**Summary of Stakeholder Comments By Topic (Laboratory Wastes)** 
**Stakeholder:** Rutgers University **Topic:** Acutely Hazardous Waste (P

- listed)
**Comment:** Current regulation states, when greater than 1 quart of acutel y hazardous waste (P

- listed materials) is generated in a satellite accumulation area, the waste must be brought to a 90/180/270

- day

storage area within 3 day s (4.0 CFR 262.34 (c) (2)). Many rem ote locations (CESQG or SQG) do not use 90/180/270

- day storage areas; instead they store all the hazardous waste in satellite accumulation areas. This creates a situation where, the generator must implement a 90/180/270

- day

storage area or ship the waste o ff site in 3 day s. Both of these options have additional burdens of cost, time, and effort. The generator program would be improved if there were different provisions for the generation of acutely hazardous waste (P

- Listed). The following are suggestions for alternative management strategies:

- Increase the 1 Quart threshold and include units better suited for solids, (Le. 5gallons or 40 pounds)

- Increase the time allowed for removal of P

- listed waste from a satellite accumulation area. This could be inc reased to 14 or 21 day s.

- Eliminate the 1 Quart threshold completel y, and institute additional labeling, container or containment requirements. **Following might be redundant w/Episodic Generation**
**- Need to resolve** 
**Stakeholder:** Rutgers University Topic: Acutel y HW for CESQGs and SQGs
**Comment:** Current regulation states, that a CESQG or SQG will be required to comply with all the L QG requirements if they generate > 2.2 pounds of acutel y hazardous waste (P

- Listed) in one month (40 CFR 261.5 (e)). These in creased requirements include having a contingency plan and completing a biennial hazardous waste report. **The generator program would be improved if the generator status limit for acutely hazardous (P** 
**- listed) waste is increased or eliminated for CESQG and S**  **QG research stations, research laboratories and research farms, since many common laboratory**  **chemicals are P**
**- Listed substances.**  The following benefits would be achieved if this limit were increases or eliminated: (See RCRA

- 2003

- 0008 for additional informat ion.)
**Stakeholder:** Northeastern University Topic: Acutel y HW for CESQGs and SQGs Comment: Acutely

Hazardous Waste. Levels established for generators of acutel y (P

- listed) hazardous waste are too low. It has been my experience that some facilities that function very well as Conditionally

E xempt Small Quantity

G enerators (CESQG) or Very S mall Quantity

G enerators (VSQG) are sometimes forced to become SQG’s or Large Quantity G enerators (L QG), because of the episodic generation of acutel y h azardous waste (i n Massachusetts, CESQG are even prohibited from generating an y acutely hazardous wastes). I would recommend the limits currentlyestablished be increased by one order of magnitude. These quantities would still be relatively low and they should not result in any

increased risk to public health, safety or the environment.
**Stakeholder:** American Chemical Society Topic: Overarching Comment
Comment: The American Chemical Society recognizes the value of effective worker safety and environmental regulations. It also recognizes the value of regulations that are easil y understood, are practical to implement and are not subject to change in interpretation from state

- to
- state and from inspector to

- inspector. Some elements of the RCRA regulation have been excellent public policy . Having a federally

- consistent chemical definition of the characteristic or assignment of hazardous waste has provided clear, efficient direction of the wastes to give priority attention in a consistent manner across the states . The requirement for evaluating and keeping records of hazardous waste until it is properl y disposed of has proven a sound management tool.
**Stakeholder:** American Chemical Society Topic: Consistency between federal and state regulations
**Comment:** Howe ver, from the beginning of the RCRA regulation, because of ambiguit y in the regulatory

l anguage and because of regular turnover of government officials at all levels, different government officials and different states continue to interpret core notions di fferentl y. This has been a special problem for chemical laboratories. The wording of the standard federal regulations was designed primarily

for large quantities of wastes consistently produced that can be evaluated readil y andfor which mishandling could pose a serious environmental problem. It was not written with laboratory

operations in mind. Laboratories routinely have no routine waste generation pattern. Laboratories have a higher capability of competently eliminating the risk of hazardous waste inter

