# Publicly Available Consumer Product Safety Information Database

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URL: https://www.frixlaw.com/law-library/documents/fr%3A2010-30491

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** December 9, 2010
- **Citation:** 75 FR 76832

## Text

CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1102
Publicly Available Consumer Product Safety Information Database

AGENCY:

Consumer Product Safety Commission.

ACTION:

Final rule.

SUMMARY:

The Consumer Product Safety Commission (“Commission,” “CPSC,” or “we”) is issuing a final rule that would establish a Publicly Available Consumer Product Safety Information Database (“Database”). Section 212 of the Consumer Product Safety Improvement Act of 2008 (“CPSIA”) amended the Consumer Product Safety Act (“CPSA”) to require the Commission to establish and maintain a publicly available, searchable database on the safety of consumer products, and other products or substances regulated by the Commission. The final rule interprets various statutory requirements pertaining to the information to be included in the Database and also establishes provisions regarding submitting reports of harm; providing notice of reports of harm to manufacturers; publishing reports of harm and manufacturer comments in the Database; and dealing with confidential and materially inaccurate information.

DATES:

Effective Date:
This rule is effective January 10, 2011.

FOR FURTHER INFORMATION CONTACT:

Mary Kelsey James, Director, Information Technology Policy and Planning, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504-7213;
mjames@cpsc.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Section 212 of the CPSIA requires the Commission to establish and maintain a product safety information database that is available to the public. Specifically, section 212 of the CPSIA amended the CPSA to create a new section 6A of the CPSA, titled “Publicly Available Consumer Product Safety Information Database.” Section 6A(a)(1) of the CPSA requires the Commission to establish and maintain a database on the safety of consumer products, and other products or substances regulated by the Commission. The Database must be publicly available, searchable, and accessible through the Commission's Web site. Section 6A of the CPSA sets forth specific content, procedures, and search requirements for the publicly available database. On May 24, 2010, we published a notice of proposed rulemaking at 75 FR 29156, which set forth the Commission's proposed interpretation and implementation of the Database provisions of section 6A of the CPSA. The comment period on the proposed rule ended on July 23, 2010. After reviewing and considering significant issues raised by the comments, the Commission is now promulgating a final rule on the statutory requirements of section 6A.

For several decades, the Commission has gathered and maintained a database of consumer complaints, known as consumer product incident reports. Such incident reports describe safety-related incidents involving the use of consumer products that fall within the scope of the Commission's jurisdiction. Pursuant to section 5(a) of the CPSA, the Commission collects information related to the causes and prevention of death, injury, and illness associated with consumer products. The Commission conducts studies and investigations of deaths, injuries, diseases, other health impairments, and economic losses resulting from accidents involving consumer products. In addition, pursuant to section 5(b) of the CPSA, the Commission may conduct research, studies, and investigations on the safety of consumer products and on improving the safety of such products. Currently, the Commission obtains information about product-related deaths, injuries, and illnesses from a variety of sources, including newspapers, death certificates, consumer complaints, and hospital emergency rooms. In addition, the Commission receives information from the public through its Internet Web site via forms reporting on product-related injuries or incidents.

To date, the data that the Commission collects and maintains on product safety have not been immediately available and searchable by the public. Before the CPSIA's enactment, the CPSA required that the Commission follow the notice provisions of section 6 of the CPSA before publicly disclosing any information that allowed the public to readily ascertain the identity of a manufacturer or private labeler of a consumer product. Section 6 of the CPSA contains requirements for giving notice of such information to the manufacturer or private labeler and providing them with an opportunity to comment on the information prior to public disclosure. Section 6 of the CPSA also requires the Commission to take reasonable steps to assure that disclosure of such information is accurate, fair in the circumstances, and reasonably related to effectuating the purposes of the CPSA. The Commission has applied the requirements in section 6 of the CPSA to Freedom of Information Act (“FOIA”) requests as well.
See Consumer Product Safety Commission et al.
v.
GTE Sylvania,
447 U.S. 102 (1980). The Commission issued regulations interpreting section 6 notice requirements at 16 CFR part 1101. Thus, consumers currently have access to incident data through reports and studies published by the Commission or through information provided in response to FOIA requests.

Section 6A of the CPSA creates a new disclosure requirement with respect to product safety-related incident reports, referred to as “reports of harm” in both the statute and the proposed rule. Specifically, section 6A of the CPSA excludes any incident report submitted for inclusion in the Database from the notice requirements of section 6(a) and (b) of the CPSA. Instead, section 6A of the CPSA sets up a new framework for collecting reports of harm, transmitting them to the manufacturer and private labeler for comment, and then posting them on a Database that is accessible on the Commission's Web site.

The notice of proposed rulemaking provided the public with an opportunity to understand how the Commission is intending to implement the new procedures in section 6A of the CPSA, and to provide comment. Prior to issuing a notice of proposed rulemaking, however, the Commission provided stakeholders with information about Database implementation, as well as offered several opportunities for stakeholder input and comment, all of which were discussed in the preamble to the proposed rule at 75 FR 29156-57. Prior Commission activities related to the Database include: Providing a detailed implementation plan to Congress; holding a public hearing on Database implementation; holding a public workshop, which sought comments on Database implementation; attending and speaking about the Database at various conferences; and creating the
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.

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 § 1102.2—Purpose

Proposed § 1102.2 would describe the purpose for a new 16 CFR part 1102 titled “Publicly Available Consumer Product Safety Information Database,” which is to set forth the Commission's interpretation, policy, and procedures to establish and maintain such Database.

We have finalized this section and made one clarification, which is to add the words “Publicly Available” to the full name of the Database.

2. Proposed § 1102.4—Scope

Proposed § 1102.4 would describe the scope of the rule to include the content, 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 § 1102.6—Definitions

Proposed § 1102.6 would define certain terms related to the establishment and maintenance of the Database.

a. Proposed § 1102.6(a)—Terms Defined in § 3 of the CPSA Apply to the Database Rule

Proposed § 1102.6(a) would explain that, except as provided in proposed § 1102.6(b), the definitions set forth in section 3 of the CPSA apply to the Database rule. For example, section 3(a)(11) of the CPSA defines a “manufacturer” as “any person who manufactures or imports a consumer product.” Because section 3(a)(11) of the CPSA defines “manufacturer,” any reference to “manufacturer” in proposed part 1102 would have the same meaning.

One comment was received related to this section, which we have finalized without change.

Comment 2—
One commenter states that the term “private labeler” should be defined in § 1102.6 of the final rule.

Response
—Section 3(a)(12) of the CPSA defines “private labeler” as “an owner of a brand or trademark on the label of a consumer product which bears a private label.” Because the CPSA defines “private labeler,” there is no need to include such a definition in the final rule.

b. Proposed § 1102.6(b)—Terms Defined Relevant to § 1102

Proposed § 1102.6(b) would define certain terms or, in some cases, interpret terms already defined in section 3 of the CPSA.

Proposed § 1102.6(b)(1) would define “additional information” as any information that the Commission determines is in the public interest to include in the Consumer Product Safety Information Database.

No comments were received related to this definition, and we have finalized it with one change, which is to add “Publicly Available” to the full name of the Database.

Proposed § 1102.6(b)(2) would define “Commission” or “CPSC” as meaning the Consumer Product Safety Commission.

No comments were received related to this definition, and we have finalized it without change.

Proposed § 1102.6(b)(3) would define “consumer product” as having the same meaning as defined in section 3(a)(5) of the CPSA, but would further explain that “consumer product” includes any other products or substances regulated by the Commission. This further clarification is based on the statutory requirement in section 6A(b)(1)(A) of the CPSA for submission of reports of harm relating to the use of consumer products and other products or substances regulated by the Commission.

No comments were received related to this definition, and, for clarity, we have added “under any other act it administers” to the end of the definition.

Proposed § 1102.6(b)(4) would define “Consumer Product Safety Information Database,” which is also referred to as the “Database,” as the database on the safety of consumer products required to be established and maintained by the Commission as described in section 6A of the CPSA.

No comments were received related to this definition. However, on our own initiative, we did incorporate the shortened name of “Database” in the final rule and added the words “Publicly Available” to the full name of the Database.

Proposed § 1102.6(b)(5) would define “harm” as any injury, illness, or death, or any risk of injury, illness, or death, as determined by the Commission. This definition is taken from section 6A(g) of the CPSA, which states that “[i]n this section, the term `harm' means (1) injury, illness, or death; or (2) risk of injury, illness, or death, as determined by the Commission.”

We received several comments related to this definition which did not lead us to make any changes. However, we are changing this definition to be consistent with the statutory language.

