(e) One commenter claimed that this provision requires VSQGs to be under the same ownership as LQGs is inconsistent with the proposed Hazardous Waste Pharmaceuticals rule (132).

EPA Response:
(a) EPA agrees with commenters that supported limiting the consolidation provision to VSQGs and LQGs that are under the control of the same person. Limiting transfers to facilities under control of the same person is appropriate because it ensures common control is maintained over both facilities and takes advantage of strong liability incentives to ensure the hazardous waste is safely managed. Additionally, if a VSQG sends hazardous waste to an LQG under the control of the same person, the LQG is likely to be more familiar with the type of hazardous waste generated by the VSQG. Furthermore, questions regarding liability and responsibility for such hazardous waste are clearer than is the case with facilities from unrelated companies.
(b) After consideration of the comments received, EPA has decided not to finalize an inter-company consolidation provision at this time. There was not enough support in the public comments and significant implementation issues were identified. It is likely that additional safeguards would need to be put in place to allow VSQG consolidation at an LQG that is not under the control of the same person. After a sufficient number of states adopt the intra-company consolidation provision, the Agency plans to evaluate how the consolidation option is working. EPA will then consider possible expansion of the provision in the future, including whether to allow VSQG consolidation at SQGs under the same control and/or LQGs under the control of a different person.
(c) EPA is finalizing the requirement that the LQG must list the VSQGs they receive waste from on the Site ID form, which is also a form including in the LQG's BR. EPA will be revising the Site ID form to allow for this and plans to consult with the RCRA Site ID expert group and take their comments into account when making those revisions to ensure that the form instructions are clear and that the data is readily accessible.
(d) EPA is using the same language for the key terms in "under the control of the same person" that we used in the exclusion from the definition of solid waste (DSW) for hazardous secondary materials that are generated and legitimately reclaimed under the control of the generator (40 CFR 261.4(a)(23)), which was promulgated on October 30, 2008, (73 FR 64668) and revised on January 13, 2015 (80 FR 57918). "Person" is defined in § 260.10 to mean an individual, trust, firm, joint stock company, federal agency, corporation (including a government corporation), partnership, association, state, municipality, commission, political subdivision of a state or any interstate body. Control means "the power to direct the policies of the generator, whether by ownership of stock, voting rights, or otherwise, except that contractors who operate facilities on behalf of a different person shall not be deemed to "control" such facilities." We have clarified in the preamble to this final rule that consistent with the October 30, 2008, final rule, companies within the same corporate structure would be considered "under the control of the same person" if they meet the definition of same "person" and "control." EPA has been explicit that contractors would not be considered to be under the control of the same person in both the DSW and the generator rules. If a contractor is operating a generator site on behalf of a different person, that person can use the consolidation provisions if they send their waste to an LQG under the same control. Additionally, EPA and the implementing state agencies do not have the expertise to review and enforce business contracts and contractor liability. If the other business arrangements mentioned by the commenters meet the definition of under the control of the same person as defined, EPA would consider those acceptable. EPA intends to evaluate how the intra-company consolidation provision is working before we consider expanding it to facilities that are under the control of a different person, such as contractors.
(e) For the reasons stated above, EPA has determined that the consolidation provision should be limited to VSQGs sending their waste to an LQG under the control of the same person. In terms of the proposed pharmaceuticals rule, the situation isn't analogous. The proposed pharmaceuticals rule was tailored specifically to that industry sector and the specific nature of the hazardous pharmaceutical waste streams. This final generator rule applies to all generators across many different industries and sectors and thus, we have determined that the VSQG consolidation should be done at an LQG under the control of the same person (i.e., same company).

Section 3.3.4 - Conditions for VSQG

Summary:
(a) Most commenters did not comment specifically on the VSQG conditions but a few agreed with the proposed conditions for VSQGs to consolidate at an LQG under the same control (70, 182). One state suggested the VSQG maintain a simple shipping log (108). Another state recommended that EPA require the generating and receiving facilities to maintain copies of all shipping papers, as well as inventory records documenting the transfer, especially since these materials may still be regulated by DOT (214). Hennepin County (Minnesota) stated that VSQGs should be recorded to maintain records at the generator site showing the amount of hazardous waste generated and shipped to the LQG (229). MCPA also recommended EPA consider requiring VSQGs to keep some type of record documenting the transfer of their waste and explained how they require VSQGs to retain the "consignment receipt" for the waste which is signed by the VSQG collection facility when it receives the waste. MCPA has found it to be a nearly de minimus burden on the VSQG and a very important tool for waste tracking and liability assessment and resolution (232). A California county suggested an annual log be kept for wastes shipped from each CESQG to the LQG (250).
(b) Marking and Labeling Containers. One commenter specifically supported the proposed labeling and marking of containers for transporting and storing CESQG waste being sent to an LQG (236). Several commenters stated that having two "systems" of labeling was confusing and unnecessary and discussed other ways to distinguish the VSQG waste from the LQG's own waste when it is consolidated. Specifically, the records that an LQG are required to keep should be sufficient to distinguish VSQG waste from the LQG's own waste. In addition, there will likely be situations where an LQG supplies the labels to the VSQG, so using one common label is reasonable (131, 134, 182, 217, 219, 220, 232). Some commenters said that the numerous conditions, including labeling at the VSQG, are too prescriptive and would limit the use of this option (77, 129, 131, 168, 233, 262). Some of these commenters specifically stated that having VSQGs label their containers with the hazardous waste code is a big disincentive since they don't have the expertise onsite to classify their wastes and aren't required to do so under the current RCRA regulations (77, 224, 262). One state and ASTSWMO asked that EPA clarify where the marking and labeling should occur at the CESQG and suggested it should occur at the point of generation, rather than at the point a decision is made to send it to the LQG (116, 217). Another state asked EPA to require the use of DOT shipping names while the HW is accumulating onsite, not just during transport, which will promote later compliance with transport labeling requirements (145). ASTSWMO noted that one state did not believe the label generally has enough information for the LQG to make a full waste determination and suggested requiring the CESQG generate a waste profile sheet prior to transferring to the LQG or use waste acceptance protocols utilized by commercial TSDFs. This could also be helpful if the LQG was not as familiar with the CESQG's individual waste streams, such as in the academic laboratory setting (217).
(c) A commenter suggested we specify that a CESQG can transport their own waste to an LQG if DOT requirements are met (60). Another state said it would be appropriate to require the vehicle that the waste be transported in be owned and under the control of the same person so there is a straight path to liability and that there is some type of financial assurance in place in case of an accident in transit (223). One state and ASTSWMO noted that the proposed rule does not require use of a HW transporter and asked EPA to consider the potential issues associated with having hazardous waste transported by a potentially less knowledgeable or accountable person or company (116, 217). Another state agency asked for clarification that a generator could use a third party hazardous materials transporter if the waste is not manifested (214). MCPA recommended limiting the entities who may transport the VSQG hazardous waste to employees of the VSQG and LQG under the control of the same person. MCPA suggested that if EPA did not limit the transportation in this way, "fly-by-night" transporters could be attracted to this market with substantial risk of improper handling, misdirected shipments, or lack of accountability (232). Another state suggested requiring the CESQG to use a uniform hazardous waste manifest when shipping to the LQG under the control of the same person (217).
(d) One association could not identify where their members would benefit from the consolidation provision and could not determine where any savings would be realized. This association thought a VSQG would still have to package, label, and manifest the waste for shipment to the affiliated LQG (192).
(e) One commenter noted that the generating CESQG site should be required to be identified as the original generator through some means, such as an EPA ID number (196). Another commenter asked for clarification on whether it is the EPA ID number for the VSQG that is required under proposed §262.14(a)(4)(viii)(B)(4) (206). One state stated that it would be beneficial to have CESQGs also notify for tracking purposes and another state stated their preference that all CESQGs notify the state (217, 248).

EPA Response:
(a) EPA has determined that the recordkeeping requirements for VSQGs consolidating at an LQG under the control of the same person should be done and maintained by the LQG. LQGs already have recordkeeping requirements under RCRA and this will not be new to them, whereas VSQGs do not have any federal recordkeeping requirements as part of the current RCRA program. Since the VSQG-LQG consolidation is simply an option for these generators, EPA is seeking to strike an appropriate balance between proper environmental management and reasonable recordkeeping burden. Otherwise, VSQGs could just continue to manage their hazardous waste by sending it to a non-hazardous landfill or combustor.
(b) EPA agrees with the commenters who recommended against labeling "VSQG" waste differently than waste at the LQG. EPA has determined that using a different label would not improve management of the hazardous waste at either generator. Therefore, EPA has decided that labeling the VSQG's waste to be consolidated with the words "Hazardous Waste" (along with an indication of the hazards  -  see Section 5.1 for comments on the other labeling requirements) is sufficient under the consolidation provision. As explained in Section 5.1 of this EPA Response to comments document, we are not requiring all of the marking and labeling requirements that were originally proposed. Specifically, we are not requiring the hazardous waste code be added until later at the LQG prior to shipment off-site. EPA has determined that requiring more information be on the containers at the VSQG would be counter-productive since VSQGs currently do not have to label at all.
(c) EPA has determined that since the consolidation provision is limited to VSQGs consolidating at an LQG under the control of the same person, we do not have to limit who is allowed to transport the VSQG waste to the LQG and the uniform hazardous waste manifest is not required. The same person who has control over the VSQG and LQG under this consolidation provision could be liable for improper hazardous waste management, so the VSQG and LQG have strong incentives to ensure that the waste arrives safely to the LQG. Since VSQGs are not required to manifest or use a hazardous waste transporter under the current regulations, we were conscious about only adding requirements that were necessary under the new consolidation provisions because if the requirements were too burdensome, VSQGs would not use the consolidation provision. Furthermore, any applicable DOT requirements continue to apply.
(d) The commenter is confused about the parameters of the VSQG consolidation provision. The VSQG would only need to label their waste with the words "Hazardous Waste" for shipment to an LQG under the same control. The waste would not need to be manifested nor would it have to go by hazardous waste transporter. Any applicable DOT shipping requirements would continue to apply.
(e) Under the federal RCRA program, VSQGs do not have to obtain an EPA ID number. While some states require this, that is a more stringent requirement. EPA is not requiring VSQGs to obtain an EPA ID number to participate in the consolidation program. However, because this is a less stringent provision than the current federal program, states will have to adopt the consolidation provisions to be effective in a particular state and they have the option of being more stringent. Thus, a state could adopt the consolidation program and require VSQGs to obtain EPA ID numbers if they so wish.

