Revised Changes to the CA Medical Waste Management Act from April and May, 2015

Dear Valued Ingenium Clients and Associates,

You may remember that we sent out an informational bulletin back in April and May of 2015 regarding some changes to the California Medical Waste Management Act. Just this past September, California passed legislation that reversed many of those changes that we alerted you to. One of the most important of these changes concerned tracking AND shipping documents. WELL…this has been revised so that only a tracking document is required to be maintained by the California Medical Waste Management Act.

REVISED CHANGE #1

REVISED CHANGE #2

REVISED CHANGE #3

REVISED CHANGE #1 – Tracking Documents: When the new California Medical Waste Management Act (MWMA) went into effect earlier this year, it required generators and transporters to possess TWO documents in relation to the disposal of medical waste…a shipping document AND a tracking document.  This was required for small quantity and large quantity medical waste generators. There is still an exemption in section 117945 for small quantity generators who are not required to register pursuant to Chapter 4 of the MWMA (see section 117925). We also pointed out that small quantity generators were required to keep their documents for three years while large quantity generators were only required to keep their documents for two years! The changes to the MWMA that took place in September of 2015 reverse the requirement for a shipping document in addition to a tracking document. So, it is once again possible to have one document satisfy the tracking document requirements of the MWMA and the shipping document requirements of the DOT. The record retention requirements however, remain the same.

Chapter 4 – Small Quantity Generator Requirements NEW – September 2015

  1. (a) A medical waste generator required to register pursuant to this chapter shall maintain for a minimum of three years individual treatment operating records, and if applicable, the tracking document for all untreated medical waste shipped offsite for treatment, and shall report or submit to the enforcement agency, upon request, all of the following:

(1) Treatment operating records. Operating records shall be maintained in written or electronic form.

(2) An emergency action plan complying with regulations adopted by the department.

(3) Tracking documents or electronically archived tracking documents maintained by the facility and medical waste hauler of all untreated medical waste shipped offsite for treatment.

(b) Documentation shall be made available to the enforcement agency onsite.

Chapter 5 – Large Quantity Generator Requirements NEW September 2015

117975(a) A large quantity medical waste generator required to register pursuant to this chapter shall maintain for a minimum of two years individual treatment records and the tracking document for all untreated medical waste shipped offsite for treatment. The generator shall report or submit to the enforcement agency, upon request, all of the following:

(1) Treatment operating records. Operating records shall be maintained in written or electronic form.

(2) An emergency action plan in accordance with regulations adopted by the department.

(3) Tracking documents or electronically archived tracking documents maintained by the facility or medical waste hauler of all untreated medical wastes shipped offsite for treatment.

(b) Documentation shall be made available to the enforcement agency onsite as soon as feasible, but no more than two business days following the request.

 Chapter 4 – Small Quantity Generator Requirements OLD

117943 – Treatment and Tracking Records

117943. (a) A medical waste generator required to register pursuant to this chapter shall maintain for a minimum of three years individual treatment operating records, and if applicable, shipping and tracking documents for all untreated medical waste shipped offsite for treatment, and shall report or submit to the enforcement agency, upon request, all of the following:

(1) Treatment operating records. Operating records shall be maintained in written or electronic form.

(2) An emergency action plan complying with regulations adopted by the department.

(3) Shipping and tracking documents or electronically archived shipping and tracking documents maintained by the facility and medical waste hauler of all untreated medical waste shipped offsite for treatment.

(b) Documentation shall be made available to the enforcement agency onsite.

117975 – Treatment and Tracking Records
(a) A large quantity medical waste generator required to register pursuant to this chapter shall maintain for a minimum of two years individual treatment records and shipping and tracking documents for all untreated medical waste shipped offsite for treatment. The generator shall report or submit to the enforcement agency, upon request, all of the following:

(1) Treatment operating records. Operating records shall be maintained in written or electronic form.

(2) An emergency action plan in accordance with regulations adopted by the department.

(3) Shipping and tracking documents or electronically archived shipping and tracking documents maintained by the facility or medical waste hauler of all untreated medical wastes shipped offsite for treatment.

(b) Documentation shall be made available to the enforcement agency onsite as soon as feasible, but no more than two business days following the request.

Chapter 6 – Medical Waste Haulers NEW September 2015

  1. (a) Except with regard to sharps waste consolidated by a home-generated sharps consolidation point approved pursuant to Section 117904, a hazardous waste transporter transporting medical waste shall maintain a completed tracking document in compliance with subdivision (b) for the purpose of tracking the medical waste from the point when the waste leaves the generator facility until it receives final treatment. At the time that the medical waste is received by a hazardous waste transporter, the transporter shall provide the medical waste generator with a copy of the tracking document. The transporter transporting medical waste shall maintain its copy of the tracking document for three years.

