## Whitmyre Research

2111 Wilson Blvd., Suite 600 Arlington, Virginia 22201 (703) 351-5072 (703) 243-4399 (FAX)

April 16, 2008

Monica Shimamura Stratospheric Protection Division SNAP Program U.S. Environmental Protection Agency (6205J) 1310 L Street, NW Washington, DC 20005

RE: Response to USEPA Request for Untrained Worker Scenario as Part of the Fault Tree Analysis for Use of HCR-188C in White Goods

Dear Ms. Shimamura:

I’d like to take this opportunity to introduce myself and to discuss further an unresolved issue that remains following Margaret Sheppard’s departure from the SNAP program. I am an exposure assessor, risk assessor, and board-certified toxicologist with almost 30 years of experience in the field. As a consultant, I have developed exposure assessment methods and have prepared numerous exposure assessment and risk assessments for submission to the USEPA on a variety of products ranging from refrigerants (SNAP) to pesticides (OPP) and PMN chemicals (OTS). I am looking forward to working with you on completing the last hurdle for approval of HCR-188C for refrigerant use in white goods -- the fault tree analysis that has been requested by the Agency.

My thanks to you and your colleagues for your continued interest in the use of HCR188C in white goods. To continue the discussion, we respectfully request that the Agency reconsider it’s request to require an untrained worker scenario in the fault tree analysis for white goods, for the following reasons:

(1) Adequate warnings will be present on canisters of HCR-188C and on appliances . Standard warnings for flammable gases apply and will be present on the warning plate of the appliance and on the canister of HCR-188C. Proposed language is
“NO SMOKING. FLAMMABLE REFRIGERANT HCR-188C IN SYSTEM. USE PROPER CARE IN CHARGING, RECOVERING, AND STORAGE OF
REFRIGERANT. ONLY CERTIFIED TRAINED TECHNICIAN TO HANDLE THIS PRODUCT.” The warning label will also refer technicians to the appliance
manufacturer’s web site for more information.Ms. Monica Shimamura Response to USEPA Request for Untrained Worker Scenario for Fault Tree Analysis April 16, 2008 Page 2

(2) Liability considerations preclude handling of flammable gases by
untrained workers . It is unlikely that a major chain (e.g., Best Buy) would attempt a repair at a homeowner’s home with untrained technicians for liability reasons. Most repairs and/or recycling are anticipated to occur at appliance servicing centers. We have directed that only trained certified technicians handle HCR-188C. It is unlikely that a service center or appliance recycling center in the US would allow an untrained technician to work with, or handle, any product that is flammable without proper training. The potential for legal liability would prevent a service center from employing untrained technicians to perform this critical work.

(3) Guidelines have been established for safe use of HCR-188CC . At the Agency’s request, detailed guidelines for the safe handling of HCR-188C have been developed. A major feature of these guidelines is the training of workers who will handle this material during its initial charging into new appliances, recovery from appliances being serviced, and recovery during recycling/disposal of appliances. As with any other product, when warning labels and safety guidelines are provided to the user, it is up to the individual end user to follow proper procedures. Safe handling is more likely to happen if the individual using the product has received proper training. This is why we are specifying that HCR-188C is to be used only by trained technicians.

(4) OSHA regulations and industry guidelines would ensure safe handling

. The use of untrained technicians for use of HCR-188C would be counter to (1) OSHArules; (2) general industry standards for handling of flammable gases; and (3) Right-toKnow laws. At a minimum, Material Safety Data Sheets (MSDSs) specific to any hazardous or flammable substance used at a job location are required to be available to workers handling any such material. An MSDS for HCR-188C would describe the
flammable nature of the material and would contain the standard hazard statements for a flammable gas. The intent of OSHA is clearly spelled out in the document “ Model Training Program for Hazard Communication ”, available from the OSHA web site. This document provides the clear intent of OSHA to place the responsibility on employers for providing chemical hazard communication programs that include MSDSs, labels and warnings, and worker training. Further, these measures must be provided at the time of the worker’s initial assignment in their work area, and whenever a new physical or chemical hazard occurs in their work area. Employee training must describe (1) methods and observations that can detect the presence or release of the hazardous material; (2) the health hazards of the chemicals located in their work area; (3) measures that workers can take to protect themselves from hazards (such as appropriate work practices); and (4) details of the hazard communication program, including an explanation of labels and MSDSs, and how the workers can obtain and use the hazard information.Ms. Monica Shimamura Response to USEPA Request for Untrained Worker Scenario for Fault Tree Analysis April 16, 2008 Page 3

(5) Requiring an untrained worker scenario is unprecedented . The handling of HCR-188C by an uninformed and untrained worker constitutes a negligent misuse scenario, because it is violation of the proposed product labeling. Being required to assess a negligent misuse scenario is unusual and seems inappropriate. In my almost 30 years of conducting hundreds of risk assessments for a variety of products under FIRFA, TSCA, Proposition 65, and for Canadian and European regulatory bodies, I have never before been required by any regulatory agency to provide an assessment of a negligent misuse scenario for any product. Nor do I see any value in performing such an assessment.

(6) Forcing an untrained worker scenario puts us in a “Catch-22”situation

. If we are required to include an untrained worker scenario in the fault tree analysis, we will literally have to perform an assessment for which input data for the fault tree model do not exist. Nor would there be any reasonable way of developing the input data for such a scenario. An analysis of such a scenario would be of limited or no value to the Agency, because it would be based solely on conjecture and not on data. I am assuming that the Agency would only want us to conduct scientifically-defensible assessments, which is not possible for the requested scenario.

I would like to remind the Agency’s Stratospheric Protection Division that Mr. Maruya received a “2008 Environmental Achievement Award” for HCR-188C from the Agency’s Region IX office on April 14, 2008, in San Francisco. We hope that this event will foster a spirit of cooperation on the part of the Agency in expediting the approval of HCR-188C for use in white goods. We are looking forward to, and would greatly appreciate, a timely response to this letter.

I will be providing a signed hardcopy of this letter to you for your files via first class mail. Feel free to contact me at (703) 351-5072 or by email at riskscicom@aol.com if you have any questions, or if you would like to discuss this letter.

Best regards,

Gary Whitmyre, D.A.B.T.

CC: Richard Maruya (A.S. Trust)