Standards and Regulations

“…safety, environmental impact, and cost… Daniels has exceeded our expectations in all three areas.”

James Herrera, Northern Michigan Supply Alliance, Project Coordinator

Daniels’ aim is to meet or exceed all applicable international and Canadian standards for medical waste and sharps disposal and to comply with all regulations relating to its operations in any given regulatory jurisdiction.

The management of sharps disposal, pharmaceutical and biomedical waste is highly regulated due to the potentially hazardous nature of the materials involved. Daniels continuously monitors all relevant laws and regulations locally and internationally and works hard to ensure its products and services are fully compliant. Healthcare professionals understand the importance of reducing risk in their workplace. It is important that they understand and trust the products and services they use in their everyday tasks. The following are examples of applicable Standards and Regulations:

Biomedical, Pharmaceutical and Sharps Container Standards

Canadian Standard Z316.6 Evaluation of Single-Use and Reusable Medical Sharps Containers for Biohazardous and Cytotoxic Waste

FDA (510K Notification) which is required for all disposable and reusable sharps containers. Sharps containers are classified by the FDA as a Class II medical device.

CAN/CGSB-43.125 Packaging of Category A and Category B infectious substances (Class 6.2) and clinical, biomedical or regulated medical waste

CSA Z317.10 Handling of healthcare waste materials

United States ASTM F2132-01 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps

United States ECRI Guidelines for Sharps Containers

United States NIOSH Selecting, Evaluating, and Using Sharps Disposal Containers

British Standard BS 7320 Specification for sharps containers

French Standard NFX 30-500

Australia/New Zealand Standard AS/NZS 4261 Reusable Containers for the Collection of Sharp Items in Human and Animal Medical Applications

Australia/New Zealand Standard AS/NZS 4478 Guide to the Reprocessing of Reusable Containers for the Collection of Sharp Items used in Animal Clinical/Medical Applications

Australian Standard AS 4031 Non-reusable Containers for the Collection of Sharp Medical Items used in Healthcare Areas

South African Standard SANS 452 Non-reusable and reusable sharps containers

Medical Waste & Associated Regulations

OSHA Bloodborne Pathogen Standard: 1910.1030

CCME - Guidelines for the Management of Biomedical Waste in Canada.

UN Guidelines for the Transport of Dangerous Goods

United Kingdom HTM 07-01 Safe Management of Healthcare Waste

Department of Transportation (DOT) Hazardous Materials Regulations

Canadian Provincial Guidelines & Regulations

Counties cannot supersede State environmental agencies or State Department of Health agencies. They can create additional rules but the vast majority of Counties are not involved in promulgating any additional rules or regulations.

The burden of compliance is on the shipper (i.e. waste generator), and as such, fines for non-compliance are generally imposed on the waste generator. Fines by the various organisations regulating the proper treatment and transportation of biomedical waste vary by scenario

Transportation of Dangerous of Goods Act & Regulations

Historical Development of Regulatory Environment

1992 – The Canadian Standards Association under the direction of the Canadian Council of ministers of the Environment (CCME) prepare a national guideline document for the management of biomedical in Canada.

1992, The Transportation of Dangerous Goods Act is enacted to promote public safety when dangerous goods are being handled, offered for transport or transported by road, rail, air or water.

1999 – The Canadian Environmental Protection Act (CEPA) is the legislative act that regulates management of hazardous waste recycling and disposal. CEPA was enacted to prevent pollution and protect the environment and human health by contributing to sustainable development.