Industry Research and Public Affairs — Hazardous Materials Safety Interpretation

Page 1US. Department of Transportation Special Programs Research and SEP 2 6 2001 Administration Alice P. Jacobsohn, Esq. Reference No.: 00-0295 Acting Director, Industry Research and Public Affairs Medical Waste Institute 4301 Connecticut Avenue, NW Washington, DC 20008 Dear Ms. Jacobsohn: This responds to your inquiry concerning the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) to household waste, particularly waste generated in connection with services rendered by a home health care provider. Please accept my apology for our delay in responding to your inquiry and for any inconvenience this may have caused. As your letter notes, § 173.134(b) of the HMR provides an exception from HMR requirements for any waste material, including garbage, trash, and sanitary waste in septic tanks, that is derived from households. The term "households" includes single and multiple residences, hotels, and motels. The intent of this exception is to exclude from regulation under the HMR waste generated by individual residences that is collected by local sanitation workers along with trash, garbage, and other non-medical household waste. The exception in § 173.134(b) applies to regulated medical waste (RMW) generated in connection with services rendered by a home health care provider that is disposed of at a residence with other non-medical household waste. However, you are correct that the exception in § 173.134(b) does not apply to RMW generated in connection with services rendered by a home health care provider that is removed by the home health care provider for disposal elsewhere. In such cases, all applicable HMR requirements apply to the transportation of the RMW. We appreciate your comments to Docket No. RSPA-98-3971 (HM-226). Be assured that your comments will be given careful consideration as we develop a final rule. I hope this information is helpful. If you have further questions, please do not hesitate to contact this office. Sincerely, Eland 7. Magalle Edward T. Mazzullo Director, Office of Hazardous Materials Standards 173.134 000295#

Page 2Edmonson EIA : #etion 8173.134 NSWMA Regulated Medical Waste Medical Waste Institute + 4301 Connecticut Avenue, NW, Suite 300, Washington, DC 20008 • 202-244-4700 October 10, 2000 Ms. Hattie L. Mitchell Chief, Regulatory Review and Reinvention U.S. Department of Transportation 400 Seventh Street, S.W. Research and Special Programs Administration Washington, D.C. 20590 Dear Ms. Mitchell: writing to you in response to your letter asking for clarification. In the letter, you stated that household waste was exempt Edward Krisiunas, Director, Inscite, sent to me a copy of the letter you wrote on March 24, 2000 (see attached). I am from RSPA's regulated medical waste rules. However, your explanation on the definition of household waste is confusing explanation such that I may update members on the rules. in light of recent activity at RSPA. As the manager of the Medical Waste Institute (MWI), I am requesting a further I understand that household waste is excepted from the rules under 49 CFR § 173.134. Under that rule, if a person generates regulated medical waste (RMW) in a residence, hotel, or motel, and disposes of that waste at the residence, hotel, or motel, then the exception applies. This would include a home care provider who enters a residence, provides care, and disposes of the waste at that residence. However, my understanding through past conversations with Ed definition of household waste and as a commercial provider, that waste must be packaged and transported in accordance Mazzullo, is that if a home care provider removes the RMW from the residence, then the waste no longer falls within the with the rules. health care infectious waste in the definition of "materials of trade" (see 62 FR 1208, at 1209). At that time, RSPA was This discussion was raised in RSPA's rulemaking, HM-200, when a commenter requested that the agency include home infectious substances (63 FR 46843, at 46847) when RSPA asked for public comment on whether home health care not ready to make a decision on the issue. This issue was re-raised in the advance notice of proposed rulemaking on providers should be exempt from the rules as a material of trade. Perhaps, RSPA was focusing on the specifics of the rules as stated in your letter to Mr. Krisiunas, then the entire discussion on materials of trade becomes irrelevant. materials of trade when it responded in these rulemakings. However, if home care providers are completely exempt from There was not a suggestion by RSPA in either of the rulemakings or any other rulemaking to change 49 CFR § 173.134. advance notice. MWI would like the agency to remove the exception altogether because we do not see a difference MWI requested that RSPA not allow a materials of trade exception for home care agency waste in its comments on the existing exception creates a market imbalance and endangers public health. Although we understand some of the between a physician transporting infectious waste and a home care agency transporting that same type of waste. The iven serious consideration and 1 have merely misunderstood the extent of your response to Mr. Krisiuna: forcement difficulties involved, MWI believes these problems can be resolved. I hope that our comments are bein I look forward to your clarification on the exception. Sincerely, Alice P. Jacobschn Senior Manager, Waste Programs and Research Alice P. Jacobsohn, Esq. CC: Ed Mazzullo, RSPA V Tom Herbert, American Waste Industries, Inc. (Chair MWI)#

Page 3us sportion MAR 24 2000 Edward Krisiunas, MT(ASCP), Reference No. 99-0106 CIC, MPH Director, Inscite 115 Lyons Road • Burlington, CT 06013 Dear Mr. Krisiunas: transported from households from regulation under the Hazardous Materials Regulations This is in response to your letter concerning a provision in 49 CFR 173.134 that excepts waste (HMR; 49 CFR Parts 171-180). You asked for a clarification of what constitutes household waste. You also asked us to explain why regulated medical waste (RMW) that is transported by a courier from a physician's office is regulated under the HMR but it is not regulated when generated by a home health care provider and discarded in household waste. I apologize for the delay in responding and any inconvenience this may have caused. Household waste is not subject to the requirements in the HMR. (See § 173.134(b)(1)(v).) In 1989, the Environmental Protection Agency (EPA) published an interim final rule (54 FR 2326, 12339) that implemented a two-year demonstration program for regulating medica vaste. EPA excluded from regulation medical waste from households, including that generate by a home health care provider. I have enclosed a copy of the preamble discussion on houschold waste that appeared in the EPA fual rule. We agreed with EPA's position. Wher we amended our infectious substance requirements in the HMR and added a definition for RMW, we provided a similar exclusion for household waste (56 FR 66124, 66142). I hope this satisfies your request. Sincerely, Hathe z. Mitchell Hattie L. Mitchell, Chief Regulatory Review and Reinvention Office of Hazardous Materials Standards Enclosures 173.134 990106 -#