|
Federal Register/Vol. 80, No. 186/Friday, September 25, 2015/Proposed Rules 58051
<br />§ 261.4(b)(1) because the exclusion
<br />applies even when the household
<br />hazardous wastes are collected. It is
<br />important to note that in order to
<br />maintain the exclusion, a retail
<br />pharmacy (or other DEA authorized
<br />collector pharmacy) can use the DEA
<br />authorized collection receptacle to
<br />collect waste generated only at
<br />households and brought to the store for
<br />collection. The hazardous waste
<br />generated by the retail pharmacy and
<br />store, including hazardous waste
<br />pharmaceuticals, are not excluded
<br />household wastes under RCRA and may
<br />not be placed in the DEA authorized
<br />receptacle.124 Furthermore, states
<br />generally regulate non -hazardous waste
<br />and they may have licensing or
<br />permitting requirements for the
<br />collection of solid waste. Because EPA
<br />would like to see the use of DEA
<br />authorized collection receptacles
<br />become widespread, we encourage
<br />states to streamline any requirements
<br />that may create a barrier to the use of
<br />the collection receptacles.
<br />Under this proposal, pharmaceuticals
<br />collected in DEA authorized collection
<br />receptacles will continue to be excluded
<br />from regulation as household hazardous
<br />waste, with some conditions. The
<br />Agency has a long-standing
<br />recommendation that household
<br />hazardous waste collection programs
<br />manage the collected waste as
<br />hazardous waste. We strongly believe
<br />that if a program goes to the expense of
<br />collecting the waste, including waste
<br />pharmaceuticals, it should manage the
<br />waste as hazardous waste, rather than
<br />manage it as municipal solid waste,
<br />which the household could do absent
<br />the collection program. However, the
<br />current household waste exemption
<br />does not require an entity that hosts a
<br />household hazardous waste collection
<br />event to manage the collected waste as
<br />hazardous waste. Typically, the parties
<br />conducting household hazardous waste
<br />collection events have been government
<br />entities—municipalities and counties. It
<br />is relatively new that retail pharmacies
<br />and others are becoming interested in
<br />performing this function. To encourage
<br />this practice, while at the same time
<br />ensuring that collection programs are
<br />managing the collected waste properly,
<br />we are proposing that pharmaceuticals
<br />that are household hazardous waste
<br />(i.e., "household waste
<br />pharmaceuticals") and are collected in
<br />DEA authorized collection receptacles
<br />lzn DEA regulations also prohibits retail pharmacy
<br />stock/inventory from being placed in the collection
<br />receptacle or mail -back envelopes (see 21 CFR
<br />1317.05(a)).
<br />where they may be co -mingled 125 with
<br />controlled substances continue to be
<br />excluded from RCRA regulation,
<br />provided they are:
<br />(1) Combusted at a municipal solid
<br />waste or hazardous waste combustor,
<br />and
<br />(2) managed in accordance with all
<br />applicable DEA regulations (see
<br />§ 266.506(a)(2)).The Agency solicits
<br />comments on all these provisions.
<br />On a separate, but related matter, EPA
<br />has received a number of inquiries
<br />about the exemption in the Clean Air
<br />Act regulations for Other Solid Waste
<br />Incinerator (OSWI) "units that combust
<br />contraband or prohibited goods" (see
<br />the exemption at 40 CFR 60.2887(p) for
<br />new OSWIs and 40 CFR 60.2993(p) for
<br />existing OSWIs). As indicated in a
<br />previous guidance memo, EPA does not
<br />consider pharmaceuticals, voluntarily
<br />collected from ultimate users in a take -
<br />back program, to be contraband or
<br />prohibited goods.126 Likewise, EPA will
<br />A consider pharmaceuticals that are
<br />voluntarily dropped off at collection
<br />receptacles to be contraband or
<br />prohibited goods. Therefore, the OSWI
<br />exemption does not apply and law
<br />enforcement may not destroy
<br />voluntarily collected pharmaceuticals in
<br />the same way that it is allowed to
<br />destroy contraband or prohibited goods.
