[Federal Register Volume 75, Number 236 (Thursday, December 9, 2010)]
[Rules and Regulations]
[Pages 76832-76872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30491]



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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  

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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.

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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; [email protected].

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 http://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 http://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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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.

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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 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.

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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 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 
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 other attachments that may help us or the 
manufacturer or private labeler to identify the product.
    Proposed Sec.  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 Sec.  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 Sec.  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.

[[Page 76841]]

    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 Sec.  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 Sec.  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 containing no discernable injury, illness, or 
death, or risk thereof, will not meet the minimum requirements for 
inclusion in the Database. Therefore, Sec.  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 Sec.  1117.3) by adding ``risk of 
injury, illness, or death * * *.'' Thus, imposing the reporting 
requirement in Sec.  1117.3 onto Sec.  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 
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 Sec.  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 Sec.  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 Sec.  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

[[Page 76842]]

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 Sec.  
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. Section 6A(b)(5) of the CPSA and Sec.  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 Sec.  
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 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 Sec.  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

[[Page 76843]]

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 Sec.  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 Sec.  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 
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 reports of harm submitted on the same incident and 
to see the value and insight provided by each reporter.
    Response--Proposed Sec.  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 Sec.  1102.10(d)(5) titled ``Category of 
submitter,'' and the ``Verification'' section previously at Sec.  
1102.10(d)(5) has been renumbered as Sec.  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 Sec.  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 Sec.  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 Sec.  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

[[Page 76844]]

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 computer-generated reports of harm, such as implementing 
Completely Automated Public Turing test to tell Computers and Humans 
Apart (``CAPTCHA'') challenge-response 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 Sec.  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 Sec.  
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 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 http://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 Sec.  1102.10(e)--Additional Information Requested on a 
Report of Harm
    Proposed Sec.  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 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 Sec.  1102.10(f)--Information Not Published
    Proposed Sec.  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

[[Page 76845]]

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 Sec.  1102.12(e).
    Comment 47--One commenter states that Sec.  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 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 Sec.  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 Sec.  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 Sec.  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 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 Sec.  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. -- This requirement is already contained in 
Sec.  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 Sec.  1102.10(d)(4).
    Response--The language in Sec.  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

[[Page 76846]]

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 Sec.  1102.10(h)--Incomplete Reports of Harm
    Proposed Sec.  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 Sec.  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 Sec.  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 
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 Sec.  1102.10(i)--Official Records of the Commission
    Proposed Sec.  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 with one modification to reflect that reports ``submitted 
to'' the Commission will become official records of the Commission.
2. Proposed Sec.  1102.12--Manufacturer Comments
    Proposed Sec.  1102.12 would identify the process for who may 
submit manufacturer comments in response to receiving a report of harm.
a. Proposed Sec.  1102.12(a)--Who May Submit
    Proposed Sec.  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, Sec.  
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 Sec.  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

[[Page 76847]]

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 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 Sec.  1102.12(b)--How To Submit
    Proposed Sec.  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 Sec.  1102.12(b)(1), changing the citation from Sec.  
1102.20(e) to (f), and we updated Sec.  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 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 Sec.  1102.12(c)--What Must Be Submitted
    Proposed Sec.  1102.12(c)(1) through (c)(4) would specify that the 
Commission will publish a manufacturer's comments related to a report 
of harm if the comment specifically relates to a report of harm; 
contains a unique identifier assigned to 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 Sec.  1102.24 (on confidential information) and 
Sec.  1102.26 (on materially inaccurate information). In addition, 
Sec.  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 Sec.  1102.12(d)--Information Published
    Proposed Sec.  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

[[Page 76848]]

Sec.  1102.24 (on confidential information) and Sec.  1102.26 (on 
materially inaccurate information).
e. Proposed Sec.  1102.12(e)--Information not Published
    Proposed Sec.  1102.12(e) would explain that the Commission will 
not publish the actual consents and verifications obtained from the 
manufacturer for such publication.
    We received no comments on this provision, and have finalized it 
without change.
3. Proposed Sec.  1102.14--Recall Notices
    Proposed Sec.  1102.14 would state that information in a voluntary 
or mandatory recall notice will be made accessible and searchable to 
the public in the Database.
    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.
4. Proposed Sec.  1102.16--Additional Information
    Proposed Sec.  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.
    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 Sec.  
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 http://www.cpsc.gov and will continue to 
be available at this site.