Comment 3
—Some commenters would remove from the definition of a report of harm the terms “or any risk of injury, illness, or death as determined by the Commission, relating to the use of a consumer product.” The commenters argued that such a determination requires an arbitrary assessment that would require Commission resources to determine whether the report of harm represents a legitimate risk. According to these commenters, reports of harm addressing risks should come from the Commission in recall notices only, not from the general public.

Response
—Section 6A(g) of the CPSA defines “harm,” as used in this section of the statute, as “(1) injury, illness, or death; or (2) risk of injury, illness, or death, as determined by the Commission.” Because the definition of “harm” is dictated by Congress in the statute, and Congress has plainly expressed its intent in the statute that the Database include reports of harm involving risks of harm, we will not remove this phrase from the definition of a report of harm. Moreover, the Database is meant to help us in our mission to protect the public against unreasonable risks of injury associated with the use of consumer products. Use of agency resources to assess risks is essential to our mission. While submitters must describe an illness, injury, or death, or risk of illness, injury, or death on the incident report form, each report of harm will be reviewed before publication to ensure that it meets the minimum requirements for publication set forth in § 1102.10(d).

Comment 4
—Some commenters propose that “any risk of injury” be defined narrowly to account for the level of risk or the potential for injury to exclude reports of harm that “have near zero risk of causing injury.” These commenters would strike the term “any” and replace it with a phrase such as “substantial risk of serious injury,” which they state has historically been used by the Commission.

Response
—We disagree with the commenters because they would have us interpret the statute in an unnecessarily narrow manner. However, we have stricken the word “any” and changed the comma to a semicolon after the first occurrence of the word “death” to make the definition consistent with the statutory language. Section 3(a)(14) of the CPSA already defines “risk of injury” as “a risk of death, personal injury, or serious or frequent illness.”

We also decline to use the phrase “substantial risk of serious injury” to qualify the types of harm or risk of harm that may be placed into the Database. Such phrase is used once in 16 CFR 1115.13(c) to describe a firm's initial obligation to report hazards under section 15(b) of the CPSA. It applies to manufacturers, importers, retailers, and distributors who have received information that reasonably supports the conclusion that one of the factors in section 15(b) of the CPSA has been met. The phrase has no relevance to the types of information included in a report of harm.

Comment 5
—One commenter states that the Commission should establish criteria for making determinations about risks of harm, arguing that speculative assertions or unsubstantiated opinions that a consumer could have been injured, without any supporting factual information indicating a nexus between the product or incident and a discernable and credible risk of injury, cannot provide the CPSC with the necessary basis for making the required determination to include these reports in the Database.

Response
—The Commission has many years of experience categorizing harm or hazards and their risks related to the use of a consumer product based on a reported incident scenario. We will continue to rely on our expertise to review reports of harm submitted for inclusion in the Database and will determine whether the minimum requirements for publication are met.

Comment 6
—One commenter states that the proposed rule does not delineate how the Commission will determine “harm” or “report of harm,” and it does not define “risk.”

Response
—Section 6A(g) of the CPSA defines “harm,” and we will adhere to this definition. We have maintained a database on injuries and risks of injury associated with the use of consumer products for many years, and will use our experience in reviewing reports of harm to ensure that the minimum requirements for inclusion in the Database are met. “Risk,” by itself, is not defined in the proposed rule or in the CPSA, but section 3(a)(14) of the CPSA defines “risk of injury” as “a risk of death, personal injury, or serious or frequent illness.”

Proposed § 1102.6(b)(6) would define “mandatory recall notice” as any notice to the public ordered by the Commission pursuant to section 15(c) of the CPSA.

No comments were received related to this definition, and we have finalized it with one grammatical change.

Proposed § 1102.6(b)(7) would define “manufacturer comment” as a comment made by a manufacturer or private labeler in response to a report of harm transmitted by the CPSC to the manufacturer or private labeler.

No comments were received related to this definition, and we have finalized it without change.

Proposed § 1102.6(b)(8) would define “report of harm” as any information submitted to the Commission through the manner described in § 1102.10(b) regarding an incident concerning any injury, illness, or death, or any risk of injury, illness, or death as determined by the Commission relating to the use of the consumer product.

We received comments regarding the definition of “harm” used in the proposed rule. As noted above in response to Comments 3 through 6, we are making minor modifications to the definition of “harm” as contained in section 6A(g) of the CPSA. Thus, we have finalized the definition of “report of harm” with one grammatical change, changing “an injury” to “any injury.” We also changed the comma to a semicolon after the first occurrence of the word “death” and inserted a comma after the second occurrence of the word “death” to ensure that the definition in the final rule is more consistent with the definition of “harm” in the statute.

Proposed § 1102.6(b)(9) would define “submitter of a report of harm” as any person or entity that submits a report of harm.

No comments were received related to this definition, and we have finalized it without change.

Section 1102.6(b)(10) of the proposed rule would define “voluntary recall notice” to mean any notice to the public by the Commission relating to a voluntary corrective action, including a voluntary recall of a consumer product taken by a manufacturer in consultation with the Commission.

No comments were received related to this definition, and we have finalized it without change.

Comment 7
—One commenter objects to use of the term “victim” in the proposed rule. The commenter states that the use of such a term implies a criminal or civil wrong, and suggests use of the word “consumer” as a more neutral term.

Response
—We will not remove the term “victim” in the final rule, but agree that the term may be confusing to some without further clarification. We have used the term “victim” for many years to describe persons actually suffering a harm or risk of harm related to the use of a consumer product as compared to others who simply may have purchased or observed the product being used. The term “victim” is used on the current incident reporting form to collect information about the individual who was injured or exposed to a possible product related hazard. In the context of that form, the use of the term “victim” does not imply a criminal or a civil wrong. Thus, for purposes of this rule, “victim” continues to refer to any individual exposed to harm or risk of harm related to a possible product related hazard, and the term does not imply that the product caused an incident.

B. Proposed Subpart B—Content Requirements

1. Proposed § 1102.10—Reports of Harm

Proposed § 1102.10 would explain the requirements for reports of harm to be included in the Database.

a. Proposed § 1102.10(a)—Who May Submit

Proposed § 1102.10(a) would identify the category of submitters specified in section 6A(b)(1)(A) of the CPSA and further clarify the persons who may fall within each of the identified groups. The list of persons under each category is not exclusive, and the proposed lists are intended to provide a greater understanding of the type of person or entity that could fall within each category of submitter.

Proposed § 1102.10(a)(1) would state that the term “consumers” includes not only users of consumer products, but also family members, relatives, parents, guardians, friends, and observers of a consumer product being used.

We received one comment related to this section, and other comments relating to the definitions under proposed § 1102.10(a) resulting in a revision to the definition of “consumers” as described in response to Comment 8 through 17.

Comment 8
—Several commenters state that the interpretation of “consumer” should not be so broad as to include those persons who were not injured by the product or who are not reliable reporters of the incident, such as those persons lacking firsthand knowledge of the product, its manufacturer, or the injury. The commenters also state that the proposed interpretation of “consumer” expands the potential for inaccurate information in the Database and goes beyond a reasonable interpretation of the term. Some commenters note, however, that information from these sources could be collected for the Commission's use, but should not be included in the Database.

Response
—The plain statutory language does not require a submitter of a report of harm to have “firsthand knowledge.” We have chosen an interpretation of “consumer” that comports with our experience in maintaining a database of consumer product incident reports. Historically, we have received reports of harm from any and all consumers in order to protect individuals who may use or enjoy consumer goods. Currently, parents, guardians, and family members are a major and important source of information collected for the most vulnerable segments of the population. In the most basic example, if the user of a consumer product is killed or seriously injured in the incident, or is an infant, he or she will be unable to enter the incident report. Parents, for example, may enter information related to consumer products used by their children, regardless of whether they personally witnessed the incident or purchased the product. Other consumers may possess important product safety information and, as a practical matter, the Commission does not have the resources to ascertain whether every submitter of a report of harm has firsthand knowledge or actually used the product. Therefore, following our current practice of receiving reports of harm from any and all consumers serves the purpose and intent of the Database and of our primary statutory mission, which is to protect consumers from unsafe products. Furthermore, a manufacturer is free to post a comment indicating whether they know if the submitter had firsthand knowledge or not. For these reasons, we disagree that inclusion of inaccurate information will necessarily result from our definition of “consumer.” Moreover, everyone who submits reports of harm to the Database is legally obligated to provide truthful and accurate information as evidenced by their verification that they have done so.

We also note that reports of harm received from individuals in some of the other statutory categories, such as other government agencies, health care professionals, and public safety entities, will likely lack firsthand knowledge about an incident. For example, a physician who treats an individual who was injured by a consumer product is unlikely to have witnessed how or when the injury occurred, but the statute permits the physician to submit a report of harm. If we find that false and fraudulent reports are being submitted for inclusion in the Database, we will consider what legal actions to take to address the problem and proceed accordingly.

