Federal Regulations
There are several federal agencies that reference sharps in their regulations. Below are some rules that may apply to self injectors.
U.S. Department of Transportation
Hazardous Materials Regulation – There are a number of requirements for the packaging and transportation of infectious substances and regulated medical waste. The requirements apply to commercial activity, i.e., health care facilities, waste haulers, treatment and disposal companies, such that self-injectors are not subjected to the rules – unless state regulations have specific transportation and disposal rules for “at-home” generated sharps.
49 CFR 173.134(a)(7) defines a sharp as any object that may be contaminated with a pathogen and that are capable of cutting or penetrating skin or a packaging material. The rule offers some examples such as needles, scalpels, broken glass, culture dishes, etc.
49 CFR 173.197 requires that sharps be placed in containers that are rigid, leak resistant, impervious to moisture, strong enough to prevent tearing or bursting during normal conditions of transport, and puncture resistant for sharps and sharps with residual fluids.
U.S. Postal Service
The Postal Service requires anyone who mails sharps waste to use USPS- authorized packages that have been tested to meet federal (DOT) hazardous materials packaging standards. The use of authorized packages is intended to ensure that leaking or damaged containers do not enter the mailstream and to protect postalemployees who handle the mail from needlestick injuries caused by broken or punctured sharps containers. Sharps mailing containers must display the USPS authorization number, the container ID number and the name of the manufacturer or distributor on the outside of the package. In addition, the outside of the package must display the proper shipping name (“Regulated Medical Waste—Sharps, UN 3291”) and the international biohazard symbol. Each sharps mailing container must include a re-sealable envelope affixed to the outside of the package that contains a four-part USPS manifest that identifies the mailer and the destination facility, and includes an emergency phone number in case the package is damaged in the mail. The USPS manifest must include any additional information required by the state from which the package is mailed.
U.S. Food and Drug Administration
Requirements for sharps containers fall within the agencies device rules. The rules apply to manufacturers and re-manufacturers of sharps containers – 21 CFR part 800.
U.S. Department of Labor, Occupational Safety and Health Administration
The Bloodborne Pathogen Standard includes some requirements for handling sharps; however, they only apply to workplaces –29 CFR 1910.1030 . For example, workplaces such as health care facilities, must use engineering and work practice controls to avoid injuries. These controls may include use of safety needle devices, needle destruction devices, and other mechanisms for reducing exposure due to waste handling. Containers must be puncture resistant and properly labeled. Other requirements include tracking of needlestick injuries on OSHA’s 300 Log, but again, this only applies to workplaces.
Other Federal Agencies
If sharps are contaminated with radioactive materials, controlled substances, or select agents, they may be subject to other requirements by the Nuclear Regulatory Commission, Centers for Disease Control and Prevention, which also provides a website for Safe Community Needle Disposal, and Federal Drug Enforcement Agency. For example, chemotherapeutic treatments use radioactive materials, which may reach the trigger level for NRC regulations. These requirements generally focus on tracking such as registering with the agencies and reporting routes of transport. None of these requirements apply to “home-injectors.”
State Requirements
Many states specifically exempt home health care from medical waste requirements, however, some have limited disposal requirements. To learn specific state regulations contact your State public health and environmental protection officials at Resources.