make a
claim of inaccurate information in a
report of harm, will also contribute to
the accuracy of the information in the
Database.
g. Proposed § 1102.20(g)—Manufacturer
Comments Received After One Year
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 not to publish a
manufacturer’s comment 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.
We received one comment on this
section, resulting in a change to the final
rule deleting the phrase ‘‘received after
one year’’ from the section heading and
deleting the words ‘‘if such comment is
received more than one year after
transmission of the report of harm to the
manufacturer or private labeler.’’
Comment 70—One commenter states
that comments should be posted to the
Database regardless of when we receive
them. The commenter states that the
proposed rule contains no explanation
or justification for a one year time limit
on comment submissions, and argues
that the statute requires publication,
without such a time limitation. The
commenter adds that many reasons for
a delay exist, including, for example,
where an incident is reported and the
submitter files a lawsuit much later, but
within a two year statute of limitations.
During such litigation, a manufacturer
will gain many facts during the
discovery period relating to the
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underlying incident report. The
commenter states that there should be
no limitation for submission of such
information. Also, allowing rejection of
comments after one year under an
amorphous ‘‘public interest’’ standard
will lead to arbitrary decisions and be
contrary to the statute, the commenter
asserts.
Response—While there was no
intention to create the appearance of a
per se one year limitation on the
submission of manufacturer and private
labeler comments in the proposed rule,
we recognize that many people may
have reasonably interpreted the
proposed rule this way. Further, we
agree with the commenter that
manufacturer comments relating to a
report of harm can provide helpful
information to consumers, no matter
when they are received and published.
Accordingly, we have removed any
language that suggests the Commission
would not post manufacturer comments
based upon the submission date of the
comment. Nevertheless, the
Commission strongly encourages
manufacturers and private labelers to
submit timely comments. The
Commission reserves the right to
determine whether it is in the public
interest to publish a manufacturer
comment. For example, it may not be in
the public interest for the Commission
to publish comments that, in the
unlikely event, contain language
reasonably described as lewd,
lascivious, or obscene. We added
language to this effect in the final rule.
2. Proposed § 1102.24—Designation of
Confidential Information
Proposed § 1102.24 would address
‘‘confidential information’’ and would
set forth criteria that must be followed
to assert a claim of confidentiality. The
proposed rule would define when
claims should be submitted, the
affirmative statements required to assist
the Commission in an evaluation of the
merits of the request, and the procedure
we will follow for determining whether
the information claimed is or is not
confidential.
a. Proposed § 1102.24(a)—‘‘Confidential
Information’’ Defined
Proposed § 1102.24(a) would interpret
‘‘confidential information’’ in a manner
similar to its meaning in section 6(a) of
the CPSA 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).
We received one comment on this
section, which we have finalized
without change.
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Comment 71—One commenter
cautions about manufacturers and
others being overbroad with claims of
confidentiality in order to avoid public
sharing of safety hazards.
Response—We must redact those
portions of a report of harm that contain
confidential information as described
under section 6A(c) of the CPSA and
§ 1102.24. Most information submitted
in a report of harm is not likely to
contain confidential information
because the submitter is likely to be
someone who is not in a confidential
relationship with the manufacturer or
private labeler, or otherwise in a
position to obtain confidential
information. Therefore, broad claims of
confidentiality are unlikely. However,
for those claims on those portions of
information that are confidential, we
will follow section 6A(c)(2)(C) of the
CPSA, redact the portion of the report
that is confidential, notify the
manufacturer, and follow the statutory
and regulatory requirements for
publication of the remainder of the
report. If a claim does not meet the
standard for confidential information,
we will notify the claimant of the
determination that the information is
not confidential, and follow the
procedures for publication in the
Database. Finally, any manufacturer that
makes a claim of confidentiality must be
willing to assist in the defense of such
claim and this should also inhibit
overuse of confidentiality claims not
made in good faith.
b. Proposed § 1102.24(b)—Designation
of Confidential Information
Proposed § 1102.24(b) would state
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.
We received one comment on this
provision, which resulted in a change to
the final rule. In addition, we have
made typographical changes.
Comment 72A—One commenter
noted that because the contact
information of a submitter of a report of
harm is not required to be disclosed to
the manufacturer/private labeler, it may
be impossible for the manufacturer/
private labeler to meet the requirement
of § 1102.24(b)(4) that requires, as part
of the designation of confidential
information, the manufacturer to
identify its relationship to the victim
and/or submitter of the report of harm.
Response—We agree with the
commenter and have accordingly
changed this provision to state that this
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information is required to the extent it
is known to the manufacturer/private
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c. Proposed § 1102.24(c)—Manner of
Submission
Proposed § 1102.24(c) would describe
the manner of submission where
confidentiality is asserted for a
designated portion of a report of harm.
The proposal would allow submission
of confidentiality assertions in the same
manner as manufacturer comments
described in § 1102.12(b) and would
require such requests to be
conspicuously marked.
We received no comments on this
provision, and have finalized it without
change.
d. Proposed § 1102.24(d)—Timing
Proposed § 1102.24(d) would explain
that a request for confidential treatment
must be received in a timely manner. If
the request was received in a timely
manner, the Commission may, in its
discretion, withhold the report of harm
from publication in the Database until it
makes a determination regarding
confidential treatment.
We received several comments on this
section and have clarified Commission
policy regarding the treatment of a
request for a designation of confidential
information.
Comment 72B—Several commenters
address the timing of a determination of
a claim of confidential information in a
report of harm. One commenter states
that confidentiality claims should be
permitted only up until the day the
report is published in the Database.
Another commenter states that reports
identified as confidential should remain
in the Database while we review such a
claim. Another commenter states that
we must make a determination of
confidential information before posting
because most reports will not contain
confidential commercial data and,
because of the support necessary to
sustain a confidentiality claim,
manufacturers are unlikely to abuse
confidentiality claims. Another
commenter suggests that we set a time
limit to determine whether information
is confidential. One commenter states
that we should carefully manage
confidential business information in the
Database by providing additional
guidance on the interaction between
section 6 of the CPSA and
confidentiality determinations; the
commenter says we should consider
options, such as coded identifiers and
devices, to provide confidential
business information. Other
commenters state that protection of
confidential information is paramount
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and is protected under section 6(a) of
the CPSA. Some commenters add that
release of confidential commercial
information is a violation of 18 U.S.C.
§ 1905 and can cause serious
competitive harm.
Response—The final rule, at
§ 1102.24(b), sets forth the process by
which a manufacturer or private labeler
identified in a report of harm and who
receives a report of harm may: (1)
Review the report for confidential
information; and (2) ask that we
designate portions of the report as
confidential information. Section
1102.24(b) also describes the
information that must accompany the
submission of a claim of confidential
information and, as stated in the
preamble to the proposed rule (75 FR at
29160), the criteria are similar to the
requirements for submission of
confidential information under section
6(a) of the CPSA. Section 6A(c) of the
CPSA requires the Commission to redact
portions of reports of harm where such
portions are claimed as confidential, if
such information meets the criteria for
confidential information under 18
U.S.C. 1905 or is subject to Exemption
4 under 5 U.S.C. 552(b)(4). This process
is similar to the practice we currently
follow for determination of confidential
information under section 6(a) of the
CPSA. The operational design of the
Database Business Portal will allow
manufacturers to provide designations
of confidential information to be
submitted over a secure portal, and will
allow manufacturers to provide
comments through a secure portal.
Therefore, additional coded identifiers
would not be necessary. The
Commission anticipates that it will be
able to resolve most, if not all,
confidentiality determinations within
10 days of transmitting the report to the
manufacturer or private labeler, so long
as designations of confidentiality have
been raised in a timely manner. Further,
as discussed in response to comment 73
below, the Commission’s experience
suggests that it is exceedingly rare that
a report of harm will contain
confidential or trade secret information.
If for whatever reason we are unable to
make a confidentiality determination in
the time frame specified in the statute,
we will redact the alleged confidential
information until such a determination
is made. The rule specifies that the
burden of proof concerning confidential
information is on the manufacturer or
private labeler. However, because we
will, as a matter of policy, redact the
alleged confidential information before
publication, information that is claimed
as confidential cannot be displayed, as
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one commenter suggested, during this
time period when the Commission is
assessing whether the information meets
the standard for confidentiality.
Comment 73—Some commenters
would have us withhold publication of
manufacturer requests for confidential
treatment until we have made a
determination and set a time limit for
resolution.
Response—If we receive a request for
confidential treatment, we will review it
and withhold the information if it meets
the interpretation of confidential
information. We will follow already
established procedures for such a
review, as well as rely on our long
history in reviewing such information.
We also will follow the procedure
specified in section 6A(c)(1)(C) of the
CPSA for treatment of information we
deem not confidential, and for notifying
the manufacturer or private labeler of
that determination. Section 6A(c)(1)(C)
directs us to notify the manufacturer
and include the information in the
Database. The manufacturer may seek
action in U.S. District Court for removal
of such information from the Database.
With regard to designations of
confidential information, we already
have procedures for determining claims
of confidentiality under section 6(a) of
the CPSA, and thus, few, if any,
manufacturers and private labelers have
contested our determinations. Because
we already have a process for the
determination of confidential
information and have substantial
experience in making such
determinations pursuant to section 6(a)
of the CPSA, and because it is unlikely
that reports of harm will contain
confidential information, we have not
added additional requirements related
to designations of confidential
information to the final rule. We expect
that confidentiality claims that are
timely submitted to the CPSC will be
reviewed, and a determination will be
made, before the report of harm is
posted.
e. Proposed § 1102.24(e)—Assistance
With Defense
Proposed § 1102.24(e) would explain
that a request for confidentiality should
be made only 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.
We received no comments on this
provision, and have finalized it without
change.
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f. Proposed § 1102.24(f)—Commission
Determination of Confidentiality
Proposed § 1102.24(f) would describe
the procedure for notifying the
manufacturer or private labeler of a
determination of a confidentiality
designation. 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.
One comment was received regarding
this section. Typographical changes to
the final rule were made.
Comment 74—One commenter states
that records flagged as confidential
should remain in the Database during
the CPSC review period.
Response—Any request that we
receive designating a portion of a report
of harm as confidential will be reviewed
in accordance with the relevant case
law, and we will make a determination.
If the comment is received in a timely
manner and is substantiated, we will
make the determination before the
information is posted in the Database.
As stated in response to Comment 72, in
the unlikely event that we are unable to
make a determination in the time frame
specified, we will redact the alleged
confidential information while we
continue to make a determination.
g. Proposed § 1102.24(g)—Commission
Determination of No Confidentiality
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.
No comments were received on this
section of the rule. We have finalized
with typographical changes.
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h. Proposed § 1102.24(h)—Removal of
Confidential Information
Proposed § 1102.24(h) would explain
that a manufacturer or private labeler
may sue in the appropriate U.S. District
Court to seek removal of alleged
confidential information published in
the Database.
No comments were received on this
section of the proposed rule, and we
have finalized it without change.
3. Proposed § 1102.26—Designation of
Materially Inaccurate Information
Proposed § 1102.26 would contain the
definitions and procedures for how
claims of materially inaccurate
information in reports of harm and
manufacturer comments can be asserted
and how we will evaluate such claims.
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We have changed the heading of this
section to ‘‘Determination of Materially
Inaccurate Information.’’
a. Proposed § 1102.26(a)—Definition of
Materially Inaccurate Information
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 creates or has the
potential to create a substantially
erroneous or substantially mistaken
belief about information in a report of
harm. We linked the ‘‘substantially
erroneous or substantially mistaken’’
element to required information in the
report of harm.
Several comments were received on
the definition of materially inaccurate
information. In response to the
comments and to clarify our definition,
we have revised the definition
consistent with the Commission’s
original intent. In addition, on our own
initiative, we have revised the list of
fields that may contain materially
inaccurate information in
§ 1102.26(a)(1) to include the required
field, ‘‘Incident date.’’ In addition, we
have made typographical changes.
Proposed § 1102.26(a)(2) would define
‘‘materially inaccurate information in a
manufacturer comment’’ 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. We linked the
‘‘substantially erroneous or substantially
mistaken belief’’ element in a
manufacturer comment to specific
information set forth in
§ 1102.26(a)(2)(i) through (v), all of
which relate to information about the
product, any Commission investigation,
the identification of a responsible party,
and any corrective action or other action
taken by the manufacturer or private
labeler of the product.
Several comments were received on
the definition of materially inaccurate
information, resulting in some changes
to the final rule as described below. In
addition, we identified the description
of the product as information upon
which a claim of material inaccuracy
could be made. We have also made
typographical changes.
Comment 75—Some commenters
support the proposed definition of
materially inaccurate information and
state that it appears to cover material
information only and not superficial or
nonsubstantive errors. In contrast, a
commenter criticizes the definition of
materially inaccurate information as
setting too high a standard and states
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that we should adopt a standard of
reasonableness instead. The commenter
points to the standard in U.S. Securities
and Exchange Commission (‘‘SEC’’)
cases on misrepresentation and claims
that the SEC standard focuses on
whether the misrepresentation misled a
reasonable investor.
Response—A definition of materially
inaccurate information was proposed to
explain what we view to be material and
indicate that we were setting a high bar
as we did not want to waste resources
disputing nonsubstantive errors in
Database entries. Black’s Law Dictionary
defines ‘‘material’’ as ‘‘important’’ and a
representation ‘‘relating to a matter
which is so substantial and important as
to influence a party to whom the
representation is made’’ and ‘‘of such a
nature that knowledge of the item
would affect a person’s decision making
in a significant way.’’ In response to this
comment, we are revising the
definitions of materially inaccurate
information in a report of harm and a
manufacturer comment to read
‘‘information that is false or misleading,
and which is so substantial and
important as to affect a reasonable
consumer’s decision making about the
product.’’ This incorporates the concepts
outlined in the proposed definition,
follows the Black’s Law Dictionary
meaning of ‘‘material,’’ and captures the
commenter’s concern about
‘‘reasonableness’’ by indicating that
something is material if a reasonable
consumer using the Database might be
affected by the false or misleading
information.
Comment 76—Several commenters
object to the particular phrases used in
the definition. Two commenters claim
that ‘‘preconditions’’ in the proposed
definition create the potential to cause
confusion and inappropriate limitations
on what can be claimed to be materially
inaccurate from a report. These
commenters allege that we just want to
publish reports of harm and
manufacturer comments side by side,
and they argue that this is insufficient
to avoid reputational harm. The
commenters state that manufacturers
have a right not to have inaccurate
information in a government-sanctioned
Database. The commenters say that
preconditions create an inappropriate
limitation on what can be claimed to be
materially inaccurate from a report of
harm.
Response—We agree that the Database
should strive for accuracy. However, we
note that Congress also required a
disclaimer to be placed on the Database,
understanding that we would receive
information that would present
challenges in terms of content and/or
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descriptions of products. The proposed
definition of materially inaccurate
information was designed not only to
ensure that information that is
inaccurate and material could be
claimed and not published, but also to
ensure that information that was
inaccurate, but not material (such as a
non substantive mistake in a report of
harm), still would be subject to
manufacturer comment and later
publication in the Database. For
example, if a report of harm contains a
misspelling of the product brand name,
we would not consider this error as
materially inaccurate. If, however, it is
claimed that the report of harm
misidentifies the product or the
manufacturer, we would consider such
errors to be possible evidence of
material inaccuracy. We are cognizant of
the issues concerning harm to
reputation and will review claims of
material inaccuracy with such concerns
in mind.
Comment 77—One commenter would
have the definition relate to the key
elements required in the report of harm,
and states that the definition was correct
to the extent that it would define
information as materially inaccurate if it
is false or misleading in a significant
and relevant way. The commenter
would simplify the definition to
‘‘information that is false or misleading
in a significant and relevant way.’’ Other
commenters claim that the definition
contains redundant words. The
commenters state that the phrase ‘‘create
or have the potential to create a
substantially erroneous or substantially
mistaken belief in a Database user’’ is
redundant as compared to ‘‘false or
misleading in a significant and relevant
way.’’ The commenters would remove
the allegedly redundant text, and claim
it adds no value, and potentially creates
room for argument and subjective
interpretation of what a Database user
may or may not think, especially where
the CPSC is intent on limiting the scope
of comments on reports of harm.
Response—We adopted the referenced
descriptive words and phrases in the
definition to give context to evaluating
the information and to provide
additional guidance to submitters of
reports of harm, manufacturers, and
Database users as to what we mean by
‘‘materially inaccurate.’’ We view the
referenced words as descriptive and not
redundant. They emphasize that the bar
for determining materially inaccurate
information is a high one. One aspect of
the definition focuses on the
information stating that it must be false
or misleading. The other aspect of the
definition focuses on the Database user
indicating the allegedly inaccurate
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information must have a potential to
create a substantially erroneous or
substantially mistaken belief in the
Database user. We are revising the
definition in response to comments but
will still focus on these two aspects of
materiality which we do not believe to
be redundant.