C. Proposed Subpart C--Procedural Requirements

1. Proposed Sec.  1102.20--Transmission of Reports of Harm to 
Identified Manufacturer or Private Labeler
    Proposed Sec.  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.
a. Proposed Sec.  1102.20(a)--Information Transmitted
    Proposed Sec.  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 Sec.  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

[[Page 76849]]

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 Sec.  1102.20(b)--Limitation on Use of Contact Information
    Proposed Sec.  1102.20(b) would follow the statutory limitation in 
section 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 Sec.  1102.20(b)(1) through (b)(4) 
would explain that verification could be related to the identity of the 
requester; the consumer product, including name, serial or model 
number; the harm or risk of harm described in the report of harm; and/
or a description of the incident related to the use of the consumer 
product.
    We have finalized this provision by deleting the words ``and/or'' 
after proposed Sec.  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 Sec.  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, 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 Sec.  1102.20(c)--Timing
    Proposed Sec.  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 Sec.  1102.20(c)(2).

[[Page 76850]]

d. Proposed Sec.  1102.20(d)--Method of Transmission
    Proposed Sec.  1102.20(d) would describe a method for transmission 
of reports of harm to a manufacturer or private labeler based on 
registration by the manufacturer or private labeler in the online 
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 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 Sec.  1102.20(e)--Size Limits of Manufacturer Comments
    Proposed Sec.  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.
f. Proposed Sec.  1102.20(f)--Manufacturer Registrations
    Proposed Sec.  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 
Sec.  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

[[Page 76851]]

transmitted notifications of a report of harm.
---------------------------------------------------------------------------

    \1\ An e-mail client is software used to manage a user's e-mail.
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    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 Sec.  1102.20(g)--Manufacturer Comments Received After One 
Year
    Proposed Sec.  1102.20(g) would address manufacturer comments 
received after one year, and would explain that a manufacturer or 
private labeler may comment on information received about a report of 
harm. The proposal would allow the Commission 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 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 Sec.  1102.24--Designation of Confidential Information
    Proposed Sec.  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 Sec.  1102.24(a)--``Confidential Information'' Defined
    Proposed Sec.  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.
    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 Sec.  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 Sec.  1102.24(b)--Designation of Confidential Information
    Proposed Sec.  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 Sec.  
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

[[Page 76852]]

information is required to the extent it is known to the manufacturer/
private labeler.
c. Proposed Sec.  1102.24(c)--Manner of Submission
    Proposed Sec.  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 
Sec.  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 Sec.  1102.24(d)--Timing
    Proposed Sec.  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 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. Sec.  
1905 and can cause serious competitive harm.
    Response--The final rule, at Sec.  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 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 Sec.  1102.24(e)--Assistance With Defense
    Proposed Sec.  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.

[[Page 76853]]

f. Proposed Sec.  1102.24(f)--Commission Determination of 
Confidentiality
    Proposed Sec.  1102.24(f) would describe the procedure for 
notifying the manufacturer or private labeler of a determination of a 
confidentiality designation. Proposed Sec.  1102.24(f) would state that 
if a portion of a report is deemed confidential, the Commission will 
notify the manufacturer or private labeler, redact the information 
deemed confidential, and publish the report of harm as redacted in the 
Database.
    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 Sec.  1102.24(g)--Commission Determination of No 
Confidentiality
    Proposed Sec.  1102.24(g) would state that, if a portion of a 
report is not deemed confidential, the Commission will notify the 
manufacturer or private labeler of the Commission's determination and 
will publish the report of harm in the Database.
    No comments were received on this section of the rule. We have 
finalized with typographical changes.
h. Proposed Sec.  1102.24(h)--Removal of Confidential Information
    Proposed Sec.  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 Sec.  1102.26--Designation of Materially Inaccurate 
Information
    Proposed Sec.  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. We have changed the heading of this section to ``Determination 
of Materially Inaccurate Information.''
a. Proposed Sec.  1102.26(a)--Definition of Materially Inaccurate 
Information
    Proposed Sec.  1102.26(a)(1) would define ``materially inaccurate 
information in a report of harm'' as information that is false or 
misleading in a significant and relevant way that 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 Sec.  1102.26(a)(1) to include the required field, 
``Incident date.'' In addition, we have made typographical changes.
    Proposed Sec.  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 Sec.  
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 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

