DRAFT -- NOT FOR DISTRIBUTION
EOSA Executive Committee Minutes
January 21, 2014
Page 6
MEETING MINUTES
EXECUTIVE COMMITTEE OF
THE ETHYLENE OXIDE STERILIZATION ASSOCIATION, INC.
Conference Call
January 21, 2014
11:00 a.m. (EST)
Representatives of the Executive Committee (Committee) of the Ethylene Oxide Sterilization Association, Inc. (EOSA) participated in a conference call on January 21, 2014. Members participating on the call included: Tim Carlson, Mike Clark, Kathy Hoffman, Chris Klosen, David Ludwig, Dale Stucker, Fenil Sutaria, Randy Viscomi, and Cheryl Work. Jake Vandevort participated on behalf of B&C® Consortia Management, L.L.C. (BCCM).
1.0 Administrative Issues
1.1 Welcome and Introductions -- Viscomi welcomed everyone and called the conference call to order at approximately 11:00 a.m. (EST).
1.2 Antitrust Reminder -- Vandevort provided the antitrust reminder.
1.3 Approval of Minutes -- Members approved the October 8, 2013, minutes as distributed. Vandevort will prepare the minutes in final, but will not redistribute them to the group.
1.4 Budget Review -- Vandevort reported on the status of the budget. An updated 2013 financial statement and the 2014 budget will be circulated by January 24, 2014.
1.5 2014 Conference Call Schedule -- Vandevort proposed the following 2014 Committee conference call schedule:
n February 18, 2014;
n March 25, 2014;
n April 8, 2014;
n May 20, 2014 (tentative);
n June 24, 2014 (tentative);
n July 22, 2014 (tentative);
n August 19, 2014 (tentative);
n September 23, 2014 (tentative);
n October 21, 2014 (tentative);
n November 18, 2014 (tentative); and
n December 16, 2014 (tentative).
Vandevort will distribute Outlook notices for the conference calls scheduled through April. Additional conference call dates will be confirmed during the next Committee call. All calls will begin at 11:00 a.m. (EST/EDT).
2.0 U.S. Environmental Protection Agency (EPA) Integrated Risk Information System (IRIS) Assessment for Ethylene Oxide (EO)
2.1 Report on Bimonthly Meeting -- Vandevort reported on the presentations and discussion during the December 12, 2013, IRIS bimonthly meeting. Presentations by EPA staff focused on enhancements to the overall IRIS process, the status of the EO assessment, and how it addressed past public comments and Science Advisory Board (SAB) recommendations. EPA’s primary goal for the second SAB review is to obtain review of sections dealing with exposure-response modeling of the epidemiological data, development of unit risk estimates, and specific charge questions on the exposure-response modeling. A secondary goal noted by EPA is to obtain review of the adequacy, transparency, and clarity of the revised draft with emphasis on genotoxicity, EPA’s response to comments (Appendix H), and the summary of major new studies (Appendix J).
Stakeholder presentations focused on many of the components captured in the EOSA and American Chemistry Council (ACC) submissions. Dr. Bill Snellings focused significant time on the unrealistically high unit risk estimates, the sharp contrast of EPA’s findings to the limited epidemiological evidence, and the unrealistically high predictions of cancer mortality.
2.2 Timelines -- During the meeting, EPA indicated it anticipates releasing the peer review draft in February followed by an SAB meeting in April.
2.3 Next Steps and Action Items for EOSA -- Vandevort will contact Jennifer Jinot (EPA) to obtain a current timeline for release of the peer review draft and scheduling of the SAB meeting. Vandevort will work with Bill Gulledge regarding the path forward. Additional information will be distributed to EOSA members when it becomes available.
3.0 Pesticide Registration Review
3.1 Report of Advocacy Efforts -- Vandevort reported on advocacy efforts regarding Registration Review. EO Member Company Registrants, the Advanced Medical Technology Association (AdvaMed), and the American Spice Trade Association (ASTA) have reviewed the materials in the docket, prepared comments, and requested a stakeholder meeting with EPA. Comments on the Preliminary Work Plan (PWP) were submitted to EPA on November 25, 2013. Stakeholders requested and were granted a meeting with EPA to discuss the PWP and path forward.
3.2 January 29, 2014, Meeting with EPA -- The stakeholder meeting with EPA is scheduled for January 29, 2014, from 1:00 p.m. - 2:30 p.m. (EST). The presentation will address topics regarding an overview of EO usage, industrial and spice sterilization, hospital sterilization, and feedback on the PWP. Vandevort will prepare a detailed report of the meeting.
4.0 American Conference of Governmental Industrial Hygienists (ACGIH) -- Update
4.1 Status of EO -- Vandevort reminded members that EO was placed on the Tier II Under Study list for both the Threshold Limit Value (TLV) and Biological Exposure Indices (BEI) committees in 2013. Inclusion on the Tier II list means that ACGIH will not move forward with a Notice of Intended Change (NIC) in 2014, however, ACGIH may elect to place EO on one or both Under Study lists again in 2014.
