Legislative Issues
The following items are being monitored by ASHE. Current information about the status of each item and a copy of the item are available.
HR 2381 Nurse and Health Care Worker Protection Act of 2009
To direct the Secretary of Labor to issue an occupational safety and health standard to reduce injuries to patients, direct-care registered nurses, and other health care providers by establishing a safe patient handling and injury prevention standard and for other purposes.
Status
Sponsor: Rep Conyers, John, Jr. [MI-14] (introduced 5/13/2009) Cosponsors Rep Woolsey, Lynn C. [CA-6] Latest Major Action: 5/9/2007. Status: Referred to the Committee on Education and Labor, Committees on Energy and Commerce, and Ways and Means.
Copy of the proposed bill.
Chemical Facility Anti-Terrorism Standards
The Department of Homeland Security has just published a revised edition of the list of chemicals (APPENDIX A) www.dhs.gov/xlibrary/assets/chemsec_appendixafinalrule.pdf from the Chemical Facility Anti-Terrorism Standards . If a facility possesses a chemical on this list above the listed screening threshold quantity, they must submit a “Top-Screen” (see above news release) to DHS.
On November 20, 2007 the Department of Homeland Security published the final Appendix A in the Federal Register. With the publication of a final Appendix A, all provisions of 6 CFR Part 27, including § 27.210(a)(1)(i), are operative and in effect.
The deadline in the Chemical Facilities Anti-Terrorism Standard (CFATS) interim final rule for submission of “Top Screens” required by 6 CFR § 27.210(a)(1)(i) will be 60 calendar days from the date of publication of Appendix A in the Federal Register.
Updated 12/19/2007:
General Chapter <797> Pharmaceutical Compounding – Sterile Preparations
Status and Update 3/18/2008
The Revised edition of USP 797 can be downloaded at www.usp.org/pdf/EN/USPNF/generalChapter797.pdf. Although there was a period of time for comments, the section on environmental specifications was not revised and none of the comments for changes were accepted by USP. It still calls for a pharmacy that does sterile compounding to adhere to a design required by drug manufacturers which is completely unreasonable in a hospital pharmacy. Although the USP states that that USP 797 will be "official" on June 1, 2008, that does not mean that it is a legal requirement. Only states in which the state pharmacy board had accepted this standard is it a requirement. The status of all states with regard to this standard is available at www.clinicaliq.com/797-state-survey
DEPARTMENT OF HOMELAND SECURITY
6 CFR Part 27
[DHS–2006–0073]
RIN 1601–AA41
Chemical Facility Anti-Terrorism Standards
AGENCY: Department Of Homeland Security.
ACTION: Interim final rule.
This rule establishes risk-based performance standards for the security of our Nation’s chemical facilities. It requires covered chemical facilities to prepare Security Vulnerability Assessments (SVAs), which identify facility security vulnerabilities, and to develop and implement Site Security Plans (SSPs), which include measures that satisfy the identified risk-based performance standards. It also allows certain covered chemical facilities, in specified circumstances, to submit Alternate Security Programs (ASPs) in lieu of an SVA, SSP, or both. The rule contains associated provisions addressing inspections and audits, recordkeeping, and the protection of information that constitutes Chemical-terrorism Vulnerability Information (CVI). Finally, the rule provides the Department with authority to seek compliance through the issuance of Orders, including Orders Assessing Civil Penalty and Orders for the Cessation of Operations.
Status
EFFECTIVE DATES: This regulation is effective June 8, 2007, except for Appendix A to part 27. A subsequent final rule document will announce the effective date of Appendix A to Part 27. Comment related to the addition of Appendix A to part 27 only will be accepted until May 9, 2007.
There were 1528 comments filed with DHs, the last one on June 7, 2007. The final rule concerning Appendix A has not yet been published.
Epinephrine and Hazardous Waste
The EPA has just published a Memorandum to clarify that epinephrine used in hospitals does not come under their classification as a hazardous waste product. (Oct 15, 2007)
Recently the Colorado Dept of Public Health and Environment in the Hazardous Materials and Waste Management Division released a document stating that the dilute solutions containing epinephrine salts used in medical applications and the resultant waste in the form of vials bags, tubing, etc. do not meet the description for PO42 epinephrine classified as a hazardous waste. The PO42 designation is from the US Environmental Protection Agency listing of hazardous waste The EPA has been asked to clarify the definition of these medical solutions of epinephrine as opposed to the industrial application. Their response as of 12/2006 is:
OSW is well aware of the Colorado/epinephrine situation, and we are currently investigating the issue. Once a decision has been made, we will be issuing guidance to the Regions. Until that time, OSW remains consistent with our long-standing interpretation that all discarded unused epinephrine is a P-listed waste.
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Lisa M. Lauer
U.S. Environmental Protection Agency
Hazardous Waste Identification Division
Office of Solid Waste
1200 Pennsylvania Avenue NW
Washington, DC 20460
Mail Code 5304P
Voice: 703-308-7418
Fax: 703-308-0514