[[Page 76854]]

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 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 materially inaccurate. 
Proposed Sec.  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 Sec.  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 Sec.  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 
``mini-litigation'' 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 Sec.  1102.26(b)--Request for Designation of Materially 
Inaccurate Information
    Proposed Sec.  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

[[Page 76855]]

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 Sec.  1102.26(b), the same way we defined it for 
making a determination and supporting a claim of confidential 
information in Sec.  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 Sec.  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 Sec.  1102.26(c)--Manner of Submission--Length of Request 
and Expedited Review
    Proposed Sec.  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 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 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 10-business-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 Sec.  1102.26(h), for removing any 
material inaccuracies after such a determination is made.
    Comment 83--One commenter states that proposed Sec.  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 Sec.  1102.26(d)--Timing of Submission
    Proposed Sec.  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

[[Page 76856]]

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 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, 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

[[Page 76857]]

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 Sec.  1102.26(e)--Assistance With Defense
    Proposed Sec.  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.
f. Proposed Sec.  1102.26(f)--Notice
    Proposed Sec.  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.
    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.
g. Proposed Sec.  1102.26(g)--Commission Determination of Material 
Inaccuracy Before Publication
    Proposed Sec.  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 Sec.  
1102.26(g)(2) and (g)(3) from Sec.  1102.10(c) to Sec.  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.

[[Page 76858]]

h. Proposed Sec.  1102.26(h)--Commission Determination of Material 
Inaccuracy After Publication
    Proposed Sec.  1102.26(h) would address a Commission determination 
where information in a report of harm or comment has been published and 
would explain that the Commission may, after an investigation, 
determine that information in a report of harm or manufacturer comment 
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 Sec.  
1102.26(h)(2) and (h)(3) from Sec.  1102.10(c) to Sec.  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.
    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 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 Sec.  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 Sec.  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 Sec.  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

[[Page 76859]]

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 Sec.  1102.26(i)--Commission Discretion
    Proposed Sec.  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 Sec.  1102.26(i)(1) from 
Sec.  1102.10(c) to Sec.  1102.10(d) and for clarity have changed 
``addition to correction'' to ``the addition of information to 
correct.''
    Proposed Sec.  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 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 Sec.  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 Sec.  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 Sec.  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 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 Sec.  1102.26(f).
j. Proposed Sec.  1102.26(j)--Commission Determination of No Material 
Inaccuracy
    Proposed Sec.  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 Sec.  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 Sec.  1102.10(d) and Sec.  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 20-
business-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

[[Page 76860]]

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 e-mail. 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 Sec.  1102.26, 
such claims will be supported and made in good faith.
k. Proposed Sec.  1102.26(k)--Commission Action in Absence of a Request
    Proposed Sec.  1102.26(k) would provide that the Commission may 
review a report of harm or manufacturer comment on its own initiative 
following the same notices and procedures set forth in Sec.  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 Sec.  1102.28--Publication of Reports of Harm
    Proposed Sec.  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 Sec.  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 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 Sec.  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 Sec.  1102.28(b) from 
Sec.  1102.10(c) to Sec.  1102.10(d).
    Comment 98--Several commenters assert that Sec.  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.

[[Page 76861]]

5. Proposed Sec.  1102.30--Publication of Manufacturer Comments
    Proposed Sec.  1102.30 would explain that the Commission will 
publish manufacturer comments that meet the minimum requirements in 
proposed Sec.  1102.12(c) at the same time as a report of harm is 
published or as soon as practicable thereafter. The proposal would 
provide examples of circumstances 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 Sec. Sec.  1102.12, 1102.24, and 1102.26 of the 
final rule. This correction is consistent with Sec.  1102.28(a), 
stating that publication of reports of harm are subject to Sec. Sec.  
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 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 Sec.  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 Sec.  1102.42--Disclaimers
    Proposed Sec.  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.''
    Response--In proposed Sec.  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 Sec.  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

[[Page 76862]]