Section 3.3.5 - Conditions for LQGs

Summary:
(a) Most commenters did not comment specifically on the LQG conditions for consolidating VSQG waste but a few were supportive of the conditions EPA proposed for the LQGs consolidating VSQG waste, including notification, recordkeeping, labeling, managing the incoming VSQG waste in compliance with its LQG status, and reporting the VSQG waste on its biennial report (134, 181, 217, 220). MPCA was specifically supportive of recordkeeping, labeling and managing the incoming VSQG waste in compliance with the requirements otherwise applicable to the LQG's own hazardous waste (232).
(b) Notification: Some commenters thought notification was not necessary and duplicative since the consolidation would be included on the LQG's biennial report or the information could be collected from the LQG's records that they are required to maintain on-site (73, 137, 213). One commenter urged EPA to make this a one-time notification or include the notification as part of re-notification or biennial reporting (88). Other commenters argued that the numerous conditions, including notification and recordkeeping by the LQG, were burdensome and would limit the use of this option or present challenges to the LQG (77, 127, 168, 212, 262). One state believes that having the LQG submit the Site ID form with the CESQG information would make compliance and enforcement unnecessarily difficult (189). A couple commenters expressed their opinion that the notification requirement would be extremely burdensome to comply with within 30 days, especially for remote field locations (213, 214, 216). ASTSWMO noted some individual state comments about the notification requirements, including that regulators would not be able to understand the complete picture because only LQGs are required to notify (217). One commenter asked for clarification about whether notification must be made exactly 30 days before the first shipment of CESQG waste to an LQG or at least 30 days before and whether that was 30 calendar or business days (220). MCPA strongly recommended EPA replace the proposed notification requirement with a non-self-implementing request for approval, such as MN's program. MCPA also recommended that EPA explicitly require the EPA identification number of the VSQG to be included in the records kept by the LQG (232). Another commenter asked for clarification on whether the notification requirement is an update or change of the LQG's form for the CESQG since the requirement seems to require a new CESQG number (240). Re-notification: EPA proposed that LQGs notify using an updated Site ID form 8700-12 within 30 days of a change in the site name, site address, or contact information for a VSQG sending their hazardous waste for consolidation at the LQG. However, some commenters said it was not necessary, particularly in the event of the contact information changing, noting the movement of personnel can occur more frequently than the site name or address changes (163, 182, 217).
(c) One state commenter suggested that if a LQG consolidates across state lines, they should be regulated to send a copy of their notification form to those state agencies in which the CESQG facilities are located (82, 217).
(d) One state commenter recommended that EPA include a clear provision that allows the accumulation time clock to start when the waste is received at the LQG site (174).Several commenters requested clarification on the accumulation start date and asked for confirmation that the generator would have 90 additional days to make new disposal arrangements (214, 217). One commenter, in requesting clarification, submitted that the LQG accumulation limits should apply to the CESQG waste on the date that it is received by the LQG (240). One state noted that the receiving LQG is directed to date the hazardous waste containers when they arrive but it is not clear whether they are to obscure the original accumulation start date (248).
(e) Two associations recommended that this provision requires notification of shipments. Without such notification, they argued that the material could be easily diverted and both first responders and the community at large would be vulnerable to the hazards associated with any diverted waste (132).
(f) ASTSWMO noted that one state thought the mixing of CESQG waste at an LQG could create a hazardous situation if the wastes are incompatible. This state suggested some level of minimum standards prior to waste acceptance and waste mixing at LQGs (217).
(g) One commenter requested confirmation that LQGs operating under the consolidation provision would also have to meet the applicable requirements in 40 CFR Part 263 (0284).
(h) One state noted that there is no explanation of what should happen if an LQG has to reject a load from a CESQG and suggests EPA add a provision for rejected loads (217).

EPA Response:
(a) EPA is finalizing the conditions that the LQG must comply with under the VSQG-LQG consolidation provision basically as proposed and thanks the commenters for their support.
(b) Notification. The Agency has determined notification is necessary in order to communicate to state regulatory agencies and inspectors the origin of the hazardous waste received by the LQG and to ensure the received shipment is managed in compliance with the conditions of the provision. EPA also believes notification by the LQG, rather than notification by the VSQG, is more efficient and less burdensome, because LQGs are already required to submit Site ID forms as part of obtaining a RCRA Identification Number and as part of the biennial reporting process. Additionally, it is more efficient for one LQG to notify on behalf of numerous VSQGs. EPA has clarified that the original notification must be submitted at least 30 days before the LQG receives the first shipment from their VSQG and notes that is calendar days. EPA notes that the information required at the federal level is the VSQG's name, site address, and a contact person. EPA does not require VSQGs to get EPA identification numbers so that is not required at the federal level. EPA disagrees with MPCA's suggestion of requiring state agency approval instead of notification because we limited the consolidation provision to VSQGs and LQGs under the control of the same person. Re-notification: EPA agrees that if the site name and address of the VSQG remains the same and only the contact person's information changes, it is not necessary for the LQG to notify again simply because the contact information for the VSQG changes and we have made that clear in the final regulatory language. Due to the fact that the VSQG consolidation provision is limited to facilities under the control of the same person, the LQG would likely have knowledge of any change in contact information and could provide that to the implementing agencies if necessary.
Recordkeeping. EPA also has determined that recordkeeping is necessary to ensure the VSQG and LQGs operating under the consolidation provision are meeting the conditions of the provision, including the condition that the VSQG and LQG are under control of the same person. Records can also be used to ensure that the hazardous waste from the VSQG is managed according to the other conditions for exemption of this provision, such as the requirement that LQGs are receiving shipments of hazardous waste from VSQGs in quantities commensurate with the VSQG's generator category. This recordkeeping condition can be fulfilled through routine business records, such as a bill of lading, and will not present an undue burden to the LQG. Additionally, the LQG can then use this information to report the hazardous waste from the VSQG on its biennial report forms.
(c) EPA is not requiring at the federal level that an LQG supply its notification to each state where the VSQGs are located but a state can be more stringent when it adopts the consolidation provision.
(d) To be clear on the accumulation start date, EPA has included this regulatory language: "If the LQG is consolidating incoming hazardous waste from a VSQG with either its own hazardous waste or with hazardous waste from another VSQG, the LQG must mark each container with the earliest date any hazardous waste in the container was accumulated on site." This will prevent an LQG from starting the accumulation clock over again, which could lead to an endless loop of accumulation. Furthermore, EPA does not require accumulation start dates at VSQGs so we are not requiring original accumulation dates to be obscured but it should be clear the date the accumulation starts at the LQG.
(e) We are not requiring notification of every shipment from the VSQG to the LQG but instead are requiring the LQG maintain records of shipments for 3 years. These records would need to be accessible to inspectors visiting the LQG.
(f) EPA is not expressly prohibiting mixtures of VSQG waste at LQGs but notes there are regulatory consequences of mixing the waste as explained in § 262.13. Because the VSQG and the LQG are under the control of the same person, there are strong incentives to handle the waste properly and EPA does not expect there to be issues with the LQG mixing incompatibles. If there is a question, the LQG can contact the VSQG.
(g) EPA confirms that LQGs that operate under the consolidation provisions will have to also comply with the applicable requirements of 40 CFR Part 263 if they act as the transporter that is sending the hazardous waste off-site to a RCRA designated facility. However, if the LQG is acting as the transporter by picking up the VSQG waste for consolidation, they would not have to comply with 40 CFR 263 for shipments between the VSQG and the LQG. With respect to the LQG's on-site management of all hazardous waste received from the VSQG, the LQG must comply with the LQG conditions for exemption in §262.17.
(h) Because the consolidation provision is limited to VSQGs and LQGs under the control of the same person and because the shipments do not require a federal hazardous waste manifest, EPA does not believe there needs to be a procedure for rejected loads. The VSQG and LQG can work together to determine the best means of handling any waste that the LQG can't take.

Section 3.3.6 - Biennial reporting for consolidation

Summary:
(a) Several commenters agreed that the LQG should be required to report the hazardous waste received from off-site CESQGs on their biennial report (BR) (125, 189, 232). The RCRAInfo Site ID expert group and Idaho made the following suggestions: a new source code be added that LQGs would use to identify this waste on the Generation and Management (GM) form and the generation quantity should be reported as 0 on the GM form since the waste was not generated at the LQG (125, 189). MCPA requested EPA consider requiring the BR be submitted in duplicate to the authorized state if the state so desires (232).

EPA Response:
(a) Biennial Reporting. EPA has decided that generators will be required to report on the biennial report hazardous waste they receive from VSQGs by type of hazardous waste. In other words, if an LQG receives the same type of hazardous waste from multiple VSQGs, it only need report the total quantity of that hazardous waste received from all VSQGs. Biennial reporting will enable states and EPA to better understand the additional volumes and types of hazardous wastes managed at an LQG, which will assist in prioritizing compliance assistance. EPA will take the comments of the RCRAInfo Site ID expert group and the states under advisement when it revises the BR instructions to account for the new consolidation provision. If a state wants to require the BR be submitted to them in addition to EPA, they would need to make that a requirement when they adopt the VSQG consolidation provision.

Section 3.3.7 - No limit on waste received from CESQGs

Summary:
(a) Two commenters specifically supported the concept that there would be no maximum limit on the amount of hazardous waste received by an LQG from its CESQG facilities. One commenter said that in most instances the amount of hazardous waste would be small (88). MCPA supports the proposed absence of a maximum limit on the amount of hazardous waste the LQG may collectively receive from a VSQG but noted that the maximum amount a facility could receive from an individual VSQG in a calendar year is 1200 kg/year due to the VSQG monthly accumulation limit. MCPA thinks it is important for EPA to explicitly state this limit as some generators might mistakenly think that once they have transferred their hazardous waste to an LQG, they themselves no longer have to count it towards their generator status (232).

EPA Response:
(a) Because LQGs currently have no maximum limit on the amount of hazardous waste they can accumulate, and because the regulations that are applicable to LQGs are protective, the Agency has determined there is no need to establish a maximum limit on the amount or types of hazardous waste that an LQG can receive from VSQGs. In fact, we believe the more hazardous waste that is shipped to LQGs, the greater potential for better management, since these hazardous wastes will be managed under the more comprehensive hazardous waste regulations, as opposed to potentially being sent to non-hazardous waste disposal facilities. In addition, the LQG will need to move the VSQG waste off site in a timely manner since the 90-day accumulation limit for the exemption from permitting will still apply. EPA also notes that the VSQG still must count the waste it generates at its site to determine its generator category in accordance with 40 CFR 262.13. Transferring their waste for consolidation at an LQG under the control of the same person does not effect this requirement.

Section 3.3.8 - Enforceability of consolidation provision

Summary:
(a) One commenter stated that if a typical LQG accepted CESQG waste during a month that it determined it was an SQG, it should not be subject to an enforcement action. This commenter suggested this could be handled by allowing the receiving facility to be either an LQG or SQG (146). MCPA supports EPA statements regarding the enforceability of the consolidation provision but notes that requiring state or EPA Region-specific approval would provide a partial mechanism to address EPA's concern regarding liability of VSQGs sending hazardous waste to a non-compliant LQG. MCPA believes that by requiring the VSQG to make sure the receiving facility has been approved by the state, the VSQG is performing some due diligence on the receiving facility and becoming knowledgeable about its general compliance history (232).

EPA Response:
(a) In terms of an enforcement action related to the VSQG-LQG consolidation provisions, EPA agrees that there shouldn't be an issue if the LQG continues to operate as an LQG and manage the VSQG waste received under the conditions for exemption in §262.17. As noted above, EPA has determined at this time to limit the consolidation provision to VSQGs sending their waste to an LQG under the control of the same person. States can be more stringent in how they implement the program and can add a state approval requirement if they see fit.

Section 3.3.9 - Interstate shipments

Summary:
(a) One commenter stated that VSQG hazardous waste from states with more stringent programs should be allowed to be sent to a consolidator LQG, as long as the waste complied with the VSQG state requirements while in that state's boundaries. This commenter stated that EPA should specify that more restrictive states cannot prevent VSQGs from using consolidator facilities in other states that have adopted those provisions because this in effect constitutes "interstate commerce" and thus the federal rules should take precedence over any state rule (107).Several commenters stated that EPA was incorrect in stating that transit states could impose more stringent requirements on CESQG waste being transported through their state and asked EPA to clarify that transit states cannot impose requirements on CESQG waste merely passing through their state for consolidation at an LQG facility (168, 188, 232). On the other hand, one state agreed that CESQGs who elect to transport waste to an LQG under the control of the same person would need to coordinate when the waste is transported either through or to another state. This state noted that one simplified approach, albeit more restrictive, would be to limit CESQG consolidation to LQGs within the same state (217). Other commenters noted that consolidation could occur across state lines and if states have differing requirements for VSQGs, it can be very confusing and challenging to comply with state regulations. These commenters asked EPA to clarify and address these issues (127, 132). The American Trucking Association recommended that states self-identify whether they adopt EPA regulations to allow shipments between VSQGs and LQGs so the information is readily accessible to generators and shippers (283).
(b) Some commenters noted that these materials need to safely and securely managed, especially during transport and that proper EPA Response to accidents could be a concern if seasonal or temporary workers put containers in private vehicles for transport to a consolidation location (127, 132). One commenter also noted that this could lead to diversion for illicit purposes (127).

