Reports about drug product packaging will be included in the CPSC safety information database.

CPSC Holds Firm on Public Database's Outlines

The agency will allow "any and all consumers" to submit reports of harm and rejected comments seeking a narrower definition of "harm." Reports about drug product packaging will be included.

How the soon-to-be-launched safety information public database from the Consumer Product Safety Commission will be used is now clear, with a CPSC rule published in the Federal Register explaining its decision on several comments. Principally, the commission said it will allow "any and all consumers" to submit reports of harm, and it will not narrow the definition of "harm" as requested.

Some commenters said leaving the database open in this way invites people with no firsthand knowledge of harm to submit inaccurate information. The commission's rule answered this by saying allowing all consumers to submit reports "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."

"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," the agency added. "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."

The proposed definition of "harm" is any injury, illness, or death, or any risk of injury, illness, or death, as determined by the commission. Some commenters said "any risk of injury" should be changed to "substantial risk of serious injury," and the definition should be narrowed to exclude reports of harm that have near zero risk of causing injury. The commission disagreed but did delete the word "any."

One commenter said 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 FDA, and the commission has authority only over the product packaging. This is true, but the commission noted a harm report must contain at least one 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. "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."

Download Center

HTML - No Current Item Deck
  • Safety Management Software - Free Demo

    IndustrySafe Safety Software’s comprehensive suite of modules help organizations to record and manage incidents, inspections, hazards, behavior based safety observations, and much more. Improve safety with an easy to use tool for tracking, notifying and reporting on key safety data.

  • Create Flexible Safety Dashboards

    IndustrySafe’s Dashboard Module allows organizations allows you to easily create and view safety KPIs to help you make informed business decisions. Our best of breed default indicators can also save you valuable time and effort in monitoring safety metrics.

  • Get the Ultimate Guide to OSHA Recordkeeping

    OSHA’s Form 300A posting deadline is February 1! Are you prepared? To help answer your key recordkeeping questions, IndustrySafe put together this guide with critical compliance information.

  • The 4 Stages of an Incident Investigation

    So, your workplace has just experienced an incident resulting in the injury or illness of a worker. Now what? OSHA recommends that you conduct investigations of workplace incidents using a four-step system.

  • Why Is Near Miss Reporting Important?

    A near miss is an accident that's waiting to happen. Learn how to investigate these close calls and prevent more serious incidents from occurring in the future.

  • Industry Safe
comments powered by Disqus

Free Whitepaper

Stand Your Ground: A Guide to Slip Resistance in Industrial Safety Footwear

This white paper helps to clarify this complexity, so you can better navigate the standards and better ensure the safety of your employees.

Download Now →

OH&S Digital Edition

  • OHS Magazine Digital Edition - November December 2019

    November/December 2019

    Featuring:

    • GAS DETECTION
      Redefining Compliance for the Gas Detection Buyer
    • FALL PROTECTION
      Don't Trip Over the Basics
    • VISION PROTECTION
      What to Look for in Head-to-Toe PPE Solutions
    • PROTECTIVE APPAREL
      Effective PPE for Flammable Dust
    View This Issue