Comment 78—One commenter objects
to the word ‘‘substantially’’ in the
definition as an additional,
unreasonably restrictive criterion with
no basis in the statute. The commenter
states that the rule fails to define the
word and inappropriately narrows the
types of false or misleading information
that would be considered materially
inaccurate. The commenter states that
the word ‘‘substantially’’ also creates an
extra step that the CPSC must interpret,
which will be inherently subjective and
will lead to arbitrary decisions about
whether to remove or correct
information that is concededly false or
misleading. The commenter also states
that the rule contains no criteria or
procedures that spell out how the
Commission staff will make such
determinations. The commenter states
that if the CPSC leaves the word
‘‘substantially’’ in the rule, we should
spell out how the evaluation will be
made and what qualifications CPSC staff
must possess to be assigned to make
such determinations.
Response—Our prior use of the word
‘‘substantially’’ in the definition of
materially inaccurate information was
consistent with the statute’s
requirement of materiality. ‘‘Substantial’’
goes to the element of materiality in a
Database user’s belief. Black’s Law
Dictionary defines ‘‘material’’ as
‘‘important’’ and a representation
‘‘relating to a matter which is so
substantial and important as to
influence a party to whom the
representation is made’’ and ‘‘of such a
nature that knowledge of the item
would affect a person’s decision making
in a ‘significant’ way.’’ However, our
revision of the definition addresses the
commenter’s concern. For example, if
we receive a report with a date of
incident identified, and then we receive
a manufacturer comment that the
product was not manufactured at the
time of the date of incident, we believe
that such a report, if properly
substantiated, would meet the definition
of materially inaccurate. With regard to
staff qualifications to make such
determinations, we have made
assessments regarding information
contained in incident reports since the
inception of the agency.
Comment 79—One commenter objects
to the word ‘‘liability’’ in determining
whether a manufacturer’s comment is
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materially inaccurate. Proposed
§ 1102.26(a)(2)(i) would include
‘‘liability’’ as information that could be
inaccurate in a manufacturer comment.
The commenter points out that if the
information were submitted under
section 15 of the CPSA and § 1115.12(a),
a company may deny that the
information it submits reasonably
supports the conclusion that its product
contains a defect that could create a
substantial product hazard. The
commenter states that manufacturers
may wish to make a similar statement in
response to a report of harm to be
included in the Database indicating that
the report does not reasonably support
the conclusion that the product contains
a defect. The commenter states that
proposed § 1102.26(a)(2)(i) could be
construed as a statement of liability, and
thus might expose the manufacturer’s
comment to challenge by the submitter
or some other interested party as being
materially inaccurate because the
product is defective. The commenter
states that such a scenario would set up
a ‘‘mini-litigation’’ in which the CPSC
essentially is being asked to make a
defect determination regarding the
product, under the guise of making a
determination regarding material
inaccuracy, as opposed to appropriately
conducting a preliminary investigation
of the potential product hazard. The
commenter contends that the Database
is not the appropriate venue for the
Commission to make a defect
determination, and the collateral effect
would be to complicate material
inaccuracy determinations regarding
manufacturer comments.
Response—The Commission agrees
that we do not want to set up a ‘‘minilitigation’’ regarding causation when we
are determining claims of material
inaccuracy. For this reason, we have
revised the rule to delete reference to
the nature, scope or cause of the harm
and liability. Instead, we have indicated
that manufacturers can claim material
inaccuracy regarding the harm or risk of
harm identified in the report.
b. Proposed § 1102.26(b)—Request for
Designation of Materially Inaccurate
Information
Proposed § 1102.26(b) would establish
the procedure for designating materially
inaccurate information. In the preamble
to the proposed rule (75 FR at 29161),
we asked whether this section should
include a burden of proof requirement
for materially inaccurate information
and, if so, what would be the meaning
of the term, and what standard would be
imposed under it.
One comment was received, resulting
in the addition of a burden of proof
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requirement for claims of material
inaccuracy, as set forth in response to
Comment 80 below. We have made a
clarification in the heading which now
reads ‘‘(b) Request for determination of
materially inaccurate information.’’
Comment 80—One commenter states
that we should impose a burden of proof
requirement in § 1102.26(b), the same
way we defined it for making a
determination and supporting a claim of
confidential information in § 1102.24(b).
A requester seeking a designation of
materially inaccurate information
should bear the burden of proof on
defining the information that is
materially inaccurate and supporting
the claim.
Response—We agree that we should
impose a burden of proof requirement
for materially inaccurate information,
similar to how we request designation
and support for confidential information
claims. Therefore, we have revised
§ 1102.26(b) to state that a requester
seeking removal or correction of alleged
materially inaccurate information,
before or after posting in the Database,
bears the burden of proving that such
information meets our definition of
materially inaccurate information and
that such requester bears the burden of
supporting the claim of materially
inaccurate information with
documentation or other information
showing that the information meets the
requirement.
c. Proposed § 1102.26(c)—Manner of
Submission—Length of Request and
Expedited Review
Proposed § 1102.26(c) would explain
the manner of submission for
manufacturers and private labelers and
all other requesters. The proposal also
would address the length of the request
and would allow for expedited review
of requests that are no more than five
pages in length, including attachments.
This provision also would state that,
regardless of the length, all submissions
would be reviewed.
We received several comments on this
section, which resulted in no changes to
the final rule.
Comment 81—One commenter
suggests that the expedited review
proposal is inherently flawed and that
we should rethink this proposal.
Sections 1102.26(c) and 1102.26(i)(2) of
the proposed rule provide
manufacturers and private labelers with
a short, 10-business-day time frame to
allege a material inaccuracy, meet the
burden of proof, and comply with the
lengthy evidentiary requirement.
Companies must decide whether to
provide: (a) Sufficient evidence, which
may be greater than five pages, and risk
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that the inaccurate report of harm be
posted before review by the Commission
staff, or (b) a shortened version of the
evidence, which meets the five pages or
less requirement, and then have the
report of harm reviewed and posted to
the Database because of insufficient
evidence of material inaccuracy.
Response—The provision for
expedited review is based on the
statutory time frames in section 6A(c)(3)
of the CPSA, where we must publish the
reports of harm not later than the tenth
business day after transmission of such
report to the manufacturer or private
labeler. A determination of material
inaccuracy is tied to the substance of the
claim and should be capable of
expression in five pages. Our experience
in reviewing comments submitted under
section 6(b) of the CPSA is that
manufacturers often repeat comments
and arguments; this repetition adds to
the length, but not necessarily to the
substance, of an argument. We
emphasize that we will accept any
length of submission, but that it may be
more difficult to make the required
determinations in the time allotted if the
length and content are voluminous. The
expedited review procedure is designed
to give manufacturers a process for
responding quickly and in a way that
will allow us to evaluate their claims
more quickly. Therefore, we are not
revising this provision.
Comment 82—One commenter states
that we should provide for an expedited
claim review within the 10 day period
before publication of the report of harm
in the Database. Another commenter
states that an expedited review gives the
CPSC no deadlines to complete such a
review, and that such a completion time
should be provided. The commenters
state that the expedited review
provision does not ensure that claims of
material inaccuracy will be resolved
before the report is published in the
Database. Another commenter states
that a five page limit for expedited
review is unreasonably restrictive
adding that we did not provide any time
period for investigating or resolving a
claim. Another commenter would revise
the rule so that, where a manufacturer
limits a claim to 10 pages, including
attachments, and submits the request
within five days of receiving the report
of harm, the CPSC would render a
decision within five days, before the
report of harm is posted in the Database.
Another commenter urges us to
implement specific procedures for
handling expedited claims of material
inaccuracy to resolve them within one
to three business days before
publication, and says we should
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prioritize resolution of these claims
quickly and fairly.
Response—We will try to decide
claims of material inaccuracy as
expeditiously as possible, but it would
be impractical to revise the rule to
impose specific time frames on our
decision making process. The number of
claims of material inaccuracy and the
possibility of other priorities that
demand our attention may affect the
timing of our decisions. We will use our
best efforts to review submissions and
make determinations within the 10business-day time frame, when
submissions are received timely. But if
no determination is made by the tenth
business day, we must post the report of
harm in the Database pursuant to
section 6A(c)(3)(A) of the CPSA. Once a
report of harm has been posted in the
Database, we will follow the procedures
set forth in section 6A(c)(4)(B) of the
CPSA, and § 1102.26(h), for removing
any material inaccuracies after such a
determination is made.
Comment 83—One commenter states
that proposed § 1102.26(c)(3) would
allow any person to challenge a
comment as materially inaccurate,
including many persons who have no
relationship to the alleged incident,
such as class action attorneys,
competitors, and others who might have
an inappropriate motive to claim
materially inaccurate information. The
commenter states that the Commission
would be creating a ‘‘free for all’’
atmosphere by encouraging such people
to collaterally battle about issues using
the CPSC’s Database. The commenter
states that the proposal would have the
CPSC serve as referee. The commenter
states that the value of inviting such
comments is extraordinarily low;
therefore, the commenter would have us
delete the provision.
Response—Nothing in the statutory
text allows us to limit who may submit
a claim of material inaccuracy.
Accordingly, we will consider any claim
of material inaccuracy as long as it
meets the minimum requirements for
submission of a claim and is
appropriately supported.
d. Proposed § 1102.26(d)—Timing of
Submission
Proposed § 1102.26(d) would address
the timing of a request for a
determination of materially inaccurate
information and state that, if a request
was received prior to publication, we
may withhold the report of harm from
publication in the Database until we
make a determination. Absent such a
determination, the report of harm would
publish on the tenth business day after
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we transmitted the report to the
manufacturer or private labeler.
We received several comments
regarding this section, which resulted in
a clarification of the final rule. The
section previously stated that the
Commission ‘‘may withhold a report of
harm from publication in the Database
until it makes a determination’’ and will
now read that the Commission ‘‘cannot
withhold a report of harm from
publication in the Database until it
makes a determination.’’ The word
‘‘generally’’ has also been deleted from
the next line.
Comment 84—Several commenters
note that we did not impose any time
frame by which our determinations had
to be made, and that the statute gives us
seven days to post the determination in
the Database after we have concluded
our investigation. Some commenters
state that, without a time frame
reference, the determination could take
forever, so we should either set a
deadline for determination, or delay the
posting of reports of harm that are
challenged until a determination is
made. The commenters also note that
the need for an expedited determination
would be removed if we make a
determination before posting, or adopt a
time limit. Other commenters assert that
we should clarify both the requirement
for challenging a report as false or
inaccurate within the response window
and the process for filing such
challenges if relevant information
becomes available beyond the response
time. Another commenter says that any
report undergoing a material inaccuracy
review after publication should be
identified or marked in the Database so
that users will be aware that the report
is undergoing such a review. Other
commenters suggest that we identify
and suspend from the 10-day
publication requirement, any
information in a report of harm
identified as materially inaccurate,
pending investigation by our staff, until
we have completed the investigation or
made necessary corrections.
Response—Section 6A of the CPSA
allows us to review information alleged
to be materially inaccurate, both before
the information is published in the
Database and after it is published.
Requests from commenters that we
suspend the 10-day publication
requirement and not publish any
information in a report of harm claimed
to be materially inaccurate until we
have completed an investigation caused
us to re-examine the requirements of the
statute. The plain language of section
6A(c)(4)(A) states that if the
determination that information is
materially inaccurate has been made
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prior to posting, then the Commission
must remove, correct, or add
information to correct the materially
inaccurate information. Further, read
together, sections 6A(c)(3)(A) and
6A(c)(4)(A) of the CPSA require that we
must publish reports of harm or
manufacturer comments in the first
instance, not later than the tenth
business day after transmission to the
manufacturer unless we have
‘‘determined’’ that the information is
materially inaccurate. The rule has been
revised to ensure consistency with the
statute.
Moreover, section 6A(f) of the CPSA
states that reports of harm included in
the Database are not subject to section
6(b) of the CPSA. Allowing delay of the
posting of reports of harm beyond the
tenth business day while the
Commission considers a claim of
material inaccuracy would be
tantamount to reinstating section 6(b) of
the CPSA with regard to that report of
harm. Such a result would be
inconsistent with the statute as Congress
intentionally excluded reports of harm
from section 6(b). Additionally, two
provisions in section 6A contemplate
that the Database may contain
materially inaccurate information.
Section 6A(b)(5) of the CPSA requires a
disclaimer regarding the accuracy of the
data. Section 6A(c)(4)(B) of the CPSA
provides a mechanism for removal of
information determined to be materially
inaccurate by the Commission. As
evidenced by the statute, Congress
balanced the accuracy of the
information in the Database with the
public’s need for more immediate access
to public safety related data. The better
reading of Congressional intent is not to
upset this balance.
Our timeline for any investigation of
whether information is materially
inaccurate once it has been published
will depend on an evaluation of the
information claimed to be materially
inaccurate. We are not adopting an
arbitrary time frame based on estimates
of yet unknown information. The
Commission will endeavor to act on
such requests in a timely manner.
We also are not adopting the
suggestion to delay posting of the
information, especially if no
determination can be made from the
information submitted about a claimed
material inaccuracy, because section
6A(c)(4) of the CPSA does not give us
that option. The final rule builds in a
process within the confines of the
statute to address the timing concerns
expressed by stakeholders. The rule
creates an electronic process for
notification of manufacturers and
private labelers of reports of harm,
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thereby expediting transmission of the
reports for comment. Recognizing the
10-day time frame built into the statute,
by this rule, the Commission has created
a fast track review system expediting
review of claims of material
inaccuracies to ensure that
manufacturers’ concerns are addressed
in a timely fashion. While we can
address manufacturers’ comments
operationally by building systems such
as these to ensure a timely comment and
response process, we cannot ignore the
timelines built into the statute. Nor
would we want to do so as the purpose
of the Database is to provide critical
safety information to consumers who up
until now have not had access to
incident data in a timely manner. If
information has not been determined to
be materially inaccurate, it must be
published in the Database. Finally, the
statute does not require us to designate
that any such report is under
investigation for material inaccuracy,
and we decline to add such information
to the Database.
Comment 85—One commenter states
that when a prima facie case of
inaccuracy is made, we should exercise
our discretion not to publish the report
of harm pending confirmation of the
veracity of the claim.
Response—Section 6A(c)(4) of the
CPSA requires that if we determine
information in a report of harm or a
comment is materially inaccurate prior
to posting the information in the
Database, we must take one of three
specific options to address the material
inaccuracy. Section 6A(c)(3) of the
CPSA requires that we publish reports
of harm (that otherwise meet the
requirements for publication) not later
than the tenth business day after the
date we transmit it to the manufacturer.
Moreover, section 6A(c)(3) also requires
publication of manufacturer comments
upon request. Unless we have
determined that the information in the
report of harm or the comment is
materially inaccurate, we must publish
the report or comment in the Database.
The language ‘‘except as provided in
paragraph 4(A),’’ allows us to withhold
from publication any information in a
report of harm or a manufacturer
comment where we can make that
determination before posting based on
the claim submitted. However, absent
such a determination, we must publish
a report of harm or manufacturer
comment. We do not have authority,
beyond what is specified in the
referenced statutory provision, to
withhold from publication a report of
harm or manufacturer comment absent
a determination of material inaccuracy.
We must be provided with legitimate
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and substantiated information
supporting such claims and have built
an expedited review system to respond,
within the confines of the statute, to our
stakeholders’ timing concerns. We will
not withhold from publication any
report of harm or manufacturer
comment where such claim is
unsupported.
e. Proposed § 1102.26(e)—Assistance
With Defense
Proposed § 1102.26(e) would explain
that a manufacturer or private labeler’s
request for a determination of material
inaccuracy should be made only by
those who intend in good faith to assist
in the defense of the correction of a
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 Commission
believes that this provision requires
those seeking a determination that
information in a report of harm or
manufacturer comment is materially
inaccurate to stand behind their
assertion where the Commission is
being sued to compel disclosure of such
information.
We received no comments on this
provision, and have finalized it without
change.
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f. Proposed § 1102.26(f)—Notice
Proposed § 1102.26(f) would state that
we will notify the person or firm
requesting a determination regarding
materially inaccurate information and
the method of resolution after resolving
such a request.
We received one comment related to
this section of the proposed rule, but
have finalized it without modification.
Comment 86—One commenter states
that the proposed rule may be fatally
flawed for not providing adequate
procedural due process for
manufacturers and private labelers
regarding determinations of confidential
and materially inaccurate information.
For example, the rule does not specify:
Who will make initial determinations
about confidential information and
materially inaccurate information;
whether there will be an appeal
procedure to challenge initial
determinations, or whether
manufacturers and private labelers must
challenge determinations in a U.S.
District Court; whether an appeal is
provided, who will make decisions on
appeal; and whether there will be a
chance to submit evidence, or make oral
argument for the record.
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Response—We have not revised the
rule to add process mechanisms for the
determination of confidential and
materially inaccurate information. We
address the confidentiality requirements
under that provision.