EPA Response:
(a) Under the RCRA program, authorized states can be more stringent than federal regulations and are not required to adopt federal regulations that would be considered less stringent than current federal regulations. The consolidation provision being finalized today offers more flexibility to VSQGs and LQGs than under current federal regulations and would be considered a less stringent rule. Thus, some states may choose not to adopt this regulation. The result is that the VSQG/LQG consolidation provision can only work for those VSQGs and LQGs that are located in the same state or in different states that all have adopted this regulation. We do not have a basis under RCRA to require states to adopt a new federal regulation that is less stringent than the current federal regulation because states may always choose to have more stringent regulations than the federal regulations. Moreover, this scenario presents a common issue that arises in the RCRA program where authorized states do not all regulate the same hazardous waste in the same manner even if the waste may be transported as "interstate commerce" through multiple states. The fact that interstate waste shipments may constitute interstate commerce is not a basis by which EPA could require all states to adopt a new federal regulation that is less stringent than the current federal regulation. Regulated entities have often had to comply with different regulations in different states for interstate shipments as a result of RCRA's authorized state program system. In addition, as part of EPA's implementation of today's final rule, we plan to make resources and tools available on our website to the public including a map that tracks state adoption of the new provisions.
(b) As noted above, because EPA has limited the VSQG consolidation provision to VSQGs and LQGs under the control of the same person, EPA has determined that the facilities will have strong incentives to ensure the proper handling and transport of the VSQG waste to the LQG. The LQG is required to maintain records of the shipments for 3 years. EPA has determined these requirements are sufficient for environmental protection without being too much of a regulatory burden that would discourage use of the consolidation provision.

Section 3.4 - Biennial report for recyclers who do not store

Biennial report for recyclers who do not store

The Agency proposed that owners or operators of facilities that recycle hazardous waste without storing them before they are recycled submit a biennial report. From experience with the RCRA program, the Agency is aware of situations where a recycling facility that does not store prior to recycling, or that received manifested hazardous waste but had a subsequent exemption, may not always submit a biennial report. Hence, both EPA and the states have an incomplete understanding of what may be occurring with the management of hazardous wastes.
Most commenters supported EPA's proposal (0085, 0125, 0134, 0174, 0178, 0181, 0185, 0206, 0217, 0229). Several stated that requiring submittal of this information would close an important information gap and provide additional information on recycling than they currently have, which is mainly just the recycling at permitted commercial TSDs. One commenter mentioned that having such information reported by the facility may serve useful in some contexts where a generator in their state has sent recyclable materials to an out-of-state facility (0174). Another commenter stated, "Collecting this information would give a better overall picture of the amount and type of waste recycled, as well as allowing oversight of these activities. It is important for States to know where these types of facilities are and how much wastes they manage." (0217)

Response: The Agency agrees with the reasons provided by those commenters that support the proposed change to the regulations.

A few commenters (0219, 0240, 0263) were against the proposed change. For example, one commenter stated, "Based on the Biennial Report Instructions, the generator already is required to report on all such hazardous waste it sends off-site to a recycler that does not store it prior to recycling. Form GM of the Biennial Report Instructions indicate that although "waste recycled, without prior storage, only in an on-site process subject to regulation under 40 CFR §261.6(c)(2)" is not required to be reported on the biennial report, there is no exception from reporting the amount of such recyclable hazardous waste when it is sent off-site. Because the generator will report the amount of recyclable hazardous waste it sends off-site to a recycling facility that does not store it, EPA should have the information it claims it needs. Thus, we do not see a need for requiring the recycling facility to report on the hazardous waste it receives in a biennial report, and requiring such reporting could lead to redundant accounting." (0219)

Response: The Agency believes that this proposed change is important and necessary. The generator may not know whether the receiving facility is storing or not storing its hazardous wastes prior to recycling. Similarly, many generators send their recyclable wastes first to a transfer or consolidation facility and then to a recycling facility. In such cases, the Agency is unable to use the generator's' GM form to identify the recycling facility. Therefore, without requiring this information directly from the recycling facility, states and the Agency have an incomplete understanding of what the receiving facility is doing, including how much hazardous wastes of different types are being recycled.

Similarly, one commenter saw no benefit to the environment of this added paperwork requirement with the associated opportunity for another possible TSD-mandate noncompliance (late or missed reports), particularly when biennial reports are only required by LQGs at present. (0263)
Response: The Agency disagrees with this commenter. First, recycling facilities that store prior to recycling are already required to submit a biennial report. Second, for oversight purposes, the Agency and states need to understand the scope and magnitude of recycling nationally. The Agency sees no reason why a facility that does not store prior to recycling hazardous waste should not have to submit a biennial report, particularly if this facility is receiving large amounts of hazardous waste. Third, the Agency believes the values and benefits of an affected facility completing a biennial report exceeds the costs of completion. Otherwise, the Agency would not have proposed this change.

A few commenters were unclear about the scope of reporting and what types of facilities had to submit a biennial report (0240, 0217). They commented that:
The proposed RCRA Improvement Rule would appear to require facilities that recycle hazardous waste without accumulating or storing it to submit biennial reports under 40 C.F.R. §265.75. EPA reasons that since these facilities receive hazardous waste using a hazardous waste transporter and hazardous waste manifest they should be treated no differently than a permitted TSDF with interim status. Although we are not absolutely sure what type of facility is intended to be affected by this requirement (and would appreciate more clarification on this topic), if the requirement is meant to apply to a re-claimer or recycler of used solvent under the conditional exception to definition of solid waste rule, 80 Fed. Reg. 1694 (Jan. 13, 2015) or to used solvent wipes, 78 Fed. Reg. 46448(July 31, 2015), it may affect some of FPA's members. A facility that is reclaiming spent solvent under the conditional exclusion for certain types of solid wastes from other facilities under common control is not "managing or treating a hazardous waste" for disposal, and therefore this situation is not analogous to a TSDF."
Therefore, one of the commenters objects to the inclusion of such activities in biennial reports or filing reports solely to cover such activities because it sees little or no benefit from the requirement  -  just another potential for a recordkeeping violation. (0240)
Response: To clarify, this requirement is not applicable to a re-claimer or recycler of used solvent under the conditional exception to definition of solid waste rule.

Another commenter asked whether this requirement would apply to those facilities that have on-site distillation units that recycle their own spent solvents daily without storing it?(0217)
Response: This requirement is not applicable to generators that have on-site distillation units that recycle their own spent solvents daily without storing it.

Another commenter recommended that EPA revise this proposal to separately require facilities that recycle hazardous waste without storing it to first obtain an EPA ID# from their authorized state or EPA, as applicable, and then subsequently to complete and submit the Biennial Report. (0229)
Response: EPA does not agree with this recommendation because current regulations already require receiving facilities accepting manifested hazardous wastes to have a RCRA ID. If not, they are out of compliance with RCRA regulations and so are the transporters who cannot deliver regulated hazardous wastes without the facility having a RCRA ID.

One commenter mentioned that if the proposed rule is finalized, significant changes would be required by EPA including the Biennial Report instructions and forms (adding codes) and the RCRAInfo database. There are also changes the States would have to make including State-specific instructions and forms as well as State hazardous waste databases. (0217)

Response: The Agency will update Biennial Report instructions and forms and the RCRAInfo database as a result of this rule.

Two commenters (0214 and 0276) sought clarification to this proposed revision.
One sought clarification about how recycling facilities that receive waste from CESQGs must report. Some CESQGs use manifests, while others use bills of lading to ship hazardous waste. (0214)
Response: VSQGs (formerly called CESQGs) are allowed to send their hazardous wastes to a RCRA permitted recycling facility or to a recycling facility under an authorized state program without having to manifest its hazardous wastes. (See 40 CFR 261.5 (g)(3) under the former regulations and 40 CFR 262.14 (a)(5) under the new regulations.) States also may be more stringent and require CESQGs to use a hazardous waste manifest when shipping their hazardous wastes to either a RCRA permitted recycling facility or to a recycling facility under an authorized state program. Under the existing and new rules, recycling facilities receiving either manifested hazardous wastes (as in the case of SQGs and LQGs) or non-manifested hazardous wastes in the case of VSQGs are required to complete and submit a biennial report. These rules apply to recycling facilities that store or do not store prior to recycling.

Another commenter sought clarification on the following:
On p 57993 at 262.13(c)(3) the term "prior storage" is used in the "on-site" recycling context. ("...is recycled without prior storage...") Typically this has always meant storage/accumulation of any length of time prior to recycling. But that is at odds with what EPA considers as "prior storage" in situations where off-site recycling is to take place. For example, RO 11365 suggests a few hours of storage may not constitute "prior storage," and RO 11411 indicates that some EPA regions allow 24 hours. [FOOTNOTE 29 ATTACHES HERE] Should not the on-site storage for a few hours of a hazardous waste prior to on-site recycling also not constitute "prior storage?" It is noted that, unlike on-site recyclers, off-site recyclers need to obtain a TSD permit for "prior storage", but this should not be the basis for allowing off-site recyclers to have a different measure of what constitutes "prior storage" than on-site recyclers. This is important when using the proposed 262.13(c) to determine whether a waste destined to be recycled on-site needs to nevertheless be counted for purposes of determining generator category. (0276)
Response: The commenter raises good points. As seen by the two RCRA Online documents identified above, the Agency has no definitive set time as to what constitutes "prior storage" prior to recycling and has deferred this issue to the regions and states as being a site-specific decision. However, rules already exist for on-site recycling. SQGs and LQGs have either 180 days or 90 days to recycle on-site the hazardous wastes they generate consistent with the 180 day and 90 day waste accumulation provision. Otherwise, the generator may be operating without a permit. Similarly, rules already exist for what to count regarding the on-site reclamation of a regulated hazardous wastes; i.e., count once per year for same wastes.

Section 3.5 - Miscellaneous part 261 comments

Comment: One commenter stated that the revision to 40 CFR 261.33(e), while logical in the context of elimination of the reference to §261.5 (which is being repealed), ignores other changes made to the tables in sections (e) and (f) since original promulgation. Specifically, the wording of the introductory paragraphs are left to state that each waste is assigned the acute hazardous waste (H) identifier (in the case of §261.33(e)) or the toxic waste (T) identifier (in the case of §261.33(f)). The proposed rule appears to delete the existing "Comment" and the text "These wastes and their corresponding EPA Hazardous Waste Numbers are:", both of which are critical to use and interpretation of these listings. Please clarify that the changes proposed are only to the first paragraph of the introductory text of paragraphs (e) and (f). (0078)
One commenter referenced 261.33(e) introductory paragraph and asked if EPA intended to remove the comment and "These wastes and their corresponding EPA Hazardous Waste Numbers are:" (0082)

One commenter referenced 261.33(f) introductory paragraph and asked if EPA intended to remove "unless otherwise designated" (it appears that some wastes in the table are otherwise designated), the comment, and "These wastes and their corresponding EPA Hazardous Waste Numbers are:" (0082)
One commenter referenced 261.33(e) & (f) and asked if comment/notes in 40 CFR still provided? Toxic only if no lettering otherwise (T), (R), (I), (C) combinations. Are the 261.33(f) listings now all (T)? Or is acetone now listed for toxicity in addition to ignitability? Used acetone would be expected to be more toxic than unused acetone, so why is there no corresponding change to the F003 listings? (0214)

EPA Response: EPA is not deleting the comment or the introductory language to the tables containing the P-lists and the U-lists as part of this change. The 5 asterisks (* * * * * ) in the proposed regulatory text indicate that the remainder of the section of regulatory text is to be left unchanged. Thanks to comments, EPA did determine that it accidentally proposed to delete the words "unless otherwise designated" from the language of 261.33(f) and is restoring them in the final rule.

Comment: 261.1(a)(1) You missed a conforming change here to remove "establishes special management requirements for hazardous waste produced by conditionally exempt small quantity generators and" from the description of contents of part 261 subpart A. (0082)
EPA Response: Thank you for your comment. EPA is correcting this oversight in the final rule.