Proposed § 1102.10(a)(2) would state that the definition of “local, state, or federal government agencies” includes, but is not limited to, local government agencies, school systems, social services, child protective services, state attorneys general, state agencies, and all executive and independent federal agencies as defined in Title 5 of the United States Code.

No comments were received on this provision, and we have finalized it with only typographical changes.

Proposed § 1102.10(a)(3) would state that the definition of “health care professionals” includes, but is not limited to, medical examiners, coroners, physicians, nurses, physician's assistants, hospitals, chiropractors, and acupuncturists.

No comments were received on this provision, and we have finalized it with one grammatical change.

Proposed § 1102.10(a)(4) would state that the definition of “child service providers” includes, but is not limited to, day care centers, day care providers, pre-kindergarten school, and child care providers.

No comments were received on this provision, and we have finalized it with minor modifications changing “day care” to “child care.”

Proposed § 1102.10(a)(5) would state that the definition of “public safety entities” includes, but is not limited to, police, fire, ambulance, emergency medical services, federal, state, and

local law enforcement entities, and other public safety officials.

No comments were received on this provision, and we have finalized it with one change for clarity. In response to comments relating to the definitions under proposed § 1102.10(a)(6), we added “and professionals, including consumer advocates and individuals who work for nongovernmental organizations, consumer advocates, consumer advocacy organizations, and trade associations so long as they have a public safety purpose” to the end of the definition.

Proposed § 1102.10(a)(6) would add “Others” to the list of submitters. The “Others” category is intended to include those persons who may not fit clearly within an identified category, but who may otherwise file a report as a “consumer.” The “Others” category would include, but is not limited to, attorneys, professional engineers, investigators, nongovernmental organizations, consumer advocates, consumer advocacy organizations, and trade associations.

We received several comments on proposed § 1102.10(a)(6). Many commenters misinterpreted the proposal as an expansion of the list of people who can submit reports. This was not the intention. The proposal states, the five statutory categories of submitters are quite broad and, given that breadth, we had concluded that the list was intended to be nonrestrictive.
See
75 FR at 29162. Currently, persons listed as examples under “Others” file reports of harm with us using our online incident reporting form by self-reporting as “consumers.” However, anyone can be classified as a consumer even if they are also acting as a doctor, lawyer, investigator, consumer advocate, or trade complainant. Moreover, many individuals who report to us work for organizations with a public health and safety purpose and, thus may be included under the category “public safety entity.” Since most if not all of the people listed in the “Others” category can fit in the categories Congress listed, we have deleted reference to “Others” in response to the comments.

Comment 9—
Some commenters state that adding “Others” is contrary to the plain meaning of the statute. The commenters argue that section 6A(b)(1)(A) of the CPSA expressly limits who may submit reports, so the Commission is acting outside its authority by adding an “Others” category.

Response—
Congress listed five broad categories of submitters and we have the authority to interpret these categories. As discussed above, the term “consumer” is quite broad, and we have consistently interpreted it in this rulemaking to include any and all consumers. This interpretation comports with our mission to protect individuals who may use or enjoy consumer products. Most of the persons and entities captured in the “Others” category are covered by the five broad categories of submitter listed in the statute. We have decided to delete the reference to “Others.”

Comment 10—
Some commenters argue that section 6A(b)(2)(B) of the CPSA, which establishes the minimum requirements for reports of harm to be included in the Database, uses the phrase “at a minimum” to set a floor to which the Commission may add requirements. Because this “at a minimum” language is missing from section 6A(b)(1)(A) of the CPSA, the commenters claim that we cannot add “Others” as a category of submitters.

Response—
The five categories of submitters set forth in section 6A(b)(1)(A) of the CPSA are so broad that they include most submitters, eliminating the need to state that these categories are “at a minimum.” Nevertheless, the category of “Others” will be deleted.

Comment 11—
Some commenters state that adding an “Others” category contradicts existing regulations that require incident reports to be verified by those with personal or firsthand knowledge. The commenters argue that including reports from those without such knowledge would reduce the Database to a blog consisting of hearsay reports from people without personal knowledge who have a vested interest in increasing the number and severity of negative reports. The commenters state that there is no indication that Congress intended to override the Commission's long-standing requirements for verification of information it intends to make public.

Response
—Congress provided a clear indication that the requirement in section 6(b) to take reasonable steps to assure accuracy does not apply to reports of harm included in the Database. Section 6A(f)(1) of the CPSA specifically provides that the provisions of sections 6(a) and (b) of the CPSA do not apply to reports of harm. Instead, verification is required for reports of harm as described in section 6A(b)(B)(v) of the CPSA, where a person submitting a report must verify that it is “true and accurate to the best of the person's knowledge.” This requirement is set forth in § 1102.10(d)(7) of the final rule. Moreover, Congress intended for the Database to include reports by those without “firsthand knowledge” or “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

allows for the submission of multiple reports of harm about the same incident because a consumer can submit a report as well as their health professional. In the Joint Explanatory Statement of the Committee of Conference on the CPSIA, the Conferees recognized the value of possible multiple reports regarding the same incident because they “could provide different relevant details and that information from those reports could be helpful to the public.” The Database system software is designed to look for potential duplicates and multiple reports and to display them to staff. Commission staff will review potential duplicate and multiple reports and “associate” them, where appropriate, so that all reports on one incident will be reflected. As explained more fully below under § 1102.10(d), we are adding one more required field: “Incident date” so that Database users are provided a date, or approximate date, of the incident. We are also clarifying the field, “Category of submitter,” by separating it from the verification requirement and displaying it in the Database as another required field so that Database users can see the category of submitter of the report of harm. We already had required this field in the NPR, but now we are separating it from the required verification. Such information should make the perspective of the submitter transparent and assist the agency in locating duplicate reports.

Comment 13—
Some commenters state that adding an “Others” category of submitter is unreasonable and contrary to sound public policy. The commenters claim that the Database's purpose is to advance public safety by better informing consumers of potential product hazards, and that Congress selected reporters who contribute to this purpose—“those who use or observe the use of the consumer product (and thus the resulting harm or risk of harm) and those who may be involved in treating or responding to the harm.” Congress chose to exclude those persons who may be commercially or financially motivated to submit reports of harm.

Response
—Having decided that the five statutory categories of submitters include most of those individuals who had previously been included in the “Others” category, these persons shall be permitted to submit reports to the Database. The purpose of the Database is to provide timely access to 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 § 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,

then the increase in such submissions will “significantly increase the costs and burdens on both the Commission and manufacturers and distributors of consumer products to review, verify, and respond to the filings.”

Response
—This comment is speculative and contrary to our research and experience. We review every report of harm and send the reports to manufacturers for comment under section 6(c) of the CPSA. Thus, even if we could choose to exclude reports of harm from “Others” in the Database, we would still collect this information for our use, and would still send it to manufacturers under section 6(c) of the CPSA. Accordingly, we do not believe that the submission of reports of harm by “Others” would have significantly increased costs or burdens, and we will receive such reports from most of those submitters under one of the five enumerated categories in the statute.

Comment 17—
Several commenters state that while reports of harm from those in an “Others” category may not be placed in the Database, the Commission may collect and use such reports for other hazard analysis purposes.

Response
—As explained above, we believe that reports of harm submitted by most of those included in the “Others” category should be included in the Database under the five categories enumerated by the statute. We do not have the authority to exclude valid reports of harm from the Database. No valid public health and safety reason exists to exclude data that meet the minimum requirements for inclusion in the Database. Such an action would be contrary to the purpose and intent of the Database. We are focusing on the quality of the data submitted, as opposed to who submitted the report. Preserving reports of harm submitted by consumers in the “Others” category strictly for Commission use would not serve the purpose of timely providing the public with access to product safety information.

b. Proposed § 1102.10(b)—Manner of Submission

Proposed § 1102.10(b) would describe how a report of harm can be submitted for inclusion in the Database. Section 6A(b)(2)(A) of the CPSA requires that the Commission establish electronic, telephonic, and paper-based means for submitting a report of harm for inclusion in the Database. Accordingly, proposed § 1102.10(b) would describe four methods (Internet, telephone, electronic mail, and paper) for submitting reports. Proposed § 1102.10(b)(1) also would explain that submitters using the Internet will use an electronic form specifically developed to collect the report of harm in the Database. Proposed § 1102.10(b)(2) would further explain how submissions over the telephone will be accepted. Proposed § 1102.10(b)(3) and (b)(4) would explain how the Commission will deal with email, facsimile, and written submissions. Proposed § 1102.10(b)(5) would give the Commission the flexibility to provide other means of submission if new means become available.