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 Sec.  
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 Sec.  1102.44--Applicability of Sections 6(a) and (b) of 
the CPSA
    Proposed Sec.  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 Sec.  1102.44(b) 
would apply sections 6(a) and (b) of the CPSA to information received 
by the Commission pursuant to section 15(b) of the CPSA, and to 
information received by the Commission pursuant to any other voluntary 
or mandatory reporting program established between a retailer, 
manufacturer, or private labeler.
    We received several comments related to this section, which has 
been finalized without substantive change. We have made two internal 
citation corrections. In Sec.  1102.44(a), we corrected a citation from 
Sec.  1102.10(c) to Sec.  1102.10(d), and in Sec.  1102.44(b), we 
corrected a citation from Sec.  1102.42 to Sec.  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, Sec.  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 Sec.  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 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, Sec.  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

[[Page 76863]]

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 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 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 http://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 http://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

[[Page 76864]]

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 computer-
generated 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 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 computer-
generated 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 
Sec.  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 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

[[Page 76865]]

manufacturers of such products or substances who wish to comment on 
those reports of harm, pursuant to section 6A of the Consumer Product 
Safety Act (CPSA) (15 U.S.C. 2055a). In addition, any person or entity 
reviewing a report of harm or manufacturer comment, either before or 
after publication in the Database, may request that the report of harm 
or manufacturer comment, or portions thereof, be excluded from the 
Database or corrected by the CPSC because it contains materially 
inaccurate information.
    We estimate the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                     Number of     Frequency of    Total annual     Minutes per    Total burden,
         16 CFR Section             respondents      responses       responses       response        in hours
----------------------------------------------------------------------------------------------------------------
16 CFR 1102.10(b)(1), (3)                 11,534               1          11,534              12           2,307
 Reports of harm--electronic....
16 CFR 1102.10(b)(2) Reports of            3,329               1           3,329              10             555
 harm--telephone................
16 CFR 1102.10(b)(4) Reports of              277               1             277              20              92
 harm--paper....................
16 CFR 1102.12(b)(1), (2)                  5,753               1           5,753             255          24,450
 Manufacturer comments--
 electronic.....................
16 CFR 102.12(b)(3) Manufacturer           1,817               1           1,817             270           8,177
 comments--paper................
16 CFR 1102.24 Requests to treat             345               1             345              15              86
 information as confidential--
 electronic.....................
16 CFR 1102.24 Requests to treat             109               1             109              30              54
 information as confidential--
 paper..........................
16 CFR 1102.26 Requests to treat           1,726               1           1,726              30             863
 information as materially
 inaccurate--electronic.........
16 CFR 1102.26 Requests to treat             545               1             545              60             545
 information as materially
 inaccurate--paper..............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          37,129
----------------------------------------------------------------------------------------------------------------

There are no capital costs or operating and maintenance costs 
associated with this collection of information.
    Our estimates are based on the following:
    The CPSC is in the process of developing the forms that will be 
used by consumers and manufacturers to submit reports and comments for 
inclusion in the Database. Because those forms are still under 
development, for present purposes, we based our burden estimates on our 
experience with similar forms and processes, and on information gleaned 
from manufacturers. Specifically, the CPSC currently has an incident 
report form that consumers and others use to report consumer safety 
incidents to the agency. The CPSC provides most of those consumer 
complaints to the manufacturer, and the manufacturer may provide 
comments to the agency.
    For present purposes, we assume that the Database will receive the 
same number of reports of harm as the CPSC received of incident reports 
in fiscal year 2009, and that the numbers by manner of submission to 
the CPSC (i.e., electronic, telephone, paper) will be the same. Thus, 
using the data from fiscal year 2009, we estimate that we will receive 
a total of 15,140 reports of harm (11,534 by electronic means, 3,329 by 
telephone, and 277 by paper submissions). We had already estimated the 
time associated with the electronic and telephone submission of 
incident reports at 12 and 10 minutes, respectively and so used those 
figures for present purposes as well. We estimate that the time 
associated with a paper form would be 20 minutes on average. Thus, we 
estimate the total burden hours associated with the submission of 
reports of harm to be 2,954 hours ((11,534 electronic report x 12 
minutes per report) + (3,329 telephone reports x 10 minutes per report) 
+ (277 paper reports x 20 minutes per report) = 177,238 minutes or 
approximately 2,954 hours)).
    In 2008, manufacturers submitted comments to the CPSC in response 
to a consumer complaint forwarded to the manufacturer about 40 percent 
of the time. We estimate that the response rate will increase in the 
case of the Database; currently, neither the incident reports nor 
manufacturer comments are routinely public. We estimate that the 
manufacturer response rate will increase 25 percent, up to a 50 percent 
response rate. Therefore we expect to receive half as many total 
manufacturer comments as reports of harm (15,140 reports of harm x 0.5 
manufacturer comments per report of harm = 7,570 manufacturer 
comments). In terms of the manner of commenting, 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 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