Section 4 - Revisions to Existing Part 262

Comment: One commenter stated that the new requirements for CESQGs, SQGs, and LQGs in sections 262.14 through 262.17 add labeling, reporting, and recordkeeping requirements that broaden the specificity of requirements and require full compliance to be classified a generator, thereby adding more ways that a generator could find itself subject to TSD requirements. The commenter stated that the reporting and recordkeeping requirements should remain focused only on LQGs, since they generate the most hazardous waste. The commenter stated that EPA should withdraw all of the added recordkeeping requirements and withdraw the applicability of TSD regulations in the case of noncompliant generators. (0263)
EPA Response: In this final rule EPA is not adding more ways that a generator could find itself subject to TSD requirements. The standards in section 262.34 (being replaced) are all conditions for exemption from permitting under the long-standing generator program regulations and the bulk of the conditions found in the new §§ 262.14 - 17 are simply reorganized from §§ 261.5 and 262.34. These requirements include some labeling, reporting, and recordkeeping requirements. EPA disagrees with the commenter's suggestion and is finalizing the framework for the generator regulations mostly as proposed.

Section 4.1 - Revisions to Purpose, Scope, and Applicability (262.1 and 262.10)

(a) Comment: One commenter stated that EPA add the following language to 262.1 or to the definition of VSQG in 260.10: "A generator that meets the requirements of §262.14 for VSQGs is exempt from all applicable independent requirements for other waste generator categories (i.e., SQG and LQG) regardless of the monthly quantity of waste generated." (0165)
(a) EPA Response: EPA does not agree with the commenter's suggestion. The commenter suggests that a VSQG would be exempt from independent requirements for other generator categories regardless of the monthly quantity of waste generated, but the generator's category is defined by how much waste is generated in a month so that factor cannot be removed from the determination of which category the generator belongs to (and which independent requirements must be followed).
(b) Comment: One commenter recommended that EPA clarify the text in 262.10(a)(3) to refer to "hazardous wastes" rather than "wastes" to be more precise about the applicability of the provision. (0174)
(b) EPA Response: EPA agrees with this comment and is making this revision in the final rule.
(c) Comment: Some commenters stated that they support the clarification provided by sections 262.1 and 262.10. (0178, 0248)
(c) EPA Response: EPA agrees with the commenters that these sections are useful and is finalizing them with some changes for further clarity and precision.
(d) Comment: Commenters stated that they support the proposed new section 262.10(a)(3) that specifically prohibits generators from sending hazardous waste to facilities that aren't "designated facilities." (0085, 0178, 0185, 0217, 0229) Commenters stated that it fills an important gap in the RCRA regulations by stating this clearly and improves the ability of authorized states to enforce this provision. (0178, 0217, 0229)
(d) EPA Response: EPA agrees with the commenters and in finalizing § 262.10(a)(3) as proposed.
(e) Comment: One commenter stated that they are not clear about the meaning and significance of the word "unless" in proposed section 262.10(a)(1). (0178)
(e) EPA Response: In response to comment on this section, EPA has revised it in the final rule, removing the word "unless" and other confusing wording.
(f) Comment: One commenter stated that section 262.10(g)(1) uses the term "applicable requirement" twice and asked if it should be "independent requirement" instead. (0178)
(f) EPA Response: EPA has revised this paragraph in the final rule and part of the revisions include replacing "applicable requirement" with "independent requirement."
(g) Comment: One commenter found proposed 262.10(g)(2) to be confusing and did not understand the regulatory effect of the section, but was concerned that it would restrict the enforcement options available to authorized states at generators of hazardous waste. (0178)
Some commenters expressed concern about the changes to section 262.10, particularly the language in proposed sections 262.10(a)(1) and (2) and section 262.10(g)(2) with regard to limiting the enforcement options for authorized states because EPA explicitly states that these facilities would be "a facility that stores hazardous waste." (0178, 0196, 0281) Commenters were concerned that this language would preclude the use of informal actions for minor violations of conditions for exemption and may have to cite the generator for a violation of operating a hazardous waste storage facility without a permit, which may not be appropriate to the severity of the actual violation. Commenters also stated that the regulations should be written reflect the generation of hazardous waste as the norm and stated that the exemptions and conditions apply not to generators, but to collectors and treaters. Commenters also were concerned that the regulations could conflict with state waste violation classification schemes. (0178, 0196, 0281)
Some commenters stated that the proposal is draconian in its approach to the classification of independent requirements and conditions for exemption and that it is an attempt to dictate enforcement policy through a rulemaking. The commenters added that the rule mandates an enforcement result that even the most aggressive enforcement official likely would not take in most circumstances. (0219)
(g) EPA Response: EPA has revised § 260.10(g) in the final rule to be more clear and to state in a more straightforward manner what the plain meaning of the section is  -  that is, that because the conditions for exemption in part 262 are part of exemptions, noncompliance with the conditions means that the facility loses the exemption. Any violations would then be considered violations of the permit, interim status, and operations requirements in parts 124, 264 through 267, 270, and in section 3010 of RCRA instead.
EPA does not consider these revisions to the regulatory language to be a change to the RCRA generator program because the regulations that were previously in §262.34 and the provisions for VSQGs in 261.5 were always conditions for exemption from storage facility permit, interim status, and operating requirements and have always worked in the same way that we explain in the proposal and final rule. For violations of generator regulations, regulatory agencies retain full enforcement discretion authority to determine whether an enforcement action is warranted in response to any given finding during an inspection and if so, what enforcement tools, including notices of violation, civil and criminal complaints, penalties and injunctive relief, are appropriate to address the detected violations. The revisions to the regulatory text in this rule do not mandate that regulatory agencies pursue enforcement actions when the previously would have exercised enforcement discretion and do not mandate the charging and penalization of every violation of regulatory requirements that legally may result when a generator loses its exemption if that action would be disproportionate to the seriousness of the generator's violations.

Section 4.1.1 - Defining and listing independent requirements and conditions of exemption