The proposed rule left open for the final rule the office names and contact information to use for email, facsimile, and paper submissions of reports of harm. Accordingly, § 1102.10(b) has been finalized with several additions. First, we included the appropriate office names and contact information in § 1102.10(b)(3) and (b)(4). Second, we made a grammatical correction to use the short name for the Database adopted in § 1102.6(b)(4).

c. Proposed § 1102.10(c)—Size Limits of Reports of Harm

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

No comments were received on this section, which we have finalized without change.

d. Proposed § 1102.10(d)—Minimum Requirements for Publication

Proposed § 1102.10(d)(1) through (d)(6) would describe the minimum requirements for publication of reports of harm in the Database. The proposal would identify the minimum required categories of information stated in sections 6A(b)(2)(B)(i) through (v) of the CPSA, and further elaborate on the type of information included under each category.

We received several comments generally related to the minimum requirements for publication, which resulted in no substantive changes to the final rule. On our own initiative, however, we have made a grammatical correction to the full name of the Database and added the words “Publicly Available” to the full name of the Database.

Comment 18
—One commenter states that the Commission should remind submitters to only file reports of harm for incidents of which they have firsthand knowledge, and actively should discourage complaints based on hearsay.

Response
—For the reasons set forth in response to Comment 8 above, we will not restrict submissions of reports of harm for inclusion in the Database to only those who have firsthand knowledge. Reports of harm that meet the statutory minimum requirements for inclusion, and the requirements as set forth in § 1102.10(d) of the final rule, will be included in the Database.

Comment 19
—Some commenters suggest that the final rule impose a time limit on when reports of harm may be included in the Database, to exclude old or stale data. Several commenters suggest a time limit of one year from the incident date, claiming that over time, data becomes inherently suspect.

Response
—As a matter of statutory interpretation, we have decided to allow submitters to enter reports of harm about product related incidents regardless of when the incident occurred because Congress imposed no limitation in section 6A of the CPSA. Because many consumer products have a long use period, and many consumer products are purchased second hand or used rather than new, it is important to collect and maintain information on these products over time. Moreover, in our experience, consumers sometimes fail to submit a report of harm until after a recall is announced in the media. Regardless of the date of occurrence and the date of entry, all reports of harm must meet the minimum requirements for inclusion in the Database as set forth in section 6A of the CPSA and § 1102.10(d) of the final rule. Moreover, as set forth in response to Comment 30 below, the Commission has decided to require the incident date, or an approximate incident date, to include a report of harm in the Database. Users can determine for themselves what weight to accord an incident that is entered long after the date of occurrence. If a manufacturer or private labeler believes that the date of the incident is relevant to users of the Database, it may highlight this fact in its comment to the report of harm.

Comment 20
—Several commenters note that the proposed rule does not indicate how long reports of harm and associated comments will remain in the Database. The commenters state that the final rule should impose a time limit after which information will be removed from the Database to ensure that the information remains helpful. The commenters also state that unless data has a time limit or sunset period, the Database may become overloaded with outdated information. The commenters suggest that if no recall occurs within one year of a report being entered, then the information should be removed but remain available through a FOIA request. Alternatively, the commenters

suggest that the Commission could tag information as “active reports” and “resolved reports.”

Response
—Setting a time limit or expiration date for reports of harm and related comments is inconsistent with the purpose of the Database. Certain hazard patterns may not emerge from the data within a specific time limit. Many consumer products have a long use period, and many consumer products are purchased used. Accordingly, it is important to collect and maintain information on products over time.

Moreover, there is no easy way to determine across all industries and all products when data about products may lose importance. For example, durable infant products, which may be purchased used, may become the subject of incident reports years after a product was purchased or even recalled. We have several examples of children being seriously injured by products that were recalled for the defect many years before. Consumers should have access to all data that the Commission has on file when they research recalls and reports of harm made about consumer products in the Database. As for the suggestion of making information available through FOIA, we believe that such a change would be contrary to the purpose and intent of the Database and would compel us to allocate resources to respond to FOIA requests concerning data that should be made available in the Database. Finally, as set forth in § 1102.10(i) of the final rule, all reports of harm submitted to the Commission become official records of the Commission in accordance with 16 CFR § 1015.1 and will be treated in accordance with that regulation, which defines agency records for purposes of the FOIA.

Comment 21
—Several commenters state that the minimum information required to submit a report of harm for inclusion in the Database in § 1102.10(d) is not detailed enough to allow those reviewing the report to understand the incident adequately, to weed out duplicate reports, and to promote investment in the report and Commission activities by the submitter. One commenter states that, without more detailed information, manufacturers will not be able to respond meaningfully to reports of harm, which will mean that the Database contains inaccurate information about their products. Thus, in cases where the incident details are insufficient to make a determination of why an event occurred, one commenter believes that the Commission should not publish the report in the Database.

Response—
We decline to amend the rule as suggested by the commenters. Determining why an incident occurred can sometimes be a time-consuming process; yet section 6A of the CPSA established procedural requirements that are measured in days. Congress is requiring us to create an “incident” database of “reports of harm,” not causation determinations. Section 6A of the CPSA requires reports of harm to be posted in the Database quickly. Thus, we cannot refrain from processing or publishing reports of harm to determine why an incident occurred.

In response to comments on the proposed rule, however, we are clarifying that one additional minimum field requirement was added in the proposed rule, and has been maintained in the final rule, the “Category of submitter.” We have considered comments on this issue, as described below, and decided to display this field in the Database. Also, in response to comments, we have decided to require an additional field “Incident date” for inclusion in the Database. These two additional field requirements will assist users in distinguishing duplicate or multiple reports and in determining what, if any, weight to give a particular report of harm. Moreover, these two additional pieces of information should be readily available and typically known by submitters of a report about a consumer product. On balance, those additional requirements should not deter a submitter from entering a legitimate report of harm.

Proposed § 1102.10(d)(1), “Description of the consumer product,” would require a word or phrase sufficient to distinguish a product identified in a report of harm as a consumer product, a component of a consumer product, or a product or substance regulated by the Commission. This description could include the name (including the brand name) of the product. Other information, such as where the product was purchased, price paid, model, serial number, date of manufacture (if known), date code, or retailer, is identified as information that would be helpful to the description of a consumer product, but not required.

We received several comments about this section of the proposed rule, and for clarity we have finalized the rule with grammatical changes to reflect the original intent of the provision that certain information in the description of the consumer product will be optional.

Comment 22—
Some commenters state that the proposed rule does not require a product name, model number, manufacture date, date code, date of purchase, or other descriptive information about a product. The commenters assert that the statute requires that the Database be searchable by date, product description, model name, and manufacturer's name to the extent practicable; therefore, at a minimum, a report of harm must contain a model number and a product name. Some commenters state that poor product identification will make it impossible for a manufacturer to comment, and that requiring that the information be included will make the Database more useful and less misleading.

Response—
We agree that the more information included about a product, the easier it will be for the Commission and Database users to identify the product. Accordingly, the Database will prompt submitters for additional information about the product at issue, including, for example, product brand, model number, serial number, and date of manufacture. We encourage submitters to enter additional, helpful information for product identification in their reports of harm; however, we will not require submitters to provide all of the information suggested by the commenters. We have amended § 1102.10(d)(1) to reflect this position. Requiring too much detail about a product may deter individuals from submitting reports. In addition, we note that section 6A(b)(2)(B)(i) of the CPSA states that reports that provide a “description of the consumer product” meet the statutory minimum for product identification. We will review each report of harm to ensure that a consumer product over which the Commission has jurisdiction is identified. Section 1102.10(d)(1) states that “the description of the consumer product must, at a minimum, include a word or phrase sufficient to distinguish the product as a consumer product, a component part of a consumer product, or a product or substance regulated by the Commission.” Thus, if we cannot identify a consumer product over which we have jurisdiction based on information in the report of harm, then the report will not meet the minimum requirements for publication.

As for the commenters' argument regarding the searchability of the Database, section 6A(b)(4) of the CPSA does not set forth minimum field requirements; rather it describes how users must be able to access data that already exists within the Database. In addition, section 6A(b)(4) of the CPSA requires that the Commission “categorize the information available in the Database in a manner consistent with the public interest and in such manner as it determines to facilitate

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 § 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 § 1102.10(d)(3) titled “Description of the harm,” would explain the requirements for describing a harm for a report of harm to be included in the Database. “Harm” as provided in section 6A(g) of the CPSA and in § 1102.6(b)(5), is an illness, injury, or death, or a risk of illness, injury, or death. The proposed rule contained a nonexclusive list of examples of the types of harm that could be included. Additionally, this section would explain that reports of harm, which relate solely to cost or quality of a product, without identifying any discernable bodily harm or risk of bodily harm, would not constitute “harm” for purposes of this part. A description of harm may include additional information, such as the severity of the injury.

