[Pharmwaste] Proposed Rule: Management Standards for Hazardous Waste Pharmaceuticals

DeBiasi, Deborah (DEQ) Deborah.DeBiasi at deq.virginia.gov
Mon Aug 31 15:43:26 EDT 2015

"Proposed Rule: Management Standards for Hazardous Waste Pharmaceuticals" has been signed by the EPA Administrator.
It usually takes a couple of weeks before it gets published in the Federal Register.
Below is the text from the website [http://www2.epa.gov/hwgenerators/proposed-rule-management-standards-hazardous-waste-pharmaceuticals ] , including a link to the prepublication version:
Proposed Rule: Management Standards for Hazardous Waste Pharmaceuticals
Basic Information
Legal Authority
42 U.S.C. §6921 - 6924
Code of Federal Regulations
40 CFR Part 260-265<http://www.ecfr.gov/cgi-bin/text-idx?SID=e890c50a0ff246a8e05409a398695337&mc=true&node=pt40.26.260&rgn=div5>
40 CFR Part 268<http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=e890c50a0ff246a8e05409a398695337&mc=true&r=PART&n=pt40.27.268>
40 CFR Part 270<http://www.ecfr.gov/cgi-bin/text-idx?SID=e890c50a0ff246a8e05409a398695337&mc=true&node=pt40.27.270&rgn=div5>
40 CFR Part 279<http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=e890c50a0ff246a8e05409a398695337&mc=true&r=PART&n=pt40.27.279>
Docket Number

  *   Rule Summary<http://www2.epa.gov/hwgenerators/proposed-rule-management-standards-hazardous-waste-pharmaceuticals#rule-summary>
  *   Rule History<http://www2.epa.gov/hwgenerators/proposed-rule-management-standards-hazardous-waste-pharmaceuticals#rule-history>
  *   Additional Resources<http://www2.epa.gov/hwgenerators/proposed-rule-management-standards-hazardous-waste-pharmaceuticals#additional-resources>

Rule Summary

The EPA Administrator signed the proposed Management Standards for Hazardous Waste Pharmaceuticals Rule on August 31, 2015, and it will be published in the Federal Register within the next few weeks.

This rule proposes a tailored, sector-specific set of regulations for the management of hazardous waste pharmaceuticals by healthcare facilities (including pharmacies) and reverse distributors. It will provide standards to ensure the management of hazardous waste pharmaceuticals is safe and workable within the healthcare setting.

In addition, the proposed pharmaceutical rule will make our drinking and surface water safer and healthier by reducing the amount of pharmaceuticals entering our waterways. Our proposal is projected to prevent the flushing of more than 6,400 tons of hazardous waste pharmaceuticals annually by banning healthcare facilities from flushing hazardous waste pharmaceuticals down the sink and toilet.

Through this proposal, EPA strives to improve the management hazardous waste pharmaceuticals at healthcare facilities (including hospitals, clinics, and retail stores with pharmacies) and reverse distributors in order to improve environmental protection.

Pre-publication Copy of the Proposed Rule

EPA is providing a pre-publication version of the proposed rule for review<http://www2.epa.gov/hwgenerators/pre-publication-copy-management-standards-hazardous-waste-pharmaceuticals-proposed-rule>. While EPA has taken steps to ensure the accuracy of this Internet copy of the rule, it is not the official version of the rule. Please refer to the official version in a forthcoming Federal Register publication, which will appear on the Government Printing Office's FDsys website<http://www.gpo.gov/fdsys/>. Once the official version of this document is published, this version will be removed from the Internet and replaced with a link to the official version.

Commenting on the Proposed Rule

Comments on this proposal will be accepted for 60 days following publication of this rule in the Federal Register. To submit comments, go to Regulations.gov<http://regulations.gov/>, search for Docket No. EPA-HQ-RCRA-2007-0932 and follow the online instructions.

Rule History

In 2008, EPA proposed to add pharmaceuticals to the types of hazardous wastes that could be managed as Universal Wastes (73 FR 73520, December 2, 2008<http://www.gpo.gov/fdsys/pkg/FR-2008-12-02/pdf/E8-28161.pdf>).  Although commenters supported the idea of new regulations for the management of pharmaceuticals, there were numerous concerns over the lack of notification requirements for those facilities that generate, handle or transport pharmaceutical "universal wastes" as well as for the lack of tracking requirements for the shipment of these wastes. Therefore, the Agency decided to not finalize the 2008 proposed rule, but rather develop another proposal for new standards for the management and disposal of pharmaceutical hazardous waste that are generated by healthcare-related facilities.

With the new rule, the concerns raised by the public comments regarding notification and tracking issues can be more fully addressed as well as other pharmaceutical hazardous waste management issues that are more specific to healthcare facilities. This new proposed rulemaking will only pertain to those pharmaceutical wastes the meet the current definition of a Resource Conservation and Recovery Act (RCRA) hazardous waste and that are generated by healthcare-related facilities.

Several of the proposed provisions are also responsive to the Notice of Data Availability (79 FR 8926, February 14, 2014<http://www.gpo.gov/fdsys/pkg/FR-2014-02-14/pdf/2014-02930.pdf>) that EPA issued on the retail sector asking for comment on hazardous waste management practices in that sector and on challenges they face in complying with RCRA.

After consolidating the feedback from these two sources, the regulated community, states and other stakeholders, EPA developed this proposal to improve the management of hazardous waste pharmaceuticals to strengthen environmental protection while ensuring businesses have the flexibility and certainty they need to successfully operate.

Additional Resources

  *   Press Release<http://yosemite.epa.gov/opa/admpress.nsf/d0cf6618525a9efb85257359003fb69d/4e6484bba71fe54985257eb20060fffb!OpenDocument>
Frequent Questions<http://www2.epa.gov/hwgenerators/frequent-questions-about-management-standards-hazardous-waste-pharmaceuticals-proposed>

Deborah L. DeBiasi
Email:   Deborah.DeBiasi at deq.virginia.gov
WEB site address:  www.deq.virginia.gov<http://www.deq.virginia.gov/>
Virginia Department of Environmental Quality
Office of Water Permits
Industrial Pretreatment/Whole Effluent Toxicity (WET) Program
PPCPs, EDCs, and Microconstituents
Mail:          P.O. Box 1105, Richmond, VA  23218
Location:  629 E. Main Street, Richmond, VA  23219
PH:         804-698-4028      FAX:      804-698-4032

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