<br />3. Management of Residues in
<br />Pharmaceutical Containers
<br />a. Regulatory background. Over the
<br />years, EPA has received numerous
<br />inquiries regarding the regulatory status
<br />of various types of containers that once
<br />heId pharmaceuticals that are
<br />considered hazardous waste when
<br />discarded because of the hazardous
<br />waste residue in the containers.
<br />Stakeholders have been particularly
<br />concerned about containers that once
<br />heId pharmaceuticals that are on the "P -
<br />list" of acutely hazardous commercial
<br />chemical products in § 261.33(e)
<br />because a generator becomes an LQG if
<br />it generates more than 1 kg of acute
<br />hazardous waste per calendar month or
<br />accumulates more than 1 kg of acute
<br />hazardous waste at any time.127 The
<br />current regulatory status of acute and
<br />non-acute commercial chemical product
<br />125 DEA does not prohibit co -mingling of
<br />controlled substances with non -controlled
<br />substances provided they are all then managed as
<br />controlled substances.
<br />126 Rudzinski to RCRA Division Directors,
<br />September 26, 2012, RCRA Online #14833 http://
<br />yosemi te. epa.gov/os w/rcra. ns f/Oc994248c23994
<br />7e 85256d090071175f/fcb11dd6f61d4
<br />61685257afe005eb5ce!OpenDocument.
<br />12] Additionally, acute hazardous wastes are
<br />included on the F -list of § 261.31; however none of
<br />those acute hazardous wastes are pharmaceuticals.
<br />residues remaining in a container are
<br />specifically addressed in § 261.33:
<br />The following materials or items are
<br />hazardous wastes if and when they are
<br />discarded or intended to be discarded
<br />(c) Any residue remaining in a
<br />container or in an inner liner removed
<br />from a container that has held any
<br />commercial chemical product or
<br />manufacturing chemical intermediate
<br />having the generic name listed in
<br />paragraphs (e) or (f) of this section,
<br />unless the container is empty as defined
<br />in § 261.7(b). [emphasis added]
<br />According to § 261.7(b)(1), there are
<br />two ways a container that held a non-
<br />acute hazardous waste can be
<br />considered "empty":
<br />A container or an inner liner removed
<br />from a container that has held any
<br />hazardous waste, except a waste that is
<br />a compressed gas or that is identified as
<br />an acute hazardous waste listed in
<br />§ 261.31 or § 261.33(e) of this chapter is
<br />empty if:
<br />(i) All wastes have been removed that
<br />can be removed using the practices
<br />commonly employed to remove
<br />materials from that type of container,
<br />e.g., pouring, pumping, aspirating, and
<br />(ii) No more than 2.5 centimeters (one
<br />in of residue remain on the bottom
<br />of the container or inner liner, or
<br />(iii)
<br />(A) No more than 3 percent by weight
<br />of the total capacity of the container
<br />remains in the container or inner liner
<br />if the container is less than or equal to
<br />119 gallons in size; or
<br />(B) No more than 0.3 percent by
<br />weight of the total capacity of the
<br />container remains in the container or
<br />in liner if the container is greater
<br />than 119 gallons in size.
<br />Therefore, if the container that held
<br />the non-acute hazardous waste
<br />P does not have its
<br />C removed by a commonly
<br />employed practice and either has one
<br />inch or less of residue remaining or has
<br />3 percent or less by weight of the total
<br />capacity of the container remaining, 126
<br />then the container is not considered
<br />"RCRA empty," even though the
<br />pharmaceutical may have been fully
<br />dispensed. If the container is not "RCRA
<br />empty," then the residues are regulated
<br />as hazardous waste (since the residues
<br />are within the container, the container
<br />must be managed as hazardous waste, as
<br />well, even if it is not itself hazardous
<br />waste). On the other hand, if the
<br />contents of the container have been
<br />removed by a commonly employed
<br />ga
<br />120 We are assuming that containers that hold
<br />pharmaceuticals are in containers less than 119
<br />llons in size.
<br />
|