(a) Comment: Some commenters agreed with the proposal to define "independent requirement" and "condition for exemption." (0085, 0127, 0134, 0145, 0159, 0178, 0185, 0217, 0223, 0248, 0257) Commenters stated that they agree that this is how the generator regulations are organized and that this change will be a great help by explaining which requirements are independent requirements and which are conditions and improve compliance. (0223, 0257)
(a) EPA Response: EPA agrees with the commenters and is including these definitions in the final rule.
(b) Comment: One commenter agreed with the concept of defining these terms but thought that the proposed definitions were confusing and legalistic and suggested EPA use language that would be more understandable to the average generator. (0134) Some commenters stated that the definitions and the proposed new language in 262.10(g) is confusing. (0154, 0160, 0174, 0217, 0224, 0232)
(b) EPA Response: EPA has not made significant changes in the final rule to the definitions in the proposed rule as they succinctly and accurately describe the difference between independent requirements and conditions for exemption where a more narrative approach would be less succinct. However, EPA has made an effort to explain more clearly in the preamble to the final rule what the significance is of the definitions and how they operate within the generator framework. EPA has made revisions to the language in §262.10(g), most notably § 262.10(g)(2) to clarify what it is saying about noncompliance with conditions for exemption as compared to independent requirements. EPA's revised language reduces references to other parts of the regulations and uses plainer English to describe how noncompliance with conditions for exemption is viewed by the Agency.
(c) Comment: One commenter stated that the definitions of "independent requirement" and "condition for exemption" should be in § 260.10 rather than § 262.1. (0217)
(c) EPA Response: EPA disagrees with this comment and is finalizing these definitions in § 262.1. The definitions refer to terms that are specific to the generator regulations in part 262 and are only applicable in part 262 and therefore are best defined in that part, closest to the regulatory text that uses them.
(d) Comment: Some commenters agreed with the proposal to state explicitly that all generators must comply with independent requirements and generators that accumulate hazardous waste must comply with conditions for exemption. (0085)
Some commenters agreed with EPA's proposal to revise section 262.10(g) to make clear the regulatory consequences of not complying with the generator regulations, stating it is useful. (0134, 0185, 0248)
One commenter agreed with EPA's changes to make the framework more clear to generators as long as no substantive modifications are made to actual requirements, limits, and exemptions imposed upon and afforded to VSQGs. (0253)
(d) EPA Response: EPA agrees with the commenters and is finalizing these pieces of the proposal in the final rule, with some changes, notably to § 262.10(g)(2), to further clarify the information in that sections regarding consequences of noncompliance with conditions for exemption. EPA also agrees that the changes made to the regulatory text in this section do not represent a change to the RCRA program, but merely clarify how that program works in the regulations themselves.
(e) Comment: One commenter stated that the introduction of the terms "independent requirement" and "condition for exemption" is unlikely to enhance understanding of the requirements. (0078, 0174, 0217) A commenter stated that the distinction between these types of requirements is already transparent to the regulated community. (0078)
(e) EPA Response: EPA disagrees with the commenters and has determined that a significant number of generators will gain understanding about how the generator rules are designed and the difference between independent requirements and conditions for exemption by including them in the regulations, as we proposed. Together with the descriptions of the program in the preamble, EPA believes these changes will inform generators more fully of their responsibilities and clear up confusion on this topic that regulated entities have expressed to EPA during the implementation of the program. EPA believes that generators should be aware of the legal consequences of noncompliance, which is what the addition of the definitions and the revisions to § 262.10(g) accomplish.
(f) Comment: Some commenters opposed the proposal or expressed concern about the changes to section 262.10, particularly the language in proposed sections 262.10(a)(1) and (2) and section 262.10(g)(2) with regard to limiting the enforcement options for authorized states because EPA explicitly states that these facilities would be "a facility that stores hazardous waste." (0116, 0178, 0196, 0217, 0232, 0281) Commenters thought that violations of generator conditions should only result in violations of the next higher level of generator status, not violations of TSDF standards and that the choice of whether to charge those violations be up to the enforcement officials for each case. (0113, 0131, 0219) Commenters were concerned that this language would preclude the use of informal actions for minor violations of conditions for exemption and may have to cite the generator for a violation of operating a hazardous waste storage facility without a permit, which may not be appropriate to the severity of the actual violation, instead of having the choice to do so. Commenters noted that the new language may be seen as draconian by third parties and misinterpreted. Commenters also stated that the regulations should be written reflect the generation of hazardous waste as the norm and stated that the exemptions and conditions apply not to generators, but to collectors and treaters. Commenters also were concerned that the regulations could conflict with state waste violation classification schemes. (0116, 0178, 0196, 0217, 0232, 0281) One commenter stated the concern that this framework would lead to generators drawing the conclusion that complying with a condition for exemption is more important than complying with an independent requirement, when the independent requirements are critical components of the program. (0232)
Some commenters stated that this approach calls into question the important ability of the implementing agency to focus appropriate enforcement based on an understanding of a facility's history. (0128, 0129, 0131, 0188, 0219, 0225, 0263) Some commenters stated that the proposal is draconian in its approach to the classification of independent requirements and conditions for exemption and that it is an attempt to dictate enforcement policy through a rulemaking. The commenters added that the rule mandates an enforcement result that even the most aggressive enforcement official likely would not take in most circumstances and that EPA does not in its proposal discuss using prosecutorial discretion in making penalties that are proportional to noncompliance. (0113, 0168, 0219, 0260) Some commenters stated that state enforcement officials do not need this new regulatory language as they do a good job enforcing the regulations. (0160)
(f) EPA Response: EPA has revised § 260.10(g) in the final rule to be more clear and to state in a more straightforward manner what the plain meaning of the section is  -  that is, that because the conditions for exemption in part 262 are part of exemptions, noncompliance with the conditions means that the facility loses the exemption. Any violations would then be considered violations of the permit, interim status, and operations requirements in parts 124, 264 through 267, 270, and in section 3010 of RCRA instead.
EPA does not consider these revisions to the regulatory language to be a change to the RCRA generator program because the regulations that were previously in §262.34 and the provisions for VSQGs in 261.5 were always conditions for exemption from storage facility permit, interim status, and operating requirements and have always worked in the same way that we explain in the proposal and final rule -- the standards in former § 262.34 have always been conditions for exemption that apply to generators and it would not be appropriate to alter the structure of the regulations to make these just apply to collectors and treaters. For violations of generator regulations retain full enforcement discretion authority to determine whether an enforcement action is warranted in response to any given finding during an inspection and if so, what enforcement tools, including notices of violation, civil and criminal complaints, penalties and injunctive relief, are appropriate to address the detected violations. The revisions to the regulatory text in this rule do not mandate that regulatory agencies pursue enforcement actions when the previously would have exercised enforcement discretion and do not mandate the charging and penalization of every violation of regulatory requirements that legally may result when a generator loses its exemption if that action would be disproportionate to the seriousness of the generator's violations.
Regarding how the revised language is seen, EPA has addressed this concern by emphasizing in the preamble to the rulemaking the point that regulatory agencies retain full enforcement discretion in taking enforcement actions. EPA does not think generators would be reasonable to infer that the independent requirements are less important than conditions for exemption because, as the commenter stated, they are a critical piece of the generator regulations. The distinction between the types of requirement illustrates not importance, but simply the legal consequences and mechanism in the case of noncompliance. EPA has heard in the comments from some states implementing the RCRA program that this is how they view the operation of the regulations and that having the regulations more clearly laid out will be helpful in implementation of the regulation and communication with generators. Some states may need to adjust their practices to account for the revisions to the language of the generator regulations, but the added descriptions in the preamble about enforcement discretion remaining unchanged were partially a result of comments from states concerned about whether EPA was intending to limit that discretion, which EPA is not.
(g) Comment: Some commenters opposed the revisions to section 262.10, including the distinction between "independent requirements" and "conditions for exemption" and the edits to 262.10(g), stating that the changes would fundamentally shift the focus of enforcement against hazardous waste generators and would make it so enforcement officials would be forced to bring an enforcement action for an unpermitted TSDF against a generator for relatively minor violations of conditions for exemption. Commenters argued that all standards should be independent requirements. (0077, 0087, 0113, 0120, 0128, 0129, 0131, 0168, 0188, 0192, 0219, 0220, 0224, 0225, 0240, 0262) Some commenters stated that the need for these provisions has not been proven and that the cumulative burden is unacceptable. (0131) Some commenters stated that these revised regulations are confusing. (0188) The commenters stated that this is disproportionate considering the potential violations and that it would lead to an excessive number of violations and unreasonable penalties, resulting in high risk and uncertainty for the generators. (0077, 0087, 0113, 0126, 0129, 0154, 0192, 0200, 0212, 0219, 0224, 0225, 0260, 0262, 0263) Commenters added that generators are attempting to comply with the standards in part 262 and are easily distinguishable from unpermitted TSDFs. Commenters argued that EPA could always enforce against flagrant non-compliers as TSDFs and that adding language will mandate stricter enforcement and some commenters suggested that EPA modify the language in 262.10(g) to state that noncompliance may lead to failure to maintain the exemption. (0077, 0128, 0212) Commenters stated that this set up of the regulations may mean that a VSQG violating the labeling requirement in the consolidation provisions or an SQG violating a condition would have to then comply with all the regulations for a TSDF or be subject to fines for violating each one or even comply with the next highest generator category, both of which would have high costs associated with them and asked if this was EPA's intention. (0113, 0120, 0128, 0131, 0154, 0168, 0192, 0200, 0212, 0219, 0220, 0224, 0225, 0233, 0240, 0260, 0262) One commenter stated that EPA seems to go out of its way in the proposal to point out that any violation could lead to a generator being an unlicensed TSDF, which could be devastating to the retail sector. (0232) Commenters stated that the proposed framework does not acknowledge the differences in risks present at different facilities and clashes with basic fairness. (0200, 0240) One commenter stated that the mere possibility of penalties that bear no relation to potential noncompliance could discourage investment in ventures that generate hazardous waste or make landlords reluctant to rent to such ventures. (0168) Some commenters stated that EPA's approach in this rulemaking to independent requirements and conditions for exemption is unlawful and contravenes the authorizing statute, Congressional intent, and the Constitution under the Due Process and Excessive Fines Clauses. Commenters stated that the RCRA statute makes it clear that permitting was never meant to apply to generators by distinguishing between standards for each in section 6922 and 6924. Commenters argued that the proposal violates the Due Process and Excessive Fines Clauses because there is little doubt that the penalties or other consequences of violation of a condition would be viewed as "grossly disproportionate to the gravity of a defendant's offense" for many of the conditions, which the Supreme Court stated was not allowed per U.S. v. Bajakajian, 524 U.S. 321, 334 (1998). (0168, 0192, 0200, 0219, 0260, 0262) Some commenters suggested that this frame work would result in noncompliant generators having to apply for TSDF permits as a result of their violations, which would be a lengthy and inappropriate process for generators. (0260)
Some commenters stated that the result of these changes would be to give EPA and the states huge and unfair leverage to settle violations of the generator requirements involving higher penalties than the gravity or economic benefit of the violation would justify. (0192)
(g) EPA Response: As stated above, EPA does not consider these revisions to the regulatory language to be a change to the RCRA generator program because the regulations that were previously in §262.34 and the provisions for VSQGs in 261.5 were always conditions for exemption from storage facility permit, interim status, and operating requirements and have always worked in the same way that we explain in the proposal and final rule. There is no increase in burden as a result of these revisions and no change to how EPA perceives the risk of different types of facilities. Contrary to the commenter's statement that these revisions are unnecessary, the confusion that has persisted over the long-standing legal consequences of noncompliance with conditions for exemption is evident in these comments, which demonstrates the need to revise the regulations to include these concepts so all generators can more easily understand them. Therefore, EPA disagrees with the commenters' suggestions to remove these revisions from the final rule or to revise them to state that generators' failure to comply with them "may lead to failure to maintain the exemption."
In addition, EPA disagrees that these revisions to the regulatory language would fundamentally shift the focus of enforcement against hazardous waste generators. EPA has made very clear in the preamble to the final rule that these revisions do not mandate regulatory agencies to bring any enforcement action for minor violations or infringe on a regulatory agency's enforcement discretion when deciding to charge violations discovered at an inspection. There will be no need for regulatory agencies to change such discretionary charging and penalty approaches and policies as a result of these revisions, so long as they are consistent with the long-standing conditional exemption scheme clarified by today's rule.Likewise, because there is no change in the framework of the regulations, EPA sees no need for there to be specific changes in whether a generator facility would be subject to getting a TSDF permit as a result of enforcement action  -  if the facility would not need to take such actions as a result of an enforcement action previously, EPA does not expect that to change.
Regarding the commenters' argument that the proposed regulations are unlawful and counter to federal statute, EPA agrees that generators, by their mere status as generators in RCRA section 3002, do not trigger permitting requirements. However, RCRA 3004 provides that storage, treatment and disposal facilities must comply with permit requirements of section 3005, and it does not contain any specific carve-out for generators or any other party that may store hazardous waste. Under its section 3002 authority, EPA long ago promulgated regulations that allowed generators to accumulate hazardous waste on-site without a RCRA permit, provided they meet certain conditions. These conditional exemptions from permitting requirements for generators that accumulate on-site have been in existence for 35 years without being overruled by Congress, an indication that Congress did not consider the conditional exemption inconsistent with its intent.
Likewise, the revisions to the language of the generator regulations will not be unlawful under the Due Process and Excessive Fines Clauses because EPA's written RCRA Civil Penalty Policy and EAB decisions have provided for penalties that reflect the level of seriousness of the noncompliance with the condition for exemption. The mere fact that noncompliance with one condition could theoretically trigger multiple other violations does not mean that excessive fines inevitably, or even rarely, will result.
Regarding the comment that the revisions would change the leverage a state has in assessing penalties, this rule is merely a restatement of the way the underlying regulatory scheme has always worked. EPA has always considered generators who accumulate on-site but do not comply with the generator accumulation conditions to be unpermitted storage facilities. EPA's position was confirmed by the Environmental Appeals Board in the In re M.A. Bruder decision. 10 E.A.D. 598 (EAB 2002). However, as indicated in that decision, EPA retains substantial discretion in calculating penalties that are commensurate with the circumstances of the violation, including considering the extent of deviation from the generator accumulation conditions rather than from the TSDF permitting requirements. These revisions in this rule create no change in a state's leverage to settle or authority to calculate appropriate penalties.

(h) Comment: One commenter stated that they believe the current regulatory language is adequate to allow the regulating entity to properly respond to violations depending on whether violations are egregious or persistent.
(h) EPA Response: As stated above, EPA does not consider these revisions to the language of the regulations as a change in how the program operates and agrees that the current regulations are adequate for regulating entities to respond to violations. However, EPA believes that the regulations should be revised to be clearer about how the framework is designed so that all generators are aware of the legal consequences on noncompliance with conditions for exemption. The comments on the proposed rule indicate some misunderstanding about the RCRA program and EPA is using these revisions to clear up that misunderstanding.
(i) Comment: Some commenters stated that if these revisions are finalized, they would expect most large quantity generators to apply for Part B permits to protect themselves from small inadvertent infractions. (0255, 0262)
(i) EPA Response: Because these revisions to the language are not a change to the regulatory framework of the generator program, EPA does not expect to see any increase in permit applications from generators as a result of them. EPA has revised the language in the preamble to the final rule to be more clear about the fact that the revisions do not impact the ability of regulating agencies to exercise enforcement discretion when charging violations and states that the revisions do not mandate a change in policy regarding whether to bring an enforcement action upon discovering a violation or what kind of enforcement vehicle to use.
(j) Comment: Commenters expressed concern that although EPA has the option to forgo an enforcement action or to bring one for illegally operating a TSDF, state enforcement agencies and environmental or citizen groups may use this framework to bring extreme action against a generator that is not a flagrant violator for a minor violation. (0126, 0168, 0188)
(j) EPA Response: State enforcement agencies are no more likely to bring "extreme action" than EPA is, and are instead likely to follow EPA's enforcement policy of avoiding such action for a minor violation. Even though RCRA allows state regulations to be more stringent than federal regulations, states often follow EPA's enforcement policies, and also similarly exercise their enforcement discretion. Private rights of action, including RCRA citizen suits, are subject to judicial decision making that is not likely to result in "extreme" penalties.