4.2 Timeline and Next Steps -- ACGIH will announce the 2014 “Under Study” list by February 1, 2014. Vandevort will continue to monitor this matter and report on new developments.
5.0 Goal and Priority Planning
5.1 Review of Subgroups and Initial Priorities -- Vandevort reviewed the subgroups that will focus on webinars and seminars, the EOSA website and outreach/communications, regulatory matters, membership retention and growth, and challenges to EO.
5.2 Next Steps -- Vandevort will schedule a conference call with subgroup chairs to discuss the initial priorities, member engagement, and the path forward. Following the conference call, a report and request for participation will be sent to EOSA members.
6.0 Environmental, Health, and Safety (EH&S) Committee Report
6.1 Process Safety Management (PSM) Webinar -- Vandevort reported that Hoffman, Ron Emerich, Kevin Wagner, and Amy Janik have prepared content for the webinar and are currently drafting the script. The next conference call is scheduled for January 27, 2014, at 3:00 p.m. (EST) to review the script, identify potential dates, and prepare outreach materials.
6.2 White Paper on Exposure Considerations for EO Sterilized Products -- A number of EH&S Committee members have volunteered to author various sections of the white paper. Vandevort will work with those members this week to schedule a conference call to review the outline, assign sections to authors, and identify a timeline for completion.
6.3 Other -- The next EH&S Committee conference call is scheduled for January 30, 2014, at 3:00 p.m. (EST). The EH&S Committee will also meet prior to the next general membership meeting.
7.0 International Issues
7.1 Germany Occupational Exposure Limit (OEL) Reductions -- Hoffman reported that within the next two weeks, Germany will effectively institute a 0.1 parts-per-million (ppm) OEL for EO. A number of efforts regarding this matter are ongoing in Germany, including a committee tasked with identifying how industry can effectively measure down to 0.1 ppm. Hoffman will provide additional information as it becomes available.
7.2 Canada Reevaluation of EO -- On December 19, 2013, Health Canada’s Pest Management Regulatory Agency (PMRA) granted the continued registration of products containing EO for sale and use in Canada. The announcement noted the IRIS assessment for EO is ongoing and, therefore, the status of EO as a pest control product in Canada may be revised. Hoffman reported that only spice usage is under review by PMRA. The requirements established by PMRA address the user of the product and, as a registered use, will require a pesticide application license. Members discussed concerns over products produced in the U.S. and shipped to Canada and how to ensure the industry remains in compliance for those products. Canada currently does not have a maximum residue limit (MRL) for EO for use on whole or ground spices and processed natural seasonings. PMRA notes that in the absence of a specific MRL, a default MRL of 0.1 ppm applies. Hoffman will provide additional information when it becomes available. This matter will be discussed during the next Committee conference call.
8.0 General Membership Meeting
8.1 Location and Logistics -- The general membership meeting is scheduled for April 14, 2014, at the Sheraton Inner Harbor in Baltimore, Maryland. The EH&S Committee will hold a meeting at the Sheraton Inner Harbor prior to the EOSA membership meeting. The membership meeting will follow the standard template including a one hour reception followed by dinner and the meeting.
8.2 Guest Speaker -- Vandevort reported that Denny Christensen will provide the feature presentation. His presentation will focus on the use of process challenge devices for EO sterilization.
8.3 Preliminary Agenda Topics -- In addition to administrative matters and the EH&S Committee report, the meeting will likely focus on the IRIS assessment for EO, registration review, international matters, and the goal and priority setting efforts. Vandevort will prepare a preliminary agenda to be reviewed during the next Committee conference call.
8.4 Next Steps -- Vandevort will work with the Sheraton Inner Harbor to obtain a cost proposal for the meeting. A meeting announcement will be distributed to EOSA members on or before February 14, 2014.
9.0 Other -- No other matters were discussed.
10.0 Summary of Action Items -- Action items are identified below:
10.1 Vandevort will circulate the 2013 year-end financials and 2014 budget by January 24, 2014.
10.2 Vandevort will prepare the October 8, 2013, minutes in final.
10.3 Vandevort will distribute Outlook meeting notices for the February - March Committee conference calls.
10.4 Vandevort will draft a report following the January 29, 2014, meeting with EPA.
10.5 Vandevort will monitor ACGIH and update the membership once the 2014 Under Study lists are released.
10.6 Vandevort will schedule a conference call with the goal and priority setting subgroup chairs.
10.7 Vandevort will prepare a preliminary agenda for the April general membership meeting and circulate it for review and discussion during the next Committee conference call.
10.8 Vandevort will work with the Sheraton Inner Harbor to obtain a cost proposal and will distribute a membership meeting announcement on or before February 14, 2014.
11.0 Adjourn -- There being no further business, the conference call adjourned at approximately 12:00 p.m. (EST).
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