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Electronic Code of Federal Regulations
Title 16: Commercial Practices
Subpart B—Content Requirements
§1102.10 Reports of harm.
§1102.12 Manufacturer comments.
§1102.14 Recall notices.
§1102.16 Additional information.
§1102.10 Reports of harm.
(a) Who may submit. The following persons or entities may submit reports of harm:
(1) Consumers including, but not limited to, users of consumer products, family members, relatives, parents, guardians, friends, attorneys, investigators, professional engineers, agents of a user of a consumer product, and observers of the consumer products being used;
(2) Local, state, or federal government agencies including, but not limited to, local government agencies, school systems, social services, child protective services, state attorneys general, state agencies, and all executive and independent federal agencies as defined in Title 5 of the United States Code;
(3) Health care professionals including, but not limited to, medical examiners, coroners, physicians, nurses, physician's assistants, hospitals, chiropractors, and acupuncturists;
(4) Child service providers including, but not limited to, child care centers, child care providers, and prekindergarten schools; and
(5) Public safety entities including, but not limited to, police, fire, ambulance, emergency medical services, federal, state, and local law enforcement entities, and other public safety officials and professionals, including consumer advocates or individuals who work for nongovernmental organizations, consumer advocacy organizations, and trade associations, so long as they have a public safety purpose.
(b) Manner of submission. To be entered into the Database, reports of harm must be submitted to the CPSC using one of the following methods:
(1) Internet submissions through the CPSC's Internet Web site on an electronic incident report form specifically developed to collect such information.
(2) Telephonic submissions through a CPSC call center, where the information is entered on the electronic incident form.
(3) Electronic mail directed to the Office of the Secretary at firstname.lastname@example.org, or by facsimile at 301-504-0127, provided that the submitter completes the incident report form available for download on the CPSC's Internet Web site specifically developed to collect such information.
(4) Written submissions to the Office of the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814-4408. The Commission will accept only those written reports of harm that use the incident report form developed for the CPSC's Internet Web site; or
(5) Other means the Commission subsequently makes available.
(c) Size limit of reports of harm. The Commission may, in its discretion, limit the data size of reports of harm, which may include attachments submitted, where such reports of harm and attachments may negatively impact the technological or operational performance of the system.
(d) Minimum requirements for publication. Subject to §§1102.24 and 1102.26, the Commission will publish in the Publicly Available Consumer Product Safety Information Database reports of harm containing all of the following information:
(1) Description of the consumer product. The description of the consumer product must, at a minimum, include a word or phrase sufficient to distinguish the product as a consumer product, a component part of a consumer product, or a product or substance regulated by the Commission. In addition to a word or phrase sufficient to distinguish the product as a consumer product, a description of a consumer product may include, but is not limited to, the name, including the brand name of the consumer product, model, serial number, date of manufacture (if known) or date code, date of purchase, price paid, retailer, or any other descriptive information about the product.
(2) Identity of the manufacturer or private labeler. The name of one or more manufacturers or private labelers of the consumer product. In addition to a firm name, identification of a manufacturer or private labeler may include, but is not limited to, a mailing address, phone number, or electronic mail address.
(3) Description of the harm. A brief narrative description of illness, injury, or death; or risk of illness, injury, or death related to use of the consumer product. Examples of a description of harm or risk of harm include, but are not limited to: Death, asphyxiation, lacerations, burns, abrasions, contusions, fractures, choking, poisoning, suffocation, amputation, or any other narrative description relating to a bodily harm or risk of bodily harm. Incident reports that relate solely to the cost or quality of a consumer product, with no discernable bodily harm or risk of bodily harm, do not constitute “harm” for purposes of this part. A description of harm may, but need not, include the severity of any injury and whether any medical treatment was received.
(4) Incident date. The date, or an approximate date, on which the incident occurred.
(5) Category of submitter. Indication of which category the submitter is in (i.e., consumers, government agencies, etc.) from §1102.10(a).
(6) Contact information. The submitter's first name, last name, and complete mailing address. Although this information will not be published in the Database, it is required information for the report of harm. Submitters also may, but are not required to, provide an electronic mail address and a phone number to allow for efficient and timely contact regarding a report of harm, when necessary.
(7) Verification. A submitter of a report of harm must affirmatively verify that he or she has reviewed the report of harm, and that the information contained therein is true and accurate to the best of the submitter's knowledge, information, and belief. Verification procedures for each method of submission will be specified.
(8) Consent. A submitter of a report of harm must consent to publication of the report of harm in the Database if he or she wants the information to be included in the Database.
