IMPORTANT INFORMATION FOR USERS OF HONEYWELL OXYFUME STERILANTS: NEW Honeywell Oxyfume Sterilant Labels July 2009 Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 United States Code 136-136y (2008), the EPA has re-registered ethylene oxide as a pesticide 1 and, in the process, changes have been made to the Oxyfume sterilant labels. The new labeling for Oxyfume 2000 sterilant blend is enclosed. There are two labels: A body label and a tag, both affixed to the gas cylinder in which Oxyfume 2000 is shipped. The changes expand the previous information for worker protection; and, based upon EPA risk assessment, including visits to ethylene oxide sterilizing facilities in hospitals and in industrial settings, more instructions have been added to define proper use of Oxyfume 2000 sterilant. We recommend that you re-familiarize yourself with the entire label. It provides valuable information needed by all users of hazardous chemicals; moreover, in the case of a registered pesticide, it is a violation of Federal Law to use any pesticide in a manner inconsistent with its labeling. (FIFRA 7 U.S.C. 136j) Here are changes of which you should be aware [Those that might require an immediate change in operations or equipment (on the tag,) are in bold blue type. See page 2 below.] BODY LABEL LABEL PURPOSE: The Oxyfume 2000 body label provides information about Oxyfume 2000 gas mix hazards, as well as those of its components -- ethylene oxide and chlorotetrafluoroethane [HCF- 124] -- and about how to avoid worker exposure and unsafe environmental discharges. It also provides information about how to manage accidents, provide first aid, and obtain emergency medical advice, including a note to the physician. CHANGES: 1. The information about managing Oxyfume Leaks or area Fire has been moved. It follows the section describing Physical and Chemical Hazards. The content of these two sections remains unchanged. 2. Following the HCFC-124 warning [in red] is a new section that more fully describes the Personal Protective Equipment [PPE] that might be needed, with instructions for its use and maintenance, including the need to clean or dispose of PPE that has been exposed to ethylene oxide. 3. The instructions for discharging effluent has been clarified and expanded. 4. Under First Aid, users are instructed in cases of overexposure to call either the Poison Control Center or a doctor. [The prior label provided instructions to call a doctor or to take the exposed person to an emergency response facility.] 1 * 1 [FIFRA definition: The term pesticide means any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest. Micro-organisms controlled by ethylene oxide sterilants are classified as pests. (FIFRA 7 U.S.C. 136) ] 1
TAG IMPORTANT INFORMATION FOR USERS OF HONEYWELL OXYFUME STERILANTS: NEW Honeywell Oxyfume Sterilant Labels July 2009 5. To avoid confusion, advice for treatment of contact exposure has been split into two sections: For eye exposure and for skin exposure. 6. The Note to the physician has been expanded to include some of the Physician Advice information that is on the Oxyfume MSDS [Section 4]. TAG PURPOSE: The Oxyfume 2000 tag provides more detailed instructions for the use, storage and disposal of Oxyfume 2000 sterilant gas and its container. CHANGES: 1. Front: Separate section starting In hospitals... stipulates what type of chamber must be used. 22.. Front:: New instruction for hospitals: Afftteerr Feebrruaarryy 28,, 20110,, aa ssiinggllee cchaambeerr prrocceessss iiss rreequiirreed fforr eetthyylleenee oxxiidee ttrreeaattmeentt ((sstteerriilliizzaattiion aand aaeerraattiion aarree tto occccurr iin tthee ssaamee cchaambeerr)) iin hosspiittaallss aand heeaalltthccaarree ffaacciilliittiieess.. 3. Front:: New instructions for contract sterilizers, starting: In contract sterilization facilities... 4. Front: Reminder to comply with the OSHA ethylene oxide rule: E. Employers in facilities that use Oxyfume 2000 must comply with all of the requirements for ethylene oxide use specified in 29 CFR 1910.1047. 5. Back:: Storage and Disposal. New Do not contaminate food, feed, or water by storage and disposal. 6. Back: Pesticide Storage: When the Oxyfume tags were first approved, Oxyfume use life was not known; thus, a 6-month use life was recommended. With over 15 years experience, providing the Oxyfume label and tag storage instructions are followed, the use life rule-ofthumb is no longer needed and has been deleted: A good rule of thumb is to use Oxyfume 2000 within 6 months of the fill date marked on the container (batch number). The instructions now read: Store according to instructions provided on label and this tag. Store away from heat in an area with adequate ventilation. Do not store in direct sunlight. To minimize polymer growth, Oxyfume 2000 must not be stored in any place where the temperature consistently exceeds 100 F. To control ethylene oxide polymer growth, use all sterilant gas on a first-in, first-out basis. 7. Back: Pesticide Disposal: New. Regulatory guidelines for disposal of a pesticide waste that cannot be disposed of by normal operations, such as the instructions for returning Oxyfume 2000 containers. 8. Back: Container Disposal: New Instruction, generally not applicable to Oxyfume 2000 users who return all their cylinders to Honeywell or to Honeywell distributors. Refillable container. Refill this container only with a non-flammable ethylene oxide mix. Do not reuse this container for any other purpose. 2
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