First, Congress established a statutory
scheme that favors disclosure of reports
of harm over a lengthy review process
for manufacturers, such as what
currently exists for FOIA requests and
the requirements of section 6(b) of the
CPSA. One purpose of the Database is
to eliminate that lengthy process, and to
provide timely consumer access to
product safety information. Moreover,
the statute specifically states that
section 6(b) of the CPSA does not apply
to the publication of reports of harm in
the Database. The statute also does not
require us to provide a formal hearing
for those contesting our decision with
regard to confidential and materially
inaccurate information, and we decline
to use resources in this manner.
Second, with regard to claims of
material inaccuracy, manufacturers and
private labelers will have an
opportunity to review a report of harm
before publication, to comment on the
report, and to claim that a report
contains a material inaccuracy. We will
take claims of material inaccuracy
seriously, and give proper consideration
to each claim. If a claim of inaccuracy
is denied based on the information
provided, manufacturers and private
labelers may submit new or additional
information to establish the claimed
inaccuracy at any time.
Finally, with regard to due process,
the Commission believes strongly in
maintaining adequate due process
protections. Due process is a flexible
concept, depending on the
circumstances, and essentially requires
notice and an opportunity to be heard,
both of which are sufficiently present in
the final rule. Mathews v. Eldridge, 424
U.S. 319, 333 (1976); Silvernail v.
County of Kent, 385 F.3d 601, 604 (6th
Cir. 2004) (‘‘The essential elements of
due process are notice and an
opportunity to be heard.’’); United States
v. Shelton Wholesale, Inc., 34 F.Supp.2d
1147, 1151–53 (W.D. Mo. 1999) (holding
that informal consultations with
personnel empowered to correct a
mistake constitutes a due process
hearing in appropriate circumstances).
Thus, at this time, we do not think that
it is necessary to establish additional
process or appeal procedures in the
final rule without a statutory obligation
to do so.
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g. Proposed § 1102.26(g)—Commission
Determination of Material Inaccuracy
Before Publication
Proposed § 1102.26(g) would outline
the steps we would take if we
determined that information in a report
of harm or manufacturer comment is
materially inaccurate before it is
published in the Database. Under the
proposal, we would: (1) Decline to add
the 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 and
1102.12(c) are met, publish the
corrected 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 and 1102.12(c) are met,
publish the updated report of harm or
manufacturer comment in the Database.
We received one comment on this
section, with no resulting changes to the
rule. However, on our own initiative, we
have corrected two internal citation
errors, changing the cite contained in
§ 1102.26(g)(2) and (g)(3) from
§ 1102.10(c) to § 1102.10(d). We also
have reiterated that the Commission
may make determinations of material
inaccuracy without the necessity of a
request from an outside party and have
changed the word ‘‘may’’ to ‘‘shall’’ prior
to (1) to be consistent with the statutory
language. In addition, in 1102.26(g)(1)
we have changed the language to ensure
consistency with the statute. We also
made typographical changes.
Comment 87—One commenter states
that if we will not withhold reports with
pending material inaccuracy claims
until resolution, we should make a
determination that if a claim has merit,
but needs more investigation, we should
give an additional 10 business days to
resolve the claim before publishing.
Response—A determination that a
claim has merit is not a determination
of materially inaccurate information.
Section 6A(c)(4) of the CPSA requires a
determination of whether there is
materially inaccurate information to
resolve the claim. We do not believe
that section 6A(c)(4) of the CPSA allows
us to extend the time without making
such a determination of material
inaccuracy before publishing in the
Database. If we determine that the
information is not materially inaccurate,
it will be posted in the Database.
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h. Proposed § 1102.26(h)—Commission
Determination of Material Inaccuracy
After Publication
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 is materially
inaccurate. The proposal would state
that the Commission shall, no later than
seven business days after 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 corrected
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 the minimum requirements for
publication are met, we would maintain
the updated comment or report of harm
in the Database.
We received several comments on this
section of the rule, which has been
finalized without substantive
modification. However, on our own
initiative, we have corrected two
internal citations in § 1102.26(h)(2) and
(h)(3) from § 1102.10(c) to § 1102.10(d).
In addition, in 1102.26(h)(1) we have
changed the language to ensure
consistency with the statute. We have
also made typographical changes.
Comment 88—One commenter asserts
that the process for subsequent
correction or cure of materially
inaccurate information will not serve to
cure the material misinformation that
could happen where such information is
published and later downloaded. The
commenter states that the issue must be
resolved first, if submitted timely by the
manufacturer or private labeler, to
prevent the Database from being filled
with inaccurate information. The
commenter further states that the harm
resulting from posting inaccurate
information far outweighs any delay in
posting for investigation, and that
rectification after publication may be
too late to prevent significant brand
damage. Other commenters state that
the rule should clarify our discretion to
delay posting, and further should
provide that, where a manufacturer has
demonstrated a good faith process for
timely investigating reports of harm, we
should exercise this discretion to delay
publication of such reports until claims
of material inaccuracy are resolved.
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Response—Under section 6A(c)(3)(A)
of the CPSA, we do not have the
discretion to delay posting reports of
harm in the Database past the tenth
business day. We will use our best
efforts to resolve claims of material
inaccuracy before publication when
timely submitted, but absent such
determination, we will publish the
report on the tenth business day.
Congress provided in section 6A(c)(4) of
the CPSA that we could review the
claim of material inaccuracy after
publication, by investigating, and then
making such a determination. The
ability to investigate a claim after
publication is an acknowledgement that
there may be instances where we need
to review and investigate the
publication of materially inaccurate
information after publication. We
encourage the submission of timely and
specific comments that will be posted
along with the report of harm. In this
way, the manufacturer has the
opportunity to address and refute any
perceived issue relating to brand or
reputation.
In addition, section 6A(b)(5) of the
CPSA addresses the issue of the content
of the information in the Database, by
requiring us to provide a clear and
conspicuous notice to users of the
Database that we do not guarantee the
accuracy, completeness, or adequacy of
the contents of the Database. Section
1102.42 declares that this information
will also appear on all documents that
are printed from the user interface in the
Database. Therefore, we cannot create
procedures to delay publication of
reports of harm and manufacturer
comments beyond the parameters set
forth in section 6A of the CPSA.
Comment 89—Some commenters
express concern about potential
reputational harm resulting from
publicly viewable reports of harm,
regardless of the manufacturer’s ability
to comment on the report. One
commenter argues that as soon as a
report of harm is made available for
public download in the Database, the
report takes on a ‘‘new, independent
existence with no restriction to
guarantee it will not reappear in some
other forum,’’ even if the report was later
removed from the Database because it
contained inaccurate information.
Another commenter is concerned about
the reputational harm caused to a
licensor when the licensor is neither the
manufacturer nor the private labeler
and, therefore, does not have the
opportunity to submit a comment prior
to the publication of a (materially
inaccurate) report of harm in the
Database. The commenter’s concern is
that it would be difficult to ‘‘unring the
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bell’’ once materially inaccurate
information in a report of harm is
published in the Database, and this
concern is compounded by the fact that
the Database is operated by the Federal
Government.
Response—Proposed § 1102.26(b)
would allow any person or entity
reviewing a report of harm or
manufacturer comment, either before or
after publication in the Database, to
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.
Because the commenters appear to be
concerned about inaccurate information
in reports of harm, we also note that
§ 1102.26(a) would define materially
inaccurate information in a report of
harm, confining it to four categories of
information: (1) Identification of a
consumer product; (2) identification of
a manufacturer or private labeler;
(3) description of the harm or risk of
harm related to the use of the consumer
product; and (4) incident date. In many
instances, a manufacturer or private
labeler should be able to identify
quickly whether inaccurate information
in a report of harm exists with respect
to any of these categories.
As an additional matter, we will
provide expedited review of claims of
materially inaccurate information in a
report of harm, where the manufacturer
or private labeler files such request
within the page limits specified by
proposed § 1102.26(c)(1). In such cases,
we will attempt, where practicable, to
expedite the determination of a claim of
material inaccuracy before publication
of the report of harm in the Database.
Even if a report of harm is published in
the Database, if we have determined that
materially inaccurate information is
contained in such report, we will make
any necessary correction, exclusion, or
addition in no more than seven business
days having made such determination.
With regard to licensors that do not
receive notification of a report of harm,
as we stated earlier in response to
Comment 67, firms are free to make
their own agreements regarding when
they must inform certain business
partners of reports of harm.
Finally, we note the disclaimer that
will appear on any documents that are
printed from the Database, in addition
to being posted on every page, including
the entrance screen, of the Database.
The statutorily-provided disclaimer
states that the Commission does not
guarantee the accuracy, completeness,
or adequacy of the contents of the
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Database, especially concerning the
accuracy, completeness, or adequacy of
information submitted by persons
outside of the CPSC. The disclaimer,
combined with the various measures for
claiming inaccurate information in a
report of harm, balances the statutory
requirements for publication against the
interest in preventing inaccurate
information from being published in the
Database.
i. Proposed § 1102.26(i)—Commission
Discretion
Proposed § 1102.26(i)(1) would state
that we would exercise our discretion,
consistent with the statutory
requirements, to remove, correct, or add
information to correct materially
inaccurate information contained in a
report of harm or manufacturer
comment, and that we favor correction
and addition to correction, over
exclusion of entire reports of harm or
manufacturer comments.
We received several comments on this
section, which has been finalized
without substantive modification. On
our own initiative, we have corrected an
internal citation error in § 1102.26(i)(1)
from § 1102.10(c) to § 1102.10(d) and for
clarity have changed ‘‘addition to
correction’’ to ‘‘the addition of
information to correct.’’
Proposed § 1102.26(i)(2) would state
that if we received a request for
correction or exclusion of materially
inaccurate information from a
manufacturer within the recommended
five-page limit, we would attempt to
make an expedited determination of a
claim of material inaccuracy. The
proposal would explain that we
generally would publish reports on the
tenth business day after transmitting a
report of harm, where either the
recommended page limit of comments
has been exceeded, or where we
otherwise have been unable to make a
determination of material inaccuracy
prior to the statutorily mandated
publication date. We would make any
necessary correction, exclusion, or
addition not later than seven business
days after making a determination that
there is materially inaccurate
information in the report of harm.
Manufacturer comments would be
published at the same time as the report
or harm or as soon thereafter as is
practicable.
We received several comments on this
section, which we have finalized with
grammatical changes. In addition, we
have deleted the words ‘‘generally,’’
‘‘either the recommended page limit of
comments has been exceeded or where,’’
and ‘‘otherwise.’’ The sentence now
reads ‘‘the Commission will publish
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reports of harm on the tenth business
day after transmitting a report of harm
where the Commission has been unable
to make a determination regarding a
claim of material inaccuracy prior to the
statutorily mandated publication date.’’
These changes are consistent with
changes made to § 1102.26(d) and
would reconcile these two sections. As
stated earlier, it reflects our belief that,
as required by the statute, unless the
Commission has determined that the
information in the report of harm or the
comment is materially inaccurate, we
must publish the report or comment in
the Database on the tenth business day
after transmitting a report of harm.
Comment 90—One commenter states
that we should consider creating a more
expedited process than what we have
proposed to resolve issues as fully as
possible before publication.
Response—The process we have set
up for expedited review is designed to
enable us to make the required statutory
determination of material inaccuracy
without getting overwhelmed by
repetitive and duplicative claims. We
believe that the process we have set up
addresses this issue, and therefore, we
are not revising the rule as suggested by
the commenter.
Comment 91—One commenter states
that with respect to notifications to the
manufacturer about a claim in proposed
§ 1102.26(f) and (j) on material
inaccuracies, we should include text of
proposed redaction, correction, or
addition to be made to the disputed
report of harm. Otherwise, the
commenter claims that we would be
making arbitrary statements concerning
the inaccuracy.
Response—As section 6A(c)(4) of the
CPSA requires, we will notify the
manufacturer where we have
determined that information is
materially inaccurate. This notification
will include information on how we
propose to address the material
inaccuracy consistent with the statutory
provisions. As noted in § 1102.26(i)(1),
we will favor correction over removal
where we determine that such
correction can address the material
inaccuracy.
Comment 92—One commenter states
that unless necessary to permit
publication in the Database, we should
not rewrite the text of documents, but
should simply redact disputed
information to ensure that additional
issues regarding accuracy do not arise.
Response—Section 6A(c)(4) of the
CPSA gives removal as one option for
addressing information determined as
materially inaccurate in the Database.
Correction of the materially inaccurate
information is also a specified option to
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resolve a material inaccuracy claim.
Section 6A(c)(4) of the CPSA also allows
us to add information to correct the
material inaccuracy. We will not adopt
the suggestion to adopt redaction as our
only option and reject the suggestion
that we not correct such information
where correction would address the
material inaccuracy. While it is possible
that such a correction might somehow
create a new issue, we do not believe
that it would create more inaccuracy
issues. Manufacturers are free, however,
to point out to us any issue about the
correction after receiving notification of
it. We do not intend the correction
process to turn into a negotiation over
the correction language, but we will
provide notice to the manufacturer as
stated in § 1102.26(f).
j. Proposed § 1102.26(j)—Commission
Determination of No Material
Inaccuracy
Proposed § 1102.26(j) would describe
the process for what we would do if we
determine that the requested
information in a report of harm does not
contain materially inaccurate
information. The proposal would have
us notify the requestor of our
determination, and publish the report in
the Database, if it meets the minimum
requirements for publication.
Several comments were received
regarding this section, but no changes to
the final rule resulted from the
comments. However, on our own
initiative, we clarified in the final rule
that the Commission determination of
no material inaccuracy may be made to
a manufacturer comment, in addition to
a report of harm. We also made an
internal citation correction in
§ 1102.26(j)(2) to correctly state where
the minimum requirements for reports
of harm and manufacturer comments
may be found in the rule: In
§ 1102.10(d) and § 1102.12(c) and added
the word ‘‘and’’ between (1) and (2) to
be consistent with the statutory
language.
Comment 93—One commenter
addresses the resource issue
surrounding the Database, and states
that if section 6(b) of the CPSA is any
guide, lack of staff could make
determinations on material inaccuracy
‘‘indefinite.’’ The commenter would
have the final rule specify a 20business-day deadline for resolution of
a claim of material inaccuracy. If the
Commission cannot resolve any claim of
material inaccuracy within 20 days, the
commenter would have the report
removed from the Database until the
claim is resolved. The commenter notes
that such a procedure would promote
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timely consideration, and provide an
impetus for quick resolution.
Response—We are considering how
best to allocate resources to address a
possible increase in information
submitted through the Database. We are
committed to providing sufficient
resources for a successful Database. We
take seriously the obligation to review
reports of harm and manufacturer
comments for minimum content
requirements, and for determination of
claims of confidential or materially
inaccurate information. However,
because section 6A of the CPSA
establishes clear deadlines for specific
actions, we cannot amend the rule to
allow additional time for review.
Comment 94—One commenter says it
may be in the best interest of the public
for the Commission to provide
notification on its Web site that reports
of harm may be updated, revised, or
corrected, but in a manner that will not
chill submissions by consumers. The
commenter adds that if a report is
altered, consumers automatically should
receive via e-mail, updated information
regarding their report of harm.
Response—Section 6A(c)(4) of the
CPSA allows the Commission to redact
or correct reports of harm for materially
inaccurate information. The current
system requirements do not provide for
updates on individual reports via email. However, consumers are free to
check the Web site for changes.
Comment 95—Some commenters
would have us audit material
inaccuracy claims to ensure that
manufacturers and others are making
such claims in good faith—instead of
frivolous claims to block public
disclosure of critical safety hazard
information.
Response—Section 6A(d) of the CPSA
requires the Commission to submit to
the appropriate congressional
committees an annual report on the
Database, which must include the
number of reports and comments for the
year, and the number of corrected or
removed reports and comments for the
year from the Database. We believe this
statutory requirement will allow us to
address the suggestion by the
commenters that the Commission audit
material inaccuracy claims to ensure
that such claims are being asserted in
good faith and not frivolously. We also
believe that by clarifying the burden of
proof requirement to § 1102.26, such
claims will be supported and made in
good faith.
k. Proposed § 1102.26(k)—Commission
Action in Absence of a Request
Proposed § 1102.26(k) would provide
that the Commission may review a
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report of harm or manufacturer
comment on its own initiative following
the same notices and procedures set
forth in § 1102.26(g) through (j).
We received several comments related
to this section, which resulted in no
changes to the final rule.
Comment 96—One commenter states
that Commission-initiated reviews of
materially inaccurate information
should be reviewed with the submitter
or the manufacturer before publication
of correction of any material inaccuracy.
Response—We will provide notice of
the result of a Commission-initiated
review to the manufacturer, where such
a review results in the Commission
taking an action under section 6A(c)(4)
of the CPSA to address information it
deems materially inaccurate. However,
the statute does not require us to await
a manufacturer’s comment or to inform
the submitter of the report of harm
before taking any action to address the
material inaccuracy, and so we will not
revise the rule as suggested by the
commenter.
