06-096 C.M.R. ch. 900, § 4 - Exemptions

A. Household Generators

This rule does not apply to household generators of biomedical waste except that sharps must be packaged in accordance with Section 12(A)(4) of this rule.

B. Small Quantity Generators

A medical facility which generates less than a total of 50 pounds of biomedical waste in any one month is exempt from the requirements of this rule for that month with the following exceptions:

(1) The facility shall register in accordance with Section 11(A).

(2) Discarded sharps, as defined in Section 7(A)(4), and discarded cultures and stocks of infectious agents, as defined in Section 7(A)(5), shall be packaged in accordance with Section 12(A), labeled in accordance with Section 12(B) and treated in accordance with Section 10.

(3) Except as provided in (4) and (5) below, transport of biomedical waste shall be by a licensed biomedical waste transporter and accompanied by a four-part manifest unless the biomedical waste is taken by the generator to another medical facility or to a permitted biomedical waste transfer or treatment facility and the amount transported is less than 50 pounds.

(4) The generator or an employee of the generator may transport sharps packaged in accordance with this rule to a licensed biomedical waste treatment facility or another medical facility that has volunteered to serve as a collection point for sharps if no more than 50 pounds of sharps are transported in one trip.

NOTE: The rule allows employees to generate biomedical waste off site at intermittent, temporary field collection points and transport it back to their facility. Included are blood drives, home health care providers and phlebotomists working at a temporary field location .

(5) A generator of biomedical waste may send up to 50 pounds of properly packaged discarded sharps via the United States Postal Service to a licensed biomedical waste treatment facility. All generators are responsible for compliance with the packaging standards contained in Section 12 of the rules.

NOTE: The enabling legislation for the mailing of discarded sharps via the United States Postal Service (USPS) specified quantities of up to 50 pounds; however, USPS guidelines limit the amount to 35 pounds.

NOTE: For a medical facility to qualify for the small quantity exemption, all categories of biomedical waste identified in Section 7 must be considered and the total amount must be less than 50 pounds per month.

Notes

06-096 C.M.R. ch. 900, § 4