We received several comments on this section of the proposed rule. We have finalized this section of the rule with corrections. We removed part of a sentence stating that the date on which the incident occurred is an example of the type of description that may be entered. We removed this language because “incident date,” or an approximation of the incident date, is now a required field, as described in response to Comment 30 below. In addition, the rule has been revised to conform to the definition of “harm” in the statute.

Comment 27—
Some commenters would remove the terms “risk of bodily harm” and “risk of injury” from § 1102.10(d)(3), and anywhere else in the proposed rule, because “[t]his database must be based on concrete instances and not on issues or injuries that may (or may not) occur.”

Response—
Section 6A(g) of the CPSA defines “harm” as used in this section of the statute as “(1) injury, illness, or death; or (2)
risk
of injury, illness, or death, as determined by the Commission” (emphasis added). Because Congress intended that risks of harm be included in the Database, we decline to revise the rule as suggested by the commenters. The Database is meant to help the Commission protect the public against unreasonable risks of injury associated with the use of consumer products. Submitters must describe an illness, injury, or death, or risk of illness, injury, or death on the incident report form. We will review each report of harm before publishing it in the Database to ensure that it meets the minimum requirements for publication.

Comment 28
—Some commenters state that the severity of risk, meaning whether and what type of medical treatment was sought, should be a required field on a report of harm if the report of harm is to be included in the Database. The commenters argue that, without knowing the severity of the risk, the public, the Commission, or a manufacturer cannot judge the magnitude of the risk presented and, in turn, assess the appropriate response to that risk.

Response
—Consistent with section 6A(b)(2)(B)(iii) of the CPSA, the final rules require the submitter to enter a description of the harm, which means the identification of a discernable illness, injury, or death, or risk of illness, injury, or death related to the use of a consumer product. While we agree that understanding whether medical treatment was sought is useful in determining the severity of a harm or risk of harm, the statute, by referring to risk of injury, illness, or death in defining “harm,” does not require injury, illness, or death to have occurred. Accordingly, we will not require specific information about whether medical treatment was sought for a report of harm to be included in the Database. The incident report form, however, will allow for entry of such information.

Comment 29
—Several commenters would define an incident causing harm more explicitly in § 1102.10(d)(3) by excluding reports of harm that relate solely to the cost, quality, customer satisfaction, or warranty disputes, or those that fail to state any discernable bodily harm or risk of bodily harm. The commenters state that Commission staff should review reports of harm and exclude those that do not address a safety issue so that the Commission and industry can focus on reports containing actual or potential harm. One commenter would limit harm to include both an actual incident and an injury as set forth in 16 CFR 1117.3 (which pertains to reporting requirements for choking incidents involving marbles, small balls, latex balloons, and other small parts).

Response
—The proposed rule already would exclude reports relating solely to cost or quality. We agree that a report of harm that identifies only quality or cost issues and does not identify a bodily harm or risk of bodily harm does not meet the minimum requirements for inclusion in the Database. “Harm” is defined in § 1102.6(b)(5), consistent with section 6A of the CPSA, as “injury, illness or death; or risk of injury, illness or death, as determined by the Commission.” Thus, reports of harm containing no discernable injury, illness, or death, or risk thereof, will not meet the minimum requirements for inclusion in the Database. Therefore, § 1102.10(d)(3) continues to state that “Incident reports that relate solely to the cost or quality of a consumer product, with no discernable bodily harm or risk of bodily harm, do not constitute `harm' for purposes of this part.”

We will not make the reporting requirements in 16 CFR 1117.3 for choking incidents involving marbles, small balls, latex balloons, and other small parts applicable to reports of harm for inclusion in the Database. Section 1117.3 creates a reporting requirement for firms that become aware of both an incident and, as a result of the incident, that a child died, suffered a serious injury, ceased breathing for any length of time, or was treated by a medical professional. In contrast, section 6A of the CPSA, through the definition of “harm” in section 6A(g) of the CPSA, covers a broader range of adverse events. The statute goes beyond “injury, illness, or death” (terms that would seem to encompass the events in § 1117.3) by adding “risk of injury, illness, or death * * *.” Thus, imposing the reporting requirement in § 1117.3 onto § 1102.10(d) would be inconsistent with section 6A of the CPSA.

Comment 30
—Several commenters would make the date of the incident a required field to help develop a response, minimize duplication, and reduce the likelihood of counterfeit reports being added to the database. For the same reasons, some commenters also would require the location of the incident to be noted. The commenters state that the burden on submitters is low, while manufacturers have only 10 days to respond. Accordingly, the commenters assert that requiring this information will help screen out duplicate reports.

Response
—We agree that requiring the date of the incident or the approximate date of an incident to be included will help in associating reports of harm submitted concerning the same incident, without deterring submission of reports. The incident date, or an approximation, should be information that is readily known and, on balance, likely will be helpful to the Commission, Database users, and those who investigate incidents. For example, the incident date will help us locate and associate multiple reports of harm submitted about the same incident. Reports of harm submitted by different persons about the same incident will not be deleted, but will be associated so that Database users can discern that only one incident occurred, for example, as opposed to two or three if several reports are filed concerning the same incident. Gathering information from different sources may assist the Commission and other users in understanding the nature of the incident, the product involved, and any injuries sustained. Additionally, because we will not restrict reports of harm to recent incidents, the ability to display both an incident date and the report filing date will help users assess that report. Accordingly, we have revised § 1102.10(d)(4) to require an “Incident date,” or an approximation, to be entered to display a report of harm in the Database.

As for the location of the incident, the form allows, but does not require, submitters to enter the location of the incident. Information regarding the location of the incident is not critical to product or hazard identification. Nevertheless, because the incident date and incident location fields are located adjacently on the form, we anticipate that submitters will be sufficiently prompted to include such information.

Proposed § 1102.10(d)(4) titled “Contact information” would require a submitter of a report of harm to provide his or her first and last name and a mailing address for the report to be published. Submitters also may provide other contact information, such as an email address or a telephone number, but such information is not required in order to publish the report.

We received several comments on this section, which we have finalized without substantive modification. “Contact information” has been renumbered in the final rule to § 1102.10(d)(6) to accommodate the addition of “Incident date” and “Category of submitter.”

Comment 31—
Several commenters address reports of harm by anonymous submitters. Some commenters state that we should not include these reports of harm in the Database. Some commenters state that we should not maintain anonymous reports for Commission use because veracity and trustworthiness are at issue and that such reports should not be used for compliance or enforcement proceedings because firms have no opportunity to investigate or refute the claims.

Response—
Reports of harm submitted anonymously do not meet the minimum requirements for inclusion in the Database and will be excluded. Section 6A(b)(2)(B)(iv) of the CPSA requires that the report contain “contact information for the person submitting the report”; therefore, an anonymous report would not satisfy this statutory requirement. Although the submitter's contact

information will not be published in the Database, it must be included for the report of harm to meet the minimum qualifications for inclusion in the Database.

As for our use of anonymous reports, the Commission has accepted incident reports submitted anonymously for many years, and we will not change this practice now. Accordingly, we will maintain anonymous reports of harm for internal use. The Commission is concerned with product safety, regardless of who submits the information to the agency, and we cannot assume that anonymous reports of harm will not contain real and significant product safety issues. While it is preferable to have contact information to enable us to follow up and investigate incident reports with greater ease, the absence of contact information does not prevent us from investigating a consumer product as long as the product is identifiable.

With regard to the use in enforcement proceedings of reports submitted anonymously, this issue involves the Commission's exercise of enforcement power and discretion and our consideration of specific facts. Such information will continue to be considered on a case-by-case basis.

Comment 32—
One commenter states that when consent is given, a submitter's contact information should be provided to the manufacturer to facilitate evaluation of the complaint. This same commenter states that we should require contact information to be given to the Commission to prevent fraud.

Response—
When a submitter of a report of harm gives consent, his or her name and contact information will be provided to the manufacturer or private labeler. This provision, contained in § 1102.20(a)(1), is consistent with section 6A(b)(6) of the CPSA. Anonymous reports will not meet the minimum requirements for inclusion in the Database and will be excluded. As set forth above, we will continue to accept and maintain anonymously submitted reports for our own use, and we decline to make contact information required information for submission of such reports to the Commission.

Comment 33—
One commenter suggests that we require every submitter to provide a phone number, and that Commission staff affirm the legitimacy of every report filed, and verify the contact information submitted in order for a report of harm to meet the minimum requirements for publication in the Database.