Chapter 6 – Medical Waste Haulers OLD

118040 – Tracking Records

118040. (a) Except with regard to sharps waste consolidated by a home-generated sharps consolidation point approved pursuant to Section 117904, a hazardous waste transporter or generator transporting medical waste shall maintain a completed shipping document in compliance with United States Department of Transportation (USDOT) requirements when medical waste is transported. In addition to the shipping document required by USDOT, a hazardous waste transporter or generator who transports medical waste to a facility, other than the final medical waste treatment facility, shall also maintain tracking documents which show the name, address, and telephone number of the medical waste generator, for purposes of tracking the generator of medical waste when the waste is transported to the final medical waste treatment facility. At the time that the medical waste is received by a hazardous waste transporter, the transporter shall provide the medical waste generator with a copy of the shipping and tracking documents for the generator’s medical waste records. The transporter or generator transporting medical waste shall maintain its copy of the shipping and tracking documents for three years.

It will now be possible to once again have one document satisfy the DOT’s and the California Medical Waste Management Act’s requirements. So, no longer a requirement to have two documents onsite for each shipment!

REVISED CHANGE #2 – Biohazard Bags: When the California Medical Waste Management Act was changed earlier this year, biohazard bags were required to be marked with certain information. In addition to the biohazard symbol, the bags were also required to be certified and marked to ASTM D1922 and D1709.  The newest definition for biohazard bags only requires the ASTM marking on bags used for DOT regulated transportation of medical waste. HOWEVER, the new definition requires that the bags used for collecting medical waste within your facility be ‘manufacturer certified’ to meet ASTM D 1709, but not necessarily marked. Important, when placing medical waste into the containers that will be used for offsite transportation, those containers MUST be lined with bags marked with the ASTM D 1922 and ASTM D 1709.

  1. NEW September 2015

(a) “Biohazard bag” means a disposable film bag used to contain medical waste. Notwithstanding subdivision (b) of Section 117605, the film bags that are used to line the United States Department of Transportation (USDOT)-approved shipping containers for transport from the generator’s facility onto roadways and into commerce to a treatment and disposal facility shall be marked and certified by the manufacturer as having passed the tests prescribed for tear resistance in the American Society for Testing Materials (ASTM) D1922, “Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method” and for impact resistance in ASTM D1709, “Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method,” as those documents were published on January 1, 2014. The film bag shall meet an impact resistance of 165 grams and a tearing resistance of 480 grams in both parallel and perpendicular planes with respect to the length of the bag.

(b) The biohazard bag that is used to collect medical waste within a facility shall be manufacturer certified to meet the ASTM D1709 dart drop test, provided that when the bag is prepared for transport offsite, it is placed into a USDOT-approved container lined with a biohazard bag that is ASTM D1709 and ASTM D1922 certified.

17630 -OLD
“Biohazard bag” means a disposable film bag that is impervious to moisture. The film bags that are used for transport shall be marked and certified by the manufacturer as having passed the tests prescribed for tear resistance in the American Society for Testing Materials (ASTM) D1922, “Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method” and for impact resistance in ASTM D1709, “Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method.”

REVISED CHANGE #3 – Pharmaceutical Container Marking: When the California Medical Waste Management Act was changed earlier this year, it required new marking requirements for containers of pharmaceuticals.  It required one label that stated “High Heat or Incineration Only”.  The new requirement as of September 2015, is that pharmaceutical containers once again be marked with one of two labels…either “High Heat” OR “Incineration Only”.

118275(a)(6) NEW September 2015

(B) Nonradioactive pharmaceutical wastes that are not subject to the federal Resource Conservation and Recovery Act of 1976 (Public Law 94-580), as amended, and that are regulated as medical waste are placed in a container or secondary container labeled with the words “HIGH HEAT” or “INCINERATION ONLY,” or with another label approved by the department, on the lid and sides, so as to be visible from any lateral direction, to ensure treatment of the biohazardous waste pursuant to Section 118222.

 118275 (a)(6) OLD

(B) Nonradioactive pharmaceutical wastes that are not subject to the federal Resource Conservation and Recovery Act of 1976 (Public Law 94-580), as amended, and that are regulated as medical waste are placed in a container or secondary container labeled with the words “HIGH HEAT OR INCINERATION ONLY,” or with another label approved by the department, on the lid and sides, so as to be visible from any lateral direction, to ensure treatment of the biohazardous waste pursuant to Section 118222

As always, if you have any questions regarding hazardous waste regulations and/or compliance, the Ingenium team is here to help you get and stay, in compliance.

Sincerely,

Scott Rendleman, MS, CHMM
Chief Compliance Officer
Ingenium

Back to Regulatory Updates