nall y than the average hazardous waste producer. State inspectors with little understanding of laboratory operations, with little experience of the development of the hazardous waste law and with great flexibility in interpretation of federal regulations m ake effective compliance training of the diverse culture of laboratory workers almost an impossible task. The worker at a given institution must be trained to the current interpretation of the potential state inspector. This inconsistency

of interpretation creates serious counterproductive tensions about small issues of legal compliance with negligible environmental impact. It reduces the opportunities for laboratory

workers to join as partners with government officials to achieve even greater environmental good of laboratory waste reduction. PROPOSAL : **It is absolutely critical that the federal government work to provide detailed interpretations of the federal regulations as they apply to laboratories**  . It is also important for the federal government to act as an active educational service to state inspectors on these matters for laboratories. **Any state wishing to be more stringent than the federal government in an interpretation is welcome to do that, but those interpretations should be clearly written and**  **c ommunicated to all as different than the basic federal interpretation of its regulations.**  **Setting federal clarity and consistency for laboratory RCRA regulations must be set as an objective for the next decade. That is a necessary step in the maturation of**  **wise, fair federal hazardous waste policy for laboratories.** 

Stakeholder: ESS Group **Topic:** Small Containers
**Comment:** Small containers of hazardous waste are often generated in lab

- like settings when a small container of virgin material is no longer usable or needed. These are ty picall y safel y accumulated in storage cabinets or on shelves in tray s to provide containment and prevent incompatible materials from mixing. Within 90 days, a contractor is ty pically hired to lab pack or otherwise properl y con solidate the wastes for offsite shipment. Currently , each small container is subject to full regulation as a container. Another method, such as maintaining logs to ensure compliance with the 90

- day limit, and the ability

to label tray s, cabinets, or shelve s instead of individual containers would ease to compliance burden, but still provide a high level of environmental protection.
Stakeholder: DOE Topic: General
Comment: ( a) The hazardous waste determination process and accumulation times est ablished in the generator regulations are reasonable for industrial generators. H owever, for academic teaching and research laboratories, where small amounts of a large variety of wastes are generated and ty pically managed in accumulation areas near their point of generation (i.e., satellite accumulation areas), DOE believes that additional flexibility would be appropriate. **To provide such flexibility, consideration should be given to adopting a “laboratory process unit”**  **concept for the purposes of defini ng the point of laboratory waste generation and clarifying**  **the start of accumulation times for laboratory wastes. D**  **OE suggests this new concept be applied to laboratories that now operate under the regulatory provisions applicable to**  **satellite accumulatio n areas [40 CFR 262.34(c)].**  **T his suggestion is further discussed below**  **and is similar to the approach adopted for several university laboratories in 40 CFR part 262, subpart J, “University Laboratories XL Project** 

**— Laboratory Environmental**  **Management Standa**  **rd.” A**  **lso** , it is consistent with the finding of the Report on Consensus Best Practices for Managing Hazardous W astes in Academic Research Institutions, Howard Hughes Medical Institute, October 2001, Attachment 2 to Report to Congress: Evaluating the Conse nsus Best Practices Developed Through the Howard Hughes Medical Institute’s Collaborative Hazardous W

aste Management Demonstration Project and the Need for Regulatory Changes to Carry Out Project Recommendations (EPA530

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- 008, March 2002, p. 29). As a general matter, in manufacturing processes the determination of when a material becomes a solid waste is made after the material is removed from the “manufacturing process unit” [40 CFR 261.4(c)]. D OE suggests that this concept also be applied to laborato ry e nvironments so that chemicals would not be considered solid waste until they have been removed from the laboratory

process unit (i.e., an area in which an experimental, analy tical, or instructional process involving the use of chemicals at one or more stations takes place under the supervision of a qualified person, such as a principal investigator, research director, laboratory manager, or other technicall y qualified individual). Under this approach, chemicals would be allowed to accumulate in the lab oratory process unit indefinitely

without making a hazardous waste determination until a specified quantity , such as 55 gallons (or one quart for acutel y hazardousmaterial), has been collected. M ore chemicals might be allowed a higher limit, such as 110

gallons (or two quarts for acutel y hazardous material), if secondary containment were provided and operations were governed b y an environmental management s ys tem (EMS). W ithin a specified time after reaching applicable threshold (e.g., 10 day s), the container(s) would need to be dated and excess material would then be moved to a central waste collection area. W aste generation from the laboratory process unit would be defined to occur when the dated containers were transferred to the central waste accumulation area from the laboratory process unit. At the central waste accumulation area, a qualified environmental professional would determine whether accumulated chemicals must be managed as hazardous waste or could be reused or recycled. Such a determinati on would be required to occur within a specified time (e.g., 30 day s) after the date on the accumulation container. Also, within the same specified time, chemicals determined to be hazardous waste would need to be transferred to either an on