[[Page 76866]]

estimated burden associated with manufacturer comments is approximately 
32,607 hours ((5,753 electronic comments x 255 minutes per comment) + 
(1,817 paper comments x 270 minutes per comment) = 1,957,605 minutes or 
approximately 32,627 hours).
    Regarding requests to designate information 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 
(Sec.  1102.24(b)); it is concrete information that we expect will be 
known or readily attainable by the entity filing the request. We 
estimate that it will take 15 minutes to submit such a request 
electronically. Because it would take longer to convey the necessary 
information on paper, and to avoid inadvertently underestimating the 
burden, we estimate that it will take twice as much time, or 30 
minutes, to submit the request on paper. We employed the same 
assumptions as used above to predict how many requests will be 
submitted electronically (454 requests x 76 percent electronic 
submission) to arrive at an estimate of 345 electronic requests and 109 
paper requests. We multiplied 345 electronic requests by 15 minutes, 
resulting in 5,175 minutes, or about 86 burden hours for the electronic 
requests. Similarly, we multiplied 109 paper requests by 30 minutes, 
resulting in 3,270 minutes, or about 54 burden hours for the paper 
requests.
    Regarding requests to designate information materially inaccurate, 
roughly 10 percent of the manufacturer comments that we currently 
receive contain a claim that the incident report contained inaccurate 
information. We used that figure to estimate that the number of 
requests to treat information as materially inaccurate will be 10 
percent of the total number of reports of harm and manufacturer 
comments that we expect, or 2,271 ([15,140 reports + 7,570 comments] x 
10 percent). 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 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 
Sec.  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 x 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 x 30 minutes = 51,780 minutes, or 863 burden hours). 
Similarly, 545 paper requests (2,271 requests x 24 percent paper = 
545), at 60 minutes each to complete, results in a burden of 545 hours 
(545 paper requests x 60 minutes = 32,700 minutes, or 545 hours).
    The total estimated burden, therefore, is 37,129 hours.

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 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

[[Page 76867]]

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 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.

0
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


Sec.  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.


Sec.  1102.4  Scope.

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


Sec.  1102.6  Definitions.

    (a) Except as specified in paragraph (b) of this section, the 
definitions in section 3 of the Consumer Product Safety Act (CPSA) (15 
U.S.C. 2052) apply to this part.
    (b) For purposes of this part, the following definitions apply:
    (1) Additional information means any information that the 
Commission determines is in the public interest to include in the 
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 Sec.  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


Sec.  1102.10  Reports of harm.

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

[[Page 76868]]

    (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 
[email protected], 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 the data size of reports of harm, which may include 
attachments submitted, where such reports of harm and attachments may 
negatively impact the technological or operational performance of the 
system.
    (d) Minimum requirements for publication. Subject to Sec. Sec.  
1102.24 and 1102.26, the Commission will publish in the 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 Sec.  
1102.10(a).
    (6) Contact information. The submitter's first name, last name, and 
complete mailing address. Although this information will not be 
published in the Database, it is required information for the report of 
harm. Submitters also may, but are not required to, provide an 
electronic mail address and a phone number to allow for efficient and 
timely contact regarding a report of harm, when necessary.
    (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 Sec.  1102.10(d)) for publication of a report of harm 
in the Database do not restrict the Commission from choosing to seek 
other categories of voluntary information in the future.
    (f) Information not published. The Commission will exclude the 
following information provided on a report of harm from publication in 
the Database:
    (1) Name and contact information of the submitter of a report of 
harm;
    (2) Victim's name 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 Sec.  1102.24;
    (6) Information determined to be materially inaccurate as set forth 
in Sec.  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

[[Page 76869]]

    (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.


Sec.  1102.12  Manufacturer comments.

