Compliance News Fall 2003

Office of Research Affairs

Compliance and Research Protection News

Winter 2004

In this Issue:

It has been pretty quiet on the regulatory front and institutions across the U.S. are digesting and implementing the requirements of the Patriot Act. As a campus we have been keeping up with what we need to do to be in compliance with the parts of those regulations that impact research and biosafety issues, thanks to Val Steinberg and Don Robinson in EH&S.

This, sadly, leads in to news of the latest round of early retirements. Several key people who have been compliance mainstays over the years were tempted by the early retirement package to retire at the end of December. Among retirements from EH&S were Jim Fox the Environmental Services Manager, Val Steinberg the Biosafety Officer, and Jim Tocci the Radiation Safety Officer. They will be missed. The good news is that those positions are to be filled and Val and Jim Fox are here part-time until their replacements are in place. We wish Val, Jim and Jim well in their next endeavors.

It seems that with each newsletter we are able to report some progress in getting systems in place that make us as a campus more efficient at managing compliance. In this issue Craig Ruberti reports progress on implementing an Environmental Management System (EMS) on campus. You may know what one pilot project that is part of the EMS has entailed if you do research in the Lederle Graduate Research Tower. To find out about the EMS and the new Chemical Environmental Management System (CEMS) check Craig's report in this issue.

Please forward this newsletter to your colleagues and associates.

If you wish to be removed from this mailing list please contact Hilary Woodcock at:

email: hilaryw@ora.umass.edu
voice: 413-577-0387

The IACUC

Research activities in the Baystate-UMass Biomedical Research Institute Baystate Research Institute (BRI) are gearing up and the practicalities of providing services to researchers in the BRI are getting worked out. It has been proposed that the UMass IACUC oversees research that uses animals at the BRI and this will entail bringing the BRI onto the Assurance UMass holds with the Office of Laboratory Welfare (OLAW). Both institutions agree on principal that this is a good move and plans to implement it are going forward. With guidance from OLAW we are on track for reaching a mutually workable arrangement. For BMC and UMass researchers involved in collaborative projects, a single protocol review is much to be preferred over the current need to submit two protocols for review and oversight by two different IACUCs.

The National Institute of Allergy and Infectious Diseases (NIAID) and the Office of Laboratory Animal Welfare (OLAW) have developed a web tutorial "How to Write an Application Involving Research Animals". This is a step by step guide to the preparation of an application and covers such topics as considering alternatives, obtaining assurances and IACUC approval, just in time processes, NIH review of animal subjects applications, grant awards, IACUC monitoring of awards and reporting requirements. It is designed specifically for NIAID applicants, but the information is relevant to any investigator submitting an application to the NIH for an activity involving animals. It is available at: http://www.niaid.nih.gov/ncn/clinical/researchanimals/tutorial/index.htm.

Human Subjects

Sessions at the annual Public Responsibility in Medicine and Research (PRIM&R) conference last December reminded attendees of the importance of continuing review of research projects that involve human subjects. Because protocol review and re-approval must take place at least annually the IRB office staff do their best to ensure your approvals don't lapse by sending a reminder out in advance of your approval anniversary date. If you forget to file the annual update report you no longer have current approval to continue your project after the expiration date of your previous approval. To double check on the status of your approval give Nancy Swett a call at 5-3428.

The IRB is continuing to look into modifying the UMass on-line training modules for researchers who work with human subjects. The goal is to provide training modules that better suit the needs of researchers in the social and behavioral sciences as well as satisfying training needs for those whose research is more biomedical in nature. The IRB is assessing newly-designed modules that separate out the training for the two areas of research while continuing to cover the basic human subjects research ethics curriculum. If the new training modules are adopted and you have already taken the current training you will not be required to re-take your training at this time.

Select Agents

At the end of January the Center of Disease Control hosted a National Symposium titled "Biosafety and Biosecurity: A New Era in Laboratory Science". The presentations were great but it will be six months before the proceedings are published. As would be expected, how to implement the provisions of the Patriot Act and handling agents on the CDC and USDA lists of Select Agents was much discussed.