(k) Comment: Some commenters stated that the tone of the proposed language in 262.1 and 262.10(g) is opposite of the other rule proposals and that EPA should focus on making the regulations easier to understand. (0160)
(k) EPA Response: Much of the Generator Improvements Rule, including the reorganization of § 262.10, is dedicated to making the rules easier to understand. EPA has also revised the language in § 262.10(g)(2) to rely less on legal and regulatory citations and to be more straight forward. EPA believes that the new language about independent requirements and conditions for exemption and consequences of noncompliance is a valuable addition because it will inform generators of the consequences of potential noncompliance with these provisions so they can better understand the regulations under which they operate.
(l) Comment: Some commenters stated that EPA should limit the conditions for exemption to those provisions that distinguish one generator status from another and remove all operating standards from sections 262.14-17. (0113, 0120, 0131, 0219, 0225)
One commenter suggested that EPA state that the distinction between accumulation and storage is the amount of time the generator keeps the waste on site. (0217)
(l) EPA Response: EPA disagrees with the commenters' suggestion that the only conditions for exemption should be the amount of waste a generator generates in a month and the only distinction between accumulation and storage should be how long the waste is kept on site. The amount of hazardous waste a generator generates determines its generator category and which set of conditions it must comply with, but EPA is not changing the nature of the conditions in this rulemaking. Previous § 262.34 clearly lays out the conditions required if a generator is going to accumulate hazardous waste on-site for 90 days or less (or 180 days or 270 days, per other subparagraphs of § 262.34) and EPA did not propose to change the nature of these conditions. They include technical standards and inspection requirements for waste management (§§262.(a)(1) and § 262.34(d)(2) & (3)); labelling standards (§ 262.34(a)(2) & (3)); emergency preparedness and prevention standards (§ 262.34(a)(4) and §262.34(d)(4) & (5)); and closure requirements (§ 262.34(a)(1)(ii)); among others. Compliance with these conditions is a long-standing prerequisite for maintaining an exemption from the permitting, interim status, and operating standards for TSDFs and establishes the distinction between accumulation as a generator and storage that must be permitted.
(m) Comment: A commenter stated they were unable to determine why some provisions were in one category and others in the other, stating that the Agency's decisions on this were arbitrary and that the Agency was deficient under the APA by not explaining its decisions. (0168) The commenter argued that under § 262.34, only the exceedance of the time or quantity limits for accumulation of hazardous waste is capable of turning a generator into a TSDF. (0168) The commenter stated that even if EPA could somehow justify its lack of rationale for designating and structuring requirements from existing Section § 262.34 as conditions for exemption, that justification would not extend to the new generator requirements being proposed for the first time, much less to existing requirements outside of Section 262.34, that EPA is proposing to now designate and structure as conditions for exemption. See, e.g., 80 Fed. Reg. at 57,997 (proposed to be codified at 40 C.F.R. § 262.16(b)(7)) (requiring SQGs to comply with land disposal restrictions requirements in Part 268) and 57,801 (proposed to be codified at 40 C.F.R. § 262.17(a)(9)) (same requirement for LQGs). (0168) The commenter raised a number of questions about the consequences of noncompliance with a single "minor" condition of the generator exemption, such as whether the generator would be subject to all TSDF requirements, before and after correcting the violation, whether the generator would have to get a permit and cease handling hazardous waste until the permit was approved, and whether the generator would be subject to corrective action, and states that because EPA did not address these questions in the proposal, the proposal is deficient under the APA. (0168)
(m) EPA Response: EPA disagrees with the commenter's assertion that under § 262.34, only the exceedance of the time or quantity limits for accumulation of hazardous waste is capable of turning a generator into a TSDF. Previous § 262.34 clearly lays out the conditions required if a generator is going to accumulate hazardous waste on-site for 90 days or less (or 180 days or 270 days, per other subparagraphs of § 262.34) and they include technical standards and inspection requirements for waste management (§§262.(a)(1) and § 262.34(d)(2) & (3)); labelling standards (§ 262.34(a)(2) & (3)); emergency preparedness and prevention standards (§ 262.34(a)(4) and §262.34(d)(4) & (5)); and closure requirements (§ 262.34(a)(1)(ii)); among others. Compliance with these conditions is a long-standing prerequisite for maintaining an exemption from the permitting, interim status, and operating standards for TSDFs and establishes the distinction between permit-exempt accumulation as a generator and storage that must be permitted. Current generator regulations that do not appear in § 262.34, such as making a hazardous waste determination, counting, notifying EPA, and keeping certain types of records do not fall within this category of conditions for exemption and are independent requirements. This is not a change from the previous language of the regulations to the new rule. Regarding the specific provisions the commenter mentions as being proposed for the first time, small and large quantity generators both have had to comply with the land disposal restrictions in part 268 -- this is not a new requirement. As Tables 6 and 7 that crosswalk the regulations in the proposed rule say, these requirements have been located in § 262.34(d)(4) for SQGs and § 262.34(a)(4) for LQGs. They are, like all the other provisions in § 262.34, conditions for exemption from permitting, interim status and operating standards for permitted facilities. As EPA has stated and clarified in this document and in the final rule, this framework for the regulations is not a change -- many generators are able to work to get back into compliance with the generator regulations without getting a permit when enforcement violations are charged, but the changes to the language in this regulation do not mandate a regulating agency to change how it handles these situations and exercises its enforcement discretion.
(n) Comment: One commenter stated that the key problems with EPA's approach are that whenever there is a violation of any one condition for exemption, multiple violations would occur and multiple penalties could be assessed. (219)
(n) EPA Response: What the commenter describes is true with every conditional exemption in the RCRA regulations. However, as described in this response-to-comment document and in the preamble to the final rule, EPA and states continue to have discretion to charge violations and calculate penalties in numerous ways depending on the circumstances of the noncompliance, considering, among other things, the potential for harm and the extent of deviation from compliance. This includes the ability of the regulators to compare the violation against compliance with the conditions as opposed to compliance with permit requirements. See In re MA Bruder, 10 E.A.D. 598 (EAB 2002), an Environmental Appeals Board decision. EPA and the states also have the discretion to charge specific violations of individual requirements as there is no mandate that every violation must be charged nor that a penalty be calculated for every violation. Furthermore, where the same act or omission may lead to numerous violations, EPA's practice includes routinely `compressing' multiple violations into single counts in our complaints. This practice is described in the RCRA Civil Penalty Policy at page 21.
(o) Comment: One commenter stated that although the preamble states that making a correct hazardous waste determination is a condition for VSQGs but an independent requirement for SQGs and LQGs, this cannot be correct because the provision must be an independent requirement for VSQGs because it is done before the management of the hazardous waste. (0077)
(o) EPA Response: EPA disagrees with the commenter's assertions that a provision must be an independent requirement because it is completed before the management of the hazardous waste. Under the previous regulations at section 261.5, CESQGs (now VSQGs) were required to make correct hazardous waste determinations as a condition of being excluded from full regulation (sections 261.5(f)(1) and 261.5(g)(1)) and this structure in the final rule is consistent with those regulations.
(p) Comment: One commenter stated that section 262.10(a) should be structured in a way that lists all the independent requirements for VSQGs. (0077) One commenter stated that regulations for VSQGs should be either independent requirements or conditions for exemption, parallel to the structure for SQGs and LQGs, and not conditions for exemption from SQG or LQG regulations. (0217)
(p) EPA Response: EPA agreed with the commenter about the structure of § 262.10(a) and has included a section that lists all the independent requirements for VSQGs in the final rule. Likewise, the revisions to this section make it clear that the provisions for VSQGs are parallel to the other generator categories, with a set of independent requirements in § 262.10(a)(1)(i) and an exemption from permitting referenced in § 262.10(a)(2)(i).
(q) Comment: One commenter stated that moving 262.10(b) in front of 262.10(a)(1) would be a more logical reading order for this section of the regulations. (0082) One commenter suggested including a reference to 262.11(a)-(d) to 260.10(b) since all generator also have to comply with 262.10(a)-(d). (0082)
(q) EPA Response: EPA is not making the changes the commenter suggested, believing that starting the section with the big picture view of what the requirements are for all generators is a useful approach for high level section of the regulations such as this one. Regarding a reference to § 262.11, EPA does not think this reference is as relevant as the one to § 262.13 because this section is about using information about your generator category to determine which regulations you must follow and § 262.13 describes how to determine your regulatory category.
(r) Comment: One commenter suggested that EPA include further guidance and examples on this topic in the final rule. (0121)
(r) EPA Response: EPA intends to provide trainings and issue guidance on the Generator Improvements Rule and will be including this topic in the training.
(s) Comment: One commenter stated that the way 262.14 VSQG conditions for exemption currently reads, it is not clear if the independent requirements apply to VSQGs that exceed quantity limits. (0214)
(s) EPA Response: The commenter did not specify which language precisely it found unclear or whether the comment is referring to generation limits per month or accumulation limits. If a VSQG exceeds its generation limits, it becomes either an SQG or an LQG and must meet all independent requirements for that category; in addition, the generator should consult either §262.16 or §262.17, as appropriate, for conditions for exemption from permitting. If the VSQG exceeds the accumulation limit of 1,000 kg, but remains within the monthly generation quantity limit for VSQGs, the generator remains a VSQG, but the waste must be managed like waste from the larger generator category.
(t) Comment: One commenter asked whether the language in 262.10(a)(2) addresses accumulation of waste in exempted units, such as wastewater treatment units at facilities that discharge to a private plant that does not have a NPDES permit but engage in NPDES equivalent treatment. (0214)
(t) EPA Response: The "exempted units" mentioned by the commenter (wastewater treatment units, or WWTUs) are defined in 40 CFR 260.10, and EPA notes that this final rule is not revising this definition in any way. Units that meet the definition of WWTU under RCRA subtitle C are exempt from RCRA permitting and interim status requirements (see 40 CFR 264.1(g)(6) and 265.1(c)(10), respectively). Part of the definition of WWTU is that the unit is "part of a wastewater treatment facility that is subject to regulation under either section 402 or 307(b) of the Clean Water Act." This part of the definition limits the scope of the exemption to WWTUs operating at facilities that discharge either directly to surface waters (i.e., subject to regulation under CWA 402) or indirectly to Publicly-Owned Treatment Works, or POTWS (i.e., subject to 307(b) of the CWA). However, the situation described by the commenter in which the discharge is to a private plant engaged in CWA-equivalent treatment does not meet this definition, therefore the unit described by the commenter does not appear to be an exempt WWTU as defined in RCRA 260.10. Since the commenter describes a WWTU that would not qualify as an exempt WWTU, the commenter's question regarding the applicability of 262.10(a)(2) to accumulation in exempt WWTUs is no longer relevant.
(u) Comment: One commenter asked if EPA's use of "those independent requirements" on page 57986 when discussing enforcement refers to part 264 requirements or the part 262 requirements the facility could have used to maintain the exemption. (0214)
(u) EPA Response: EPA was in this section referring to the TSDF requirements from which compliance with part 262 provides an exemption, not the "independent requirements" in part 262 itself. EPA has removed "independent" from this language in the final rule.
(v) Comment: One commenter stated that Table 1 in the proposed rule was useful and should be included in the regulations. (0217)
(v) EPA Response: EPA is not including this table in the regulations as it is a summary of requirements and does not include the detail needed for regulatory language. However, EPA intends to update the table and issue it as guidance for implementation of the final rule.
(w) Comment: One commenter stated that they read the preamble statement at pg 57934 that states that "this new addition will reinforce to generators that they must meet these independent requirements whether or not they accumulate waste on-site" to mean that EPA perceives generators to have a difficult time complying with the current requirements. The commenter disagreed and believed the current standards are mostly clear and that this statement is confusing -- the commenter argued that generators that do not accumulate hazardous waste on site are not subject to independent requirements. (0217)
(w) EPA Response: EPA disagrees with the commenter. The independent requirements as laid out in the proposal are triggered by the generation of hazardous waste and are applicable to all generators regardless of whether they accumulate the hazardous waste on site. These provisions (e.g., §§ 262.11, § 262.12 (previous), 262.40, 262.41) refer either to "a person who generates solid waste" or a "generator," defined in § 260.10 as "any person, by site, whose act or process produces hazardous waste..." None of these provisions refer to the generator having to accumulate that waste for the provision to kick in. In the current regulations, these provisions contingent on accumulation are in §262.34 and are the "conditions for exemption" discussed in the new rulemaking. The confusion evident on this topic in the comments to the proposal illustrates the need for the new clearer language.
(x) Comment: One commenter stated that EPA should not assume that "virtually every generator accumulates or stores its hazardous waste on site for some period" as some retail outlets are progressing to a daily delivery model in which stores receive a shipment of product every day and can send single items that might be hazardous waste back to distribution centers that day. The commenter argued that this would mean that a store had no accumulation of hazardous waste. (0243)
(x) EPA Response: A hazardous waste determination must be made at the point of generation. That may mean the retail store has generated a hazardous waste if the returned product cannot be used/reused or recycled. If a hazardous waste has been generated because it cannot be recycled, then the waste starts being accumulated as well  -  even if for a short period of time. Therefore, even though the waste spends very little time being accumulated, the generator must follow the applicable RCRA regulations. EPA notes that if the generator operates within the accumulation limits outlined in section 262.15 of 55 gallons of hazardous waste or 1 quart or kilogram of acute hazardous wastes and follows the other conditions in 262.15, accumulation in a satellite accumulation area may be an option for these operations.
(y) Comment: One commenter states that the proposed section 270.1(c)(2) changes the specific exemption for generators from RCRA permits to restrict the exemption to only those generators in compliance with "all of the conditions for exemption in" the new sections 40 CFR 262.14, 262.15, 262.16, and 262.17. The commenter added that currently this exemption is broadly open to generators who store hazardous waste for less time than the thresholds in 40 CFR 262.34 and that being penalized for some minor infraction of the numerous requirements in the new sections should not force a generator to apply for a Part B permit as the draft regulations would do. That is a mandatory penalty that does not fit the infraction. Because applying for a Part B permit exposes a facility to being investigated under RCRA Corrective Action, a fact that is not known by many generators, this change is of even greater adverse consequence and of even greater cost for the regulated community. The commenter stated that regulator discretion needs to be re-enabled so that minor infractions will receive commensurately minor penalties. (0263)
(y) EPA Response: EPA has purposely made this change to § 270.1(c)(2) as a part of its revisions to this rulemaking to make it clear that in order for a generator to be excluded from permitting requirements, they must meet all the conditions for exemption, as laid out in the final rule at §§ 262 14-17. This is consistent with similar changes being made throughout the generator regulations to make clear how the regulations have always been intended to work. As discussed earlier in this section of the Response to Comments, in practice, it is rare that a generator that is not complying with the conditions for exemption has to apply for a permit as a result of an enforcement action rather than coming back into compliance and EPA is not affecting an implementing agency's ability to exercise enforcement discretion during enforcement actions.