Response
—We decline to revise the rule as suggested by the commenter. Section 6A(b)(5) of the CPSA and § 1102.42 direct us to provide clear and conspicuous notice to Database users that we do not guarantee the accuracy, completeness, or adequacy of the contents of the Database, and Section 6A(b)(2)(B)(v) of the CPSA and § 1102.10(d)(7) specify the form of verification required from submitters of reports of harm. No additional verification is required by the statute and would be contrary to the intent of 6A to provide prompt public release of reports of harm that otherwise meet the requirements for posting in the Database.

Comment 34—
Several commenters state that the Database should encourage the release of contact information to manufacturers to enhance accuracy and product safety. One commenter states that consent to release contact information to manufacturers should be required to post a report of harm because it is the only way that manufacturers can resolve complaints and determine whether products are counterfeit. Another commenter notes that absence of contact information for the submitter is a complete bar to a manufacturer's ability to respond to a report of harm.

Response—
We will transmit contact information to the manufacturer or private labeler pursuant to section 6A(b)(2)(B)(iv) of the CPSA. The statute does not permit us to disclose the name, address, or other contact information of a submitter of a report of harm without the submitter's express written consent. Neither transmission of a report of harm to a manufacturer or private labeler nor publication of a report in the Database is conditioned on a submitter agreeing to provide contact information to the manufacturer or private labeler. Consequently, we are not amending the rule to create such a requirement. We do not agree that the absence of contact information on a particular report prevents a manufacturer from commenting on a report of harm. Manufacturers may have received similar claims from other consumers. In fact, manufacturers often receive far more incident reports directly from consumers than the CPSC receives. In those cases, manufacturers and private labelers may be able to distinguish product issues more quickly than the CPSC and may be in a better position than the CPSC to respond, regardless of whether contact information is provided.

With regard to counterfeit products, neither section 6A of the CPSA nor the final rule addresses counterfeit products. We previously have conducted recalls on counterfeit products. A product's status as counterfeit does not change the safety implications and the potential need to remove such a product from the hands of consumers. We work with manufacturers to ascertain the true manufacturer of such counterfeit products when there is an issue concerning consumer safety.

Comment 35—
One commenter would require identification of the victim by name for a report of harm to appear in the Database, although the information would be provided only to the Commission and would not be published. The commenter explains that identifying the victim would allow the Commission to cross-check data and prevent duplication, especially where different people report the same incident. The victim's identification would allow the Commission to clarify which reports are about the same incident if multiple reports are submitted.

Response—
Section 6A(b)(2)(B) of the CPSA does not require identification of the victim by name, and we are not revising the rule as suggested by the commenter. Although knowing the victim's name would help associate reports of harm for the same incident, we can appreciate how a submitter might consider such information to be private. For example, some parents, while eager to report an incident and to provide details about the injury sustained and the age and gender of their child, may not want to provide the child's name. Likewise, other submitters, such as health care professionals or government agencies, may want to report details about a victim's injury, age, and gender, but may not know the victim's name or may have a legal obligation to keep the victim's name confidential. To help identify and associate duplicate reports, we have decided to add “Incident date,” or an approximation, as a required minimum field. Providing such information should not be burdensome because typically it would be known or could be approximated.

Comment 36—
Some commenters would require the submitter of a report of harm to provide either an e-mail address or a phone number as part of the required contact information in § 1102.10(d)(4) to allow for timely contact of the submitter and verification of the report of harm. The commenters argue that, without this information, it will be impossible for manufacturers to have a meaningful chance to verify the report of harm within the required 10 business days.

Response—
Section 6A(b)(6) of the CPSA does not require the Commission

to release contact information to the manufacturer or private labeler unless the submitter provides written consent to do so. Accordingly, manufacturers and private labelers are not entitled to verify the report of harm with the submitter before they submit comments or before the report of harm is posted in the Database. We recognize, however, that when a submitter does consent to release his or her contact information to the manufacturer or private labeler, having an e-mail address or a phone number is the preferred method for contacting the submitter because of the time limitations imposed by section 6A of the CPSA. Thus, when a submitter consents to releasing his or her contact information to a manufacturer or private labeler, the Database will ask, but not require, the submitter to provide an e-mail address or phone number to allow for timely follow up.

Proposed § 1102.10(d)(5), entitled “Verification,” would require submitters to verify that they have reviewed the report of harm and that the information contained in the report is true and accurate to the best of the submitters' knowledge, information, and belief. As originally proposed, this section also required, as part of the verification process, that submitters of reports of harm indicate into what category they fit (
i.e.,
consumer, government agency, health care professional).

We received several comments related to this section. We have finalized the first two sentences without modification. We deleted the last two sentences regarding the category of submitter, as discussed below in response to Comment 40, and this section has been renumbered to 1102.10(d)(7).

Comment 37—
Several commenters state that the final rule should require submitters to make an affirmation or oath regarding the truth of the information submitted in order to be included in the Database.

Response
—We agree. This is already a statutory requirement, and we have required this in § 1102.10(d)(7).

Comment 38—
Several commenters state that the incident report form should include a notation regarding the penalties for filing a false report to ensure that accurate information is submitted. The commenters say that the Commission should take an aggressive stance to discourage malicious and false information from being submitted and pursue enforcement actions, including seeking monetary penalties.

Response
—If we receive false reports, we will take all appropriate actions available to remove materially inaccurate information from the 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 § 1102.10(d)(5) would include the category of submitter as a minimum field requirement. Although identification of the category of submitter is required information, the proposed rule stated that the information would not be published in the Database. We agree that the category of submitter is an important piece of information to collect and display so that Database users can better understand not only who submitted the report of harm but also the relationship of the submitter to the victim. It is especially important to help users understand the submitter's perspective when the Database may include multiple reports on the same incident. Accordingly, to clarify that “Category of submitter” is a minimum requirement for inclusion of a report of harm in the Database, we have revised the final rule to create a new § 1102.10(d)(5) titled “Category of submitter,” and the “Verification” section previously at § 1102.10(d)(5) has been renumbered as § 1102.10(d)(7). Section 1102.10(d)(5) now reads as follows: “Category of submitter. Indication of which category the submitter is in (consumer, government agency, health care professional, etc. * * *) from § 1102.10(a).” We have removed similar language from the “Verification” section.

Comment 41—
One commenter would have us provide the category of submitter for a report of harm to manufacturers. The commenter notes that § 1102.10(d)(5) states that the information will be required at verification but will not be published in the Database. The commenter also claims that there is no reason or justification for depriving Database users of this information.

Response—
As set forth above in response to the previous comment, the category of submitter remains a required field, and has been removed from the “Verification” section to § 1102.10(d)(5) of the final rule. For the reasons discussed above, information on the category of submitter will be transmitted to the manufacturer or private labeler, and will be displayed in the Database.

Comment 42—
Some commenters suggest using e-mail verification and validation to ensure that reports of harm are not “spam” (
i.e.,
a form of e-mail where the same message is sent in large quantities to multiple parties). The commenters state that a report of harm should not be published unless the report can be validated.

Response
—We considered using e-mail verification and validation

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 § 1102.10(d)(6) titled “Consent” would explain that the submitter of a report of harm must consent to inclusion of the report of harm in the Database for the report to be published. If no consent is provided by the submitter, then the report will not be published in the Database.

Several comments were received, resulting in no substantive changes to the final rule. We renumbered “Consent” in the final rule to § 1102.10(d)(8), to accommodate the addition of “Incident date” and “Category of submitter.”

Comment 43—
One commenter suggests that, on the incident report form, the language related to consents be consistent and suggests using “May we” for the consent to provide contact information to manufacturers as well as the consent to include the report of harm in the Database. The commenter states that this language may encourage consumers to provide contact information to manufacturers to enhance consumer safety and would allow for proper investigation of the complaint.

Response—
The commenter is focusing on language contained on a draft of the incident report form rather than language in the proposed rule itself. We agree that it would be appropriate to make the language consistent for the consents collected from submitters of reports of harm; therefore, we have changed the language on the incident report form so that both of the consents collected begin with “May we.”

Comment 44—
One commenter states that the term “verification” implies a level of CPSC validation of reports of harm that is unlikely to exist and that is in contrast to the disclaimer. The 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 § 1102.10(e)—Additional Information Requested on a Report of Harm

Proposed § 1102.10(e), regarding “Additional information requested on a report of harm,” would describe the Commission's ability to seek other categories of voluntary information. In the preamble to the proposed rule, we invited comment on whether additional categories should include demographic data, such as race, or additional data about the product in question, such as whether the product still contained all of its original parts, or had been altered in any way that was not in accordance with a manufacturer's instructions.

Several comments were received related to this section, which has been finalized with a clarification as to the appropriate consent for minors.