Comment 97—One commenter asserts
that any inaccuracy in a report should
warrant removal of the entire report
until all other facts can be verified and
a corrected report can be posted.
Response—Section 6A(c)(4) of the
CPSA requires that the Commission
make a determination regarding a
material inaccuracy claim before we
may take steps to resolve the claim.
Adopting the commenter’s suggestion to
remove a report for any inaccuracies
would be contrary to section 6A(c)(4) of
the CPSA, which allows materially
inaccurate information to be removed,
added to, or corrected only after a
determination of material inaccuracy.
Under the commenter’s suggestion, a
report with an error in the description
of the incident, such as the time of day,
or the color of the product, would have
to be removed. We do not believe that
such information would meet the
threshold for material inaccuracy, and
so we will not revise the rule as
suggested by the commenter.
4. Proposed § 1102.28—Publication of
Reports of Harm
Proposed § 1102.28(a) would explain
that reports of harm will be published
in the Database as soon as practicable,
but no later than 10 business days after
such report of harm is transmitted by
the CPSC to the manufacturer or private
labeler.
Proposed § 1102.28(b) would explain
an exception to the 10-business day
deadline where reports of harm may be
published beyond the 10-day time frame
if we determine that the report of harm
misidentifies or fails to identify all
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manufacturers or private labelers. The
information would have to be corrected
through the procedures for materially
inaccurate information. The provision
also would state that once the
manufacturer or private labeler has been
identified correctly, the time frames in
§ 1102.28(a) will apply.
We received several comments related
to this section, which did not result in
any modifications to the final rule. On
our own initiative, we have corrected an
internal citation error in § 1102.28(b)
from § 1102.10(c) to § 1102.10(d).
Comment 98—Several commenters
assert that § 1102.28(b) would not
provide sufficient time to investigate
meaningfully and respond to reports of
harm. Some commenters state that a
company ‘‘needs the time to review its
files, retrieve test reports, confer with its
many suppliers, etc. A meaningful
comment period is essential to the
development of a meaningful consumer
complaint database.’’ The commenters
note that this places a heavy burden on
manufacturers, and that we should
consider adopting provisions for
exceptions and extensions, perhaps up
to 30 days, where the 10-day time frame
is not possible, or would be ‘‘manifestly
unfair.’’ The commenters also state that
we should work with industry to
develop realistic time frames for
businesses to respond.
Response—We are bound by the time
frame set forth in section 6A(c)(3)(A) of
the CPSA and do not have the authority
to establish a different time frame.
Moreover, establishing a different time
frame would be inconsistent with the
direction given in section 6A(f)(1) of the
CPSA to not apply the provisions of
section 6(a) and (b) of the CPSA to
reports of harm. Section 6(b) of the
CPSA requires that we wait 15 days
after notifying a manufacturer of our
intent to publicly disclose
manufacturer-specific information to the
public. In contrast, under section 6A of
the CPSA, once we transmit a report of
harm to a manufacturer or private
labeler, we must publish the report of
harm no later than the tenth business
day after transmission unless a
determination of material inaccuracy
has been made.
Comment 99—A commenter states
that reports of harm submitted after a
certain time period (e.g., one year)
following the alleged harm should not
be published.
Response—For the reasons provided
in response to Comment 19 above, we
are not adopting this suggestion, which
is not required by section 6A(b) of the
CPSA.
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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 that may make it
impracticable to publish a manufacturer
comment at the same time as a report of
harm: (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.
We received several comments on this
section, which has been finalized with
modification. On our own initiative, we
have corrected the internal citations to
state that publication of a manufacturer
comment is subject to §§ 1102.12,
1102.24, and 1102.26 of the final rule.
This correction is consistent with
§ 1102.28(a), stating that publication of
reports of harm are subject to
§§ 1102.10, 1102.24, and 1102.26. In
addition, we struck the second example
of a circumstance that would make it
impracticable to publish a manufacturer
comment at the same time as a report of
harm because it was inaccurate. A claim
by a third party that a manufacturer
comment contains a material inaccuracy
could be made only after the
manufacturer comment had already
been published in the Database. A
manufacturer comment would remain in
the Database until the Commission
made a determination about any alleged
material inaccuracy.
Comment 100—One commenter
suggests that information published in
the Database (reports of harm and
manufacturer comments), and the fact of
its publication, should be declared
inadmissible as evidence to establish
the truth of such information.
Response—The commenter’s
suggestion goes beyond the scope of this
rulemaking. We do not believe that
section 6A of the CPSA authorizes us to
issue a regulation that would address
the admissibility in judicial proceedings
of information in the Database. Such
matters are left to the legislative and
judicial branches. For example, courts
can decide whether to exclude database
entries as inadmissible based on the
arguments advanced by the commenter.
However, we will treat information
contained in the Database (reports of
harm and manufacturer comments) in
the same manner in which we currently
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treat other official agency records that
are sought by litigants for use in private
litigation. Current regulations, at 16 CFR
1016.3(b), provide a process for
authentication of official agency records
by the Secretary of the Commission, and
requests for authentication of
information contained in the Database
should be made in accordance with that
regulation.
Comment 101—One commenter is
concerned about whether comments
would always be displayed when a
report of harm is accessed through the
Database. This commenter reasons that,
absent such a requirement, there is a
risk that a search of the Database might
reveal a report of harm without also
revealing a related comment.
Response—Comments associated with
a report of harm will always be
displayed when a report of harm is
accessed through the Database, provided
the comment meets the minimum
requirements for publication (see
§ 1102.12(a)). However, if a comment
does not meet the minimum
requirements for publication, for
example, when we do not have the
consent of the manufacturer or private
labeler to publish the comment to the
Database, it will not be published in the
Database and, therefore, will not be
displayed when the corresponding
report of harm is accessed.
D. Proposed Subpart D—Notice and
Disclosure Requirements
1. Proposed § 1102.42—Disclaimers
Proposed § 1102.42 would require a
disclaimer stating that the CPSC does
not guarantee the accuracy,
completeness, or adequacy of the
contents of the Database, particularly
with respect to the accuracy,
completeness, or adequacy of the
information submitted by persons
outside the CPSC. This provision
requires that the Database prominently
and conspicuously display such a
disclaimer on the Database and on any
documents printed from the Database.
Several comments were received on
this section, which has been finalized
with one slight modification, shortening
the second mention of the Database to
‘‘Database.’’
Comment 102—One commenter
would have the disclaimer for the
Database read as follows: ‘‘The fact of
publication in whole or in part in the
Consumer Product Safety Information
Database, or later modification,
retraction or removal therefrom, may
not be used to establish the truth or
falsehood of any reported allegations or
comment in any related litigation.’’
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Response—In proposed § 1102.42 we
provided the following disclaimer,
which would be displayed prominently
and conspicuously on the Database and
on any documents that are printed from
the Database: ‘‘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 commenter’s
proposed revision of the disclaimer
regarding the use of information in any
related litigation speaks to the issue of
whether Database information is
inadmissible in other forums. We will
not revise the rule because admissibility
is a matter for the legislative and
judicial branches.
Comment 103—One commenter
would amend the Disclaimer section to
have the disclaimer read: ‘‘prominently
and conspicuously displayed on the
database and on any documents that are
downloaded, printed or otherwise
transferred from the Database.’’ This
commenter suggests the use of an
electronic watermark. Another
commenter notes that the disclaimer
should be repeated at every chance on
the Database, on any intake complaint
forms, and on the information released
in the Database.
Response—The disclaimer was
specified in section 6A(b)(5) of the
CPSA and is described in § 1102.42. We
will conspicuously display the
disclaimer on Web pages, including the
online incident report form, and
documents that can be printed or
otherwise transferred from the Database.
At this time our system does not create,
via software, a permanent disclaimer
that goes on any data exported from the
Database.
Comment 104—One commenter notes
that we should clarify that the
disclaimer will be ‘‘prominently and
conspicuously’’ displayed on each
document in the Database when it is
displayed for electronic review, as well
as if and when the document is printed
(even remotely to nongovernmental
computers). This commenter states that
it is important so as not to be viewed as
self-authenticating public records under
the Federal Rules of Evidence and state
rules of evidence.
Response—We have described how
the disclaimer will be displayed on the
Database and on printed documents.
How a court will treat any document
printed from the Database is dependent
upon how the document is presented
and whether a court would view the
document as self-authenticating under
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the appropriate Federal or State
evidentiary rules.
Comment 105—Some commenters
criticize the proposed disclaimer,
stating that the Commission did not
indicate clearly that reports of harm
included in the Database contained
information submitted by persons
outside of the Commission.
Response—Section 1102.42 uses the
disclaimer found in section 6A(b)(5) of
the CPSA, which states that the
Commission does not guarantee the
accuracy, completeness, or adequacy of
the contents of the Database; however,
we added language strengthening this
disclaimer by drawing particular
reference to the accuracy, completeness,
or adequacy of information submitted
by persons outside of the CPSC.
Therefore, we believe that we have
addressed sufficiently the concerns
raised by the commenters, by notifying
users of the Database that information in
the Database has been provided by
individuals outside of the Commission.
Comment 106—One commenter states
that the disclaimer in § 1102.42 does not
go far enough in explaining the
limitations of the data, particularly in
‘‘data sets’’ produced by conducting a
search of the Database. This commenter
states that the disclaimer should explain
the anecdotal nature of the data, and
that it cannot be used for broad,
statistical purposes; the commenter also
states that the disclaimer should state
clearly the concerns about accuracy,
completeness, or adequacy. The
commenter suggests that the disclaimer
explain the lack of verification by the
CPSC of the ‘‘facts’’ in the reports, and
caution users against drawing
conclusions about the named products
based on these data.
Response—We believe that we have
addressed adequately these concerns by
proposing a disclaimer that closely
tracks the statute, but draws particular
attention to the fact that the Database
contains information submitted by
persons outside of the Commission. The
Database is not a Database of
government-generated data. The
information is generated by external
third parties. The Database will be
searchable and sortable, as required by
section 6A. The disclaimer speaks to the
anecdotal nature of the data.
2. Proposed § 1102.44—Applicability of
Sections 6(a) and (b) of the CPSA
Proposed § 1102.44(a) would explain
that sections 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 sections 6(a)
and (b) of the CPSA to information
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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.
We received several comments related
to this section, which has been finalized
without substantive change. We have
made two internal citation corrections.
In § 1102.44(a), we corrected a citation
from § 1102.10(c) to § 1102.10(d), and in
§ 1102.44(b), we corrected a citation
from § 1102.42 to § 1102.44(a), and we
shortened the name of the Database to
‘‘Database.’’
Comment 107—One commenter states
that, ‘‘notwithstanding Congressional
direction for this database,’’ section 6 of
the CPSA should apply to information
in the Database. The commenter further
states that ‘‘Section 6(b) of the CPSA was
not repealed by the CPSIA.’’ The
commenter asserts that the Commission
should take reasonable steps to ensure
that the information published in the
Database is ‘‘accurate and fair in the
circumstances’’ and that accuracy
protections of section 6 of the CPSA
contribute to the ‘‘ultimate release of
information that consumers can
reasonably rely upon.’’
Response—We do not agree that we
can ‘‘opt’’ to apply sections 6(a) and (b)
of the CPSA to the submission,
disclosure, and publication of
information provided in a report of
harm when section 6A(f)(1) of the CPSA
provided an express exemption to
sections 6(a) and (b) of the CPSA for
reports of harm submitted to the
Database. Thus, § 1102.44 continues to
state that sections 6(a) and (b) of the
CPSA do 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).
Comment 108—One commenter is
concerned about whether we will retain,
as agency records, the originals of
documents that have subsequently been
modified or excluded from the Database
because of claims of material
inaccuracy. The commenter explains
that it believes that the Database
provisions in the statute required that
the originals be purged as records of the
agency. The commenter asks that, if we
disagree or believe that the Federal
Records Act requires those documents
to be maintained, we make it clear that
the documents are still subject to
sections 6(a) and (b) of the CPSA if
requested under FOIA or otherwise.
Response—We disagree with this
commenter’s analysis that information
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purged from the Database does not
comprise official agency records subject
to the Federal Records Act; therefore,
when we receive requests for
information purged from the Database
under the FOIA or otherwise, we will
invoke all applicable Federal laws,
including sections 6(a) and (b) of the
CPSA, prior to the release of any such
information.
Comment 109—One commenter asks
that we clarify that reports submitted
under section 15 of the CPSA and
reports submitted under other voluntary
retailer reporting programs would not be
disclosed in the Database. The
commenter’s concern is that the current
confidentiality protections surrounding
this data facilitate dialogue between
retailers and the CPSC. The commenter
is concerned that, if that level of trust
is compromised, or confidentiality is
reduced, it would affect the ability of
the CPSC to have full and frank
discussions with manufacturers and
retailers.
Response—Section 6A of the CPSA
exempts reports of harm submitted to
the Database from sections 6(a) and (b)
of the CPSA; however, it clearly states
that it does not exempt reports
submitted under section 15 of the CPSA
or reports submitted under any other
mandatory or voluntary retailer,
manufacturer, or private labeler
reporting program with the
Commission. Therefore, § 1102.44
specifically states that information
received by the Commission pursuant to
section 15 of the CPSA or any other
mandatory or voluntary reporting
program established between a retailer,
manufacturer, or private labeler and the
Commission is not exempted from the
requirements of sections 6(a) and (b) of
the CPSA. This means that the
Commission could not publish such
information in the Database without
first complying with the notice
provisions of sections 6(a) and (b) of the
CPSA. In this phase of the Database, we
are not publishing reports submitted
under section 15(b) of the CPSA or
reports submitted under any other
mandatory or voluntary retailer,
manufacturer, or private labeler
reporting program. Comments Regarding
Implementation of the Database
Unrelated to a Specific Section in the
Rule.
Comment 110—The Commission
should commit resources for
educational outreach and training, and
publish an official guidance tailored
specifically to manufacturers and
private labelers.
Response—We have committed staff
and support resources dedicated to
industry and consumer education
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regarding the Database. This effort
includes developing a process to
identify, confirm, register, and train
businesses that wish to utilize the
Business Portal to electronically
respond to reports of harm.
We are working with industry trade
associations and consumer advocacy
organizations in this effort.
Documentation and other support
materials, as well as information
sessions will be available in the months
preceding the ‘‘go-live’’ date. Calendar
dates for information sessions will be
posted on the Public Calendar on our
Web site.
Comment 111—One commenter states
that unverified reports in the Database
should not create section 15 reporting
obligations. The commenter states that
because submitters are not required to
provide contact information to
manufacturers, unverified and
inaccurate reports are bound to end up
in the Database. The commenter states
that the rule should state that
transmitted reports of harm will not
trigger any CPSA reporting requirement,
due to the nature of the contents of the
Database and its purpose, and that the
overall purpose is to provide a tool for
consumers to obtain reliable
information, rather than be a source of
information to manufacturers about
potential product issues.
Response—Section 6A does not
specifically exempt Database
information from consideration in
section 15 cases and, therefore, we will
not adopt the suggestion that we
specifically exclude information in the
Database from consideration in such
cases. While it is true that the Database
is subject to a disclaimer that the
Commission does not guarantee the
accuracy, completeness, or adequacy of
the contents of the Database,
information in the Database will be
verified by the submitter. Information in
the Database may be used for a variety
of purposes, not the least of which
could be identifying potential hazards
associated with consumer products
whether by the manufacturer or the
Commission.
Comment 112—A commenter states
that the rule should ensure that users do
not circumvent minimum requirements
for Database entry by posting incidents
and comments through Commission
social media outlets. It would be
appropriate to obtain some assurances
that this will not be permitted.
Response—On the Web pages of all of
the social media accounts utilized by
the Commission, clear and conspicuous
policies are posted regarding the
appropriate way to post content related
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to incident reporting and directing users
to the Database for such purposes.
Comment 113—Some commenters
state that it is ‘‘crucial’’ for the CPSC to
implement the Database in the
narrowest scope possible and then
expand it (i.e., start with specific
product categories that present the most
risk and gradually open up the
Database) to other products.
Commenters state that this would
ensure reliability and the long-term
success of the Database by minimizing
mistakes, minimizing the impact of
mistakes, providing the CPSC with
flexibility to make changes, reducing the
burden on CPSC resources, and enabling
time to work out an efficient means of
handling the paperwork involved in
maintaining the Database. The
commenters estimate that it would take
22 dedicated full-time employees to
handle the potential increase in incident
reports. The commenters state that the
CPSC has the opportunity to engage
stakeholders in discussions on how to
improve and resolve problems as they
arise. Commenters state that the
Database should include a forum for this
type of implementation discussion,
naming Facebook development as an
example. Commenters allege that staged
implementation is consistent with
congressional intent and the
commenters point to the General
Accounting Office study requirement as
indication that Congress knew the
Database would need to be modified
and improved as time progresses.