- site 90

- day hazardous waste storage facility or a permitted on

- site or off

- site hazardous waste treatment, storage, or disposal facility

. Amaximum capacity could be established for accumulation of hazardous wastes within the central waste accumulation area. Inherent in this approach is the reality that laboratory

operations occur b y or under the supervision of a principal investigator, research director, laboratory manager, or other technicall y qualified person, and occur within an area assigned to that perso n. A ctivities not occurring within such an area, or outside the scope of supervision by such a responsible person, would not be considered to occur within a laboratory process unit. P rior to the time chemicals are moved to the central collection area fro m the laboratory process unit, the chemicals would be subject to the applicable laboratory

p ractice regulations promulgated under the Occupational Health and Safety A ct (see 29 CFR 1910.1450, “Occupational Exposure to Hazardous Chemicals in Laboratories”). In corporating this laboratory p rocess unit approach into the generator regulations would be a more workable s ys tem than the existing satellite accumulation area s ys tem as it has been applied to some laboratory settings. S pecifically , the existing provis ions in 40 CFR 262.34(c)(1), which allow a generator without a permit or interim status to accumulate limited quantities of hazardous waste “in containers at or near any point of generation where wastes initially

accumulate that is under the control of the operator of the process generating the waste,” have been interpreted in the way s listed below when applied to some laboratories. Incertain cases, each experiment/research station in a laboratory has been interpreted to be a “process generating the was te.”

 Similarly , each experiment/research station has sometimes been interpreted to be “the point of generation where wastes initially accumulate.” Under this interpretation, a separate waste accumulation container must be placed at or near each experim ent station.

 In some cases, the individual researcher at each experiment/research station has been interpreted to be “the operator of the process generating the waste.” H ence, each researcher has been required to maintain control of the waste accumulation containernear his/her experiment station. F urthermore, “control” has been interpreted to mean that, because individual researchers cannot be present to monitor their waste accumulation containers at all times, locking devices must be used. Restricting building access has been determined to be insufficient for meeting this requirement. Overall, these interpretations result in a very narrow definition of “operator of the process,” which appears to be inconsistent with the definitions of “gen erator,” “person,” and “operator,” in 40 CFR 260.10, and EPA guidance [EPA, “Hazardous Waste Generated in Laboratories,” Memorandum from E. Cotsworth to RCRA Senior Policy Advisors in EPA Regions I

– X, Faxback #14618, August 16, 2002].

 Individual res earchers have been required to characterize wastes accumulated in containers and assign Land Disposal Restrictions (LDR) treatment standards codes before transfer of the containers to a central accumulation area. DOE believes that the interpretations listed above may cause the undesirable outcomes listed below, which would be alleviated with no adverse effect on personnel safety, human health, or the environment if the suggested laboratory process unit approach wer e adopted and implemented.
 Requiring a separate waste container for each experiment/research station significantl y increases the number of waste containers in a laboratory, which increases the potential for accidental spills and releases of potentiall y hazardous chemicals.
 Requiring that hazardous waste determinations be made at each experiment/research station significantl y reduces the opportunity f or reuse and recycle of surplus chemicals, because individual researchers are not necessarily aware o f reuse and recycle opportunities throughout the laboratory facility

.