(e) Additional information requested on report of harm. The minimum requirements (at §1102.10(d)) for publication of a report of harm in the Database do not restrict the Commission from choosing to seek other categories of voluntary information in the future.
(f) Information not published. The Commission will exclude the following information provided on a report of harm from publication in the Database:
(1) Name and contact information of the submitter of a report of harm;
(2) Victim's name and contact information, if the victim or the victim's parent, guardian, or appropriate legally authorized representative, has not provided appropriate legal consent;
(3) Photographs that in the determination of the Commission are not in the public interest, including photographs that could be used to identify a person or photographs that would constitute an invasion of personal privacy based on the Privacy Act of 1974, Public Law 93-579 as amended;
(4) Medical records without the consent of the person about whom such records pertain or without the consent of his or her parent, guardian, or appropriate legally authorized representative;
(5) Confidential information as set forth in §1102.24;
(6) Information determined to be materially inaccurate as set forth in §1102.26;
(7) Reports of harm retracted at any time by the submitters of those reports, if they indicate in writing to the Commission that they supplied materially inaccurate information;
(8) Consents and verifications associated with a report of harm; and
(9) Any other information submitted on or with a report of harm, the inclusion of which in the Database, the Commission determines is not in the public interest. The Commission shall consider whether the information is related to a product safety purpose served by the Database, including whether or not the information helps Database users to:
(i) Identify a consumer product;
(ii) Identify a manufacturer or private labeler of a consumer product;
(iii) Understand a harm or risk of harm related to the use of a consumer product; or
(iv) Understand the relationship between a submitter of a report of harm and the victim.
(g) Reports of harm from persons under the age of 18. The Commission will not accept any report of harm when the report of harm is or was submitted by anyone under the age of 18 without consent of the parent or guardian of that person.
(h) Incomplete reports of harm. Any information received by the Commission related to a report of harm that does not meet the requirements for submission or publication will not be published, but will be maintained for internal use.
(i) Official records of the Commission. All reports of harm that are submitted to the Commission become official records of the Commission in accordance with 16 CFR 1015.1. Alteration (or disposition) of any such records will only be in accordance with the procedures specified in this part.
§1102.12 Manufacturer comments.
(a) Who may submit. A manufacturer or private labeler may submit a comment related to a report of harm if the report of harm identifies such manufacturer or private labeler.
(b) How to submit. A manufacturer or private labeler may submit comments to the CPSC using one of the following methods:
(1) A manufacturer or private labeler who registers with the Commission as described in §1102.20(f) may submit comments through a manufacturer portal maintained on the CPSC's Internet Web site;
(2) A manufacturer or private labeler may submit comments by electronic mail, directed to the Office of the Secretary at email@example.com; or
(3) A manufacturer or private labeler may submit written comments directed to the Office of the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814-4408.
(c) What must be submitted. Subject to §§1102.24 and 1102.26, the Commission will publish manufacturer comments related to a report of harm transmitted to a manufacturer or private labeler in the Database if such manufacturer comment meets the following requirements:
(1) Manufacturer comment relates to report of harm. The manufacturer or private labeler's comment must relate to information contained in a specific report of harm that identifies such manufacturer or private labeler and that is submitted for publication in the Database.
(2) Unique identifier. A manufacturer comment must state the unique identifier provided by the CPSC.
(3) Verification. A manufacturer or private labeler must verify that it has reviewed the report of harm and the comment related to the report of harm and that the information contained in the comment is true and accurate to the best of the firm's knowledge, information, and belief.
(4) Request for publication. When a manufacturer or private labeler submits a comment regarding a report of harm, it may request that the Commission publish such comment in the Database. A manufacturer or private labeler must affirmatively request publication of the comment, and consent to such publication in the Database, for each comment submitted to the CPSC.
(d) Information published. Subject to §§1102.24 and 1102.26, the Commission will publish a manufacturer comment and the date of its submission to the CPSC in the Database if the comment meets the minimum requirements for publication as described in paragraph (c) of this section.
(e) Information not published. The Commission will not publish in the Database consents and verifications associated with a manufacturer comment.
§1102.14 Recall notices.
All information presented in a voluntary or mandatory recall notice that has been made available to the public shall be accessible and searchable in the Database.
§1102.16 Additional information.
In addition to reports of harm, manufacturer comments, and recall notices, the CPSC shall include in the Database any additional information it determines to be in the public interest, consistent with the requirements of section 6(a) and (b) of the CPSA.