(a)
(1)
(i)
(ii)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(b)
(1) A material that does not contain an infectious substance or that is unlikely to cause disease in humans or animals.
(2) Non-infectious biological materials from humans, animals, or plants. Examples include non-infectious cells, tissue cultures, blood or plasma from individuals not suspected of having an infectious disease, DNA, RNA or other non-infectious genetic elements.
(3) A material containing micro-organisms that are non-pathogenic to humans or animals.
(4) A material containing pathogens that have been neutralized or inactivated such that they no longer pose a health risk.
(5) A material with a low probability of containing an infectious substance, or where the concentration of the infectious substance is at a level naturally occurring in the environment so it cannot cause disease when exposure to it occurs. Examples of these materials include: Foodstuffs; environmental samples, such as water or a sample of dust or mold; and substances that have been treated so that the pathogens have been neutralized or deactivated, such as a material treated by steam sterilization, chemical disinfection, or other appropriate method, so it no longer meets the definition of an infectious substance.
(6) A biological product, including an experimental or investigational product or component of a product, subject to Federal approval, permit, review, or licensing requirements, such as those required by the Food and Drug Administration of the U.S. Department of Health and Human Services or the U.S. Department of Agriculture.
(7) Blood collected for the purpose of blood transfusion or the preparation of blood products; blood products; plasma; plasma derivatives; blood components; tissues or organs intended for use in transplant operations; and human cell, tissues, and cellular and tissue-based products regulated under authority of the Public Health Service Act (42 U.S.C. 264-272) and/or the Food, Drug, and Cosmetic Act (21 U.S.C. 332
(8) Blood, blood plasma, and blood components collected for the purpose of blood transfusion or the preparation of blood products and sent for testing as part of the collection process, except where the person collecting the blood has reason to believe it contains an infectious substance, in which case the test sample must be shipped as a Category A or Category B infectious substance in accordance with § 173.196 or § 173.199, as appropriate.
(9) Dried blood spots or specimens for fecal occult blood detection placed on absorbent filter paper or other material.
(10) A Division 6.2 material, other than a Category A infectious substance, contained in a patient sample being transported for research, diagnosis, investigational activities, or disease treatment or prevention, or a biological product, when such materials are transported by a private or contract carrier in a motor vehicle used exclusively to transport such materials. Medical or clinical equipment and laboratory products may be transported aboard the same vehicle provided they are properly packaged and secured against exposure or contamination. If the human or animal sample or biological product meets the definition of regulated medical waste in paragraph (a)(5) of this section, it must be offered for transportation and transported in conformance with the appropriate requirements for regulated medical waste.
(11) A human or animal sample (including, but not limited to, secreta, excreta, blood and its components, tissue and tissue fluids, and body parts) being transported for routine testing not related to the diagnosis of an infectious disease, such as for drug/alcohol testing, cholesterol testing, blood glucose level testing, prostate specific antibody testing, testing to monitor kidney or liver function, or pregnancy testing, or for tests for diagnosis of non-infectious diseases, such as cancer biopsies, and for which there is a low probability the sample is infectious.
(12) Laundry and medical equipment and used health care products, as follows:
(i) Laundry or medical equipment conforming to the regulations of the Occupational Safety and Health Administration of the Department of Labor in 29 CFR 1910.1030. This exception includes medical equipment intended for use, cleaning, or refurbishment, such as reusable surgical equipment, or equipment used for testing where the components within which the equipment is contained essentially function as packaging. This exception does not apply to medical equipment being transported for disposal.
(ii) Used health care products not conforming to the requirements in 29 CFR 1910.1030 and being returned to the manufacturer or the manufacturer's designee are excepted from the requirements of this subchapter when offered for transportation or transported in accordance with this paragraph (b)(12). For purposes of this paragraph, a health care product is used when it has
(A) Each used health care product must be drained of free liquid to the extent practicable and placed in a watertight primary container designed and constructed to assure that it remains intact under conditions normally incident to transportation. For a used health care product capable of cutting or penetrating skin or packaging material, the primary container must be capable of retaining the product without puncture of the packaging under normal conditions of transport. Each primary container must be marked with a BIOHAZARD marking conforming to 29 CFR 1910.1030(g)(1)(i).
(B) Each primary container must be placed inside a watertight secondary container designed and constructed to assure that it remains intact under conditions normally incident to transportation. The secondary container must be marked with a BIOHAZARD marking conforming to 29 CFR 1910.1030(g)(1)(i).
(C) The secondary container must be placed inside an outer packaging with sufficient cushioning material to prevent movement between the secondary container and the outer packaging. An itemized list of the contents of the primary container and information concerning possible contamination with a Division 6.2 material, including its possible location on the product, must be placed between the secondary container and the outside packaging.
(D) Each person who offers or transports a used health care product under the provisions of this paragraph must know about the requirements of this paragraph.
(13) Any waste or recyclable material, other than regulated medical waste, including—
(i) Household waste as defined in § 171.8, when transported in accordance with applicable state, local, or tribal requirements.
(ii) Sanitary waste or sewage;
(iii) Sewage sludge or compost;
(iv) Animal waste generated in animal husbandry or food production; or
(v) Medical waste generated from households and transported in accordance with applicable state, local, or tribal requirements.
(14) Corpses, remains, and anatomical parts intended for interment, cremation, or medical research at a college, hospital, or laboratory.
(15) Forensic material transported on behalf of a U.S. Government, state, local or Indian tribal government agency, except that—
(i) Forensic material known or suspected to contain a Category B infectious substance must be shipped in a packaging conforming to the provisions of § 173.24.
(ii) Forensic material known or suspected to contain a Category A infectious substance or an infectious substance listed as a select agent in 42 CFR Part 73 must be transported in packaging capable of meeting the test standards in § 178.609 of this subchapter. The secondary packaging must be marked with a BIOHAZARD symbol conforming to specifications in 29 CFR 1910.1030(g)(1)(i). An itemized list of contents must be enclosed between the secondary packaging and the outer packaging.
(16) Agricultural products and food as defined in the Federal Food, Drug, and Cosmetics Act (21 U.S.C. 332
(c)
(1) A regulated medical waste transported by a private or contract carrier is excepted from—
(i) The requirement for an “INFECTIOUS SUBSTANCE” label if the outer packaging is marked with a “BIOHAZARD” marking in accordance with 29 CFR 1910.1030; and
(ii) The specific packaging requirements of § 173.197, if packaged in a rigid non-bulk packaging conforming to the general packaging requirements of §§ 173.24 and 173.24a and packaging requirements specified in 29 CFR 1910.1030, provided the material does not include a waste concentrated stock culture of an infectious substance. Sharps containers must be securely closed to prevent leaks or punctures.
(2) A waste stock or culture of a Category B infectious substance may be
(d) If an item listed in paragraph (b) or (c) of this section meets the definition of another hazard class or if it is a hazardous substance, hazardous waste, or marine pollutant, it must be offered for transportation and transported in accordance with applicable requirements of this subchapter.