 Requiring researchers to make hazardous waste determinations and assign LDR treatment standards codes significantl y increases the number of persons requiring training. In addition, it may result in waste characterizations being made by personnel that are less qualified than an environmental professional who would routinely p erform this task at a central accumulation area. DOE notes that compliance with 40 CFR 262.34(c)(1) was not as significant an issue before regulations implementing the LDR program were promulgated. H owever, for the purpose of identifying the point at which materials become subject to the LDR treatment standards, the EPA has articulated certain interpretations of the meaning of the term “point of generation.” A s a result, regulatory

i nspectors are now interpreting the term “point of generation” as having the same meaning for purposes of evaluating compliance with satellite accumulation area requirements as for LDR program purposes. In some cases, this has resulted in a determination that the point of generation for laboratory wastes is located upstream of the container in which waste accumulates, because the waste leaves the “process” prior to placement in the container. D OE submits that it is impractical to expect that full waste designation for newl y generated laboratory wastes can be made before they

have been accumulated in containers, collected, and evaluated in the context of other laboratory

wastes generated at the same facility

. A ccordingl y, DOE suggests that the point of generation at which laboratory waste should be characterized is the point at which the accumulation container exits the laboratory process unit and is placed in a central accumulationarea. T his regulatory approach would allow trained environmental professionals to fully designate waste after accumulation in order to provide for full evaluation of reuse and recycling opportunities at the laboratory facility, LDR compliance, and proper disposal, while assuring safe management during waste accumulation periods. (b) If the EPA decides not to adopt the laboratory process unit approach suggested in Specific Comment IV .2, item 1(a), DOE suggests that the Agency (either in guidance o r the preamble to an NPRM or final rule) explicitly interpret certain laboratory processes as being subject to the manufacturing process unit approach [40 CFR 261.4(c)]. F or example, High Pressure Liquid Chromatograph y (HP LC ) equipment uses solvents to carry chemical samples into the HPL C unit. Within the unit, the carrier solvent containing the chemical sample is pumped through a column that separates the chemical from the solvent. T he carrier solvent exits the column and is collected in a small contain er. T he solvent enters the container through a tube that penetrates the top of the container. D OE suggests that the container into which the solvent is conveyed be considered part of the HPL C unit and that the whole HPL C, including the container, be cons idered a manufacturing process unit. I f this approach were adopted, then pursuant to 40 CFR 261.4(c), the solvent collected in the container would not become solid or hazardous waste until it has been removed from the unit. In addition, there would be no further need to debate whether, due to the tube penetration at the top, the container complies the requirement in 40 CFR 265.173(a) that storage containers be closed unless waste is being added or removed. (c) If the EPA decides not to adopt the laborat ory process unit approach suggested in Specific Comment IV.2, item 1(a), DOE also suggests that EPA consider modifying 40 CFR 262.34(c) by creating a new type of generator accumulation area. T his would be a central accumulation area for short

- term aggregation (or staging) of hazardous wastes as they are being moved from satellite accumulation areas to on

- site 90

- day storage facilities or permitted treatment, storage, or disposal facilities located either on site or off site. T he concept would be similar t o the “transfer facility” concept that already exists for hazardous waste transporters in 40 CFR 263.12. S pecificall y, DOE suggests modifying 40 CFR 262.34(c) by adding the following provisions in an appropriate location:
A generator may

accumulate hazardous wastes without a permit or interim status and without complying with the requirements in 40 CFR 262.34(a) (applicable to generator storage up to 90 day s) at a central location near the point of generation for the purpos e of sorting, consolidating, or repackaging the wastes provided that: (i) the wastes are in containers; (ii) no waste remains in the central area longer than 10 day s; and (iii) the generator complies with the hazardous waste container requirements in 40 CF R 265.171, 265.172, and 265.173. In the approach suggested here, the accumulation of hazardous waste laboratory chemicals in containers at or near their point of generation would remain subject to the existing requirements applicable to satellite accumulat ion areas [40 CFR 262.34(c)]. H owever, the generator would not necessarily

be required to transfer excess accumulated hazardous wastes within 3 day s directly from the satellite accumulation area to either on

- site 90

- day storage units or permitted on

- site or off

- site treatment, storage, or disposal units. Instead, the generator would have the option to transfer excess wastes to the new central accumulation unit instead, where the waste could be held in containers for up to 10 day s without a permit. D uring the 10 day s, the waste could be sorted, consolidated, or repackaged prior to being transferred to either on

- site 90

- day storage units orpermitted on

- site or off

- site treatment, storage, or disposal units. 2. Although 40 CFR 262.34(a)(2) does not state that tanks are subject to its date marking requirement, EPA guidance indicates that the Agency intended for both tanks and containers to be marked with accumulation start dates [ see 51 FR 10146, 10160 (March 24, 1986); EPA, “RCRA, Superfund, and EPCRA Call Center Monthly