Comment 45
—One commenter states that the Commission should request, but not require, the following information on a report of harm to substantiate the claim: (1) Verification that the label instructions were followed; (2) the date on which the harm occurred; (3) a brief description of the incident, including how the product was being used, where it was being used, a description of what happened, whether other products were being used, how much product was used over time; and (4) whether the manufacturer was contacted before submitting the report of harm.

Response
—We will collect more information about an incident on a report of harm than is minimally required to include the report in the Database. We will display such additional information, if consent is provided. For example, the current online incident report form asks whether the manufacturer has been contacted before filing a report of harm. We will continue to collect this information on the new reporting form. Also, as set forth in response to Comment 30, we have decided to make the incident date, or an approximate incident date, required information on a report of harm. The detail of an incident has been, and will continue to be, important information on a report of harm. The incident report form will have space for a narrative description of the incident, with guidance on the types of information that should be included. Finally, we will not specifically ask whether label instructions were read or followed because it unnecessarily implies that the consumer may be at fault. Manufacturers must evaluate safety with respect to the intended use, as well as the reasonably foreseeable misuse of a product.

Comment 46
—One commenter states that the Commission should require the submitter to retain the product for at least one year.

Response
—Currently, we request, but do not require, that a submitter retain the product for at least 30 days so that a CPSC investigator can review and inspect the product, if necessary. We will continue to advise submitters on the new version of the incident report form to retain the product for at least 30 days. We do not believe that section 6A of the CPSA gives us the authority to impose product retention requirements on individuals as a condition of their submitting reports of harm to the Database.

f. Proposed § 1102.10(f)—Information Not Published

Proposed § 1102.10(f), “Information not published,” would describe the information that will not be published in the Database, including the name and contact information of the submitter of a report of harm; the victim's name and contact information (if provided); photographs depicting a person or injury because of privacy concerns or because the Commission has determined that they are not in the public interest; medical records without the consent of the person about whom such records pertain (or that person's parent or guardian if the person is a minor); confidential information; materially inaccurate information; reports of harm retracted by submitters who indicate in writing to the Commission that they supplied materially inaccurate information; and/or any other material submitted on or with a report of harm that the Commission determines is not in the public interest to publish. In making such a public interest determination, the Commission will consider whether the information is related to a product safety purpose served by the Database, including whether the information helps Database users to identify a consumer product; identify the manufacturer or private labeler of a

consumer product; understand the risk of harm related to the use of a consumer product; or understand the relationship between the submitter of a report of harm and the victim.

Several comments were received related to this section. We changed “materially inaccurate information” to “information determined to be materially inaccurate” to be consistent with the statute. We have also made two grammatical changes, one to (f)(7), changing it from “Submitters of reports of harm may retract reports at any time * * *” to “Reports of harm retracted at any time by the submitters of those reports,” and one to (f)(8) deleting the words “to publish.” In addition, we added language clarifying that the Commission will exclude from publication in the Database consents and verifications associated with the submission of a report of harm. This change reflects our response to comment 65 and is consistent with § 1102.12(e).

Comment 47
—One commenter states that § 1102.10(f)(3) should limit photographs to pictures of whole products, solely for identification purposes. The commenter asserts that the Commission should prohibit photographs of injuries, components, or people, and states that such pictures are not in the public interest and should not be published.

Response
—We agree that, for product identification purposes, photographs of the whole product are often the most useful. However, close-up photographs of the product labeling or the defect at issue may involve photographing a component part of the product. We also have jurisdiction over component parts of consumer products. Accordingly, we are not revising the rule as suggested by the commenter.

Section 1102.10(f)(3) provides that photographs that the Commission determines are not in the public interest will not be published, “including photographs that depict a person or injury or constitute an invasion of personal privacy based on the Privacy Act of 1974, Public Law 93-579 as amended.” Upon reflection, we will not and cannot, prevent submitters from uploading photographs and documents that may be helpful to the Commission in any subsequent investigation, including photographs of injuries. However, we recognize that some photographs may be inappropriate for publishing in the Database. Therefore, we will review every photograph and attachment to determine whether it is relevant to the report of harm, violates any person's privacy, and is in the public interest to publish. Product photographs are likely to always be found to be in the public interest to display. Photographs from which a person can be identified will not be published, unless the photograph is altered in such a way that it could not be used to identify a person. Photographs of injuries where a person cannot be identified may be published.

Thus, we changed “photographs that depict a person or injury or constitute an invasion of personal privacy” to “photographs that could be used to identify a person or photographs that would constitute an invasion of personal privacy.” This change reflects the Commission's desire to allow photographs of injuries to be published, including those that depict or represent an image of a person, as long as the image could not be used by a Database user to determine the identity of the individual in the picture. The Commission will still exercise discretion and may decline to post a picture it determines is not in the public interest because it is too gruesome.

Comment 48—
Some commenters approve of the Commission's use of criteria under proposed § 1102.10(f)(8) when exercising discretion regarding what goes into the Database when it is in the “public interest.” The commenters state that the proposed criteria will ensure that a wide variety of information will be published.

Response—
We agree and have finalized this section with one grammatical change deleting the word “determination.”

Comment 49—
One commenter states that, if the Commission publishes attachments to a report of harm, the Commission should ensure that a submitter's or a victim's private information is not published in the Database.

Response
—Consistent with § 1102.10(f), we will not publish a submitter or victim's name or personally identifying information contained in any attachment, or any other information inconsistent with the Privacy Act of 1974, or the public interest, without the appropriate legal consents. Each attachment will be reviewed for content, and if necessary, not displayed or will be redacted before publication to exclude such information.

Comment 50—
Some commenters ask whether a submitter can withdraw a report of harm.

Response
—As set forth in § 1102.10(f)(7), a submitter may retract a report at any time, if he or she indicates, in writing, to the Commission that he or she supplied materially inaccurate information. The reason that we are not permitting submitters to freely withdraw a report of harm is our concern that submitters may be subject to external pressure to withdraw reports of harm for any number of reasons, including settlement agreements with manufacturers conditioned on such withdrawal.

g. Proposed § 1102.10(g)—Reports of Harm From Persons Under the Age of 18

Proposed section 1102.10(g), entitled “Reports of harm from persons under the age of 18,” would state that the Commission will not accept reports of harm submitted by persons under the age of 18 years without the consent of the parent or guardian of that person. The rationale for requiring consent on reports by a minor is the fact that age of legal consent in many jurisdictions is 18 years old. Review of a report of harm by a parent or guardian will also ensure that information about a harm or risk of harm is being disclosed publicly with the parent's consent, which addresses concerns related to the privacy of such information. Further, if a parent or guardian reviews the report, consent may also improve the accuracy of the information that the report contains.

Two comments were received related to this section, which has been finalized without change.

Comment 51—
One commenter says that the minimum age to submit a report of harm should be 18 years old. Reports regarding injuries to minors should be submitted by a parent or guardian rather than the injured minor to ensure a degree of maturity in submitters and to increase accuracy.

Response—
We agree. _ This requirement is already contained in § 1102.10(g). No one under 18 may submit a report of harm without a parent or guardian submitting his or her own contact information and approving the submission.

Comment 52—
One commenter states that the proposed rule does not require a reporter to provide his or her age, but does restrict those under 18 from submitting a report of harm. The commenter states that, while the CPSC may intend to include this in the reporting form, age and consent are omitted from § 1102.10(d)(4).

Response—
The language in § 1102.10(g) accurately reflects the intended requirement and how the information is conveyed on the reporting form. Age of the submitter of a report of harm is not, and was not intended to be, a required field. However, submitters will be prompted to certify that they are 18 years old or older. If they are not, a parent or guardian must provide a name and

complete mailing address, and submit the report of harm. A submitter cannot complete a report of harm without certifying that he or she is 18 years of age or older.

h. Proposed § 1102.10(h)—Incomplete Reports of Harm

Proposed § 1102.10(h) on “Incomplete reports of harm” would explain that information received related to a report of harm that is incomplete because it does not meet the requirements for submission or publication will be maintained for internal use.

Several comments were received related to this section, which has been finalized without modification.

Comment 53—
Several commenters address incomplete reports of harm in proposed § 1102.10(h). The commenters claim that incomplete reports of harm should not be published in the Database. Some commenters suggest that consumers be able to return to incomplete reports of harm to finish them at a later date. The commenters also state that the Commission may keep incomplete reports of harm for its own use, but other commenters state that the Commission should not maintain incomplete reports of harm for its own use.