Mark Hemphill from the CDC provided an overview of the new regulations and the detailed procedures for approving work with a select agent or toxin. His presentation made very clear the general requirements of the new Select Agents Rule and the current status of implementing this regulation. Alas, he was not willing to share his PowerPoint presentation though he said that something similar will be on the CDC's web site eventually. In the meantime, someone from the Lawrence Livermore Laboratory has kindly shared his own presentation. It is very basic because he removed everything from his slides that would indicate where the presentation originated but it is packed with useful background information.

So if you are thinking about a new project that will use agents on the USDA and/or CDC's lists of Select Agents the compliance office in Goodell has a (very) basic PowerPoint presentation that provides background information about the regulations as well the practical things you will need to bear in mind as you plan your project. If you aren't sure what agents are on the Select Agents lists you can find the lists on the EH&S web site http://www.ehs.umass.edu/appendixa.html. We plan to put the PowerPoint presentation on the compliance web site but if you would like to view it sooner rather than later contact Hilary Woodcock at hilaryw@ora.umass.edu. She will email you the presentation or could present it to a group.

EMS and CEMS

Improved Management and Accountability through Environmental Management Systems

In March 2002 UMass Amherst was selected as one of three New England educational institutions to participate in a U.S. Environmental Protection Agency sponsored initiative to implement an Environmental Management System (EMS). An EMS provides a structure for an institution to analyze and identify ways to improve management practices and overall environmental performance, resulting in increased efficiencies, cost savings, improved communication, and compliance assurance.

As part of this initiative, Tower A of the Lederal Graduate Research Center (GRC) was selected for a pilot project in the Chemistry and Biochemistry & Molecular Biology Departments. One activity targeted by the EMS was the management of chemicals via an on-line chemical inventory program, The Chemical Environmental Management System (CEMS). Each PI was asked to examine their inventory and purge any unwanted chemicals. Following that, a group from EH&S bar-coded every chemical container and entered it into the system. There are currently 26,000 containers in the system. To keep the system current, all chemicals are received by the stockroom, entered into the system, and then delivered. When a chemical is used up the PI peels off the barcode and sticks it on a disposal form. Stockroom personnel remove the barcode from the system.

The CEMS has been up and running since August 2003 and its benefits are many:

Improved Inventory Management: The implementation of CEMS will significantly improve inventory management within the labs. It allows users real-time access to their inventories to check for date sensitive chemicals or for chemicals that are hard to manage (e.g., regulated by EPA and DEA).	MSDS and Hazardous Waste Disposal: CEMS currently houses thousands of MSDS sheets that can be accessed by anyone on campus. Hazardous waste generators can also submit waste pickup requests through CEMS.
Emergency Response: Quick and easy access to inventories provides Health and Safety personnel the information they need to know to respond quickly and correctly.	Minimizes Expensive Disposal Costs: The likelihood of finding unknowns in the lab is significantly reduced thereby minimizing the associated expensive disposal costs.
Enhanced Reuse and Exchange Program: Unused chemicals can be easily placed on the reuse and exchange database reducing disposal costs and unnecessary purchases.	Annual Inventory Requirement: CEMS eliminates the need for faculty to compile a manual inventory saving them time that can be better spent elsewhere.

The next step is to evaluate how to implement the chemical inventory program campus-wide. EH&S is working with people from the Isenberg School of Management and will consult with stakeholders to identify a model that will be effective and efficient and meet researchers' needs throughout campus.

Meanwhile, the implementation of the EMS continues. EH&S anticipates that the implementation effort in the GRC will wrap up by mid-March 2004 while on the other side of campus the Fleets Service EMS implementation effort is coming to a close. Utilities Maintenance begin efforts to apply the EMS this February.

For more information on the UMass EMS effort contact Craig Ruberti, EH&S, at 545-5119 or cruberti@ehs.umass.edu. To access the CEMS website visit http://www.umass.cems.sr.unh.edu. For more information on the Chemical Inventory program contact Al Sorensen, EH&S, at 545-5112 or sorensen@ehs.umass.edu.