Report,” EPA530

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- 002f, Faxback #14683, June 2003]. D OE suggests that the EPA modify 40 CFR 262.34 to clarify the requirement for marking the accumulation start date on a hazardous waste tank. 3. DOE suggests that the EPA consider the following other clarifications in 40 CFR 262.34(c), if the laboratory process unit approach is not adopted:
 40 CFR 262.34(c)(1) allows a generator to accumulate hazardous waste without a permit in containers “at or near any point of generation.” T he def inition of the phrase “at or near,” as used in this section, is not clear. A s a result, the question of proper location for a satellite accumulation area has frequentl y been raised during regulatory inspections at DOE facilities. D OE believes the confusi on would be lessened if guidance on this point were available. D OE would appreciate having such guidance structured to also address a related issue concerning accumulation of flammable or reactive materials that must be stored in accordance with the Unifo rm Fire Code (UFC). It is not alway s possible to provide UFC

- compliant accumulation “at or near” the point of generation. H ence, DOE encourages the EPA to consider issuing an interpretation of the phrase “at or near the point of generation” that would provide sufficient flexibility to accommodate the safety requirements for storage/accumulation of hazardous wastes imposed by other applicable regulations (such as the UFC).
DOE suggests that the EPA consider modifying 40 CFR 262.34 to explicitly authorize generators to treat hazardous wastes without a permit or interim status in accumulation areas located near the point of generation, if such treatment is performed in a tank or container that complies with the technical standards in 40 CFR 265, subpart I o r subpart J, as appropriate. In addition, the EPA should consider specifying in 40 CFR 262.34 that, while the treatment cannot involve incineration, burning, or other thermal treatment, any other treatment technology protective of human health and enviro nment and that can be safel y performed in a tank or container would be acceptable. 4. Another aspect of 40 CFR part 262, subpart J, “University L aboratories XL Project

—Laboratory

Environmental Management Standard” [ see 40 CFR 262.104], that DOEbelieves should be made available to all laboratories is allowing containers too small to be labeled

(e.g., vials, test tubes, and other glass waste) to be placed into secondary containers for labeling. 5. 5. DOE supports finali zation of the changes to the Uniform Hazardous Waste Manifest program proposed in the Federal Register on May 22, 2001 [66 FR 28239

- 28318]. In particular (consistent with the Department’s comments submitted October 4, 2001, Docket Number F

- 2000

- UWMP

- FFFFF ), DOE encourages the EPA to move toward use of a single, easil y acquired manifest form while retaining origination and/or destination States’ ability t o require additional information on the form. D OE also supports the development of an electronic manife st sy stem that would simplify the task of preparation and tracking of these important documents. 6. 6. DOE suggests that the EPA add a definition for “empty tank” to the regulations, including delineation of the status of the residue in an empty t ank, sim ilar to 40 CFR 261.7 (Residues of hazardous Waste in Empty Containers). 7. 40 CFR Section 262.34(a) requires generators who accumulate hazardous waste for less than 90 day s to comply

with the requirements in 40 CFR 265, subpart D with respect to their 90

- day storage units. S ubpart D requires that the owner/operator file a written report to the Regional Administrator within 15 day s after an incident occurs that requires implementing the contingency

plan [40 CFR 265.56(j)]. D OE suggests that the EPA consid er clarifying the meaning of the phrase “implementing the contingency plan” in this requirement, at least with respect to 90

- day

storage units. S pecifically, DOE suggests that a written report be required only if the contingency plan was implemented in re sponse to an event that could threaten human health or the environment. 8. 8

. 40 CFR Section 262.34(b) allows generators to request an extension of up to 30 days to the 90

- day accumulation time. T he EPA Regional Administrator may grant such an extension on a case - by

- case basis if the need for the extension arises due to unforeseen, temporary , and uncontrollable circumstances. D OE suggests that the EPA consider providing a self

- implementing provision for extensions of the ty pe described in 40 CFR 262.34(b) if secondary

containment for the affected storage unit has been provided. T he generator could still be required to establish and document that the circumstances requiring the extension were unforeseen, temporary , and uncontrollable. H owever, instead o f submitting such documentation to the Regional Administrator, it would be available in the generator’s records for review by the EPA (and authorized State representatives) at any time.