Response—
The comments raised a point of clarification regarding reports of harm. An abandoned report of harm is a report that may be complete or is incomplete but is never “submitted” by the consumer by pressing the “submit” button in the online form. Abandoned reports will not be kept by the Commission. In contrast to an abandoned report, an incomplete report of harm is submitted by pressing the “submit” button in the online form. Incomplete reports of harm are considered incomplete reports because they do not meet the minimum requirements for publication in the Database, as set forth in § 1102.10(d), and therefore, will not be published in the Database. Under section 5(a)(1) of the CPSA, we have an obligation to “maintain an Injury Information Clearinghouse to collect, investigate, analyze, and disseminate injury data, and information, relating to the causes and prevention of death, injury, and illness associated with consumer products.” Because of this mandate, for many years we have maintained a database on consumer product safety incidents, including information submitted online. The incident report form for reports of harm developed for the Database, both online and paper formats, will replace the incident report form currently in use. Regardless of whether reports of harm meet all of the requirements for submission into the Database, we will continue to maintain useful data for internal use under section 5(a)(1) of the CPSA as long as such information is submitted. A report that is not eligible for inclusion in the Database may still contain important information. For example, some reports will not meet publication requirements because the submitter failed to enter a required field. Other submitters may enter all of the substantively required fields, but the report may fail to qualify for inclusion in the Database because the submitter did not consent to publication.

Regarding the ability to save a report of harm, submitters who register a password will be able to save a report of harm, and to return to the report for up to 30 days to edit and submit it. Once the submitter presses “submit,” the report of harm is deemed officially submitted. Once the report has been submitted, we will review the report to determine whether the minimum requirements for publication have been met. Reports of harm that are not submitted within 30 days of initiating the report are considered abandoned, and will not be maintained by the Commission.

Comment 54—
Some commenters ask whether we will notify a manufacturer if an incomplete report of harm is filed.

Response
—Reports of harm that do not meet the minimum qualifications for publication in the Database will not be sent to the manufacturer or private labeler pursuant to section 6A of the CPSA. However, such reports of harm may be sent to the manufacturer or private labeler pursuant to section 6(c) of the CPSA. We are currently considering whether notices under section 6(c) of the CPSA will be sent to the manufacturer through the Business Portal being developed for notices under section 6A of the CPSA. Regardless of how they are transmitted, a notice of incident report under section 6(c) of the CPSA will follow the time frames in existence now, and will not be subject to the shorter time frames for notices under section 6A of the CPSA.

i. Proposed § 1102.10(i)—Official Records of the Commission

Proposed § 1102.10(i), “Official records of the Commission,” would explain that reports of harm accepted by the Commission become official records of the Commission in accordance with 16 CFR 1015.1, and that alteration (or disposition) of these records can only be undertaken in accordance with the procedures specified in this Part.

No comments were received related to this section, which has been finalized with one modification to reflect that reports “submitted to” the Commission will become official records of the Commission.

2. Proposed § 1102.12—Manufacturer Comments

Proposed § 1102.12 would identify the process for who may submit manufacturer comments in response to receiving a report of harm.

a. Proposed § 1102.12(a)—Who May Submit

Proposed § 1102.12(a) would state that manufacturers or private labelers who receive a report of harm from the CPSC may submit a comment if the report of harm identifies such manufacturer or private labeler.

We received several comments related to this section, which has been finalized without change.

Comment 55—
One commenter felt that industry members, other than those specifically identified in the report of harm, should be able to submit comments on a report of harm. According to this commenter, § 1102.16 authorizes the Commission to include in the Database any additional information it determines to be in the public interest.

Response
—We are not revising the proposed rule as suggested by the commenter. Section 6A(c)(1) of the CPSA contains the procedural requirements for transmission of a report of harm to a manufacturer or private labeler. Transmission is required when a report contains the minimum requirements for publication, as set forth in section 6A(b)(2)(B) and § 1102.10(d) of the final rule. If these minimum requirements are satisfied, then the statute requires the Commission, to the extent practicable, to transmit the report to the
manufacturer or private labeler identified in the report
. If the Commission transmits such report to a manufacturer or private labeler pursuant to section 6A(c)(1) of the CPSA, the manufacturer or private labeler who receives the report from the Commission may submit comments to the Commission on the information contained in such report, pursuant to section 6A(c)(2) of the CPSA (containing the procedural requirements for submitting comments in response to a report of harm). Therefore, based upon a plain reading of the statute, we believe that the procedural requirements of section 6A(c) of the CPSA, concerning both transmission and commenting, are unambiguous, and relate only to manufacturers or private labelers who are identified in a report of harm and

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 § 1102.12(b)—How To Submit

Proposed § 1102.12(b) would provide the mechanism by which comments would be submitted; it would be via an online Business Portal, where the manufacturer would be able to register to submit comments on a secure, nonpublic portal provided through the Commission's Database. The proposal also would allow comments to be submitted by electronic mail or regular mail directed to the Commission's Office of the Secretary.

Several comments were received related to this section, resulting in no substantive changes to the final rule. On our own initiative, we made two corrections in the final rule. We corrected an internal citation error in § 1102.12(b)(1), changing the citation from § 1102.20(e) to (f), and we updated § 1102.12(b)(2) to include an email address for the Office of the Secretary.

Comment 59—
One commenter suggests that manufacturers or private labelers be allowed to designate more than one employee or representative to comment on their behalf.

Response
—We have designed the Business Portal such that transmission of a report of harm will be made to the registered account user and additional recipients who can receive the notification of that transmission. Through the Business Portal, we will permit businesses to designate multiple email recipients, but allow only one account holder to submit a response. This will enable notification to more than one person per account in the event that someone is out of the office or not available; at the same time it will ensure that duplicate or multiple reports are not received from the same manufacturer/private labeler.

Comment 60—
One commenter suggests that manufacturers or private labelers be able to group common reports of harm found in the Business Portal, and provide a single response that can be tied to all of such reports of harm.

Response
—The ability of a manufacturer or private labeler to group common reports of harm and provide a single response is not currently a design feature of the Database software program. However, we are currently evaluating how this may be incorporated into the technology for inclusion in a subsequent release of the software. The rule is drafted with sufficient flexibility to accommodate such a future modification without requiring revision of the rule.

C. Proposed § 1102.12(c)—What Must Be Submitted

Proposed § 1102.12(c)(1) through (c)(4) would specify that the Commission will publish a manufacturer's comments related to a report of harm if the comment specifically relates to a report of harm; contains a unique identifier assigned to the report; includes the manufacturer's verification of the truth and accuracy of its comment; includes a manufacturer's affirmative request that its comment be published; and consents to such publication. These requirements must be met for the manufacturer's comment to be published in the Database.

We received no comments on this provision. On our own initiative, however, we have finalized this section with clarifications. Section 1102.12(c) has been corrected to state that manufacturer comments will be published subject to § 1102.24 (on confidential information) and § 1102.26 (on materially inaccurate information). In addition, § 1102.12(c)(2) clarifies that every report of harm has a unique identifier that must be stated by the manufacturer or private labeler submitting a comment on a report of harm.

d. Proposed § 1102.12(d)—Information Published

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

No comments were received on this section of the proposed rule. However, on our own initiative, we clarified that a manufacturer's comments will be published in the Database subject to

§ 1102.24 (on confidential information) and § 1102.26 (on materially inaccurate information).

e. Proposed § 1102.12(e)—Information not Published

Proposed § 1102.12(e) would explain that the Commission will not publish the actual consents and verifications obtained from the manufacturer for such publication.

We received no comments on this provision, and have finalized it without change.

3. Proposed § 1102.14—Recall Notices

Proposed § 1102.14 would state that information in a voluntary or mandatory recall notice will be made accessible and searchable to the public in the Database.

We received one comment on this section of the rule, which we have finalized without modification.

Comment 61—
One commenter states that mixing recall information with incident report information may cause confusion, and that recall information must be clearly identified.

Response
—Including recall information in a product search is vital to Database users, so that they can immediately see whether a product has been recalled, in addition to viewing reports of harm involving the product. Accordingly, the search display screen will clearly identify recall information. Reports also will be displayed in a manner that identifies the nature of such information. Both will be clearly distinguishable as separate items in the Database.

4. Proposed § 1102.16—Additional Information

Proposed § 1102.16 would state that in addition to reports of harm, manufacturer comments, and recall notices required to be in the Database pursuant to section 6A(b)(1) of the CPSA, the Database will include any additional information that we determine is in the public interest, consistent with the requirements of section 6(a) and (b) of the CPSA.

Several comments were received related to this section, which has been finalized without modification.

Comment 62—
One commenter states that this provision does not specify who may submit the additional information that the CPSC decides to include in the Database. The commenter states that this section provides the ideal location for industry members—other than the named company or other professional organization—to comment on the incident or injury.

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 pr

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2010-30491. Public record. Not legal advice.