(z) Comment: Commenters stated that proposed section 270.1(c)(2)(iii) deletes the explicit exclusion from Part B permitting for CESQGs by deleting the reference to 261.5 and failing to add the reference to 261.14 (USEPA instead notes 261.14 in 270.1(c)(2) but ties the exclusion to compliance with the section). One commenter argued that this is a quantum leap in regulatory exposure for CESQGs to serious consequences for such small hazardous waste generators and that the explicit exclusion from Part B permitting for CESQGs needs to be retained. (0263, 0266)
(z) EPA Response: EPA has revised this section in the final rule to include a reference to § 262.14 after determining that it made an error by deleting the reference to persons who own or operate facilities solely for the treatment, storage, or disposal of hazardous waste excluded from regulations under 261.5 (now 262.14). The implications of deleting the VSQG reference from this section were greater than EPA realized in the proposed rule.

Section 4.1.2 - Deletion of 262.10(c)

(a) Comment: Commenters agreed with EPA's proposal to delete and reserve section 262.10(c) from the generator regulations. (0085, 0174, 0185, 0217, 0232, 0248)
(a) EPA Response: EPA agrees with the commenters and is deleting this section in the final rule.
(b) Comment: One commenter suggested that instead of deleting and reserving 262.10(c), EPA should revise it to codify the long-standing EPA interpretation regarding treatment by generators in tanks and containers, which would strengthen the ability of states to allow such treatment when it is appropriate and prevent it when it is not appropriate. (0178)
(b) EPA Response: EPA is not going to use this section of the regulations for a different set of regulations, such as treatment in tanks and containers. Replacing the contents of §262.10(c) with other text would lead to confusion in the future when a person examining a reference to this section of the regulations has to determine if the reference refers to §262.10(c) before or after the promulgation to the Generator Rule. In addition, codifying this interpretation was not proposed in the original rulemaking and is out of scope of this final rule.
(c) Comment: A commenter stated that language in § 262.10(c) accounts for accumulation of waste in exempted units, such as waste water treatment units. The commenter stated that the removal of this language without the addition of a clarification on the "point of generation" is an issue, especially with regard to implementation of the land disposal restrictions. The commenter added that this deletion is a serious gap because subtitle C facilities may not have a waste profiling process, or if they do, they may not be aware of the 268.40 and 488 standards that apply to decharacterized hazardous waste. (0214)
(c) EPA Response: EPA disagrees with the commenter. After examining the history of this provision, described in the proposed rule at 80 FR 57934-5, EPA determined that this is an outdated provision that originally applied to generators that manage treat, store, or dispose on site, a category of generator that used to have distinct requirements from generators that transport waste off-site but no longer do. All the original requirements listed in § 262.10(c) (§§ 262.11, 262.12, 262.40, 262.42, and 262.70) are independent requirements applicable to all generators regardless of management or accumulation of the waste, even if it is in an exempt unit. The reference to § 262.34 added in 1982 would also not apply to exempt units because § 262.34 requires the use of containers, tanks, drip pads, or containment buildings for the storage of hazardous waste. EPA is deleting and reserving this obsolete section in the final rule.

Section 4.1.3 - Enforceability under section 3008 if not meeting requirements

All comments on section 3008 addressed in Section 4.1.1.

Section 4.1.4 - Deletion of Labs XL

Comment: Commenters stated that they agreed with the deletion of the references to the obsolete Labs XL. (0085, 0174, 0185, 0217, 0221, 0232, 0248)
EPA Response: EPA is promulgating this revision in the final rule.

Section 4.1.5 - Generators shall not transport to non-designated facility

(a) Comment: Commenters agreed with EPA's proposal in § 262.10(a)(3) to add a provision stating that generators may not transport to a non-designated facility. (0085, 0134, 0178, 0181, 0195, 0217, 0223, 0232, 0248) One commenter stated that they have a similar provision in their state and it is useful for training generators and for enforcement purposes. (0232)
(a) EPA Response: EPA agrees with the commenters and is promulgating this provision in the final rule.
(b) Comment: One commenter suggested that EPA expand the language in this provision to explicitly state that generators may not place their hazardous waste in the trash. (0178)
(b) EPA Response: EPA notes that this provision applied to all categories of generator and that under federal regulations, a municipal solid waste landfill permitted, registered and licensed by the state would be a designated facility for VSQGs.
(c) Comment: One commenter suggested that EPA define what is considered "offering" for these purposes. (0223)
(c) EPA Response: The term "offer hazardous waste" is one that is used regularly in the hazardous waste regulations, particularly in the regulations for shipment and the Hazardous Waste Manifest and EPA believes that it is well understood by the regulated community.
(d) Comment: One commenter asked if this provision would cover generators that send waste that does not meet treatment standards to a subtitle C landfill that does not treat waste before landfilling. (0214)
(d) EPA Response: This provision is a reference only to the type of facility to which the generator is transporting its hazardous waste. Failure to meet treatment standards prior to shipment would be noncompliance with those requirements.
(e) Comment: Commenters stated that adding a new provision specifying that generators may not transport to a non-designated facility is unnecessary. (0077) Commenters argued that it is unnecessary because the regulations and statute already place the responsibility on the generators for the ultimate disposition of the hazardous waste. (0077)
(e) EPA Response: EPA disagrees with the commenter. EPA and several other commenters on this provision believe that this provision is useful in making this requirement clear for all generators and for implementing agencies to point to when educating generators, performing compliance assistance, and enforcing the regulations.
(f) Comment: One commenter stated that they are concerned that this proposed provision would seem to prohibit states from maintaining many of the commonsense and environmentally protective options they have provided for utilities managing hazardous waste in the absence of follow-up from EPA on the Utilities XL consolidation project, such as authorizing the use of transfer facilities, allowing for hazardous waste determinations to be made at consolidation facilities, and/or agreeing to allow utilities to consolidate at the nearest manned facility or establish other best management practices. (0093) (f) EPA Response: It is EPA's understanding that when utilities are consolidating waste from remote facilities, particularly unmanned facilities, those facilities are VSQGs. If a state has a program in place for consolidation of VSQG waste, as mentioned in the comment, EPA believes that in many or most cases, these consolidation facilities would meet the requirements as a facility a VSQG may ship hazardous waste to, specifically as a facility "authorized to manage hazardous waste by a state with a hazardous waste management program approved under part 271." EPA does not expect that this provision will interfere with that type of program.

Section 4.1.6 - Other

There are no comments organized to this section of the comment outline.

Section 4.2 - Waste Determinations

Comment: The numerous proposals associated with changes to part 262.11 pertaining to Hazardous Waste determinations and documentation while still keeping CESQGs (or if they become Very Small Quantity Generators) unaffected by these changes. (0076)

Response: CESQGs/VSQGs are not affected by the changes to 40 CFR 262.11. However, they continue to be subject to making an accurate hazardous waste determination.

Comment: Upon review of the docket named above, we are concerned that the proposed rule changes to 40 CFR Part 262.11 establish requirements that will place additional ongoing functional and financial burdens on laboratories in many sectors. We do not believe that a balancing of these burdens has been given due consideration in the EPA reasoning for imposing these new requirements.

In preparing this comment, ACS has carefully vetted the concerns raised below with hazardous waste experts at a variety of leading academic institutions and in related professional organizations. These experts have raised concerns in greater detail on the general issues described in this comment. Many of their concerns are related to specific state interpretations of the RCRA regulations, which -- as you can see in the attached policy statement -- also remain the primary concern of the ACS with regard to RCRA impacts on laboratory waste management. Thus, while this comment addresses the EPA docket request within the general purview of the ACS policy statement, we agree that concerns by other laboratory stakeholders are important to consider in reviewing this rule. (0083)
Response: The Agency disagrees with the above comment. The Agency's policy and position from the beginning of the RCRA program has been that a waste determination must be made at the point of generation (i.e., the point at which the material first becomes a solid waste under RCRA.  See, for example, 55 FR 11830, March 29, 1990). This includes both the time and place the waste is first generated. By requiring that the hazardous waste determination be made at the point of generation in § 262.11(a), the final regulation clarifies that the determination cannot be made downstream in the process, where other materials could be mixed with the waste or where the waste may have changed its physical or chemical characteristics. A generator's hazardous waste determination at the initial point of generation is critical to ensure proper management of the waste not only by the generator, but also by transporters and TSDFs who rely on the generator's determination to allow them to safely manage the waste and provide appropriate treatment and disposal. This proposed revision to § 262.11 is not a substantive change to the program; preambles to a number of previous rules explain that EPA has always maintained that hazardous waste determinations must be made at the initial point of generation . (See 45 FR33095-96, May 19, 1980 and 55 FR 11830, March 29, 1990)
The Agency is also aware that many generators, such as academic and industrial laboratories, generate new or different waste streams frequently, and that making hazardous waste determinations for multiple waste streams is more difficult than when a generator has a small number of waste streams that seldom vary. However, EPA stresses that in the laboratory setting, it may be even more important to make accurate hazardous waste determinations at the point of generation, so that emergency scenarios involving mixing of incompatible wastes or other dangerous situations can be avoided and lab worker safety maintained. Whether a generator generates one new waste daily or annually, the process for making a hazardous waste determination is still the same. Through knowledge of the process or materials, and/or through testing, all generators must make a hazardous waste determination at the point of generation. The Agency would expect generators producing new wastes frequently to establish efficient processes to make those waste determinations, particularly to the extent they can use knowledge of the materials or feedstocks in the waste determination process.

The Agency realizes that the educational and industrial laboratory sectors raised concerns about the undue waste determination burden from the large numbers of potentially hazardous wastes that might be generated at their sites. EPA realizes that these sectors operate differently from the traditional industrial hazardous waste generators. In fact, to address laboratory sector concerns, EPA developed an optional set of alternative standards in 40 CFR part 262 subpart K, entitled, "Alternative Requirements for Hazardous Waste Determination and Accumulation of Unwanted Material for Laboratories Owned by Eligible Academic Entities." This rule was designed to account for the manner in which academic laboratories operate. In addition, a few years ago, the EPA began a review of how RCRA hazardous waste regulations apply to the retail sector in order to better understand retailers' challenges in complying with RCRA regulation. These efforts are on-going.