Response—Congress required that
implementation of the Database occur
18 months after our implementation
report to Congress. We submitted our
implementation report in September
2009. We are on track to fulfill that
mandate.
We already have started the process of
planning and testing internal business
processes against the requirements of
the implemented software. This
includes planning for data intake,
processing, and notification of
manufacturers and private labelers. We
are aligning staff and support resources
to new business processes in
anticipation of the implementation. We
anticipate this alignment around new
processes to be completed several
months before the ‘‘go-live’’ date in
March 2011. We believe these steps
address the commenters concerns and
would obviate the need for a phased
introduction of the Database.
Comment 114—‘‘[T]he regulation does
not include crucial information on how
this database will be implemented.
Although the CPSC has shared some of
its plan with the public, much is still
not known. It is quite possible that the
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format for submitting reports of harm
and the data input techniques to be used
for reporting, will have a major impact
on the accuracy of the data in the
database.’’
Response—The implementation plan
is not appropriate for the text of a
regulation. Starting in September 2009,
we submitted a report to Congress on
implementation of the Database. We
held a public hearing on November 10,
2009, regarding implementation. In
addition, we held a two-day workshop
in January 2010, regarding
implementation, and requested
comments. All of this information is
available on the Commission’s Web site
at https://www.cpsc.gov. Thus, we have
committed staff and support resources
through the ‘‘go-live’’ date in a dedicated
effort to inform industry and educate
consumers regarding the Database. This
effort further includes creation of a Web
site on https://www.saferproducts.gov
devoted to Database education and
implementation issues, which is
periodically updated with new content.
The Commission has also conducted
focus groups on the input forms and
Database screens. The Commission
plans to send staff to attend and speak
at conferences to teach on the Database.
It also plans to develop a process to
identify, confirm, register, and train
businesses that wish to utilize the
Business Portal to electronically
respond to reports of harm.
We are working with industry trade
associations and consumer advocacy
organizations in this effort.
Documentation and other support
materials are being developed, and
information sessions will be available in
the months preceding the ‘‘go-live’’ date.
Calendar dates for information sessions
will be posted on the Public Calendar
on our Web site.
Comment 115—Some commenters
state that the manner of registering and
contacting manufacturers and private
labelers will greatly affect their ability to
comment on the data in a timely
fashion. A first look at the proposed
manufacturer registration system
identified a number of significant
issues. To insure that the Database
properly serves its intended purpose,
the details of the Database should be
shared with the public for comment
before it is implemented.
Response—Our education and
outreach efforts are described above in
response to Comment 115. We are
actively engaged in an industry and
consumer education effort that includes
developing a process to identify,
confirm, register, and train businesses
that wish to utilize the Business Portal
to electronically respond to reports of
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harm. Documentation and other support
materials, as well as information
sessions will be available in the months
preceding the ‘‘go-live’’ date. Calendar
dates for information sessions will be
posted on the Public Calendar on our
Web site.
Comment 116—Some commenters
state that valid reports of harm may
come from the same IP address, such as
government, health facilities, and
consumer organizations, and that these
multiple, but valid, reports should be
accepted.
Response—Multiple, valid reports
will be accepted from the same IP
address. The first release of the software
will contain features to protect against
computer-generated reports and flag
potentially duplicate reports for staff
review.
The software and mechanisms that we
use to detect multiple reports from the
same IP address will be used to detect
a nefarious denial of service type of
attack. A denial of service attack is an
attempt to make a computer resource
unavailable to its intended users.
Commonly, the perpetrator of such an
attack would saturate a public Web site
with extraordinarily high numbers of
information requests. Such computergenerated high volume would limit the
target’s ability to respond to legitimate
(human) use.
Comment 117—One commenter states
that the Report to Congress mockup
shows a static, noncheckable
verification, and suggests that we
require consumers to affirmatively attest
by clicking on something in the portal.
Response—We noted this suggested
requirement/feature in several forums,
and have implemented it by requiring
that submitters select a check mark box
on the incident report form for it to be
submitted and published.
Comment 118—Commenters discuss
discouraging false complaints regarding
consumer products. The commenters
suggest that the final rule contain a
mechanism for the prompt removal of
false complaints. Computer-generated
reports should not be accepted. Another
commenter states that the system should
detect multiple reports from the same IP
address, which are then flagged for
further inspection.
Response—We agree that the Database
should not contain materially
fraudulent or false complaints about
consumer products. Section 1102.26
details the designation and disposition
of materially inaccurate information.
Also, the Database software will assist
with fraud prevention. The Database
implementation team is working closely
with the enterprise information security
team to ensure that the Database uses
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industry best practices for security and
complies with federal and CPSC specific
security requirements. For example, the
first release of the software will contain
features to protect against computergenerated reports and flag potentially
duplicate reports for CPSC review.
However, despite our best efforts to
ensure that legitimate reports of harm
are being filed, we cannot
independently verify that every report
of harm submitted is legitimate and
accurate. Congress required that the
Database contain a disclaimer, which is
set forth in § 1102.42 of the final rule.
IV. 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 final 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.
V. Paperwork Reduction Act
The final 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). In a
May 24, 2010 Federal Register notice
regarding the proposed rule (75 FR
29156, 29173–75), we described the
information collection and the annual
reporting burden. Our estimate included
the time for reviewing instructions,
searching existing data sources,
gathering and maintaining the data
needed, and completing and reviewing
each collection of information.
We invited 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
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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. We received
one comment about the burden
estimates contained in the proposed
rule. The comment summary and
response appear below.
Comment: A commenter states that
the annual reporting burden is
significantly underestimated because
the Commission based the estimate on
current reporting figures. Also, the
commenter states that it will take
manufacturers and private labelers more
than 4 hours to investigate and respond
to a report of harm.
Response: With regard to the
estimated annual reporting burden and
time needed for manufacturers and
private labelers to investigate and
respond to a report of harm, the
preamble to the proposed rule explained
that we based our estimates on our
experience with our incident report
forms for fiscal year 2009 (75 FR at
29174). The commenter has not
provided any alternative data or
methodology that would support
adjusting our estimates. We also note
that in our research on other agency
databases, we were unable to determine
conclusively whether CPSC will
experience an increase in reports when
the public facing database is launched.
Accordingly, we decline to alter or
amend the estimated burdens.
Title: Publicly Available Consumer
Product Safety Information Database.
Description: The final rule allows
consumers to submit reports of harm
involving the use of consumer products
or other products or substances
regulated by the CPSC, and also allows
manufacturers of such products or
substances to comment on the reports of
harm. The reports and comments will be
part of the Database operated and
maintained by the CPSC. A
manufacturer identified in a report of
harm and who receives a report of harm
from the 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
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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
76865
by the CPSC because it contains
materially inaccurate information.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
16 CFR Section
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 102.12(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 Database will receive the same
number of reports of harm as the CPSC
received of incident reports in fiscal
year 2009, and that the numbers by
manner of submission to the CPSC (i.e.,
electronic, telephone, paper) will be the
same. Thus, using the data from fiscal
year 2009, we estimate that we will
receive a total of 15,140 reports of harm
(11,534 by electronic means, 3,329 by
telephone, and 277 by paper
submissions). We had already estimated
the time associated with the electronic
and telephone submission of incident
reports at 12 and 10 minutes,
respectively and so used those figures
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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 Database;
currently, neither the incident reports
nor manufacturer comments are
routinely public. We estimate that the
manufacturer response rate will increase
25 percent, up to a 50 percent response
rate. Therefore we expect to receive half
as many total manufacturer comments
as reports of harm (15,140 reports of
harm × 0.5 manufacturer comments per
report of harm = 7,570 manufacturer
comments). In terms of the manner of
commenting, currently we do not keep
track of how many manufacturer
comments are submitted electronically
versus in paper form. Because the
Database will be online, we will assume
that most manufacturers will utilize
electronic options for participating in
the Database, especially when the
Database (unlike the current incident
reporting system) will not give
manufacturers the option of submitting
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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 there are
two actions involved in a manufacturer
comment: (1) The research and
preparation necessary to comment; and
(2) the act of providing the comment. To
estimate 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 minutes). Thus, the
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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 as 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
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). Section
1102.26(b) of the proposed rule would
specify what must be included in such
a request. 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
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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 as
described in § 1102.26(b)(4). We
anticipate that this will double the
amount of time it takes to file the
request, or require 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). Because 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.
VI. Executive Order 12988
According to Executive Order 12988
(February 5, 1996), agencies must state
in clear language the preemptive effect,
if any, of new regulations. This
regulation is issued under the authority
of the CPSA, wherein preemption is
discussed in section 26 of the CPSA.
Section 26 of the CPSA only addresses
the preemptive effect of consumer
product safety standards under the
CPSA. The current rule is not a
consumer product safety standard under
the CPSA. Accordingly, the Commission
has determined that this rule does not
contain requirements that impact the
states.
VII. 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
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provides an explanation for that
conclusion.
The proposed rule did not contain an
initial RFA analysis, stating that
preliminary analysis establishes that the
proposed rule will have little or no
effect on small businesses. While the
agency anticipates that the new
Database likely will increase the number
of consumer-generated reports over the
number of incident reports currently
filed with the Commission, this will not
have a significant impact on a
substantial number of small businesses.
Because of the small increase in the
expected number of incident reports,
relative to the large number of small
manufacturers that produce consumer
products, relatively few small
manufacturers will receive even a single
incident report. Moreover, because
small manufacturers have smaller sales
volumes than large manufacturers, they
are less likely than large manufacturers
to receive an incident report for
comment. Even if a small firm does
receive an incident report and chooses
to respond, the amount of time to do so
likely would not be more than
approximately 4 hours, on average.
The Commission invited comment on
this analysis and the preliminary
certification statement. One comment
was received as discussed below. Based
on this, we decline to provide a
complete RFA analysis on the economic
impact of the rule on small businesses
prior to implementation of the final
rule, and certify that no such analysis is
required.
Comment—One commenter disagrees
that the proposed rule will have little or
no impact on small businesses based on
the time and resources required to
respond to reports of harm. The
commenter states that small businesses
must contract out for legal, engineering,
and testing services, which will all
likely take more than a few hours to
complete an analysis and which will
place a significant financial burden on
these small firms. Furthermore, when ‘‘a
few hours’’ is multiplied by the number
of small businesses subject to this rule,
the commenter claims the time burden
becomes substantial. Based on the
resource allocation required of small
businesses, the commenter states that
the Commission should complete a
regulatory flexibility analysis on the
economic impact of the rule on small
businesses prior to implementation of
the proposed rule.
Response—Our analysis does not rule
out the possibility that some small
businesses may be adversely affected by
the rule. However, under the RFA, the
inquiry is whether the rule would have
a significant economic impact on a
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substantial number of small entities. If
a severe safety defect is alleged in an
incident report, a small business may
need to devote substantial resources to
investigate the incident. However, such
an investigation would not necessarily
be attributable to the Database, because
a severe product defect would need to
be investigated, even in the absence of
the Database. Moreover, it is expected
that only a small proportion of small
businesses will receive even a single
incident report.
According to our analysis, no more
than an additional five percent of small
manufacturers of consumer products
will be affected by the Database rule
annually. Of these, only a very small
percentage of the incidents reported
would merit a large investigation effort.
Based on the CPSC’s Freedom of
Information Act (‘‘FOIA’’) experience, it
is rare that a small firm devotes
substantial time and effort responding to
incident reports. Thus, while it is
possible that a small number of small
businesses may experience a
‘‘significant’’ impact in investigating
certain incidents, the number of small
businesses experiencing such an impact
would not be ‘‘substantial.’’
Moreover, many impacts attributed to
the Database rule are indirect in that
they do not arise from direct regulation
of the production activities of entities.
Consequently, these impacts generally
are not subject to the analytical
requirements of the RFA. Nevertheless,
in forming a basis for certification, we
performed a threshold analysis, which
quantifies the expected impact of a
regulation, and to a large degree, forms
the analytical substance of a formal RFA
analysis. In sum, it is expected that the
average cost of responding
electronically to one incident report is
$280, and that the impact on an average
small manufacturer (with revenue of
$6.4 million) would amount to about
0.0044 percent of sales. Even if an
average small manufacturer received
and responded to 10 incident reports
during the year, the cost still would be
considerably less than one-tenth of one
percent of the value of shipments.
Further analysis would not change these
results or provide additional insight into
the expected impacts of the rule.
Accordingly, we decline to provide a
complete RFA analysis on the economic
impact of the rule on small businesses,
and will certify that no such analysis is
required.
VIII. Effective Date
The Administrative Procedure Act
(‘‘APA’’) generally requires that the
effective date of a rule be at least 30
days after publication of a final rule. 5
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Jkt 223001
U.S.C. 553(d). Accordingly, the effective
date of the final rule is 30 days after the
date of publication of a final rule in the
Federal Register.
List of Subjects in 16 CFR Part 1102
Administrative practice and
procedure, Business and industry,
Consumer protection, Reporting and
recordkeeping requirements.
■ For the reasons stated above, the
Commission amends Title 16 of the
Code of Federal Regulations by adding
a new Part 1102 to read as follows:
PART 1102—PUBLICLY AVAILABLE
CONSUMER PRODUCT SAFETY
INFORMATION DATABASE
Subpart A—Background and Definitions
Sec.
1102.2 Purpose.
1102.4 Scope.
1102.6 Definitions.
Subpart B—Content Requirements
1102.10 Reports of harm.
1102.12 Manufacturer comments.
1102.14 Recall notices.
1102.16 Additional information.
Subpart C—Procedural Requirements
1102.20 Transmission of reports of harm to
the identified manufacturer or private
labeler.
1102.24 Designation of confidential
information.
1102.26 Determination of materially
inaccurate information.
1102.28 Publication of reports of harm.
1102.30 Publication of manufacturer
comments.
Subpart D—Notice and Disclosure
Requirements
1102.42 Disclaimers.
1102.44 Applicability of sections 6(a) and
(b) of the CPSA.
Authority: 15 U.S.C. 2051, 2051 note,
2052, 2055, 2055a, 2065, 2068, 2070, 2071,
2072, 2076, 2078, 2080, 2087.
Subpart A—Background and
Definitions
§ 1102.2
Purpose.
This part sets forth the Commission’s
interpretation, policy, and procedures
with regard to the establishment and
maintenance of a Publicly Available
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.
§ 1102.4
Frm 00037
Fmt 4701
Database, including all information
published therein.
§ 1102.6
Definitions.
(a) Except as specified in paragraph
(b) of this section, the definitions in
section 3 of the Consumer Product
Safety Act (CPSA) (15 U.S.C. 2052)
apply to this part.
(b) For purposes of this part, the
following definitions apply:
(1) Additional information means any
information that the Commission
determines is in the public interest to
include in the Publicly Available
Consumer Product Safety Information
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 under any
other act it administers.
(4) Harm means injury, illness, or
death; or risk of injury, illness, or death,
as determined by the Commission.
(5) Mandatory recall notice means any
notice to the public required of a firm
pursuant to an order issued by the
Commission under section 15(c) of the
CPSA.
(6) 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.
(7) Publicly Available Consumer
Product Safety Information Database,
also referred to as the Database, means
the database on the safety of consumer
products established and maintained by
the CPSC as described in section 6A of
the CPSA.
(8) Report of harm means any
information submitted to the
Commission through the manner
described in § 1102.10(b), 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.
(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
Scope.
This part applies to the content,
procedure, notice, and disclosure
requirements of the Publicly Available
Consumer Product Safety Information
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§ 1102.10
Reports of harm.
(a) Who may submit. The following
persons or entities may submit reports
of harm:
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(1) Consumers including, but not
limited to, users of consumer products,
family members, relatives, parents,
guardians, friends, attorneys,
investigators, professional engineers,
agents of a user of a consumer product,
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, and acupuncturists;
(4) Child service providers including,
but not limited to, child care centers,
child care providers, and
prekindergarten schools; and
(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 professionals, including consumer
advocates or individuals who work for
nongovernmental organizations,
consumer advocacy organizations, and
trade associations, so long as they have
a public safety purpose.
(b) Manner of submission. To be
entered into the 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 directed to the
Office of the Secretary at info@cpsc.gov,
or by facsimile at 301–504–0127,
provided that the 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 to the Office
of the Secretary, Consumer Product
Safety Commission, 4330 East West
Highway, Bethesda, MD 20814–4408.
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
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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 Publicly Available Consumer
Product Safety Information 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.
In addition to a word or phrase
sufficient to distinguish the product as
a consumer product, a description of a
consumer product may include, 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. In addition to a firm
name, identification of a manufacturer
or private labeler may include, but is
not limited to, a mailing address, phone
number, or electronic mail address.
(3) Description of the harm. A brief
narrative description of 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
severity of any injury and whether any
medical treatment was received.
(4) Incident date. The date, or an
approximate date, on which the
incident occurred.