    (a) Who may submit. A manufacturer or private labeler may submit a 
comment related to a report of harm if the report of harm identifies 
such manufacturer or private labeler.
    (b) How to submit. A manufacturer or private labeler may submit 
comments to the CPSC using one of the following methods:
    (1) A manufacturer or private labeler who registers with the 
Commission as described in Sec.  1102.20(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 
[email protected]; 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 Sec. Sec.  1102.24 and 
1102.26, the Commission will publish manufacturer comments related to a 
report of harm transmitted to a manufacturer or private labeler in the 
Database if such manufacturer comment meets the following requirements:
    (1) Manufacturer comment relates to report of harm. The 
manufacturer or private labeler's comment must relate to information 
contained in a specific report of harm that identifies such 
manufacturer or private labeler and that is 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 Sec. Sec.  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.


Sec.  1102.14  Recall notices.

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


Sec.  1102.16  Additional information.

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

Subpart C--Procedural Requirements


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

    (a) Information transmitted. Except as provided in paragraphs 
(a)(1) through (a)(3) of this section, the Commission will transmit all 
information provided in a report of harm, 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

[[Page 76870]]

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.
    (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.


Sec.  1102.24  Designation of confidential information.

    (a) For purposes of this section, ``confidential information'' is 
considered to be information that contains or relates to a trade secret 
or other matter referred to in 18 U.S.C. 1905 or that is subject to 5 
U.S.C. 552(b)(4).
    (b) A manufacturer or private labeler identified in a report of 
harm and who receives a report of harm from the CPSC may review such 
report of harm for confidential information and request that portions 
of the report of harm be designated as confidential information. Each 
requester seeking such a designation of confidential information bears 
the burden of proof and must:
    (1) Specifically identify the exact portion(s) of the report of 
harm claimed to be confidential;
    (2) State whether the information claimed to be confidential has 
ever been released in any manner to a person who was not an employee or 
in a confidential relationship with the company;
    (3) State whether the information so specified is commonly known 
within the industry or is readily ascertainable by outside persons with 
a minimum of time and effort;
    (4) 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 Sec.  1102.12(b). A request for designation of 
confidential 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.

[[Page 76871]]

Sec.  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;
    (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 Sec.  1102.26(b) to no more than five pages, including 
attachments, to allow for the expedited review of the request. 
Regardless of length, all submissions will be reviewed.
    (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 Sec.  1102.12(b). Such requests should be conspicuously marked.
    (3) All other requests. All other requests for a Commission 
determination of materially inaccurate information contained in a 
report of harm or manufacturer comment made by any other person or firm 
must be submitted to the CPSC using one of the methods listed below. 
The request seeking a Commission determination of materially inaccurate 
information may be made through:
    (i) Electronic mail. By electronic mail directed to the Office of 
the Secretary at [email protected]; 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 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 Sec. Sec.  
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 Sec. Sec.  
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

[[Page 76872]]

from the Database, including any associated documents, photographs, or 
comments;
    (2) Correct the information, and, if the minimum requirements for 
publication as set forth in Sec. Sec.  1102.10(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 Sec. Sec.  
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 Sec. Sec.  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 Sec.  1102.26(c)(1), the Commission shall attempt, where 
practicable, to make an expedited determination of a claim of material 
inaccuracy. Given the requirement of section 6A of the CPSA that 
reports of harm be published, the Commission will 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 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 Sec. Sec.  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.


Sec.  1102.28  Publication of reports of harm.

    (a) Timing. Subject to Sec. Sec.  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 Sec.  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 Sec.  
1102.26 for materially inaccurate information in a report of harm. Once 
a manufacturer or a private labeler has been identified correctly, the 
time frame set forth in paragraph (a) of this section shall apply.


Sec.  1102.30  Publication of manufacturer comments.

    Timing. Subject to Sec. Sec.  1102.12, 1102.24, and 1102.26, the 
Commission will publish in the Database manufacturer comments submitted 
in response to a report of harm that meet the minimum requirements set 
forth in Sec.  1102.12(c). This publication will occur at the same time 
as the report of harm is published or as soon 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


Sec.  1102.42  Disclaimers.

    The Commission does not guarantee the accuracy, completeness, or 
adequacy of the contents of the Consumer Product Safety Information 
Database, particularly with respect to the accuracy, completeness, or 
adequacy of information submitted by persons outside of the CPSC. The 
Database will contain a notice to this effect that will be prominently 
and conspicuously displayed on the Database and on any documents that 
are printed from the Database.


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

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