From a practical viewpoint, those involved in conducting experiments in a laboratory setting will need to make a hazardous waste determination when they have a generated a waste they know will be disposed. The question that needs to be answered is whether the waste is hazardous or not, and why; i.e., what hazard is exhibited that makes the waste a hazardous waste, such as ignitable, toxic, corrosive and reactive. Once they know the hazard they can place a label in an appropriate place where the waste will be stored until it is picked up and moved to a central accumulation area. The Agency believes technical staff can help those working in a lab to determine whether their experiments will produce a hazardous waste and determine why the waste is hazardous. The Agency also believes students, researchers, etc. are already being trained in this determination because they have to be aware of the potential hazards they are dealing with. (In fact this commenter said so; i.e., "While these individuals are aware of the associated hazards, that knowledge does not qualify them to make hazardous waste determinations."
The problem appears to be whether the researcher will need to identify the RCRA waste codes. The process for identifying RCRA waste codes begins at the point of generation, but the actual marking of these codes on a container must occur prior to the wastes being sent off-site to a RCRA permitted TSDF, or prior to being treated and disposed of on-site. In other words, sufficient time will exist for the technical experts in the laboratory to identify the RCRA waste codes to complete the waste determination process. The Agency was not clear about this in the proposed rule. The Agency believes this process should alleviate this issue in a laboratory setting.
Comment: The rule maintains the current ambiguous situation regarding the "point of generation" of hazardous waste and where the application of RCRA requirements begins;

2. The requirements for documentation of hazardous waste determinations, even when the waste is determined not to be hazardous, have significantly more impact on the management of laboratory waste than on other hazardous waste generation settings; and

3. The additional labelling requirements for hazardous waste will impose a significant burden on laboratory waste generators without providing the benefits described in the docket. (0083)
Response: The Agency disagrees with the above comments. With respect to the "point of generation" comment, the Agency's policy and position from the beginning of the RCRA program has been that a waste determination must be made at the point of generation (i.e., the point at which the material first becomes a solid waste under RCRA.  See, for example, 55 FR 11830, March 29, 1990). This includes both the time and place the waste is first generated. By requiring that the hazardous waste determination be made at the point of generation in § 262.11(a), the final regulation clarifies that the determination cannot be made downstream in the process, where other materials could be mixed with the waste or where the waste may have changed its physical or chemical characteristics. A generator's hazardous waste determination at the initial point of generation is critical to ensure proper management of the waste not only by the generator, but also by transporters and TSDFs who rely on the generator's determination to allow them to safely manage the waste and provide appropriate treatment and disposal. This proposed revision to § 262.11 is not a substantive change to the program; preambles to a number of previous rules explain that EPA has always maintained that hazardous waste determinations must be made at the initial point of generation . (See 45 FR33095-96, May 19, 1980 and 55 FR 11830, March 29, 1990)
With respect to the requirements for hazardous waste determination documentation, the Agency is not finalizing the proposed requirement that SQGs and LQGs maintain records of their non-hazardous waste determinations. Therefore, the Agency believes this comment is no longer applicable. Generators shall keep records only for those solid wastes found to be hazardous wastes.
With respect to the comment on labeling requirements, the Agency believes we have clarified how the process shall work. From a practical viewpoint, when a hazardous waste is first generated at the point of generation, a hazardous waste determination will have to be made. The question that needs to be answered is whether the waste is hazardous or not, and why; i.e., what hazard is exhibited that makes the waste a hazardous waste, such as ignitable, toxic, corrosive and reactive. Once they know the hazard they can place a label in an appropriate place where the waste will be stored until it is picked up and moved to a central accumulation area. In a laboratory setting, the Agency also believes students, researchers, etc. are already being trained in this determination because they have to be aware of the potential hazards they are dealing with. (In fact this commenter said so; i.e., "While these individuals are aware of the associated hazards, that knowledge does not qualify them to make hazardous waste determinations."
The issue appears to be whether a worker, researcher, etc.  will need to identify the RCRA waste codes. The process for identifying RCRA waste codes begins at the point of generation, but the actual marking of these codes on a container must occur prior to the wastes being sent off-site to a RCRA permitted TSDF, or prior to being treated and disposed of on-site. In other words, sufficient time will exist for the technical experts in the laboratory to identify the RCRA waste codes to complete the waste determination process. The Agency was not clear about this in the proposed rule. The Agency believes this process should alleviate the concerns of this commenter.
Comment: While the EPA concern about inadequate waste determination processes by some generators is understandable, the proposed solution does not scale at all with the problem in the laboratory setting. Because laboratories produce many individual containers of different mixtures of hazardous chemicals in a wide variety of sizes and configurations, from 5 milliliter vials to 5 gallon drums, documenting the basis for a hazardous determination on a container by container process will significantly increase the amount of record keeping required to meet these regulatory requirements.

In addition, many hazardous chemicals used in laboratories are not designated "hazardous wastes" by the current EPA definitions, including most new chemicals that have come into use in the 35 years since 1980. The result for chemicals such as ethidium bromide -- whose labelling criteria are set by, among others, the Department of Transportation -- is that their shipping requirements will be different than for EPA-identified hazardous wastes. Consequently, there will be significant confusion created by the waste determination documentation for both waste handlers and government inspectors when chemicals such as ethidium bromide are lab packed in containers that also contain RCRA hazardous waste.

The proposed heightened requirement for hazardous waste determination documentation parallels and exacerbates the current administrative burden borne by lab pack generators with regard to the Land Disposal Restriction (LDR) documentation that is required as part of the shipping paper package. We have described the burden in previous correspondence and meetings with the EPA and continue to believe that the LDR paperwork is an unreasonable requirement for lab waste generators to meet, particularly because it has been an obsolete program since 2000.

One possible alternative to these documentation burdens required by the RCRA regulations would be to identify the creation of a lab pack as the point of hazardous waste determination and thus the point of imposition of the documentation requirements. As suggested by the EPA, the creation of an electronic tool to facilitate this lab packing process by personnel specifically trained in RCRA waste codes is likely to increase compliance rates that the EPA is seeking with this proposed rule. ACS would be glad to work with the EPA on designing such software to address the EPA and generator's needs for proper documentation of lab packed wastes.

Point 3

Since laboratory waste is containerized in a wide variety of sizes and shapes, the proposal for additional labelling requirements to include hazard warnings will be 1) impractical for the smallest containers due to the size of the labels and 2) of limited value, since many containers are too small to be considered in developing a response plan to a hazmat incident. Here again, imposing the labelling requirements at the point of lab pack creation is the most reasonable approach to addressing the concerns described in the docket.

We appreciate the EPA's desire to continue to improve the RCRA hazardous waste management system. However, because the proposed rules impact such a variety of industries and settings, it is very important for the EPA to take a conservative approach in making changes to the system that is the basis upon which many institutional laboratory waste management processes have been developed. We believe that the three issues described above require rethinking to justify such changes. (0083)
Response: The previous response to this commenter's concerns are also applicable to the concerns raised here as well.
Comment: Environmental regulatory burdens are inappropriately placed on many academic, commercial, and government laboratories when regulations designed to address large-scale industrial operations are applied to laboratories. Research, development, instructional, and service laboratories generate a broad range of small quantities of hazardous wastes, but are forced to individually manage each type of waste with the same rigor applied to those who create large amounts of relatively few wastes. By applying an industrial regulatory scheme to laboratories, unintended, ineffective, and inappropriate burdens are placed on these facilities. (0083)
Response: The response to this commenter's first comments above are responsive to the concerns raised here as well.
Comment: There are several procedures and guidance documents in place to make hazardous waste determinations. By using these procedures and guidance documents, the steps necessary to produce records that identify a material as a solid waste are in place. However, as is noted in the preamble there are "solid wastes that clearly have no potential to be hazardous," and no documentation is available for such wastes. The preamble states that "the Agency is not interested in entities that generate solid wastes that clearly have no potential to be hazardous." But the Agency (EPA) and the state have interest in SRS and the wastes generated here.

There is nothing in the proposed wording of 262.11(e) that allows solid waste that "clearly has no potential to be hazardous" to be exempt from the requirement to maintain records supporting "solid and hazardous waste determinations, including records that identify a material as a solid waste." The statement "Generators may wish to segregate any of their municipal solid waste from other solid and hazardous wastes to avoid potential comingling" provides no relief because it presumes "municipal solid waste" to be a clearly defined and understood set of wastes that everyone agrees upon. This is not necessarily the case. With vague language such as this in the regulation, individual inspectors have the discretion to require records for practically any solid waste they observe. A regulated entity, such as SRS, cannot point to any clear wording in the regulation that says ''these solid waste streams do not require documentation supporting their determination." Wording addressing this point is needed. (0092)
Response: The Agency is not finalizing the proposed requirement that SQGs and LQGs maintain records of their non-hazardous waste determinations. Therefore, this comment is no longer applicable. Generators shall keep records only for those solid wastes found to be hazardous wastes.
Comment: SRNS agrees that solid and hazardous waste determinations need to be accurate and makes diligent efforts to insure SRS waste determinations are accurate. In the course of making waste determinations at SRS, it is sometimes necessary due to the level of radioactivity present in a waste to use methods in on-site laboratories in order to characterize a radioactively contaminated waste, rather than sending the waste sample to a certified offsite laboratory. The state has been contacted in such cases, and their acceptance of the necessity of such steps has been obtained. The proposed wording of the last sentence of 262.11(d)(2) in reference to "a test other than a test method set forth in subpart C of 40 CFR part 261" says "However, such tests do not, by themselves, provide definitive results." This wording implies that the EPA expects the use of more data or information than just such test results when making waste characterizations. If this is the case, then the EPA should clearly state what is acceptable, rather than just stating that such tests, by themselves, do not provide definitive results. As currently proposed, the language leaves both the regulated community and the federal and state inspectors in question of just what does "provide definitive results" or if definitive results are necessary. We recommend deleting the last sentence, as it does not clarify the requirement, or adding to it in order to make the requirement clear. (0092)

Response:  The concerns expressed by this commenter are not completely clear.  If the commenter is concerned about the results of radiological testing and how they are to be used, the Agency would note that radiologic wastes are not regulated under RCRA unless they also exhibit a hazardous characteristic or are listed as hazardous.  Therefore, the results of radiologic testing are not part of the RCRA hazardous waste determination, and would need to conform with the requirements of the agency that co-regulates the waste (most likely the Department of Energy or the Nuclear Regulatory Commission).

If the commenter is concerned that their in-house laboratory is not capable of performing the regulatory tests identified in 40 CFR 261 Subpart C, and so evaluation of the waste using non-regulatory tests is performed, the Agency considers this to be using knowledge to make the RCRA determination.   As the regulations allow the use of testing (using the Part 261 Subpart C tests) or knowledge of the waste (including alternate tests), this is an acceptable approach.  However, only the results of testing using the Part 261 Subpart C tests are considered definitive by themselves for making an accurate hazardous waste determination.  This is because these tests are part of the Part 261 Subpart C regulations, and where they exist, the regulatory standard is defined as a certain result when the applicable test is performed.

The information needed to make an accurate knowledge-based determination may be different for different wastes.  The Agency urges generators taking this approach to be sure alternative (non-regulatory) tests used can produce information that is relevant to the hazard characteristic being assessed, and that other available, relevant information about the waste, such as properties of known components of the waste, the process producing the waste, feedstock chemicals used, etc. also be considered in conjunction with the test results when making the determination.

As we point out in preamble, most generators use knowledge of the process and associated chemical feedstocks in making their waste determinations, but situations may exist where process knowledge does not produce a clear conclusion, and additional information is needed.  In such a case, a non-SW-846 test method that nonetheless illustrates properties of the waste may provide information that leads to a determination that is clearer and well supported.  However, when such testing is done, the generator needs to understand why that particular test was chosen over other possible tests. Generators may not have knowledge of the possibilities for testing and may need to rely on expert advice from a laboratory or technical consultant. In such a situation, the generator should get the expert advice in writing, so that the implementing Agency can understand and evaluate the appropriateness of using the particular test chosen and the meaning of the test result for the waste being evaluated. This is necessary in order for the generator to have a well-reasoned and documented RCRA determination.

      When evaluating a waste for compliance with the hazardous characteristics for which there is a regulatory test, obviously the generator should use that test if at all possible, because when properly performed, its results will be definitive in making the RCRA determination. However, in choosing a non-regulatory test to better understand waste properties, choice of testing requires judgement, and test results by themselves will not provide definitive results regarding the RCRA classification, because such tests are not part of the regulatory definition of the RCRA characteristic.

      Without such documentation, the implementation of the RCRA waste determination may become difficult. Generators are obligated to make accurate RCRA hazardous waste determinations. Generators without an informed, well-reasoned and documented basis for their RCRA classification are more likely to make an incorrect determination, which in turn could make them subject enforcement action.