(5) Category of submitter. Indication
of which category the submitter is in
(i.e., consumers, government agencies,
etc.) from § 1102.10(a).
(6) Contact information. The
submitter’s first name, last name, and
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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.
(7) 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.
(8) 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 and contact
information, if the victim or the victim’s
parent, guardian, or appropriate legally
authorized representative, has not
provided appropriate legal consent;
(3) Photographs that in the
determination of the Commission are
not in the public interest, including
photographs that could be used to
identify a person or photographs that
would 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;
(6) Information determined to be
materially inaccurate as set forth in
§ 1102.26;
(7) Reports of harm retracted at any
time by the submitters of those reports,
if they indicate in writing to the
Commission that they supplied
materially inaccurate information;
(8) Consents and verifications
associated with a report of harm; and
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(9) 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. The Commission 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 submitted
to 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.
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§ 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(f) 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
Secretary at info@cpsc.gov; or
(3) A manufacturer or private labeler
may submit written comments directed
to the Office of the Secretary, Consumer
Product Safety Commission, 4330 East
West Highway, Bethesda, MD 20814–
4408.
(c) What must be submitted. Subject
to §§ 1102.24 and 1102.26, the
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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 submitted for publication 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 and 1102.26, 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.
§ 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,
consistent with the requirements of
section 6(a) and (b) of the CPSA.
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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, provided such
report 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 (for example, by
checking a box on the report of harm)
to provide such information to the
manufacturer or private labeler;
(2) Photographs that could be used to
identify a person; and
(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 may include 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;
(4) Description of the incident related
to use of the consumer product;
(5) Date or approximate date of the
incident; and/or
(6) Category of submitter.
(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. If the Commission cannot
determine whom the manufacturer or
private labeler is from the report of
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harm, or otherwise, then it will not post
the report of harm on the Database but
will maintain the report for internal
agency use. Examples of circumstances
that may arise that may make
transmission of the report of harm
impracticable within five business days
include, but are not limited to:
(1) The manufacturer or private
labeler is out of business with no
identifiable successor;
(2) The submitter misidentified a
manufacturer or private labeler;
(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 (f) 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 that 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.
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(g) Manufacturer comments. 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 discretion, where it
determines it is in the public interest,
may choose not to publish a
manufacturer comment in the Database.
For example, it may not be in the public
interest for the Commission to publish
comments that, in the unlikely event,
contain language reasonably described
as lewd, lascivious, or obscene.
§ 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) If known, 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
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treatment must be conspicuously
marked.
(d) Timing of submission. In order to
ensure that the allegedly confidential
information is not placed in the
database, a request for designation of
confidential information must be
received by the Commission in a timely
manner prior to the 10th business day
after the date on which the Commission
transmits the report to the manufacturer
or private labeler. If a request for
confidential treatment is submitted in a
timely fashion, the Commission will
either make a determination on the
claim prior to posting on the 10th
business day after transmittal to the
manufacturer or, as a matter of policy,
redact the allegedly confidential
information from a report of harm before
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
thereafter might 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
U.S. District Court for the District of
Columbia.
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§ 1102.26 Determination 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, and which is
so substantial and important as to affect
a reasonable consumer’s decision
making about the product, including:
(i) The identification of a consumer
product;
(ii) The identification of a
manufacturer or private labeler;
(iii) The harm or risk of harm related
to use of the consumer product; or
(iv) The date, or approximate date on
which the incident occurred.
(2) Materially inaccurate information
in a manufacturer comment means
information that is false or misleading,
and which is so substantial and
important as to affect a reasonable
consumer’s decision making about the
product, including:
(i) The description of the consumer
product;
(ii) The identity of the firm or firms
responsible for the importation,
manufacture, distribution, sale, or
holding for sale of a consumer product;
(iii) The harm or risk of harm related
to the use of a consumer product;
(iv) The status of a Commission,
manufacturer, or private labeler
investigation;
(v) Whether the manufacturer or
private labeler is engaging in a
corrective action and whether such
action has not been approved by the
Commission; or
(vi) Whether the manufacturer has
taken, or promised to take, any other
action with regard to the product.
(b) Request for determination 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. Each
requester seeking an exclusion or
correction bears the burden of proof and
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;
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(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;
(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
(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—
(1) 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.
(2) 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
info@cpsc.gov; or
(ii) Paper-based. Written submission
directed to the Office of the Secretary,
Consumer Product Safety Commission,
4330 East West Highway, Bethesda, MD
20814–4408.
(d) Timing of submission. A request
for a Commission determination
regarding materially inaccurate
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information may be submitted at any
time. If a request for determination of
materially inaccurate information is
submitted prior to publication of a
report of harm in the Database, the
Commission cannot withhold the report
of harm from publication in the
Database until it makes a determination.
Absent a determination, the
Commission will publish reports of
harm on the tenth business day after
transmitting a report of harm to the
manufacturer or private labeler.
(e) Assistance with defense. No
request for a determination of materially
inaccurate information should be made
by any person who does not intend in
good faith, and so certifies in writing, to
assist the Commission in the defense of
any judicial proceeding that thereafter
might 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
information in a report of harm or
manufacturer comment is materially
inaccurate information before it is
published in the Database, the
Commission shall:
(1) Decline to add the materially
inaccurate information to the Database;
(2) Correct the materially inaccurate
information, and, if the minimum
requirements for publication as set forth
in §§ 1102.10(d) 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(d) 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 information
determined to be materially inaccurate
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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(d) 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(d) and 1102.12(c) are met,
maintain the report of harm or
manufacturer comment in the Database.
(i) Commission discretion.
(1) In exercising its discretion to
remove, correct, or add information to
correct materially inaccurate
information contained in a report of
harm or manufacturer comment, the
Commission shall preserve the integrity
of information received for publication
in the Database whenever possible.
Subject to §§ 1102.10(d) and 1102.12(c),
the Commission shall favor correction,
and the addition of information to
correct, 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 publish reports of
harm on the tenth business day after
transmitting a report of harm, where the
Commission has been 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
seven 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
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of harm is published, or as soon
thereafter as practicable.
(j) Commission determination of no
material inaccuracy. If the Commission
determines that the requested
information in a report of harm or
manufacturer comment does not contain
materially inaccurate information, the
Commission will:
(1) Notify the requester of its
determination; and
(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(d) and 1102.12(c).
(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
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(d) in the
Database beyond the 10-business-day
time frame set forth in paragraph (a) of
this section if the Commission
determines that 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.
Timing. Subject to §§ 1102.12,
1102.24, and 1102.26, the Commission
will publish in the Database
manufacturer comments submitted in
PO 00000
Frm 00042
Fmt 4701
Sfmt 9990
response to a report of harm that meet
the minimum 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 thereafter as
practicable. An example of a
circumstance that may make it
impracticable to publish a manufacturer
comment at the same time as a report of
harm includes when the Commission
did not receive the comment until on or
after the publication date of the report
of harm.
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 Database will
contain a notice to this effect that will
be prominently and conspicuously
displayed on the Database and on any
documents that are printed from the
Database.
§ 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(d) in the Database.
(b) Limitation on construction.
Section 1102.44(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: November 30, 2010.
Todd A. Stevenson,
Secretary, United States Consumer Product
Safety Commission.
[FR Doc. 2010–30491 Filed 12–8–10; 8:45 am]
BILLING CODE 6355–01–P
E:\FR\FM\09DER3.SGM
09DER3
Agencies
[Federal Register Volume 75, Number 236 (Thursday, December 9, 2010)]
[Rules and Regulations]
[Pages 76832-76872]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30491]
[[Page 76831]]
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Part III
Consumer Product Safety Commission
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16 CFR Part 1102
Publicly Available Consumer Product Safety Information Database; Final
Rule
Federal Register / Vol. 75 , No. 236 / Thursday, December 9, 2010 /
Rules and Regulations
[[Page 76832]]
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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: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Consumer Product Safety Commission (``Commission,''
``CPSC,'' or ``we'') is issuing a final rule 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 final rule interprets various statutory requirements pertaining to
the information to be included in the Database and also establishes
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: Effective Date: This rule is effective January 10, 2011.
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
Section 212 of 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. On May 24, 2010, we
published a notice of proposed rulemaking at 75 FR 29156, which set
forth the Commission's proposed interpretation and implementation of
the Database provisions of section 6A of the CPSA. The comment period
on the proposed rule ended on July 23, 2010. After reviewing and
considering significant issues raised by the comments, the Commission
is now promulgating a final rule on 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. Such incident reports describe safety-related incidents
involving 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. In addition,
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 via forms reporting on product-related injuries
or incidents.
To date, the data that the Commission collects and maintains on
product safety have 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 them with 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 section 6 notice
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.
Section 6A of the CPSA creates a new disclosure requirement with
respect to product safety-related incident reports, referred to as
``reports of harm'' in both the statute and the proposed rule.
Specifically, section 6A of the CPSA excludes any incident report
submitted for inclusion in the Database from the notice requirements of
section 6(a) and (b) of the CPSA. Instead, section 6A of the CPSA sets
up a new framework for collecting reports of harm, transmitting them to
the manufacturer and private labeler for comment, and then posting them
on a Database that is accessible on the Commission's Web site.
The notice of proposed rulemaking provided the public with an
opportunity to understand how the Commission is intending to implement
the new procedures in section 6A of the CPSA, and to provide comment.
Prior to issuing a notice of proposed rulemaking, however, the
Commission provided stakeholders with information about Database
implementation, as well as offered several opportunities for
stakeholder input and comment, all of which were discussed in the
preamble to the proposed rule at 75 FR 29156-57. Prior Commission
activities related to the Database include: Providing a detailed
implementation plan to Congress; holding a public hearing on Database
implementation; holding a public workshop, which sought comments on
Database implementation; attending and speaking about the Database at
various conferences; and creating the https://www.saferproducts.gov Web
site, where updates on implementation of the Database are provided.
Information on all of these Commission activities and public comments
are available on the CPSC Web site at https://www.cpsc.gov/about/cpsia/sect212.html.
We received 37 comments on the proposed rule. After reviewing the
comments, the Commission made several changes to the final rule, all of
which are discussed in detail in section III below.
[[Page 76833]]
II. Statutory Authority
The Commission is issuing this 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 Final Rule, Comments on the Proposed Rule, and
the Commission's Responses
The final rule establishes a new 16 CFR part 1102, ``Publicly
Available Consumer Product Safety Information Database.'' The new part
consists of four subparts:
Subpart A--Background and Definitions;
Subpart B--Content Requirements;
Subpart C--Procedural Requirements;
Subpart D--Notice and Disclosure Requirements.
Below, we describe and explain each subpart and section of the
final rule, as well as describe and respond to significant issues
raised by the comments on the proposed rule (75 FR 29156, May 24, 2010)
pertaining to each section. In addition to comments on each of the
subparts of the final rule, we have added a section ``E'' below to
address Database implementation comments that are not directly related
to a section of the proposed rule. To make it easier to identify
comments and the Commission's responses, the word ``Comment'' will
appear in italics before each comment description, and the word
``Response'' will appear in italics before the Commission's response.
We have grouped comments based on the section of the proposed rule to
which they pertain and their similarity, and we have numbered the
comments to help distinguish between different comment themes. The
number assigned to each comment summary is for organizational purposes
only and does not signify the comment's value, importance, or order in
which it was received.
A. Proposed Subpart A--Background and Definitions
1. Proposed Sec. 1102.2--Purpose
Proposed Sec. 1102.2 would describe the purpose for a new 16 CFR
part 1102 titled ``Publicly Available Consumer Product Safety
Information Database,'' which is to set forth the Commission's
interpretation, policy, and procedures to establish and maintain such
Database.
We have finalized this section and made one clarification, which is
to add the words ``Publicly Available'' to the full name of the
Database.
2. Proposed Sec. 1102.4--Scope
Proposed Sec. 1102.4 would describe the scope of the rule to
include the content, procedure, notice, and disclosure requirements for
all information published in the Database.
We received one comment related to this section. The section has
been finalized with one correction, which is to add the words
``Publicly Available'' to the full name of the Database.
Comment 1--One commenter states that incident reports involving
over-the-counter drugs and dietary supplements should not be included
in the Database because food and drugs are regulated and monitored by
the U.S. Food and Drug Administration (``FDA''). The commenter notes
that the Commission has regulatory authority only over product
packaging, and asserts that consumers will inadvertently submit drug or
supplement safety information to the Commission rather than to the
manufacturer or the FDA. If the Commission includes complaints
regarding product packaging in the Database, the commenter states that
the Commission should not only instruct consumers that only product
packaging complaints can be reported in the Database, but should also
regularly monitor the Database to ensure that complaints involve only
products over which the Commission has jurisdiction.
Response--Section 1102.10(d)(1) of the final rule states that to be
included in the Database, a report of harm 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 report of harm that does
not identify a product or substance over which the Commission has
jurisdiction will not be included in the Database. Every report of harm
will be reviewed to ensure that the minimum requirements for
publication are met before being published in the Database. Also, as
with our current online incident report form, the Database will
describe the products that are not within the Commission's
jurisdiction, including food and drugs. This information will include
links to the appropriate government agencies that do have jurisdiction.
We have no intention of including reports of harm solely involving
products or substances not within our jurisdiction, but will include
all products and substances that do fall within our jurisdiction,
including complaints about drug product packaging.
3. Proposed Sec. 1102.6--Definitions
Proposed Sec. 1102.6 would define certain terms related to the
establishment and maintenance of the Database.
a. Proposed Sec. 1102.6(a)--Terms Defined in Sec. 3 of the CPSA Apply
to the Database Rule
Proposed Sec. 1102.6(a) would explain that, except as provided in
proposed Sec. 1102.6(b), the definitions set forth in section 3 of the
CPSA apply to the Database rule. 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.
One comment was received related to this section, which we have
finalized without change.
Comment 2--One commenter states that the term ``private labeler''
should be defined in Sec. 1102.6 of the final rule.
Response--Section 3(a)(12) of the CPSA defines ``private labeler''
as ``an owner of a brand or trademark on the label of a consumer
product which bears a private label.'' Because the CPSA defines
``private labeler,'' there is no need to include such a definition in
the final rule.
b. Proposed Sec. 1102.6(b)--Terms Defined Relevant to Sec. 1102
Proposed Sec. 1102.6(b) would define certain terms or, in some
cases, interpret terms already defined in section 3 of the CPSA.
Proposed Sec. 1102.6(b)(1) would define ``additional information''
as any information that the Commission determines is in the public
interest to include in the Consumer Product Safety Information
Database.
No comments were received related to this definition, and we have
finalized it with one change, which is to add ``Publicly Available'' to
the full name of the Database.
Proposed Sec. 1102.6(b)(2) would define ``Commission'' or ``CPSC''
as meaning the Consumer Product Safety Commission.
No comments were received related to this definition, and we have
finalized it without change.
Proposed Sec. 1102.6(b)(3) would define ``consumer product'' as
having the same meaning as defined in section 3(a)(5) of the CPSA, but
would further explain that ``consumer product'' includes any other
products or substances regulated by the Commission. 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.
[[Page 76834]]
No comments were received related to this definition, and, for
clarity, we have added ``under any other act it administers'' to the
end of the definition.
Proposed Sec. 1102.6(b)(4) would define ``Consumer Product Safety
Information Database,'' which is also referred to as the ``Database,''
as the database on the safety of consumer products required to be
established and maintained by the Commission as described in section 6A
of the CPSA.
No comments were received related to this definition. However, on
our own initiative, we did incorporate the shortened name of
``Database'' in the final rule and added the words ``Publicly
Available'' to the full name of the Database.
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. This definition is taken from section
6A(g) of the CPSA, which states that ``[i]n this section, the term
`harm' means (1) injury, illness, or death; or (2) risk of injury,
illness, or death, as determined by the Commission.''
We received several comments related to this definition which did
not lead us to make any changes. However, we are changing this
definition to be consistent with the statutory language.
Comment 3--Some commenters would remove from the definition of a
report of harm the terms ``or any risk of injury, illness, or death as
determined by the Commission, relating to the use of a consumer
product.'' The commenters argued that such a determination requires an
arbitrary assessment that would require Commission resources to
determine whether the report of harm represents a legitimate risk.
According to these commenters, reports of harm addressing risks should
come from the Commission in recall notices only, not from the general
public.
Response--Section 6A(g) of the CPSA defines ``harm,'' as used in
this section of the statute, as ``(1) injury, illness, or death; or (2)
risk of injury, illness, or death, as determined by the Commission.''
Because the definition of ``harm'' is dictated by Congress in the
statute, and Congress has plainly expressed its intent in the statute
that the Database include reports of harm involving risks of harm, we
will not remove this phrase from the definition of a report of harm.
Moreover, the Database is meant to help us in our mission to protect
the public against unreasonable risks of injury associated with the use
of consumer products. Use of agency resources to assess risks is
essential to our mission. While submitters must describe an illness,
injury, or death, or risk of illness, injury, or death on the incident
report form, each report of harm will be reviewed before publication to
ensure that it meets the minimum requirements for publication set forth
in Sec. 1102.10(d).
Comment 4--Some commenters propose that ``any risk of injury'' be
defined narrowly to account for the level of risk or the potential for
injury to exclude reports of harm that ``have near zero risk of causing
injury.'' These commenters would strike the term ``any'' and replace it
with a phrase such as ``substantial risk of serious injury,'' which
they state has historically been used by the Commission.
Response--We disagree with the commenters because they would have
us interpret the statute in an unnecessarily narrow manner. However, we
have stricken the word ``any'' and changed the comma to a semicolon
after the first occurrence of the word ``death'' to make the definition
consistent with the statutory language. Section 3(a)(14) of the CPSA
already defines ``risk of injury'' as ``a risk of death, personal
injury, or serious or frequent illness.''
We also decline to use the phrase ``substantial risk of serious
injury'' to qualify the types of harm or risk of harm that may be
placed into the Database. Such phrase is used once in 16 CFR 1115.13(c)
to describe a firm's initial obligation to report hazards under section
15(b) of the CPSA. It applies to manufacturers, importers, retailers,
and distributors who have received information that reasonably supports
the conclusion that one of the factors in section 15(b) of the CPSA has
been met. The phrase has no relevance to the types of information
included in a report of harm.
Comment 5--One commenter states that the Commission should
establish criteria for making determinations about risks of harm,
arguing that speculative assertions or unsubstantiated opinions that a
consumer could have been injured, without any supporting factual
information indicating a nexus between the product or incident and a
discernable and credible risk of injury, cannot provide the CPSC with
the necessary basis for making the required determination to include
these reports in the Database.
Response--The Commission has many years of experience categorizing
harm or hazards and their risks related to the use of a consumer
product based on a reported incident scenario. We will continue to rely
on our expertise to review reports of harm submitted for inclusion in
the Database and will determine whether the minimum requirements for
publication are met.
Comment 6--One commenter states that the proposed rule does not
delineate how the Commission will determine ``harm'' or ``report of
harm,'' and it does not define ``risk.''
Response--Section 6A(g) of the CPSA defines ``harm,'' and we will
adhere to this definition. We have maintained a database on injuries
and risks of injury associated with the use of consumer products for
many years, and will use our experience in reviewing reports of harm to
ensure that the minimum requirements for inclusion in the Database are
met. ``Risk,'' by itself, is not defined in the proposed rule or in the
CPSA, but section 3(a)(14) of the CPSA defines ``risk of injury'' as
``a risk of death, personal injury, or serious or frequent illness.''
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.
No comments were received related to this definition, and we have
finalized it with one grammatical change.
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 transmitted by the CPSC to the manufacturer or private
labeler.
No comments were received related to this definition, and we have
finalized it without change.
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 any injury, illness,
or death, or any risk of injury, illness, or death as determined by the
Commission relating to the use of the consumer product.
We received comments regarding the definition of ``harm'' used in
the proposed rule. As noted above in response to Comments 3 through 6,
we are making minor modifications to the definition of ``harm'' as
contained in section 6A(g) of the CPSA. Thus, we have finalized the
definition of ``report of harm'' with one grammatical change, changing
``an injury'' to ``any injury.'' We also changed the comma to a
semicolon after the first occurrence of the word ``death'' and inserted
a comma after the second occurrence of the word ``death'' to ensure
that the definition in the final rule is more consistent with the
definition of ``harm'' in the statute.
Proposed Sec. 1102.6(b)(9) would define ``submitter of a report of
harm'' as any person or entity that submits a report of harm.
[[Page 76835]]
No comments were received related to this definition, and we have
finalized it without change.
Section 1102.6(b)(10) of the proposed rule would define ``voluntary
recall notice'' to mean 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.
No comments were received related to this definition, and we have
finalized it without change.
Comment 7--One commenter objects to use of the term ``victim'' in
the proposed rule. The commenter states that the use of such a term
implies a criminal or civil wrong, and suggests use of the word
``consumer'' as a more neutral term.
Response--We will not remove the term ``victim'' in the final rule,
but agree that the term may be confusing to some without further
clarification. We have used the term ``victim'' for many years to
describe persons actually suffering a harm or risk of harm related to
the use of a consumer product as compared to others who simply may have
purchased or observed the product being used. The term ``victim'' is
used on the current incident reporting form to collect information
about the individual who was injured or exposed to a possible product
related hazard. In the context of that form, the use of the term
``victim'' does not imply a criminal or a civil wrong. Thus, for
purposes of this rule, ``victim'' continues to refer to any individual
exposed to harm or risk of harm related to a possible product related
hazard, and the term does not imply that the product caused an
incident.
B. Proposed Subpart B--Content Requirements
1. Proposed Sec. 1102.10--Reports of Harm
Proposed Sec. 1102.10 would explain the requirements for reports
of harm to be included in the Database.
a. Proposed Sec. 1102.10(a)--Who May Submit
Proposed Sec. 1102.10(a) would identify the category of submitters
specified in section 6A(b)(1)(A) of the CPSA and further clarify the
persons who may fall within each of the identified groups. The list of
persons under each category is not exclusive, and the proposed lists
are intended to provide a greater understanding of the type of person
or entity that could fall within each category of submitter.
Proposed Sec. 1102.10(a)(1) would state that the term
``consumers'' includes not only users of consumer products, but also
family members, relatives, parents, guardians, friends, and observers
of a consumer product being used.
We received one comment related to this section, and other comments
relating to the definitions under proposed Sec. 1102.10(a) resulting
in a revision to the definition of ``consumers'' as described in
response to Comment 8 through 17.
Comment 8--Several commenters state that the interpretation of
``consumer'' should not be so broad as to include those persons who
were not injured by the product or who are not reliable reporters of
the incident, such as those persons lacking firsthand knowledge of the
product, its manufacturer, or the injury. The commenters also state
that the proposed interpretation of ``consumer'' expands the potential
for inaccurate information in the Database and goes beyond a reasonable
interpretation of the term. Some commenters note, however, that
information from these sources could be collected for the Commission's
use, but should not be included in the Database.
Response--The plain statutory language does not require a submitter
of a report of harm to have ``firsthand knowledge.'' We have chosen an
interpretation of ``consumer'' that comports with our experience in
maintaining a database of consumer product incident reports.
Historically, we have received reports of harm from any and all
consumers in order to protect individuals who may use or enjoy consumer
goods. Currently, parents, guardians, and family members are a major
and important source of information collected for the most vulnerable
segments of the population. In the most basic example, if the user of a
consumer product is killed or seriously injured in the incident, or is
an infant, he or she will be unable to enter the incident report.
Parents, for example, may enter information related to consumer
products used by their children, regardless of whether they personally
witnessed the incident or purchased the product. Other consumers may
possess important product safety information and, as a practical
matter, the Commission does not have the resources to ascertain whether
every submitter of a report of harm has firsthand knowledge or actually
used the product. Therefore, following our current practice of
receiving reports of harm from any and all consumers serves the purpose
and intent of the Database and of our primary statutory mission, which
is to protect consumers from unsafe products. Furthermore, a
manufacturer is free to post a comment indicating whether they know if
the submitter had firsthand knowledge or not. For these reasons, we
disagree that inclusion of inaccurate information will necessarily
result from our definition of ``consumer.'' Moreover, everyone who
submits reports of harm to the Database is legally obligated to provide
truthful and accurate information as evidenced by their verification
that they have done so.
We also note that reports of harm received from individuals in some
of the other statutory categories, such as other government agencies,
health care professionals, and public safety entities, will likely lack
firsthand knowledge about an incident. For example, a physician who
treats an individual who was injured by a consumer product is unlikely
to have witnessed how or when the injury occurred, but the statute
permits the physician to submit a report of harm. If we find that false
and fraudulent reports are being submitted for inclusion in the
Database, we will consider what legal actions to take to address the
problem and proceed accordingly.
Proposed Sec. 1102.10(a)(2) would state that the definition of
``local, state, or federal government agencies'' includes, but is 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.
No comments were received on this provision, and we have finalized
it with only typographical changes.
Proposed Sec. 1102.10(a)(3) would state that the definition of
``health care professionals'' includes, but is not limited to, medical
examiners, coroners, physicians, nurses, physician's assistants,
hospitals, chiropractors, and acupuncturists.
No comments were received on this provision, and we have finalized
it with one grammatical change.
Proposed Sec. 1102.10(a)(4) would state that the definition of
``child service providers'' includes, but is not limited to, day care
centers, day care providers, pre-kindergarten school, and child care
providers.
No comments were received on this provision, and we have finalized
it with minor modifications changing ``day care'' to ``child care.''
Proposed Sec. 1102.10(a)(5) would state that the definition of
``public safety entities'' includes, but is not limited to, police,
fire, ambulance, emergency medical services, federal, state, and
[[Page 76836]]
local law enforcement entities, and other public safety officials.
No comments were received on this provision, and we have finalized
it with one change for clarity. In response to comments relating to the
definitions under proposed Sec. 1102.10(a)(6), we added ``and
professionals, including consumer advocates and individuals who work
for nongovernmental organizations, consumer advocates, consumer
advocacy organizations, and trade associations so long as they have a
public safety purpose'' to the end of the definition.
Proposed Sec. 1102.10(a)(6) would add ``Others'' to the list of
submitters. The ``Others'' category is intended to include those
persons who may not fit clearly within an identified category, but who
may otherwise file a report as a ``consumer.'' The ``Others'' category
would include, but is not limited to, attorneys, professional
engineers, investigators, nongovernmental organizations, consumer
advocates, consumer advocacy organizations, and trade associations.
We received several comments on proposed Sec. 1102.10(a)(6). Many
commenters misinterpreted the proposal as an expansion of the list of
people who can submit reports. This was not the intention. The proposal
states, the five statutory categories of submitters are quite broad
and, given that breadth, we had concluded that the list was intended to
be nonrestrictive. See 75 FR at 29162. Currently, persons listed as
examples under ``Others'' file reports of harm with us using our online
incident reporting form by self-reporting as ``consumers.'' However,
anyone can be classified as a consumer even if they are also acting as
a doctor, lawyer, investigator, consumer advocate, or trade
complainant. Moreover, many individuals who report to us work for
organizations with a public health and safety purpose and, thus may be
included under the category ``public safety entity.'' Since most if not
all of the people listed in the ``Others'' category can fit in the
categories Congress listed, we have deleted reference to ``Others'' in
response to the comments.
Comment 9--Some commenters state that adding ``Others'' is contrary
to the plain meaning of the statute. The commenters argue that section
6A(b)(1)(A) of the CPSA expressly limits who may submit reports, so the
Commission is acting outside its authority by adding an ``Others''
category.
Response--Congress listed five broad categories of submitters and
we have the authority to interpret these categories. As discussed
above, the term ``consumer'' is quite broad, and we have consistently
interpreted it in this rulemaking to include any and all consumers.
This interpretation comports with our mission to protect individuals
who may use or enjoy consumer products. Most of the persons and
entities captured in the ``Others'' category are covered by the five
broad categories of submitter listed in the statute. We have decided to
delete the reference to ``Others.''
Comment 10--Some commenters argue that section 6A(b)(2)(B) of the
CPSA, which establishes the minimum requirements for reports of harm to
be included in the Database, uses the phrase ``at a minimum'' to set a
floor to which the Commission may add requirements. Because this ``at a
minimum'' language is missing from section 6A(b)(1)(A) of the CPSA, the
commenters claim that we cannot add ``Others'' as a category of
submitters.
Response--The five categories of submitters set forth in section
6A(b)(1)(A) of the CPSA are so broad that they include most submitters,
eliminating the need to state that these categories are ``at a
minimum.'' Nevertheless, the category of ``Others'' will be deleted.
Comment 11--Some commenters state that adding an ``Others''
category contradicts existing regulations that require incident reports
to be verified by those with personal or firsthand knowledge. The
commenters argue that including reports from those without such
knowledge would reduce the Database to a blog consisting of hearsay
reports from people without personal knowledge who have a vested
interest in increasing the number and severity of negative reports. The
commenters state that there is no indication that Congress intended to
override the Commission's long-standing requirements for verification
of information it intends to make public.
Response--Congress provided a clear indication that the requirement
in section 6(b) to take reasonable steps to assure accuracy does not
apply to reports of harm included in the Database. Section 6A(f)(1) of
the CPSA specifically provides that the provisions of sections 6(a) and
(b) of the CPSA do not apply to reports of harm. Instead, verification
is required for reports of harm as described in section 6A(b)(B)(v) of
the CPSA, where a person submitting a report must verify that it is
``true and accurate to the best of the person's knowledge.'' This
requirement is set forth in Sec. 1102.10(d)(7) of the final rule.
Moreover, Congress intended for the Database to include reports by
those without ``firsthand knowledge'' or ``personal knowledge,'' as the
statute expressly allows reports of harm to be submitted by those
unlikely to have personal knowledge, such as other government agencies
and public safety entities. However, Congress implemented three
mechanisms to help control inaccuracies: The ability of the
manufacturer to comment as set forth in section 6A(c)(2)(A) of the
CPSA; the ability to remove material inaccuracies as set forth in
section 6A(c)(4) of the CPSA; and the disclaimer requirement provided
in section 6A(b)(5) of the CPSA.
Comment 12--Some commenters state that, other than consumers, the
other categories of submitters listed in sections 6A(b)(1)(A)(2)
through (b)(1)(A)(5) of the CPSA have various legal obligations to
accurately and objectively record and report safety incidents,
injuries, and suspected child abuse as part of their professional
responsibilities. The commenters claim that adding an ``Others''
category will increase inaccurate reports of harm being entered into
the Database and will also increase the possibility of duplicative
reports being entered about the same incident.
Response--Everyone who reports information to the Database, whether
a consumer, governmental entity, health care professional, child care
provider or public safety entity, has a legal obligation to provide
accurate information and will be required to verify that they have done
so. For example, attorneys are subject to numerous ethical obligations
and are likely to have a legal obligation to submit a report of harm if
the client directs them to do so. As another example, 18 U.S.C. 1001
makes the knowing and willful submission of a materially false,
fictitious or fraudulent report to a government agency criminal. In our
experience, the category of submitter is more indicative of the type of
detail that can be provided about an incident, rather than the quality
or veracity of the data entered. Moreover, nothing in section 6A of the
CPSA dictates that the individual who enters reports of harm be someone
who purchased or used a product or who has a legal responsibility to
report safety incidents to another government agency. Such a limitation
would not serve the purpose of the Database. For these reasons and
because the categories of ``consumer'' and ``public safety entity''
include most of the persons and entities listed in the proposed rule as
reporting under the ``Others'' category, the commenters' concerns are
unpersuasive.
With regard to duplicative reports, we note that the statutory list
of submitters
[[Page 76837]]
allows for the submission of multiple reports of harm about the same
incident because a consumer can submit a report as well as their health
professional. In the Joint Explanatory Statement of the Committee of
Conference on the CPSIA, the Conferees recognized the value of possible
multiple reports regarding the same incident because they ``could
provide different relevant details and that information from those
reports could be helpful to the public.'' The Database system software
is designed to look for potential duplicates and multiple reports and
to display them to staff. Commission staff will review potential
duplicate and multiple reports and ``associate'' them, where
appropriate, so that all reports on one incident will be reflected. As
explained more fully below under Sec. 1102.10(d), we are adding one
more required field: ``Incident date'' so that Database users are
provided a date, or approximate date, of the incident. We are also
clarifying the field, ``Category of submitter,'' by separating it from
the verification requirement and displaying it in the Database as
another required field so that Database users can see the category of
submitter of the report of harm. We already had required this field in
the NPR, but now we are separating it from the required verification.
Such information should make the perspective of the submitter
transparent and assist the agency in locating duplicate reports.
Comment 13--Some commenters state that adding an ``Others''
category of submitter is unreasonable and contrary to sound public
policy. The commenters claim that the Database's purpose is to advance
public safety by better informing consumers of potential product
hazards, and that Congress selected reporters who contribute to this
purpose--``those who use or observe the use of the consumer product
(and thus the resulting harm or risk of harm) and those who may be
involved in treating or responding to the harm.'' Congress chose to
exclude those persons who may be commercially or financially motivated
to submit reports of harm.
Response--Having decided that the five statutory categories of
submitters include most of those individuals who had previously been
included in the ``Others'' category, these persons shall be permitted
to submit reports to the Database. The purpose of the Database is to
provide timely access to safety-related consumer product incidents. The
timeliness of the data release is a crucial aspect of the Database.
Congress has expressed a public policy favoring prompt disclosure of
these incidents in the interest of public safety. Indeed, Congress
would not have us refuse to publish reports of harm involving deaths
and serious injuries simply because the report was submitted by the
consumer's counsel or the consumer's survivors. Accordingly, our
evaluation of what is ``unreasonable and contrary to sound public
policy'' differs from the commenters' evaluation. Our goal is to
provide the public with timely product safety information, which would
not be served by excluding valid reports of harm based on criteria that
have little or nothing to do with the quality or validity of a report.
Nothing in the statute states that product safety information can
come only from those who ``use or observe the use'' of the consumer
product, and/or those who may be involved ``in treating or responding''
to the harm. Creating an artificial limitation that is not present in
the statute would conflict with our experience in maintaining a
database on the safety of consumer products. As explained above, not
all submitters will personally use the consumer product or view the
incident; however, that does not make their report invalid (i.e.,
parents of minor children, relatives of victims who died or were
seriously injured as a result of the incident, friends and family of
elderly or disabled persons, and attorneys whose clients were killed or
seriously injured may also submit reports). Persons included in the
``Others'' category may not have viewed the incident, but still may
have a distinct, educated, and valuable understanding of the facts,
either learned from the victim, or derived from investigation and
analysis. Moreover, as a practical matter, the Commission cannot
research every submission to the Database to determine who submitted
it, whether they used or observed the use of the product, or whether
they have some other bias or financial interest.
The fact that a submitter may have a professional interest in the
report does not negate the truth of the report. If the Commission
determines that a report is false, it will be removed or corrected. If
the Commission determines that false incident reports are being filed,
we will consider what legal actions to take to address the problem and
proceed accordingly.
Comment 14--Some commenters say that limiting submitters to the
five statutorily enumerated categories is supported by the legislative
history of section 6A of the CPSA. The commenters state that the House
and Senate versions of the bill were different regarding who could
submit reports of harm. The Senate version originally permitted ``other
nongovernmental sources'' to submit reports of harm for inclusion in
the Database, but this version was not incorporated into the final
bill. Thus, the commenters suggest that the removal of this provision
indicates the intent to exclude ``Others'' from submitting reports of
harm.
Response--We have previously noted the breadth of the entities
listed in the statute that can file a report of harm and our conclusion
that the list is intended to be nonrestrictive. 75 FR at 29162. The
original Senate version of the bill also stated that health care
professionals include ``physicians, hospitals, and coroners'' and that
public safety entities include ``police and fire fighters.'' All of
these entities were removed in the final legislation. Nevertheless, we
are unwilling to interpret section 6A of the CPSA as prohibiting
physicians, hospitals, coroners, police, and fire fighters from
submitting reports of harm. Having decided to remove the ``Others''
category, we conclude this comment is now moot.
Comment 15--Some commenters state that if the Commission intends to
use section 6A(b)(3) of the CPSA [pertaining to additional information]
to add reports of harm from ``Others'' to the Database, then the
Commission must find that inclusion of those reports of harm are ``in
the public interest,'' and that the reports must also meet the
requirements of sections 6(a) and (b) of the CPSA. Adding an ``Others''
category under section 6A(b)(1)(A) of the CPSA, the commenters allege,
improperly evades the requirements for including additional information
under section 6A(b)(3) of the CPSA, and makes that section superfluous.
Response--We interpret section 6A(b)(3) of the CPSA to mean that,
in addition to the information required to be in the Database,
including reports of harm, manufacturer comments, and recall notices,
any additional categories of information must be in the public interest
and subject to sections 6(a) and (b) of the CPSA. This interpretation
is set forth in Sec. 1102.16, which includes other categories of
information in the Database other than reports of harm, manufacturer
comments, and recall notices. Our interpretation is that additional
information does not refer to reports of harm because all reports of
harm meeting the minimum requirements for publication already are
included in the Database. Additional categories of information could
include, for example, internal CPSC reports, such as in-depth
investigations, and product safety assessments.
Comment 16--Some commenters state that if the Commission includes
reports of harm in the Database submitted by those in the proposed
``Others'' category,
[[Page 76838]]
then the increase in such submissions will ``significantly increase the
costs and burdens on both the Commission and manufacturers and
distributors of consumer products to review, verify, and respond to the
filings.''
Response--This comment is speculative and contrary to our research
and experience. We review every report of harm and send the reports to
manufacturers for comment under section 6(c) of the CPSA. Thus, even if
we could choose to exclude reports of harm from ``Others'' in the
Database, we would still collect this information for our use, and
would still send it to manufacturers under section 6(c) of the CPSA.
Accordingly, we do not believe that the submission of reports of harm
by ``Others'' would have significantly increased costs or burdens, and
we will receive such reports from most of those submitters under one of
the five enumerated categories in the statute.
Comment 17--Several commenters state that while reports of harm
from those in an ``Others'' category may not be placed in the Database,
the Commission may collect and use such reports for other hazard
analysis purposes.
Response--As explained above, we believe that reports of harm
submitted by most of those included in the ``Others'' category should
be included in the Database under the five categories enumerated by the
statute. We do not have the authority to exclude valid reports of harm
from the Database. No valid public health and safety reason exists to
exclude data that meet the minimum requirements for inclusion in the
Database. Such an action would be contrary to the purpose and intent of
the Database. We are focusing on the quality of the data submitted, as
opposed to who submitted the report. Preserving reports of harm
submitted by consumers in the ``Others'' category strictly for
Commission use would not serve the purpose of timely providing the
public with access to product safety information.
b. Proposed Sec. 1102.10(b)--Manner of Submission
Proposed Sec. 1102.10(b) would describe how a report of harm can
be submitted for inclusion in the Database. Section 6A(b)(2)(A) of the
CPSA requires that the Commission establish electronic, telephonic, and
paper-based means for submitting a report of harm for inclusion in the
Database. Accordingly, proposed Sec. 1102.10(b) would describe four
methods (Internet, telephone, electronic mail, and paper) for
submitting reports. Proposed Sec. 1102.10(b)(1) also would explain
that submitters using the Internet will use an electronic form
specifically developed to collect the report of harm in the Database.
Proposed Sec. 1102.10(b)(2) would further explain how submissions over
the telephone will be accepted. Proposed Sec. 1102.10(b)(3) and (b)(4)
would explain how the Commission will deal with email, facsimile, and
written submissions. Proposed Sec. 1102.10(b)(5) would give the
Commission the flexibility to provide other means of submission if new
means become available.
The proposed rule left open for the final rule the office names and
contact information to use for email, facsimile, and paper submissions
of reports of harm. Accordingly, Sec. 1102.10(b) has been finalized
with several additions. First, we included the appropriate office names
and contact information in Sec. 1102.10(b)(3) and (b)(4). Second, we
made a grammatical correction to use the short name for the Database
adopted in Sec. 1102.6(b)(4).
c. Proposed Sec. 1102.10(c)--Size Limits of Reports of Harm
Proposed Sec. 1102.10(c) would impose 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.
No comments were received on this section, which we have finalized
without change.
d. Proposed Sec. 1102.10(d)--Minimum Requirements for Publication
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 would identify the minimum required categories
of information stated in sections 6A(b)(2)(B)(i) through (v) of the
CPSA, and further elaborate on the type of information included under
each category.
We received several comments generally related to the minimum
requirements for publication, which resulted in no substantive changes
to the final rule. On our own initiative, however, we have made a
grammatical correction to the full name of the Database and added the
words ``Publicly Available'' to the full name of the Database.
Comment 18--One commenter states that the Commission should remind
submitters to only file reports of harm for incidents of which they
have firsthand knowledge, and actively should discourage complaints
based on hearsay.
Response--For the reasons set forth in response to Comment 8 above,
we will not restrict submissions of reports of harm for inclusion in
the Database to only those who have firsthand knowledge. Reports of
harm that meet the statutory minimum requirements for inclusion, and
the requirements as set forth in Sec. 1102.10(d) of the final rule,
will be included in the Database.
Comment 19--Some commenters suggest that the final rule impose a
time limit on when reports of harm may be included in the Database, to
exclude old or stale data. Several commenters suggest a time limit of
one year from the incident date, claiming that over time, data becomes
inherently suspect.
Response--As a matter of statutory interpretation, we have decided
to allow submitters to enter reports of harm about product related
incidents regardless of when the incident occurred because Congress
imposed no limitation in section 6A of the CPSA. Because many consumer
products have a long use period, and many consumer products are
purchased second hand or used rather than new, it is important to
collect and maintain information on these products over time. Moreover,
in our experience, consumers sometimes fail to submit a report of harm
until after a recall is announced in the media. Regardless of the date
of occurrence and the date of entry, all reports of harm must meet the
minimum requirements for inclusion in the Database as set forth in
section 6A of the CPSA and Sec. 1102.10(d) of the final rule.
Moreover, as set forth in response to Comment 30 below, the Commission
has decided to require the incident date, or an approximate incident
date, to include a report of harm in the Database. Users can determine
for themselves what weight to accord an incident that is entered long
after the date of occurrence. If a manufacturer or private labeler
believes that the date of the incident is relevant to users of the
Database, it may highlight this fact in its comment to the report of
harm.
Comment 20--Several commenters note that the proposed rule does not
indicate how long reports of harm and associated comments will remain
in the Database. The commenters state that the final rule should impose
a time limit after which information will be removed from the Database
to ensure that the information remains helpful. The commenters also
state that unless data has a time limit or sunset period, the Database
may become overloaded with outdated information. The commenters suggest
that if no recall occurs within one year of a report being entered,
then the information should be removed but remain available through a
FOIA request. Alternatively, the commenters
[[Page 76839]]
suggest that the Commission could tag information as ``active reports''
and ``resolved reports.''
Response--Setting a time limit or expiration date for reports of
harm and related comments is inconsistent with the purpose of the
Database. Certain hazard patterns may not emerge from the data within a
specific time limit. Many consumer products have a long use period, and
many consumer products are purchased used. Accordingly, it is important
to collect and maintain information on products over time.
Moreover, there is no easy way to determine across all industries
and all products when data about products may lose importance. For
example, durable infant products, which may be purchased used, may
become the subject of incident reports years after a product was
purchased or even recalled. We have several examples of children being
seriously injured by products that were recalled for the defect many
years before. Consumers should have access to all data that the
Commission has on file when they research recalls and reports of harm
made about consumer products in the Database. As for the suggestion of
making information available through FOIA, we believe that such a
change would be contrary to the purpose and intent of the Database and
would compel us to allocate resources to respond to FOIA requests
concerning data that should be made available in the Database. Finally,
as set forth in Sec. 1102.10(i) of the final rule, all reports of harm
submitted to the Commission become official records of the Commission
in accordance with 16 CFR Sec. 1015.1 and will be treated in
accordance with that regulation, which defines agency records for
purposes of the FOIA.
Comment 21--Several commenters state that the minimum information
required to submit a report of harm for inclusion in the Database in
Sec. 1102.10(d) is not detailed enough to allow those reviewing the
report to understand the incident adequately, to weed out duplicate
reports, and to promote investment in the report and Commission
activities by the submitter. One commenter states that, without more
detailed information, manufacturers will not be able to respond
meaningfully to reports of harm, which will mean that the Database
contains inaccurate information about their products. Thus, in cases
where the incident details are insufficient to make a determination of
why an event occurred, one commenter believes that the Commission
should not publish the report in the Database.
Response--We decline to amend the rule as suggested by the
commenters. Determining why an incident occurred can sometimes be a
time-consuming process; yet section 6A of the CPSA established
procedural requirements that are measured in days. Congress is
requiring us to create an ``incident'' database of ``reports of harm,''
not causation determinations. Section 6A of the CPSA requires reports
of harm to be posted in the Database quickly. Thus, we cannot refrain
from processing or publishing reports of harm to determine why an
incident occurred.
In response to comments on the proposed rule, however, we are
clarifying that one additional minimum field requirement was added in
the proposed rule, and has been maintained in the final rule, the
``Category of submitter.'' We have considered comments on this issue,
as described below, and decided to display this field in the Database.
Also, in response to comments, we have decided to require an additional
field ``Incident date'' for inclusion in the Database. These two
additional field requirements will assist users in distinguishing
duplicate or multiple reports and in determining what, if any, weight
to give a particular report of harm. Moreover, these two additional
pieces of information should be readily available and typically known
by submitters of a report about a consumer product. On balance, those
additional requirements should not deter a submitter from entering a
legitimate report of harm.
Proposed Sec. 1102.10(d)(1), ``Description of the consumer
product,'' would require a word or phrase sufficient to distinguish a
product identified in a report of harm as a consumer product, a
component of 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 identified as
information that would be helpful to the description of a consumer
product, but not required.
We received several comments about this section of the proposed
rule, and for clarity we have finalized the rule with grammatical
changes to reflect the original intent of the provision that certain
information in the description of the consumer product will be
optional.
Comment 22--Some commenters state that the proposed rule does not
require a product name, model number, manufacture date, date code, date
of purchase, or other descriptive information about a product. The
commenters assert that the statute requires that the Database be
searchable by date, product description, model name, and manufacturer's
name to the extent practicable; therefore, at a minimum, a report of
harm must contain a model number and a product name. Some commenters
state that poor product identification will make it impossible for a
manufacturer to comment, and that requiring that the information be
included will make the Database more useful and less misleading.
Response--We agree that the more information included about a
product, the easier it will be for the Commission and Database users to
identify the product. Accordingly, the Database will prompt submitters
for additional information about the product at issue, including, for
example, product brand, model number, serial number, and date of
manufacture. We encourage submitters to enter additional, helpful
information for product identification in their reports of harm;
however, we will not require submitters to provide all of the
information suggested by the commenters. We have amended Sec.
1102.10(d)(1) to reflect this position. Requiring too much detail about
a product may deter individuals from submitting reports. In addition,
we note that section 6A(b)(2)(B)(i) of the CPSA states that reports
that provide a ``description of the consumer product'' meet the
statutory minimum for product identification. We will review each
report of harm to ensure that a consumer product over which the
Commission has jurisdiction is identified. Section 1102.10(d)(1) states
that ``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.'' Thus, if we cannot identify
a consumer product over which we have jurisdiction based on information
in the report of harm, then the report will not meet the minimum
requirements for publication.
As for the commenters' argument regarding the searchability of the
Database, section 6A(b)(4) of the CPSA does not set forth minimum field
requirements; rather it describes how users must be able to access data
that already exists within the Database. In addition, section 6A(b)(4)
of the CPSA requires that the Commission ``categorize the information
available in the Database in a manner consistent with the public
interest and in such manner as it determines to facilitate
[[Page 76840]]
easy use by consumers and shall ensure, to the extent practicable, that
the Database is sortable and accessible by * * * (B) the name of the
consumer product * * *; [and] (C) the model name * * *.'' (emphasis
added). We interpret this language to mean that when a report of harm
contains information such as a model number, it should be ``sortable
and accessible'' by such information. Thus, if a report of harm
contains a model name or number, users will be able to search and sort
based on this information.
Comment 23--Some commenters state that the description of a
consumer product should be detailed enough so that the CPSC, the
manufacturer, and a user of the Database will be able to identify the
product.
Response--We agree that a description of the consumer product
should be detailed enough to identify the product. Section
1102.10(d)(1) states that ``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.'' Each
report of harm will be reviewed before entry into the Database.
Comment 24--Some commenters ask us to clarify: (1) What information
is required for a sufficient product description, and (2) how the staff
will determine what the product is, and whether to post the report of
harm in the Database.
Response--Section 1102.10(d)(1) establishes the minimum
requirements for a description of the consumer product, and is
consistent with section 6A(b)(2)(B)(i) of the CPSA, which simply
requires that the report of harm contain ``a description of the
consumer product (or other product or substance regulated by the
Commission) * * *.'' We will review each report of harm before entry
into the Database. If we cannot distinguish the item described in a
report of harm as a consumer product within the Commission's
jurisdiction, then the report of harm will not satisfy the minimum
requirements for inclusion in the Database.
Comment 25--Several commenters state that a product UPC Code should
be required for entry into the Database. Another commenter suggested
using Global Trade Item Numbers.
Response--We are interested in refining the ability of the Database
to identify consumer products using these automatic identification
technologies and our information technology staff currently is
evaluating automatic identification technologies for use in future
software versions of the Database. The rule is drafted broadly enough
to enable such future operational change.
Proposed Sec. 1102.10(d)(2) titled ``Identity of the manufacturer
or private labeler,'' would describe that a report of harm must name a
manufacturer or private labeler for the report to be published.
One comment related to this section of the rule was received, which
resulted in no changes to the final rule. However, on our own
initiative, we clarified in the second sentence of the description that
additional contact information may be provided for a manufacturer or
private labeler, but is not required. Accordingly, the second sentence
now states: ``In addition to a firm name, identification of a
manufacturer or private labeler may include, but is not limited to, a
mailing address, phone number, or electronic mail address.''
Comment 26--One commenter would require submitters to include
traceability information in a report of harm. If the traceability
information does not match to the stated importer, manufacturer, or
retailer records, the name of that entity should not appear in the
Database without further investigation and proof that the subject
product belongs to the named firm, the commenter argued.
Response--We interpret this comment to mean that if a consumer
product cannot be verified as belonging to a particular manufacturer or
priv